Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)
Sanofi Pasteur Europe
J07BB02
influenza vaccine (split virion, inactivated)
Vaccines
Influenza, Human; Immunization
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.The use of Intanza should be based on official recommendations.
Revision: 18
Withdrawn
2009-02-24
20 B. PACKAGE LEAFLET Medicinal product no longer authorised 21 PACKAGE LEAFLET: INFORMATION FOR THE USER INTANZA 15 MICROGRAM/STRAIN SUSPENSION FOR INJECTION Influenza vaccine (split virion, inactivated) 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, pharmacist or nurse. - This vaccine has been prescribed for you only. Do not pass it on to others. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What INTANZA is and what it is used for 2. What you need to know before you use INTANZA 3. How to use INTANZA 4. Possible side effects 5. How to store INTANZA 6. Contents of the pack and other information 1. WHAT INTANZA IS AND WHAT IT IS USED FOR INTANZA is a vaccine. This vaccine is recommended to help to protect you against flu. The vaccine may be administered to individuals of 60 years of age and over, especially in those who run an increased risk of associated complications. When an injection of INTANZA is given, the immune system (body's natural defences) will develop protection against flu infection. INTANZA will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them. Full effect of the vaccine is generally achieved 2-3 weeks after the vaccination. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INTANZA DO NOT USE INTANZA: - If you are allergic to: The active substances, Any of the other ingredients of this vaccine (listed in section 6), Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9. - If you have an illness with fever or acute infection, the vaccination shall be postponed until after you have recovered. WARNINGS AND PRECAUTIONS Talk to your docto Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT INTANZA 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus (inactivated, split) of the following strains*: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) ............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) ............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) .................... 15 micrograms HA** Per 0.1 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2017/2018 season. For the full list of excipients, see section 6.1. INTANZA may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and octoxinol 9, which are used during the manufacturing process (see section 4.3). 3. PHARMACEUTICAL FORM Suspension for injection. Colourless and opalescent suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications. The use of INTANZA should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Individuals 60 years of age and over: 0.1 ml. _Paediatric population_ INTANZA is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy. Medicinal product no longer authorised 3 Method of administration Immunisation should be carried out by intradermal route. The recom Aqra d-dokument sħiħ