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RABIGAM® IM

REGISTRATION NUMBER
T/30.2/748

PROPRIETARY NAME
(and dosage form)

RABIGAM^® IM
(Solution for Intramuscular Injection)

DESCRIPTIVE NAME OF MEDICINE
Human rabies immunoglobulin

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

SCHEDULING STATUS
S4

COMPOSITION
Rabigam IM contains gammaglobulin derived from pooled human plasma, sourced from non-remunerated healthy donors, with a high titre of antibodies to the rabies virus.
Each unit of plasma has been individually testedand found non-reactive for hepatitis B surface antigen, antibodies to the hepatitis C virus and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Rabigam IM is prepared by cold ethanol fractionation to further reduce the risk of viral transmission.
Each 2 ml ampoule contains 300 IU (150 IU/mL) rabies virus antibodies.
This preparation contains no antimicrobial preservative and is stabilised with glycine.

IDENTIFICATION
A clear, pale yellow or light brown liquid exhibiting a slight opalescence.

PHARMACOLOGICAL ACTION OF THE MEDICINE
Rabies immunoglobulin confers passive immunity against rabies.
The pharmacodynamic effects in vivo of the specific neutralising antibodies against rabies virus are not fully documented, but rabies immunoglobulin has been proven to be effective in preventing the rabies infection.

INDICATIONS
Rabies immunoglobulin (passive immunisation) is indicated for all persons known or suspected to have been exposed to the rabies virus and is used in conjunction with the rabies vaccine (active immunisation).
Rabies immunoglobulin must be given for any mucous membrane exposure to saliva i.e. licks, and all single and multiple bites or scratches inflicted by a suspected rabid animal, especially if associated with any signs of bleeding, irrespective of the interval between exposure and initiation of treatment.
Individuals previously immunised with rabies vaccine and whose antibody titre has been recently confirmed as adequate, should be treated with the vaccine only.

CONTRA-INDICATIONS
Rabigam IM is not indicated for patients with proven immunity.
The risk-benefit ratio in patients with a history of IgA deficiency or severe anaphylactic reactions to plasma products should be considered.
The safety of intramuscular immunoglobulin in pregnancy has not been established in controlled clinical trials. Long-lasting clinical experience with immunoglobulin (in particular anti-D immunoglobulin does indicate that no harmful effects on the course of the pregnancy, or on the foetus, or on the neonate are to be expected. Therefore, Rabigam IM may be given with caution during pregnancy and lactation.
Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Intramuscular injections are not advocated for persons with bleeding disorders. The risk of withholding rabies immunoglobulin should however, be weighed against the risk of administering an IM injection to persons with bleeding disorders.
Known hypersentivity.

WARNING:
This intramuscular preparation must not be given intravenously.

DOSAGE AND DIRECTIONS FOR USE
The standard recommended dose is 20 IU per kilogram body mass administered at the same time, but at a different anatomical site, as the vaccine. This dose is applicable to both children and adults.
Infiltrate the entire dose of Rabigam IM into the depth of and around the wound if anatomically possible. Administer the remainder of the dose by deep intramuscular injection at a site separate from that used for the vaccine. Ensure that the wound has been adequately infiltrated with immunoglobulin locally before suturing, if suturing is necessary.
The recommended dose should not be exceeded.
Discard any unused portion.
Warm the ampoule to body temperature before intramuscular injection. Do not administer with the same syringe or into the same anatomical site as the rabies vaccine.
Note:

•	Laboratory diagnosis should not delay initiation of treatment but failure to detect rabies virus in the offending animal may warrant the halting of treatment.
•	Rabies immunoglobulin must be administered as soon as possible (that is, on the day that treatment is started) after suspected exposure to rabies, in conjunction with rabies vaccine.
•	If initiation of treatment is delayed for any reason, rabies immunglobulin should still be given, regardless of the interval between exposure and treatment, up to the seventh day after the first dose of vaccine was given.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Local reactions, which include pain and tenderness, may occur at the injection site. Headache, fever, chills, flushing, lightheadedness, backache, nausea and cutaneous reactions have been reported.
Anaphylactic reactions may occur, especially if this intramuscular preparation is given intravenously. Measures to treat anaphylaxis, including adrenaline, should be immediately available when administering Rabigam IM.
Persons with selective IgA deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation and subsequent reaction to IgA-containing material, such as blood and plasma derived medicinal products.
Special precautions:
Repeated doses of the rabies immunoglobulin should not be administered once rabies vaccine treatment has been started, because this could prevent full development of the active immunity expected from the vaccine.
Infectious diseases due to the transmission of infectious agents, cannot be totally excluded. Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products.
Interference with serological testing: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Immunoglobulin administration may impair, for a period of at least 6 weeks and up to 3 months, the efficacy of live attenuated virus vaccines such as measles, mumps, rubella and varicella. These vaccines should be administered at least 14 days prior to or 3 months after administration of Rabigam IM.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT
Doses in excess of 40 IU per kilogram body mass may result in significant depression of active immunity.

PRESENTATION
300 IU in single dose, clear, colourless 2 mL glass ampoule.

STORAGE DIRECTIONS
Transport within 72 hours below 37°C.
Store between 2°C and 8°C.
Do not freeze.
Protect from light.
Keep out of reach of children.

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATAL BIOPRODUCTS INSTITUTE
Reg. No. 94/02044/08

PRIVATE BAG X9043                PINETOWN 3600 Telephone: (031) 719 6789

10 EDEN ROAD PINETOWN 3610 Telefax: (031) 708 5614

DATE OF PUBLICATION OF PACKAGE INSERT
9/96

P0980 2/2000

Updated on this site: May 2000

Please note that the Natal Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at (+27)(+31) 719 6789 or 082 870 3705 or 082 895 0056.
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