What Fluenz contains
The active substances are Reassortant influenza virus live attenuated of the following strains 107.00.5AOfficial strain H1N1 like strain actual strain AOfficial strain H3N2 like strain actual strain BOfficial strain like strain actual strain 107.00.5107.00.5 FFU FFU 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 20XX/20XX 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:
BelgiëBelgiqueBelgien NV AstraZeneca SA Tel 32 2 370 48 11 LuxembourgLuxemburg NV AstraZeneca SA TélTel 32 2 370 48 11
AstraZeneca UK Limited . 359 2 971 25 33 Magyarország AstraZeneca Kft Tel. 36 1 883 6500
eská republika AstraZeneca Czech Republic s.r.o. Tel 420222807111 Malta Associated Drug Co. Ltd Tel 356 2277 8000
Danmark AstraZeneca AS Tlf 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
AstraZeneca A.E. 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 SuomiFinland AstraZeneca Oy PuhTel 358 10 23 010
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 {MM/YYYY}.
Fluenz is a trademark of MedImmune, LLC.
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Instructions for health professionals
The following information is intended for medical or healthcare professionals only:
Fluenz is for nasal use only.
- Do not use with a needle. Do not inject.
- Fluenz is administered as a divided dose in both nostrils as described below. (See also, How Fluenz is given, in section 3) .
- After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
- The patient can breathe normally while the vaccine is being administered ? there is no need to actively inhale or sniff.
Check expiry date Product must be used before date on applicator label. Prepare the applicator Remove rubber tip protector. Do not remove dose-divider clip at the other end of the applicator. Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz is delivered into the nose. Remove dose-divider clip For administration in the other nostril, pinch and remove the dose-divider clip from plunger. Depress the plunger With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further. Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine.
See section 5 for advice on storage and disposal