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Exalgo


Pronunciation: HYE-droe-MOR-fone
Generic Name: Hydromorphone Extended-Release
Brand Name: Exalgo

Exalgo contains hydromorphone, a narcotic pain medicine. Tell your doctor if you have a history of alcohol or other substance abuse or dependence before you use Exalgo.

Exalgo is used to treat constant (around-the-clock), moderate to severe pain that is expected to last for an extended amount of time. Exalgo is not for patients who only need occasional or "as-needed" pain relief. It should not be used to treat pain after surgery.

Exalgo should only be used by patients who have already been taking narcotic pain medicine and are tolerant to its effect. Use of Exalgo by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems. Fatal overdose can occur if Exalgo is accidentally swallowed, especially in children.

Swallow Exalgo whole. Do NOT break, crush, chew, dissolve, or inject Exalgo. Doing so may cause the release of too much medicine into the bloodstream, which could be fatal.


Exalgo is used for:

Treating moderate to severe pain in patients who are already tolerant to narcotic pain medicine.

Exalgo is an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system to reduce pain.

Do NOT use Exalgo if: you are allergic to any ingredient in Exalgo, including sulfites or to any other codeine- or morphine-related medicine (eg, morphine, codeine, oxycodone) you are not already taking narcotic pain medicine you have difficult or slowed breathing, or you are having a severe asthma attack you have certain stomach or bowel problems (blockage, paralytic ileus, "blind loops," narrow bowel, "short gut" syndrome, inflammation, Meckels diverticulum), cystic fibrosis, or you have had bowel surgery that resulted in narrowing of the bowels you have increased pressure in the brain you are taking sodium oxybate (GHB) or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Exalgo:

Some medical conditions may interact with Exalgo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease [COPD], sleep apnea), seizures (eg, epilepsy), adrenal gland problems (eg, Addison disease), an enlarged prostate, heart problems (eg, cor pulmonale), low blood pressure, an underactive thyroid, or urinary blockage if you have severe drowsiness, a recent head injury, spinal problems, growths in the brain, or increased pressure in the brain if you have liver or kidney problems, gallbladder problems, pancreas problems, or stomach or bowel problems (eg, inflammation, constipation), severe diarrhea caused by an antibiotic, or if you have had stomach or bowel surgery if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts if you have a personal or family history of mental or mood problems, alcohol abuse, or other substance abuse or dependence if you are very overweight, in very poor health, or will be having surgery if you are dehydrated or have low blood volume, low blood oxygen levels, high blood carbon dioxide levels, or shock caused by serious heart problems

Some MEDICINES MAY INTERACT with Exalgo. Tell your health care provider if you are taking any other medicines, especially any of the following:

Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased Anticholinergics (eg, scopolamine, benztropine) because the risk of severe constipation or trouble urinating may be increased Barbiturate anesthetics (eg, thiopental), cimetidine, MAOIs (eg, phenelzine), or sodium oxybate (GHB) because the risk of severe drowsiness, coma, or slowed or difficult breathing may be increased Agonist/antagonist analgesics (eg, pentazocine) or naltrexone because they may decrease Exalgo's effectiveness and withdrawal may occur Rifamycins (eg, rifampin) because they may decrease Exalgo's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Exalgo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Exalgo:

Use Exalgo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Exalgo comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Exalgo refilled. Take Exalgo by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Swallow Exalgo whole. Do NOT break, crush, chew, dissolve, or inject Exalgo. Take Exalgo at the same time each day. Do not take it more often than 1 time per day. Do not change your dose or suddenly stop taking Exalgo without checking with your doctor. If Exalgo is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Exalgo properly. If you miss a dose of Exalgo, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses within 24 hours of each other. If you miss Exalgo for 3 or more days, check with your doctor before you take another dose.

Ask your health care provider any questions you may have about how to use Exalgo.

Important safety information: Exalgo may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol, other opiate pain medicines, or certain other medicines. Use Exalgo with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol while you are taking Exalgo. Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Exalgo; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Exalgo may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Exalgo may be habit-forming. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Misuse or abuse of Exalgo may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death. You may notice the tablet shell in your stool. This is normal and not a cause for concern. Exalgo contains sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if this product has sulfites in it. Constipation is a common side effect of Exalgo. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Exalgo. Severe or persistent diarrhea may decrease the amount of Exalgo that is absorbed into your body. This may make the medicine less effective, or cause withdrawal symptoms. Tell your doctor if you have severe or persistent diarrhea. If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor. Tell your doctor or dentist that you take Exalgo before you receive any medical or dental care, emergency care, or surgery. Use Exalgo with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness and breathing problems. Exalgo should be used with extreme caution in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Exalgo may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Exalgo while you are pregnant. Exalgo is found in breast milk. Do not breast-feed while taking Exalgo.

When used for long periods of time or at high doses, Exalgo may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Exalgo stops working well. Do not take more than prescribed.

Some people who use Exalgo for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Dependence is unlikely to be an issue in terminally ill patients where comfort is more important.

If you are taking Exalgo regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Exalgo is suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping Exalgo.

Possible side effects of Exalgo:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness, drowsiness; headache; lightheadedness; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; seizure; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, or headache; shallow, slowed, or difficult breathing; stomach swelling; tremor; trouble urinating; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Exalgo side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; chest pain; cold and clammy skin; coma; confusion; difficult or slow breathing; limp muscles; numbness of an arm or leg; pinpoint pupils; seizures; severe drowsiness or dizziness; slow or irregular heartbeat.

Proper storage of Exalgo:

Store Exalgo at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store Exalgo in the bathroom. Keep Exalgo out of the reach of children and away from pets.

General information: If you have any questions about Exalgo, please talk with your doctor, pharmacist, or other health care provider. Exalgo is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Exalgo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Exalgo resources Exalgo Side Effects (in more detail) Exalgo Use in Pregnancy & Breastfeeding Drug Images Exalgo Drug Interactions Exalgo Support Group 4 Reviews for Exalgo - Add your own review/rating Exalgo Prescribing Information (FDA) Exalgo Advanced Consumer (Micromedex) - Includes Dosage Information Exalgo Consumer Overview Dilaudid Prescribing Information (FDA) Dilaudid Consumer Overview Dilaudid-HP Advanced Consumer (Micromedex) - Includes Dosage Information Dilaudid-HP Prescribing Information (FDA) Hydromorphone Prescribing Information (FDA) Hydromorphone Hydrochloride Monograph (AHFS DI) Palladone Prescribing Information (FDA) Compare Exalgo with other medications Pain
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NEULASTA


Neulasta 6 mg solution for injection in a pre-filled syringe

pegfilgrastim

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Neulasta is and what it is used for 2. Before you use Neulasta 3. How to use Neulasta 4. Possible side effects 5. How to store Neulasta 6. Further information What Neulasta Is And What It Is Used For

Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.

Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.

Before You Use Neulasta Do not use Neulasta if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of Neulasta. Take special care with Neulasta

Please tell your doctor:

if you experience a cough, fever and difficulty breathing;
if you have sickle cell anaemia;
if you get left upper abdominal pain or pain at the tip of your shoulder;
if you have an allergy to latex. The needle cover on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions. Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Neulasta has not been tested in pregnant women. It is important to tell your doctor if you:

are pregnant;
think you may be pregnant; or
plan to become pregnant.

You must stop breast feeding if you use Neulasta.

Driving and Using Machines

The effect of Neulasta on the ability to drive or use machines is not known.

Important information about some of the ingredients of Neulasta

Neulasta contains sorbitol (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Neulasta. Neulasta is essentially sodium-free.

How To Use Neulasta

Neulasta is for use in adults aged 18 and over.

Always take Neulasta exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

Do not shake Neulasta vigorously as this may affect its activity.

Injecting Neulasta yourself

Your doctor may decide that it would be more convenient for you to inject Neulasta yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

For further instructions on how to inject yourself with Neulasta, please read the section at the end of this leaflet.

If you use more Neulasta than you should

If you use more Neulasta than you should contact your doctor, nurse or pharmacist.

If you forget to inject Neulasta

If you have forgotten a dose of Neulasta, you should contact your doctor to discuss when you should inject the next dose.

NEULASTA Side Effects

Like all medicines, Neulasta can cause side effects, although not everybody gets them.

A very common side effect (likely to occur in more than 1 in 10 patients) is bone pain. Your doctor will tell you what you can take to ease the bone pain.

Common side effects (likely to occur in fewer than 1 in 10 patients) include; pain and redness at the site of the injection, headaches, and general aches and pains in the joints, muscles, chest, limbs, neck or back. An uncommon side effect (likely to occur in fewer than 1 in 100 patients) is nausea.

Allergic-type reactions to Neulasta, including redness and flushing, skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face), have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.

Increased spleen size and very rare cases (likely to occur in fewer than 1 in 10,000 patients) of spleen rupture have been reported after the use of Neulasta. Some cases of splenic rupture were fatal.

It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.

Rare (likely to occur in fewer than 1 in 1000 patients) cases of breathing problems have been reported after taking G-CSFs. If you have a cough, fever and difficulty breathing please tell your doctor.

Some changes may occur in your blood, but these will be detected by routine blood tests. Your platelet count may become low which might result in bruising. Your white blood cell count may become high for a short period of time.

Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role.

Very rarely (likely to occur in fewer than 1 in 10,000 patients) cutaneous vasculitis (inflammation of the blood vessels in the skin) has occurred in patients receiving Neulasta.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Neulasta

Keep out of the reach and sight of children.

Do not use Neulasta after the expiry date which is stated on the box and on the syringe label (EXP). The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

You may take Neulasta out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.

Do not freeze. Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.

Keep the container in the outer carton in order to protect from light.

Do not use Neulasta if you notice it is cloudy or there are particles in it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Neulasta contains

Neulasta contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.

The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.

The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.

What Neulasta looks like and contents of the pack

Neulasta is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).

Each pack contains 1 pre-filled syringe. The syringes are provided either with or without a blister wrapping. It is a clear, colourless liquid.

Marketing Authorisation Holder and Manufacturer: Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands Further information

If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Amgen Limited Tel: +44 (0)1223 420305

This leaflet was last approved in December 2009.

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.

Instructions for injecting with the Neulasta pre-filled syringe

This section contains information on how to give yourself an injection of Neulasta. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist. If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.

How do you, or the person injecting you, use Neulasta pre-filled syringe?

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.

Equipment that you need

To give yourself a subcutaneous injection you will need:

a pre-filled syringe of Neulasta; and
alcohol wipes or similar. What should I do before I give myself a subcutaneous injection of Neulasta? 1. Remove from the refrigerator.
2. Do not shake the pre-filled syringe.
3. Do not remove the cover from the syringe until you are ready to inject.
4. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
5. Check the appearance of Neulasta. It must be a clear and colourless liquid. If there are particles in it, you must not use it.
6. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Neulasta in any other way (for example, do not warm it in a microwave or in hot water).
7. Wash your hands thoroughly.
8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach. How do I prepare my Neulasta injection?

Before you inject Neulasta you must do the following:

1. Hold the syringe barrel and gently take the cover from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.
2. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
3. You can now use the pre-filled syringe. Where should I give my injection?

The most suitable places to inject yourself are:

the top of your thighs; and
the abdomen, except for the area around the navel.

If someone else is injecting you, they can also use the back of your arms.

How do I give my injection? 1. Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
2. Put the needle fully into the skin as shown by your nurse or doctor.
3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
4. Inject the liquid slowly and evenly, always keeping your skin pinched.
5. After injecting the liquid, remove the needle and let go of your skin.
6. If you notice a spot of blood at the injection site dab away with a cotton ball or tissues. Do not rub the injection site. If needed, you may cover the injection site with a bandage.
7. Only use each syringe for one injection. Do not use any Neulasta that is left in the syringe.

Remember

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes Do not put the cover back on used needles.
Keep used syringes out of the reach and sight of children.
The used syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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Potassium Chloride Solution


Pronunciation: po-TAS-ee-um KLOR-ide
Generic Name: Potassium Chloride
Brand Name: Generic only. No brands available.

Injectable potassium chloride products in strengths of 1.5 mEq and 2 mEq per mL must be diluted before injecting into the vein. Instruct patients that injection of potassium concentrate may cause instant death. However, injectable potassium chloride products in strengths of 0.1, 0.2, 0.3, and 0.4 mEq per mL are intended for use with a calibrated infusion device and do not require dilution.


Potassium Chloride Solution is used for:

Treating and preventing potassium deficiency where oral doseforms are not possible.

Potassium Chloride Solution is an injectable potassium supplement. It works by restoring the potassium level in your body if your potassium level is low.

Do NOT use Potassium Chloride Solution if: you are allergic to any ingredient in Potassium Chloride Solution you are taking a potassium-sparing diuretic (eg, triamterene) you have a high blood potassium level or kidney failure

Contact your doctor or health care provider right away if any of these apply to you.

Before using Potassium Chloride Solution:

Some medical conditions may interact with Potassium Chloride Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a high acidity of your body fluids (acidosis), adrenal gland problems, diarrhea, or kidney problems

Some MEDICINES MAY INTERACT with Potassium Chloride Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aldosterone blockers (eg, spironolactone), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or potassium-sparing diuretics (eg, triamterene) because the risk of high blood potassium levels may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Potassium Chloride Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Potassium Chloride Solution:

Use Potassium Chloride Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Potassium Chloride Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Potassium Chloride Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Potassium Chloride Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Potassium Chloride Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Potassium Chloride Solution MUST be diluted before use. It is very important to carefully check that the right amount of medicine is drawn into the syringe before injecting the medicine into its diluent solution. If this solution is given by way of a pumping device, be sure to stop the pumping action before the container runs dry or air embolism may occur. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Potassium Chloride Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Potassium Chloride Solution.

Important safety information: Check with your doctor before you use a salt substitute or a product that has potassium in it. Too much or too little potassium can adversely affect your heart. Be sure that your health care provider and pharmacist are aware of any heart medicines you are taking. Lab tests, including electrolyte monitoring and kidney function, may be performed while you use Potassium Chloride Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Potassium Chloride Solution with caution in the ELDERLY; they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Potassium Chloride Solution while you are pregnant. It is not known if Potassium Chloride Solution is found in breast milk. If you are or will be breast-feeding while you use Potassium Chloride Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Potassium Chloride Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; fever; infection at the injection site; nausea; vein irritation; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; chest pain; confusion; heart problems; irregular heartbeat; low blood pressure; muscle weakness; numbness or tingling in your hands or feet; stomach pain; vomit that looks like coffee grounds; weak or heavy legs; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Potassium Chloride side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fast, slow, or irregular heartbeat; limp muscles; listlessness; muscle weakness or paralysis; slow or difficult breathing.

Proper storage of Potassium Chloride Solution:

Store Potassium Chloride Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Potassium Chloride Solution out of the reach of children and away from pets.

