Страна: Индонезия
Език: индонезийски
Източник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TYPHOID VI POLYSACCHARIDE, INACTIVATED HEPATITIS A VIRUS
AVENTIS PHARMA - Indonesia
TYPHOID VI POLYSACCHARIDE, INACTIVATED HEPATITIS A VIRUS
25 MCG /160 IU
SUSPENSI INJEKSI
DUS, 1 SYRINGE @ 1 DOSIS (0,5 ML)
SANOFI PASTEUR - France
2021-01-26
VIVAXIM COMBINED TYPHOID (PURIFIED Vi POLYSACCHARIDE) AND HEPATITIS A (INACTIVATED) VACCINE COMPOSITION The dual-chamber syringe contains 0.5 millilitre of inactivated hepatitis A vaccine and 0.5 millilitre of typhoid polysaccharide vaccine which are mixed prior to administration. After reconstitution, 1 dose (1 mL) contains: Originally contained in the suspension: Hepatitis A virus, GBM strain (inactivated) 1,2 ................................................................................ 160 U 3 1 Produced in human diploid (MRC-5) cells 2 Adsorbed on aluminium hydroxide hydrated (0.3 milligram Al) 3 In the absence of an international standardised reference, the antigen content is expressed using an in- house reference. Originally contained in the solution: Salmonella typhi (Ty2 strain) capsular Vi polysaccharides ...............................................25 micrograms Excipient(s) with known effect (see section Special warnings and precautions for use): Phenylalanine ....................................................................................................................................... 10 micrograms For the full list of excipients, see section List of excipients VIVAXIM may contain traces of neomycin, which is used during the manufacturing process (see section Contraindications). PHARMACEUTICAL FORM Suspension for injection in a prefilled dual chamber syringe. The inactivated hepatitis A vaccine is a cloudy and whitish suspension; the typhoid polysaccharide vaccine is a clear and colourless solution. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS VIVAXIM is indicated for combined active immunisation against typhoid fever and infection with Hepatitis A virus in subjects aged 16 years or more. VIVAXIM must be administered according to official recommendations. POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 1 m l of mixed vaccine. Initial protection is obtained after a single injection of VIVAXIM. Protective antibody levels are only obtained 14 days after administration Прочетете целия документ