jectofer injections
 

Pills
 

ED Pills

ED Drugs
 

Jectofer


Jectofer may be available in the countries listed below.

Ingredient matches for Jectofer Iron Sorbitex

Iron Sorbitex is reported as an ingredient of Jectofer in the following countries:

Bahrain Cyprus Egypt Iraq Jordan Kuwait Lebanon Libya Qatar Saudi Arabia Syria United Arab Emirates Yemen

International Drug Name Search


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Water for Injections BP 2ml, 5ml, 10ml & 20ml


1. Name Of The Medicinal Product

Water for Injections B.P. 2ml, 5ml, 10ml & 20ml.

2. Qualitative And Quantitative Composition

Each 1ml of solution contains 1ml of Water for Injections B.P.

3. Pharmaceutical Form

Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For the reconstitution, dilution and making-up of appropriate drugs where Water for Injections is the diluent of choice, and for use as an irrigant.

4.2 Posology And Method Of Administration

Route of administration: For S.C., I.M. or IV. injection, or as appropriate to the reconstituted drug.

Dosage: In accordance with the particular situation for which Water for Injections B.P. is being used.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

May be used during this period.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

No effects anticipated with the proposed use.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Not applicable.

6.2 Incompatibilities

Water for Injections B.P. should not be mixed with any other agents unless their compatibility has been established.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

2ml, 5ml, 10ml and 20ml hermetically sealed translucent plastic ampoules, polypropylene Ph.Eur., packed in cardboard cartons to contain 10, 20, 50 and 100 ampoules.

6.6 Special Precautions For Disposal And Other Handling

For S/C, I/M or I/V Injection or as appropriate to the reconstituted drug.

If only part of an ampoule is used, discard the remaining solution.

Use as directed by the physician.

Keep out of reach of children.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 2848/0152.

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorization : 10/10/91.

10. Date Of Revision Of The Text

August 2001


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ecallantide


Generic Name: ecallantide (e KAL an tide)
Brand Names: Kalbitor

What is ecallantide?

Ecallantide is used to treat attacks of hereditary angioedema (an immune system disorder). This medication is used in people who are at least 16 years old.

Ecallantide is not a cure for hereditary angioedema.

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

What is the most important information I should know about ecallantide? You should not receive ecallantide if you are allergic to it.

Before you receive ecallantide, tell your doctor if you have a history of any type of allergy.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast-feeding. Make sure any doctor caring for you afterward knows that you have received this medication. What should I discuss with my health care provider before receiving ecallantide? You should not receive ecallantide if you are allergic to it.

Before you receive ecallantide, tell your doctor if you have a history of any type of allergy.

FDA pregnancy category C. It is not known whether ecallantide will harm an unborn baby. Tell your doctor if you are pregnant. It is not known whether ecallantide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. In an emergency situation, it may not be possible before you are treated with ecallantide to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication. How is ecallantide given?

Ecallantide is injected under the skin. You will receive this injection in a clinic or hospital setting where you can be monitored in case the medication causes serious side effects.

Ecallantide is usually given in 3 separate injections. If you still have symptoms of the angioedema attack, more injections may be given within 24 hours.

What happens if I miss a dose?

Since ecallantide is given by a healthcare professional, you are not likely to miss a dose.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving ecallantide?

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

Ecallantide side effects Tell your caregivers right away if you have any of these signs of an allergic reaction within 1 hour after receiving ecallantide:

chest pain or discomfort, fast or weak heartbeat;

flushing (warmth, redness, or tingly feeling);

feeling like you might pass out;

itching, rash, or hives;

runny nose, sneezing, stuffy nose;

wheezing, cough, throat irritation, trouble breathing; or

swelling of your face, lips, tongue, or throat.

An allergic reaction to ecallantide can cause symptoms that are very similar to the signs of hereditary angioedema. Your caregivers will watch you closely while you are receiving ecallantide to make sure you are not having an allergic reaction.

Less serious side effects may include:

headache;

stomach pain, nausea, vomiting, diarrhea;

fever;

tired feeling;

sore throat; or

pain, bruising, itching, redness, rash, or irritation where the injection was given.

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.

Ecallantide Dosing Information

Usual Adult Dose for Hereditary Angioedema:

30 mg subcutaneously in three 10 mg injections. If the attack persists, an additional dose of 30 mg may be administered within a 24 hour period.

Usual Pediatric Dose for Hereditary Angioedema:

16 years or older:
30 mg subcutaneously in three 10 mg injections. If the attack persists, an additional dose of 30 mg may be administered within a 24 hour period.

What other drugs will affect ecallantide?

There may be other drugs that can interact with ecallantide. 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 ecallantide resources Ecallantide Side Effects (in more detail)Ecallantide Use in Pregnancy & BreastfeedingEcallantide Support Group0 Reviews for Ecallantide - Add your own review/rating ecallantide Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Ecallantide Professional Patient Advice (Wolters Kluwer) Ecallantide MedFacts Consumer Leaflet (Wolters Kluwer) Ecallantide Monograph (AHFS DI) Kalbitor Prescribing Information (FDA) Kalbitor Consumer Overview Compare ecallantide with other medications Hereditary Angioedema Where can I get more information? Your doctor or pharmacist can provide more information about ecallantide.

See also: ecallantide side effects (in more detail)


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Sterets H Pre-Injection Swabs (Molnlycke Health Care )


1. Name Of The Medicinal Product

Sterets H Pre-Injection Swabs.

2. Qualitative And Quantitative Composition

Isopropyl Alcohol BP 70% v/v; Chlorhexidine Acetate BP 0.5% w/v.

3. Pharmaceutical Form

Sachets containing viscose swab impregnated with isopropyl alcohol and chlorhexidine acetate.

4. Clinical Particulars 4.1 Therapeutic Indications

To be used for pre-injection site cleansing.

4.2 Posology And Method Of Administration

Topical. There are no differences in use between adults, the elderly and children. Use the wipe to cleanse the injection site.

4.3 Contraindications

None stated.

4.4 Special Warnings And Precautions For Use

Avoid contact with eyes or broken skin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcohol should not be brought into contact with some vaccines and skin test injections (patch tests). If in doubt, consult the vaccine manufacturers' literature.

4.6 Pregnancy And Lactation

No special precautions required.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Normally without side effects although minor skin reactions have been attributed to chlorhexidine and to isopropyl alcohol (infrequent, minor).

4.9 Overdose

Not applicable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Isopropyl alcohol has disinfectant properties. Chlorhexidine is a disinfectant that is effective against a wide range of vegetative Gram-positive and Gram-negative bacteria. A 0.5% solution of chlorhexidine acetate in 70% isopropyl alcohol is used for pre-operative disinfection of the skin. The solution is appropriate for swabbing on to cleanse and lower the skin bacteriological count prior to injections.

5.2 Pharmacokinetic Properties

There is little absorption of isopropyl alcohol through intact skin. Chlorhexidine acetate is adsorbed on to the skin surface but there is minimal further absorption. Pharmacokinetic particulars are not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

60 months unopened.

6.4 Special Precautions For Storage

Store in a cool dry place, away from direct sunlight. Flammable contents. Flash point 24oC. Product/contents should be kept away from a naked flame.

6.5 Nature And Contents Of Container

100 sachets per box. Printed aluminium foil laminated sachets (laminates of coated paper/polyethylene/aluminium foil/surlyn, the surlyn layer innermost).

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Ltd, Tubiton House, Medlock Street, Oldham, OL1 3HS, UK.

8. Marketing Authorisation Number(S)

21248/0026.

9. Date Of First Authorisation/Renewal Of The Authorisation

3rd February 2006.

10. Date Of Revision Of The Text

February 2006.


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Supartz


Pronunciation: HYE-al-ure-ON-ate SOE-dee-um
Generic Name: Hyaluronate Sodium
Brand Name: Examples include Hyalgan and Supartz
Supartz is used for:

Treating knee pain in patients with osteoarthritis who have not received relief from other treatments.

Supartz is a hyaluronic acid derivative. It works by increasing the effectiveness of the fluid within the knee joint to act as a lubricant and shock absorber.

Do NOT use Supartz if: you are allergic to any ingredient in Supartz you have an infection or skin disease near the joint or injection site

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

Before using Supartz:

Some medical conditions may interact with Supartz. 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 are allergic to birds or bird products (eg, eggs, feathers, poultry)

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

Quaternary ammonium salts because side effects may occur

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

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

Supartz comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Supartz refilled. Supartz is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Supartz at home, a health care provider will teach you how to use it. Be sure you understand how to use Supartz. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Supartz is usually given as a series of injections 1 week apart for a total of 3 to 5 injections depending upon the particular product you are using. You may not experience relief until you have received several injections. Do not use Supartz if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Do not use disinfectants containing ammonium salts to prepare the skin for injection because side effects may occur. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Supartz, contact your doctor to establish a new dosing schedule.

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

Important safety information: Supartz may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Supartz with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. You may experience a temporary inflammation in your knee after using Supartz. If the inflammation is severe or continues, contact your doctor. Avoid strenuous activity or prolonged (more than 1 hour) weight-bearing activity (eg, running, tennis, heavy lifting) for at least 48 hours after you are injected with Supartz. Supartz should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Supartz, contact your doctor. You will need to discuss the benefits and risks of using Supartz while pregnant. It is not known if Supartz is found in breast milk. If you are or will be breast-feeding while you are using Supartz, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Supartz:

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:

Back pain; mild bruising, heat, redness, swelling, or pain at the injection site; temporary achy feeling; temporary knee inflammation.

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

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

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

See also: Supartz 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.

Proper storage of Supartz:

Supartz is usually handled and stored by a health care provider. If you are using Supartz at home, store Supartz as directed by your pharmacist or health care provider. Keep Supartz out of the reach of children and away from pets.

General information: If you have any questions about Supartz, please talk with your doctor, pharmacist, or other health care provider. Supartz 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 Supartz. 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 Supartz resources Supartz Side Effects (in more detail) Supartz Use in Pregnancy & Breastfeeding Supartz Drug Interactions Supartz Support Group 3 Reviews for Supartz - Add your own review/rating Compare Supartz with other medications Osteoarthritis
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Hyalgan


Pronunciation: HYE-al-ure-ON-ate SOE-dee-um
Generic Name: Hyaluronate Sodium
Brand Name: Examples include Hyalgan and Supartz
Hyalgan is used for:

Treating knee pain in patients with osteoarthritis who have not received relief from other treatments.

Hyalgan is a hyaluronic acid derivative. It works by increasing the effectiveness of the fluid within the knee joint to act as a lubricant and shock absorber.

Do NOT use Hyalgan if: you are allergic to any ingredient in Hyalgan you have an infection or skin disease near the joint or injection site

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

Before using Hyalgan:

Some medical conditions may interact with Hyalgan. 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 are allergic to birds or bird products (eg, eggs, feathers, poultry)

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

Quaternary ammonium salts because side effects may occur

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

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

Hyalgan comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Hyalgan refilled. Hyalgan is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Hyalgan at home, a health care provider will teach you how to use it. Be sure you understand how to use Hyalgan. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Hyalgan is usually given as a series of injections 1 week apart for a total of 3 to 5 injections depending upon the particular product you are using. You may not experience relief until you have received several injections. Do not use Hyalgan if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Do not use disinfectants containing ammonium salts to prepare the skin for injection because side effects may occur. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Hyalgan, contact your doctor to establish a new dosing schedule.

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

Important safety information: Hyalgan may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Hyalgan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. You may experience a temporary inflammation in your knee after using Hyalgan. If the inflammation is severe or continues, contact your doctor. Avoid strenuous activity or prolonged (more than 1 hour) weight-bearing activity (eg, running, tennis, heavy lifting) for at least 48 hours after you are injected with Hyalgan. Hyalgan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Hyalgan, contact your doctor. You will need to discuss the benefits and risks of using Hyalgan while pregnant. It is not known if Hyalgan is found in breast milk. If you are or will be breast-feeding while you are using Hyalgan, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Hyalgan:

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:

Back pain; mild bruising, heat, redness, swelling, or pain at the injection site; temporary achy feeling; temporary knee inflammation.

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

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

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

See also: Hyalgan 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.

Proper storage of Hyalgan:

Hyalgan is usually handled and stored by a health care provider. If you are using Hyalgan at home, store Hyalgan as directed by your pharmacist or health care provider. Keep Hyalgan out of the reach of children and away from pets.