General information: If you have any questions about Potassium Chloride Solution, please talk with your doctor, pharmacist, or other health care provider. Potassium Chloride Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Potassium Chloride Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Potassium Chloride resources Potassium Chloride Side Effects (in more detail)Potassium Chloride Use in Pregnancy & BreastfeedingDrug ImagesPotassium Chloride Drug InteractionsPotassium Chloride Support Group5 Reviews for Potassium Chloride - Add your own review/rating Compare Potassium Chloride with other medications HypokalemiaPrevention of Hypokalemia
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Fibrogammin P


CSL Behring

FIBROGAMMIN P 250 IU

Powder and solvent for injection or infusion

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your haemophilia nurse. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In This Leaflet:

1. What Fibrogammin P is and what it is used for
2. Before you use Fibrogammin P
3. How to use Fibrogammin P
4. Possible side effects
5. Storing Fibrogammin P
6. Further information

What Fibrogammin P Is And What It Is Used For

Fibrogammin P (Factor XIII) is a product made from human plasma (this is the liquid part of the blood). It is used to prevent or stop the bleeding that you might get because of a lack of factor XIII in your blood, a condition that you have had from birth. Factor XIII is needed for the formation of blood clots which help bleeding to stop and helps slow healing wounds to heal more quickly.

Before You Use Fibrogammin P Do not use Fibrogammin P If you are allergic to any of the ingredients (see section 6). If you are unsure about this, ask your doctor. Take special care with Fibrogammin P If you experience any signs of an allergic reaction to Fibrogammin P (for example a rash, tight chest, wheezing or feeling dizzy), stop injecting the product immediately and contact your doctor. You should visit your doctor or haemophilia treatment centre regularly to ensure that your dose is correct. The doctor may wish to carry out some tests to make sure that you are getting the right amount. If your bleeding is not being controlled with Fibrogammin P, tell your doctor immediately. You may have developed an inhibitor (an antibody which can cancel out the effects of factor XIII) and your doctor may wish to carry out more tests to confirm this. If you have ever had a blood clot (thrombosis), you should ask your doctor for advice. Taking or using other medicines

There are no medicines that are known to react with Fibrogammin P. However, if you are taking another medicine and are concerned, please ask your doctor or haemophilia nurse.

Pregnancy and breast-feeding

If you are pregnant or planning a family soon, or if you are breast-feeding, ask your doctor for advice before using this product.

Driving and using machines

Fibrogammin P does not affect your ability to drive or use machines.

Important information about some of the ingredients of Fibrogammin P

Fibrogammin P contains up to 17 mg sodium per vial. Please take this into account if you are on a sodium (salt) controlled diet as you may need to cut down on the salt in your diet.

Fibrogammin P contains up to 24 mg glucose per vial. Please take this into account if you have diabetes.

Important safety information related to infections

When medicines are made from human blood, steps are taken to stop infections (e.g. HIV and Hepatitis) being passed on to the patient. This includes:

Careful selection of the blood donors Testing of each donation for signs of infection Steps in the manufacture which can kill or remove viruses

However, there is still a small chance of an infection being passed on to the patient. This may include a new virus or infection. Therefore, every time Fibrogammin P is used, it is important to note the name and batch number of the medicine (found on the carton).

How To Use Fibrogammin P

The amount of factor XIII you need will depend on several factors, such as your weight, the severity of your condition, the site and severity of bleeding or the need to prevent bleeding during an operation or investigation.

Fibrogammin P is given by injection or infusion into a vein.

If you have been prescribed Fibrogammin P to use at home, your doctor or haemophilia centre nurse will make sure that you are shown how to inject it and how much to use.

If you are in any doubt about injecting Fibrogammin P, go back to your doctor or haemophilia centre for more advice and training before attempting to treat yourself.

Follow the directions given to you by your doctor or haemophilia nurse. You can also use the directions given below as a guide.

Directions for preparing and administering Fibrogammin P Wash your hands thoroughly using soap and warm water. Warm the Fibrogammin P powder vial and the liquid (Water for Injections) ampoule to room or body temperature without opening either container. You can do this by leaving them to stand at room temperature for about an hour after taking them out of the fridge or, if you need them quickly by holding them in your hands for a few minutes.
DO NOT expose the containers to direct heat or stand them on a radiator. They must not be heated above body temperature (37? C). Hold the water ampoule upright and shake it to move any liquid from the ampoule tip. Break off the ampoule tip with your thumb and index finger. Draw the water up into a sterile syringe with a sterile needle attached. Remove the cap from the powder vial and clean the rubber stopper with antiseptic solution. Allow to dry. Inject the water through the rubber stopper into the powder vial and swirl gently to dissolve. The solution should be clear or slightly cloudy, but should not contain particles. Once you have made up the solution, it should be used immediately. If this is not possible it should be used up within 8 hours. The solution should be put back in the fridge during this time. The solution should be injected at a maximum rate of 4 ml per minute. Any unused solution should be left in the vial or syringe. Dispose of all ampoules, vials, needles, syringes and antiseptic swabs in a ‘Sharps box’ or as you have been told. Do not throw them away with your household rubbish. If you use more Fibrogammin P than you should

No symptoms of overdose with Fibrogammin P have been reported. However, if you accidentally inject a large overdose, then you should tell your doctor or haemophilia centre immediately.

If you forget to use Fibrogammin P

Inject your normal dose as soon as you remember and then continue as instructed by your doctor or haemophilia nurse.

Fibrogammin P Side Effects

Like all medicines, Fibrogammin P can cause side effects, although not everybody gets them.

Rare side effects (affect less than 1 in 1,000 people):

Fever Rash, itchy swellings on the skin (hives) Low blood pressure which could make you feel faint or dizzy Difficulty breathing

Fibrogammin P could increase your risk of a thrombosis.

Symptoms of a thrombosis include:

Unusual pain or swelling in your legs Sudden sharp pain in your chest Sudden difficulty breathing An unusual, severe or long-lasting headache Dizziness or fainting

If you have any of these symptoms, stop your injection immediately and contact your doctor.

If you notice that your Fibrogammin P is less effective than usual, contact your doctor or haemophilia centre immediately.

Storing Fibrogammin P

Store in a fridge at 2 °C to 8 °C, in the original packaging. Do not freeze.

Keep out of the reach and sight of children.

Do not use Fibrogammin P after the expiry date on the carton.

Further Information What Fibrogammin P contains

The active substance is:

250 International Units (IU) human plasma coagulation factor XIII

Other ingredients are:

human albumin glucose sodium chloride traces of sodium hydroxide or hydrochloric acid may also be present, (used for pH adjustment).

Bottles of product and liquid may appear partly empty but this is normal and does not mean that there is the wrong amount of powder or solution.

Marketing Authorisation Holder and Manufacturer CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany

This leaflet was last approved on: 07/2010

For further information contact

CSL Behring UK Limited Hayworth House Market Place Haywards Heath West Sussex RH16 1DB UK Telephone number:01444 447 405
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naloxone and pentazocine


Generic Name: naloxone and pentazocine (oral) (nal OX one and pen TAZ oh seen)
Brand Names: Talwin NX

What is naloxone and pentazocine?

Pentazocine is in a group of drugs called narcotic pain relievers.

Naloxone is an special narcotic drug that reverses the effects of other narcotic medicines.

The combination of naloxone and pentazocine is used to treat moderate-to-severe pain. Naloxone is included in this combination to prevent the misuse of the narcotic ingredient.

Naloxone and pentazocine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about naloxone and pentazocine?

Never crush a naloxone and pentazocine tablet to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of pentazocine and similar prescription drugs.

Pentazocine may be habit-forming and should be used only by the person it was prescribed for. Naloxone and pentazocine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking naloxone and pentazocine. Alcohol can increase some of the side effects of narcotic pain medicine. Never take more than your prescribed dose of naloxone and pentazocine. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Naloxone and pentazocine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using naloxone and pentazocine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. What should I discuss with my health care provider before taking naloxone and pentazocine?

Before using naloxone, tell your doctor if you are using any other narcotic pain medicines. The pain-relieving effects of any narcotic medications you use will be reversed if you use them while you are taking naloxone and pentazocine.

Do not use this medication if you have ever had an allergic reaction to naloxone (Narcan) or pentazocine. Pentazocine may be habit-forming and should be used only by the person it was prescribed for. Naloxone and pentazocine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using naloxone and pentazocine, tell your doctor if you are allergic to any drugs, or if you have:

asthma, COPD, sleep apnea, or other breathing disorders;

liver or kidney disease;

heart disease or history of heart attack;

brain tumor or head injury;

epilepsy or other seizure disorder;

low blood pressure;

gallbladder disease;

mental illness;

a history of drug or alcohol addiction; or

if you have recently received other narcotic pain medicine or methadone.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take naloxone and pentazocine.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether naloxone and pentazocine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take naloxone and pentazocine?

Never crush a naloxone and pentazocine tablet to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of pentazocine and similar prescription drugs.

Take this medication exactly as it was prescribed for you. Never take naloxone and pentazocine in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not stop using naloxone and pentazocine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store naloxone and pentazocine at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Pentazocine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Naloxone and pentazocine dosage (in more detail)

What happens if I miss a dose?

Since this medication is sometimes used as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include extreme drowsiness, weak pulse, shallow breathing, or fainting.

What should I avoid while taking naloxone and pentazocine? Do not take naloxone and pentazocine with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Do not drink alcohol while you are taking naloxone and pentazocine. Alcohol can increase some of the side effects of narcotic pain medicine. Naloxone and pentazocine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Naloxone and pentazocine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using naloxone and pentazocine and call your doctor at once if you have any of these serious side effects:

confusion, hallucinations;

fast heart rate;

weak or shallow breathing;

chest pain;

seizure (convulsions);

cold, clammy skin;

tremors;

confusion, unusual thoughts or behavior;

severe anxiety or restlessness; or

feeling like you might pass out.

Less serious side effects may include:

dizziness, drowsiness;

headache, weakness;

sleep problems (insomnia), strange dreams;

diarrhea, constipation;

nausea, vomiting, loss of appetite;

warmth, redness, or tingly feeling under your skin;

sweating;

blurred vision; or

ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Naloxone and pentazocine Dosing Information

Usual Adult Dose for Pain:

Initial: 50 mg orally every 3 to 4 hours. May increase dose to 100 mg if needed.
Maximum dose: 600 mg/day.

Usual Geriatric Dose for Pain:

Initial: 50 mg orally every 3 to 4 hours. Cautious use and the lower end of the dosing range is recommended in elderly patients.

Usual Pediatric Dose for Pain:

>12 years:
Initial: 50 mg orally every 3 to 4 hours. May increase dose to 100 mg if needed.
Maximum dose: 600 mg/day.

What other drugs will affect naloxone and pentazocine?

Before you take naloxone and pentazocine, tell your doctor if you are now using or have recently used other narcotic medications such as:

fentanyl (Actiq, Duragesic);

hydrocodone (Lortab, Vicodin);

hydromorphone (Dilaudid, Palladone);

levorphanol (Levo-Droman);

meperidine (Demerol);

methadone (Diskets, Methadose, Dolophine);

morphine (Duramorph, Kadian, MS Contin, Oramorph, and others);

nalbuphine (Nubain);

oxycodone (Oxycontin);

oxymorphone (Numorphan, Opana); or

pentazocine (Talwin Lactate).

This list is not complete and there may be other drugs that can interact with naloxone and pentazocine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More naloxone and pentazocine resources Naloxone and pentazocine Side Effects (in more detail) Naloxone and pentazocine Dosage Naloxone and pentazocine Use in Pregnancy & Breastfeeding Drug Images Naloxone and pentazocine Drug Interactions Naloxone and pentazocine Support Group 12 Reviews for Naloxone and pentazocine - Add your own review/rating Compare naloxone and pentazocine with other medications Pain Where can I get more information? Your pharmacist can provide more information about naloxone and pentazocine.

See also: naloxone and pentazocine side effects (in more detail)


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papaverine Injection


pa-PAV-er-een

Available Dosage Forms:

Solution Injectable

Therapeutic Class: Peripheral Vasodilator

Uses For papaverine

Papaverine belongs to the group of medicines called vasodilators. Vasodilators cause blood vessels to expand, thereby increasing blood flow. Papaverine is used to produce erections in some men with erectile dysfunction. When papaverine is injected into the penis (intracavernosal), it increases blood flow to the penis, which results in an erection.

Papaverine injection should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Papaverine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, papaverine is used in certain patients with the following medical conditions:

Low doses of a three-drug combination of papaverine, phentolamine, and alprostadil as an injection may be used to treat erectile dysfunction. Before Using papaverine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For papaverine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to papaverine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing the use of papaverine for erectile dysfunction in the elderly with use in other age groups, papaverine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking papaverine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using papaverine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ginkgo Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of papaverine. Make sure you tell your doctor if you have any other medical problems, especially:

Bleeding problems—These conditions increase the risk of bleeding at the place of injection. Liver disease—Papaverine can cause liver damage when it is given in ways that allow it to get into the bloodstream (by mouth or by injection into a muscle, a vein, or an artery); when papaverine is given by intracavernosal injection, liver damage is much less likely because the medicine enters the bloodstream very slowly. Priapism (history of) or Sickle cell disease—Patients with these conditions have an increased risk of priapism (erection lasting longer than 4 hours) while using papaverine. Proper Use of papaverine

To give papaverine injection:

Cleanse the injection site with alcohol. Using a sterile needle, inject the medicine slowly and directly into the base of the penis as instructed by your doctor. Papaverine should not be injected just under the skin. The injection is usually not painful, although you may feel some tingling in the tip of your penis. If the injection is very painful or you notice bruising or swelling at the place of injection, that means you have been injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection. After you have completed the injection, put pressure on the place of injection to prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that it will work better.

papaverine usually begins to work in about 10 minutes. You should attempt intercourse within 2 hours after injecting the medicine.

Dosing

The dose of papaverine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of papaverine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form: For the treatment of erectile dysfunction: Adults—30 to 60 milligrams (mg) injected very slowly into the area of your penis as directed by your doctor. Allow one or two minutes to completely inject the dose. Do not inject more than one dose in a day. Also, do not use papaverine more than two days in a row or more than three times a week. Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using papaverine

Use papaverine injection exactly as directed by your doctor . Do not use more of it and do not use it more often than ordered. If too much is used, the erection may become so strong that it lasts too long and does not reverse when it should. This condition is called priapism, and it can be very dangerous. If the effect is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts for longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

If you notice bleeding at the site when you inject papaverine, put pressure on the spot until the bleeding stops. If it doesn't stop, check with your doctor.

It is important for you to examine your penis regularly. Check with your doctor if you find a lump where the medicine has been injected or if you notice that your penis is becoming curved. These may be signs that unwanted tissue is growing (called fibrosis), which should be seen by your doctor.

papaverine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Dizziness erection continuing for more than 4 hours, or painful erection lumps in the penis

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Bruising or bleeding at place of injection burning (mild) along penis difficulty in ejaculating swelling at place of injection

Papaverine injected into the penis may cause tingling at the tip of the penis. This is no cause for concern.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: papaverine Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More papaverine Injection resources Papaverine Injection Side Effects (in more detail) Papaverine Injection Use in Pregnancy & Breastfeeding Drug Images Papaverine Injection Drug Interactions Papaverine Injection Support Group 0 Reviews · Be the first to review/rate this drug
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immune globulin subcutaneous


Generic Name: immune globulin (subcutaneous) (im MYOON GLOB yoo lin (sub koo TANE ee us))
Brand Names: Hizentra, Vivaglobin

What is immune globulin?

