국가: 아일랜드
언어: 영어
출처: 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 - LIKE STRAIN (B/BRISBANE/60/2008)
Novartis Vaccines and Diagnostics S.r.l.
Suspension for Injection
1999-02-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AGRIPPAL Suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated) (2011/2012 SEASON) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase), of the following strains*: A/California/07/2009 (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 fertilized hens’ eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the 2011/2012season. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. The vaccine appears as a clear liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza, especially in those who run an increased risk of associated complications. The use of AGRIPPAL 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 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/03/2012_ _CRN 2106327_ _page number: 1_ weeks. Immunisation should be carried out by intramuscular or deep subcutaneous injection. For instructions for preparation, see section 6.6. 4.3 CONTRAINDICATIONS Hypersensitivity to the active s 전체 문서 읽기