Imogam rabies - ht

Name: Imogam rabies - ht

Proper Use of rabies immune globulin

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.

Imogam Rabies-HT Side Effects

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

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

Rare
  • 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:

Less common
  • Fever
  • pain, soreness, tenderness, or stiffness at the injection site
Rare
  • 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.

What do I need to tell my doctor BEFORE I take Imogam Rabies-HT?

  • 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.

How is this medicine (Imogam Rabies-HT) best taken?

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.

What are some other side effects of Imogam Rabies-HT?

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.

How do I store and/or throw out Imogam Rabies-HT?

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

Warnings

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

Dosage and Administration

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

How Supplied

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.

References

  1. Recommendation of the Advisory Committee on Immunization Practices (ACIP). Human Rabies prevention - United States, 1999. MMWR 48: No. RR-1, 1999
  2. Krebs JW, et al. Rabies surveillance in the United States during 1996. J Am Vet Med Assoc 211: 1525-1539, 1997
  3. Noah DL, et al. Epidemiology of human rabies in the United States, 1980 to 1996. Ann Intern Med 128: 922-930, 1998
  4. Centers for Disease Control and Prevention (CDC). Human Rabies - New Hampshire, 1996. MMWR 46: 267-270, 1997
  5. Mitmoonpitak C, et al. Current status of animal rabies in Thailand. J Vet Med Sci 59: 457-460, 1997
  6. CDC. Human rabies - Montana and Washington, 1997 MMWR 46: 770-774, 1997
  7. CDC. Human rabies - Texas and New Jersey, 1997. MMWR 47: 1-5, 1998
  8. Krebs JW, et al. Causes, costs and estimates of rabies postexposure prophylaxis treatments in the United States. J Public Health Manage Pract 4: 57-63, 1998
  9. Bernard KW, et al. Neuroparalytic illness and human diploid cell rabies vaccine. JAMA 248: 3136-3138, 1982
  10. CDC. Systemic allergic reactions following immunization with human diploid cell rabies vaccine. MMWR 33: 185-187, 1984
  11. Dreesen EW, et al. Immune complex-like disease in 23 persons following a booster dose of rabies human diploid cell vaccine. Vaccine 4: 45-49, 1986
  12. Aoki FY, et al. Immunogenicity and acceptability of a human diploid-cell culture rabies vaccine in volunteers. Lancet 1: 660-662, 1975
  13. Cox JH, et al. Prophylactic immunization of humans against rabies by intradermal inoculation of human diploid cell culture vaccine. J Clin Microbiol 3: 96-101, 1976
  14. Anderson LJ, et al. Postexposure trial of a human diploid cell strain rabies vaccine. J Infect Dis 142: 133-138, 1980
  15. Bahmanyar M, et al. Successful protection of humans exposed to rabies infection. Postexposure treatment with the new human diploid cell rabies vaccine and antirabies serum. JAMA 236: 2751-2754, 1976
  16. Hattwick MAW. Human rabies. Public Health Rev 3: 229-274, 1974
  17. Wiktor TJ, et al. Development and clinical trials of the new human rabies vaccine of tissue culture (human diploid cell) origin. Dev. Biol Stand 40: 3-9, 1978
  18. World Health Organization (WHO). WHO expert committee on rabies. Seventh Report. Geneva. WHO Tech Rep Ser 709: 1-104, 1984
  19. Kuwert EK, et al. Immunization against rabies with rabies immune globulin, human (RIGH) and a human diploid cell strain (HDCS) rabies vaccine. J Biol Stand 6: 211-219, 1978
  20. Wilde H, et al. Failure of postexposure treatment of rabies in children. Clin Infect Dis 22: 228-232, 1996
  21. CDC. Human rabies despite treatment with rabies immune globulin and human diploid cell rabies vaccine - Thailand. MMWR 36: 759-760, 765, 1987
  22. Shill M, et al. Fatal rabies encephalitis despite appropriate postexposure prophylaxis. A case report. N Engl J Med 316: 1257-1258, 1987
  23. Wilde H, et al. Failure of rabies postexposure treatment in Thailand. Vaccine 7: 49-52, 1989
  24. Habel K, et al. Laboratory data supporting clinical trial of antirabies serum in persons bitten by rabid wolf. Bull WHO 13: 773-779, 1955
  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
  26. Loofbourow JC, et al. Rabies immune globulin (human). Clinical trials and dose determination. JAMA 217:1825-1831, 1971
  27. Helmick CG, et al. A clinical study of Mérieux human rabies immune globulin. J Biol Stand 10:357-367, 1982
  28. Lang J, et al. Evaluation of the safety and immunogenicity of a new, heat-treated human rabies immune globulin using a sham, postexposure prophylaxis of rabies. Biologicals 26: 7-15, 1998
  29. WHO Expert Committee on Rabies. WHO Tech Rep Ser 523: 50-51, 1973
  30. ACIP. Human Rabies - California, 1994. MMWR 43: 455-457, 1994
  31. Wilde H, et al. Failure of Postexposure Treatment of Rabies in Children. Clin Infect Dis 22: 228-232, 1996
  32. Afshar A. A review of non-bite transmission of rabies virus infection. Br Vet J 135: 142-148, 1979
  33. Winkler WG, et al. Airborne rabies transmission in a laboratory worker. JAMA 226: 1219-1221, 1973
  34. CDC. Rabies in a laboratory worker - New York. MMWR 26: 183-184, 1977
  35. Gode GR, et al. Two rabies deaths after corneal grafts from one donor {letter}. Lancet 2: 791, 1988
  36. Fudenberg HH. Sensitization to immunoglobulins and hazards of gamma globulin therapy, pp 211-220 in Merler E, Editor Immunoglobulins: biologic aspects and clinical uses. National Academy of Sciences, Wash., DC. 1970
  37. Pineda AA, et al. Transfusion reactions associated with anti-lgA antibodies: report of four cases and review of the literature. Transfusion 15:10-15, 1975
  38. Janeway CA, et al. The gamma globulins. IV. Therapeutic uses of gamma globulins. N Engl J Med 275: 826-831, 1966
  39. Kjellman H. Adverse reactions to human immune serum globulin in Sweden (1969-1978). pp 143-150. Immunoglobulins: characteristics and uses of intravenous preparations. Alving BM and Finlayson JS, Editors. US Dept. Health & Human Services, DHHS Publ. No. (FDA) 80-9005, Wash., DC. 1980
  40. CDC. Vaccine Adverse Event Reporting System - United States. MMWR 39: 730-733, 1990
  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
  42. Food and Drug Administration. New Reporting Requirements for Vaccine Adverse Events. FDA Drug Bull 18(2), 16-18, 1988
  43. World Health Organization. WHO expert committee on rabies. WHO Tech Rep Ser 824: 1992
  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

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