Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A
GlaxoSmithKline Biologicals S.A.
J07BB02
influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Influenza vaccines
Influenza, Human; Immunization; Disease Outbreaks
Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).Pandemrix should be used in accordance with Official Guidance.
Revision: 23
Withdrawn
2008-05-20
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER PANDEMRIX SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. - This vaccine has been prescribed for you only. Do not pass it on to others. - If you get any of side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Pandemrix is and what it is used for 2. What you need to know before you receive Pandemrix 3. How Pandemrix is given 4. Possible side effects 5. How to store Pandemrix 6. Contents of the pack and other information 1. WHAT PANDEMRIX IS AND WHAT IT IS USED FOR WHAT PANDEMRIX IS AND WHAT IT IS USED FOR Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus. Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix). HOW PANDEMRIX WORKS 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. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE PANDEMRIX PANDEMRIX SHOULD NOT BE GIVEN: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Pandemrix suspension and emulsion for emulsion for injection. Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains: Split influenza virus, inactivated, containing antigen * equivalent to: _ _ A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms ** * propagated in eggs ** haemagglutinin AS03 adjuvant composed of squalene (10.69 milligrams), DL- α -tocopherol (11.86 milligrams) and polysorbate 80 (4.86 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. Excipient with known effect The vaccine contains 5 micrograms thiomersal For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension and emulsion for emulsion for injection. The suspension is a colourless light opalescent liquid. The emulsion is a whitish to yellowish homogeneous milky liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8). Pandemrix should be used in accordance with Official Guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 3 The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects See sections 4.4, 4.8 and 5.1 for details. No data are available in children aged less than 6 months. _Adults aged 18 years and older: _ One dose of 0.5 ml at an elected dat Lestu allt skjalið