Influvac suspension for injection

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like strain (A/Guangdong-Maonan/SWL1536/2019, CNIC-1909), A/HongKong/2671/2019 (H3N2)-like strain (A/HongKong/2671/2019, IVR-208), B/Washington/02/2019-like strain (B/Washington/02/2019, wild type)

Tilgjengelig fra:

ABBOTT Biologicals B.V. Veerweg 12

ATC-kode:

J07BB02

INN (International Name):

A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like strain (A/Guangdong-Maonan/SWL1536/2019, CNIC-1909), A/HongKong/2671/2019 (H3N2)-like strain (A/HongKong/2671/2019, IVR-208), B/Washington/02/2019-like strain (B/Washington/02/2019, wild type)

Dosering :

15mcg haemagglutinin/dose+ 15mcg haemagglutinin/dose+ 15mcg haemagglutinin/dose

Legemiddelform:

suspension for injection

Enheter i pakken:

(1) pre-filled syringe 0,5ml

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2021-02-25

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTIC
1.
NAME OF THE MEDICAL PRODUCT
Influvac
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (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**
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 2020/2021 season.
For a full list of excipients see section 5.1.
Influvac
2020/2021
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 4.3).
3.
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringes; a colorless clear
liquid, filled in single-dose
syringes (glass, Type I).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza is indicated in adults and children from 6
months of age; especially
those who run an increased risk of associated complications.
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
me