Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1)
Novartis Vaccines and Diagnostics S.r.l.
J07BB02
prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Vaccines
Influenza, Human
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/Vietnam/1194/2004 (H5N1)-like strain.; Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic should be used in accordance with official recommendations.
Withdrawn
2010-11-29
24 B. PACKAGE LEAFLET Medicinal product no longer authorised 25 PACKAGE LEAFLET: INFORMATION FOR THE USER PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVE THIS VACCINE. - 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, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is and what it is used for 2. Before you receive Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 3. How Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is given 4. Possible side effects 5. How to store Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 6. Further information 1. WHAT PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS IS AND WHAT IT IS USED FOR Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults (from 18 to 60 years old). and elderly (over 60 years old). It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus. Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world. The symptoms of pandemic flu are similar to those of an ordinary flu but may be more severe. When a person is given the vaccine, the immune system (the body’s natural defense Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ _ _ _ _ Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspension for injection in pre-filled syringe. Prepandemic 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)-like strain (NIBRG-14) 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** 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 For a 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/Vietnam/1194/2004 (H5N1)-like strain (see section 5.1). Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 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. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) following a 1, 22 day primary vaccination schedule, and booster vaccination (see sections 4.8 and 5.1). There is limited experience in elderly over 70 yea Lire le document complet