מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181
Novartis Vaccines and Diagnostics S.r.l.
J07BB02
influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Influenza vaccines
Influenza, Human; Immunization; Disease Outbreaks
Prophylaxis of influenza caused by A (H1N1v) 2009 virus.Focetria should be used in accordance with official guidance.
Revision: 9
Withdrawn
2007-05-02
35 B. PACKAGE LEAFLET Medicinal product no longer authorised 36 PACKAGE LEAFLET: INFORMATION FOR THE USER FOCETRIA SUSPENSION FOR INJECTION Influenza vaccine H1N1v (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 any of the side effects gets serious, talk to your doctor. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET : 1. What Focetria is and what it is used for 2. What you need to know before you receive Focetria 3. How Focetria is given 4. Possible side effects 5. How to store Focetria 6. Contents of the pack and other information 1. WHAT FOCETRIA IS AND WHAT IT IS USED FOR Focetria is a vaccine to prevent influenza (flu) caused by A(H1N1v) 2009 virus. 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 ingredient in the vaccine can cause flu. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FOCETRIA DO NOT RECEIVE FOCETRIA: if you have previously had a sudden life-threatening allergic reaction to any ingredient of Focetria (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE RECEIVING FOCETRIA TAKE SPECIAL CARE WITH FOCETRIA: if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal (only for the multidose vial presentation), to egg and, chicken protein קרא את המסמך השלם
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Focetria suspension for injection in pre-filled syringe Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin. Adjuvant MF59C.1 containing: squalene 9.75 milligrams polysorbate 80 1.175 milligrams sorbitan trioleate 1.175 milligrams 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 caused by A (H1N1v) 2009 virus (see section 4.4). Focetria should be used in accordance with Official Guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects. Posology Adults (18-60 years): One dose of 0.5 ml at an elected date. Immunogenicity data obtained at three weeks after one dose of Focetria H1N1v suggest that a single dose may be sufficient. If a second dose is administered there should be an interval of at least three weeks between the first and second dose. Elderly (>60 years): One dose of 0.5 ml at an elected date. A second dose of vaccine should be given after an interval of at least three weeks. _Paediatric population _ Medicinal product no longer authorised 3 Children and adolescents aged 3-17 years: One dose of 0.5 ml at an elected date. Immunogenicity data obtained at three weeks after one dose of Focetria H1N1v suggest that a single dose may be sufficient. If a second dose is administered there should be an interval of at least three weeks between the first and second dose. Children aged 6 months to 35 months : One dose of 0.5 ml at a קרא את המסמך השלם