Imogam rabies - ht

This section provides information on the proper use of a number of products that contain rabies immune globulin. It may not be specific to Imogam Rabies-HT. Please read with care.

You will receive this medicine while you are in a hospital or clinic. A doctor, nurse, or other trained health professional will give you this medicine. It is given as a shot in the upper arm (deltoid) or thigh muscle. It may also be injected into the wound that caused your exposure to rabies (e.g., animal bite or scratch).

This medicine is given preferably at the time of your first rabies vaccine dose. It may also be given through the seventh day after the first dose of rabies vaccine is given.

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:

• Cloudy or bloody urine
• high blood pressure
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• swelling of the face, feet, or lower legs

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:

• Fever
• pain, soreness, tenderness, or stiffness at the injection site

• Skin rash

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.

• If you have an allergy to rabies immune globulin, thimerosal, or any other part of Imogam Rabies-HT (rabies immune globulin (human)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.
• It is given as a shot into the skin.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Headache.
• Muscle or joint pain.
• Signs of a common cold.
• Dizziness.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Rabies Immune Globulin (Human) USP, Imogam Rabies - HT, is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. An alcohol fractionation procedure used to purify the immunoglobulin component removes and/or inactivates both enveloped and non-enveloped viruses to a certain extent. An added heat treatment process (60°C, 10 hours) further inactivates both enveloped and non-enveloped viruses. Despite these measures, it is still theoretically possible that known or unknown infectious agents may be present. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health-care provider to the Director of Scientific and Medical Affairs, Aventis Pasteur Inc., telephone 1-800-822-2463. The physician should discuss the risks and benefits of this product with the patient.

Imogam Rabies - HT should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin.

Persons with specific IgA deficiency have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products containing IgA. 36,37

Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

Imogam Rabies - HT should be used in conjunction with Rabies Vaccine such as Rabies Vaccine Imovax Rabies, for intramuscular immunization, vaccine prepared from human diploid cell cultures. The recommended dose of Imogam Rabies - HT is 20 IU/kg (0.133 mL/kg) or 9 IU/lb (0.06 mL/lb) of body weight administered at time of the first vaccine dose. 25,26,43 The gluteal area should never be used for HDCV, RVA, or PCEC injections because administration of HDCV in this area results in lower neutralizing antibody titers. 1,43,44 If anatomically feasible, the full dose of Rabies Immune Globulin (Human) (RIG) should be thoroughly infiltrated in the area around and into the wounds. Any remaining volume should be injected intramuscularly at a site distant from vaccine administration. 1 Two injections would be given in the gluteal muscle if the volume is greater than 5 mL.

Human Rabies Immune Globulin (HRIG) should never be administered in the same syringe or into the same anatomical site as vaccine. Because HRIG may partially suppress active production of antibody, no more than the recommended dose should be given. 1,27

Imogam Rabies - HT is supplied in 2 mL and 10 mL vials with minimal potency of 150 International Units per milliliter (IU/mL). Vial, 2 mL contains 300 IU which is sufficient for a child weighing 15 kg (33 lb). Product No. 49281-190-20.

Vial, 10 mL contains a total of 1,500 IU which is sufficient for an adult weighing 75 kg (165 lb). Product No. 49281-190-10

STORAGE

Imogam Rabies - HT should be stored in the refrigerator between 2° and 8°C (35° and 46°F). Do not freeze.

Imogam Rabies - HT CONTAINS NO PRESERVATIVE AND UNUSED PORTION MUST BE DISCARDED IMMEDIATELY.

1. Recommendation of the Advisory Committee on Immunization Practices (ACIP). Human Rabies prevention - United States, 1999. MMWR 48: No. RR-1, 1999
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18. World Health Organization (WHO). WHO expert committee on rabies. Seventh Report. Geneva. WHO Tech Rep Ser 709: 1-104, 1984
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22. Shill M, et al. Fatal rabies encephalitis despite appropriate postexposure prophylaxis. A case report. N Engl J Med 316: 1257-1258, 1987
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25. Cabasso VJ, et al. Rabies immune globulin of human origin: preparation and dosage determination in non-exposed volunteer subjects. Bull WHO 45: 303-315, 1971
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41. CDC. National Childhood Vaccine Injury Act. Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197-200, 1988
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44. Fishbein DB, et al. Administration of human diploid-cell rabies vaccine in the gluteal area. N Engl J Med 318: 124-125, 1988

                                              Product Information

                                           as of November 1999

Manufactured by:

Aventis Pasteur SA

Lyon France

US Govt License #1279

Distributed by:

Aventis Pasteur Inc.

Swiftwater PA 18370 USA

1-800-VACCINE (1-800-822-2463)         4125