Rabies Vaccine Inactivated (Freeze-Dried)

Description

RABIVAX-S [Rabies Vaccine Inactivated (Freeze dried)] is a sterile, purified inactivated rabies vaccine prepared on vero cells. RABIVAX-S vaccine is freeze dried and is provided with diluent (1 dose of powder in vial and 1 ml of diluent in ampoule). The vaccine has the appearance of a white dry cake. The vaccine conforms to the World Health Organization (W.H.O.) requirements.

Composition
One vial of powder and diluent for solution for injection for one immunisation dose (1 ml) contains: Rabies virus (Pitman-Moore Strain) (PM - VERO) adapted and grown on Vero Cells, inactivated by using b-propiolactone.

Each dose of 1 ml contains potency of Rabies antigen of at least 2.5 IU.

Reconstitute with 1 ml of Sterile Water for Injections.

Dose: 1 ml by intramuscular injection.

Diluent: Sterile Water for Injections I.P.

Indications

RABIVAX-S is indicated for the prevention of rabies in children and adults. It can be used before or after exposure, as a primary immunization or as a booster dose.

Pre-Exposure Prophylaxis

Pre-exposure vaccination should be offered to subjects at high risk of contamination by the rabies virus. This vaccination is particularly recommended for veterinarians, veterinary medicine students, animal keepers, hunters, forestry workers, animal handlers, butchers, personnel in rabies research laboratories, children at high risk of exposure or prior to visits to areas in which rabies is endemic.

Post-Exposure Prophylaxis

RABIVAX-S is indicated in post-exposure prophylaxis of rabies infection, when given to individuals with suspected rabies exposure. RABIVAX-S must always be used as per recommendations of the World Health Organization (WHO), depending on the type of contact with a suspected rabid animal.

For all categories, immediate washing and flushing of all wounds and scratches is recommended. If indicated tetanus prophylaxis should also be given with tetanus toxoid. Treatment should be started as early as possible after exposure.

Dose Schedule

Pre-Exposure Prophylaxis, Intramuscular: 1 ml, 3 doses, Day 0, 7 and 21 or 28.

Pre-Exposure Prophylaxis, Intradermal: 0.1 ml, 3 doses, Day 0, 7 and 21 or 28.

Post-Exposure Prophylaxis, Intramuscular: 1 ml, 5 doses, Day 0, 3, 7, 14 and 28.

Post-Exposure Prophylaxis, Intradermal: 0.1 ml + 0.1 ml, 4 doses, Day 0, 3, 7 and 28.

Storage

The vaccine should be stored between 2ºC and 8ºC.

Shelf Life

36 months.