General information: If you have any questions about Hyalgan, please talk with your doctor, pharmacist, or other health care provider. Hyalgan 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 Hyalgan. 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 Hyalgan resources Hyalgan Side Effects (in more detail) Hyalgan Use in Pregnancy & Breastfeeding Hyalgan Drug Interactions Hyalgan Support Group 0 Reviews for Hyalgan - Add your own review/rating Hyalgan injection Concise Consumer Information (Cerner Multum) Hyalgan Advanced Consumer (Micromedex) - Includes Dosage Information Compare Hyalgan with other medications Osteoarthritis
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insulin lispro and insulin lispro protamine


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 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 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 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 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 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. 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.

Insulin lispro and insulin lispro protamine Dosing Information

Usual Adult Dose for Diabetes Mellitus Type I:

Insulin lispro-lispro protamine is a mixture of rapid and intermediate-acting insulins and is given subcutaneously 1 to 3 times daily. It should be given within 15 minutes before a meal.
Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.
Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal.
Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2-5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type II:

Insulin lispro-lispro protamine is a mixture of rapid and intermediate-acting insulins and is given subcutaneously 1 to 3 times daily. It should be given within 15 minutes before a meal.
Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents. Insulin may be considered if patients are very hyperglycemic or symptomatic and/or not controlled with oral agents. Insulin may exacerbate obesity, further increase insulin resistance, and increase the frequency of hypoglycemia.
Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.
Conventional regimen:
Initial dose, monotherapy: Total insulin requirement: 0.1 unit/kg/day. When insulin is used alone, twice daily injections are recommended for better glycemic control. The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.
Maintenance dose, monotherapy: An average of 0.65 units/kg/day in 2 divided doses of lispro-lispro protamine insulin has been used in studies. Total daily insulin requirements may progress to 1.5 to 2.5 units/kg or higher in patients with obesity and insulin resistance.
Intensive regimen:
The necessity for and efficacy of intensive insulin therapy in type II diabetes has been controversial. The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Initial dose, monotherapy: 0.5 to 1.5 unit/kg/day subcutaneously.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 2.5 units/kg or higher in patients with obesity and insulin resistance.

What other drugs will affect 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 insulin lispro and insulin lispro protamine resources Insulin lispro and insulin lispro protamine Use in Pregnancy & Breastfeeding Insulin lispro and insulin lispro protamine Drug Interactions Insulin lispro and insulin lispro protamine Support Group 1 Review for Insulin lispro and insulin lispro protamine - Add your own review/rating Compare insulin lispro and insulin lispro protamine 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.
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carboprost


Generic Name: carboprost (KAR boe prost)
Brand Names: Hemabate

What is carboprost?

Carboprost is a form of prostaglandin (a hormone-like substance that occurs naturally in the body). Prostaglandins help to control functions in the body such as blood pressure and muscle contractions.

Carboprost is used to treat severe bleeding after childbirth (postpartum).

Carboprost is also used to produce an abortion by causing uterine contractions. It is usually given between the 13th and 20th weeks of pregnancy, but may be given at other times for medical reasons. Carboprost is often used when another method of abortion has not completely emptied the uterus, or when a complication of pregnancy would cause the baby to be born too early to survive.

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

What is the most important information I should know about carboprost?

Carboprost usually causes nausea, vomiting, and/or diarrhea. You may be given to control these things before you are given carboprost.

You should not receive this medication if you are allergic to carboprost, or have certain conditions such as pelvic inflammatory disease, a breathing disorder, heart disease, liver disease, or kidney disease. Serious side effects of carboprost may include severe pelvic cramping, vaginal bleeding, high fever, and severe vomiting or diarrhea.

Before you receive carboprost, tell your doctor if you have been treated with any other drugs that may cause contractions of the uterus. Carboprost can increase the effects of these other drugs, and they should not be used together.

Your cervix (opening of the uterus) will need to be checked after you receive carboprost. Do not miss any scheduled follow-up visits to your doctor.

In some cases, carboprost may not produce a complete abortion and the procedure must be repeated. What should I discuss with my health care provider before receiving carboprost? You should not receive this medication if you are allergic to carboprost, or have certain conditions. Tell your doctor if you have:

pelvic inflammatory disease;

a lung disorder or breathing problem;

heart disease;

kidney disease; or

liver disease.

Before receiving carboprost, tell your doctor if you are allergic to any drugs, or if you have:

high or low blood pressure;

diabetes;

epilepsy or other seizure disorder;

any scarring in your uterus;

a history of asthma; or

a history of heart, kidney, or liver disease.

If you have any of these conditions, you may not be able to receive carboprost, or you may need dosage adjustments or special tests during treatment.

If you are receiving this medication for purposes other than abortion or postpartum bleeding, tell your doctor if you are pregnant. How is carboprost given?

Carboprost is given as an injection into a muscle. You will receive this injection in a clinic or hospital setting.

You may also be given medication to control nausea, vomiting, or diarrhea caused by carboprost.

To be sure this medication has been effective, your cervix (opening of the uterus) will need to be checked after the procedure. Do not miss any scheduled follow-up visits to your doctor.

In some cases, carboprost may not produce a complete abortion and the procedure must be repeated. What happens if I miss a dose?

Since this medication is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose? Tell your caregivers right away if you think you have received too much of this medicine. An overdose of carboprost is unlikely to occur in a hospital or clinic setting. What should I avoid while receiving carboprost?

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

Carboprost 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 any of these serious side effects:

severe pelvic pain, cramping, or vaginal bleeding;

high fever;

feeling light-headed or short of breath;

severe nausea, vomiting, or diarrhea; or

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects include:

mild fever that may come and go;

chills, numbness, or tingly feeling;

mild nausea or diarrhea;

cough;

headache;

breast pain or tenderness;

menstrual type pain; or

ringing in your ears.

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

Carboprost Dosing Information

Usual Adult Dose for Abortion:

Initial dose: 250 mcg (1 mL) intramuscularly once. The dose should be administered deep into the muscle with a tuberculin syringe.
Subsequent doses of 250 mcg (1 mL) may be administered at 1.5 to 3.5 hour intervals depending on uterine response.
An optional test dose of 100 mcg (0.4 mL) may be administered initially. The dose may be increased to 500 mcg (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 mcg (1 mL).
The total dose of carboprost administered should not exceed 12 milligrams and continuous administration of the drug for more than 2 days is not recommended.
Abortion induced by carboprost may be expected to be incomplete in about 20% of cases (the same percentage as with spontaneous abortions).
While the incidence of cervical trauma is extremely small, the cervix should always be examined immediately postabortion.

Usual Adult Dose for Postpartum Bleeding:

Initial dose: 250 mcg (1 mL) administered deeply intramuscularly once.
Clinical trials have reported that 73% of cases responded to single injections.
In some selected cases, multiple dosing at intervals of 15 to 90 minutes was reported to have had a successful outcome.
The need for additional injections and the interval at which additional injections should be administered must be determined by the attending physician as dictated by the course of clinical events.
The total dose of carboprost should not exceed 2 mg (8 doses or 8 mL).

What other drugs will affect carboprost?

Before you receive carboprost, tell your doctor if you have been treated with any other drugs that may cause contractions of the uterus, such as:

dinoprostone (Prostin E2);

mifepristone (Mifeprex (RU-486)

misoprostol (Cytotec); or

oxytocin (Pitocin).

Carboprost can increase the effects of these other drugs, and they should not be used together.

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

More carboprost resources Carboprost Side Effects (in more detail) Carboprost Dosage Carboprost Use in Pregnancy & Breastfeeding Carboprost Support Group 0 Reviews for Carboprost - Add your own review/rating carboprost Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information Carboprost Tromethamine Monograph (AHFS DI) Hemabate Prescribing Information (FDA) Compare carboprost with other medications Abortion Postpartum Bleeding Where can I get more information? Your doctor or pharmacist can provide more information about carboprost.

See also: carboprost side effects (in more detail)


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Testosterone Enanthate Ampoules (Cambridge Laboratories)


What you should know about Testosterone Enantate Ampoules

Please read this leaflet carefully. This leaflet contains information about Testosterone Enantate Ampoules, which will be given to you by injection. Although you will not be taking this medicine yourself, this leaflet contains important information to help you understand how Testosterone Enantate is used. Keep it until the course of treatment has been finished, as you may want to read it again.

Always follow your doctor's advice, and if there is anything you do not understand, please ask your doctor or nurse to explain it.

What do Testosterone Enantate Ampoules contain?

Each ampoule contains 250 mg of Testosterone Enantate (the active ingredient) together with the inactive ingredients benzyl benzoate and castor oil for injection.

Testosterone Enantate is supplied in packs of 3 ampoules, each ampoule containing 1 ml.

Testosterone Enantate is an androgen, a male type of hormone.

The holder of the product licence for this medicine is

Cambridge Laboratories Limited Deltic House Kingfisher Way Silverlink Business Park Wallsend Tyne & Wear NE28 9NX

The ampoules are made by

Schering AG Berlin Germany What is Testosterone Enantate used for?

In men Testosterone Enantate is used when natural levels of this hormone are low, which can cause loss of interest in sex, low fertility and other problems. In women Testosterone Enantate is used to treat certain diseases of the breast.

When should Testosterone Enantate not be used?

Since androgens (male hormones) can stimulate the growth of cancer of the prostate gland, men must not be given Testosterone Enantate if they have prostatic cancer. For this reason, men should have regular examinations of the prostate gland during treatment with Testosterone Enantate. Men with breast cancer should not be given Testosterone Enantate.

Testosterone Enantate Ampoules should not be used to treat women who are pregnant or breast-feeding.

You should not be given Testosterone Enantate Ampoules if you have a liver tumour or a history of such tumours, if you have a kidney disease called nephrosis or if you have too much calcium in your blood.

What else should you know before having an injection of Testosterone Enantate?

Male hormones such as Testosterone Enantate are not suitable for increasing muscular development in healthy people or for increasing physical ability.

Special care is needed when Testosterone Enantate is used in the elderly and in patients with the following conditions:

Kidney problems Heart disease Liver disease High blood pressure Migraine Diabetes Cancer that has spread to the bones

If you suffer from any of these and think that the doctor who has prescribed Testosterone Enantate for you is not aware of this, you should tell him or her straight away.

Regular blood tests may be needed if you are also being treated with some medicines that slow down the clotting of the blood. Testosterone Enantate may be less effective in epileptic patients who are taking Phenobarbital, so if this applies to you please make sure that the doctor treating you knows about it.

How Testosterone Enantate is used

Testosterone Enantate is given by injection into a muscle, usually every 2 to 3 weeks. The injections are continued for as long as your doctor considers necessary, but men receiving long-term treatment may later be given injections at 3 to 6 week intervals.

If you would like any other information about the use of Testosterone Enantate, please ask your doctor or nurse.

Side-effects

When hormones such as Testosterone Enantate are used in high doses or over a long period of time, they may result in the retention of too much water, and even swelling of the ankles in some cases. If you have a tendency to this problem, make sure your doctor checks you very carefully while you are receiving treatment with Testosterone Enantate Ampoules.

Women who receive Testosterone Enantate may develop acne, increased growth of hair on the face and body, thinning of scalp hair and deepening of the voice (particular care is necessary in women whose occupations involve singing or speaking).

If men receive long-term and high-dose treatment with Testosterone Enantate, the number of sperms they produce is reduced. Men may experience frequent or persistent erections whilst under Testosterone Enantate treatment. If this happens, make sure to tell your doctor so that he may reduce the dose or stop the treatment in order to avoid injury to the penis.

Occasionally coughing, shortness of breath and changes in the circulation of the blood may develop while Testosterone Enantate is being injected or immediately after the injection.

The doctor may arrange for women receiving Testosterone Enantate to have regular blood tests. If these show an increased level of calcium, he will stop the treatment.

In very rare cases liver tumours have been observed after the use of hormones such as Testosterone Enantate. In a few isolated cases this has been followed by internal bleeding which can be life-threatening. Tell your doctor if you have any new "stomach" discomfort or pain that does not soon clear up.

Other side effects that have sometimes occurred with Testosterone Enantate are headache, depression, feeling sick, jaundice, breast enlargement in men, an increase in the number of red blood cells, anxiety, feeling weak, abnormal sensations, increased bone growth and premature sexual development in boys.

If you are worried about side-effects or if you think that Testosterone Enantate has caused any other side-effect, please tell your doctor, nurse or pharmacist about it.

Storing Testosterone Enanthate

Testosterone Enantate Ampoules should not be used after the expiry date given on the label. They should be stored away from light.

All medicines should be kept out of the reach of children.

