VAXIGRIP TETRA SH

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/MARYLAND/15/2016, BX-69A (VICTORIA LINEAGE)), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS (A/MICHIGAN/45/2015, NYMC X-275), A/SWITZERLAND/8060/2017 (H3N2)-LIK

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/MARYLAND/15/2016, BX-69A (VICTORIA LINEAGE)), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS (A/MICHIGAN/45/2015, NYMC X-275), A/SWITZERLAND/8060/2017 (H3N2)-LIK

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® SH
QUADRIVALENT INFLUENZA VACCINE
(SPLIT VIRION, INACTIVATED)
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
A/Sydney/5/2021 (H1N1)pdm09-like virus
(A/Sydney/5/2021, SAN-013) ..................................... 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 (Southern
Hemisphere) for the
2023 season.
For the full list of excipients, see section List of excipients
VaxigripTetra SH 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 SH 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 use of VaxigripTetra SH