Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
A/CALIFORNIA/07/2009 (H1N1) A/PERTH/16/2009 (H3N2) LIKE STRAIN (A/VICTORIA/210/2009) B/BRISBANE/60/2008 (B)
Baxter Healthcare Limited
A/CALIFORNIA/07/2009 (H1N1) A/PERTH/16/2009 (H3N2) LIKE STRAIN (A/VICTORIA/210/2009) B/BRISBANE/60/2008 (B)
Milligram
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PREFLUCEL SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE 2012/2013 SEASON Influenza Vaccine (split virion, inactivated, prepared in cell cultures) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any of the side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What PREFLUCEL is and what it is used for 2. What you need to know before you receive PREFLUCEL 3. How PREFLUCEL is given 4. Possible side effects 5. How to store PREFLUCEL 6. Contents of the pack and other information 1. WHAT PREFLUCEL IS AND WHAT IT IS USED FOR PREFLUCEL is a vaccine. This vaccine helps to protect adults and elderly against influenza (flu). The use of PREFLUCEL should be based on official recommendations. When a person is given the vaccine PREFLUCEL, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against disease. None of the ingredients in the vaccine can cause flu. Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Therefore, this is why you might need to be vaccinated every year. The greatest risk of catching flu is during the cold months between October and March. If you were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you run the risk of catching flu until then. Your doctor will be able to recommend the best ti Olvassa el a teljes dokumentumot
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 a 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. 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 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/04/2014_ _CRN 2139479_ _page number: 1_ 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 th Olvassa el a teljes dokumentumot