FLUARIX TETRA NH

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

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

Tersedia dari:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Nama Internasional):

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

Dosis:

15 MCG /15 MCG /15 MCG /15 MCG

Bentuk farmasi:

SUSPENSI INJEKSI

Unit dalam paket:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

Diproduksi oleh:

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

Tanggal Otorisasi:

2021-12-31

Karakteristik produk

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