Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Reassortant influenza virus (live attenuated) of the following strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain
MedImmune LLC
J07BB03
influenza vaccine (live attenuated, nasal)
Vaccines
Influenza, Human; Immunization
Prophylaxis of influenza in individuals 24 months to less than 18 years of age.The use of Fluenz should be based on official recommendations.
Revision: 4
Withdrawn
2011-01-27
21 B. PACKAGE LEAFLET Medicinal product no longer authorised 22 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUENZ NASAL SPRAY SUSPENSION Influenza vaccine (live attenuated, nasal) 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 THE VACCINE IS GIVEN BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - This vaccine has been prescribed for you or your child only. Do not pass it on to others. - If any of the side effects gets serious, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Fluenz is and what it is used for 2. What you need to know before you are given Fluenz 3. How Fluenz is given 4. Possible side effects 5. How to store Fluenz 6. Contents of the pack and other information 1. WHAT FLUENZ IS AND WHAT IT IS USED FOR Fluenz is a vaccine to prevent influenza (flu). It is used in children and adolescents 24 months to less than 18 years of age. 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. Fluenz vaccine viruses are grown in chicken eggs. The vaccine targets three strains of influenza virus each year, following the annual recommendations by the World Health Organisation. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FLUENZ YOU WILL NOT BE GIVEN FLUENZ IF YOU ARE ALLERGIC to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of Fluenz (listed in section 6 “Contents of the pack and other information”). For signs of allergic reactions, see section 4 “Possible Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 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 FLUENZ nasal spray suspension Influenza vaccine (live attenuated, nasal) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029) 10 7.0±0.5 FFU*** A/Victoria/361/2011 (H3N2)-like strain (A/Texas/50/2012, MEDI 237514) 10 7.0±0.5 FFU*** B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, MEDI 237751) 10 7.0±0.5 FFU*** .......................................................................................................per 0.2 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks. ** produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs). *** fluorescent focus units This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2013/2014 season. The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, suspension The suspension is colourless to pale yellow, clear to opalescent. Small white particles may be present. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in individuals 24 months to less than 18 years of age. The use of FLUENZ should be based on official recommendations. Medicinal product no longer authorised 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Children and adolescents from 24 months: _ 0.2 ml (administered as 0.1 ml per nostril). For children who have not previously been vaccinated against seasonal Lestu allt skjalið