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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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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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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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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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Tylan 200



Dosage Form: FOR ANIMAL USE ONLY
Tylan® 200

tylosin
Injection

For Use in Swine, Beef Cattle

and Non-lactating Dairy Cattle Only

NADA 12-965 Approved by FDA

DESCRIPTION:

Tylan 200 Injection is a sterile solution of tylosin base in 50% propylene glycol with 4% benzyl alcohol and water for injection. Each mL contains 200 mg of tylosin activity (as tylosin base).

ACTIONS:

Tylan has an antibacterial spectrum that is essentially gram-positive, but it is also active against certain spirochetes, large viruses, and certain gram-negative organisms (not including coliforms). It has also been found to be active against certain Mycoplasma species.

INDICATIONS:

In beef cattle and non-lactating dairy cattle, Tylan 200 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Actinomyces pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Actinomyces pyogenes.

In swine, Tylan 200 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

ADMINISTRATION AND DOSAGE:

Tylan 200 Injection is administered intramuscularly.

BEEF CATTLE AND NON-LACTATING DAIRY CATTLE—Inject intramuscularly 8 mg per pound of body weight one time daily (1 mL per 25 pounds).Treatment should be continued 24 hours following remission of disease signs, not to exceed 5 days. Do not inject more than 10 mL per site.

SWINE—Inject intramuscularly 4 mg per pound of body weight (1 mL per 50 pounds) twice daily. Treatment should be continued 24 hours following remission of disease signs, not to exceed 3 days. Do not inject more than 5 mL per site.

SIDE EFFECTS:

Side effects consisting of an edema of the rectal mucosa, anal protrusion, diarrhea, erythema, and pruritus have been observed in some hogs following the use of tylosin. Discontinuation of treatment effected an uneventful recovery from the reaction.

CAUTION:

Do not mix Tylan 200 Injection with other injectable solutions as this may cause a precipitation of the active ingredients. Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.

PRECAUTION:

Adverse reactions, including shock and death may result from overdosage in baby pigs.

Do not attempt injection into pigs weighing less than 25 pounds (0.5 mL), with the common syringe. It is recommended that Tylan 50 Injection be used in pigs weighing less than 25 pounds.

If tylosin medicated drinking water is used as a follow-up treatment for swine dysentery the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues.

WARNING:

Discontinue use in cattle 21 days before slaughter.

Discontinue use in swine 14 days before slaughter. Do not use in lactating dairy cattle.

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

HOW SUPPLIED:

Tylan 200 Injection is supplied in 100 mL, 250 mL, and 500 mL vials with aluminum sealed rubber stoppers.

Store at 72°F (22°C) or below.

*Elanco® and Tylan® are trademarks of Eli Lilly and Company.

Text revised:          April, 2004
Literature revised:   April, 2004

Manufactured for:
Elanco Animal Health
A Division of Eli Lilly and Company

Indianapolis, IN 46285, USA

To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

PA9021DEAMP (I-APR-04)

Principal Display Panel

Principal Display Panel – 250 ml Bottle Label

ELANCO* AH 0206-38W

Tylan® 200

Tylosin

Injection

200 mg per mL

For Use In Cattle and Swine Only

An Antibiotic

Indications: In Beef Cattle and Non-lactating Dairy Cattle, Tylan 200 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Actinomyces pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Actinomyces pyogenes.

In Swine, Tylan 200 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

250 mL

Principal Display Panel – 250 ml Carton Label

ELANCO* AH 0206-38W

Tylan® 200

Tylosin

Injection

200 mg per mL

For Use In Cattle and Swine Only

The Original Tylan 200

An Antibiotic

For Cattle Diseases

Pneumonia Shipping Fever Metritis Diphtheria Foot Rot

For Swine Diseases

Pneumonia Mycoplasmal Arthritis Dysentery Erysipelas

250 mL


Tylan 200 
tylosin  injection, solution Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 0986-0206 Route of Administration INTRAMUSCULAR DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TYLOSIN (TYLOSIN) TYLOSIN 200 mg  in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   BENZYL ALCOHOL   WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0986-0206-03 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 1 250 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (0986-0206-03) 2 0986-0206-05 500 mL In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA12965 06/03/2010
Labeler - Elanco Animal Health Co (807447169) Establishment Name Address ID/FEI Operations Norbrook Laboratories Limited 232880554 MANUFACTURE Establishment Name Address ID/FEI Operations Evonik Degussa Corporation 130890994 API MANUFACTURE Revised: 06/2010Elanco Animal Health Co

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Epinephrine Solution


Pronunciation: EP-i-NEF-rin
Generic Name: Epinephrine
Brand Name: Generic only. No brands available.
Epinephrine Solution is used for:

Treating severe allergic reactions (eg, difficulty breathing; rash; hives; itching; tightness in the chest; severe dizziness swelling of the mouth, lips, or tongue) caused by insect stings or bites, foods, drugs, or other causes. It may also be used for other conditions as determined by your doctor.

Epinephrine Solution is a sympathomimetic. It works on blood vessels to improve blood pressure and on the smooth muscle of the lungs to help breathing. It also works by decreasing rash, hives, and swelling.

Do NOT use Epinephrine Solution if: you are allergic to any ingredient in Epinephrine Solution, unless your doctor tells you otherwise

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

Before using Epinephrine Solution:

Some medical conditions may interact with Epinephrine 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 (eg, sulfites) if you have heart disease, chest pain, high blood pressure, blood vessel problems, diabetes, Parkinson disease, thyroid problems, mood or mental disorders (eg, depression), asthma, or an irregular heartbeat

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

Bromocriptine, furazolidone, or linezolid because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased Antiarrhythmics (eg, quinidine), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), or droxidopa because the risk of irregular heartbeat may be increased Antihistamines (eg, chlorpheniramine), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), levothyroxine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Epinephrine Solution's side effects Alpha-blockers (eg, prazosin), beta-blockers (eg, propranolol), ergot alkaloids (eg, ergotamine), or phenothiazines (eg, chlorpromazine) because they may decrease Epinephrine Solution's effectiveness Guanethidine because its effectiveness may be decreased by Epinephrine Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epinephrine 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 Epinephrine Solution:

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

An extra patient leaflet is available with Epinephrine Solution. Talk to your pharmacist if you have questions about this information. Epinephrine Solution may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Epinephrine Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Epinephrine Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Check Epinephrine Solution regularly. Replace Epinephrine Solution if the expiration date has passed, if it contains particles or is discolored (pink or darker than slightly yellow), or if the syringe is cracked or damaged in any way. Inject Epinephrine Solution only into the outer thigh as directed by your health care provider. Do not inject into the buttocks or into a vein. Go to the nearest hospital emergency room immediately after use. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of epinephrine. Show the thigh where the injection was given to the doctor. Give your used syringe to the doctor for inspection and proper disposal. If you accidentally inject yourself with Epinephrine Solution, seek immediate medical attention. 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. Epinephrine Solution is usually given in an emergency situation. If you are unable to use Epinephrine Solution, seek medical attention immediately. If you miss a dose of Epinephrine Solution, seek immediate medical attention.

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

Important safety information: Only inject Epinephrine Solution into the outer thigh. Never inject Epinephrine Solution into hands, fingers, feet, or toes. Doing so may cause a loss of blood flow and result in tissue damage to these areas. If you accidentally inject Epinephrine Solution into any of these areas, seek immediate emergency medical attention. It may be helpful to train others how to give Epinephrine Solution in case you are unable to give it to yourself during a reaction. Diabetes patients - Epinephrine Solution may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur or persist, tell your doctor right away. Patients with Parkinson disease may notice a temporary worsening of symptoms (eg, uncontrolled muscle movements). If these symptoms persist, contact your doctor. Use Epinephrine Solution with caution in the ELDERLY; they may be more sensitive to its effects. Caution is advised if Epinephrine Solution is used in CHILDREN who weigh less than 66 lbs (30 kg); 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 Epinephrine Solution while you are pregnant. It is not known if Epinephrine Solution is found in breast milk. If you are or will be breast-feeding while you use Epinephrine Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Epinephrine 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:

Dizziness; feeling anxious, nervous, or fearful; headache; nausea; paleness; restlessness; shakiness or weakness; sweating; 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; fast or irregular heartbeat; wheezing.

