Vaxigrip Tetra Suspension for Injection in Pre-filled Syringe

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

INACTIVATED,INFLUENZA VIRUS TYPE A (H3N2); INACTIVATED,INFLUENZA VIRUS TYPE A (H1N1); INACTIVATED,INFLUENZA VIRUS TYPE B (B/VICTORIA); INACTIVATED,INFLUENZA VIRUS TYPE B (B/YAMAGATA)

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

INACTIVATED,INFLUENZA VIRUS TYPE A (H3N2); INACTIVATED,INFLUENZA VIRUS TYPE A (H1N1); INACTIVATED,INFLUENZA VIRUS TYPE B (B/VICTORIA); INACTIVATED,INFLUENZA VIRUS TYPE B (B/YAMAGATA)

Units in package:

1 Pre-Filled Syringes; 10 Pre-Filled Syringes; 20 Pre-Filled Syringes

Manufactured by:

SANOFI PASTEUR

Patient Information leaflet

Not Applicable

Summary of Product characteristics

Internal
NH2023/2024
MY/VAX/0523/NH2023/2024
1.
NAME OF THE MEDICINAL PRODUCT
VAXIGRIPTETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION,INACTIVATED)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022,
IVR-238)…15 micrograms HA**
A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/9/2021,
IVR-228)……………… 15 micrograms HA**
B/Austria/1359417/2021 - like strain(B/Michigan/01/2021, wild type)
...................
15 micrograms HA**
B/Phuket/3073/2013
- like strain (B/Phuket/3073/2013, wild type)
.............................. 15
micrograms HA**
For one 0.5 mLdose
*
propagated
in
fertilised
hens’
eggs
from
healthy
chicken flocks
**
haemagglutinin
This vaccine complies with the WHO recommendations (Northern
Hemisphere) for the 2023/2024
season. For the full list of excipients, see section 6.1.
VaxigripTetra may contain traces of eggs, such as ovalbumin, and of
neomycin, formaldehyde and
octoxinol-9, which are used during the manufacturing process (see
section 4.3).
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine, after shaking gently, is a colourless opalescent liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
VaxigripTetra 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 infants less than 6 months of age and born to
women vaccinated during
pregnancy (see Sections 4.4, 4.6 and 5.1).
The use of VaxigripTetra should be based on official recommendations.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Based on clinical experience with the trivalent vaccine, annual
revaccination with influenza vaccine is
recommended given the duration of immunity provided by the vacc