INFLUVAC suspension for injection 0.5ml

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

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)

Fáanlegur frá:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC númer:

J07BB02

Skammtar:

15mcg haemagglutinin/0.5ml

Lyfjaform:

INJECTION, SUSPENSION

Samsetning:

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

Stjórnsýsluleið:

SUBCUTANEOUS, INTRAMUSCULAR

Gerð lyfseðils:

Prescription Only

Framleitt af:

Abbott Biologicals B.V.

Leyfisstaða:

ACTIVE

Leyfisdagur:

2006-01-17

Vara einkenni

PAGE 1 OF 1
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PHARMACODE:
ORIGINATING FROM LCR / MKPR Number:
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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 0 .5 ml Suspension for injection
Singapore Influvac
MKPR-03716-2023-HA-DCP
MKP-06401-2023
LCS 120 43045 120x575mm fold 120x23mm
N.A.
Leaflet
LTS 1-0-7
PROCESS BLACK
X
09/01/2024
V. Peric
Helvetica Neue / 9 pt
MKP-06401-2023_d1
PROCESS BLACK
MKP-06401-2023
MKP-06401-2023
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/Thailand/8/2022 (H3N2)-like strain
(A/Thailand/8/2022, IVR-237)
15 micrograms HA**
-
B/Austria/1359417/2021-like strain
(B/Austria/1359417/2021, BVR-26)
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 (southern hemisphere) and competent authority decision
for
the 2024 season.
For a full list of excipients see section 5.1.
Influvac
®
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 prefilled syringe; a colourless clear
liquid, filled in
single-dose syringes.
3.
CLINICAL PARTICULARS
3.1 Therapeuti