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. Symptoms may include chest pain; confusion; extreme paleness or coldness of the skin; fast or irregular heartbeat; one-sided weakness; severe headache or dizziness; slurred speech; trouble breathing; vision problems.

Proper storage of Epinephrine Solution:

Store Epinephrine Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the carrying case provided. Do not refrigerate, freeze, or expose to extreme heat. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Epinephrine Solution out of the reach of children and away from pets.

General information: If you have any questions about Epinephrine Solution, please talk with your doctor, pharmacist, or other health care provider. Epinephrine 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 Epinephrine 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 Epinephrine resources Epinephrine Use in Pregnancy & Breastfeeding Epinephrine Drug Interactions Epinephrine Support Group 11 Reviews for Epinephrine - Add your own review/rating Compare Epinephrine with other medications Adams-Stokes Syndrome Allergic Reactions Asthma, acute Asystole AV Heart Block COPD, Acute Electromechanical Dissociation Shock
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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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interferon beta-1b


Generic Name: interferon beta-1b (in ter FEAR on BAY ta 1b)
Brand Names: Betaseron, Extavia

What is interferon beta-1b?

Interferon beta-1b is made from human proteins. Interferons help the body fight viral infections.

Interferon beta-1b is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Interferon beta-1b may also be used for other purposes other than those listed in this medication guide.

What is the most important information I should know about interferon beta-1b? This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1b if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using interferon beta-1b, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, a bleeding or blood-clotting disorder, anemia (low red blood cells), or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1b if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Interferon beta-1b is given as an injection under the skin, usually at bedtime every 48 hours (2 days). You may be given instructions on how to use your injections at home. You may be shown how to inject your medicine 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.

To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before using interferon beta-1b? Do not use this medication if you are allergic to interferons or human albumin. Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1b if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

liver disease;

a thyroid disorder;

epilepsy or other seizure disorder;

a bleeding or blood-clotting disorder, such as hemophilia;

anemia (lack of red blood cells); or

a history of depression or suicidal behavior.

FDA pregnancy category C. This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1b if you are pregnant. Tell your doctor if you become pregnant during treatment. It is not known whether interferon beta-1b 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.

Interferon beta-1b is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, 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 use interferon beta-1b?

Interferon beta-1b is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine 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.

Interferon beta-1b is injected into a skin area of the thigh, stomach, buttocks, or back of the upper arm. 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.

Interferon beta-1b is usually given as one injection at bedtime every 48 hours (2 days). Follow the directions on your prescription label. Try to use your injections at the same time each dosing day.

Interferon beta-1b is a powder that comes in a single-use vial (bottle) with a liquid (diluent) that must be mixed with the powder in the vial. Gently swirl but do not shake the vial after mixing the medicine. Allow any bubbles or foam to settle before drawing the medicine into a syringe.

If the medicine has changed colors or has any particles in it, call your doctor for a new prescription.

Do not draw your interferon beta-1b dose into a syringe until you are ready to give yourself an injection. Use a different place on your skin each time you inject this medication. Do not inject interferon beta-1b into the same skin area two times in a row.

Use each disposable needle only one time. 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.

To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store interferon beta-1b vials at room temperature away from moisture and heat. After mixing the medicine you should use it right away, or within 3 hours after mixing if you store it in a refrigerator. Do not freeze. What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. Then wait at least 48 hours before using another injection, and restart your dosing schedule at that time. Do not use more than one injection every 48 hours (2 days).

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an interferon beta-1b overdose are not known. What should I avoid while using interferon beta-1b?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using interferon beta-1b.

Interferons can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Interferon beta-1b 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 interferon beta-1b and call your doctor at once if you have any of these serious side effects:

depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;

bruising, swelling, oozing, or skin changes where the injection was given;

weight changes, pounding heartbeats, feeling too hot or cold;

fever, chills, body aches, flu symptoms; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

weakness;

headache;

muscle pain or weakness;

sleep problems (insomnia);

stomach pain;

swelling in your hands or feet;

skin rash; or

irregular menstrual periods.

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.

Interferon beta-1b Dosing Information

Usual Adult Dose for Multiple Sclerosis:

Initial: 0.0625 mg subcutaneously every other day, and increased (by 25% increments) every 2 weeks, over a 6 week period, to maintenance dose
Maintenance: 0.25 mg subcutaneously every other day

Usual Adult Dose for Colorectal Cancer:

Phase II trials - advanced colorectal carcinoma (n=81)
9 million international units subcutaneously on days 1, 3, and 5, thereafter 3 times a week (in combination with fluorouracil)

Usual Pediatric Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy:

Case (n=1)
1.5 million international units subcutaneously twice a week for 1 week, then 3 million international units 3 times a week

Usual Pediatric Dose for Multiple Sclerosis:

Study (n=1)
Greater than 8.5 years: 8 million international units (0.25 mg) subcutaneously every other day

What other drugs will affect interferon beta-1b?

There may be other drugs that can affect interferon beta-1b. 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 interferon beta-1b resources Interferon beta-1b Side Effects (in more detail) Interferon beta-1b Use in Pregnancy & Breastfeeding Interferon beta-1b Drug Interactions Interferon beta-1b Support Group 2 Reviews for Interferon beta-1b - Add your own review/rating interferon beta-1b Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Interferon Beta-1b Professional Patient Advice (Wolters Kluwer) Interferon Beta-1b Solution MedFacts Consumer Leaflet (Wolters Kluwer) Betaseron Prescribing Information (FDA) Betaseron Consumer Overview Extavia Prescribing Information (FDA) Extavia Consumer Overview Compare interferon beta-1b with other medications Chronic Inflammatory Demyelinating Polyradiculoneuropathy Colorectal Cancer Multiple Sclerosis Where can I get more information? Your pharmacist can provide more information about interferon beta-1b.

See also: interferon beta-1b side effects (in more detail)


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Epinephrine Auto-Injector


Pronunciation: EP-i-NEF-rin
Generic Name: Epinephrine
Brand Name: Adrenaclick or Twinject
Epinephrine Auto-Injector is used for:

Treating severe allergic reactions (eg, difficulty breathing; rash; hives; itching; tightness in the chest; swelling of the mouth, lips, or tongue) caused by insect stings or bites, foods, drugs, or other causes. It may also be used for other conditions as determined by your doctor.

Epinephrine Auto-Injector is a sympathomimetic. It works on different receptors in the body to relax the smooth muscle of the lungs, which improves breathing.

Do NOT use Epinephrine Auto-Injector if: you are allergic to any ingredient in Epinephrine Auto-Injector, unless your doctor tells you otherwise

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

Before using Epinephrine Auto-Injector:

Some medical conditions may interact with Epinephrine Auto-Injector. 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 (eg, sulfites) if you have glaucoma, heart disease, chest pain, high blood pressure, blood vessel problems, diabetes, Parkinson disease, thyroid problems, mood or mental disorders, depression, asthma, or an irregular heartbeat

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

Alpha-blockers (eg, prazosin), beta-blockers (eg, propanolol), droxidopa, ergot alkaloids (eg, ergotamine), or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased Bromocriptine, furazolidone, linezolid, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased Antihistamines (eg, diphenhydramine), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), levothyroxine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or medicines for irregular heartbeat (eg, quinidine) because they may increase the risk of Epinephrine Auto-Injector's side effects Guanethidine because its effectiveness may be decreased by Epinephrine Auto-Injector

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epinephrine Auto-Injector 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 Epinephrine Auto-Injector:

Use Epinephrine Auto-Injector as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Epinephrine Auto-Injector. Talk to your pharmacist if you have questions about this information. Epinephrine Auto-Injector may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Epinephrine Auto-Injector at home, a health care provider will teach you how to use it. Be sure you understand how to use Epinephrine Auto-Injector. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Check Epinephrine Auto-Injector regularly. Replace the injector unit if it contains particles, is discolored (pink or brown), or is cracked or damaged in any way. Inject Epinephrine Auto-Injector only into the outer thigh. Do not inject into the buttocks or into a vein. Immediately after use, go to the nearest hospital emergency room. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of epinephrine. Show the thigh where the injection was given to the doctor. Give your used auto-injector to the doctor for inspection and proper disposal. 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. Epinephrine Auto-Injector is usually given as a one-time dose in an emergency situation. If you are unable to use Epinephrine Auto-Injector, seek medical attention immediately. If you miss a dose of Epinephrine Auto-Injector, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Epinephrine Auto-Injector.

Important safety information: Never put your thumb, fingers, or hand over the tip of the auto-injector. Do NOT remove the cap until ready to use. Only inject Epinephrine Auto-Injector into the outer thigh. Never inject Epinephrine Auto-Injector into hands, fingers, feet, or toes. Doing so may cause a loss of blood flow and result in tissue damage to these areas. If you accidentally inject Epinephrine Auto-Injector into any of these areas, seek immediate emergency medical attention. It may be helpful to train others how to give Epinephrine Auto-Injector in case you are unable to give it to yourself during a reaction. Diabetes patients - Epinephrine Auto-Injector may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Patients with Parkinson disease may notice a temporary worsening of symptoms (eg, uncontrolled muscle movements). If these symptoms persist, contact your doctor. Use Epinephrine Auto-Injector 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 Epinephrine Auto-Injector while you are pregnant. It is not known if Epinephrine Auto-Injector is found in breast milk. If you are or will be breast-feeding while you use Epinephrine Auto-Injector, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Epinephrine Auto-Injector:

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:

Anxiety; difficulty sleeping; dizziness; fearfulness; headache; nausea; nervousness; paleness; sweating; tremors; vomiting; weakness.

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; fast or irregular heartbeat; wheezing.

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. Symptoms may include chest pain; extreme paleness or coldness of the skin; fast or irregular heartbeat; one-sided weakness; severe headache or dizziness; trouble breathing.

Proper storage of Epinephrine Auto-Injector:

Store Epinephrine Auto-Injector at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the carrying case provided. Do not refrigerate or freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Epinephrine Auto-Injector out of the reach of children and away from pets.

General information: If you have any questions about Epinephrine Auto-Injector, please talk with your doctor, pharmacist, or other health care provider. Epinephrine Auto-Injector 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 Epinephrine Auto-Injector. 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 Epinephrine resources Epinephrine Use in Pregnancy & Breastfeeding Epinephrine Drug Interactions Epinephrine Support Group 11 Reviews for Epinephrine - Add your own review/rating Compare Epinephrine with other medications Adams-Stokes Syndrome Allergic Reactions Asthma, acute Asystole AV Heart Block COPD, Acute Electromechanical Dissociation Shock
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Adrenaclick Auto-Injector


Pronunciation: EP-i-NEF-rin
Generic Name: Epinephrine
Brand Name: Adrenaclick or Twinject
Adrenaclick Auto-Injector is used for:

Treating severe allergic reactions (eg, difficulty breathing; rash; hives; itching; tightness in the chest; swelling of the mouth, lips, or tongue) caused by insect stings or bites, foods, drugs, or other causes. It may also be used for other conditions as determined by your doctor.

Adrenaclick Auto-Injector is a sympathomimetic. It works on different receptors in the body to relax the smooth muscle of the lungs, which improves breathing.

Do NOT use Adrenaclick Auto-Injector if: you are allergic to any ingredient in Adrenaclick Auto-Injector, unless your doctor tells you otherwise

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

Before using Adrenaclick Auto-Injector:

Some medical conditions may interact with Adrenaclick Auto-Injector. 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 (eg, sulfites) if you have glaucoma, heart disease, chest pain, high blood pressure, blood vessel problems, diabetes, Parkinson disease, thyroid problems, mood or mental disorders, depression, asthma, or an irregular heartbeat

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

Alpha-blockers (eg, prazosin), beta-blockers (eg, propanolol), droxidopa, ergot alkaloids (eg, ergotamine), or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased Bromocriptine, furazolidone, linezolid, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased Antihistamines (eg, diphenhydramine), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), levothyroxine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or medicines for irregular heartbeat (eg, quinidine) because they may increase the risk of Adrenaclick Auto-Injector's side effects Guanethidine because its effectiveness may be decreased by Adrenaclick Auto-Injector

This may not be a complete list of all interactions that may occur. Ask your health care provider if Adrenaclick Auto-Injector 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 Adrenaclick Auto-Injector:

Use Adrenaclick Auto-Injector as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Adrenaclick Auto-Injector. Talk to your pharmacist if you have questions about this information. Adrenaclick Auto-Injector may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Adrenaclick Auto-Injector at home, a health care provider will teach you how to use it. Be sure you understand how to use Adrenaclick Auto-Injector. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Check Adrenaclick Auto-Injector regularly. Replace the injector unit if it contains particles, is discolored (pink or brown), or is cracked or damaged in any way. Inject Adrenaclick Auto-Injector only into the outer thigh. Do not inject into the buttocks or into a vein. Immediately after use, go to the nearest hospital emergency room. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of epinephrine. Show the thigh where the injection was given to the doctor. Give your used auto-injector to the doctor for inspection and proper disposal. 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. Adrenaclick Auto-Injector is usually given as a one-time dose in an emergency situation. If you are unable to use Adrenaclick Auto-Injector, seek medical attention immediately. If you miss a dose of Adrenaclick Auto-Injector, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Adrenaclick Auto-Injector.

Important safety information: Never put your thumb, fingers, or hand over the tip of the auto-injector. Do NOT remove the cap until ready to use. Only inject Adrenaclick Auto-Injector into the outer thigh. Never inject Adrenaclick Auto-Injector into hands, fingers, feet, or toes. Doing so may cause a loss of blood flow and result in tissue damage to these areas. If you accidentally inject Adrenaclick Auto-Injector into any of these areas, seek immediate emergency medical attention. It may be helpful to train others how to give Adrenaclick Auto-Injector in case you are unable to give it to yourself during a reaction. Diabetes patients - Adrenaclick Auto-Injector may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Patients with Parkinson disease may notice a temporary worsening of symptoms (eg, uncontrolled muscle movements). If these symptoms persist, contact your doctor. Use Adrenaclick Auto-Injector 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 Adrenaclick Auto-Injector while you are pregnant. It is not known if Adrenaclick Auto-Injector is found in breast milk. If you are or will be breast-feeding while you use Adrenaclick Auto-Injector, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Adrenaclick Auto-Injector:

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:

Anxiety; difficulty sleeping; dizziness; fearfulness; headache; nausea; nervousness; paleness; sweating; tremors; vomiting; weakness.

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; fast or irregular heartbeat; wheezing.

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: Adrenaclick 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; extreme paleness or coldness of the skin; fast or irregular heartbeat; one-sided weakness; severe headache or dizziness; trouble breathing.

Proper storage of Adrenaclick Auto-Injector:

Store Adrenaclick Auto-Injector at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the carrying case provided. Do not refrigerate or freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Adrenaclick Auto-Injector out of the reach of children and away from pets.

General information: If you have any questions about Adrenaclick Auto-Injector, please talk with your doctor, pharmacist, or other health care provider. Adrenaclick Auto-Injector 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 Adrenaclick Auto-Injector. 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 Adrenaclick resources Adrenaclick Side Effects (in more detail) Adrenaclick Use in Pregnancy & Breastfeeding Adrenaclick Drug Interactions Adrenaclick Support Group 0 Reviews for Adrenaclick - Add your own review/rating Compare Adrenaclick with other medications Adams-Stokes Syndrome Allergic Reactions Asthma, acute Asystole AV Heart Block COPD, Acute Electromechanical Dissociation Shock
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Mixtard 30 100 IU / ml Suspension for Injection in a vial


Mixtard 30

100 IU/ml suspension for injection in a vial

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. 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 breast-feeding

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.

