BEGRIVAC 15/15/15mc %v/v Suspension for Injection

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

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

Beschikbaar vanaf:

Novartis Vaccines and Diagnostics GmbH

INN (Algemene Internationale Benaming):

A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 R

Dosering:

15/15/15mc %v/v

farmaceutische vorm:

Suspension for Injection

Prescription-type:

Product subject to prescription which may not be renewed (A)

Autorisatie-status:

Withdrawn

Autorisatie datum:

0000-00-00

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Begrivac 2010/2011 suspension for injection
Influenza vaccine (split virion, inactivated)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*
A/California/7/2009 (H1N1) – derived strain used
NYMC X-181
15.0 micrograms HA **
A/Perth/16/2009 (H3N2) – like strain used
15.0 micrograms HA **
NYMC X-187 – derived from A/Victoria/210/2009
B/Brisbane/60/2008 – derived strain used
15.0 micrograms HA **
NYMC BX-35
per 0.5 ml dose
*propagated in fertilized hen eggs from healthy chicken flocks, purified, split by tween-ether, inactivated by
formaldehyde
**haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2010/2011
season.
_For a full list of excipients see section 6.1._
3 PHARMACEUTICAL FORM
Suspension for injection
Slightly opalescent.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
The use of Begrivac 2010/2011 should be based on official recommendations.
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. Dosages of 0.25 ml or 0.5 ml have been used.
For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4
weeks.
Immunisation should be carried out by intramuscular or deep subcutaneous injection.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/11/2010_
_CRN 2091815_
_page number: 1_
_For instructions for preparation, see section 6.6._
4.3 CONTRAINDICATIONS
Hypersensitivity to t