Country: European Union
Language: English
Source: EMA (European Medicines Agency)
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1)
Resilience Biomanufacturing Ireland Limited
J07BB01
pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
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.
Revision: 8
Withdrawn
2009-10-16
39 B. PACKAGE LEAFLET Medicinal product no longer authorised 40 PACKAGE LEAFLET: INFORMATION FOR THE USER PANDEMIC INFLUENZA VACCINE H5N1 BAXTER SUSPENSION FOR INJECTION PANDEMIC INFLUENZA VACCINE (H5N1) (WHOLE VIRION, INACTIVATED, PREPARED IN CELL CULTURE) READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU ARE VACCINATED 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 pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for 2. What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 3. How PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given 4. Possible side effects 5. How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 6. Contents of the pack and other information 1. WHAT PANDEMIC INFLUENZA VACCINE H5N1 BAXTER IS AND WHAT IT IS USED FOR PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals aged 6 months adults and older. It is used to prevent influenza (flu) in an officially declared pandemic. Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world. The symptoms (signs) of pandemic flu are similar to those of an ‘ordinary’ flu but are usually more severe. The vaccine works by helping the body to produce its own protection (antibodies) against the disease. 2. WHAT YOU NEED TO KNOW BEFORE YOUR ARE VACCINATED WITH PANDEMIC INFLUENZA VACCINE H5N1 BAXTER DO NOT USE PANDEMIC INFLUENZA VACCINE H5N1 BAXTER • if you previously had a serious allergic reaction (i.e. life-threatening) to PANDEMIC INFLUENZA VACCINE H5N1 BAXTER. • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine. The active substance and Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Suspension for injection Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza vaccine (whole virion, inactivated) containing antigen * of: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**per 0.5 ml dose * produced in Vero cells ** haemagglutinin This vaccine complies with the WHO recommendation and EU decision for the pandemic. The vaccine is available in a multidose container (see section 6.5 for the number of doses per vial). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The vaccine is an off-white, opalescent, translucent suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and children from 6 months onwards: _ One dose of 0.5 ml at an elected date. _ _ A second dose of vaccine should be given after an interval of at least 3 weeks. Method of administration Immunization should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass. For further information, see section 5.1. 4.3 CONTRAINDICATIONS History of an anaphylactic (i.e. life-threatening) reaction to the active substance, to any of the excipients listed in section 6.1 or to trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine. However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need. Medicinal product no longer authorised 3 See section 4.4. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE • Hypersensitivity reactions, including anaphylaxis, have been reported followin Read the complete document