Fluenz
influenza vaccine (live attenuated, nasal)
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.
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 Fluenz is and what it is used for
What you need to know before you are given Fluenz
How Fluenz is given
Possible side effects
How to store Fluenz
Medicinal product no longer authorised
Contents of the pack and other information
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.
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.
if the child is less than 24 months of age. Children less than 24 months of age should not receive this vaccine 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.
Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take any other medicines.
This is because of the risk of Reye’s syndrome, a very rare but serious disease that can affect the brain and liver.
Your doctor, nurse or pharmacist will decide if Fluenz can be given at the same time as other vaccines.
Medicinal product no longer authorised
If you are pregnant, think you may be pregnant, plan to become pregnant soon or are breast feeding, tell your doctor, nurse or pharmacist before receiving this vaccine. Fluenz is not recommended for women who are pregnant or are breast-feeding.
Fluenz must only be used as a nasal spray.
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.
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.
(may affect up to 1 in 1,000,000 people):
severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
(may affect more than 1 in 10 people):
runny or stuffy nose
reduced appetite
weakness
headache
(may affect up to 1 in 10 people):
fever
muscle aches
(may affect up to 1 in 100 people):
rash
Medicinal product no longer authorised
nose bleed
allergic reactions
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.
Keep this vaccine out of the sight and reach 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.
Before use, the vaccine may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above 25°C. If the vaccine has not been used after this 12-hour period, it should be disposed of.
Any unused product or waste material should be disposed of in accordance with local requirements for medical waste. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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/Texas/50/2012, MEDI 237514) 107.0±0.5 FFU***
B/Massachusetts/2/2012-like strain
(B/Massachusetts/2/2012, MEDI 237751) 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 2013/2014 season.
Medicinal product no longer authorised
The other ingredients are sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections.
This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10.
The suspension is a colourless to pale yellow liquid that is clear to slightly cloudy. Small white particles may be present.
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:
UAB ,,AstraZeneca Lietuva“ Tel: +370 5 2660550
ТП AstraZeneca UK Limited
Тел.: +359 2 971 25 33
Tél/Tel: +32 2 370 48 11
AstraZeneca Czech Republic s.r.o. Tel: +420222807111
Associated Drug Co. Ltd Tel: +356 2277 8000
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca Eesti OÜ Tel: +372 6549 600
AstraZeneca AS Tlf: +47 21 00 64 00
Medicinal product no longer authorised
AstraZeneca A.E.
Τηλ: +30 2 106871500
AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00
AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 874 35 00
AstraZeneca
Tél: +33 1 41 29 40 00
AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00
AstraZeneca Pharma SRL Tel: +40 21 317 60 41
AstraZeneca Pharmaceuticals (Ireland) Ltd Tel: +353 1609 7100
AstraZeneca UK Limited Tel: +386 1 51 35 600
Vistor hf.
Sími: +354 535 7000
AstraZeneca S.p.A. Tel: +39 02 98011
Αλέκτωρ Φαρμακευτική Λτδ Τηλ: +357 22490305
AstraZeneca AB
Tel: +46 8 553 26 000
SIA AstraZeneca AB Latvija Tel: +371 67321747
Fluenz is a trademark of MedImmune, LLC.
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The following information is intended for medical or healthcare professionals only:
Medicinal product no longer authorised
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.
Product must be used before date on applicator label.
Remove rubber tip protector. Do not remove dose-divider clip at the
other end of the
applicator.
With the patient in an upright position, place the tip just inside the nostril
to ensure Fluenz is
delivered into the nose.
With a single motion, depress plunger as
until the dose-divider clip prevents you from going further.
For administration in the other nostril, pinch and
remove the dose-divider
clip from plunger.
Place the tip just inside the other nostril and with a single motion,
depress plunger as
Medicinal product no longer authorised