VAXIGRIP TETRA NH

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09 LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/H

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09 LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/H

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:

SANOFI PASTEUR - France

Tanggal Otorisasi:

2020-07-08

Karakteristik produk

VAXIGRIPTETRA® NH
QUADRIVALENT INFLUENZA VACCINE
(SPLIT VIRION, INACTIVATED)
SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
A/Victoria/4897/2022 (H1N1)pdm09-like virus
(A/Victoria/4897/2022, IVR-238) ............................... 15
micrograms HA**
A/Darwin/9/2021 (H3N2)-like virus
(A/Darwin/9/2021, IVR-228) ...................................... 15
micrograms HA**
B/Austria/1359417/2021-like virus (B/Michigan/01/2021, wild type)
....................................................................................
15 micrograms HA**
B/Phuket/3073/2013 - like virus (B/Phuket/3073/2013, wild type)
....................................................................................
15 micrograms HA**
For one 0.5 mL dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU
decision for the 2023/2024 season.
For the full list of excipients, see section List of excipients
VaxigripTetra NH may contain traces of eggs, such as ovalbumin, and of
neomycin,
formaldehyde and octoxinol-9, which are used during the manufacturing
process (see
section Contraindications).
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine, after shaking gently, is a colourless opalescent liquid.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
VaxigripTetra NH is indicated for the prevention of influenza disease
caused by the two
influenza A virus subtypes and the two influenza B virus types
contained in the vaccine
for:
- active immunisation of adults, including pregnant women, and
children from 6
months of age.
- passive protection of infant(s) from birth to less than 6 months of
age following
vaccination
of
pregnant
women
(see
Sections
posology
and
method
of
administration; Special warnings and precautions for use; Fertility,
pregnancy and
lactation and Pharmacodynamic properties – clinical trials).
The