Երկիր: Ինդոնեզիա
Լեզու: ինդոնեզերեն
Աղբյուրը: 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
2022-01-03
FAW_leaFLUTETSHinj_version 01_circ2_22Jan24 _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/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022, IVR-237); 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 (Southern Hemisphere) for the season 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 _FLUARIX TETRA_ should not be administered to subjects with Կարդացեք ամբողջական փաստաթուղթը