Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: 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
ERS_leaFLUTETSHinj_MA Transfer SBP to GWI (Project Rinjani)_circ1_26Nov21 _Page 1 of 7 _ FLUARIX TETRA QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) QUALITATIVE AND QUANTITATIVE COMPOSITION _FLUARIX TETRA_ is an inactivated influenza vaccine (split virion), containing antigens (propagated in embryonated eggs) equivalent to the following types and subtypes: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Singapore/GP1908/2015, IVR-180) A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) 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 2017. 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. PHARMACEUTICAL FORM Suspension for injection. CLINICAL PARTICULARS 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_). 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 less than 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 subj Baca dokumen lengkapnya