Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.
Sanofi Pasteur S.A.
J07BB02
pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
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.
Withdrawn
2010-06-08
Medicinal product no longer authorised 31 B. PACKAGE LEAFLET Medicinal product no longer authorised 32 PACKAGE LEAFLET: INFORMATION FOR THE USER HUMENZA SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) FOR THE MOST UP-TO-DATE INFORMATION PLEASE CONSULT THE WEBSITE OF THE EUROPEAN MEDICINES AGENCY : HTTP://WWW.EMA.EUROPA.EU/. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 HUMENZA is and what it is used for 2. Before you receive HUMENZA 3. How HUMENZA is given 4. Possible side effects 5. How to store HUMENZA 6. Further information 1. WHAT HUMENZA IS AND WHAT IT IS USED FOR HUMENZA is a vaccine to prevent pandemic influenza (flu). Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world. The symptoms (signs) 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 defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. 2. BEFORE YOU RECEIVE HUMENZA YOU SHOULD NOT RECEIVE HUMENZA: - if you have previously had a sudden life-threatening allergic reaction to any ingredient of HUMENZA (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately ava Прочетете целия документ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT HUMENZA suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION HUMENZA consists of two vials: one vial containing the antigen (suspension) and one vial containing the adjuvant (emulsion), which are mixed prior to administration. After mixing, 1 dose (0.5ml) contains: Split influenza virus*, inactivated containing antigen equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A).......................................3.8 micrograms** * propagated in eggs ** expressed in microgram haemagglutinin This vaccine complies with the WHO recommendation and EU decision for the pandemic. AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams) The suspension and emulsion, once mixed, form a multidose vaccine in a vial. See section 6.5 for the number of doses per vial. Excipients: The vaccine contains 11.3 micrograms thiomersal. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension and emulsion for emulsion for injection. The antigen is a colourless limpid to opalescent suspension. The adjuvant is a white opaque emulsion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1). Pandemic influenza vaccine should be used in accordance with Official Guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology In the different age groups, there are limited data (adults aged 18 to 60 years), very limited data (adults aged 61 years and over, children aged 6 months to 17 years) or no data (children aged less than 6 months) with HUMENZA as detailed in sections 4.4, 4.8 and 5.1. Medicinal product no longer authorised 3 Children fr Прочетете целия документ