Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
YELLOW FEVER VACCINE
AVENTIS PHARMA - Indonesia
YELLOW FEVER VACCINE
CAIRAN INJEKSI
DUS, 10 VIAL @ 1 DOSIS + 10 PREFILLED SYRINGE PELARUT @ 0,5 ML
SANOFI PASTEUR - France
2015-03-26
STAMARIL PASTEUR ATTENUATED YELLOW FEVER VACCINE NAME OF THE MEDICINAL PRODUCT STAMARIL PASTEUR, powder and solvent for suspension for injection in multidose container Yellow fever vaccine (Live) QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Yellow fever virus 1 17 D-204 strain (live, attenuated)not less than 1000 LD 50 units 2 1 produced in specified pathogen-free chick embryos 2 The statistically determined lethal dose in 50% of animals tested For a full list of excipients, see section LIST OF EXCIPIENTS. PHARMACEUTICAL FORM Powder and solvent for suspension for injection. Before reconstitution, the powder is homogeneous beige to orange beige; the solvent is a limpid solution. THERAPEUTIC INDICATIONS STAMARIL PASTEUR is a powder with solvent for single-dose suspension for injection (0.5 mL). This medicine is indicated in the prevention of yellow fever for travelers to area where there is a persisting or periodical risk of yellow fever transmission. Yellow fever vaccination should not be prescribed for individuals who are not risk of exposure to infection. POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ Primary vaccination The vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed. Adults and children aged 9 months and over: A single dose of 0.5 ml of reconstituted vaccine. Re-vaccination: The duration of protection is expected to be at least 10 years and may be a life-long protection. In accordance with WHO recommendations, the validity of a certificate of vaccination against yellow fever shall extend for the life of the person vaccinated. However, re-vaccination may be needed in some individuals who had an insufficient immune response after their primary vaccination if they continue to be at risk for yellow fever virus infection, or in certain travellers to high risk areas of yellow fever virus infection. _METHOD OF ADMINISTRATION _ It is preferable that the vaccine Preberite celoten dokument