INFLUVAC NH

Country: Indonesia

Language: Indonesian

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

Active ingredient:

HAEMAGGLUTININ STRAIN A (H1N1); HAEMAGGLUTININ STRAIN A (H3N2); HAEMAGGLUTININ STRAIN B

Available from:

ABBOTT INDONESIA - Indonesia

INN (International Name):

HAEMAGGLUTININ STRAIN A (H1N1); HAEMAGGLUTININ STRAIN A (H3N2); HAEMAGGLUTININ STRAIN B

Pharmaceutical form:

CAIRAN INJEKSI

Units in package:

DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML

Manufactured by:

ABBOTT BIOLOGICALS B.V - NETHERLANDS

Authorization date:

2017-05-22

Summary of Product characteristics

INFLUVAC NH 2023/2024
INFLUENZA VACCINE
NAME OF THE MEDICINAL PRODUCT
Influvac, suspension for injection (influenza vaccine, surface
antigen, inactivated)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the following
strains*:
-A/Victoria/4897/2022 (H1N1)pdm09-like virus
(A/Victoria/4897/2022, IVR-238)
15 micrograms HA **
- A/Darwin/9/2021 (H3N2)-like virus
(A/Darwin/9/2021, SAN-10)
15 micrograms HA **
-B/Austria/1359417/2021-like virus
(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
(northern
hemisphere) and competent authority decision for the 2023/2024 season.
For a full list of excipients see section List of excipients.
Influvac
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 Contraindications).
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringes, a colourless clear
liquid, filled in single-dose syringes.
DISETUJUI OLEH BPOM: 04/10/2023
ID: EREG100346VR12300137
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in adults over 18 years of age; especially
those who run an increased risk of
associated complications.
The use of Influvac should be based on official recommendations.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml.
METHOD OF ADMINISTRATION
Method of Administration
Immunisation should be carried out by intramuscular or deep
subcutaneous injection.
Precautions to be taken before handling or administrating the
medicinal product:
For instructions for preparation of the medicinal product before
administration, see section Special
precautions for disposal and other handling.
It should be administered before the beginning of the influenza season