Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
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
Novartis Vaccines and Diagnostics GmbH
A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 R
15/15/15mc %v/v
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
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 Soma hati kamili