Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181) A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A) B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B)
Abbott Healthcare Products Ltd
A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181) A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X
15,15,15 Microgram
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Influvac Sub-unit, suspension for injection (influenza vaccine, surface antigen, inactivated). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*: - A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, X-181) 15 micrograms HA ** - A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012, X-223A) 15 micrograms HA ** - B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, BX-51B) 15 micrograms HA ** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin. This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2014/2015 season. For a full list of excipients see section 6.1. Influvac may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin, which are used during the manufacturing process (see section 4.3). 3 PHARMACEUTICAL FORM Suspension for injection in prefilled syringes; a colourless clear liquid, filled in single-dose syringes (glass, type I). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza, especially those who run an increased risk of associated complications. Influvac is indicated in adults and children from 6 months of age. The use of Influvac should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults: 0.5 ml. _Paediatric population_ Children from 36 months onwards: 0.5 ml. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 31/07/2014_ _CRN 2148606_ _page number: 1_ C Baca dokumen lengkap