Pajjiż: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
INFLUENSAVACCIN
BIO FARMA - Indonesia
INFLUENSAVACCIN
CAIRAN INJEKSI
DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML (1 DOSIS)
SANOFI PASTEUR - France
2018-10-17
VAXIGRIP ® 2018/2019 STRAINS INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) 1. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is influenza virus*, split, inactivated, I dose containing antigens equivalent to: ADULTS -A/Michigan/45/2015 (HINI)pdm09-like virus………………15 µg HA** -A/ Singapore/INFIMH-16-0019/2016 (H3N2)-like virus…..15 µg HA** -B/Colorado/06/2017-like virus……………………………….15 µg HA** For one 0.5 mL dose PEDIATRIC USE - A/Michigan/45/2015 (HINI) pdm09-like virus…………… 7.5 µg HA** -A/ Singapore/INFIMH-16-0019/2016 (H3N2)-like virus…7.5 µg HA** -B/Colorado/06/2017-like virus……………………………..7.5 µg HA** For one 0.25 mL dose * propagated in eggs ** hemagglutinin The vaccine complies with the WHO recommendation (northern hemisphere) for the 2018-2019 season. VAXIGRIP may contain traces of eggs, such as ovalbumin, and of neomycin, formaldehyde and octoxinol- 9, which are used during the manufacturing process 2. PHARMACEUTICAL FORM Suspension for injection in prefilled syringe. The vaccine, after shaking gently, is a slightly whitish and opalescent liquid. 3. CLINICAL PARTICULARS 3.1. THERAPEUTIC INDICATIONS VAXIGRIP ® is a suspension for injection in prefilled syringe of 0.5 ml in box of 1 or vial 5 mL VAXIGRIP ® , pediatric use, is a suspension for injection in a prefilled syringe of 0.25 mL in box of 1. This vaccine is recommended for the prevention of influenza, in adults and in children aged from 6 to 35 months (pediatric use), particularly in subjects showing a high risk of associated complications. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: Adult and children from 36 months: one 0.5 mL dose. Page 1 of 12 DISETUJUI OLEH BPOM 07/04/2020 ID REG EREG10040911900184-7 Children from 6 to 35 months: 0.25 mL dose. For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. METHOD OF ADMINISTRATION: Intramuscular route, or deep subcutaneous injection. The vac Aqra d-dokument sħiħ