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Imogam Rabies

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Imogam Rabies

Warnings
Precautions

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 (rabies immune globulin (human)) 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

PRECAUTIONS

General

Care is to be taken by the health-care provider for the safe and effective use of this product.

EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THIS PRODUCT.

Imogam® Rabies – HT (rabies immune globulin (human)) should not be administered intravenously because of the potential for serious reactions. Injection should be made intramuscularly (see DOSAGE AND ADMINISTRATION section for injection procedure) and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactoid reactions. As with all preparations given intramuscularly, bleeding complications may be encountered in patients with bleeding disorders.

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

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis or other infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

Pregnancy

Reproductive Studies – Pregnancy Category C

Animal reproduction studies have not been conducted with Imogam® Rabies – HT (rabies immune globulin (human)) . It is also not known whether Imogam® Rabies – HT (rabies immune globulin (human)) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Imogam® Rabies – HT (rabies immune globulin (human)) should be given to a pregnant woman only if clearly needed.

REFERENCES

1. Recommendation of the Advisory Committee on Immunization Practices (ACIP). Human Rabies prevention – United States, 1999. MMWR 48:No. RR-1, 1999

27. Helmick CG, et al. A clinical study of Mérieux human rabies immune globulin. J Biol Stand 10:357-367, 1982

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

Last reviewed on RxList: 10/23/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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