Date of preparation of this leaflet: August 2001


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Eligard


leuprolide acetate
Dosage Form: injectable suspension
Eligard® 7.5 mg, 22.5 mg, 30 mg, 45 mg
(leuprolide acetate for injectable suspension) Eligard Description

Eligard® is a sterile polymeric matrix formulation of leuprolide acetate for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period.

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone. The chemical name is 5 - oxo - L - prolyl - L - histidyl - L - tryptophyl - L - seryl - L - tyrosyl - D - leucyl - L - leucyl - L - arginyl - N - ethyl - L - prolinamide acetate (salt) with the following structural formula:

Eligard® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. Eligard® is administered subcutaneously, where it forms a solid drug delivery depot.

One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. ATRIGEL® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP).

Refer to Table 1 for the delivery system composition and constituted product formulation for each Eligard® product.

Table 1. Eligard® Delivery System Composition and Constituted Product Formulation Eligard®
7.5 mg Eligard®
22.5 mg Eligard®
30 mg Eligard®
45 mg ATRIGEL® Delivery System Syringe Polymer PLGH PLG PLG PLG Polymer description Copolymer containing carboxyl endgroups Copolymer with hexanediol Copolymer with hexanediol Copolymer with hexanediol   Polymer DL-lactide to Glycolide Molar Ratio 50:50 75:25 75:25 85:15   Constituted Product Polymer delivered 82.5 mg 158.6 mg 211.5 mg 165 mg NMP delivered 160.0 mg 193.9 mg 258.5 mg 165 mg   Leuprolide acetate delivered 7.5 mg 22.5 mg 30 mg 45 mg   Approximate Leuprolide free base equivalent 7.0 mg 21 mg 28 mg 42 mg   Approximate administered formulation weight 250 mg 375 mg 500 mg 375 mg   Approximate injection volume 0.25 mL 0.375 mL 0.5 mL 0.375 mL Eligard - Clinical Pharmacology

Leuprolide acetate, an LH-RH agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses. Animal and human studies indicate that after an initial stimulation, chronic administration of leuprolide acetate results in suppression of testicular and ovarian steroidogenesis. This effect is reversible upon discontinuation of drug therapy.

In humans, administration of leuprolide acetate results in an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of leuprolide acetate results in decreased levels of LH and FSH. In males, testosterone is reduced to below castrate threshold (? 50 ng/dL). These decreases occur within two to four weeks after initiation of treatment. Long-term studies have shown that continuation of therapy with leuprolide acetate maintains testosterone below the castrate level for up to seven years.

PHARMACODYNAMICS

Following the first dose of Eligard®, mean serum testosterone concentrations transiently increased, then fell to below castrate threshold (? 50 ng/dL) within three weeks for all Eligard® concentrations.

Continued monthly treatment with Eligard® 7.5 mg maintained castrate testosterone suppression throughout the study. No breakthrough of testosterone concentrations above castrate threshold (> 50 ng/dL) occurred at any time during the study once castrate suppression was achieved (Figure 1).

One patient received less than a full dose of Eligard® 22.5 mg at baseline, never suppressed and withdrew from the study at Day 73. Of the 116 patients remaining in the study, 115 (99%) had serum testosterone levels below the castrate threshold by Month 1 (Day 28). By Day 35, 116 (100%) had serum testosterone levels below the castrate threshold. Once testosterone suppression was achieved, one patient (< 1%) demonstrated breakthrough (concentrations > 50 ng/dL after achieving castrate levels) following the initial injection; that patient remained below the castrate threshold following the second injection (Figure 2).

One patient withdrew from the Eligard® 30 mg study at Day 14. Of the 89 patients remaining in the study, 85 (96%) had serum testosterone levels below the castrate threshold by Month 1 (Day 28). By Day 42, 89 (100%) of patients attained castrate testosterone suppression. Once castrate testosterone suppression was achieved, three patients (3%) demonstrated breakthrough (concentrations > 50 ng/dL after achieving castrate levels) (Figure 3).

One patient at Day 1 and another patient at Day 29 were withdrawn from the Eligard® 45 mg study. Of the 109 patients remaining in the study, 108 (99.1%) had serum testosterone levels below the castrate threshold by Month 1 (Day 28). One patient did not achieve castrate suppression and was withdrawn from the study at Day 85. Once castrate testosterone suppression was achieved, one patient (< 1%) demonstrated breakthrough (concentrations > 50 ng/dL after achieving castrate levels) (Figure 4).

Leuprolide acetate is not active when given orally.

PHARMACOKINETICS Absorption Eligard® 7.5 mg

The pharmacokinetics/pharmacodynamics observed during three once-monthly injections in 20 patients with advanced prostate cancer is shown in Figure 1. Mean serum leuprolide concentrations following the initial injection rose to 25.3 ng/mL (Cmax) at approximately 5 hours after injection. After the initial increase following each injection, serum concentrations remained relatively constant (0.28 – 2.00 ng/mL).
 

Figure 1 Pharmacokinetic/Pharmacodynamic Response (N=20) to Eligard® 7.5 mg – Patients Dosed Initially and at Months 1 and 2

A reduced number of sampling timepoints resulted in the apparent decrease in Cmax values with the second and third doses of Eligard® 7.5 mg (Figure 1).

Eligard® 22.5 mg

The pharmacokinetics/pharmacodynamics observed during two injections every three months (Eligard® 22.5 mg) in 22 patients with advanced prostate cancer is shown in Figure 2. Mean serum leuprolide concentrations rose to 127 ng/mL and 107 ng/mL at approximately 5 hours following the initial and second injections, respectively. After the initial increase following each injection, serum concentrations remained relatively constant (0.2 – 2.0 ng/mL).
 

Figure 2 Pharmacokinetic/Pharmacodynamic Response (N=22) to Eligard® 22.5 mg – Patients Dosed Initially and at Month 3

Eligard® 30 mg

The pharmacokinetics/pharmacodynamics observed during injections administered initially and at four months (Eligard® 30 mg ) in 24 patients with advanced prostate cancer is shown in Figure 3. Mean serum leuprolide concentrations following the initial injection rose rapidly to 150 ng/mL (Cmax) at approximately 3.3 hours after injection. After the initial increase following each injection, mean serum concentrations remained relatively constant (0.1 – 1.0 ng/mL).
 

Figure 3 Pharmacokinetic/Pharmacodynamic Response (N=24) to Eligard® 30 mg – Patients Dosed Initially and at Month 4

Eligard® 45 mg

The pharmacokinetics/pharmacodynamics observed during injections administered initially and at six months (Eligard® 45 mg) in 27 patients with advanced prostate cancer is shown in Figure 4. Mean serum leuprolide concentrations rose to 82.0 ng/mL and 102 ng/mL (Cmax) at approximately 4.5 hours following the initial and second injections, respectively. After the initial increase following each injection, mean serum concentrations remained relatively constant (0.2 – 2.0 ng/mL).
 

Figure 4 Pharmacokinetic/Pharmacodynamic Response (N=27) to Eligard® 45 mg - Patients Dosed Initially and at Month 6

There was no evidence of significant accumulation during repeated dosing. Nondetectable leuprolide plasma concentrations have been occasionally observed during Eligard® administration, but testosterone levels were maintained at castrate levels.

Distribution

The mean steady-state volume of distribution of leuprolide following intravenous bolus administration to healthy male volunteers was 27 L.1 In vitro binding to human plasma proteins ranged from 43% to 49%.

1 Sennello LT et al. Single-dose pharmacokinetics of leuprolide in humans following intravenous and subcutaneous administration. J Pharm Sci 1986; 75(2): 158–160. Metabolism

In healthy male volunteers, a 1-mg bolus of leuprolide administered intravenously revealed that the mean systemic clearance was 8.34 L/h, with a terminal elimination half-life of approximately 3 hours based on a two compartment model.1

No drug metabolism study was conducted with Eligard®. Upon administration with different leuprolide acetate formulations, the major metabolite of leuprolide acetate is a pentapeptide (M-1) metabolite.

Excretion

No drug excretion study was conducted with Eligard®.

Special Populations Geriatrics

The majority of the patients (approximately 70%) studied in the clinical trials were age 70 and older.

Pediatrics

The safety and effectiveness of Eligard® in pediatric patients have not been established (see CONTRAINDICATIONS).

Race

In patients studied, mean serum leuprolide concentrations were similar regardless of race. Refer to Table 2 for distribution of study patients by race.

Table 2. Race Characterization of Study Patients Race Eligard®
7.5 mg Eligard®
22.5 mg Eligard®
30 mg Eligard®
45 mg White 26 19 18 17 Black - 4 4 7 Hispanic 2 2 2 3 Renal and Hepatic Insufficiency

The pharmacokinetics of Eligard® in hepatically and renally impaired patients have not been determined

Drug-Drug Interactions

No pharmacokinetic drug-drug interaction studies were conducted with Eligard®.

Clinical Studies

One open-label, multicenter study was conducted with each Eligard® formulation (7.5 mg, 22.5 mg, 30 mg, and 45 mg) in patients with Jewett stage A though D prostate cancer who were treated with at least a single injection of study drug (Table 3). These studies evaluated the achievement and maintenance of castrate serum testosterone suppression over the duration of therapy (Figures 5–8).

During the AGL9904 study using Eligard® 7.5 mg, once testosterone suppression was achieved, no patients (0%) demonstrated breakthrough (concentration >50 ng/dL) at any time in the study.

During the AGL9909 study using Eligard® 22.5 mg, once testosterone suppression was achieved, only one patient (< 1%) demonstrated breakthrough following the initial injection; that patient remained below the castrate threshold following the second injection.

During the AGL0001 study using Eligard® 30 mg, once testosterone suppression was achieved, three patients (3%) demonstrated breakthrough. In the first of these patients, a single serum testosterone concentration of 53 ng/dL was reported on the day after the second injection. In this patient, castrate suppression was reported for all other timepoints. In the second patient, a serum testosterone concentration of 66 ng/dL was reported immediately prior to the second injection. This rose to a maximum concentration of 147 ng/dL on the second day after the second injection. In this patient, castrate suppression was again reached on the seventh day after the second injection and was maintained thereafter. In the final patient, serum testosterone concentrations > 50 ng/dL were reported at 2 and at 8 hours after the second injection. Serum testosterone concentration rose to a maximum of 110 ng/dL on the third day after the second injection. In this patient, castrate suppression was again reached eighteen days after the second injection and was maintained until the final day of the study, when a single serum testosterone concentration of 55 ng/dL was reported.

During the AGL0205 study using Eligard® 45 mg, once testosterone suppression was achieved, one patient (<1%) demonstrated breakthrough. This patient reached castrate suppression at Day 21 and remained suppressed until Day 308 when his testosterone level rose to 112 ng/dL. At Month 12 (Day 336), his testosterone was 210 ng/dL.

Table 3. Summary of Eligard® Clinical Studies 7.5 mg 22.5 mg 30 mg 45 mg * One patient received less than a full dose at Baseline, never suppressed, and was withdrawn at Day 73 and given an alternate treatment. † All non-evaluable patients who attained castration by Day 28 maintained castration at each timepoint up to and including the time of withdrawal. ‡ One patient withdrew on Day 14. All 7 non-evaluable patients who had achieved castration by Day 28 maintained castration at each timepoint, up to and including the time of withdrawal. § Two patients were withdrawn prior to the Month 1 blood draw. One patient did not achieve castration and was withdrawn on Day 85. All 5 non-evaluable patients who attained castration by Day 28, maintained castration at each timepoint up to and including the time of withdrawal. ¶ Two patients withdrew for reasons unrelated to drug. Study number AGL9904 AGL9909 AGL0001 AGL0205 Total Number of patients 120 (117 completed) 117* (111 completed†) 90 (82 completed‡) 111 (103 completed§) Jewett Stages Stage A - 2 2 5 Stage B - 19 38 43 Stage C 89 60 16 19 Stage D 31 36 34 44 Treatment 6 monthly injections 1 injection (4 patients) 1 injection (5 patients) 1 injection (5 patients) 2 injections, one every three months (113 patients) 2 injections, one every four months (85 patients) 2 injections, one every six months (106 patients)       Duration of therapy 6 months 6 months 8 months 12 months Mean testosterone concentration (ng/dL) Baseline 361.3 367.1 385.5 367.7 Day 2 574.6 (Day 3) 588.0 610.0 588.6   Day 14 Below Baseline (Day 10) Below Baseline Below Baseline Below Baseline   Day 28 21.8 27.7 (Day 21) 17.2 16.7   Conclusion 6.1 10.1 12.4 12.6   Number of patients below castrate threshold
(? 50 ng/dL) Day 28 112 of 119 (94.1%) 115 of 116 (99%) 85 of 89 (96%) 108 of 109 (99.1%) Day 35 - 116 (100%) - -   Day 42 119 (100%) - 89 (100%) -   Conclusion 117¶ (100%) 111 (100%) 81 (99%) 102 (99%)    

Figure 5 Eligard® 7.5 mg Mean Serum Testosterone Concentrations (n=117)


 

Figure 6 Eligard® 22.5 mg Mean Serum Testosterone Concentrations (n=111)


 

Figure 7 Eligard® 30 mg Mean Serum Testosterone Concentrations (n=90)


 

Figure 8 Eligard® 45 mg Mean Serum Testosterone Concentrations (n=103)

Serum PSA decreased in all patients in all studies whose Baseline values were elevated above the normal limit. Refer to Table 4 for a summary of the effectiveness of Eligard® in reducing serum PSA values.