Immune globulin is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin subcutaneous (for injection under the skin) is used to treat primary immune deficiency.

Immune globulin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about immune globulin? You should not use this medication if you have ever had an allergic reaction to an immune globulin, if you have immune globulin A (IgA) deficiency with antibody to IgA, or if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).

Before using this medication, tell your doctor if you have blood circulation problems or a blood vessel disorder, a history of stroke or blood clot, or if you have been bed-ridden due to severe illness.

Immune globulin is usually given once every week. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.

Subcutaneous immune globulin is for injection only under the skin. Do not inject this medicine into a vein.

If you use this medication at home, keep a diary of the days and times you used the medication and where you injected it on your body.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common. What should I discuss with my health care provider before using immune globulin? You should not use this medication if you have ever had an allergic reaction to an immune globulin, if you have immune globulin A (IgA) deficiency with antibody to IgA, or if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood). You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

If you have any of these other conditions, you may need a dose adjustment or special tests:

blood circulation problems or a blood vessel disorder;

a history of stroke or blood clot; or

if you have been bed-ridden due to severe illness.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common. FDA pregnancy category C. It is not known whether immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is immune globulin given?

Immune globulin subcutaneous is given as an injection using an infusion pump. The medicine enters the body through a needle or catheter placed under your skin. The catheter is attached to the pump with an infusion tube.

You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Immune globulin must be given slowly, and the infusion can take about 1 hour to complete. You may need to use up to 4 catheters to inject this medicine into different body areas at the same time. Your care provider will show you the best places on your body to inject the medication. Follow your doctor's instructions.

Subcutaneous immune globulin is for injection only under the skin. Do not inject this medicine into a vein. Before injecting the medicine, test to make sure the needle is not in a vein. To do this, gently pull back on the plunger of the syringe connected to the infusion tube. If blood flows back into the syringe, remove the catheter and tubing and throw them away. Start over with a new catheter and syringe, insert the needle in a new place on your body, and test for blood flow-back again.

Immune globulin is usually given once every week. Follow your doctor's dosing instructions. If you use this medication at home, keep a diary of the days and times you gave the injection and where you injected it on your body.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give yourself an injection. Do not mix immune globulin with other medications in the same infusion. Do not use the medication if it has changed colors, looks cloudy, or has particles in it. Call your doctor for a new prescription.

Use disposable injection items (needle, catheter, tubing) only once. Throw away the used items in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using immune globulin.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store Hizentra in the original carton at room temperature, away from moisture, heat, and light. Do not freeze. Store Vivaglobin in its original carton in the refrigerator. Do not freeze. Take the medicine out and allow it to reach room temperature before preparing your dose.

Throw away any immune globulin that has become frozen. Throw away any unused medication after the expiration date on the label has passed.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using immune globulin? Do not receive a "live" vaccine while using immune globulin The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Gu?rin), and nasal flu vaccine. Immune globulin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all;

pain, swelling, redness, warmth, or a lump in your arms or legs;

pale or yellowed skin, dark colored urine, fast heart rate;

fever, severe headache, sore throat, neck stiffness, chills, increased sensitivity to light, confusion, and general ill feeling;

chest pain or tightness, trouble breathing; or

signs of new infection such as high fever, chills, body aches, flu symptoms, or sores in your mouth and throat.

Less serious side effects may include:

pain, redness, warmth, itching, and swelling of skin where the injection was given;

nausea, vomiting, diarrhea, stomach pain;

headache;

mild skin rash;

back pain;

joint or muscle pain; or

tired feeling;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Immune globulin Dosing Information

Usual Adult Dose for Primary Immunodeficiency Syndrome:

Begin treatment one week after receiving a regularly scheduled IGIV infusion.
Initial dose: calculated by multiplying the previous IGIV dose by 1.37, then dividing this dose into weekly doses based on the patient's previous IGIV treatment, administered subcutaneously; for example, if IGIV was administered every three weeks, divide by 3.
Recommended weekly doses: 100 to 200 mg/kg body weight subcutaneously.

Usual Pediatric Dose for Primary Immunodeficiency Syndrome:

Begin treatment one week after receiving a regularly scheduled IGIV infusion.
>=2 years:
Initial dose: calculated by multiplying the previous IGIV dose by 1.37, then dividing this dose into weekly doses based on the patient's previous IGIV treatment, administered subcutaneously; for example, if IGIV was administered every three weeks, divide by 3.
Recommended weekly doses: 100 to 200 mg/kg body weight subcutaneously.

What other drugs will affect immune globulin?

There may be other drugs that can interact with immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information? Your doctor or pharmacist can provide more information about immune globulin.
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AVONEX 30 micrograms powder and solvent for solution for injection


AVONEX 30 micrograms powder and solvent for solution for injection

(Interferon beta-1a)

BIO-SET Presentation

Read all of this leaflet carefully before you start using this medicine.

Even if you have used Avonex before, some of the information may have changed.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,please tell your doctor or pharmacist.

(Notes information)

Latest issue: 12/2008

This leaflet is changed from time to time.

Please check every time you get your prescription refilled to see if the leaflet has been updated.

In this leaflet: 1. What AVONEX is and what it is used for 2. Before you use AVONEX 3. How to use AVONEX 4. Possible side effects 5. How to store AVONEX 6. Further information 7. How to inject AVONEX What Avonex Is And What It Is Used For What AVONEX is

The active ingredient in Avonex is a protein called interferon beta-1a. Interferons are natural substances made in your body to help protect you from infections and diseases. The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.

What AVONEX is used for

Avonex is used to treat Multiple Sclerosis (MS). Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS.

Everyone has their own set of MS symptoms. These can include:

feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness, numbness in the face, arms or legs acute or chronic pain, bladder and bowel problems, sexual problems and problems seeing things difficulty in thinking and concentrating, depression.

MS also tends to flare up from time to time: this is called a relapse.

(Notes information)

Avonex works best when you use it at the same time, once a week, on a regular basis.

Do not stop your Avonex treatment without speaking to your neurologist.

Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS. Your doctor will advise you for how long you can use Avonex or when to stop.

How AVONEX works

Multiple sclerosis is linked to nerve (brain or spinal cord) damage. In MS, your body’s defence system reacts against it’s own myelin – the ‘insulation’ that surrounds nerve fibres. When myelin is damaged, the messages between the brain and other parts of the body are disrupted. This is what causes the symptoms of MS. Avonex seems to work by stopping your body’s defence system from attacking the myelin.

Before You Use Avonex Do not use AVONEX if you are allergic (hypersensitive) to interferon beta, human serum albumin or any of the other ingredients in Avonex if you are pregnant, do not start using Avonex if you have severe depression or think about committing suicide.

Talk to a doctor straight away if any of these apply to you.

(Notes information)

Avonex and allergic reactions. Because Avonex is based on a protein, there is a small chance of an allergic reaction.

More about depression. If you have severe depression or thoughts about suicide, you must not use Avonex.

If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods.

Take special care with AVONEX

Talk to your doctor first:

If you have or have had in the past:

depression or problems affecting your moods thoughts about committing suicide.

Changes to your mood, thoughts about suicide, feeling unusually sad, anxious or worthless, should be reported to your doctor immediately.

epilepsy or other seizure disorders not controlled by medication serious kidney or liver problems a low number of white blood cells or platelets, which can cause an increased risk of infection, bleeding or anaemia heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmias).

Talk to your doctor if you have any of these conditions, or if they worsen whilst taking Avonex.

Tell your doctor you are using AVONEX: if you are having a blood test. Avonex may interfere with the results.

(Notes information)

Sometimes you will need to remind other medical staff that you are being treated with Avonex. For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result.

Using other medicines

If you are using other medicines, especially those used to treat epilepsy or depression. Avonex may affect other medicines or be affected by them. This includes any other medicines including medicines obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant, do not start using Avonex.

If you could get pregnant, you need to use contraception while you use Avonex. If you are planning a baby or if you become pregnant while you are using Avonex, tell your doctor. You and your doctor can discuss if you should carry on with treatment. If you are already pregnant, or think that you might be, talk to a doctor as soon as you can. If you want to breastfeed talk to your doctor first. Driving and using machines

If you feel dizzy, do not drive. Avonex makes some people feel dizzy. If this happens to you, or if you get any other side effects that could affect your ability, do not drive or use machines.

Important information about some of the ingredients of AVONEX

This medicine is essentially ‘sodium-free’. It contains less than 23 mg (1 mmol) sodium in each weekly dose.

How To Use Avonex

The usual dose for adults and adolescents aged 12 years and over

One injection of Avonex, once a week.

Try to use Avonex at the same time on the same day each week.

Not for children

Avonex is not to be used in children below the age of 12 years.

Injecting yourself

You can inject Avonex yourself without the help of your doctor, if they have trained you to do this. The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX).

If you have trouble handling the syringe, ask your doctor who may be able to help.

(Notes information)

There are more details on how to inject Avonex at the end of this leaflet.

Alternate needle:

Your pack of Avonex already includes a needle for injection. It may be possible for your doctor to prescribe you a shorter and thinner needle, depending on your body type. Talk to your doctor to see if this is appropriate for you.

If you have problems handling the syringe, talk to your doctor about using a syringe grip. This is a specially designed holder to help you with injecting Avonex.

How long to use AVONEX

Your doctor will tell you how long you need to keep using Avonex. It is important to continue using Avonex regularly. Do not make changes unless your doctor tells you.

If you inject too much

You should only have one injection of Avonex, once a week. If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice.

If you miss an injection

If you miss your usual weekly dose, inject a dose as soon as you can. Then leave a week before using Avonex again. Continue injecting on this new day every week. If you have a preferred day for using Avonex, talk to your doctor about managing the dose, to get back to your preferred day.

Do not use two injections to make up for a missed injection.

Possible Side Effects

Like all medicines, Avonex can cause side effects, although not everyone gets them.

(Notes information)

Although the list of possible side effects can seem worrying, it’s possible that you may not have any of them.

Serious side effects: get medical help

Serious allergic reactions

If you get any of these:

swelling of the face, lips or tongue difficulty breathing a rash.

Call a doctor immediately. Do not use any more Avonex until you have spoken to a doctor.

Depression

If you get any symptoms of depression:

feeling unusually sad, anxious or worthless.

Call a doctor immediately.

Liver problems

If you get any of these symptoms:

yellowing of your skin or the whites of your eyes (jaundice) itching all over feeling sick, being sick (nausea and vomiting) easy bruising of the skin.

Call a doctor immediately as they may be signs of a possible liver problem.

Side effects seen in clinical trials

(Notes information)

Side effects seen in clinical trials. These are the side effects that people reported when Avonex was being tested. The figures are based on how many people said they’d had them. It gives you an idea how likely you are to get similar side effects.

Very common side effects
(at least 1 in 10 people are affected)

flu-like symptoms – headache, muscle aches, chills or a fever: see Flu-like symptoms, below headache.

Common side effects
(less than 1 in 10 people are affected)

loss of appetite feeling weak and tired difficulty sleeping depression flushing runny nose diarrhoea (loose stools) feeling or being sick (nausea or vomiting) numbness or tingling of skin rash, bruising of the skin increased sweating, night sweats pain in your muscles, joints, arms, legs or neck muscle cramps, stiffness in the joints and muscles pain, bruising and redness at the injection site changes to blood tests. Symptoms you might notice are tiredness, repeated infection, unexplained bruising or bleeding.

Uncommon side effects
(less than 1 in 100 people affected)

hair loss changes to your monthly period burning feeling at the site of injection.

Rare side effects
(less than 1 in 1,000 people affected)

difficulty breathing.

If any of the effects trouble you, talk to your doctor.

Other side effects

(Notes information)

These effects have been seen in people using Avonex, but we do not know how likely they are to happen.

an underactive or overactive thyroid nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (seeing or hearing things that are not real), confusion or suicide numbness, dizziness, seizures or fits and migraines an awareness of your heartbeat (palpitations), a rapid or irregular heartbeat, or heart problems which would have the following symptoms: a reduced ability to exercise, inability to lie flat in bed, shortness of breath or swollen ankles liver problems as described above nettle rash or blister-like rash, itching, worsening of psoriasis if you have it swelling or bleeding at the site of injection, or chest pain after an injection gaining or losing weight changes to test results, including changes to liver function tests.

If any of the effects trouble you, talk to your doctor.

Effects of the injection Feeling faint: Your first injection of Avonex may be given by your doctor. It may make you feel faint. You may even actually faint. This is unlikely to happen again. Just after an injection, your muscles may feel tense or very weak – as though you are having a relapse. This is rare. It only happens when you inject and the effects soon pass. They may happen any time after starting on Avonex. If you notice any irritation or skin problems after an injection, talk to your doctor.

Flu-like symptoms

(Notes information)

Three simple ways to help reduce the impact of flu-like symptoms:

1. Use your Avonex injection just before bedtime. This may allow you to sleep through the effects. 2. Take paracetamol or ibuprofen half an hour before your Avonex injection and continue taking it for up to a day. Speak to your doctor or pharmacist about a suitable dose. 3. If you have a fever, drink plenty of water to keep you hydrated.

Some people find that after injecting Avonex, they feel like they have flu. Signs are:

headache muscle aches chills or a fever.

These symptoms are not really flu.

You can’t pass it on to anyone else. They are more common when you first start using Avonex. As you keep using your injections, the flu-like symptoms gradually decrease.

How To Store Avonex

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the label.

Store below 25 °C.

Once prepared in the syringe use as soon as possible. However, the prepared syringe can be stored in the fridge (between 2 °C and 8 °C) for up to 6 hours before you inject. Do not freeze.

Bring it out half an hour before injecting.

Do NOT use AVONEX if you notice:

The seal of the cap of the BIO-SET device is broken. The sealed plastic tray is damaged or opened. The liquid in the vial obtained after reconstitution is not colourless or slightly yellow in colour or you can see particles floating in it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information Ingredients

The active ingredient is: Interferon-beta 1a 30 micrograms

The other ingredients are: Human serum albumin, sodium chloride, dibasic sodium phosphate and monobasic sodium phosphate.

What is in your Avonex pack

A box of Avonex Bioset has four doses of Avonex.

Each dose comes in a sealed plastic tray and has a white to off-white coloured powder in a glass container (vial) and an injection syringe filled with water. These are mixed together to make up the injection you take (solution for injection). A separate needle to give the injection is also included in the tray.

Marketing Authorisation Holder is: Biogen Idec Limited Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom Avonex is made by: Biogen Idec BV Robijnlaan 8 NL-2132 WX Hoofddorp The Netherlands Biogen Idec Denmark Manufacturing ApS Biogen Idec All? 1 DK-3400 Hiller?d Denmark

You can get a larger print version of this leaflet by calling the local representatives.

For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Biogen Idec Limited Tel:+44 (0) 1628 50 1000

This leaflet was last approved in 12/2008

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu

How To Inject Avonex

You should have had training in how to inject Avonex.

