Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
influenza vaccine (split virion, inactivated) 15 µg
Abbott Biologicals B.V.
J07BB02
influenza vaccine (split virion, inactivated)
suspension for injection in pre-filled syringe
Authorised
2011-02-08
_MT PL Influvac _ _ _ _ _ _ _ _ _ _NL/H/0137/001 Apr2015 _ 1/5 PACKAGE LEAFLET: INFORMATION FOR THE USER INFLUVAC, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE Influenza vaccine (surface antigen, inactivated) 2015/2016 season READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE VACCINATED. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist - This vaccine has been prescribed for you or your child. Do not pass it on to others. - If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 IN THIS LEAFLET 1 What influvac is and what it is used for 2 What you need to know before you or your child use influvac 3 How to use influvac 4 Possible side effects 5 How to store influvac 6 Contents of the pack and other information. 1. WHAT INFLUVAC IS AND WHAT IT IS USED FOR Influvac is a vaccine. This vaccine helps to protect you or your child against influenza (flu), particularly in subjects who run a high risk of associated complications. The use of Influvac should be based on official recommendations. When a person is given the vaccine Influvac, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the 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 or your child might need to be vaccinated every year. The greatest risk of catching flu is durin Citiți documentul complet
_MT SPC Influvac _ _ _ _NL/H/0137/001April 2015 _ 1/5 1.3.1 COMMON EU SPC FOR INFLUENZA VACCINE 1. NAME OF THE MEDICINAL PRODUCT Influvac, 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/Switzerland/9715293/2013 (H3N2) – like strain (A/Switzerland/9715293/2013 NIB-88) 15 micrograms HA ** - B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) 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 2015/2016 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. _ _ Citiți documentul complet