Table 4 Effect of Eligard® on Patient Serum PSA Values Eligard® 7.5 mg 22.5 mg 30 mg 45 mg * Among patients who presented with elevated levels at Baseline Mean PSA Reduction at Study Conclusion 94% 98% 86% 97% Patients with Normal PSA at Study Conclusion* 94% 91% 93% 95%

Other secondary efficacy endpoints evaluated included WHO performance status, bone pain, urinary pain and urinary signs and symptoms. Refer to Table 5 for a summary of these endpoints.

Table 5 Secondary Efficacy Endpoints Eligard®
7.5 mg Eligard®
22.5 mg Eligard®
30 mg Eligard®
45 mg * WHO Status = 0 classified as "fully active." † WHO Status = 1 classified as "restricted in strenuous activity but ambulatory and able to carry out work of a light or sedentary nature." ‡ WHO Status = 2 classified as "ambulatory but unable to carry out work activities." § Pain score scale: 1 (no pain) to 10 (worst pain possible). Baseline WHO Status = 0* 88% 94% 90% 90% WHO Status = 1† 11% 6% 10% 7%   WHO Status = 2‡ 3%   Mean Bone Pain§ (range) 1.22 (1–9) 1.20 (1–9) 1.20 (1–7) 1.38 (1–7)   Mean Urinary Pain (range) 1.12 (1–5) 1.02 (1–2) 1.01 (1–2) 1.22 (1–8)   Mean Urinary Signs and Symptoms (range) Low 1.09 (1–4) Low Low   Number of Patients with Prostate Abnormalities 102 (85%) 96 (82%) 66 (73%) 89 (80%)   Month 6 Month 6 Month 8 Month 12 Follow-up WHO Status = 0 Unchanged 96% 87% 94% WHO Status = 1 Unchanged 4% 12% 5%   WHO Status = 2 1% 1%   Mean Bone Pain (range) 1.26 (1–7) 1.22 (1–5) 1.19 (1–8) 1.31 (1–8)   Mean Urinary Pain (range) 1.07 (1–8) 1.10 (1–8) 1.00 (1–1) 1.07 (1–5)   Mean Urinary Signs and Symptoms (range) Modestly Decreased 1.18 (1–7) Modestly Decreased Modestly Decreased   Number of Patients with Prostate Abnormalities 77 (64%) 76 (65%) 54 (60%) 60 (58%)   Indications and Usage for Eligard

Eligard® is indicated for the palliative treatment of advanced prostate cancer.

Contraindications Eligard® is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs or any of the components of Eligard®. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature.2 Eligard® is contraindicated in women and in pediatric patients and was not studied in women or children. Moreover, leuprolide acetate can cause fetal harm when administered to a pregnant woman. Major fetal abnormalities were observed in rabbits but not in rats after administration of leuprolide acetate throughout gestation. There were increased fetal mortality and decreased fetal weights in rats and rabbits. The effects on fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug. The possibility exists that spontaneous abortion may occur. 2 MacLeod TL et al. Anaphylactic reaction to synthetic luteinizing hormone releasing hormone. Fertil Steril 1987 Sept; 48(3): 500–502. Warnings

Eligard® 7.5 mg 22.5 mg 30 mg, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Eligard® 45 mg causes a transient increase in serum concentrations of testosterone during the first two weeks of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, or bladder outlet obstruction. Isolated cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using LH-RH agonists (see PRECAUTIONS).

If spinal cord compression or ureteral obstruction develops, standard treatment of these complications should be instituted.

Precautions General

Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy (see WARNINGS section).

Laboratory Tests

Response to Eligard® should be monitored by measuring serum concentrations of testosterone and prostate specific antigen periodically.

In the majority of patients, testosterone levels increased above Baseline during the first week, declining thereafter to Baseline levels or below by the end of the second or third week. Castrate levels were generally reached within two to four weeks.

Castrate testosterone levels were maintained for the duration of the treatment with Eligard® 7.5 mg. No increases to above the castrate level occurred in any of the patients.

Castrate levels were generally maintained for the duration of treatment with Eligard® 22.5 mg.

Once castrate levels were achieved with Eligard® 30 mg, most (86/89) patients remained suppressed throughout the study.

Once castrate levels were achieved with Eligard® 45 mg, only one patient (< 1%) experienced a breakthrough, with testosterone levels > 50 ng/dL.

Results of testosterone determinations are dependent on assay methodology. It is advisable to be aware of the type and precision of the assay methodology to make appropriate clinical and therapeutic decisions.

Drug Interactions

See PHARMACOKINETICS.

Drug/Laboratory Test Interactions

Therapy with leuprolide acetate results in suppression of the pituitary-gonadal system. Results of diagnostic tests of pituitary gonadotropic and gonadal functions conducted during and after leuprolide therapy may be affected.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year carcinogenicity studies were conducted with leuprolide acetate in rats and mice. In rats, a dose-related increase of benign pituitary hyperplasia and benign pituitary adenomas was noted at 24 months when the drug was administered subcutaneously at high daily doses (0.6 to 4 mg/kg). There was a significant but not dose-related increase of pancreatic islet-cell adenomas in females and of testicular interstitial cell adenomas in males (highest incidence in the low dose group). In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years. Patients have been treated with leuprolide acetate for up to three years with doses as high as 10 mg/day and for two years with doses as high as 20 mg/day without demonstrable pituitary abnormalities. No carcinogenicity studies have been conducted with Eligard®.

Mutagenicity studies have been performed with leuprolide acetate using bacterial and mammalian systems and with Eligard® 7.5 mg in bacterial systems. These studies provided no evidence of a mutagenic potential.

Pregnancy Teratogenic Effects

Pregnancy category X

(see CONTRAINDICATIONS).

Pediatric Use

Eligard® is contraindicated in pediatric patients and was not studied in children (see CONTRAINDICATIONS).

Adverse Reactions

The safety of all Eligard® formulations was evaluated in clinical trials involving patients with advanced prostate cancer. In addition, the safety of Eligard® 7.5 mg was evaluated in 8 surgically castrated males (Table 7). Eligard®, like other LH-RH analogs, caused a transient increase in serum testosterone concentrations during the first one to two weeks of treatment. Therefore, potential exacerbations of signs and symptoms of the disease during the first weeks of treatment are of concern in patients with vertebral metastases and/or urinary obstruction or hematuria. If these conditions are aggravated, it may lead to neurological problems such as weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms (see WARNINGS and PRECAUTIONS).

During the clinical trials, injection sites were closely monitored. Refer to Table 6 for a summary of reported injection site events.

Table 6 Reported Injection Site Adverse Events 7.5 mg 22.5 mg 30 mg 45 mg * Following injection of Eligard® 30 mg, three of the 35 burning/stinging events were reported as moderate. † A single event reported as moderate pain resolved within two minutes and all 3 mild pain events resolved within several days following injection of Eligard® 30 mg. ‡ Transient pain was reported as mild in intensity in nine of ten (90%) events and moderate in intensity in one of ten (10%) events following injection of Eligard® 45 mg. § Erythema was reported following 2 injections of Eligard® 22.5 mg. One report characterized the erythema as mild and it resolved within 7 days. The other report characterized the erythema as moderate and it resolved within 15 days. Neither patient experienced erythema at multiple injections. ¶ Mild bruising was reported following 5 (2.3%) study injections and moderate bruising was reported following 2 (<1%) study injections of Eligard® 45 mg. Study Number AGL9904 AGL9909 AGL0001 AGL0205 Number of patients 120 117 90 111 Treatment 1 injection every month up to 6 months 1 injection every 3 months up to 6 months 1 injection every 4 months up to 8 months 1 injection every 6 months up to 12 months Number of injections 716 230 175 217   Transient burning/stinging 248 (34.6%) injections;84% reported as mild 50 (21.7%) injections; 86% reported as mild 35 (20%) injections; 100% reported as mild 35 (16%) injections; 91.4% reported as mild* Pain (generally brief and mild) 4.3% of injections (18.3% of patients) 3.5% of injections (6.0% of patients) 2.3% of injections† (3.3% of patients) 4.6% of injections‡ Erythema (generally brief and mild) 2.6% of injections (12.5% of patients) 0.9% of injections§ (1.7% of patients) 1.1% of injections (2.2% of patients) Bruising (Mild) 2.5% of injections (11.7% of patients) 1.7% of injections (3.4% of patients) 2.3% of injections¶ Pruritis 1.4% of injections (9.2% of patients) 0.4% of injections (0.9% of patients) Induration 0.4% of injections (2.5% of patients) Ulceration 0.1% of injections (> 0.8% of patients)

These localized adverse events were non-recurrent over time. No patient discontinued therapy due to an injection site adverse event.

The following possibly or probably related systemic adverse events occurred during clinical trials with Eligard®, and were reported in > 2% of patients (Table 7). Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug-related are excluded.

Table 7 Summary of Possible or Probably Related Systemic Adverse Events Reported by > 2% of Patients treated with Eligard® 7.5 mg 7.5 mg 22.5 mg 30 mg 45 mg In the patient populations studied with Eligard® 7.5 mg, a total of 86 hot flashes/sweats adverse events were reported in 70 patients. Of these, 71 events (83%) were mild; 14 (16%) were moderate; 1 (1%) was severe.
In the patient population studied with Eligard® 22.5 mg, a total of 84 hot flashes/sweats adverse events were reported in 66 patients. Of these, 73 events (87%) were mild; 11 (13%) were moderate; none were severe.
In the patient population studied with Eligard® 30 mg, a total of 75 hot flash adverse events were reported in 66 patients. Of these, 57 events (76%) were mild; 16 (21%) were moderate; 2 (3%) were severe.
In the patient population studied with Eligard® 45 mg, a total of 89 hot flash adverse events were reported in 64 patients. Of these, 62 events (70%) were mild; 27 (30%) were moderate; none were severe. * Expected pharmacological consequences of testosterone suppression. Study Number AGL9904 AGL9802 AGL9909 AGL0001 AGL0205 Number of patients 120 8 117 90 111 Treatment 1 injection every month up to 6 months 1 injection (surgically castrated patients) 1 injection every 3 months up to 6 months 1 injection every 4 months up to 8 months 1 injection every 6 months up to 12 months Body System Adverse Event Number (Percent) Body as a Whole Malaise and Fatigue 21 (17.5 %) 7 (6.0%) 12 (13.3%) 13 (11.7%) Weakness 4 (3.6%)   Nervous System Dizziness 4 (3.3%) 4 (4.4%) Vascular
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atropine and pralidoxime


Generic Name: atropine and pralidoxime (AT roe peen and PRAL i DOX eem)
Brand Names: DuoDote

What is atropine and pralidoxime?

Atropine blocks the action of chemical called acetylcholine (ah see til KO leen), which may exist in high levels in the body after a poisoning. Atropine also stimulates the heart and reduces the secretions of the nose, mouth, and lungs to improve breathing.

Pralidoxime reverses muscle weakness or paralysis caused by a poison or nerve agent.

The combination of atropine and pralidoxime is used as an antidote to treat poisoning by a pesticide (insect spray) or a chemical that interferes with the central nervous system, such as nerve gas.

This medication is not effective as an antidote for all types of pesticide poisonings. You may need medications or additional treatments.

Atropine and pralidoxime may also be used for purposes not listed in this medication guide.