These notes are a reminder. If there’s anything you’re not sure about, check with your doctor or pharmacist.

Where to inject Avonex is injected into a muscle, for example, the upper thigh muscle. Injection of Avonex into the buttocks is not recommended. Use a different injection site each week. This means less risk of irritation to your skin and muscle. Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound. A Getting ready 1. Take a tray out of the box.

Check the expiry date on the lid of the tray. Do not use it if it is out-of-date.

Peel back the paper lid completely. Check the blister tray contains:

one BIO-SET (vial + base + cap) one syringe one injection needle (see picture “Contents of the plastic tray”). 2. Wash your hands thoroughly with soap and water and dry them. 3. Prepare alcohol wipes and sticking plasters (not supplied) if you need them. 4. Find a clean, hard surface to lay out the items needed for your injection. Lay the tray down on it. B. Preparing the injection 1 Remove cap off the vial
Twist, then pull cap off.
Do not touch the connection port. 2 Pull the cap off the syringe
Hold the base of the syringe. Pull the cap off.
Do not touch the connection port.
Do not push on the plunger. 3 Line up the syringe and vial
Place the Bio-Set on a flat surface.
Line up the two connection ports so that they are in a straight line.
Hold the syringe by the base. Screw it firmly clockwise into the vial. 4 Push the syringe down until it clicks
Keep the Bio-Set on the flat surface and hold the syringe by the base.
Keep them in a straight line.
Tip: If the syringe is at an angle to the Bio-Set, it will leak.
Push the syringe until it clicks. 5 Mix the water and powder
Slowly inject all the water from the syringe into the vial.
Tip: Don’t push the plunger quickly. This turns the solution to foam that can’t be drawn into the syringe.
Push the plunger right down to get air out of the syringe. 6 Dissolve the powder fully
Pick up the vial and the syringe, keeping them attached and straight.
Gently swirl the vial until all the powder has dissolved.
Do not shake: this will make froth. 7 Fill the syringe
Turn the syringe and vial upside down, still in a straight line.
Tip: If the syringe is at an angle to the Bio-Set, it will leak.
Slowly pull the plunger until all the liquid is in the syringe. 8 Separate syringe and vial
Hold the filled syringe by the base. Turn it anti-clockwise to remove it from the Bio-Set vial.
Do not touch the connection port on the syringe. C: Giving the injection 1 Check the liquid in the syringe
It should be clear and colourless.
If the solution is any colour except colourless or slightly yellow, or if you can see particles floating in it, do not inject. 2 Fit the needle
Unwrap the needle to expose the connection port. Keep the cover on.
Push and twist the needle clockwise onto the syringe.
Now pull off the plastic needle cover.
Do not twist it.
Tip: If you twist the needle cover to remove it, you may accidentally remove the needle as well. 3 Remove any air
To remove air, point the syringe needle upwards. Gently tap to bring air bubbles to the top.
Push the plunger carefully to remove the air. Don’t let more than a small drop of liquid escape. 4 Clean and stretch the injection site
If you need to, use an alcohol wipe to clean the skin at the injection site you’ve chosen. Allow the skin to dry.
With one hand, stretch the skin around the injection site.
Relax your muscle.
5 Make the injection
Insert the injection needle with a quick dart-like thrust at right angles to the skin, into the muscle
The needle must go all the way in.
Press the plunger slowly until the syringe is empty. 6 Pull the needle out
Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
If you use alcohol wipes, hold one on the injection site.
Put a plaster over the site of injection if you need to.
Dispose of the rubbish properly
After you have finished each injection, put the needle, syringe and vial into a special container (such as a sharps bin), not in ordinary rubbish. Waste paper and used wipes can be put in an ordinary rubbish bin.
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Novofine


Pronunciation: IN-su-lin
Generic Name: Insulin
Brand Name: Examples include BD Ultrafine and Novofine
Novofine is used for:

Injecting insulin (and other solutions as determined by your doctor) into a preselected site of the body.

Do NOT use Novofine if: you are allergic to any ingredient in Novofine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Novofine:

Some medical conditions may interact with Novofine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Novofine. However, no specific interactions with Novofine are known at this time.

Ask your health care provider if Novofine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Novofine:

Use Novofine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Carefully attach the needle to your insulin pen as you have been shown. Prepare and inject your insulin following the procedure you have been shown. Do not remove the cap from the needle until you are ready to give the injection. Do not recap the needle after the injection. You may accidentally stick yourself trying to recap the needle. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Novofine, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Novofine.

Important safety information: Use only needles designed for insulin delivery to give your insulin injection. Different insulin pens may require different pen needles. Make sure that you have the correct needle for your device. Ask your pharmacist if you have questions about which needle you need. Do not reuse needles, syringes, or other materials. Do not carry an insulin pen with a needle attached to it. Doing so may affect the accuracy of your insulin dose. Use a different site for each injection; about 1 inch away from previous injection sites, but in the same general area. Use all available sites in the same general area before switching to a different area. Do not use the same injection site more often than once every month or two. Possible side effects of Novofine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Redness, swelling, or itching at injection sites.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center or emergency room immediately.

Proper storage of Novofine:

Store the needles at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in the original package. Store away from heat, moisture, and light. Keep Novofine and needles out of the reach of children and away from pets.

General information: If you have any questions about Novofine, please talk with your doctor, pharmacist, or other health care provider. Novofine is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Novofine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Novofine resources Novofine Use in Pregnancy & Breastfeeding Novofine Drug Interactions Novofine Support Group 0 Reviews · Be the first to review/rate this drug
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phentolamine Injection


fen-TOL-a-meen

Commonly used brand name(s)

In the U.S.

OraVerse Regitine

Available Dosage Forms:

Solution Injectable Powder for Solution

Therapeutic Class: Antihypertensive

Pharmacologic Class: Alpha-Adrenergic Blocker

Uses For phentolamine

Phentolamine given by injection causes blood vessels to expand, thereby increasing blood flow. When injected into the penis (intracavernosal), it increases blood flow to the penis, which results in an erection.

phentolamine should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Phentolamine may also be used to reverse the effects of an anesthetic medicine in soft tissues, such as the lips and tongue. It may be used to help quickly restore normal sensation and function in patients who have received local dental anesthesia .

Phentolamine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, phentolamine is used in certain patients with the following medical conditions:

Low doses of a three-drug combination of phentolamine, papaverine, and alprostadil as an injection may be used to treat erectile dysfunction. Before Using phentolamine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For phentolamine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to phentolamine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of phentolamine for the reversal of soft-tissue anesthesia in children younger than 6 years of age. Safety and efficacy have not been established .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing the use of phentolamine for erectile dysfunction in the elderly, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking phentolamine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using phentolamine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Tadalafil

Using phentolamine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Alprenolol Atenolol Betaxolol Bevantolol Bisoprolol Bucindolol Carteolol Carvedilol Celiprolol Dilevalol Esmolol Labetalol Levobunolol Mepindolol Metipranolol Metoprolol Nadolol Nebivolol Oxprenolol Penbutolol Pindolol Propranolol Sotalol Talinolol Tertatolol Timolol Vardenafil Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of phentolamine. Make sure you tell your doctor if you have any other medical problems, especially:

Bleeding problems—These conditions increase the risk of bleeding at the place of injection. Priapism (history of) or Sickle cell disease—Patients with these conditions have an increased risk of priapism (erection lasting longer than 4 hours) while using phentolamine. Proper Use of phentolamine

To give the injection:

Cleanse the injection site with alcohol. Using a sterile needle, inject the medicine slowly and directly into the base of the penis as instructed by your doctor. It should not be injected just under the skin. The injection is usually not painful, although you may feel some tingling in the tip of your penis. If the injection is very painful or you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection. After you have completed the injection, put pressure on the place of injection to prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that it will work better.

phentolamine usually begins to work in about 10 minutes. You should attempt intercourse within 2 hours after injecting the medicine.

To reverse the effects of a soft-tissue anesthetic medicine, a dentist or other trained health professional will give you phentolamine. phentolamine is usually injected at the same spot where you have received the local dental anesthesia .

Dosing

The dose of phentolamine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of phentolamine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form: For the treatment of impotence: Adults— 0.5 to 1 milligram (mg) injected very slowly into the area of your penis as directed by your doctor. Allow one or two minutes to completely inject the dose. Do not inject more than one dose in a day. Also, do not use phentolamine more than two days in a row or more than three times a week. Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using phentolamine

Use the injection exactly as directed by your doctor. Do not use more of it and do not use it more often than ordered. If too much is used, the erection may become so strong that it lasts too long and does not reverse when it should. This condition is called priapism, and it can be very dangerous. If the effect is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts for longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

If you notice bleeding at the site when you inject the medicine, put pressure on the spot until the bleeding stops. If it doesn't stop, check with your doctor.

It is important for you to examine your penis regularly. Check with your doctor if you find a lump where the medicine has been injected or if you notice that your penis is becoming curved. These may be signs that unwanted tissue is growing (called fibrosis), which should be seen by your doctor.

phentolamine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Dizziness erection continuing for more than 4 hours, or painful erection lumps in the penis

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare Bruising or bleeding at place of injection burning (mild) along penis difficulty in ejaculating swelling at place of injection

Phentolamine injected into the penis may cause tingling at the tip of the penis. This is no cause for concern.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: phentolamine Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More phentolamine Injection resources Phentolamine Injection Side Effects (in more detail) Phentolamine Injection Use in Pregnancy & Breastfeeding Phentolamine Injection Drug Interactions Phentolamine Injection Support Group 0 Reviews for Phentolamine Injection - Add your own review/rating Compare phentolamine Injection with other medications Dermal Necrosis, Treatment Pheochromocytoma Pheochromocytoma Diagnosis Reversal of Anesthesia
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Alphanine SD


Generic Name: factor ix complex (Intravenous route, Injection route)

FAK-tor NINE

Commonly used brand name(s)

In the U.S.

Alphanine SD Bebulin Bebulin VH Benefix Mononine Profilnine SD Proplex T

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antihemophilic Agent

Uses For Alphanine SD

Factor IX is a protein produced naturally in the body. It helps the blood form clots to stop bleeding. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. This is a condition in which the body does not make enough factor IX. If you do not have enough factor IX and you become injured, your blood will not form clots as it should, and you may bleed into and damage your muscles and joints.

Injections of one form of factor IX, called factor IX complex, also are used to treat certain people with hemophilia A. In hemophilia A, sometimes called classical hemophilia, the body does not make enough factor VIII, and, just as in hemophilia B, the blood cannot form clots as it should. Injections of factor IX complex may be used in patients in whom the medicine used to treat hemophilia A is no longer effective. Injections of factor IX complex also may be used for other conditions as determined by your doctor.

The factor IX product that your doctor will give you is obtained naturally from human blood or artificially by a man-made process. Factor IX obtained from human blood has been treated and is not likely to contain harmful viruses such as hepatitis B virus, hepatitis C (non-A, non-B) virus, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made factor IX product does not contain these viruses.

Factor IX is available only with your doctor's prescription.

Before Using Alphanine SD

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Blood clots may be especially likely to occur in premature and newborn babies, who are usually more sensitive than adults to the effects of injections of factor IX.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Blood clots or a history of medical problems caused by blood clots or Liver disease—Risk of bleeding or developing blood clots may be increased Proper Use of factor ix complex

This section provides information on the proper use of a number of products that contain factor ix complex. It may not be specific to Alphanine SD. Please read with care.

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.

To prepare this medicine:

Take the dry medicine and the liquid (diluent) out of the refrigerator and bring them to room temperature, as directed by your doctor. When injecting the liquid (diluent) into the dry medicine, aim the stream of liquid (diluent) against the wall of the container of dry medicine to prevent foaming. Swirl the container gently to dissolve the medicine. Do not shake the container.

Use this medicine right away. It should not be kept longer than 3 hours after it has been prepared.

A plastic disposable syringe and filter needle must be used with this medicine. The medicine may stick to the inside of a glass syringe, and you may not receive a full dose.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The condition for which you are using this medicine. Your body weight. The amount of factor IX your body is able to make. How much, how often, and where in your body you are bleeding. Whether or not your body has built up a defense (antibody) against this medicine. Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Some factor IX products must be stored in the refrigerator, and some may be kept at room temperature for short periods of time. Store this medicine as directed by your doctor or the manufacturer.

Precautions While Using Alphanine SD

If you were recently diagnosed with hemophilia B, you should receive hepatitis A and hepatitis B vaccines to reduce even further your risk of getting hepatitis A or hepatitis B from factor IX products.

After a while, your body may build up a defense (antibody) against this medicine. Tell your doctor if this medicine seems to be less effective than usual.

It is recommended that you carry identification stating that you have hemophilia A or hemophilia B. If you have any questions about what kind of identification to carry, check with your health care professional.

Alphanine SD Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare Changes in facial skin color fast or irregular breathing puffiness or swelling of the eyelids or around the eyes shortness of breath, troubled breathing, tightness in chest, and/or wheezing skin rash, hives, and/or itching

Check with your doctor immediately if any of the following side effects occur:

More common Bluish coloring (especially of the hands and feet) convulsions dizziness or lightheadedness when getting up from a lying or sitting position increased heart rate large blue or purplish patches in the skin (at places of injection) nausea or vomiting pains in chest, groin, or legs (especially calves) persistent bleeding from puncture sites, gums, or inner linings of the nose and/or mouth, or blood in the stool or urine severe pain or pressure in the chest and/or the neck, back, or left arm severe, sudden headache shortness of breath or fast breathing sudden loss of coordination sudden and unexplained slurred speech, vision changes, and/or weakness or numbness in arm or leg

Check with your doctor immediately if any of the following side effects occur:

Less common Burning or stinging at place of injection changes in blood pressure or pulse rate chills drowsiness fever headache nausea or vomiting redness of face shortness of breath

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Alphanine SD side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Alphanine SD resources Alphanine SD Side Effects (in more detail) Alphanine SD Use in Pregnancy & Breastfeeding Alphanine SD Drug Interactions Alphanine SD Support Group 0 Reviews for Alphanine SD - Add your own review/rating Alphanine SD Prescribing Information (FDA) Alphanine SD Concise Consumer Information (Cerner Multum) AlphaNine SD MedFacts Consumer Leaflet (Wolters Kluwer) BeneFIX Prescribing Information (FDA) BeneFIX Monograph (AHFS DI) BeneFix MedFacts Consumer Leaflet (Wolters Kluwer) Benefix injectable Concise Consumer Information (Cerner Multum) Mononine Prescribing Information (FDA) Mononine MedFacts Consumer Leaflet (Wolters Kluwer) Compare Alphanine SD with other medications Factor IX Deficiency Factor VII Deficiency Hemophilia A with Inhibitors Hemophilia B
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Aquamephyton


Generic Name: phytonadione (fye toe na DYE own)
Brand Names: Mephyton, Vitamin K1

What is Aquamephyton (phytonadione)?

Phytonadione is a man-made form of vitamin K. Phytonadione is important in the production of substances that cause the blood to clot.

Phytonadione is used to treat vitamin K deficiency and to treat certain bleeding or blood clotting problems.

