Influvac suspension for injection

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

influenza vaccine inactivated (surface antigen)-A/Brisbane/02/2018 (H1N1) pdm-like strain (A/Brisbane/02/2018, IVR-190), A/Kansas/14/2017 (H3N2)-like strain (A/ A/Kansas/14/2017, NYMC X-327), B/Colorado/06/2017-like strain (B/ Victoria/2/87/ lineage) (B/Maryland/15/2016, NYMC BX-69 A)

Beschikbaar vanaf:

ABBOTT Biologicals B.V. Veerweg 12

ATC-code:

J07BB02

INN (Algemene Internationale Benaming):

influenza vaccine inactivated (surface antigen)-A/Brisbane/02/2018 (H1N1) pdm-like strain (A/Brisbane/02/2018, IVR-190), A/Kansas/14/2017 (H3N2)-like strain (A/ A/Kansas/14/2017, NYMC X-327), B/Colorado/06/2017-like strain (B/ Victoria/2/87/ lineage) (B/Maryland/15/2016, NYMC BX-69 A)

Dosering:

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

farmaceutische vorm:

suspension for injection

Eenheden in pakket:

(1) pre-filled syringe 0,5ml

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2019-10-11

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTIC
1/5
1.
NAME OF THE MEDICAL PRODUCT
Influvac
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase) of
the following
strains*:
-
A/Brisbane/02/2018 (H1N1)pdm09-like strain
(A/Brisbane/02/2018,
IVR-190)………………………………,,,,,,,,,,,…...15
micrograms HA**
-
A/Kansas/14/2017 (H3N2)-like strain
(A/Kansas/14/2017, NYMC
X-327)……………………,,,,,,,,,,,,,,,,,,,,……15 micrograms
HA**
-
B/Colorado/06/2017-like strain
(B/Maryland/15/2016, NYMC
BX-69A)………………………………….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 2019/2020 season.
For a full list of excipients see section 5.1.
Influvac
2019/2020
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).
3.
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringes; a colourless 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
medication