Before using Mixtard Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab. Do not use Mixtard In insulin infusion pumps If the protective cap is loose or missing.
Each vial has a protective, tamper-proof plastic cap. If it isn’t in perfect condition when you get the vial, return the vial to your supplier 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. How to use this insulin

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. Mixtard vials are for use with insulin syringes with the corresponding unit scale.

Just before injecting this insulin 1. Roll the vial between your hands until the liquid is uniformly white and cloudy.
Resuspending is easier if the insulin has reached room temperature 2. Draw air into the syringe, in the same amount as the dose of insulin you need 3. Inject the air into the vial: push the needle through the rubber stopper and press the plunger 4. Turn the vial and syringe upside down 5. Draw the right dose of insulin into the syringe 6. Pull the needle out of the vial 7. Make sure there is no air left in the syringe: point the needle upwards and push the air out 8. Check you have the right dose 9. Inject straight away. Inject the insulin Inject the insulin under the skin. Use the injection technique advised by your doctor or diabetes nurse Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered. 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 vials that are not being used are 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. Keep the vials in the original package.

The vials that are being used or about to be used are not to be kept in a refrigerator. After removing the vial 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 them with you and keep them at room temperature (not above 25°C) for up to 6 weeks.

Always keep the vial in the outer carton 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 vial contains 10 ml equivalent to 1000 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 or 5 vials of 10 ml or in a multipack of 5 ? (1 ? 10 ml) vials.

Not all packs may be marketed.

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

This leaflet was last approved in 09/2007

Mixtard is a trademark owned by Novo Nordisk A/S, Denmark

© 1998/2007

Novo Nordisk A/S

8-0191-01-086-3


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Twinject Auto-Injector


Pronunciation: EP-i-NEF-rin
Generic Name: Epinephrine
Brand Name: Examples include EpiPen and Twinject
Twinject Auto-Injector is used for:

Treating severe allergic reactions (eg, difficulty breathing; rash; hives; itching; tightness in the chest; severe dizziness; swelling of the mouth, lips, or tongue) caused by insect stings or bites, foods, drugs, or other causes. It may also be used for other conditions as determined by your doctor.

Twinject Auto-Injector is a sympathomimetic. It works on blood vessels to improve blood pressure and on the smooth muscle of the lungs to help breathing. It also works by decreasing rash, hives, and swelling.

Do NOT use Twinject Auto-Injector if: you are allergic to any ingredient in Twinject Auto-Injector, unless your doctor tells you otherwise

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

Before using Twinject Auto-Injector:

Some medical conditions may interact with Twinject Auto-Injector. 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 (eg, sulfites) if you have heart disease, chest pain, high blood pressure, blood vessel problems, diabetes, Parkinson disease, thyroid problems, mood or mental disorders (eg, depression), asthma, or an irregular heartbeat

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

Bromocriptine, furazolidone, or linezolid, because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased Antiarrhythmics (eg, quinidine), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), or droxidopa because the risk of irregular heartbeat may be increased Alpha-blockers (eg, prazosin), beta-blockers (eg, propanolol), droxidopa, ergot alkaloids (eg, ergotamine), or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased Antihistamines (eg, chlorpheniramine), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), levothyroxine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Twinject Auto-Injector's side effects Alpha-blockers (eg, prazosin), beta-blockers (eg, propanolol), ergot alkaloids (eg, ergotamine), and phenothiazines (eg, chlorpromazine) because they may increase the risk of Twinject Auto-Injector's side effects Guanethidine because its effectiveness may be decreased by Twinject Auto-Injector

This may not be a complete list of all interactions that may occur. Ask your health care provider if Twinject Auto-Injector 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 Twinject Auto-Injector:

Use Twinject Auto-Injector as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Twinject Auto-Injector. Talk to your pharmacist if you have questions about this information. Twinject Auto-Injector may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Twinject Auto-Injector at home, a health care provider will teach you how to use it. Be sure you understand how to use Twinject Auto-Injector. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Check Twinject Auto-Injector regularly. Replace Twinject Auto-Injector if the expiration date has passed, if it contains particles or is discolored (pink or darker than slightly yellow), or if it is cracked or damaged in any way. If Twinject Auto-Injector has been dropped, inspect it for damage or leakage and replace it if necessary. Inject Twinject Auto-Injector only into the outer thigh, as directed by your health care provider. Do not inject into the buttocks or into a vein. Go to the nearest hospital emergency room immediately after use. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of epinephrine. Show the thigh where the injection was given to the doctor. Give your used auto-injector to the doctor for inspection and proper disposal. 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. Twinject Auto-Injector is usually given in an emergency situation. If you are unable to use Twinject Auto-Injector, seek medical attention immediately. If you miss a dose of Twinject Auto-Injector, seek immediate medical attention.

Ask your health care provider any questions you may have about how to use Twinject Auto-Injector.

Important safety information: Never put your thumb, fingers, or hand over the tip of the auto-injector. Do NOT remove the cap until you are ready to use Twinject Auto-Injector. Only inject Twinject Auto-Injector into the outer thigh. Never inject Twinject Auto-Injector into hands, fingers, feet, or toes. Doing so may cause a loss of blood flow and result in tissue damage to these areas. If you accidentally inject Twinject Auto-Injector into any of these areas, seek immediate emergency medical attention. It may be helpful to train others how to give Twinject Auto-Injector in case you are unable to give it to yourself during a reaction. Diabetes patients - Twinject Auto-Injector may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur or persist, tell your doctor right away. Patients with Parkinson disease may notice a temporary worsening of symptoms (eg, uncontrolled muscle movements). If these symptoms persist, contact your doctor. Use Twinject Auto-Injector 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 Twinject Auto-Injector while you are pregnant. It is not known if Twinject Auto-Injector is found in breast milk. If you are or will be breast-feeding while you use Twinject Auto-Injector, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Twinject Auto-Injector:

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:

Dizziness; feeling anxious, nervous, or fearful; headache; nausea; nervousness; paleness; restlessness; shakiness or weakness; sweating; 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; fast or irregular heartbeat; wheezing.

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: Twinject 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; confusion; extreme paleness or coldness of the skin; fast or irregular heartbeat; one-sided weakness; severe headache or dizziness; slurred speech; trouble breathing; vision problems.

Proper storage of Twinject Auto-Injector:

Store Twinject Auto-Injector at room temperature, between 60 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the carrying case provided. Do not refrigerate or freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Twinject Auto-Injector out of the reach of children and away from pets.

General information: If you have any questions about Twinject Auto-Injector, please talk with your doctor, pharmacist, or other health care provider. Twinject Auto-Injector 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 Twinject Auto-Injector. 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 Twinject resources Twinject Side Effects (in more detail) Twinject Use in Pregnancy & Breastfeeding Twinject Drug Interactions Twinject Support Group 0 Reviews for Twinject - Add your own review/rating Compare Twinject with other medications Adams-Stokes Syndrome Allergic Reactions Asthma, acute Asystole AV Heart Block COPD, Acute Electromechanical Dissociation Shock
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Norditropin Simplexx 10mg / 1.5ml


Norditropin SimpleXx 10 mg/1.5 ml

solution for injection in cartridges

Somatropin

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, ask your doctor or pharmacist. This medicine has been prescribed for you personally. 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 Norditropin SimpleXx is and what it is used for 2. Before you use Norditropin SimpleXx 3. How to use Norditropin SimpleXx 4. Possible side effects 5. How to store Norditropin SimpleXx 6. Further information. What Norditropin SimpleXx is and what it is used for

Norditropin SimpleXx contains a biosynthetic human growth hormone called somatropin which is identical to the growth hormone produced naturally in the body. Children need growth hormone to help them grow, but adults also need it for their general health.

Norditropin SimpleXx comes as a solution in a cartridge ready for you to inject after you have put it in the matching NordiPen injection pen.

Norditropin SimpleXx is used to treat growth failure in children:

If they have no or very low production of growth hormone If they have Turner syndrome (a genetic problem which may affect growth) If they have reduced kidney function If they are short and were born small for gestational age (SGA).