What is the most important information I should know about atropine and pralidoxime? If possible, before you receive atropine and pralidoxime, tell your doctor if you have heart disease, coronary artery disease, a heart rhythm disorder, high blood pressure, narrow-angle glaucoma, kidney disease, enlarged prostate, urination problems, a breathing disorder such as asthma or COPD, if you are allergic to any medication, or if you have recently had a heart attack. Also tell your doctor if you are pregnant or breast-feeding. In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast-feeding. Make sure any doctor caring for you afterward knows that you have received this medication. What should I discuss with my health care provider before receiving atropine and pralidoxime? If possible, before you receive atropine and pralidoxime, tell your doctor if you have:

an allergy to any medication;

heart disease, coronary artery disease;

high blood pressure;

kidney disease;

asthma, COPD (chronic obstructive pulmonary disorder), bronchitis, emphysema, or other breathing problem;

a heart rhythm disorder;

narrow-angle glaucoma;

an enlarged prostate or urination problems; or

if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether atropine and pralidoxime will harm an unborn baby. Tell your doctor if you are pregnant. Atropine and pralidoxime can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby. In an emergency situation, it may not be possible before you are treated with atropine and pralidoxime to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication. How is atropine and pralidoxime given?

Atropine and pralidoxime is injected into a muscle in your upper thigh. A healthcare provider will give you this injection.

Atropine and pralidoxime is usually given as soon as possible after the onset of poisoning symptoms. If you still have symptoms after 10 to 15 minutes, you will receive 2 more injections.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving this medication.

After treatment with atropine and pralidoxime, you may be watched for up to 72 hours to make sure the medicine has been effective and you no longer have any effects of the poison.

What happens if I miss a dose?

Since atropine and pralidoxime is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Overdose may occur if you receive atropine and pralidoxime but you have not actually been exposed to the specific poisons this medication is designed to treat. Symptoms may include vision problems, feeling unsteady, loss of balance or coordination, trouble concentrating, fast heart rate, confusion, hallucinations (seeing or hearing things), decreased sweating, hot and dry skin, fainting, weak or shallow breathing, or breathing that stops. What should I avoid after receiving atropine and pralidoxime?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Atropine can decrease sweating and you may be more prone to heat stroke for a short time after receiving this medication.

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

Atropine and pralidoxime side effects

Some of the side effects of atropine and pralidoxime may be similar to the symptoms of poisoning. Your caregivers will watch you closely to determine whether your body is responding well to the medication, or if you are having any serious 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. Tell your caregivers at once if you have a serious side effect such as:

pounding heartbeats or fluttering in your chest;

painful or difficult urination;

trouble swallowing;

feeling like you might pass out;

confusion;

loss of movement in any part of your body;

slow heart rate, weak pulse, fainting, slow breathing (breathing may stop); or

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

dry mouth, dry nose, dry skin;

dry eyes, blurred vision;

increased sensitivity of your eyes to light;

headache;

dizziness, drowsiness;

muscle weakness;

constipation, stomach pain, bloating, nausea, vomiting;

loss of interest in sex, impotence; 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.

Atropine and pralidoxime Dosing Information

Usual Adult Dose for Organophosphate Poisoning:

TREATMENT OF MILD SYMPTOMS
Mild symptoms include blurred vision, miosis, excessive, unexplained runny nose, increased salivation such as sudden drooling, chest tightness or difficulty breathing, tremors throughout the body or muscular twitching, nausea and/or vomiting, unexplained wheezing, coughing or increased airway secretions, acute onset of stomach cramps, and tachycardia or bradycardia.
First dose: In the situation of known or suspected organophosphorous poisoning, administer one (1) atropine-pralidoxime 2.1 mm/0.7 mL-600 mg/ 2 mL injection (DuoDote auto-injector) into the midlateral thigh if the patient experiences two or more MILD symptoms of nerve gas or insecticide exposure. Emergency medical services personnel with mild symptoms may self-administer a single dose of atropine-pralidoxime (DuoDote).
Wait 10 to 15 minutes for atropine-pralidoxime (DuoDote) to take effect. If, after 10 to 15 minutes, the patient does not develop any SEVERE symptoms (strange or confused behavior, severe difficulty breathing or copious secretions from lungs/airway, severe muscular twitching and general weakness, involuntary urination and defecation, convulsions or unconsciousness), no additional atropine-pralidoxime (DuoDote) injections are recommended, but definitive medical care should ordinarily be sought immediately. For emergency medical services personnel who have self-administered atropine-pralidoxime (DuoDote), an individual decision will need to be made to determine their capacity to continue to provide emergency care.
Additional doses: If, at any time after the first dose, the patient develops any of the SEVERE symptoms listed above, administer two (2) additional atropine-pralidoxime (DuoDote) injections in rapid succession, and immediately seek definitive medical care.
TREATMENT OF SEVERE SYMPTOMS
Severe symptoms include strange or confused behavior, severe difficulty breathing or copious secretions from lungs/airway, severe muscular twitching and general weakness, involuntary urination and defecation, convulsions or unconsciousness.
Immediately administer three (3) atropine-pralidoxime (DuoDote) injections into the patient's midlateral thigh in rapid succession, and immediately seek definitive medical care.

Usual Adult Dose for Nerve Agent Poisoning:

TREATMENT OF MILD SYMPTOMS
Mild symptoms include blurred vision, miosis, excessive, unexplained runny nose, increased salivation such as sudden drooling, chest tightness or difficulty breathing, tremors throughout the body or muscular twitching, nausea and/or vomiting, unexplained wheezing, coughing or increased airway secretions, acute onset of stomach cramps, and tachycardia or bradycardia.
First dose: In the situation of known or suspected organophosphorous poisoning, administer one (1) atropine-pralidoxime 2.1 mm/0.7 mL-600 mg/ 2 mL injection (DuoDote auto-injector) into the midlateral thigh if the patient experiences two or more MILD symptoms of nerve gas or insecticide exposure. Emergency medical services personnel with mild symptoms may self-administer a single dose of atropine-pralidoxime (DuoDote).
Wait 10 to 15 minutes for atropine-pralidoxime (DuoDote) to take effect. If, after 10 to 15 minutes, the patient does not develop any SEVERE symptoms (strange or confused behavior, severe difficulty breathing or copious secretions from lungs/airway, severe muscular twitching and general weakness, involuntary urination and defecation, convulsions or unconsciousness), no additional atropine-pralidoxime (DuoDote) injections are recommended, but definitive medical care should ordinarily be sought immediately. For emergency medical services personnel who have self-administered atropine-pralidoxime (DuoDote), an individual decision will need to be made to determine their capacity to continue to provide emergency care.
Additional doses: If, at any time after the first dose, the patient develops any of the SEVERE symptoms listed above, administer two (2) additional atropine-pralidoxime (DuoDote) injections in rapid succession, and immediately seek definitive medical care.
TREATMENT OF SEVERE SYMPTOMS
Severe symptoms include strange or confused behavior, severe difficulty breathing or copious secretions from lungs/airway, severe muscular twitching and general weakness, involuntary urination and defecation, convulsions or unconsciousness.
Immediately administer three (3) atropine-pralidoxime (DuoDote) injections into the patient's midlateral thigh in rapid succession, and immediately seek definitive medical care.

What other drugs will affect atropine and pralidoxime?

If possible, before you receive this medication, tell your doctor about all other medicines you use, especially:

aminophylline (Phyllocontin, Truphylline);

morphine (Avinza, Kadian, MS Contin, Oramorph);

reserpine;

theophylline (Elixophyllin, Theo-24, Uniphyl);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

a tranquilizer such as chlorpromazine (Thorazine), fluphenazine (Permitil), perphenazine (Trilafon), prochlorperazine (Compazine), thioridazine (Mellaril), or trifluperazine (Stelazine).

This list is not complete and other drugs may interact with atropine and pralidoxime. 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 atropine and pralidoxime resources Atropine and pralidoxime Use in Pregnancy & BreastfeedingAtropine and pralidoxime Drug InteractionsAtropine and pralidoxime Support Group0 Reviews for Atropine and pralidoxime - Add your own review/rating Compare atropine and pralidoxime with other medications Nerve Agent PoisoningOrganophosphate Poisoning Where can I get more information? Your doctor or pharmacist can provide more information about atropine and pralidoxime.
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Oruvail IM Injection


Oruvail IM Injection

Ketoprofen

Please read this leaflet carefully BEFORE you have your Oruvail IM injection. This leaflet is a summary of the important information about your medicine.

Keep it in a safe place. You may want to refer to it again. If you have any questions or are not sure about anything to do with your treatment, ask your doctor or pharmacist for more information.

What Is In Oruvail Im Injection?

The active ingredient is ketoprofen, 100mg in 2ml of solution.

The solution also contains the following inactive ingredients: arginine, benzyl alcohol, water and E330.

Oruvail IM injection is available in packs of 10 ampoules each having 2 ml of injection solution.

Oruvail IM injection is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDS).

The company responsible (also known as the marketing authorisation holder) for Oruvail is:

Aventis Pharma Ltd 50 Kings Hill Avenue Kings Avenue West Malling Kent ME19 4AH

The product is made by

Aventis Pharma Dagenham Essex RM10 7XS UK Why Have You Been Prescribed Oruvail?

Oruvail IM injection is normally used to treat painful flare ups of rheumatism, arthritis, pulled or strained muscles and tendons, gout, other painful conditions of the bone or muscle and pain and inflammation following orthopaedic surgery. If you need any further information on your condition, please ask your doctor.

Before Taking Your Medicine

Tell your doctor or nurse if any of the following apply:

If you have had an allergic reaction after taking Oruvail (or similar products) in the past If you are sensitive or allergic to any of the inactive ingredients If you are allergic to aspirin or any other non-steroidal anti-inflammatory drug If you suffer from any other allergies If you have or have had a stomach ulcer If you get indigestion or heartburn If you suffer from asthma If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) If you have any kidney problems If you are pregnant, or planning a pregnancy If you are breast feeding If the patient is under 12 years of age If you are taking any other medicines. Some medicines may change the way Oruvail works e.g. aspirin or other non-steroidal anti-inflammatory drugs used to treat pain or inflammation, warfarin used to reduce clotting of the blood, sulphonamide antibiotics used to treat infection, phenytoin used to treat epilepsy, methotrexate used to treat cancer.

If you have to go to a doctor, dentist or hospital for any reason, tell them that you are having Oruvail injections.

Special Warnings

Oruvail should not affect your ability to drive or operate machinery.

However, Oruvail may occasionally cause drowsiness or dizziness in which case you should not drive or operate machinery.

How To Take Your Medicine

The usual adult dose is 1 to 2ml by injection into the muscle.

This may be repeated every 4 hours up to a maximum of 4ml in 24 hours. Treatment by injection is not normally continued for longer than 3 days. Elderly patients will normally be given the lowest effective dose.

Medicines such as Oruvail may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Oruvail is not recommended for children.

Treatment by injection will usually be followed by a course of Oruvail capsules taken by mouth.

Does Oruvail Have Side Effects?

As well as benefits, all medicines may occasionally have unwanted effects in some patients. These are called side effects.

Minor side effects of Oruvail, that are well known, are indigestion, nausea, constipation, diarrhoea, heartburn, abdominal discomfort, headache, dizziness, confusion, drowsiness, insomnia, mood change, pain or burning sensation at the site of injection. You do not need to worry about them unless they become troublesome - in which case, you should contact your doctor.

Some side effects may be more serious and you should tell your doctor immediately if you have any of the following:

Wheezing Tightness of the chest Faintness Skin rash Sensitivity to sunlight Swollen ankles Bad stomach pains Vomiting blood or dark coffee coloured granules Passing dark tarry bowel motions Bruising on your body Yellowing of the skin, aching limbs Reduced urine levels, low back pain

Do not be alarmed by this list of possible events.

Most people take Oruvail without any problems.

Medicines such as Oruvail may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

All medicines may have unwanted effects which are not mentioned in the product leaflet. If you notice any other changes in your health whilst taking this medicine, tell your doctor immediately.

Expiry Date

You must not use medication after the expiry date.

This is given in two places:

on the carton on the ampoule

In both places it is given as ‘EXP’ followed by the month and year.

The injection should not be used after the end of that month.

Storage Of Oruvail

Your hospital pharmacist will normally keep the injection for you, in a safe place - out of reach of children and protected from light.

It should be kept below 30°C.

REMEMBER: These injections are for you. Only a doctor may prescribe them for you. Never give your medicines to other people. They may harm other people even if their symptoms appear the same as yours.

Oruvail is a trademark.

This leaflet was revised in May 2007.


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insulin glulisine


Generic Name: insulin glulisine (IN su lin GLOO lis een)
Brand Names: Apidra, Apidra OptiClik Cartridge, Apidra SoloStar Pen

What is insulin glulisine?

Insulin glulisine is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin glulisine is a faster-acting form of insulin than regular human insulin.

