Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INFLUENZA SPLIT VIRUS, INACTIVATED
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
INFLUENZA SPLIT VIRUS, INACTIVATED
1units Units; 1units Units
GlaxoSmithKline Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG
Not Applicable Lue koko asiakirja
INTERNATIONAL PRODUCT INFORMATION CONFIDENTIAL 1 FLUARIX TETRA QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED), SUSPENSION FOR INJECTION QUALITATIVE AND QUANTITATIVE COMPOSITION Fluarix Tetra is an inactivated influenza vaccine (split virion), containing antigens (propagated in embryonated eggs) equivalent to the following strains: A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238); A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/6/2021, IVR-227); B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26); B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type). This vaccine complies with the WHO recommended strains (Northern Hemisphere) for the season 2023/2024. Each 0.5 mL vaccine dose contains 15 µg haemagglutinin of each of the recommended strains. Fluarix Tetra meets the WHO requirements for biological substances and influenza vaccines and the European Pharmacopoeia requirements for influenza vaccines. CLINICAL INFORMATION INDICATIONS Fluarix Tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine (see _Pharmacodynamics_ ). The use of Fluarix Tetra should be based on official recommendations. DOSAGE AND ADMINISTRATION Fluarix Tetra should be administered as a single 0.5 mL injection. Children 6 months to less than 9 years of age who have not previously been vaccinated against influenza should receive a second dose of 0.5 mL after an interval of at least 4 weeks. Children aged <6 months The safety and efficacy of Fluarix Tetra in children aged <6 months have not been established. Vaccination should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass). INTERNATIONAL PRODUCT INFORMATION CONFIDENTIAL 2 CONTRAINDICATIONS Fluarix Tetra should not be administered to subjects with known hypersensitivity after previous administration Lue koko asiakirja