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. 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 Medical Affairs, Connaught Laboratories, 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. ^38,39

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 should not be administered intravenously because of the potential for serious reactions. Injection should be made intramuscularly 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.

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

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.

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