Phytonadione may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Aquamephyton (phytonadione)?

Tell your doctor and dentist that you are taking phytonadione before having any type of surgery.

What should I discuss with my healthcare provider before taking Aquamephyton (phytonadione)?

Phytonadione may affect other medical conditions or treatments. Talk to your doctor before taking phytonadione if you have other health problems or conditions, or if you take other medications.

Phytonadione is in the FDA pregnancy category C. This means that it is not known whether phytonadione will be harmful to an unborn baby. Do not take phytonadione without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether phytonadione passes into breast milk and if it will affect a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. How should I take Aquamephyton (phytonadione)?

Take phytonadione exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each oral dose with a full glass of water.

Injectable forms of phytonadione are usually administered by a healthcare professional. If you are injecting phytonadione at home, your doctor or nurse will give you detailed instructions regarding preparation, administration, and storage of the medication.

Do not take more phytonadione than is prescribed.

It is important to take phytonadione regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with phytonadione to monitor progress and side effects.

Store phytonadione at room temperature away from moisture and heat. Protect phytonadione from light, as light decreases the effectiveness of the medication. What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if an overdose is suspected.

Symptoms of a phytonadione overdose are not known.

What should I avoid while taking Aquamephyton (phytonadione)?

Tell your doctor and dentist that you are taking phytonadione before having any type of surgery.

Aquamephyton (phytonadione) side effects Seek emergency medical attention or contact your doctor immediately if you experience any serious side effects from phytonadione such as:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

dizziness;

fast or irregular heartbeats; or

increased sweating.

Other less serious side effects may be more likely to occur. Continue to use phytonadione and talk to your doctor if you experience

flushing of the face;

an unusual taste in the mouth; or

pain or irritation at the injection site (injectable form).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Aquamephyton (phytonadione)?

Before taking phytonadione, tell your doctor about all other medicines you are taking, especially any of the following:

warfarin (Coumadin);

mineral oil;

orlistat (Xenical);

cholestyramine (Questran, Prevalite);

a salicylate such as aspirin (Acuprin, Ecotrin, Ascriptin, Bayer, others); choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid);

a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), or tolmetin (Tolectin); or

an antibiotic.

You may not be able to take phytonadione, or you may require a dosage adjustment or special monitoring during treatment.

Medications other than those listed here may also interact with phytonadione. Tell your doctor about all other prescription and over-the-counter medicines that you take, including vitamins, minerals, and herbal products.

More Aquamephyton resources Aquamephyton Side Effects (in more detail)Aquamephyton Use in Pregnancy & BreastfeedingAquamephyton Drug InteractionsAquamephyton Support Group0 Reviews for Aquamephyton - Add your own review/rating Phytonadione Prescribing Information (FDA) Phytonadione Monograph (AHFS DI) Phytonadione MedFacts Consumer Leaflet (Wolters Kluwer) Mephyton Advanced Consumer (Micromedex) - Includes Dosage Information Mephyton Prescribing Information (FDA) Mephyton MedFacts Consumer Leaflet (Wolters Kluwer) Vitamin K1 Prescribing Information (FDA) Compare Aquamephyton with other medications Hypoprothrombinemia, Anticoagulant InducedHypoprothrombinemia, Not Associated with Anticoagulant TherapyHypoprothrombinemia, ProphylaxisVitamin K Deficiency Where can I get more information? Your pharmacist has more information about phytonadione written for health professionals that you may read.

See also: Aquamephyton side effects (in more detail)


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Mixtard 30 InnoLet 100 IU / ml suspension for injection in a pre-filled pen


Mixtard 30 InnoLet

100 IU/ml suspension for injection in a pre-filled pen

Insulin human (rDNA)

Read all of this leaflet carefully before you start using your insulin. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist. This side of the leaflet: 1. What Mixtard is and what it is used for 2. Before you use Mixtard 3. How to use Mixtard 4. What to do in an emergency 5. Possible side effects 6. How to store Mixtard 7. Further information

Overleaf: How to use your InnoLet

What Mixtard is and what it is used for

Mixtard is human insulin to treat diabetes. Mixtard is a mixture of fast-acting insulin and long-acting insulin. This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 24 hours.

Before you use Mixtard Do not use Mixtard If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information). Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar). See 4 What to do in an emergency for more about hypos. Take special care with Mixtard If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections. Using other medicines

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.

Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Pregnancy and breastfeeding

If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.

Driving and using machines

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

How to use Mixtard

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Eat a meal or snack containing carbohydrates within 30 minutes of the injection.

It is recommended that you measure your blood glucose regularly.

Injecting insulin

See overleaf for detailed instructions.

Before using Mixtard Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination. Do not use Mixtard In insulin infusion pumps If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’t been stored correctly or been frozen (see 6 How to store Mixtard) If it’s not uniformly white and cloudy when it’s resuspended.

Mixtard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist.

What to do in an emergency If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away. They must not give you any food or drink as it could choke you.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted. Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

If you take too much insulin If you eat too little or miss a meal If you exercise more than usual. If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

If you get any of these signs, test your blood sugar level and test your urine for ketones if you can. Then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of hyperglycaemia Having forgotten to take your insulin Repeatedly taking less insulin than you need An infection or a fever Eating more than usual Less exercise than usual. Possible side effects

Like all medicines, Mixtard can cause side effects, although not everybody gets them. Mixtard may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.

Side effects reported uncommonly

(in less than 1 patient in 100)

Changes at the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.

Seek medical advice immediately:

if signs of allergy spread to other parts of the body, or if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.

You may have a very rare serious allergic reaction to Mixtard or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Mixtard.

Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

Side effects reported very rarely

(in less than 1 patient in 10,000)

Vision problems. When you first start your treatment, it may disturb your vision, but the reaction usually disappears.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.

How to store Mixtard

Keep out of the reach and sight of children.

Do not use Mixtard after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

The InnoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).

Do not store them in or too near the freezer section or cooling element.

Do not freeze.

The InnoLet that is being used, about to be used or carried as a spare is not to be kept in a refrigerator. After removing the InnoLet from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use. See 3 How to use Mixtard. You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks. Always keep the pen cap on your InnoLet when you’re not using it in order to protect it from light. Mixtard must be protected from excessive heat and sunlight.

Mixtard should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Mixtard 30 contains The active substance is insulin human made by recombinant biotechnology (30% as soluble insulin and 70% as isophane insulin). 1 ml contains 100 IU of insulin human. 1 pre-filled pen contains 3 ml equivalent to 300 IU The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections. What Mixtard looks like and contents of the pack

The suspension for injection comes as a cloudy, white, aqueous suspension.

It is supplied in packs of 1, 5 or 10 pre-filled pens of 3 ml. Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S Novo All? DK-2880 Bagsv?rd Denmark

Now turn over for information on how to use your InnoLet.

This leaflet was last approved in 09/2007

Mixtard , InnoLet and NovoFine S are trademarks owned by Novo Nordisk A/S, Denmark

© 2000/2007

Novo Nordisk A/S

Information on how to use Mixtard 30 InnoLet

Please read the following instructions carefully before using your Mixtard 30 InnoLet .

Introduction

Mixtard 30 InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit. Mixtard 30 InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length. Look for an S on the needle box. The S stands for short cap.

As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.

Preparing for injection

Check the label to make sure that your Mixtard 30 InnoLet contains the correct type of insulin. Take off the pen cap (as shown by the arrow).

Resuspending is easier when the insulin has reached room temperature.

Suspending the insulin

Before every injection:

Check there are at least 12 units of insulin left in the cartridge to allow even resuspending. If there are less than 12 units left, use a new Mixtard 30 InnoLet Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated until the liquid appears uniformly white and cloudy After resuspending, complete all of the following stages of injection without delay.

Attaching the needle

Disinfect the rubber membrane with a medicinal swab Always use a new needle for each injection to prevent contamination Remove the protective tab from a NovoFine S needle Screw the needle straight and tightly onto Mixtard 30 InnoLet (picture 1B) Pull off the big outer needle cap and the inner needle cap. You may want to store the big outer needle cap in the compartment.

Priming to expel air

Small amounts of air may collect in the needle and cartridge during normal use.

To avoid injection of air and ensure proper dosing:

Dial 2 units by turning the dose selector clockwise Hold Mixtard 30 InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C). Keeping the needle upwards, press the push-button and the dose selector returns to zero A drop of insulin must appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

If a drop of insulin still does not appear, the device is defective and must not be used.

Setting the dose Always check that the push-button is fully depressed and the dose selector is set at zero Dial the number of units required by turning the dose selector clockwise (picture 2). Do not use the residual scale to measure your dose of insulin You will hear a click for every single unit dialled. The dose can be corrected by turning the dial either way.

You cannot set a dose larger than the number of units left in the cartridge.

Injecting the insulin Insert the needle into your skin. Use the injection technique advised by your doctor Deliver the dose by pressing the push-button fully down (picture 3). You will hear clicks as the dose selector returns to zero After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button Remove the needle after each injection. Removing the needle Replace the big outer needle cap and unscrew the needle (picture 4). Dispose of it carefully.

Use a new needle for each injection.

Remove the needle after each injection and store InnoLet without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.

Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.

Dispose of your used Mixtard 30 InnoLet carefully without the needle attached.

Maintenance

Your Mixtard 30 InnoLet is designed to work accurately and safely. It must be handled with care.

Do not refill Mixtard 30 InnoLet.

You can clean your Mixtard 30 InnoLet by wiping it with a medicinal swab. Do not soak it, wash or lubricate it. This may damage the mechanism.

8-9603-01-002-3


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Corifact


Generic Name: factor XIII (FAK tor 13 (thirteen))
Brand Names: Corifact

What is factor XIII?

Factor XIII is used to prevent bleeding episodes in people with a hereditary bleeding disorder caused by a deficiency of Factor XIII.

Factor XIII will not treat a bleeding episode that has already begun.

Factor XIII may also be used for purposes not listed in this medication guide.

What is the most important information I should know about factor XIII? You should not use this medication if you are allergic to factor XIII or to any medicine made with human plasma.

Before using factor XIII, tell your doctor if you have liver disease.

You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Call your doctor at once if you have new or worsening bleeding episodes, sudden numbness or weakness, chest pain, coughing up blood, problems with vision or speech, or pain, swelling, warmth, or redness in one or both legs. What should I discuss with my healthcare provider before taking factor XIII? You should not use this medication if you are allergic to factor XIII or to any medicine made with human plasma.

To make sure you can safely take factor XIII, tell your doctor if you have liver disease.

FDA pregnancy category C. It is not known whether factor XIII will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether factor XIII passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Factor XIII is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication. How should I take factor XIII?

Factor XIII is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Factor XIII is usually given once every 4 weeks. Follow your doctor's dosing instructions very carefully.

Factor XIII is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Allow the mixture to reach room temperature before giving the injection. Do not heat the medicine before using.

Factor XIII should look clear or slightly yellow in color. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Do not mix factor XIII with other injectable medications in the same IV line.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Store unmixed factor XIII in the refrigerator, do not freeze. Keep the medicine in its original container. Unopened vials of factor XIII may also be stored at room temperature for up to 6 months, away from moisture, heat, and light. Do not refrigerate an unopened vial that has been stored at room temperature. After mixing factor XIII with a diluent, store at room temperature and use within 4 hours. Do not refrigerate or freeze.

Throw away any unused factor XIII after the expiration date on the label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of factor XIII.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking factor XIII?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Factor XIII side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

new or worsening bleeding episodes;

unusual bruising;

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

pain, swelling, warmth, or redness in one or both legs.

Less serious side effects may include:

fever, chills, flu symptoms;

stomach pain, vomiting, diarrhea,

headache;

joint pain;

mild rash or itching; or

cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect factor XIII?

There may be other drugs that can interact with factor XIII. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Corifact resources Corifact Side Effects (in more detail) Corifact Use in Pregnancy & Breastfeeding Corifact Support Group 0 Reviews for Corifact - Add your own review/rating Corifact Prescribing Information (FDA) Corifact Advanced Consumer (Micromedex) - Includes Dosage Information Corifact MedFacts Consumer Leaflet (Wolters Kluwer) Corifact Consumer Overview Compare Corifact with other medications Factor XIII Deficiency Where can I get more information? Your pharmacist can provide more information about factor XIII.

See also: Corifact side effects (in more detail)


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methylnaltrexone


Generic Name: methylnaltrexone (METh IL nal TREX own)
Brand Names: Relistor

What is methylnaltrexone?

Methylnaltrexone is a special narcotic drug that blocks certain effects of other narcotic medicines.

Methylnaltrexone reduces constipation caused by narcotic medications that are often used to treat pain in people with terminal illness.

Methylnaltrexone works by preventing this side effect without reducing the pain-relieving effects of the narcotic.

Methylnaltrexone is usually given after laxatives have been tried without successful treatment of constipation.

Methylnaltrexone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about methylnaltrexone? You should not use this medication if you are allergic to methylnaltrexone, or if you have a blockage in your stomach or intestines.

Before you use methylnaltrexone, tell your doctor if you have severe or ongoing diarrhea.

Prepare your dose in a syringe only when you are ready to give yourself an injection. After loading a syringe, if you cannot give the injection right away keep it at room temperature and use it within 24 hours. Methylnaltrexone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. What should I discuss with my health care provider before receiving methylnaltrexone? You should not use this medication if you are allergic to methylnaltrexone, or if you have a blockage in your stomach or intestines.

To make sure you can safely use methylnaltrexone, tell your doctor if you have any of these other conditions:

cancer;

a stomach ulcer; or

colitis or other intestinal disorder.

FDA pregnancy category B. Methylnaltrexone is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether methylnaltrexone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is methylnaltrexone used?

Methylnaltrexone is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication is usually given once every other day, but not more often than once every 24 hours.

Methylnaltrexone can produce a bowel movement within 30 minutes after injection.

Prepare your dose in a syringe only when you are ready to give yourself an injection. After loading a syringe, if you cannot give the injection right away keep it at room temperature and use it within 24 hours.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Methylnaltrexone should look clear or slightly yellow in color. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Store at room temperature away from moisture, heat, and light. Do not freeze. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use this medication more than once in a 24-hour period.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness, or feeling like you might pass out.

What should I avoid while using methylnaltrexone? Methylnaltrexone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not use any other laxatives that your doctor has not prescribed. Methylnaltrexone side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or ongoing diarrhea, stomach pain that will not go away, black or bloody stools, coughing up blood, or nausea or vomiting that are new or worsening symptoms.

Less serious side effects may include:

stomach pain, gas;

mild nausea or diarrhea;

dizziness; or

increased sweating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Methylnaltrexone Dosing Information

Usual Adult Dose for Constipation -- Chronic:

Less than 38 kg: 0.15 mg/kg subcutaneously every other day as needed
38 to less than 62 kg: 8 mg subcutaneously every other day as needed
62 to 114 kg: 12 mg subcutaneously every other day as needed
More than 114 kg: 0.15 mg/kg subcutaneously every other day as needed
The usual schedule is one dose every other day, as needed, but no more frequently than one dose in a 24-hour period.

What other drugs will affect methylnaltrexone?

