This leaflet was NOT given to the parents when the Fluenz vaccine was given to their children. although it states on the top of the leaflet that this is the Package Leaflet Information for the user. PACKAGE LEAFLET: INFORMATION FOR THE USER Fluenz nasal spray suspension Influenza vaccine (live attenuated, nasal) Read all of this leaflet carefully before the vaccine is given − 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. Do not pass it on to others. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1. What Fluenz is and what it is used for 2. Before you are given Fluenz 3. How Fluenz is given 4. Possible side effects 5. How to store Fluenz 6. Further 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. 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 (these are listed in section 6 “Further Information”). For signs of allergic reactions, see section 4 “Possible side effects”. • if you have a blood disorder or a cancer that affects the immune system. • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine, or other treatment. • if you are under 18 years of age and already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever). This is because of the risk of a very rare but serious disease (Reye’s syndrome). If any of these apply, tell your doctor, nurse or pharmacist. Take special care with Fluenz Tell your doctor, nurse or pharmacist: • if the child is less than 24 months of age because of the risk of side effects. • if you have severe asthma or are currently wheezing. • if you are in close contact with someone with a severely weakened immune system (for example, a bone marrow transplant patient needing isolation). If any of these apply, tell your doctor, nurse or pharmacist before vaccination. He or she will decide if Fluenz is suitable for you. Using other medicines and other vaccines Tell your doctor, nurse or pharmacist if the person being vaccinated is taking or has recently taken any other medicines, including medicines that do not require a prescription. • Do not give acetylsalicylic acid to children aged less than 18 years for 4 weeks after vaccination with Fluenz unless your doctor, nurse or pharmacist tells you otherwise. • It is recommended that Fluenz is not given at the same time as influenza-specific antiviral medicines. Your doctor, nurse or pharmacist will decide if Fluenz can be given at the same time as other vaccines. Pregnancy and breast-feeding • If you are pregnant (or think you might be) or breast-feeding, tell your doctor, nurse or pharmacist. Fluenz is not recommended for women who are pregnant or are breast-feeding. 3. How Fluenz is given A doctor, nurse or pharmacist will administer Fluenz. Fluenz must only be used as a nasal spray. Fluenz must not be injected. Fluenz will be given as a spray in each nostril. You can breathe normally while you are given Fluenz. You do not need to actively inhale or sniff. Dosage • The recommended dose for children and adolescents is 0.2 ml Fluenz, administered as 0.1 ml in each nostril. • Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks. Follow your doctor, nurse or pharmacist’s instructions about when your child should return for the second dose. 4. Possible side effects Like all medicines, Fluenz can cause side effects, although not everybody gets them. Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz. Very common (affects more than 1 user in 10): • runny or stuffy nose • reduced appetite • weakness • headache Common (affects 1 to 10 users in 100): • fever • muscle aches Uncommon (affects 1 to 10 users in 1,000): • rash • nose bleed • allergic reactions: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor, nurse or pharmacist. 5. How to store Fluenz Keep out of the reach and sight of children. Do not use Fluenz after the expiry date which is stated on the applicator label after the letters EXP. Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light. Any unused product or waste material should be disposed of in accordance with local requirements for medical waste. Vaccines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What Fluenz contains The active substances are: Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain A/California/7/2009, MEDI 228029) 107.0±0.5 FFU*** A/Victoria/361/2011 (H3N2)-like strain (A/Victoria/361/2011, MEDI 231411) 107.0±0.5 FFU*** B/Wisconsin/1/2010-like strain (B/Wisconsin/1/2010, MEDI 028507) 107.0±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 (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2012/2013 season. The other ingredients are sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections. What Fluenz looks like and contents of the pack This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in pack sizes of 1 and 10. Not all pack sizes may be available in your country. The suspension is a colourless to pale yellow liquid that is clear to slightly cloudy. Small white particles may be present. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, Netherlands, (Tel) +31 24 371 7310 Manufacturer: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, UK For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: België/Belgique/Belgien NV AstraZeneca SA Tel: +32 2 370 48 11 Luxembourg/Luxemburg NV AstraZeneca SA Tél/Tel: +32 2 370 48 11 България ТП AstraZeneca UK Limited Тел.: +359 2 971 25 33 Magyarország AstraZeneca Kft Tel.: +36 1 883 6500 Česká republika AstraZeneca Czech Republic s.r.o. Tel: +420222807111 Malta Associated Drug Co. Ltd Tel: +356 2277 8000 Danmark AstraZeneca A/S Tlf: +45 43 66 64 62 Nederland AstraZeneca BV Tel: +31 79 363 2222 Deutschland AstraZeneca GmbH Tel: +49 41 03 7080 Norge AstraZeneca AS Tlf: +47 21 00 64 00 Eesti AstraZeneca Eesti OÜ Tel: +372 6549 600 Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 Ελλάδα AstraZeneca A.E. Τηλ: +30 2 106871500 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 874 35 00 España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00 France AstraZeneca Tél: +33 1 41 29 40 00 România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 Ireland AstraZeneca Pharmaceuticals (Ireland) Ltd Tel: +353 1609 7100 Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 Ísland Vistor hf. Sími: +354 535 7000 Slovenská republika AstraZeneca AB o.z. Tel: +421 2 5737 7777 Italia AstraZeneca S.p.A. Tel: +39 02 98011 Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 Κύπρος Αλέκτωρ Φαρμακευτική Λτδ Τηλ: +357 22490305 Sverige AstraZeneca AB Tel: +46 8 553 26 000 Latvija SIA AstraZeneca AB Latvija Tel: +371 67321747 United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836 Lietuva UAB ,,AstraZeneca Lietuva“ Tel: +370 5 2660550 This leaflet was last approved in 08/2012. Detailed information on this medicine is available on the European Medicines Agency web site: ema.europa.eu. Fluenz is a trademark of MedImmune, LLC.
Posted on: Mon, 24 Nov 2014 17:49:11 +0000
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