FLUARIX TETRA

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

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

제공처:

GLAXO WELLCOME INDONESIA - Indonesia

INN (International Name):

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

복용량:

15 MCG /15 MCG /15 MCG /15 MCG

약제 형태:

SUSPENSI INJEKSI

패키지 단위:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

Manufactured by:

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

승인 날짜:

2022-01-03

제품 특성 요약

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