Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
A/SINGAPORE686 - LIKE STRAIN (H1N1) A/WUHAN /359/95 (H3N2)-LIKE STRAIN B/BEIJING /184/93-LIKE STRAIN
Chiron Vaccines Limited
Suspension for Injection
1998-08-14
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluvirin, Suspension for injection in pre-filled syringe. [Influenza Vaccine (Surface antigen, Inactivated) Ph. Eur.] 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase) propagated in embryonated chicken eggs, inactivated by betapropiolactone, split by nonoxynol 9 and purified, of strains: This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the year 2004/2005. For excipients see 6.1. 3 PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza, especially in those who run an increased risk of associated complications. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children from 4 years: 0.5 ml. 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. A/New Caledonia/20/99 (H1N1) - like strain (A/New Caledonia/20/99 (IVR-116)) Ph. Eur. 15 micrograms** Haemagglutinin A/Fujian/411/2002(H3N2) – like strain (A/Wyoming/3/2003 X-147) 15 micrograms** Haemagglutinin B/Shanghai/361/2002 - like strain (B/Jiangsu/10/2003) 15 micrograms** Haemagglutinin per 0.5 ml dose. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2007_ _CRN 2035477_ _page number: 1_ 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances, to any of the excipients and to eggs, chicken proteins, betapropiolactone, nonoxynol 9, neomycin, polymyxin, formaldehyde, or thiomersal. Immunisation shall be postponed in patients with febrile illness or acu Διαβάστε το πλήρες έγγραφο