VAXIGRIP PEDIATRIC USE

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

INFLUENSAVACCIN

Disponible depuis:

BIO FARMA - Indonesia

DCI (Dénomination commune internationale):

INFLUENSAVACCIN

forme pharmaceutique:

CAIRAN INJEKSI

Unités en paquet:

DUS, 1 PRE-FILLED SRYNGE @ 0,25 ML (1 DOSIS)

Fabriqué par:

SANOFI PASTEUR - France

Date de l'autorisation:

2018-10-17

Résumé des caractéristiques du produit

VAXIGRIP
INACTIVATED INFLUENZA VACCINE
(SPLIT VIRION)
2020/2021 STRAINS
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is influenza virus*, split, inactivated, 1 dose
containing antigens equivalent to:
ADULTS
- A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09 - like virus
(A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)
......................................................................15
µg HA**
- A/Hong Kong/2671/2019 (H3N2) - like virus (A/Hong Kong/2671/2019,
IVR-208) ................15 µg HA**
- B/Washington/02/2019 - like virus (B/Washington/02/2019, wild
type).......................................15 µg HA**
For one 0.5 mL dose
PEDIATRIC USE
- A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09 - like virus
(A/Guangdong-Maonan/SWL1536/2019,
CNIC-1909)......................................................................7.5
µg HA**
- A/Hong Kong/2671/2019 (H3N2) - like virus (A/Hong Kong/2671/2019,
IVR-208).................7.5 µg HA**
- B/Washington/02/2019 - like virus (B/Washington/02/2019, wild
type).......................................7.5 µg HA**
For one 0.25 mL dose
*propagated in eggs
** haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere)
for the 2020-2021 season.
VAXIGRIP may contain traces of eggs, such as ovalbumin, and of
neomycin, formaldehyde and octoxinol-9,
which are used during the manufacturing process.
2. PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
The vaccine, after shaking gently, is a slightly whitish and
opalescent liquid.
3. CLINICAL PARTICULARS
3.1. THERAPEUTIC INDICATIONS
VAXIGRIP is a suspension for injection in prefilled syringe of 0.5 mL
in box of 1 or vial 5 mL VAXIGRIP,
pediatric use, is a suspension for injection in a prefilled syringe of
0.25 mL in box of 1. This vaccine is
recommended for the prevention of influenza, in adults and in children
aged from 6 to 35 months
(pediatric use), particularly in subjects showing a high risk of
associated complications.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY