FLUARIX TETRA

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Tersedia dari:

GLAXO WELLCOME INDONESIA - Indonesia -

Dosis:

15 MCG /15 MCG /15 MCG /15 MCG

Bentuk farmasi:

SUSPENSI INJEKSI

Komposisi:

B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/DARWIN/9/2021 (H3N2) LIKE VIRUS (A/DARWIN/6/2021, IVR-227), B/AUSTRIA/1359417/2021-LIKE STRAIN(B/AUSTRIA/1359417/2021, BVR-26), A/SYDNEY/5/2021 (H1N1)PDM09 LIKE STRAIN (A/SYDNEY/5/202

Unit dalam paket:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

Kelas:

Obat

Diproduksi oleh:

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

Status otorisasi:

Berlakus/d 03-01-2027

Tanggal Otorisasi:

2023-03-25

Karakteristik produk

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