Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)
Seqirus S.r.l.
J07BB02
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Vaccines
Influenza, Human; Immunization; Disease Outbreaks
Active immunisation against H5N1 subtype of influenza-A virus.This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/05 (H5N1)-like strain.Aflunov should be used in accordance with official recommendations.
Revision: 15
Authorised
2010-11-28
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE USER AFLUNOV SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Zoonotic 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 AFLUNOV is and what it is used for 2. What you need to know before you receive AFLUNOV 3. How AFLUNOV is given 4. Possible side effects 5. How to store AFLUNOV 6. Contents of the pack and other information 1. WHAT AFLUNOV IS AND WHAT IT IS USED FOR AFLUNOV is a vaccine for use in adults from 18 onwards, intended to be given in the context of outbreaks of zoonotic influenza viruses (coming from birds) with pandemic potential to prevent flu caused by H5N1 viruses similar to the vaccine strain reported in section 6. Zoonotic influenza viruses occasionally infect humans, and can cause disease ranging from mild upper respiratory infection (fever and cough) to rapid progression to severe pneumonia, acute respiratory distress syndrome, shock and even death. Human infections are primarily caused by contact with infected animals, but do not spread easily between people. AFLUNOV is intended also to be given when there is anticipation of a possible pandemic due to the same or a similar strain. When a person is given the vaccine, 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. As with all vaccines, AFLUNOV may not fully protect all persons who are vaccinated. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE AFLUNOV YOU SHOULD NOT RECEIVE AFLUNOV: • if you have previously had a sudden life-threatening aller Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AFLUNOV suspension for injection in pre-filled syringe. Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** expressed in microgram haemagglutinin. Adjuvant MF59C.1 containing: squalene 9.75 milligrams per 0.5 ml polysorbate 80 1.175 milligrams per 0.5 ml sorbitan trioleate 1.175 milligrams per 0.5 ml sodium citrate 0.66 milligrams per 0.5 ml citric acid 0.04 milligrams per 0.5 ml Excipient with known effect: The vaccine contains 1.899 milligrams of sodium and 0.081 milligrams of potassium per 0.5 ml dose. AFLUNOV may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin, 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 Active immunisation against H5N1 subtype of Influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/2005 (H5N1)-like strain (see sections 4.4 and 5.1). AFLUNOV should be used in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and elderly (18 years of age and above): One dose of 0.5 ml at an elected date. A second dose of 0.5 ml should be given after an interval of at least 3 weeks. 3 AFLUNOV has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) followin Pročitajte cijeli dokument