Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
A/CALIFORNIA/07/2009 (H1N1), A/VICTORIA/361/2011 (A/H3N2), B/HUBEI-WUJIAGANG/158/2009 (B)
Nanotherapeutics Bohumil S.R.O
J07BB02
A/CALIFORNIA/07/2009 (H1N1), A/VICTORIA/361/2011 (A/H3N2), B/HUBEI-WUJIAGANG/158/2009 (B)
Unknown
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Influenza vaccines
Withdrawn
2017-03-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Preflucel suspension for injection in a pre-filled syringe Influenza Vaccine (split virion, inactivated, prepared in cell cultures) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus (inactivated, split) of the following strains*: * propagated in Vero cells (continuous cell line of mammalian origin) ** haemagglutinin This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2012/2013 season. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection in a pre-filled syringe. PREFLUCEL is a clear to opalescent suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in adults and elderly. The use of PREFLUCEL should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults (18 years of age and older) and elderly (older than 60 years of age): 0.5 ml _Paediatric population_ The safety and efficacy in subjects below 18 years of age have not been evaluated (see section 5.1). Method of administration Immunization should be carried out by intramuscular injection (into the deltoid muscle). For instructions of the vaccine before administration, see section 6.6. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.) or residues (e.g. formaldehyde, benzonase or sucrose). It is recommended to postpone the immunization in patients with moderate or severe acute illness with or without fever. A/California/07/2009 (H1N1) 15 micrograms HA** A/Victoria/361/2011 (A/H3N2) 15 micrograms HA** B/Hubei-Wujiagang/158/2009 (B) 15 micrograms HA** per 0.5 ml dose HEALTH PRODUCTS REGULATORY AUTHORITY ___________________________________________________________ Read the complete document