Insulin glulisine is used to treat diabetes in adults and children who are at least 4 years old. It is usually given together with a long-acting insulin.

Insulin glulisine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about insulin glulisine?

Insulin glulisine is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

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.

Insulin glulisine 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.

What should I discuss with my healthcare provider before using insulin glulisine? Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin glulisine, tell your doctor if you have liver or kidney disease.

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

Insulin glulisine 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.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether insulin glulisine is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin glulisine 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 insulin glulisine?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin glulisine is given as an injection (shot) under your skin using a needle and syringe, an injection pen, or an insulin pump. It may also be given through a needle placed into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. 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.

Insulin glulisine is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.

Insulin glulisine should be thin, clear, and colorless. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

If you use this medication with an insulin pump, do not mix or dilute insulin glulisine with any other insulin. Call your doctor at once if you think your infusion pump is not working properly.

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.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Infusion pump tubing, catheters, and the needle location on your skin should be changed every 48 hours.

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.

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

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin glulisine dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials, cartridges, 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, cartridges, or injection pens 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.

Storing after your first use: You may keep "in-use" vials in the refrigerator or at room temperature, protected from light. Use within 28 days.

In-use cartridges or injection pens must be stored at room temperature, away from heat and bright light. Do not refrigerate an in-use cartridge or injection pen. Keep it at room temperature and use within 28 days. An infusion set should be stored at room temperature and used within 48 hours.

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

What happens if I miss a dose?

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

It is important to keep insulin glulisine 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 if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using insulin glulisine? Do not change the brand of insulin glulisine or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin glulisine. Do not expose insulin glulisine to high heat. Throw the medication away if it becomes hotter than 98 degrees F. Insulin glulisine 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 glulisine. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Insulin glulisine can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.

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

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.

Insulin glulisine Dosing Information

Usual Adult Dose for Diabetes Mellitus Type I:

Insulin glulisine is a rapid-acting insulin and is given 1 to 4 times daily within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump. Intravenous administration of insulin glulisine is possible under strict medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.
Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.
Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal.
Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro, glulisine) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type II:

Insulin glulisine is a rapid-acting insulin and is given 1 to 4 times daily within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump. Intravenous administration of insulin glulisine is possible under strict medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.
Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents. Insulin may be considered if patients are very hyperglycemic or symptomatic and/or not controlled with oral agents. Insulin may exacerbate obesity, further increase insulin resistance, and increase the frequency of hypoglycemia.
Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.
Conventional regimen:
Initial dose, monotherapy: Total insulin requirement: 0.1 unit/kg/day. When insulin is used alone, twice daily injections are recommended for better glycemic control. The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 1.5 to 2.5 units/kg or higher in patients with obesity and insulin resistance.
Intensive regimen:
The necessity for and efficacy of intensive insulin therapy in type II diabetes has been controversial. The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro, glulisine) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Initial dose, monotherapy: 0.5 to 1.5 unit/kg/day subcutaneously.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Usual Pediatric Dose for Diabetes Mellitus Type I:

4 years and older:
Insulin glulisine is a rapid-acting insulin and is given 1 to 4 times daily within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump. Intravenous administration of insulin glulisine is possible under strict medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose. Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro, glulisine) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels. Total daily insulin requirements: Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously

What other drugs will affect insulin glulisine?

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);

guanethidine (Ismelin);

lanreotide (Somatuline Depot);

niacin (Niaspan, Niacor, Advicor);

octreotide (Sandostatin);

pramlintide (Symlin);

reserpine;

beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

There are many other medicines that can increase or decrease the effects of insulin glulisine on lowering your blood sugar. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you. More insulin glulisine resources Insulin glulisine Side Effects (in more detail) Insulin glulisine Use in Pregnancy & Breastfeeding Insulin glulisine Drug Interactions Insulin glulisine Support Group 1 Review for Insulin glulisine - Add your own review/rating insulin glulisine Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Insulin Glulisine Monograph (AHFS DI) Insulin Glulisine Cartridges MedFacts Consumer Leaflet (Wolters Kluwer) Apidra Prescribing Information (FDA) Apidra Consumer Overview Compare insulin glulisine with other medications Diabetes, Type 1 Diabetes, Type 2 Where can I get more information? Your pharmacist can provide more information about insulin glulisine.

See also: insulin glulisine side effects (in more detail)


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Adrenaline (Epinephrine) Injection BP 1 in 1000


Adrenaline (epinephrine) 1 in 1000 Injection

Important information about your medicine Your doctor or nurse will give you the injection. If this injection causes you any problems talk to your doctor, nurse or pharmacist. Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine. Please tell your doctor or pharmacist, if you are taking any other medicines. Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it. Keep this leaflet. You may need to read it again If you have any further questions, please ask your doctor or your pharmacist. 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. Where to find information in this leaflet 1. What Adrenaline (epinephrine) 1 in 1000 Injection is and what it is used for 2. Before you are given Adrenaline (epinephrine) 1 in 1000 Injection 3. How to use Adrenaline (epinephrine) 1 in 1000 Injection 4. Possible side effects 5. Storing Adrenaline (epinephrine) 1 in 1000 Injection 6. Further information What Adrenaline (epinephrine) 1 in 1000 Injection is and what it is used for

Adrenaline is used in life-threatening emergencies such as acute allergic reactions.

It is an active chemical produced in the body. Adrenaline acts on receptors in the body and can increase the speed and force of heart muscle contractions, relieve narrowing of the lungs passages helping breathing and relieve some of the symptoms of acute allergic reaction.

Before you are given Adrenaline (epinephrine) 1 in 1000 Injection You should NOT be given Adrenaline (epinephrine) 1 in 1000 Injection if you: are sensitive or allergic to adrenaline or any of the other ingredients in this injection. Please tell your doctor or nurse before being given the injection if you: are in shock or have lost a lot of blood. have any heart disease. have Phaeochromocytoma (a tumour on the adrenal gland). have low blood levels of Potassium or high blood levels of Calcium. have a tumour on your prostate gland. are suffering from glaucoma (increased pressure in the eye). are going to have an operation under general anaesthetic. are a diabetic. are suffering from high blood pressure. Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Adrenaline (epinephrine) 1 in 1000 Injection:

Other medicines to treat high blood pressure or a heart condition. Corticosteroids (medicines used to treat inflammatory conditions in your body such as asthma or arthiritis). Aminophylline and Theophylline (medicines to help you breathe). Any cough or cold remedies. Antihistamines (for the treatment of allergies). Antidepressant medicines (for example; imipramine). Medicines to treat mental illness (for example; chlorpromazine, pericyazine, or fluphenazine). Medicines to treat an underactive thyroid gland. Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant. The doctor will then decide if the injection is suitable for you.

Please tell your doctor or nurse before being given this injection if you are breast feeding - this injection should not be used by nursing (breast feeding) mothers.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Adrenaline (epinephrine) 1 in 1000 Injection.

How to use Adrenaline (epinephrine) 1 in 1000 Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection.

Adrenaline must NOT be injected into fingers, toes, ears, nose or genitalia. Intramuscular injection in the buttocks should be avoided.

Possible side effects

Like all medicines, Adrenaline (epinephrine) 1 in 1000 Injection can cause side effects, although not everybody gets them.

Allergic reactions to Adrenaline and to Sodium Metabisulphite (contained in this injection) have been reported. The possibility of these should not stop you from using this injection for the treatment of serious allergic reactions or other emergency situations. Tell your doctor immediately if you have any difficulty breathing, a rash or itchy skin. You may suffer from anxiety, headache or tremors. If you suffer from Parkinson’s Disease, you may notice that the symptoms or rigidity and tremor get worse. You may feel weak or dizzy. High blood sugar levels may occur. Low blood levels of potassium may occur. Metabolic acidosis (an in-balance of certain constituents in your blood) may occur. You may experience a faster heart beat or high blood pressure. Chest pain may occur. In rare cases the increase in blood pressure following Adrenaline Injection has caused bleeding around the brain and paralysis. You may experience coldness of the extremities. You may experience difficulty in breathing or sweating. You may experience nausea or vomiting. There may be some tissue damage at the site of injection after repeated injections of adrenaline, and elsewhere in the body (for example; in the fingers and toes, liver and kidney). You may find it difficult to pass urine.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Storing Adrenaline (epinephrine) 1 in 1000 Injection

Your injection will be stored in a cool place and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

Further information What Adrenaline (epinephrine) 1 in 1000 Injection contains:

Each ml of solution for injection contains 1 mg of adrenaline (epinephrine) as the acid tartrate.

Adrenaline Injection contains the following inactive ingredients: sodium metabisulphite, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

What Adrenaline (epinephrine) 1 in 1000 Injection looks like and contents of the pack:

The injection is supplied in 1 ml clear glass ampoules. 10 ampoules supplied in each carton.

The marketing authorisation number of this medicine is: PL 01502/0024

Marketing Authorisation Holder: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 03.03.2009

43823/20/09


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Metalyse 8,000 units


Metalyse

8,000 units powder and solvent for solution for injection

Tenecteplase

Read all of this leaflet carefully before you start receiving this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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 METALYSE is and what it is used for
2. Before you receive METALYSE
3. How is METALYSE administered
4. Possible side effects
5. How to store METALYSE
6. Further information

What Metalyse Is And What It Is Used For

METALYSE is a powder and solvent for solution for injection. This means that each pack contains:

one vial of 8,000 units METALYSE powder and one pre-filled syringe containing 8 ml water for injections.

Before use, the solvent (water for injections) is added to the powder to form a solution that is given by injection.

METALYSE belongs to a group of medicines called thrombolytic agents. These medicines help to dissolve blood clots. Tenecteplase is a recombinant fibrin-specific plasminogen activator.

METALYSE is used to treat myocardial infarctions (heart attacks) within 6 hours after the onset of symptoms and helps to dissolve the blood clots that have formed in the blood vessels of the heart. This helps to prevent the damage caused by heart attacks and has been shown to save lives.

Before You Receive Metalyse

METALYSE will not be prescribed and given by your doctor

if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to the active ingredient tenecteplase, to gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of METALYSE. If treatment with Metalyse is nevertheless considered to be necessary, facilities for reanimation should be immediately available in case of need; if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including: a bleeding disorder or tendency to bleed (haemorrhage) stroke (cerebrovascular event) very high, uncontrolled blood pressure a head injury severe liver disease a stomach ulcer (peptic ulcer) varicose veins in the gullet (oesophageal varices) abnormality of the blood vessels (e.g. an aneurysm) certain tumours inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis); if you are taking tablets/capsules used to “thin” the blood, such as warfarin or coumarin (anti-coagulants); if you have an inflamed pancreas (pancreatitis); if you have recently had major surgery including surgery to your brain or spine; if you have been given cardiopulmonary resuscitation (chest compressions) for more than 2 minutes duration, in the last two weeks. Your doctor will take special care with METALYSE if you have had any allergic reaction other than a sudden life-threatening allergic reaction (severe hypersensitive) to the active substance tenecteplase, to gentamicin (a trace residue from the manufacturing process), or to any of the other ingredients of Metalyse (see section 6: “Further information”); if you have high blood pressure; if you have problems with circulation of blood in the brain (cerebrovascular disease); if you have had gastrointestinal (gut) or genitourinary bleeding within the last ten days (this may cause blood in stools or urine); if you have a heart valve abnormality (e.g. mitral stenosis) with an abnormal heart rhythm (e.g. atrial fibrillation); if you have had an intramuscular injection in the last two days; if you are aged over 75 years; if you weigh less than 60 kg. Taking 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 for advice before you are given METALYSE.

How Is Metalyse Administered

The doctor calculates your dose of METALYSE according to your bodyweight, based on the following scheme:

Bodyweight less than 60kg 6,000 units

Bodyweight 60 to 70kg 7,000 units

Bodyweight 70 to 80kg 8,000 units

Bodyweight 80 to 90kg 9,000 units

Bodyweight above 90kg 10,000 units

Your doctor will give you medication to prevent blood clotting in addition to METALYSE, as soon as possible after your chest pain starts.

METALYSE is given by a single injection into a vein by a doctor who is experienced in the use of this type of drug.

Your doctor will give METALYSE as soon as possible after your chest pain starts as a single dose.

Repetition is not recommended.

