Fluenz Tetra
influenza vaccine (live attenuated, nasal)
Influenza vaccine (live attenuated, nasal)
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 Tetra is and what it is used for
What you need to know before you are given Fluenz Tetra
How Fluenz Tetra is given
Possible side effects
How to store Fluenz Tetra
Contents of the pack and other information
Fluenz Tetra is a vaccine to prevent influenza (flu). It is used in children and adolescents 24 months to less than 18 years of age. Fluenz Tetra will help to protect against the four virus strains contained in the vaccine, and other strains closely related to them.
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 Tetra vaccine viruses are grown in chicken eggs. Each year the vaccine targets four strains of influenza, following the annual recommendations by the World Health Organisation.
if you have ever had a severe allergic reaction to eggs or egg proteins. 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 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 Tetra 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, including medicines that do not require a prescription.
Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Fluenz Tetra unless your doctor, nurse or pharmacist tells you otherwise. This is because of the risk of Reye’s syndrome, a very rare but serious disease that can affect the brain and liver.
It is recommended that Fluenz Tetra is not given at the same time as influenza-specific antiviral medicines, such as oseltamivir and zanamivir. This is because the vaccine may work less effectively.
Your doctor, nurse or pharmacist will decide if Fluenz Tetra can be given at the same time as other vaccines.
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 Tetra is not recommended for women who are pregnant or are breast-feeding.
Fluenz Tetra has no or negligible influence on the ability to drive and use machines.
Fluenz Tetra must only be used as a nasal spray.
Fluenz Tetra will be given as a spray in each nostril. You can breathe normally while you are given Fluenz Tetra. You do not need to actively inhale or sniff.
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 if and when your child should return for the second dose.
If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist.
Like all medicines, this vaccine can cause side effects, although not everybody gets them. In clinical studies with the vaccine, most side effects were mild in nature and short term.
Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz Tetra.
(may affect up to 1 in 10,000 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
(may affect up to 1 in 10 people):
fever
muscle aches
headache
(may affect up to 1 in 100 people):
rash
nose bleed
allergic reactions
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 this vaccine 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.
Keep the nasal applicator in the outer carton in order to protect from light.
Before use, the vaccine may be taken out of the refrigerator once 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 discarded.
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 four strains**:
A/Victoria/2570/2019 (H1N1)pdm09 - like strain
(A/Victoria/1/2020, MEDI 340505) 107.0±0.5 FFU***
A/Cambodia/e0826360/2020 (H3N2) - like strain
(A/Tasmania/503/2020, MEDI 339018) 107.0±0.5 FFU***
B/Washington/02/2019 - like strain
(B/Washington/02/2019, MEDI 323797) 107.0±0.5 FFU***
B/Phuket/3073/2013 - like strain
(B/Phuket/3073/2013, MEDI 306444) 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 2021/2022 season.
The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen 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 1 and 10. Not all pack sizes may be available in your country.
The suspension is colourless to pale yellow, clear to slightly cloudy. Small white particles may be present.
AstraZeneca AB
SE-151 85
Södertälje Sweden
AstraZeneca Nijmegen B.V.,
Lagelandseweg 78 Nijmegen, 6545CG Netherlands
MedImmune, UK Limited Plot 6, Renaissance Way Boulevard Industry Park Speke
Liverpool L24 9JW United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB AstraZeneca Lietuva
Tel: +370 5 2660550
АстраЗенека България ЕООД Тел.: +359 24455000
AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111
Associated Drug Co. Ltd
Tel: +356 2277 8000
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca
Tel: +372 6549 600
AstraZeneca AS
Tlf: +47 21 00 64 00
AstraZeneca A.E.
Τηλ: +30 210 6871500
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 22 245 73 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) DAC 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 00704500
AstraZeneca Oy
Puh/Tel: +358 10 23 010
Αλέκτωρ Φαρμακευτική Λτδ
Τηλ: +357 22490305
AstraZeneca AB
Tel: +46 8 553 26 000
SIA AstraZeneca Latvija
Tel: +371 67377100
AstraZeneca UK Ltd
Tel: +44 1582 836 836
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The following information is intended for healthcare professionals only:
Do not use Fluenz Tetra if the expiry date has passed or the sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage.
Check the appearance of the vaccine before administration. The suspension should be colourless to pale yellow, clear to opalescent. Small white particles may be present.
Fluenz Tetra is administered as a divided dose in both nostrils as described below. (See also,
How Fluenz Tetra 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 Tetra is delivered into
the nose.
For administration in the other nostril, pinch and
remove the dose-divider clip from plunger.