INFLEXAL V

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)

Available from:

Crucell Italy S.r.l.

Dosage:

15 Microgram

Pharmaceutical form:

Suspension for Injection

Authorization date:

2006-08-18

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
INFLEXAL V
Suspension for injection
Influenza vaccine (surface antigen, inactivated, virosome)
2011/2012 season
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase), virosome, of the following strains*:
A/California/7/2009 (H1N1) derived strain used NYMC X-181
15 micrograms HA**
A/Perth/16/2009 (H3N2)-like strain used NYMC X-187 derived from A/Victoria/210/2009
15 micrograms HA**
B/Brisbane/60/2008
15 micrograms HA**
per 0.5 ml dose
* propagated in fertilised hen’s eggs from healthy chicken flocks
** haemagglutinin
Inflexal V is an inactivated influenza vaccine formulated with virosomes as carrier/adjuvant system, composed of
highly purified surface antigens of strain A and B of the influenza virus propagated in fertilized hen’s eggs.
This vaccine complies with the WHO recommendation (Northern hemisphere) and EU decision for the 2011/2012
season.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
Slightly opalescent liquid supplied in a pre-filled syringe.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
The use of Inflexal V should be based on official recommendations.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/09/2011_
_CRN 2102720_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children from 36 months: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited. Dosaged of 0.25 or 0.5 ml have been used.
For children, who have not previously been vaccinated, a second dose should be given after a