País: Indonésia
Língua: indonésio
Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09 LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/H
AVENTIS PHARMA - Indonesia
B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09 LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/H
15 Mcg /15 Mcg /15 Mcg /15 MCG
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0.5 ML
SANOFI PASTEUR - France
2020-07-08
VAXIGRIPTETRA® NH QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) SUSPENSION FOR INJECTION IN PREFILLED SYRINGE QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus (inactivated, split) of the following strains*: A/Victoria/4897/2022 (H1N1)pdm09-like virus (A/Victoria/4897/2022, IVR-238) ............................... 15 micrograms HA** A/Darwin/9/2021 (H3N2)-like virus (A/Darwin/9/2021, IVR-228) ...................................... 15 micrograms HA** B/Austria/1359417/2021-like virus (B/Michigan/01/2021, wild type) .................................................................................... 15 micrograms HA** B/Phuket/3073/2013 - like virus (B/Phuket/3073/2013, wild type) .................................................................................... 15 micrograms HA** For one 0.5 mL dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2023/2024 season. For the full list of excipients, see section List of excipients VaxigripTetra NH may contain traces of eggs, such as ovalbumin, and of neomycin, formaldehyde and octoxinol-9, which are used during the manufacturing process (see section Contraindications). PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. The vaccine, after shaking gently, is a colourless opalescent liquid. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS VaxigripTetra NH is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine for: - active immunisation of adults, including pregnant women, and children from 6 months of age. - passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see Sections posology and method of administration; Special warnings and precautions for use; Fertility, pregnancy and lactation and Pharmacodynamic properties – clinical trials). The Leia o documento completo