Norditropin SimpleXx is used as a growth hormone replacement in adults:

In adults Norditropin SimpleXx is used to replace growth hormone if their growth hormone production has been decreased since childhood or has been lost in adulthood because of a tumour, treatment of a tumour or a disease that affects the gland which produces growth hormone.

Before you use Norditropin SimpleXx Do not use Norditropin SimpleXx If you are allergic (hypersensitive) to somatropin, to phenol or to any of the other ingredients of Norditropin SimpleXx (listed in section 6, Further information) If you have had a kidney transplant If you are pregnant or breast-feeding (See pregnancy and breast-feeding) If you have a cancer, a tumour or are still in anti-tumour therapy If you have an acute critical illness e.g. open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure. Take special care with Norditropin SimpleXx If you have diabetes If you have ever had a cancer or another kind of tumour If you have recurrent headaches, eyesight problems, nausea or if vomiting occurs If you have abnormal thyroid function If you develop scoliosis If you are over 60 years of age, or have received somatropin treatment as an adult for more than 5 years, as experience is limited If you suffer from kidney disease your kidney function should be monitored by your physician.

Tell your doctor if any of these apply to you as Norditropin SimpleXx may not be suitable.

Using other medicines

Your doctor needs to know if you are already being treated with:

Glucocorticoids or sex steroids – your adult height may be affected if you use Norditropin SimpleXx and glucocorticoids or sex steroids at the same time Insulin - as your dose may need to be adjusted Thyroid hormone.

Tell your doctor or pharmacist if you are taking other medicines or have recently taken any. This includes medicines obtained without a prescription.

Pregnancy and breast-feeding Pregnancy. Stop the treatment and tell your doctor if you become pregnant while you are using Norditropin SimpleXx Breast-feeding. Do not use Norditropin SimpleXx while you are breast-feeding as somatropin might pass into your milk. Driving and using machines

Norditropin SimpleXx does not affect the use of any machines or the ability to drive safely.

How to use Norditropin SimpleXx

Always use Norditropin SimpleXx exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Usual dose

The dose for children depends on their body weight and body surface area. The adult dose depends on height, weight, gender and growth hormone sensitivity and will be adjusted until you are on the right dose.

Children with low production or lack of growth hormone: The usual dose is 25 to 35 microgram per kg body weight per day or 0.7 to 1.0 mg per m? body surface area per day. Children with Turner syndrome: The usual dose is 45 to 67 microgram per kg body weight per day or 1.3 to 2.0 mg per m? body surface area per day. Children with kidney disease: The usual dose is 50 microgram per kg body weight per day or 1.4 mg per m? body surface area per day. Children born small for gestational age (SGA): The usual dose is 35 microgram per kg body weight per day or 1.0 mg per m? body surface area per day until final height is reached. (In clinical trials of short children born SGA doses of 33 and 67 microgram per kg body weight per day have typically been used.) Adults with low production or lack of growth hormone: The usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose each month until you are on the right dose. The usual maximum dose is 1.0 mg per day. When to use Norditropin SimpleXx Inject your daily dose into the skin every evening just before bedtime. Using the cartridges to inject yourself Norditropin SimpleXx solution comes in cartridges ready to be used in the matching NordiPen. The NordiPen instruction manual tells you how to use the cartridges in the injection pen Check each new Norditropin SimpleXx cartridge before you use it. Do not use any cartridge that is damaged or cracked Only use a Norditropin SimpleXx cartridge if the solution inside is clear and colourless Vary the area you inject so you do not harm your skin Do not share your Norditropin SimpleXx cartridge with anyone else. How long you will need treatment for If you are using Norditropin SimpleXx for growth failure because of Turner syndrome, a kidney disease or if you were born small for gestational age (SGA), continue using Norditropin SimpleXx until you stop growing If you lack growth hormone, continue using Norditropin SimpleXx into adulthood Do not stop using Norditropin SimpleXx without discussing it with your doctor first. If you use too much: Tell your doctor if you inject too much Norditropin SimpleXx. Long-term overdosing can cause abnormal growth and coarsening of facial features. If you forget a dose: Take the next dose as usual, at the normal time. Do not take a double dose to make up for a forgotten dose. Possible side effects

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

Very rare effects in children and adults

(may affect up to 1 in 10,000 people):

Rash; wheezing; swollen eyelids, face or lips; complete collapse. Any of these may be signs of allergic reactions Headache, eyesight problems, feeling sick (nausea) and being sick (vomiting).
These may be signs of raised pressure in the brain Serum thyroxin levels may decrease

If you get any of these effects, see a doctor as soon as possible. Stop using Norditropin SimpleXx until your doctor says you can continue treatment.

Formation of antibodies directed against somatropin has been rarely observed during Norditropin therapy.

Cases of leukaemia and relapse of brain tumours have also been reported in patients treated with somatropin (the active ingredient in Norditropin SimpleXx), although there is no evidence that somatropin was responsible.

If you think you are suffering from any of these diseases, speak to your doctor.

Other side effects in children:

Uncommon effects

(may affect up to 1 in 100 children):

Headache Redness, itching and pain in the area of injection.

Rare effects

(may affect up to 1 in 1000 children):

Rash Muscle and joint pain Swollen hands and feet due to fluid retention.

In rare cases, children using Norditropin SimpleXx have experienced hip and knee pain or have started limping. These symptoms may be caused by a disease affecting the top of the thigh bone (Legg-Calv? disease) or because the end of the bone has slipped from the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin SimpleXx.

In children with Turner syndrome, a few cases of increased growth of hands and feet compared to height have been observed in clinical trials.

A clinical trial in children with Turner syndrome has shown that high doses of Norditropin can possibly increase the risk of getting ear infections.

Other side effects in adults:

Very common effects

(may affect more than 1 in 10 adults):

Swollen hands and feet due to fluid retention.

Common effects

(may affect up to 1 in 10 adults):

Headache Feeling of skin crawling (formication) and numbness or pain mainly in fingers Joint pain and stiffness; muscle pain.

Uncommon effects

(may affect up to 1 in 100 adults):

Type 2 diabetes Carpal tunnel syndrome tingling and pain in fingers and hands Itching (can be intense) and pain in the area of injection Muscle stiffness.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, as you may need to reduce your dose.

How to store Norditropin SimpleXx

Keep out of the reach and sight of children.

Do not use Norditropin SimpleXx after the expiry date which is stated on the package.

The expiry date refers to the last day of that month.

Store unused Norditropin SimpleXx cartridges in a refrigerator (2°C to 8°C) in the outer carton, in order to protect from light. Do not freeze or expose to heat.

After starting to use a Norditropin SimpleXx 10 mg/1.5 ml cartridge in an injection pen you can either:

Keep it in the pen for up to 4 weeks in a refrigerator (2°C and 8°C), or Keep it in the pen for up to 3 weeks at room temperature (below 25°C).

Do not continue to use Norditropin SimpleXx cartridges which have been frozen or exposed to excessive temperatures.

Check each new Norditropin SimpleXx cartridge before you use it. Do not use any cartridge that is damaged or cracked.

Do not use any Norditropin SimpleXx cartridge if the solution inside is not clear and colourless.

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 Norditropin SimpleXx contains The active substance is somatropin The solution also contains mannitol; histidine; poloxamer 188; phenol; water for injections; hydrochloric acid and sodium hydroxide. What Norditropin SimpleXx looks like and contents of the pack

Norditropin SimpleXx is a clear and colourless solution in a 1.5 ml glass cartridge ready for injection in the NordiPen injection pen.

1 ml of solution contains 6.7 mg somatropin.

1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin SimpleXx is available in three strengths:

5 mg/1.5 ml, 10 mg/1.5 ml and 15 mg/1.5 ml (equivalent to 3.3 mg/ml, 6.7 mg/ml and 10 mg/ml, respectively).

Manufacturer

Norditropin SimpleXx is made by:

Novo Nordisk A/S Novo All? DK-2880 Bagsv?rd Denmark Marketing authorisation holder Novo Nordisk Limited Broadfield Park Brighton Road Crawley West Sussex RH11 9RT UK

This leaflet was last approved in 02/2010.

