Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
RABIES VACCINE
BIO FARMA - Indonesia
RABIES VACCINE
2,5 IU
SERBUK INJEKSI
DUS, 1 VIAL @ 1 DOSIS + 1 SYRINGE @0,5 ML NaCl 4 %
SANOFI PASTEUR - France
2019-07-22
VERORAB PURIFIED INACTIVATED RABIES VACCINE, PREPARED ON VERO CELLS COMPOSITION After reconstitution, 1 dose (0.5 mL) contains: Rabies virus*, WISTAR Rabies PM/WI38 1503‐3M strain (inactivated) ≥ 2.5 IU** * Produced in VERO cells ** Quantity measured according to the NIH test against the international standard List of excipients Powder: - Maltose - 20% Human albumin solution - Basal Medium Eagle (mixture of mineral salts including potassium, vitamins, dextrose and amino- acids including L-Phenylalanine) - Water for injections - Hydrochloric acid and sodium hydroxide for pH adjustment Solvent: - Sodium chloride - Water for injections PHARMACEUTICAL FORM Powder and diluent for suspension for injection. Before reconstitution, the powder is a white and homogeneous pellet. The solvent is a clear and colorless solution. THERAPEUTIC INDICATIONS This medicinal product is a vaccine. PRE-EXPOSURE This vaccine is recommended for the prevention of rabies in subjects at a high risk of exposure. All subjects at a permanent risk, such as diagnostic, research and production laboratory staff working on rabies virus, should be vaccinated. A serological test is recommended every 6 months. A booster injection should be administered when the antibody titre is below the level considered to guarantee protection: 0.5 I.U./mL. The following categories should be vaccinated given the frequency of exposure to the risk: - Veterinarians (and assistants), gamekeepers, hunters, forest rangers, slaughter- house personnel, cavers, taxidermists. - Subjects exposed enzootic areas: children, adults and travelers visiting these areas. POST-EXPOSURE - After confirmed or suspected exposure, vaccination must be started immediately at the risk of contamination with rabies. It must be performed in a rabies treatment centre. The treatment is adapted to the type of wound and the status of the animal. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The vaccination schedule should be adapted according to the circumstances of the vaccination and the subject Preberite celoten dokument