DESCRIPTION
ANTIRABIES SERUM is a sterile, non-pyrogenic solution for intramuscular administration, containing antiviral substances obtained from the blood plasma of healthy equines that have been immunized against rabies, by vaccination. In addition, it also contains the antimicrobial agent phenol.

COMPOSITION
1. Antirabies Serum 1000 IU/5ml
Each vial contains:
Equine anti rabies immunoglobulin fragments 200 IU/ml
Preservative: Phenol 0.25% v/v.

2. Antirabies Serum 1500 IU/5ml
Each vial contains:
Equine anti rabies immunoglobulin fragments 300 IU/ml
Preservative: Phenol 0.25% v/v.

THERAPEUTIC INDICATIONS
Antirabies Serum provides rabies antibodies before an active response to anti-rabies vaccine takes place. It is used to provide passive immunity against rabies in postexposure prophylaxis of individuals, exposed to the disease or virus after contact with a rabid animal or an animal presumed to be rabid. Antirabies serum itself does not constitute an antirabies treatment and should always be used in conjunction with rabies vaccine.

CONTRA-INDICATIONS
Antirabies Serum should be administered with caution to individuals who have exhibited previous systemic allergic reactions to immune globulin/hyper sensitivity to equine serum, thrombocytopenia or bleeding disorders since bleeding may occur following intramuscular administration of the drug.

SPECIAL WARNINGS AND PRECAUTIONS
Despite the high degree of purification of the serum, it is recommended to perform a skin test before administering Antirabies Serum. The skin test consists of an intradermal injection with a 1:10 dilution of Antirabies Serum (0.1 ml) on the outside of the forearm so as to obtain an induration of 3 mm diameter. An equivalent intradermal injection of physiological saline solution is used as control. The observations made 15 minutes after intradermal injection is considered to be positive if erythema (>6mm), local oedema or a systemic reaction is observed and the control shows no such dermal reaction. Purified equine Anti Rabies Serum (the active constituent of rabies immunoserum) has been reported to be safe and affordable alternative to human rabies immunoglobulin. A positive test result is not a formal contraindication for the use of serotherapy" but it should be considered as a warning. Although systemic reactions to preparations containing immunoglobulins are rare, Adrenaline, Corticosterords and Anti-histaminic drugs should be available for treatment of acute anaphylaxis, if it occurs. A negative test is not an absolute guarantee for the absence of an immediate allergic type reaction. Do not inject intravenously.

DRUG INTERACTIONS
Rabies prevention after contamination risk requires simultaneous administration of antirabies immunoglobulin and vaccine. To minimize interaction, rabies antiserum and rabies vaccine shall be injected to different parts of body as collaterally. Anti Rabies Serum should not be administered to individuals who have previously received a recommended pre-exposure or post-exposure treatment with rabies vaccine. The immunoglobulin should not be administered from the same syringe as the vaccine. Antibodies contained in Anti Rabies Serum may interfere with the immune response to certain live virus vaccines. If simultaneous vaccine is deemed necessary, the live virus vaccine should be administered at a separate site remote from that of ERIG.


PREGNANCY AND LACTATION
Because of the potential risks of inadequately treated rabies exposure and considering the lethal risk associated with rabies; pregnancy is not a contraindication to post-exposure prophylaxis. It is not known if ERIG affects fertility. Information on the distribution of ERIG into milk is not available; it is not known if transmission of ERIG to a nursing infant presents any unusual risk.


DOSAGE AND ADMINISTRATION
FIRST-AID TREATMENT
Prompt local treatment of bite wounds and scratches that may be contaminated with rabies virus is important, whatever the time elapsed since the contact. First aid or local treatment consists of immediate through flushing and washing of the wound with water or soap and water followed by application of 70% alcohol (700 ml per litre) or tincture or povodine iodine.

For prevention of rabies or post-exposure therapy in previously non-immunized individuals, Anti Rabies Serum should always be administered in conjunction with rabies vaccine. The dose required for each patient should be accurately calculated prior to usage. The recommended dose is 40 I.U./KG of body weight. If anatomically feasible, local infiltration of entire ERIG dose around the wound if recommended as it provides additional virus neutralising antibodies at the site of contamination with the virus. Dilute Anti Rabies Serum to the required volume with normal saline and infiltrate into the wound. In the event that a remainder of passive immunoglobulin product is left after the wound is infiltrated, it should be administered by deep intramuscular injection at an injection site distant from vaccine injection site.
Children and adults receive the same dose of 40 I.U./Kg of body weight. Anti Rabies Serum is administered only once, at the beginning of post-exposure treatment in combination with the rabies vaccine and treatment should begin no later than 24 hours after exposure. If vaccine therapy is initiated without ERIG, then ERIG may be administered through the 7th day after the first dose of the vaccine.
When indicated, begin anti-tetanus treatment and administer antimicrobial drugs to control infections other than rabies.


ADVERSE EFFECTS
Immediate or delayed hypersensitivity type reactions may develop with administration of Anti Rabies Serum. The observed immediate reactions are anaphylactoid reactions with hypotension, dyspnea, urticaria. Delayed reactions contist of local pain, tenderness, soreness or stiffness of muscles at injection site, low grade fever, pruritis, rash or urticaria, adenopathy, angioedema and arthralgia.


STORAGE
ANTIRABIES SERUM should be stored between 2° - 8° C. DO NOT FREEZE.

PRESENTATION
1500 IU/5 ml vial
1000 IU/5 ml vial