Norditropin and SimpleXx are Trademarks owned by Novo Nordisk Health Care AG Switzerland

NordiPen is a trademark owned by Novo Nordisk A/S, Denmark

© 1999 / 2008

8-2071-01-002-4


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interferon gamma-1b


Generic Name: interferon gamma-1b (in ter FEER on GAM a)
Brand Names: Actimmune

What is interferon gamma-1b?

Interferon gamma-1b is made from human proteins. Interferons help the body fight viral infections.

Interferon gamma-1b is a specific interferon used to prevent infections in people with a condition called chronic granulomatous disease. Interferon gamma-1b is also used to treat a congenital bone disorder called osteopetrosis.

Interferon gamma-1b may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about interferon gamma-1b? Do not use this medication if you are allergic to interferon gamma-1b, or to drug products made from E. Coli bacteria.

Before using interferon gamma-1b, tell your doctor if you are allergic to any drugs, or if you have heart rhythm problems, congestive heart failure, history of heart disease or blood clots, or epilepsy or another seizure disorder.

Interferon gamma-1b is usually given three times weekly. Do not use the medication every day unless your doctor has told you to.

Store interferon gamma-1b in the refrigerator but do not allow it to freeze. Throw away any interferon gamma-1b that has been out of the refrigerator for more than 12 hours. Do not put it back into the refrigerator.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before using interferon gamma-1b? You should not use this medication if you are allergic to interferon gamma-1b, or to drug products made from E. Coli bacteria.

Before using interferon gamma-1b, tell your doctor if you are allergic to any drugs, or if you have:

heart rhythm problems;

congestive heart failure;

history of heart disease or blood clots; or

epilepsy or other seizure disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use interferon gamma-1b.

FDA pregnancy category C. This medication may 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 interferon gamma-1b 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 use interferon gamma-1b?

Interferon gamma-1b is given as an injection under the skin of your upper arm or thigh. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your 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.

Interferon gamma-1b is usually given 3 times weekly. Do not use the medication every day unless your doctor has told you to.

Use a different place on your arm or thigh each time you give yourself an injection. Your doctor will show you the places on your body where you can safely inject the medication. Do not inject interferon gamma-1b into the same place two times in a row.

Use each disposable needle only one time. 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.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

A single use vial of interferon gamma-1b is for one dose only. After measuring your dose from the vial, throw the bottle away even if there is still some medication left in it.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your interferon gamma-1b dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. Store interferon gamma-1b in the refrigerator but do not allow it to freeze. Throw away any interferon gamma-1b that has been out of the refrigerator for more than 12 hours. Do not put it back into the refrigerator. What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. 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 confusion, drowsiness, dizziness, loss of balance or coordination, or flu-like symptoms.

What should I avoid while using interferon gamma-1b?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using interferon gamma-1b.

Interferon gamma-1b 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 interferon gamma-1b and call your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms;

easy bruising or bleeding, unusual weakness;

feeling light-headed, fainting;

fast or uneven heart rate; or

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

Less serious side effects may include:

problems with memory or concentration;

weakness, tired feeling, lack of coordination;

pain or redness where the injection was given;

nausea, vomiting, diarrhea;

muscle or joint pain; or

headache.

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.

Interferon gamma-1b Dosing Information

Usual Adult Dose for Osteopetrosis:

BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly.

Usual Adult Dose for Chronic Granulomatous Disease:

BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly.

Usual Adult Dose for Idiopathic Pulmonary Fibrosis:

Study (n = 9)
200 mcg subcutaneously three times weekly (in combination with prednisolone 7.5 mg/day) for 12 months.

Usual Adult Dose for Cutaneous T-cell Lymphoma:

Case study (Granulomatous slack skin)
2,000,000 units IV daily for 14 days.

Usual Pediatric Dose for Chronic Granulomatous Disease:

Greater than or equal to 1 year old:
BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly
Less than 1 year old: no data available

What other drugs will affect interferon gamma-1b?

There may be other drugs that can affect interferon gamma-1b. 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 interferon gamma-1b resources Interferon gamma-1b Side Effects (in more detail) Interferon gamma-1b Use in Pregnancy & Breastfeeding Interferon gamma-1b Drug Interactions Interferon gamma-1b Support Group 0 Reviews for Interferon gamma-1b - Add your own review/rating Interferon Gamma-1b Professional Patient Advice (Wolters Kluwer) Interferon Gamma-1B MedFacts Consumer Leaflet (Wolters Kluwer) Actimmune Prescribing Information (FDA) Actimmune Monograph (AHFS DI) Actimmune Advanced Consumer (Micromedex) - Includes Dosage Information Compare interferon gamma-1b with other medications Chronic Granulomatous Disease Cutaneous T-cell Lymphoma Idiopathic Pulmonary Fibrosis Osteopetrosis Rheumatoid Arthritis Where can I get more information? Your pharmacist can provide more information about interferon gamma-1b.

See also: interferon gamma-1b 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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Wycillin


Generic Name: procaine penicillin (PRO kane PEN i SIL in)
Brand Names: Wycillin

What is procaine penicillin ?

Procaine penicillin is an antibiotic that fights bacteria in your body.

Procaine penicillin is used to treat many different types of infections caused by bacteria, including syphilis (a sexually transmitted disease).

Do not use this medication for any other infection that has not been checked by your doctor.

Procaine penicillin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about procaine penicillin ? You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

Before using procaine penicillin, tell your doctor if you have asthma or a history of allergies, or kidney disease.

Do not inject this medication into a vein or life-threatening side effects may result.

Use this medication for the full prescribed length of time. Call your doctor if your infection does not improve, or if it gets worse while using procaine penicillin.

Tell your doctor about all other medications you use, especially gout medication, a blood thinner, a diuretic, a tetracycline antibiotic, or a non-steroidal anti-inflammatory drug (NSAID).

Procaine penicillin can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using procaine penicillin. Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

After you have finished your treatment with procaine penicillin, your doctor may want to do tests to make sure your infection has completely cleared up.

What should I discuss with my health care provider before using procaine penicillin ? You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceclor, Ceftin, Duricef, Keflex, Lorabid, Omnicef, Spectracef, and others.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use procaine penicillin:

asthma or a history of allergies; or

kidney disease. FDA pregnancy category B. Procaine penicillin is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Procaine penicillin can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using procaine penicillin. Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Procaine penicillin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Wycillin (procaine penicillin)?

Procaine penicillin is given as an injection into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine 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.

Procaine penicillin must be injected slowly into a muscle of the buttock or upper thigh.

Do not inject the medication into a vein or life-threatening side effects could result.

Your procaine penicillin injections should be given at evenly spaced intervals.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Procaine penicillin will not treat a viral infection such as the common cold or flu.

Call your doctor if your infection does not improve, or if it gets worse while using procaine penicillin.

Use each disposable needle only one time. 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.

This medication can cause you to have unusual results with certain lab tests, including tests to check for glucose (sugar) in the urine. Tell any doctor who treats you that you are using procaine penicillin.

After you have finished your treatment with procaine penicillin, your doctor may want to do tests to make sure your infection has completely cleared up.

Store this medication in the refrigerator. Do not freeze. Do not use the mixed medication if it has changed colors or has any particles in it. What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed 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 mood changes, agitation, confusion, and seizure (convulsions). What should I avoid while using Wycillin (procaine penicillin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop using this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Do not receive a "live" vaccine such as typhoid vaccine, cholera vaccine, or BCG (Bacillus Calmette and Gu?rin) vaccine. Procaine penicillin 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 a serious side effect such as:

diarrhea that is watery or bloody;

peeling skin , severe pain, or changes in skin color where the medicine was injected;

dizziness, joint or muscle pain;

fast or pounding heartbeats;

numbness, tingling, pain, swelling, or redness in your arms or legs;

confusion, agitation, depression, unusual thoughts or behavior;

chest pain, problems with vision or speech;

feeling like you might pass out;

fever, chills, dizziness, muscle pain, rapid breathing or heart rate;

uncontrolled muscle movements, problems with balance or walking;

pale skin, easy bruising or bleeding, unusual weakness;

sore throat, flu symptoms;

urinating less than usual or not at all;

rash or itching with swollen glands, joint pain, or general ill feeling; or

slow heart rate, weak pulse, fainting, slow breathing.

