Influvac (season 2015/2016)

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

influenza vaccine inactivated (surface antigen): A/California/7/2009/H1N1/pdm09 - like strain A/California/7/2009/NYMC X-181, A/Switzerland/9715293/2013/H3N2 - like strain A/Switzerland/9715293/2013, NIB-88, B/Phuket/3073/2013

Available from:

ABBOTT Biologicals B.V. Veerweg 12

INN (International Name):

influenza vaccine inactivated (surface antigen): A/California/7/2009/H1N1/pdm09 - like strain A/California/7/2009/NYMC X-181, A/

Dosage:

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

Pharmaceutical form:

suspension for i/m and s/c injection

Prescription type:

Prescription

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTIC
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INFLUVAC 2015/2016
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza
virus
surface
antigens
(haemagglutinin
and
neuraminidase)
of
the
following
strains*:
- A/California/7/2009 (H1N1)pdm09-like strain
(A/California/7/2009, X-181)
15
micrograms
HA
**
- A/Switzerland/9715293/2013 (H3N2)-like strain
(A/Switzerland/9715293/2013, NIB-88)
15
micrograms
HA
**
- B/Phuket/3073/2013
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
2015/2016 season.
For a full list of excipients see section 5.1.
Influvac 2015/2016 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 syringes; a colourless clear
liquid, filled in single-dose
syringes (glass, Type I).
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
Prophylaxis
of
influenza;
especially
those
who
run
an
increased
risk
of
associated
complications.
Influvac 2015/2016 is indicated in adults and children from 6 months
of age.
The use of Influvac 2015/2016 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.
SUMMARY OF PRODUCT CHARACTERISTIC
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C