Χώρα: Ινδονησία
Γλώσσα: Ινδονησιακά
Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
A/MICHIGAN/45/2015 (H1N1) PDM09 LIKE VIRUS (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE VIRUS (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS (B/BRISBANE/60/2008, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS
GLAXO WELLCOME INDONESIA - Indonesia
A/MICHIGAN/45/2015 (H1N1) PDM09 LIKE VIRUS (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE VIRUS (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS (B/BRISBANE/60/2008, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS
15 MCG /15 MCG /15 MCG /15 MCG
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0,5 ML
GLAXO SMITHKLINE BIOLOGICALS NL DER SMITHKLINE BEECHAM PHARMA GMBH & CO. KG - Federal Republic of Ge
2021-12-31
FAW_leaFLUTETNHinj_Update strain 2023-2024+new GSK logo_circ1_30May23 – for submission _Page 1 of 7 _ 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 immunization of children & adolescents from 6 months of age, adult with high risk factor (>18 years old), and elderly (>60 years old) 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). CONTRAINDICATIONS _FLUAR Διαβάστε το πλήρες έγγραφο