Less serious side effects may include:

pain where the injection was given;

vaginal itching or discharge;

white patches in your mouth or throat;

nausea, vomiting;

blurred vision, ringing in your ears;

headache, dizziness; or

mild skin rash,

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 Wycillin (procaine penicillin)?

Tell your doctor about all other medications you use, especially:

probenecid (Benemid);

a blood thinner such as warfarin (Coumadin);

a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor HCT, Vasoretic, Zestoretic), and others;

methotrexate (Rheumatrex, Trexall);

a tetracycline antibiotic, such as demeclocycline (Declomycin, Ledermycin), doxycycline (Adoxa, Doryx, Vibramycin, Periostat), minocycline (Minocin), or tetracycline (Broadspec, Panmycin, Sumycin); or

NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others.

This list is not complete and there may be other drugs that can interact with procaine penicillin. 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 Wycillin resources Wycillin Side Effects (in more detail) Wycillin Use in Pregnancy & Breastfeeding Wycillin Drug Interactions Wycillin Support Group 0 Reviews for Wycillin - Add your own review/rating Compare Wycillin with other medications Anthrax Prophylaxis Bacterial Infection Congenital Syphilis Cutaneous Bacillus anthracis Diphtheria Endocarditis Fusospirochetosis, Trench Mouth Neurosyphilis Pneumonia Rat-bite Fever Skin Infection Streptococcal Infection Syphilis, Early Syphilis, Latent Tertiary Syphilis Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Where can I get more information? Your doctor or pharmacist can provide more information about procaine penicillin.

See also: Wycillin side effects (in more detail)


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Humalog Mix 75/25 Pen


Generic Name: insulin lispro and insulin lispro protamine (IN soo lin LISS pro and IN soo lin LISS pro PRO ta meen)
Brand Names: HumaLOG Mix 50/50, HumaLOG Mix 50/50 KwikPen, HumaLOG Mix 50/50 Pen, HumaLOG Mix 75/25, HumaLOG Mix 75/25 KwikPen, HumaLOG Mix 75/25 Pen

What is Humalog Mix 75/25 Pen (insulin lispro and insulin lispro protamine)?

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting form of insulin. Insulin lispro protamine is an intermediate-acting form of insulin.

Insulin lispro and insulin lispro protamine is used to treat type 1 diabetes in adults. It is usually given together with another long-acting insulin.

Insulin lispro and insulin lispro protamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Humalog Mix 75/25 Pen (insulin lispro and insulin lispro protamine)? Use this medication within 15 minutes before eating a meal.

Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Signs of blood sugar that is too high (hyperglycemia) may include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your insulin dose.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another. What should I discuss with my healthcare provider before using Humalog Mix 75/25 Pen (insulin lispro and insulin lispro protamine)? Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

To make sure you can safely use insulin lispro and insulin lispro protamine, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

FDA pregnancy category B. This medication 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 insulin lispro and insulin lispro protamine 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 use Humalog Mix 75/25 Pen (insulin lispro and insulin lispro protamine)?

Insulin is injected under the skin. You will 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.

Use this medication within 15 minutes before eating a meal.

Insulin lispro and insulin lispro protamine should appear cloudy after mixing. Do not use the medication if it has changed colors or has any particles in it. Return the medication to your pharmacy for a new supply.

Use a different place on your injection skin area each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Use each disposable needle only one time. 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.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Ask your doctor how to adjust your insulin dose if needed. Do not change your medication dose or schedule without your doctor's advice. Wear a medical alert tag or carry an ID card stating that you have diabetes. Any medical care provider who treats you should know that you are diabetic. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Unopened vials may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days. Unopened injection pens may also be stored at room temperature for up to 10 days, away from heat and bright light. Throw away any insulin not used within 10 days. Storing after your first use: You may keep "in-use" vials in the refrigerator, protected from light. Use within 28 days. Do not refrigerate an in-use injection pen. Keep it at room temperature and use within 10 days.

Do not freeze insulin lispro and insulin lispro protamine, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since this medication is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin lispro and insulin lispro protamine, be sure to eat a meal within 15 minutes. Do not use extra insulin lispro and insulin lispro protamine to make up a missed dose.

Keep insulin lispro and insulin lispro protamine on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

What should I avoid while using Humalog Mix 75/25 Pen (insulin lispro and insulin lispro protamine)? Do not change the brand of insulin lispro and insulin lispro protamine or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. It can lower your blood sugar. Do not expose insulin lispro and insulin lispro protamine to high heat. Humalog Mix 75/25 Pen (insulin lispro and insulin lispro protamine) side effects Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Insulin lispro and insulin lispro protamine can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin lispro and insulin lispro protamine.

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 Humalog Mix 75/25 Pen (insulin lispro and insulin lispro protamine)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

albuterol (Proventil, Ventolin);

clonidine (Catapres);

reserpine; or

beta-blockers such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

There are many other medicines that can increase or decrease the effects of insulin lispro and insulin lispro protamine on lowering your blood sugar. 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 Humalog Mix 75/25 Pen resources Humalog Mix 75/25 Pen Side Effects (in more detail) Humalog Mix 75/25 Pen Use in Pregnancy & Breastfeeding Humalog Mix 75/25 Pen Drug Interactions Humalog Mix 75/25 Pen Support Group 0 Reviews for Humalog Mix 75/25 Pen - Add your own review/rating HumaLog Mix 50/50 Vials MedFacts Consumer Leaflet (Wolters Kluwer) Humalog Mix 50/50 Pens MedFacts Consumer Leaflet (Wolters Kluwer) Humalog Mix 50/50 Advanced Consumer (Micromedex) - Includes Dosage Information Humalog Mix 75/25 Prescribing Information (FDA) Compare Humalog Mix 75/25 Pen with other medications Diabetes, Type 1 Diabetes, Type 2 Where can I get more information? Your pharmacist can provide more information about insulin lispro and insulin lispro protamine.

See also: Humalog Mix 75/25 Pen side effects (in more detail)


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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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Follitropin Alfa Solution


Pronunciation: FALL-lee-tro-pin
Generic Name: Follitropin Alfa
Brand Name: Gonal-f RFF Pen
Follitropin Alfa Solution is used for:

Treating infertility in certain women. It may also be used for other conditions as determined by your doctor.

This is a fertility medicine that helps develop eggs in the ovaries in women trying to become pregnant. Follitropin Alfa Solution is usually used with fertility programs and other fertility medicines.

Do NOT use Follitropin Alfa Solution if: you are allergic to any ingredient in Follitropin Alfa Solution you have primary ovarian failure (eg, your ovaries do not make eggs) you have uncontrolled thyroid or adrenal problems you have hormone-sensitive tumors you have pituitary tumor or other brain lesion or tumor you are pregnant or think you may be pregnant you have cancer in your female organs (eg, ovaries, breast, uterus) you have heavy or irregular bleeding from your uterus or vagina you have ovarian cysts or enlargement, not due to polycystic ovary syndrome (PCOS)

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

Before using Follitropin Alfa Solution:

Some medical conditions may interact with Follitropin Alfa Solution. Tell your health care provider 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 urinary tract bleeding if you have an adrenal gland or thyroid problem if you have blood clotting or breathing problems (eg, asthma)

Some MEDICINES MAY INTERACT with Follitropin Alfa Solution. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Follitropin Alfa 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 Follitropin Alfa Solution:

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

An extra patient leaflet is available with Follitropin Alfa Solution. Talk to your pharmacist if you have questions about this information. Follitropin Alfa Solution is sometimes used at home as an injection. Use Follitropin Alfa Solution exactly as prescribed. Do not change the dose unless your doctor tells you to. Your doctor will tell you the number of units of the pen to use each day and the number of days to use the same pen. Follitropin Alfa Solution is an injection given under the skin. Your doctor or health care provider will instruct you as to how to inject yourself. Do not use Follitropin Alfa Solution at home until your health care provider has shown you the correct way. Make sure that you understand how to properly prepare and measure your dose. If you have any questions about preparing or measuring the dose, contact your health care provider. Prime the pen before the first use. You only need to prime the first time you use a new pen. Do not touch the needle or allow it to touch any surface. Allow the liquid solution to come to room temperature before you inject. Check that the liquid is clear before you inject. Do not use the injection if it contains any particles. Report this to your health care provider immediately. It is normal for a small amount of drug to be left over in the medicine pen. Discard any remaining medicine in the pen after your injection. If you are traveling, keep the pen away from light and extreme temperatures. If you use too much medicine in the pen, call your health care provider at once. If you miss a dose of Follitropin Alfa Solution, do not double the dose. Contact your doctor if to find out when you should take your next dose.