Possible Side Effects

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

Evaluation of side effects is based on the following frequencies:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

The side effects described below have been experienced by people given METALYSE:

Very Common:

bleeding

Common:

bleeding at the injection or puncture site nosebleeds genitourinary bleeding (you may notice blood in your urine) bruising gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)

Uncommon:

irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest internal bleeding in the abdomen (retroperitoneal bleeding) bleeding in the brain (cerebral haemorrhage). Death or permanent disability may occur following bleeding in the brain or other serious bleeding events bleeding in the eyes (eye haemorrhage)

Rare:

low blood pressure (hypotension) bleeding in the lungs (pulmonary haemorrhage) hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), swelling of the throat bleeding into the area surrounding the heart (haemopericardium) blood clot in the lung (pulmonary embolism) and in the vessels of other organ systems (thrombotic embolisation)

Not known :

fat embolism (clots consisting of fat) nausea vomiting body temperature increased (fever) blood transfusions as consequence of bleedings

As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration:

Very common:

Low blood pressure (hypotension) Irregular heart beat Chest pain (angina pectoris)

Common:

Further heart attack (recurrent ischaemia) Heart failure Shock due to heart failure Inflammation of the lining around the heart Fluid in the lungs (pulmonary oedema)

Uncommon:

Heart arrest Problem with the heart valve or heart lining (mitral valve incompetence, pericardial effusion) Blood clot in the veins (venous thrombosis) Fluid between the heart lining and the heart (cardiac tamponade) Rupture of the heart muscle (myocardial rupture)

Rare:

Blood clot in the lung (pulmonary embolism)

These cardiovascular events can be life-threatening and may lead to death.

In case of bleeding in the brain events related to the nervous system have been reported e.g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).

Tell your doctor immediately if you think you are experiencing any of these side effects.

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 Metalyse

Keep out of the reach and sight of children.

Do not store above 30°C.

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

Once METALYSE has been reconstituted it may be stored for 24 hours at 2-8°C and 8 hours at 30°C. However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.

Do not use METALYSE after the expiry date which is stated on the label/carton.

Further Information What METALYSE contains The active substance is tenecteplase. One vial contains 8,000 units of tenecteplase. One pre-filled syringe contains 8 ml of water for injections. The other ingredients are L-arginine, phosphoric acid and polysorbate 20. The METALYSE solvent is water for injections. Gentamicin is contained as trace residue from the manufacturing process. What METALYSE looks like and contents of the pack

The folding box contains one vial with a lyophilised powder, one ready for use syringe with a solvent, one vial adapter and one needle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65 D-88397 Biberach/Riss Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom Boehringer Ingelheim Ltd. Tel:+44 1344 424 600

This leaflet was last approved in 06/2010

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

74366-01


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Myochrysine


Generic Name: gold compound (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

Ridaura

Available Dosage Forms:

Capsule Uses For Myochrysine

The gold compounds are used in the treatment of rheumatoid arthritis. They may also be used for other conditions as determined by your doctor.

In addition to the helpful effects of this medicine in treating your medical problem, it has side effects that can be very serious. Before you take this medicine, you should discuss with your doctor the good that this medicine will do as well as the risks of using it.

Auranofin is available only with your doctor's prescription. The other gold compounds are given by your health care professional.

Schering-Plough discontinued aurothioglucose in May 2002.

Before Using Myochrysine Allergies

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

Pediatric

Auranofin has been tested only in adult patients and there is no specific information about its use in children. However, gold sodium thiomalate have been tested in children and have not been shown to cause different side effects or problems than they do in adults.

Geriatric

These medicines have been tested and have not been shown to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Studies on birth defects with gold compounds have not been done in humans. However, studies in animals have shown that gold compounds may cause birth defects.

Breast Feeding

Gold sodium thiomalate pass into the breast milk and may cause unwanted effects in nursing babies. It is not known whether auranofin passes into the breast milk.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Artemether Chloroquine Halofantrine Hydroxychloroquine Mefloquine Penicillamine Primaquine Proguanil Pyrimethamine Quinacrine Quinidine Quinine

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

Penicillamine 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Blood or blood vessel disease or Colitis or Kidney disease (or history of) or Lupus erythematosus or Sj?gren's syndrome or Skin disease—The chance of unwanted effects may be increased. Proper Use of gold compound

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

In order for this medicine to work, it must be taken regularly as ordered by your doctor. Continue receiving the injections or taking auranofin even if you think the medicine is not working. You may not notice the effects of this medicine until after three to six months of regular use.

For patients taking auranofin:

Do not take more of this medicine than ordered by your doctor. Taking too much auranofin may increase the chance of serious unwanted effects.

If you have any questions about this, check with your doctor.

Dosing

The dose medicines in this class 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 these medicines. 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 auranofin For oral dosage form (capsules): For arthritis: Adults—6 milligrams (mg) once a day or 3 mg twice a day. After six months, your doctor may increase the dose to 3 mg three times a day. Children—Dose must be determined by your doctor. For injection dosage form: For arthritis: Adults and teenagers—10 milligrams (mg) for the first dose, then 25 mg once a week for the next two weeks, then 25 or 50 mg once a week. The medicine is injected into a muscle. After several months, the injections may be given less often (25 or 50 mg every two weeks for a while, then every three or four weeks). Children 6 to 12 years of age—2.5 mg for the first dose, then 6.25 mg once a week for the next two weeks, then 12.5 mg once a week. The medicine is injected into a muscle. After several months, the injections may be given less often (6.25 or 12.5 mg every three or four weeks). Children younger than 6 years of age—Dose must be determined by your doctor. For gold sodium thiomalate For injection dosage form: For arthritis: Adults and teenagers—10 milligrams (mg) for the first dose, then 25 mg a week later, then 25 or 50 mg once a week. The medicine is injected into a muscle. After several months, the injections may be given less often (25 or 50 mg every two weeks for a while, then every three or four weeks). Children—10 mg for the first dose, then 1 mg per kilogram (about 0.45 mg per pound) of body weight, but not more than a total of 50 mg, once a week. The medicine is injected into a muscle. After several months, the same dose may be given less often (every two weeks for a while, then every three or four weeks). Missed Dose

Call your doctor or pharmacist for instructions.

For patients taking auranofin: If you miss a dose of this medicine, and your dosing schedule is—

One dose a day—Take the missed dose as soon as possible. However, if you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses. More than one dose a day—Take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Myochrysine

Gold compounds may cause some people to become more sensitive to sunlight than they are normally. These people may break out in a rash after being in the sun, or a skin rash that is already present may become worse. To protect yourself, it is best to:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible. Wear protective clothing. Ask your doctor if you may apply a sun block product. Products that have a skin protection factor (SPF) of at least 15 work best, but some patients may require a product with a higher SPF number, especially if they have a fair complexion. Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

For patients taking auranofin:

Your doctor should check your progress at regular visits. Blood and urine tests may be needed to make certain that this medicine is not causing unwanted effects.

For patients receiving gold injections:

Immediately following an injection of this medicine, side effects such as dizziness, feeling faint, flushing or redness of the face, nausea or vomiting, increased sweating, or unusual weakness may occur. These will usually go away after you lie down for a few minutes. If any of these effects continue or become worse, or if you notice any other effects within 10 minutes or so after receiving an injection, tell your health care professional right away. Joint pain may occur for 1 or 2 days after you receive an injection of this medicine. This effect usually disappears after the first few injections. However, if this continues or is bothersome, check with your doctor. Myochrysine Side Effects

Gold compounds have been shown to cause tumors and cancer of the kidney when given to animals in large amounts for a long time. However, these effects have not been reported in humans receiving gold compounds for arthritis. If you have any questions about this, check with your doctor.

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

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

More common Irritation or soreness of tongue—less common with auranofin metallic taste—less common with auranofin redness, soreness, swelling, or bleeding of gums—rare with auranofin skin rash or itching ulcers, sores, or white spots on lips or in mouth or throat Less common Bloody or cloudy urine hives Rare Abdominal or stomach pain, cramping, or burning (severe) bloody or black, tarry stools confusion convulsions (seizures) coughing, hoarseness, difficulty in breathing, shortness of breath, tightness in chest, or wheezing dark urine decreased urination decreased vision difficulty in swallowing feeling of something in the eye fever hair loss hallucinations (hearing, seeing, or feeling things that are not there) irritation of nose, throat, or upper chest area, possibly with hoarseness or coughing irritation of vagina nausea, vomiting, or heartburn (severe and/or continuing) numbness, tingling, pain, or weakness, especially in the face, hands, arms, or feet pale stools painful or difficult urination pain in lower back, side, or lower abdomen (stomach) area pain, redness, itching, or tearing of eyes pinpoint red spots on skin problems with muscle coordination red, thickened, or scaly skin sore throat and fever with or without chills swelling of face, fingers, ankles, lower legs, or feet swellings (large) on face, eyelids, mouth, lips, and/or tongue swollen and/or painful glands unusual bleeding or bruising unusual tiredness or weakness vomiting of blood or material that looks like coffee grounds yellow eyes or skin

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

More common with auranofin; rare with injections Abdominal or stomach cramps or pain (mild or moderate) bloated feeling, gas, or indigestion (mild or moderate) decrease or loss of appetite diarrhea or loose stools nausea or vomiting (mild or moderate) Less common Constipation—with auranofin joint pain—with

Some patients receiving auranofin have noticed changes in the taste of certain foods. If you notice a metallic taste while receiving any gold compound, check with your doctor as soon as possible. If you notice any other taste changes while you are taking auranofin, it is not necessary to check with your doctor unless you find this effect especially bothersome.

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

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

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

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


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ProHance Vials


1. Name Of The Medicinal Product

ProHance

2. Qualitative And Quantitative Composition

Gadoteridol 279.3mg/ml (0.5M)

3. Pharmaceutical Form

Sterile solution for intravenous injection

4. Clinical Particulars 4.1 Therapeutic Indications

Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier.

ProHance can also be used for whole body MRI including the head, neck, liver, breast, muscoloskeletal system and soft tissue pathologies.

4.2 Posology And Method Of Administration

Adults

The recommended dose of ProHance for imaging most brain and spinal pathologies is 0.1 mmol/kg. However, doses of 0.3 mmol/kg have been shown to be useful in patients suspected of having cerebral metastases or other poorly enhancing lesions.

The recommended dose for whole body MRI is 0.1 mmol/kg.

Children (2 years and above)

The recommended dose of ProHance for brain imaging and spine pathologies is 0.1 mmol/kg (0.2 ml/kg).

ProHance has been used in only a limited number of children aged between 6 months and 2 years. If an MRI procedure must be performed in this group, particular caution should be exercised.

The safety and efficacy of doses higher than 0.1 mmol/kg and sequential or repeat procedures have not been established.

To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml normal saline flush. The imaging procedure should be completed within 1 hour after injecting ProHance.

Special Populations

Impaired renal function

ProHance should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4). If it is necessary to use ProHance, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days.

Infants from 6 months to 1 year of age

Due to immature renal function in infants up to 1 year of age, ProHance should only be used in patients 6 to 12 months of age after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days.

Use of ProHance is not recommended in children less than 6 months of age.

Use for whole body MRI is not recommended in children less than 18 years of age

Elderly (aged 65 years and above)

No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).

4.3 Contraindications

A history of previous hypersensitivity to ProHance, its constituents or other gadolinium-based contrast. ProHance is contraindicated in children under 6 months of age.

4.4 Special Warnings And Precautions For Use

Anaphylactic reactions have been observed following the use of gadoteridol. Appropriate drugs and instruments for emergency measures must be readily available.

Transitory changes in serum iron (within normal range in the majority of cases) have been observed in some patients after administration of ProHance and these changes were shown not to be clinically significant.

Since Gadoteridol is renally cleared from the body, caution should be exercised in patients with severely impaired renal function.

Impaired renal function

Prior to administration of ProHance, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with ProHance, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI.

Haemodialysis shortly after ProHance administration may be useful at removing ProHance from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

Infants from 6 months to 1 year of age

Due to immature renal function in infants up to 1 year of age, ProHance should only be used in patients 6 to 12 months of age after careful consideration.

Elderly

As the renal clearance of gadoteridol may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions with gadoteridol. No clinically significant changes or trends in laboratory tests were seen in clinical trials with ProHance.

4.6 Pregnancy And Lactation

Pregnancy

There are no data from the use of gadoteridol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ProHance should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteridol.

Lactation

Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3). At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing breast feeding for a period of 24 hours after administration of ProHance, should be at the discretion of the doctor and lactating mother.

4.7 Effects On Ability To Drive And Use Machines

There are no known effects of ProHance on the ability to drive or operate machinery.

4.8 Undesirable Effects

The accepted safety considerations and procedures that are required for Magnetic Resonance Imaging are applicable when ProHance is used for contrast enhancement.