Before receiving methylnaltrexone, tell your doctor if you use any narcotic medication, such as:

buprenorphine (Buprenex, Subutex);

butorphanol (Stadol);

codeine (Tylenol with codeine);

hydrocodone (Lortab, Vicodin);

hydromorphone (Dilaudid);

levorphanol (Levo-Dromoran);

meperidine (Demerol);

methadone (Dolophine, Methadose);

morphine (Kadian, MS Contin, Roxanol);

nalbuphine (Nubain);

naloxone (Narcan);

oxycodone (OxyContin, Roxicodone, Percocet);

oxymorphone (Numorphan); or

propoxyphene (Darvon, Darvocet).

This list is not complete and other drugs may interact with methylnaltrexone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More methylnaltrexone resources Methylnaltrexone Side Effects (in more detail) Methylnaltrexone Use in Pregnancy & Breastfeeding Methylnaltrexone Support Group 7 Reviews for Methylnaltrexone - Add your own review/rating methylnaltrexone Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Methylnaltrexone MedFacts Consumer Leaflet (Wolters Kluwer) Methylnaltrexone Bromide Monograph (AHFS DI) Relistor Prescribing Information (FDA) Relistor Consumer Overview Compare methylnaltrexone with other medications Constipation, Chronic Constipation, Drug Induced Where can I get more information? Your doctor or pharmacist can provide more information about methylnaltrexone.

See also: methylnaltrexone side effects (in more detail)


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Geref Diagnostic


Generic Name: sermorelin (Injection route)

ser-moe-REL-in

Commonly used brand name(s)

In the U.S.

Geref Geref Diagnostic

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Growth Hormone Releasing Hormone Analog

Uses For Geref Diagnostic

Sermorelin is a synthetic (man-made) version of a naturally occurring substance that causes release of growth hormone from the pituitary gland. Growth hormone is naturally produced by the pituitary gland and is necessary for growth in children. In children who fail to grow normally because their bodies are not producing enough growth hormone, this medicine may be used to increase the amount of growth hormone produced by the pituitary gland.

This medicine is available only with your doctor's prescription.

Before Using Geref Diagnostic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Underactive thyroid—This condition can interfere with the effects of sermorelin Proper Use of sermorelin

This section provides information on the proper use of a number of products that contain sermorelin. It may not be specific to Geref Diagnostic. Please read with care.

If you are injecting this medicine yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine needed has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve the condition.

Each package of sermorelin contains a patient instruction sheet. Read this sheet carefully and make sure you understand:

How to prepare the injection. Proper use of disposable syringes and needles, including safe handling and disposal. How to give the injection. How long the injection is safe to use.

It is best to use a different place on the body for each injection (for example, abdomen, hip, thigh, or upper arm). To help you remember to do this, you may want to keep a record of the date and location for each injection.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Geref Diagnostic

It is very important that your doctor check your progress at regular visits.

Geref Diagnostic Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common Pain, redness, or swelling at the place of injection Rare Itching trouble in swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare Dizziness flushing headache sleepiness trouble sitting still

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Geref Diagnostic resources Geref Diagnostic Use in Pregnancy & BreastfeedingGeref Diagnostic Support Group0 Reviews · Be the first to review/rate this drug Geref MedFacts Consumer Leaflet (Wolters Kluwer)
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Edex


Generic Name: alprostadil (Intraurethral route, Intravenous route, Intracavernosal route)

al-PROS-ta-dil

Intravenous route(Solution)

Apnea is experienced by about 10% to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used only where ventilatory assistance is immediately available .

Commonly used brand name(s)

In the U.S.

Caverject Edex Muse Prostin VR Pediatric

In Canada

Muse Micro

Available Dosage Forms:

Powder for Solution Kit Suppository Solution

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Prostaglandin

Uses For Edex

Alprostadil belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. Alprostadil is used to produce erections in some men who need treatment for erectile dysfunction (sexual impotence). This medicine causes an erection because it increases the blood flow to the penis.

Alprostadil injection should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Alprostadil is used alone or with medical tests to help diagnose erectile dysfunction that may be caused by nerve or blood vessel problems in the penis.

Alprostadil is available only with your doctor's prescription.

Before Using Edex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Heparin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased Bleeding problems—Chance of bleeding at the place of injection may be increased Infection of penis or Red or itchy (inflamed) penis—Conditions may worsen with the use of alprostadil suppositories. Also, local skin problems and minor bleeding from inserting the suppository may occur Conditions causing thickened blood or slower blood flow, including leukemia; multiple myeloma (tumors of the bone marrow); polycythemia, sickle cell disease, or thrombocythemia (blood problems) or Priapism (history of)—Patients with these conditions have an increased risk of priapism (erection lasting longer than 6 hours) while using alprostadil Proper Use of alprostadil

This section provides information on the proper use of a number of products that contain alprostadil. It may not be specific to Edex. Please read with care.

Special patient directions come with the suppositories and some of the injection medicines. Read the directions carefully before using the medicine.

For the injections—There are several alprostadil products that can be injected. Although the injection method is the same, the mixing procedures are different. Be sure you know which of these products you will be using and the proper way to mix the injection.

One product called Alprostadil for Injection (brand names Caverject and Edex) is available as a powder in an injection bottle (vial). Caverject must be mixed with a solution called Bacteriostatic Water for Injection USP. Edex must be mixed with a solution called Sodium Chloride Injection USP. The solution for mixing comes with your product and may be already loaded into a syringe or contained in another injection bottle (vial). Another product is called Alprostadil Injection (brand names Prostin VR Pediatric and Prostin VR). Although the medicine is already in solution, it is much too strong to be injected into the penis. The solution must be mixed (diluted) with another liquid that is sold as a separate prescription, called 0.9% Sodium Chloride Injection USP. In most cases, a pharmacist will make this solution for you, giving you the proper strength that you need. Check with your doctor or pharmacist to make sure the solution has been diluted before using it.

It is important to follow several steps to prepare your alprostadil injection correctly. Before drawing up the medicine into the syringe:

Wash your hands with soap and water. Set the bottles on a clean surface. Wipe the top of the injection bottles with an alcohol swab. Do not wipe the needle. Throw away the alcohol swab. You may need to attach the needle to the syringe. Do not take the cap off yet.

How to mix Caverject:

If the syringe already contains the Bacteriostatic Water for Injection USP, then you need only add the plunger to the syringe. To do this: Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force. Hold the syringe by the barrel (not the plunger) and take the cap off the needle. You are now ready to mix the water and the powder. Skip to the directions under the title, “To mix the water and powder." If the syringe does not already contain the Bacteriostatic Water for Injection USP, you must withdraw 1 milliliter (mL) of it from the bottle provided. To do this: Pick up the syringe and take the cap off the needle. Pull the plunger back to the 1-mL mark on the syringe. This pulls air into the syringe. Insert the needle into rubber top of the bottle while it is upright and inject the 1 mL of air into the bottle. Turn the bottle upside down using one hand. Be sure the tip of the needle is covered by solution. With your other hand, pull the plunger back slowly to withdraw 1 mL of solution into the syringe. Remove the needle and skip to the directions under the title, "To mix the water and powder." To mix the water and powder: Insert the needle into the bottle of alprostadil and inject 1 milliliter of Bacteriostatic Water for Injection USP from your syringe into the bottle of alprostadil. Remove the needle from the bottle, holding the barrel of the syringe. Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle. Follow the directions below, “How to draw your dose into the syringe."

How to mix Edex:

The syringe already contains the Sodium Chloride Injection USP. You need only attach the needle to the syringe and add the plunger. To do this: Remove the needle from its package. Do not remove the needle cap. Gently screw the needle into place on the syringe tip. Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force. Hold the syringe by the barrel (not the plunger) and take the cap off the needle. You are now ready to mix the Sodium Chloride Injection USP and the powder. Insert the needle into the bottle of alprostadil and inject 1.2 milliliters of the Sodium Chloride Injection USP from your syringe into the bottle of alprostadil. Remove the needle from the bottle, holding the barrel of the syringe. Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle. Follow the directions below, “How to draw your dose into the syringe."

How to mix Prostin VR or Prostin VR Pediatric:

You will need to get exact mixing instructions from your doctor or pharmacist if you are given two solutions to be mixed. Follow them carefully, asking the pharmacist or doctor any questions that you might have before injecting the medicine. After you or the pharmacist has mixed these solutions, follow the directions below, “How to draw your dose into the syringe."

How to draw your dose into the syringe (for all injection products):

Check the solution to make sure it is clear. Do not use the mixture if you can see anything solid in the solution or if the solution is cloudy or colored. After the alprostadil solution is mixed and the needle is inserted into the alprostadil bottle, turn the bottle with the syringe as a unit upside down in one hand. Be sure the tip of the needle is covered by the solution. With your other hand, pull the plunger back slowly to draw the correct dose of the medicine into the syringe. Hold the syringe with the measuring scale at eye level to see that the proper dose is withdrawn and to check for air bubbles. To remove air bubbles, tap gently on the measuring scale of the syringe to move any bubbles to the top of the syringe near the needle. If your dose measures too low in the syringe, withdraw more solution from the bottle. If there is too much medicine in the syringe, put some back into the bottle. Then check your dose again. Remove the needle from the bottle, holding the barrel of the syringe, not the plunger. Place the cover back on the needle. You are now ready to inject your dose. Follow the directions below, “How to give the alprostadil injection."

How to give the alprostadil injection:

Choose a spot on your penis as directed by your doctor where you will give the injection. Clean the injection site with alcohol. Sitting upright or slightly reclined, hold your penis against the side of your thigh so that it cannot move. Remove the cover from the needle and hold the needle at a 90-degree angle to the place of injection. Insert the needle until almost all of the metal part of the needle is inserted into the penis. Do not inject the medicine just under the surface of the skin, at the top or head of the penis, or at the base of the penis near the scrotum or testes. Avoid injecting the medicine into blood vessels that you can see. Press the plunger down slowly, taking 5 to 10 seconds to release the dose into the penis. The injection is usually not painful. If the injection is very painful or if you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection. Remove the needle and recap it. After you have completed the injection, put pressure on the place of injection for about 5 minutes or until any bleeding stops. This will prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that the medicine will work better.

Choose a different place of injection each time you use the medicine to prevent skin problems. This includes switching the place of injection from the right side of the penis for one injection to the left side for the next injection.

After a single-use injection is mixed, the medicine must be used immediately. Throw away any unused mixture in the syringe. It cannot be stored for a later injection.

Do not reuse your needles.

How to throw away the syringes and bottles safely:

Dispose of your materials properly. Caverject comes in a plastic case that can be permanently locked with the red locking device that is included with the packaging. When the case label is removed, you can see a hole in the center of the case. The red locking device can be inserted and, by firmly pressing it down with your thumb, you will permanently lock the case. The locked case is safe to be thrown away.

If you do not have the plastic case or are using Prostin VR or Prostin VR Pediatric injection, unscrew the needle from the barrel of the syringe. Then bend, break, or cut the needle into two pieces with wire cutters. The pieces can be placed in a heavy plastic container, such as a bleach container, and thrown away. Or you may give them to a health care professional to throw away. If you have any questions about disposing of the syringe and needles, ask your health care professional.

For suppositories—Before inserting the suppository, you should urinate. The small amount of urine normally left in your urethra will help dissolve the suppository after it is inserted.

How to insert suppositories:

Remove the delivery device containing the suppository from the foil. Remove the cap from the applicator stem. Stretch your penis upward to extend its length, pressing your penis top and bottom. Gently insert the delivery stem up to its collar into your urethra (located at the top of the penis). If you have pain or a pulling feeling in the penis, withdraw the device and start again. Press the button down slowly as far as it will go. This releases the suppository into the urethra. After holding the delivery device within your penis still for 5 seconds, carefully rock the penis and delivery device as a unit from side to side. This helps remove the suppository from the device. Remove the delivery device while your penis is upright. Look at the device to make sure that the suppository was completely released. Repeat the process if a part of the suppository remains in the device. After the suppository is completely released, roll your penis between your hands for 10 seconds. This helps to dissolve the suppository. If you feel any stinging, continue this motion to help stop it. Sitting, standing, or walking for 10 minutes while an erection is developing helps increase the blood flow to your penis to gain a proper erection.

How to throw away the suppository delivery device safely:

Replace the cap on the delivery device. After storing it in the foil, fold and throw away.

For injections or suppositories—This medicine usually begins to work in about 5 to 10 minutes. You should attempt intercourse within 10 to 30 minutes after using the medicine. An erection may continue after ejaculation.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For the treatment of erectile dysfunction: For injection dosage form: Adults—1.25 to 60 micrograms (mcg) as a single dose once a day. Your exact dose will be determined by your doctor. Inject this medicine very slowly into your penis as shown to you by your doctor ten to thirty minutes before intercourse. Allow five to ten seconds to completely inject the dose. Do not inject more than one dose within twenty-four hours. Also, do not use this medicine for more than two days in a row or more than three times a week. For suppository dosage form: Adults—125, 250, 500, or 1000 mcg as a single dose once a day. Your exact dose will be determined by your doctor. Insert this medicine into the urethra of your penis as shown to you by your doctor ten to thirty minutes before intercourse. Do not insert more than two doses within twenty-four hours. Storage

Store in the refrigerator. Do not freeze.

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Alprostadil for Injection while in the powder form can be stored at room temperature (between 15 and 25 °C or 59 and 77 °F) for 3 months. After it is mixed, the solution must be used immediately. Suppositories may be stored at room temperature

Precautions While Using Edex

Do not use alprostadil if you have a penile implant unless advised by doctor.

If using the alprostadil suppository, use a condom when having sexual intercourse with a pregnant female. Although harm to the fetus is unlikely, using a condom will protect the fetus from exposure to this medicine. If a woman can become pregnant, use of contraceptive methods is recommended because the effects of this medicine on early pregnancy are not known.

Use alprostadil exactly as directed by your doctor . Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the erection lasts too long and does not reverse when it should. This condition is called priapism. If the erection is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

If you notice bleeding at the place where you injected the medicine, put pressure on the spot until the bleeding stops. If it doesn't stop within 10 minutes, check with your doctor.

Edex Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Curving of penis with pain during erection erection continuing for 4 to 6 hours erection continuing longer than 6 hours with severe and continuing pain of the penis swelling in or pain of the testes Symptoms of too much medicine being absorbed into the body Dizziness faintness pelvic pain flu-like symptoms

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Bleeding at place of injection, short-term mild bleeding or spotting from urethra (suppository only) pain at place of injection painful erection stinging of urethra (suppository only) Rare

Female partners may experience itching or stinging of vagina when you first begin using the alprostadil suppository. These side effects may not be caused from the medicine but may result if female partner has not had frequent or recent sexual intercourse.

