BEGRIVAC Suspension for Injection 15/15/15mc %v/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-03-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
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:
Novartis Vaccines and Diagnostics GmbH
Dosage:
15/15/15mc %v/v
Pharmaceutical form:
Suspension for Injection
Authorization date:
1998-04-03
Summary of Product characteristics
License
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 in pre-filled syringe.
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:
Read the complete document
