FLUARIX TETRA NH

国: インドネシア

言語: インドネシア語

ソース: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

有効成分:

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

から入手可能:

GLAXO WELLCOME INDONESIA - Indonesia

INN（国際名）:

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

投薬量:

15 MCG /15 MCG /15 MCG /15 MCG

医薬品形態:

SUSPENSI INJEKSI

パッケージ内のユニット:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

製:

GLAXO SMITHKLINE BIOLOGICALS NL DER SMITHKLINE BEECHAM PHARMA GMBH & CO. KG - Federal Republic of Ge

承認日:

2021-12-31

製品の特徴

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