Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INACTIVATED,INFLUENZA VIRUS TYPE A (H3N2); INACTIVATED,INFLUENZA VIRUS TYPE A (H1N1); INACTIVATED,INFLUENZA VIRUS TYPE B (B/VICTORIA); INACTIVATED,INFLUENZA VIRUS TYPE B (B/YAMAGATA)
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
INACTIVATED,INFLUENZA VIRUS TYPE A (H3N2); INACTIVATED,INFLUENZA VIRUS TYPE A (H1N1); INACTIVATED,INFLUENZA VIRUS TYPE B (B/VICTORIA); INACTIVATED,INFLUENZA VIRUS TYPE B (B/YAMAGATA)
1 Pre-Filled Syringes; 10 Pre-Filled Syringes; 20 Pre-Filled Syringes
SANOFI PASTEUR
Not Applicable Lees het volledige document
Internal NH2023/2024 MY/VAX/0523/NH2023/2024 1. NAME OF THE MEDICINAL PRODUCT VAXIGRIPTETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION,INACTIVATED) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus (inactivated, split) of the following strains*: A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238)…15 micrograms HA** A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/9/2021, IVR-228)……………… 15 micrograms HA** B/Austria/1359417/2021 - like strain(B/Michigan/01/2021, wild type) ................... 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type) .............................. 15 micrograms HA** For one 0.5 mLdose * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the WHO recommendations (Northern Hemisphere) for the 2023/2024 season. For the full list of excipients, see section 6.1. VaxigripTetra may contain traces of eggs, such as ovalbumin, and of neomycin, formaldehyde and octoxinol-9, which are used during the manufacturing process (see section 4.3). 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. The vaccine, after shaking gently, is a colourless opalescent liquid. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS VaxigripTetra 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 infants less than 6 months of age and born to women vaccinated during pregnancy (see Sections 4.4, 4.6 and 5.1). The use of VaxigripTetra should be based on official recommendations. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Based on clinical experience with the trivalent vaccine, annual revaccination with influenza vaccine is recommended given the duration of immunity provided by the vacc Lees het volledige document