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

Available from:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Name):

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

Units in package:

10 Pre-Filled Syringes; 1 Pre-Filled Syringes

Manufactured by:

Abbott Biologicals B.V

Patient Information leaflet

Not applicable

Summary of Product characteristics

PAGE 1 OF 1
MASCHERINA
INVOLVED PLANT:
PRODUCT NAME:
CUTTING GUIDES / SIZE:
AFFILIATE ORIGINATOR:
COMMODITY CODE:
COLORS:
FONT STYLE / MINIMUM FONT SIZE FOR TEXT:
NOTES:
PHARMACODE:
ORIGINATING FROM LCR / MKPR Number:
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Packaging & Label
Management
COMMODITY TYPE:
Abbott - Established Pharmaceuticals Division
Version Number: 1.0
Effective date: 05-SEP-2021
Approved date: 22-JUL-2021
QMForm051768/1
PLM.14.01.F01
Olst Influvac
Influvac Tetra 0.5 ml Suspension for injection
Malaysia Influvac
LCR-19196-2023-DEV
1134744
LCS 120 43045 120x575mm fold to 120x23mm
91
Leaflet
LTS 1-0-7
PROCESS BLACK
( I X X X I I )
Helvetica Neue / 7 pt
X
18/04/2023
V. Peric
1134744_d1
PROCESS BLACK
1134744
1134744
FRONT
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) 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, SAN-010)
15 micrograms HA **
-
B/Austria/1359417/2021-like strain
(B/Austria/1359417/2021, BVR-26)
15 micrograms HA **
-
B/Phuket/3073/2013-like strain
(B/Phuket/3073/2013, wild type)
15 micrograms HA **
per 0.5 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin.
This vaccine complies with the World Health Organisation (WHO)
recommendation (Northern
hemisphere) and EU recommendation for the 2023/2024 season.
For a full list of excipients see section 5.1.
Influvac
®
Tetra 2023/2024 may contain traces of eggs (such as ovalbumin, chicken
proteins),
formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or
gentamicin, which are used
during the manufacturing process (see section 3.3).
2.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
A colourless clear