Bruising or clotted blood in penis at place of injection, usually caused by an incorrect injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Edex side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Edex resources Edex Side Effects (in more detail) Edex Use in Pregnancy & Breastfeeding Edex Drug Interactions Edex Support Group 9 Reviews for Edex - Add your own review/rating Edex MedFacts Consumer Leaflet (Wolters Kluwer) Edex injectable and transurethral Concise Consumer Information (Cerner Multum) Alprostadil MedFacts Consumer Leaflet (Wolters Kluwer) Alprostadil Prescribing Information (FDA) Alprostadil Monograph (AHFS DI) Caverject Prescribing Information (FDA) Muse Suppository MedFacts Consumer Leaflet (Wolters Kluwer) Muse Prescribing Information (FDA) Prostin VR Pediatric Prescribing Information (FDA) Compare Edex with other medications Erectile Dysfunction
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Muse


Generic Name: alprostadil (Intraurethral route, Intravenous route, Intracavernosal route)

al-PROS-ta-dil

Intravenous route(Solution)

Apnea is experienced by about 10% to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used only where ventilatory assistance is immediately available .

Commonly used brand name(s)

In the U.S.

Caverject Edex Muse Prostin VR Pediatric

In Canada

Muse Micro

Available Dosage Forms:

Powder for Solution Kit Suppository Solution

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Prostaglandin

Uses For Muse

Alprostadil belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. Alprostadil is used to produce erections in some men who need treatment for erectile dysfunction (sexual impotence). This medicine causes an erection because it increases the blood flow to the penis.

Alprostadil injection should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Alprostadil is used alone or with medical tests to help diagnose erectile dysfunction that may be caused by nerve or blood vessel problems in the penis.

Alprostadil is available only with your doctor's prescription.

Before Using Muse

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Heparin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased Bleeding problems—Chance of bleeding at the place of injection may be increased Infection of penis or Red or itchy (inflamed) penis—Conditions may worsen with the use of alprostadil suppositories. Also, local skin problems and minor bleeding from inserting the suppository may occur Conditions causing thickened blood or slower blood flow, including leukemia; multiple myeloma (tumors of the bone marrow); polycythemia, sickle cell disease, or thrombocythemia (blood problems) or Priapism (history of)—Patients with these conditions have an increased risk of priapism (erection lasting longer than 6 hours) while using alprostadil Proper Use of alprostadil

This section provides information on the proper use of a number of products that contain alprostadil. It may not be specific to Muse. Please read with care.

Special patient directions come with the suppositories and some of the injection medicines. Read the directions carefully before using the medicine.

For the injections—There are several alprostadil products that can be injected. Although the injection method is the same, the mixing procedures are different. Be sure you know which of these products you will be using and the proper way to mix the injection.

One product called Alprostadil for Injection (brand names Caverject and Edex) is available as a powder in an injection bottle (vial). Caverject must be mixed with a solution called Bacteriostatic Water for Injection USP. Edex must be mixed with a solution called Sodium Chloride Injection USP. The solution for mixing comes with your product and may be already loaded into a syringe or contained in another injection bottle (vial). Another product is called Alprostadil Injection (brand names Prostin VR Pediatric and Prostin VR). Although the medicine is already in solution, it is much too strong to be injected into the penis. The solution must be mixed (diluted) with another liquid that is sold as a separate prescription, called 0.9% Sodium Chloride Injection USP. In most cases, a pharmacist will make this solution for you, giving you the proper strength that you need. Check with your doctor or pharmacist to make sure the solution has been diluted before using it.

It is important to follow several steps to prepare your alprostadil injection correctly. Before drawing up the medicine into the syringe:

Wash your hands with soap and water. Set the bottles on a clean surface. Wipe the top of the injection bottles with an alcohol swab. Do not wipe the needle. Throw away the alcohol swab. You may need to attach the needle to the syringe. Do not take the cap off yet.

How to mix Caverject:

If the syringe already contains the Bacteriostatic Water for Injection USP, then you need only add the plunger to the syringe. To do this: Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force. Hold the syringe by the barrel (not the plunger) and take the cap off the needle. You are now ready to mix the water and the powder. Skip to the directions under the title, “To mix the water and powder." If the syringe does not already contain the Bacteriostatic Water for Injection USP, you must withdraw 1 milliliter (mL) of it from the bottle provided. To do this: Pick up the syringe and take the cap off the needle. Pull the plunger back to the 1-mL mark on the syringe. This pulls air into the syringe. Insert the needle into rubber top of the bottle while it is upright and inject the 1 mL of air into the bottle. Turn the bottle upside down using one hand. Be sure the tip of the needle is covered by solution. With your other hand, pull the plunger back slowly to withdraw 1 mL of solution into the syringe. Remove the needle and skip to the directions under the title, "To mix the water and powder." To mix the water and powder: Insert the needle into the bottle of alprostadil and inject 1 milliliter of Bacteriostatic Water for Injection USP from your syringe into the bottle of alprostadil. Remove the needle from the bottle, holding the barrel of the syringe. Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle. Follow the directions below, “How to draw your dose into the syringe."

How to mix Edex:

The syringe already contains the Sodium Chloride Injection USP. You need only attach the needle to the syringe and add the plunger. To do this: Remove the needle from its package. Do not remove the needle cap. Gently screw the needle into place on the syringe tip. Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force. Hold the syringe by the barrel (not the plunger) and take the cap off the needle. You are now ready to mix the Sodium Chloride Injection USP and the powder. Insert the needle into the bottle of alprostadil and inject 1.2 milliliters of the Sodium Chloride Injection USP from your syringe into the bottle of alprostadil. Remove the needle from the bottle, holding the barrel of the syringe. Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle. Follow the directions below, “How to draw your dose into the syringe."

How to mix Prostin VR or Prostin VR Pediatric:

You will need to get exact mixing instructions from your doctor or pharmacist if you are given two solutions to be mixed. Follow them carefully, asking the pharmacist or doctor any questions that you might have before injecting the medicine. After you or the pharmacist has mixed these solutions, follow the directions below, “How to draw your dose into the syringe."

How to draw your dose into the syringe (for all injection products):

Check the solution to make sure it is clear. Do not use the mixture if you can see anything solid in the solution or if the solution is cloudy or colored. After the alprostadil solution is mixed and the needle is inserted into the alprostadil bottle, turn the bottle with the syringe as a unit upside down in one hand. Be sure the tip of the needle is covered by the solution. With your other hand, pull the plunger back slowly to draw the correct dose of the medicine into the syringe. Hold the syringe with the measuring scale at eye level to see that the proper dose is withdrawn and to check for air bubbles. To remove air bubbles, tap gently on the measuring scale of the syringe to move any bubbles to the top of the syringe near the needle. If your dose measures too low in the syringe, withdraw more solution from the bottle. If there is too much medicine in the syringe, put some back into the bottle. Then check your dose again. Remove the needle from the bottle, holding the barrel of the syringe, not the plunger. Place the cover back on the needle. You are now ready to inject your dose. Follow the directions below, “How to give the alprostadil injection."

How to give the alprostadil injection:

Choose a spot on your penis as directed by your doctor where you will give the injection. Clean the injection site with alcohol. Sitting upright or slightly reclined, hold your penis against the side of your thigh so that it cannot move. Remove the cover from the needle and hold the needle at a 90-degree angle to the place of injection. Insert the needle until almost all of the metal part of the needle is inserted into the penis. Do not inject the medicine just under the surface of the skin, at the top or head of the penis, or at the base of the penis near the scrotum or testes. Avoid injecting the medicine into blood vessels that you can see. Press the plunger down slowly, taking 5 to 10 seconds to release the dose into the penis. The injection is usually not painful. If the injection is very painful or if you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection. Remove the needle and recap it. After you have completed the injection, put pressure on the place of injection for about 5 minutes or until any bleeding stops. This will prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that the medicine will work better.

Choose a different place of injection each time you use the medicine to prevent skin problems. This includes switching the place of injection from the right side of the penis for one injection to the left side for the next injection.

After a single-use injection is mixed, the medicine must be used immediately. Throw away any unused mixture in the syringe. It cannot be stored for a later injection.

Do not reuse your needles.

How to throw away the syringes and bottles safely:

Dispose of your materials properly. Caverject comes in a plastic case that can be permanently locked with the red locking device that is included with the packaging. When the case label is removed, you can see a hole in the center of the case. The red locking device can be inserted and, by firmly pressing it down with your thumb, you will permanently lock the case. The locked case is safe to be thrown away.

If you do not have the plastic case or are using Prostin VR or Prostin VR Pediatric injection, unscrew the needle from the barrel of the syringe. Then bend, break, or cut the needle into two pieces with wire cutters. The pieces can be placed in a heavy plastic container, such as a bleach container, and thrown away. Or you may give them to a health care professional to throw away. If you have any questions about disposing of the syringe and needles, ask your health care professional.

For suppositories—Before inserting the suppository, you should urinate. The small amount of urine normally left in your urethra will help dissolve the suppository after it is inserted.

How to insert suppositories:

Remove the delivery device containing the suppository from the foil. Remove the cap from the applicator stem. Stretch your penis upward to extend its length, pressing your penis top and bottom. Gently insert the delivery stem up to its collar into your urethra (located at the top of the penis). If you have pain or a pulling feeling in the penis, withdraw the device and start again. Press the button down slowly as far as it will go. This releases the suppository into the urethra. After holding the delivery device within your penis still for 5 seconds, carefully rock the penis and delivery device as a unit from side to side. This helps remove the suppository from the device. Remove the delivery device while your penis is upright. Look at the device to make sure that the suppository was completely released. Repeat the process if a part of the suppository remains in the device. After the suppository is completely released, roll your penis between your hands for 10 seconds. This helps to dissolve the suppository. If you feel any stinging, continue this motion to help stop it. Sitting, standing, or walking for 10 minutes while an erection is developing helps increase the blood flow to your penis to gain a proper erection.

How to throw away the suppository delivery device safely:

Replace the cap on the delivery device. After storing it in the foil, fold and throw away.

For injections or suppositories—This medicine usually begins to work in about 5 to 10 minutes. You should attempt intercourse within 10 to 30 minutes after using the medicine. An erection may continue after ejaculation.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For the treatment of erectile dysfunction: For injection dosage form: Adults—1.25 to 60 micrograms (mcg) as a single dose once a day. Your exact dose will be determined by your doctor. Inject this medicine very slowly into your penis as shown to you by your doctor ten to thirty minutes before intercourse. Allow five to ten seconds to completely inject the dose. Do not inject more than one dose within twenty-four hours. Also, do not use this medicine for more than two days in a row or more than three times a week. For suppository dosage form: Adults—125, 250, 500, or 1000 mcg as a single dose once a day. Your exact dose will be determined by your doctor. Insert this medicine into the urethra of your penis as shown to you by your doctor ten to thirty minutes before intercourse. Do not insert more than two doses within twenty-four hours. Storage

Store in the refrigerator. Do not freeze.

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Alprostadil for Injection while in the powder form can be stored at room temperature (between 15 and 25 °C or 59 and 77 °F) for 3 months. After it is mixed, the solution must be used immediately. Suppositories may be stored at room temperature

Precautions While Using Muse

Do not use alprostadil if you have a penile implant unless advised by doctor.

If using the alprostadil suppository, use a condom when having sexual intercourse with a pregnant female. Although harm to the fetus is unlikely, using a condom will protect the fetus from exposure to this medicine. If a woman can become pregnant, use of contraceptive methods is recommended because the effects of this medicine on early pregnancy are not known.

Use alprostadil exactly as directed by your doctor . Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the erection lasts too long and does not reverse when it should. This condition is called priapism. If the erection is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

If you notice bleeding at the place where you injected the medicine, put pressure on the spot until the bleeding stops. If it doesn't stop within 10 minutes, check with your doctor.

Muse Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Curving of penis with pain during erection erection continuing for 4 to 6 hours erection continuing longer than 6 hours with severe and continuing pain of the penis swelling in or pain of the testes Symptoms of too much medicine being absorbed into the body Dizziness faintness pelvic pain flu-like symptoms

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Bleeding at place of injection, short-term mild bleeding or spotting from urethra (suppository only) pain at place of injection painful erection stinging of urethra (suppository only) Rare

Female partners may experience itching or stinging of vagina when you first begin using the alprostadil suppository. These side effects may not be caused from the medicine but may result if female partner has not had frequent or recent sexual intercourse.

Bruising or clotted blood in penis at place of injection, usually caused by an incorrect injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Muse side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Muse resources Muse Side Effects (in more detail) Muse Use in Pregnancy & Breastfeeding Muse Drug Interactions Muse Support Group 4 Reviews for Muse - Add your own review/rating Muse Prescribing Information (FDA) Muse Suppository MedFacts Consumer Leaflet (Wolters Kluwer) Muse injectable and transurethral Concise Consumer Information (Cerner Multum) Alprostadil Monograph (AHFS DI) Alprostadil Prescribing Information (FDA) Alprostadil MedFacts Consumer Leaflet (Wolters Kluwer) Caverject Prescribing Information (FDA) Edex MedFacts Consumer Leaflet (Wolters Kluwer) Prostin VR Pediatric Prescribing Information (FDA) Compare Muse with other medications Erectile Dysfunction
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Humulin Vials, Cartridges and Pens


1. Name Of The Medicinal Product

HUMULIN* S (Soluble) 100IU/ml solution for injection in vial

HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge

HUMULIN I (Isophane) 100IU/ml suspension for injection in vial

HUMULIN I (Isophane) 100IU/ml suspension for injection in cartridge

HUMULIN I KwikPen (Isophane) 100IU/ml suspension for injection

HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial

HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge

HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection

2. Qualitative And Quantitative Composition

1ml contains 100IU human insulin (produced in E. coli by recombinant DNA technology).

HUMULIN S:

One vial contains 10ml equivalent to 1000IU of soluble insulin.

One cartridge contains 3ml equivalent to 300IU of soluble insulin.

HUMULIN I:

One vial contains 10ml equivalent to 1000IU of isophane insulin.

One cartridge contains 3ml equivalent to 300IU of isophane insulin.

HUMULIN I KwikPen:

One pre-filled pen contains 3ml equivalent to 300IU of isophane insulin.

HUMULIN M3:

One vial contains 10ml equivalent to 1000IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin.

One cartridge contains 3ml equivalent to 300IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin.

HUMULIN M3 KwikPen:

One pre-filled pen contains 3ml equivalent to 300IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

HUMULIN S: A solution for injection in a cartridge or vial. HUMULIN S is a sterile, clear, colourless, aqueous solution of human insulin.

HUMULIN I: A suspension for injection in a cartridge, vial or pre-filled pen. HUMULIN I is a sterile suspension of a white, crystalline precipitate of isophane human insulin in an isotonic phosphate buffer.

HUMULIN M3: A suspension for injection in a cartridge, vial or pre-filled pen. HUMULIN M3 is a sterile suspension of human insulin in the proportion of 30% soluble insulin to 70% isophane insulin.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.

4.2 Posology And Method Of Administration

The dosage should be determined by the physician, according to the requirement of the patient.

HUMULIN S should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. It may also be administered intravenously.

HUMULIN I and HUMULIN M3 should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. This formulation should not be administered intravenously.

Subcutaneous administration should be in the upper arms, thighs, buttocks or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.

Care should be taken when injecting any HUMULIN insulin preparations to ensure that a blood vessel has not been entered. After any insulin injection, the injection site should not be massaged. Patients must be educated to use proper injection techniques.

