Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)
Seqirus S.r.l.
J07BB02
pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Influenza vaccines
Influenza, Human; Immunization; Disease Outbreaks
Prophylaxis of influenza in an officially declared pandemic situation.Pandemic influenza vaccine should be used in accordance with official guidance.
Revision: 13
Authorised
2009-10-18
71 B. PACKAGE LEAFLET 72 PACKAGE LEAFLET: INFORMATION FOR THE USER FOCLIVIA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Pandemic Influenza Vaccine (H5N1) (surface antigen, inactivated, adjuvanted) 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Foclivia is and what it is used for 2. What you need to know before you receive Foclivia 3. How Foclivia is given 4. Possible side effects 5. How to store Foclivia 6. Contents of the pack and other information 1. WHAT FOCLIVIA IS AND WHAT IT IS USED FOR Foclivia is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic. Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious. It is for use in to prevent flu caused by the H5N1 type of the virus. When a person is given the vaccine, the body’s natural defence system (immune system) produces its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. As with all vaccines, Foclivia may not fully protect all persons who are vaccinated. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FOCLIVIA FOCLIVIA SHOULD NOT BE GIVEN IF YOU: - have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia, - are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia, - are allergic to eggs, chicken protein, ovalbumin, - are allergic to kanamycin sulphate and neomycin sulphate (antibiotics), formaldehyde, hydrocortisone, cetyltrimethylammonium bromide ( Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Foclivia suspension for injection in pre-filled syringe Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** expressed in micrograms haemagglutinin. Adjuvant MF59C.1 containing: Squalene 9.75 milligrams Polysorbate 80 1.175 milligrams Sorbitan trioleate 1.175 milligrams Sodium citrate 0.66 milligrams Citric acid 0.04 milligrams This vaccine complies with the WHO recommendations and EU decision for the pandemic. Foclivia may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin sulphate, neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Milky-white liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in an officially declared pandemic situation. Foclivia should be used in accordance with Official Guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Individuals 6 months of age and older: administer two doses (0.5 ml each), 21 days apart. Data on a third dose (booster) administered 6 months after the first dose are limited (see sections 4.8 and 5.1). Paediatric population 3 No data are available in children aged less than 6 months. Method of administration The vaccine is administered by intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older individuals. 4.3 CONTRAINDICATIONS History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (eggs, chicken protein Przeczytaj cały dokument