Influvac Suspension for Injection

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

INACTIVATED INFLUENZA VACCINE TYPE A (A/NEW CALEDONIA/20/99 IVR-116 (H1N1); INACTIVATED INFLUENZA VACCINE TYPE B (B/SHANGHAI/361/2002-LIKE (B/JIANGSU/10/2003); INACTIVATED INFLUENZA VACCINE TYPE A (A/FUJIAN/411/2002(H3N2)-LIKE (A/WYOMING/3/2003 X-147 REASS)

Prieinama:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Tarptautinis Pavadinimas):

INACTIVATED INFLUENZA VACCINE TYPE A (A/NEW CALEDONIA/20/99 IVR-116 (H1N1); INACTIVATED INFLUENZA VACCINE TYPE B (B/SHANGHAI/361/2002-LIKE (B/JIANGSU/10/2003); INACTIVATED INFLUENZA VACCINE TYPE A (A/FUJIAN/411/2002(H3N2)-LIKE (A/WYOMING/3/2003 X-147 REASS)

Vienetai pakuotėje:

1Units Units; 10Units Units

Pagaminta:

Abbott Biologicals B.V.

Prekės savybės

_ 2021/2022_
1.QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the following
strains*:
-
A/Victoria/2570/2019 (H1N1)pdm09-like strain
15 micrograms HA**
(A/Victoria/2570/2019, IVR-215)
-
A/Cambodia/e0826360/2020 (H3N2)-like strain
15 micrograms HA**
-
(A/Cambodia/e0826360/2020, IVR-224)
-
B/Washington/02/2019-like strain
15 micrograms HA**
(B/Washington/02/2019, wild type)
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 2021/2022 season.
For a full list of
excipients see section 5.1.
Influvac
®
2021/2022
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. THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Influvac
®
2021/2022 is indicated in adults and children from 6 months of age.
The use of Influvac
®
2021/2022
should
be
based
on
official
recommendations.
Vaccination
is
particularly
recommended for the following categories of patients, depending on
national immunization
policies:
-
Persons aged ≥ 65 years, regardless their health condition.
-
Adults and children with chronic disorders of the pulmonary or
cardiovascular systems,
including asthma.
-
Adults and children with chronic metabolic diseases such as diabetes
mellitus.
-
Adults and children with chronic renal dysfunction.
-
Adults
and
children
with
immunodeficiencies
due
to
disease
or
immunosuppressant
medication (e.g., cytostatics or corticosteroids) or radiotherapy.
-
Children and teenagers (6 months �