HUMULIN I (Isophane) may be administered in combination with HUMULIN S (Soluble). (See 'Instructions for use and handling' for 'Mixing of insulins'.)

HUMULIN Mixture formulation is a ready-made defined mixture of soluble and isophane insulin designed to avoid the need for the patient to mix insulin preparations. A patient's treatment regimen should be based on their individual metabolic requirements.

Each pack contains a patient information leaflet with instructions on how to inject insulin.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to HUMULIN or to the formulation excipients, unless used as part of a desensitisation programme.

Under no circumstances should any HUMULIN formulation, other than HUMULIN S (Soluble), be given intravenously.

4.4 Special Warnings And Precautions For Use

Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, mixture), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.

Some patients taking human insulin may require a change in dosage from that used with animal-source insulins. If an adjustment is needed, it may occur with the first dose or during the first several weeks or months.

A few patients who experienced hypoglycaemic reactions after transfer to human insulin have reported that the early warning symptoms were less pronounced or different from those experienced with their previous animal insulin. Patients whose blood glucose is greatly improved, e.g., by intensified insulin therapy, may lose some or all of the warning symptoms of hypoglycaemia and should be advised accordingly. Other conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, diabetic nerve disease, or medications such as beta-blockers. Uncorrected hypoglycaemic and hyperglycaemic reactions can cause loss of consciousness, coma or death.

The use of dosages which are inadequate, or discontinuation of treatment, especially in insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis, conditions which are potentially lethal.

Treatment with human insulin may cause formation of antibodies, but titres of antibodies are lower than those to purified animal insulin.

Insulin requirements may change significantly in diseases of the adrenal, pituitary, or thyroid glands, and in the presence of renal or hepatic impairment.

Insulin requirements may be increased during illness or emotional disturbances.

Adjustment of insulin dosage may also be necessary if patients change their level of physical activity or change their usual diet.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Some medicinal products are known to interact with glucose metabolism. The physician should take possible interactions into account and ask patients about their other medications in addition to human insulin.

Insulin requirements may be increased by substances with hyperglycaemic activity, such as glucocorticoids, thyroid hormones, growth hormone, danazol, beta2-sympatomimetics (such as ritodrine, salbutamol, terbutaline), thiazides.

Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics (OHA), salicylates (for example, acetylsalicylic acid), certain antidepressants (monoamine oxidase inhibitors), certain angiotensin-converting enzyme (ACE) inhibitors (captopril, enalapril), angiotensin II receptor blockers, non-selective beta-blocking agents, and alcohol.

Somatostatin analogues (octreotide, lanreotide) may both decrease or increase insulin dose requirements.

4.6 Pregnancy And Lactation

It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients with diabetes should be advised to inform their doctors if they are pregnant or are contemplating pregnancy.

Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.

Patients with diabetes who are lactating may require adjustments in insulin dose and/or diet.

4.7 Effects On Ability To Drive And Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g., driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving; this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Undesirable Effects

Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e.g., a patient's level of diet and exercise.

Local allergy in patients is common (1/100 to <1/10). Redness, swelling, and itching can occur at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, local reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.

Systemic allergy, which is very rare (<1/10,000) but potentially more serious, is a generalised allergy to insulin. It may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalised allergy may be life-threatening. In the rare event of a severe allergy to HUMULIN, treatment is required immediately. A change of insulin or desensitisation may be required.

Lipodystrophy at the injection site is uncommon (1/1,000 to <1/100).

4.9 Overdose

Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin relative to food intake and energy expenditure.

Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.

Mild hypoglycaemic episodes will respond to oral administration of glucose or sugar products.

Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously.

If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. However, glucose solution must be given intravenously if glucagon is not available, or if the patient fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.

Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may occur after apparent clinical recovery.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmaco-therapeutic group:

HUMULIN S: ATC code, A10A B01

HUMULIN I: ATC code, A10A C01

HUMULIN M3: ATC code, A10A D01

HUMULIN S is a rapidly-acting insulin preparation.

HUMULIN I is an intermediate-acting insulin preparation.

HUMULIN M3 (Mixture 3) is an intermediate-acting insulin preparation.

The prime activity of insulin is the regulation of glucose metabolism.

In addition, insulin has several anabolic and anti-catabolic actions on a variety of different tissues. Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.

The typical activity profile (glucose utilisation curve) following subcutaneous injection is illustrated below by the heavy line. Variations that a patient may experience in timing and/or intensity of insulin activity are illustrated by the shaded area. Individual variability will depend on factors such as size of dose, site of injection temperature and physical activity of the patient.

5.2 Pharmacokinetic Properties

The pharmacokinetics of insulin do not reflect the metabolic action of that hormone. Therefore, it is more appropriate to examine glucose utilisation curves (as discussed above) when considering the activity of insulin.

5.3 Preclinical Safety Data

HUMULIN is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic toxicity assays.

6. Pharmaceutical Particulars 6.1 List Of Excipients

For HUMULIN S preparations:

m-cresol

Glycerol

Water for injections

The following may be used to adjust pH:

Hydrochloric acid and/or

Sodium hydroxide

For HUMULIN I and HUMULIN M3 preparations:

m-cresol

Glycerol

Phenol

Protamine sulphate

Dibasic sodium phosphate 7H2O

Zinc oxide

Water for injections

The following may be used to adjust pH:

Hydrochloric acid and/or

Sodium hydroxide

6.2 Incompatibilities

HUMULIN preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.

6.3 Shelf Life

Vials: The shelf-life for HUMULIN S, HUMULIN I and HUMULIN M3 presentations is two years.

Once in use the vials may be used for up to 28 days. Do not use beyond this period. When in use the vials should not be stored above 30°C.

Cartridges: The shelf-life for the HUMULIN S presentation is two years. The shelf-life for HUMULIN I and HUMULIN M3 presentations is 3 years.

After insertion of the cartridge in the pen, the solution or suspension should be used in 28 days. Do not use beyond this period. When in use the cartridges should not be stored above 30°C.

Pre-filled pens: The shelf-life for HUMULIN I- and M3 KwikPen presentations is 3 years.

Once in use HUMULIN I- and M3 KwikPen may be used for up to 28 days. Do not use beyond this period. When in use HUMULIN I- and M3 KwikPen should not be stored above 30°C.

6.4 Special Precautions For Storage

Store in a refrigerator (2°C-8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Keep the container in the outer carton.

6.5 Nature And Contents Of Container

Vials: 10ml of solution or suspension in a vial (Type I glass) with a stopper (rubber) sealed with a seal (aluminium) combined with a flip top (plastic).

Pack size 1 or 2.

Cartridges: 3ml solution or suspension in a cartridge (Type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber).

Pack size of 5.

Pre-filled pens: 3ml suspension in a cartridge (Type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber) in a pre-filled pen.

HUMULIN I- and M3 KwikPen: Pack size of 5, or 2 x 5 x 3ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Do not reuse needles. Dispose of the needle in a responsible manner. Needles and pens must not be shared. Vials, cartridges and HUMULIN I- and M3 KwikPen can be used until empty, then properly discard. Any unused product or waste material should be disposed of in accordance with local requirements.

Instructions for use and handling

A Vials

A solution or suspension for injection in a 10ml vial to be used in conjunction with an appropriate syringe (100 IU/ml markings).

B Cartridges

A solution or suspension for injection in a 3ml cartridge to be used with a CE marked pen as recommended in the information provided by the device manufacturer.

C Pre-filled pens

A suspension for injection in a pre-filled /disposable pen injector containing a 3ml cartridge. HUMULIN I- and M3 KwikPen delivers up to 60 units per dose in single unit increments.

a) Preparing a dose

Vials or cartridges containing HUMULIN S formulation do not require resuspension and should only be used if it is clear, colourless, with no solid particles visible and if it is of water-like appearance.

Vials containing HUMULIN I or the HUMULIN M3 formulations should be rotated several times in the palms of the hands before use to completely resuspend the insulin, until it appears uniformly cloudy or milky. Cartridges and pre-filled pens containing HUMULIN I and HUMULIN M3 formulations should be rolled in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing, which may interfere with the correct measurement of the dose.

The vials, cartridges, and pre-filled pens should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the vial or cartridge, giving a frosted appearance.

HUMULIN S and I Vials: Mixing of insulins - The shorter-acting insulin should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting preparation. It is advisable to inject directly after mixing. However, if a delay is necessary, a consistent routine must be followed.

Alternatively, a separate syringe or, separate cartridges of HUMULIN S and I, can be used for administration of the correct amount of each formulation.

Vials:

Prepare your syringe prior to injection, as directed by your doctor or diabetes specialist nurse.

Use an insulin syringe marked for the strength of insulin being administered.

Cartridges and pre-filled pens:

The cartridges are not designed to allow any other insulin to be mixed in the cartridge. Cartridges are not designed to be refilled.

The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.

Follow the instructions with HUMULIN I- and M3 KwikPen for attaching the needle and administering the insulin injection.

For HUMULIN I- and M3 KwikPen, a needle must always be attached before priming, dialling, and injecting an insulin dose. HUMULIN I- and M3 KwikPen should always be primed before each injection. Failure to prime HUMULIN I- and M3 KwikPen may result in an inaccurate dose.

b) Injecting a dose

Inject the correct dose of insulin, as directed by your doctor or diabetes specialist nurse.

Use of the injection sites should be rotated so that the same site is not used more than approximately once a month.

Each pack contains a patient information leaflet with instructions on how to inject insulin.

7. Marketing Authorisation Holder

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire, RG24 9NL

8. Marketing Authorisation Number(S)

HUMULIN S vial:

PL 00006/0216

HUMULIN I vial:

PL 00006/0228

HUMULIN M3 vial:

PL 00006/0233

 

 

HUMULIN S cartridge:

PL 00006/0242

HUMULIN I cartridge:

PL 00006/0257

HUMULIN M3 cartridge:

PL 00006/0260

 

 

HUMULIN I KwikPen:

PL 00006/0338

HUMULIN M3 KwikPen:

PL 00006/0341

9. Date Of First Authorisation/Renewal Of The Authorisation

HUMULIN S vial:

Date of first authorisation:

Date of last renewal:

16 February 1987

24 April 2006

HUMULIN I vial:

Date of first authorisation:

Date of last renewal:

16 February 1987

24 April 2006

HUMULIN M3 vial:

Date of first authorisation:

Date of last renewal:

28 April 1987

24 April 2006

HUMULIN S cartridge:

Date of first authorisation:

Date of last renewal:

23 November 1990

24 April 2006

HUMULIN I cartridge:

Date of first authorisation:

Date of last renewal:

23 November 1990

24 April 2006

HUMULIN M3 cartridge:

Date of first authorisation:

Date of last renewal:

16 November 1990

24 April 2006

HUMULIN I KwikPen:

Date of first authorisation:

Date of last renewal:

19 September 1997

24 April 2006

HUMULIN M3 KwikPen:

Date of first authorisation:

Date of last renewal:

19 September 1997

24 April 2006

10. Date Of Revision Of The Text

02 June 2010

LEGAL CATEGORY

POM

HUMULIN* (human insulin [prb]) is a trademark of Eli Lilly and Company. HU29M


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Trelstar LA Mixject


Generic Name: triptorelin (TRIP toe REL in)
Brand Names: Trelstar Depot, Trelstar Depot Mixject, Trelstar LA, Trelstar LA Mixject

What is Trelstar LA Mixject (triptorelin)?

Triptorelin is a man-made form of a hormone that regulates many processes in the body. Triptorelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

Triptorelin is used to treat the symptoms of prostate cancer. Triptorelin treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

Triptorelin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Trelstar LA Mixject (triptorelin)? You should not use this medication if you are allergic to triptorelin or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

Before using triptorelin, tell your doctor if you have any type of cancer that has spread to your spine, a bladder obstruction or problems with urination, diabetes, heart disease, high blood pressure, high cholesterol, a history of stroke or heart attack, or if you smoke.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin. Some of the side effects of triptorelin are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels. Call your doctor at once if you have pain or burning when you urinate, blood in your urine, bone pain, numbness, tingling, muscle weakness, or loss of movement in any part of your body. Although triptorelin is not for use by women, this medication can cause birth defects and should not be used by a woman who is pregnant or who may become pregnant. What should I discuss with my healthcare provider before using Trelstar LA Mixject (triptorelin)? You should not use this medication if you are allergic to triptorelin or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

If you have any of these other conditions, you may need a triptorelin dose adjustment or special tests:

any type of cancer that has spread to your spine;

a bladder obstruction or problems with urination;

diabetes, heart disease, high blood pressure, recent weight gain, high cholesterol (especially in men);

heart disease, high blood pressure, high cholesterol;

a history of heart attack or stroke; or

if you smoke.

FDA pregnancy category X. Although triptorelin is not for use by women, this medication can harm an unborn baby or cause birth defects. Triptorelin should not be used by a woman who is pregnant or who may become pregnant. It is not known whether triptorelin passes into breast milk or if it could harm a nursing baby. Although triptorelin is not for use by women, this medication should not be used while breast-feeding a baby. How should I use Trelstar LA Mixject (triptorelin)?

Triptorelin is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

This medication comes with a vial (bottle) of powder medicine and a prefilled syringe of sterile water. The powder must be mixed with the sterile water before using the medicine. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not save the mixture for later use. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Triptorelin is usually given once every 4, 12, or 24 weeks. Your dose schedule will depend on the strength of triptorelin you are using. Follow your doctor's dosing instructions very carefully.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store vials and prefilled syringes at room temperature away from moisture, heat, and light. Do not freeze. What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of triptorelin.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Trelstar LA Mixject (triptorelin)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Trelstar LA Mixject (triptorelin) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect. Some of these side effects are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels:

painful or difficult urination, burning when you urinate, blood in the urine;

bone pain;

numbness, tingling, or muscle weakness (especially in your legs and feet);

loss of movement in any part of your body;

fever, chills, body aches, flu symptoms;

sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech; or

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

hot flashes;

back pain, pain or swelling in your legs;

headache, dizziness, tired feeling;

decreased interest in sex, impotence, trouble having an orgasm;

nausea, vomiting, diarrhea, upset stomach;

sleep problems (insomnia);

breast pain or swelling; or

pain where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trelstar LA Mixject (triptorelin)?

There may be other drugs that can interact with triptorelin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Trelstar LA Mixject resources Trelstar LA Mixject Side Effects (in more detail) Trelstar LA Mixject Use in Pregnancy & Breastfeeding Trelstar LA Mixject Drug Interactions Trelstar LA Mixject Support Group 1 Review for Trelstar LA Mixject - Add your own review/rating Trelstar Depot Prescribing Information (FDA) Trelstar Depot MedFacts Consumer Leaflet (Wolters Kluwer) Trelstar Depot Advanced Consumer (Micromedex) - Includes Dosage Information Trelstar LA Prescribing Information (FDA) Triptorelin Pamoate Monograph (AHFS DI) Compare Trelstar LA Mixject with other medications Prostate Cancer Where can I get more information? Your doctor or pharmacist can provide more information about triptorelin.

See also: Trelstar LA Mixject side effects (in more detail)


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