Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 PREFILLED SYRINGE @ 0,5 ML
2022-09-24
ERS_leaFLUTETNHinj_MA Transfer SBP to GWI (Project Rinjani)_circ1_26Jul21 _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 (Northern Hemisphere) for the season 2017/2018. 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 administere Baca dokumen lengkapnya