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

Important safety information: Follitropin Alfa Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Follitropin Alfa Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. You will need to have a complete gynecological and hormone evaluation prior to starting therapy with Follitropin Alfa Solution. Your partner should be evaluated for fertility problems. Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may occur in some patients who use Follitropin Alfa Solution. Contact your doctor right away if you develop severe stomach pain or bloating; nausea, vomiting, or diarrhea; sudden unexplained weight gain; shortness of breath; or decreased urination. Follitropin Alfa Solution may cause multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births. Lab tests, including ultrasound or drawing an estradiol level, may be performed while you use Follitropin Alfa Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Follitropin Alfa Solution should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Follitropin Alfa Solution if you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are or will be breast-feeding while you use Follitropin Alfa Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Follitropin Alfa 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:

Breast pain; discomfort, pain, or mild bruising at the injection site; headache; mild stomach pain or nausea; sinus inflammation; sore throat; stuffy nose.

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); abnormal vaginal bleeding; calf pain or tenderness; chest pain; confusion; decreased urination; diarrhea; fever; one-sided weakness; severe or persistent stomach pain, upset, or bloating; severe or persistent nausea; severe pelvic or back pain; shortness of breath; slurred speech; sudden, unexplained weight gain; unusual vaginal itching, discharge, or odor; vision changes; vomiting.

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: Follitropin Alfa 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 of overdose may include nausea; severe headache; severe stomach pain or swelling; vomiting; weakness; weight gain.

Proper storage of Follitropin Alfa Solution:

Store Follitropin Alfa Solution in the refrigerator (36 to 46 degrees F; 2 to 8 degrees C) until the expiration date. It can be kept at room temperature (68 to 77 degrees F; 20 to 25 degrees C) for up to 1 month or until the expiration date, whichever comes first. Protect from light. Do not freeze. Keep Follitropin Alfa Solution out of the reach of children and away from pets.

General information: If you have any questions about Follitropin Alfa Solution, please talk with your doctor, pharmacist, or other health care provider. Follitropin Alfa 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 Follitropin Alfa 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 Follitropin Alfa resources Follitropin Alfa Side Effects (in more detail) Follitropin Alfa Use in Pregnancy & Breastfeeding Follitropin Alfa Drug Interactions Follitropin Alfa Support Group 2 Reviews for Follitropin Alfa - Add your own review/rating Compare Follitropin Alfa with other medications Follicle Stimulation Hypogonadism, Male Ovulation Induction
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Avonex


Generic Name: interferon beta-1a (in ter FEAR on BAY ta)
Brand Names: Avonex, Avonex Prefilled Syringe, Rebif

What is interferon beta-1a?

Interferon beta-1a is made from human proteins. Interferons help the body fight viral infections.

Interferon beta-1a is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Interferon beta-1a may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about interferon beta-1a? This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1a if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using interferon beta-1a, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, heart disease, chest pain (angina), congestive heart failure, a heart rhythm disorder, or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1a if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself. 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.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver or thyroid function may also need to be tested. Visit your doctor regularly.

What should I discuss with my healthcare provider before using interferon beta-1a? Do not use this medication if you are allergic to interferons or human albumin. Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1a if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

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

liver disease;

epilepsy or other seizure disorder;

heart disease, chest pain (angina), congestive heart failure, or a heart rhythm disorder;

a thyroid disorder; or

a history of depression or suicidal behavior.

FDA pregnancy category C. This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1a if you are pregnant. Tell your doctor if you become pregnant during treatment. It is not known whether interferon beta-1a 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.

Avonex powder contains albumin, but the Avonex prefilled syringe does not. Albumin comes from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, 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 use interferon beta-1a?

Avonex is injected into a muscle. It is usually given once weekly at bedtime, on the same day each week (such as every Monday). Follow your doctor's instructions.

Rebif is injected under the skin. It is usually given 3 times per week (such as Monday, Wednesday, and Friday) at the same time on each dosing day. Follow your doctor's instructions.

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.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

The powder form of Avonex must be mixed with a liquid (diluent) in the medicine vial. Gently swirl but do not shake the vial after mixing the medicine. The mixture should be clear or light yellow. Do not use the mixture if it has changed colors or has any particles in it. Mix a new dose or call your doctor for a new prescription.

Do not draw your dose into a syringe until you are ready to give yourself an injection.

Each prefilled syringe or 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 after injecting your dose.

Use each disposable needle only one time. 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.

Interferon beta-1 can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your liver or thyroid function may also need to be tested. Visit your doctor regularly.

Store interferon beta-1a in a refrigerator. Do not freeze. You may take the Avonex prefilled syringe out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using. Interferon beta-1a may be kept at room temperature for short periods if protected from light. Avonex powder or Rebif prefilled syringes can be stored at room temperature for up to 30 days. Avonex prefilled syringes can be stored at room temperature for only 7 days. After mixing Avonex powder with a diluent, store in the refrigerator and use it within 6 hours.

Throw away any interferon beta-1a that has become frozen or has been exposed to light or high heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication. Your injections should be at least 48 hours apart. Do not use interferon beta-1a injections 2 days in a row.

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 interferon beta-1a? Avoid drinking alcohol. It may increase your risk of liver damage.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Interferon beta-1a 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 a serious side effect such as:

depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;

easy bruising or bleeding, weakness;

seizure (convulsions);

numbness or tingling in your hands or feet;

pain or burning when you urinate;

pain, swelling, or skin changes where the injection was given;

fever, chills, body aches, flu symptoms; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

headache, dizziness;

stomach pain; or

runny or stuffy nose.

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 interferon beta-1a?

Interferon beta-1a can harm your liver. This effect is increased when you also use other medicines harmful to the liver. Many other drugs (including some over-the-counter medicines) can be harmful to the liver, such as:

acetaminophen (Tylenol);

cancer medications;

tuberculosis medications;

birth control pills or hormone replacement therapy;

methotrexate (Rheumatrex, Trexall);

arthritis medications such as auranofin (Ridaura);

an antibiotic;

HIV/AIDS medications;

cholesterol medications such atorvastatin (Lipitor), simvastatin (Zocor), and others;

an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), lisinopril (Prinivil, Zestril), and others;

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), indomethacin (Indocin), and others; or

seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or valproic acid (Depakene).

This list is not complete and other drugs may interact with interferon beta-1a. 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 Avonex resources Avonex Side Effects (in more detail)Avonex Use in Pregnancy & BreastfeedingAvonex Drug InteractionsAvonex Support Group14 Reviews for Avonex - Add your own review/rating Avonex Advanced Consumer (Micromedex) - Includes Dosage Information Avonex Consumer Overview Avonex Prefilled Syringes MedFacts Consumer Leaflet (Wolters Kluwer) Avonex Prescribing Information (FDA) Interferon Beta-1a Professional Patient Advice (Wolters Kluwer) Interferon Beta-1a MedFacts Consumer Leaflet (Wolters Kluwer) Rebif Prescribing Information (FDA) Rebif Consumer Overview Compare Avonex with other medications Multiple SclerosisNeuritis Where can I get more information? Your doctor or pharmacist can provide more information about interferon beta-1a.

See also: Avonex side effects (in more detail)


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