Side effects: Taste disturbance (primarily metallic taste) nausea, urticaria, pain at injection site, convulsions and hypotension have been reported. Headache and chest pain have been rarely reported. These occurrences were transient and resolved without residual effect. The occurrences were not related to age, gender, rate of injection or dose administered.

Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with ProHance, most of which were in patients co-administered other gadolinium-containing contrast agents (see section 4.4).

4.9 Overdose

There have been no cases of overdose reported to date, consequently, neither signs nor symptoms of overdosage have been identified. In the event of overdosage occurring, the patient should be observed and treated symptomatically.

ProHance can be removed by haemodialysis. However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Gadoteridol is a non-ionic paramagnetic contrast medium for Magnetic Resonance Imaging.

When placed in a magnetic field, gadoteridol decreases T1 relaxation times in targeted areas. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.

Gadoteridol does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that have a normal blood-brain barrier, e.g. cysts, mature post-operative scars, etc. However, disruption of the blood-brain barrier or normal vascularity allows penetration of gadoteridol into lesions such as neoplasms, abscesses, and subacute infarcts.

5.2 Pharmacokinetic Properties

The pharmacokinetics of intravenously administered gadoteridol in normal subjects conforms to a two- compartment open model with mean distribution and elimination half-lives (reported as mean ± SD) of about 0.20 ± 10.04 hours and 1.57 ± 10.08 hours, respectively.

Gadoteridol is exclusively eliminated in the urine with 94.4 ± 4.8% (mean ± SD) of the dose excreted within 24 hours post injection. There is no detectable biotransformation or decomposition of gadoteridol.

The renal and plasma clearance rates (1.41 ± 0.33 ml/min/kg and 1.50 ± 0.35 ml/min/kg, respectively) of gadoteridol are essentially identical, indicating no alteration in elimination kinetics on passage through the kidneys and that the drug is essentially cleared through the kidney. The volume of distribution (204 ± 58 ml 1 kg) is equal to that of extra cellular water, and clearance is similar to that of substances which are subject to glomerular filtration.

No serum protein binding was detected in rats.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Calteridol Calcium

Tromethamine USP

Hydrochloric Acid Ph Eur

Sodium Hydroxide Ph Eur

Water for Injections Ph Eur

6.2 Incompatibilities

ProHance should not be admixed with any other drug.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store at room temperature (15-30°C.), protect from light. ProHance should not be frozen.

6.5 Nature And Contents Of Container

Vials: Type 1 glass vials with grey butyl stoppers and aluminium seals containing 5,10, 15 or 20ml.

6.6 Special Precautions For Disposal And Other Handling

The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.

7. Marketing Authorisation Holder

Bracco International B.V.

Strawinskylaan 3051

1077 ZX Amsterdam

The Netherlands

8. Marketing Authorisation Number(S)

14447/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

29/10/1992

10. Date Of Revision Of The Text

28/09/2010


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Alphanine SD


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

FAK-tor NINE

Commonly used brand name(s)

In the U.S.

Alphanine SD Bebulin Bebulin VH Benefix Mononine Profilnine SD Proplex T

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antihemophilic Agent

Uses For Alphanine SD

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

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

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

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

Before Using Alphanine SD

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

Allergies

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

Pediatric

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

Geriatric

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

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

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

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

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

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

To prepare this medicine:

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

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

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

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

Dosing

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

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

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

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Alphanine SD

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

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

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

Alphanine SD Side Effects

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

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

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

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

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

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

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

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

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

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

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

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

More Alphanine SD resources Alphanine SD Side Effects (in more detail) Alphanine SD Use in Pregnancy & Breastfeeding Alphanine SD Drug Interactions Alphanine SD Support Group 0 Reviews for Alphanine SD - Add your own review/rating Alphanine SD Prescribing Information (FDA) Alphanine SD Concise Consumer Information (Cerner Multum) AlphaNine SD MedFacts Consumer Leaflet (Wolters Kluwer) BeneFIX Prescribing Information (FDA) BeneFIX Monograph (AHFS DI) BeneFix MedFacts Consumer Leaflet (Wolters Kluwer) Benefix injectable Concise Consumer Information (Cerner Multum) Mononine Prescribing Information (FDA) Mononine MedFacts Consumer Leaflet (Wolters Kluwer) Compare Alphanine SD with other medications Factor IX Deficiency Factor VII Deficiency Hemophilia A with Inhibitors Hemophilia B
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Sterile Potassium Chloride Concentrate 15% (hameln)


Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. 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 your medicine is and what it is used for 2. Before you receive it 3. How it is administered 4. Possible side effects 5. Storing your injection 6. Use by date Sterile Potassium Chloride Concentrate 15%

Each ml contains 0.15 g potassium chloride in a sterile solution for injection. The other ingredients are hydrochloric acid and water for injections.

Holder of the Marketing Authorisation: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln Pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany What potassium chloride is and what it is used for

Potassium chloride occurs naturally in your body.

It is used to replace the loss of potassium from your body, if this cannot be achieved when given by mouth or in the diet.

The injection is supplied in clear glass ampoules containing 10 ml.

10 ampoules are supplied in each carton.

Before the injection is given to you

Please tell your doctor, nurse or pharmacist before being given the injection if you:

suffer from impaired kidney function suffer from Addison's disease (a disease characterised by a reduced secretion of hormones from a gland situated near the kidneys) are very dehydrated suffer from heat cramps suffer from disturbances in the salt content of your blood are pregnant or breast-feeding

Please inform your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, especially diuretics (water tablets) as these may interfere with this injection.

How the injection is given to you

Your doctor, nurse or pharmacist will give you the injection.

Sterile Potassium Chloride Concentrate 15% may be given by an intravenous injection (into a vein).

In emergencies, it may be necessary to give the injection without your knowledge.

Your doctor will decide on the correct dosage for you and when or how the injection will be given.

The injection must be diluted at least 50 times before it is given to you.

Possible side effects

Like all medicines, potassium chloride can have side effects.

Potassium chloride may cause the following side effects:

pain at the site of injection inflammation of the vein into which the solution is being injected raised blood levels of potassium

If you experience these or any other side effects not mentioned in this leaflet, please inform your doctor, nurse or pharmacist

Storing your injection

Your injection will be stored under 25°C, protected from light and out of the reach and sight of children.

Use by date

The doctor, nurse or pharmacist will check that the injection is not past its expiry date before giving you the injection.

This leaflet was last updated on March 25th 2004.

PL01502/0007R

43856/19/04


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Hyalovet



Dosage Form: FOR ANIMAL USE ONLY
Hyalovet®
(hyaluronate sodium)
Veterinary Injection

NADA 140-806, Approved by FDA

For intra-articular administration in horses only

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

Hyaluronic acid is the prototype of a wide range of saccharide biopolymers (glycosaminoglycans or mucopolysaccharides) consisting of repeating disaccharide units of N-acetyl-D-glucosamine and D-glucuronic acid linked by beta 1-3 and beta 1-4 glycosidic bonds. A component of all mammalian connective tissue, hyaluronic acid confers viscoelastic and lubricating properties to synovial fluid1 and structural integrity to cartilage matrix2. As a therapeutic agent, hyaluronic acid injected into arthritic joints has been shown, in a variety of animal model systems including horses3, to improve joint function and to activate tissue repair processes in articular cartilage.

Hyalovet (hyaluronate sodium) is clear, colorless, viscous solution of a specific fraction of highly purified hyaluronic acid obtained by a molecular filtration procedure from biological material (rooster combs). The specific hyaluronic acid fraction from which Hyalovet is made has a high degree of molecular definition with an average molecular weight of 500,000-730,000 D.

Each filled 2 mL glass syringe or 2 mL glass vial contains:

Hyaluronate sodium........................................20.0 mg

Sodium chloride..............................................17.0 mg

Monobasic sodium phosphate...........................0.1 mg

Dibasic sodium phosphate.................................1.2 mg

Water for injection.......................................q.s., 2 mL

Indications:

Hyalovet is indicated for the intra-articular treatment of carpal or fetlock joint dysfunction in horses due to acute or chronic, non-infectious synovitis associated with equine osteoarthritis.

Dosage and Administration:

The recommended dose of Hyalovet (hyaluronate sodium) is 2 mL (20 mg hyaluronate sodium) in small or medium sized joints (carpus, fetlock) given by intra-articular injection. More than one joint may be treated at the same time. If necessary, the injection may be repeated after one or more weeks, but not to exceed 2 injections per week for a total of 4 weeks.

Hyalovet should be injected using strict aseptic technique. Excess synovial fluid should be removed prior to injection.

For best results horses should be given two days of rest or limited exercise before resuming normal training.

Contraindications:

There are no known contraindications.

Warning:

Do not use in horses intended for human consumption. Not for human use. Hyalovet Injection must not be administered intravascularly.

Precautions:

Used or partially used syringes should be crushed and disposed of in an approved landfill.

Adverse Reactions:

As with any intra-articular injection a mild inflammatory response (tenderness, heat and swelling) may be seen in the joint following Hyalovet injection. The response is self limiting but may last from two to five days after treatment. If inflammation is excessive or severe, the possibility of infection should be considered and appropriate antibiotic therapy instituted.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance call 1-866-638-2226.

Clinical Pharmacology:

Results of gel chromatography studies demonstrate that Hyalovet (hyaluronate sodium) induces aggregation of cartilage proteoglycans sub-units as previously described for other fractions of hyaluronic acid2. In equine model studies of acute synovitis of the carpal joint, a single intra-articular injection of Hyalovet resulted in statistically significant (p<0.05) functional improvement with regard to lameness, swelling, pain, heat and joint flexion in a dosage dependent fashion. In chronic osteoarthritis secondary to carpal fracture in horses, a single intra-articular injection of 20 mg Hyalovet resulted in statistically significant (p<0.05) reduction in radiopharmaceutical uptake in subchondral bone, as compared to saline injected controls, a finding consistent with reduced inflammation. In controlled clinical trials in horses with lameness due to arthroses of the carpal or fetlock joints, intra-articular injection of 20 mg Hyalovet resulted in marked reduction in clinical lameness, pain on palpation, pain on flexion and facilitated return to training. A measurable and statistically significant (p<0.005) decrease in joint circumference was detected in the horses.

Animal Safety:

In subacute toxicity studies, in horses, intra-articular injection of Hyalovet at the recommended dosage (20 mg/joint) and at 3X and 5X multiples of that dosage, daily for four days followed by twice weekly injections for four additional weeks, resulted in no evidence of toxicity either locally within the joint or systemically in the horses. Slight increases in synovial fluid leucocytes and protein were attributed to the trauma associated with frequent joint injections.

Results of skin testing in horses following repeated intra-articular injections of 40 mg Hyalovet into tibiotarsal joints indicated that the product is non-antigenic in horses; no sensitization was detected.

Storage:

Store at or below 25°C (77° F).

How Supplied:

Hyalovet Veterinary Injection is supplied in a 2 mL syringe or vial containing 20 mg hyaluronate sodium per 2 mL.

NDC 0010-4705-01: 2 mL syringe

NDC 0010-4705-02: 2 mL vial

References: Swann, D.A. et al: Role of hyaluronic acid in joint lubrication. Annals of the Rheumatic Diseases, 33 (1974): 318-326. Hascall, V.C. and Heinegard, D.: Aggregation of cartilage proteoglycans. I. The role of hyaluronic acid. Journal of Biological Chemistry, 249 (1974): 423-433. Gingerich, D.A. et al: Effect of exogenous hyaluronic acid on joint functions in experimentally-induced equine osteoarthritis: dosage titration studies. Research in Veterinary Science, 30 (1981): 192-197.

Hyalovet is a registered trademark of TRB Chemedica International S.A., Geneva, Switzerland.

© 2010 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

Product of Italy

12360

D4450C

680370/3

Manufactured for:

Boehringer Ingelheim Vetmedica, Inc.

St. Joseph, MO 64506 U.S.A.

Vial Label Syringe Label Vial Carton Syringe Carton
Hyalovet 
hyaluronate sodium  liquid Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0010-4705 Route of Administration INTRA-ARTICULAR DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYALURONATE SODIUM (HYALURONIC ACID) HYALURONIC ACID 20 mg  in 2 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0010-4705-01 1 SYRINGE In 1 CARTON contains a SYRINGE 1 2 mL In 1 SYRINGE This package is contained within the CARTON (0010-4705-01) 2 0010-4705-02 1 VIAL In 1 CARTON contains a VIAL 2 2 mL In 1 VIAL This package is contained within the CARTON (0010-4705-02)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140806 05/31/1988
Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091) Revised: 12/2010Boehringer Ingelheim Vetmedica, Inc.

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