País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
INFLUENSAVACCIN
BIO FARMA - Indonesia
INFLUENSAVACCIN
CAIRAN INJEKSI
DUS, 1 PRE-FILLED SRYNGE @ 0,25 ML (1 DOSIS)
SANOFI PASTEUR - France
2018-10-17
VAXIGRIP INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) 2020/2021 STRAINS 1. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is influenza virus*, split, inactivated, 1 dose containing antigens equivalent to: ADULTS - A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09 - like virus (A/Guangdong-Maonan/SWL1536/2019, CNIC-1909) ......................................................................15 µg HA** - A/Hong Kong/2671/2019 (H3N2) - like virus (A/Hong Kong/2671/2019, IVR-208) ................15 µg HA** - B/Washington/02/2019 - like virus (B/Washington/02/2019, wild type).......................................15 µg HA** For one 0.5 mL dose PEDIATRIC USE - A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09 - like virus (A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)......................................................................7.5 µg HA** - A/Hong Kong/2671/2019 (H3N2) - like virus (A/Hong Kong/2671/2019, IVR-208).................7.5 µg HA** - B/Washington/02/2019 - like virus (B/Washington/02/2019, wild type).......................................7.5 µg HA** For one 0.25 mL dose *propagated in eggs ** haemagglutinin The vaccine complies with the WHO recommendation (northern hemisphere) for the 2020-2021 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 Llegiu el document complet