INFLUVAC TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Influenza Virus (SH) A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022, IVR-237); Influenza Virus (SH) A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238); Influenza Virus (SH) B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26); Influenza Virus (SH) B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type)

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC code:

J07BB02

Pharmaceutical form:

INJECTION, SUSPENSION

Composition:

Influenza Virus (SH) A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022, IVR-237) 15 micrograms HA/0.5ml; Influenza Virus (SH) A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) 15 micrograms HA/0.5ml; Influenza Virus (SH) B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) 15 micrograms HA/0.5ml; Influenza Virus (SH) B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) 15 micrograms HA/0.5ml

Administration route:

SUBCUTANEOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Abbott Biologicals B.V.

Authorization status:

ACTIVE

Authorization date:

2018-12-04

Patient Information leaflet

PAGE 1 OF 1
MASCHERINA
INVOLVED PLANT:
Olst Influvac
Influvac Tetra 0.5ml Suspension for Injection
1125666
LCS 120 43042 120x460mm fold 120x23mm
168
LTS 1-0-7
Leaflet
Singapore Influvac
LCR-15070-2020-DEV
PRODUCT NAME:
CUTTING GUIDES / SIZE:
AFFILIATE ORIGINATOR:
COMMODITY CODE:
COLORS:
FONT STYLE / MINIMUM FONT SIZE FOR TEXT:
NOTES:
PHARMACODE:
ORIGINATING FROM LCR / MKPR Number:
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Packaging & Label
Management
COMMODITY TYPE:
Abbott - Established Pharmaceuticals Division
Version Number: 2.0
Effective date: 15-MAR-2017
Approved date:
QMRec122373/2 SOLID 0001299978
EPLD.14.02.F03
Helvetica Neue / 8 pt
( I X I X I I X )
PROCESS BLACK
16/04/2020
M. Blaz
24/04/2020
M. Blaz
29/04/2020
M. Blaz
X
X
X
1125666_d3
PROCESS BLACK
1125666
1.
NAME OF THE MEDICINAL PRODUCT
Influvac Tetra, suspension for injection in pre-filled syringe 0.5 ml
(influenza vaccine, surface antigen, inactivated).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the
following strains*:
-
A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like strain
(A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)
15 micrograms HA **
-
A/Hong Kong/2671/2019 (H3N2)-like strain
(A/Hong Kong/2671/2019, IVR-208)
15 micrograms HA **
-
B/Washington/02/2019-like strain
(B/Washington/02/2019, wild type)
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 2020/2021 season.
For a full list of excipients see section 6.1.
Influvac Tetra may contain traces of eggs (such as ovalbumin, chicken
proteins),
formaldehyde, cetyltrimet