Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1)
Ology Bioservices Ireland LTD
J07BB01
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)
Influenza vaccines
Influenza, Human; Immunization; Disease Outbreaks
Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Vepacel should be used in accordance with Official guidance.,
Revision: 9
Withdrawn
2012-02-17
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE USER VEPACEL SUSPENSION FOR INJECTION Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 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. - If you get any of the side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What VEPACEL is and what it is used for 2. What you need to know before you receive VEPACEL 3. How VEPACEL is given 4. Possible side effects 5. How to store VEPACEL 6. Contents of the pack and other information 1. WHAT VEPACEL IS AND WHAT IT IS USED FOR VEPACEL is a vaccine for use in individuals aged 6 months and older. It is intended to be given before 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 are usually 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. As with all vaccines, VEPACEL may not fully protect all persons who are vaccinated. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE VEPACEL YOU SHOULD NOT RECEIVE VEPACEL - if you have previously had a severe allergic reaction to any ingredient of VEPACEL (these are listed at the end of the leaflet – section 6) or to any substances that may be present i Прочитайте повний документ
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 VEPACEL suspension for injection in multidose container Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Influenza virus (whole virion, inactivated), containing antigen* of strain: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** * produced in Vero cells ** haemagglutinin This is 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. Clear to opalescent suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1). The use of this vaccine should be in accordance with official recommendations. 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 0.5 ml should be given after an interval of at least three weeks. _other paediatric Population _ No data is available on the safety and efficacy of VEPACEL in children younger than 6 months of age. 3 Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass. See section 6.6 for administration instructions. 4.3 CONTRAINDICATIONS History of anaphylactic reactions to the active substance, or to any of the excipients listed in section 6.1, or trace residues (formaldehy Прочитайте повний документ