Country: European Union
Language: English
Source: EMA (European Medicines Agency)
influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type)
Seqirus GmbH
J07BB02
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Vaccines
Influenza, Human; Immunization
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications.Optaflu should be used in accordance to official guidance.
Revision: 16
Withdrawn
2007-06-01
24 B. PACKAGE LEAFLET Medicinal product no longer authorised 25 PACKAGE LEAFLET: INFORMATION FOR THE USER OPTAFLU SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 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. - 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 Optaflu is and what it is used for 2. What you need to know before you receive Optaflu 3. How Optaflu is given 4. Possible side effects 5. How to store Optaflu 6. Contents of the pack and other information 1. WHAT OPTAFLU IS AND WHAT IT IS USED FOR Optaflu is a vaccine against flu (influenza). Due to the kind of manufacturing Optaflu is free of chicken/egg protein. When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause the flu. Optaflu is used to prevent flu in adults, especially in those who run an increased risk of experiencing associated complications in case they fall ill with flu. The vaccine targets three strains of influenza virus following the recommendations by the World Health Organisation for the 2015/2016 season. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE OPTAFLU YOU SHOULD NOT RECEIVE OPTAFLU if you are allergic to influenza vaccine or any of the other ingredients of this vaccine (listed in section 6) if you have an acute infection. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before receiving Optaflu. BEFORE receiving the vaccine YOU should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT OPTAFLU suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (2015/2016 season) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains: A/California/7/2009 (H1N1)pdm09 - like strain (A/Brisbane/10/2010, wild type) 15 micrograms HA** A/Switzerland/9715293/2013 (H3N2) - like strain (A/South Australia/55/2014, wild type) 15 micrograms HA** B/Phuket/3073/2013 – like strain (B/Utah/9/2014, wild type) 15 micrograms HA** per 0.5 ml dose ………………………………………. * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2015/2016 season. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Clear to slightly opalescent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications. Optaflu should be used in accordance to Official guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults from the age of 18 years: One dose of 0.5 ml _ _ Medicinal product no longer authorised 3 _Paediatric population _ The safety and efficacy of Optaflu in children and adolescents less than 18 years of age have not yet been established. No data are available. Therefore, Optaflu is not recommended for use in children and adolescents less than 18 years of age (see section 5.1). Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Immunisation shall be postponed in patients with febrile Read the complete document