Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
A/CALIFORNIA/07/2009 (H1N1)V A/BRISBANE/59/2007 (H1N1) - LIKE STRAIN (A/BRISBANE/59/2007, IVR-148) PH.EUR B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)
Abbott Healthcare Products Ltd
15,15,15 Microgram
Suspension for Injection
1998-05-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Influvac Sub-unit 2011/2012, suspension for injection (influenza vaccine, surface antigen, inactivated). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*: * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin. This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2011/2012 season. For a full list of excipients see section 6.1. 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 in those who run an increased risk of associated complications. The use of Influvac Sub-unit 2011/2012 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. For instructions for preparation, see _section 6.6, Special precautions for disposal of a used medicinal product or waste_ _derived from such medicinal product and other handling of the product._ 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances, to any of the excipients and to residues of eggs, chicken proteins (such as ovalbumin), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin. -A/California/7/2009 (H1N1): derived s Прочетете целия документ