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Fluenz Tetra - Patient leaflet, side effects, dosage

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Patient leaflet - Fluenz Tetra

1. What Fluenz Tetra is and what it is used for

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.

How Fluenz Tetra works

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.

2. What you need to know before you are given Fluenz Tetra

You will not be given Fluenz Tetra:

  • if you are allergic to gentamicin, gelatin or any of the other ingredients of this vaccine (listed in

section 6 “Contents of the pack and other information”).

  • if you have ever had a severe allergic reaction to eggs or egg proteins. For signs ofallergic

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

ofa 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.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before vaccination:

  • 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.

Other medicines, other vaccines and Fluenz Tetra

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.

Pregnancy and breast-feeding

  • 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.

Driving and using machines

  • Fluenz Tetra has no or negligible influence on the ability to drive and use machines.
  • 3. How Fluenz Tetra is given

Fluenz Tetra will be administered under the supervision of a doctor, nurse or pharmacist.

Fluenz Tetra must only be used as a nasal spray.

Fluenz Tetra must not be injected.

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.

Dosage

The recommended dose for children and adolescents is 0.2 ml Fluenz Tetra, 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 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.

4. Possible side effects

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.

Some side effects may be serious

Very rare

(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.

Tell your doctor straight away or seek urgent medical care if you experience any of the effects

above.

Other possible side effects of Fluenz Tetra

Very common

(may affect more than 1 in 10 people):

  • runny or stuffy nose
  • reduced appetite
  • weakness

Common

(may affect up to 1 in 10 people):

  • fever
  • muscle aches
  • headache

Uncommon

(may affect up to 1 in 100 people):

  • rash
  • nose bleed
  • allergic reactions

Reporting of side effects

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.

5. How to store Fluenz Tetra

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.

6. Contents of the pack and other information

What Fluenz Tetra contains

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)

A/Cambodia/e0826360/2­020 (H3N2) – like strain (A/Tasmania/503/2020, MEDI 339018)

B/Washington/02/2019 – like strain (B/Washington/02/2019, MEDI 323797)

B/Phuket/3073/2013 – like strain (B/Phuket/3073/201­3, MEDI 306444)


107.0±0.5 FFU


107.0±0.5 FFU


107.0±0.5 FFU


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.

What Fluenz Tetra 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 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.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85

Sodertalje

Sweden

Manufacturer

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

Authorisation Holder:

België/Belgiqu­e/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Efc^rapufl

Acmpa3eHeKa Etnrapua EOOfl

Ten.: +359 24455000

Česká republika

AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

Danmark

AstraZeneca A/S

Tlf: +45 43 66 64 62

Deutschland

AstraZeneca GmbH

Tel: +49 40 809034100

Eesti

AstraZeneca

Tel: +372 6549 600

EÀÀàôa

AstraZeneca A.E.

TnX: +30 210 6871500

España

AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

France

AstraZeneca

Tél: +33 1 41 29 40 00

Hrvatska

AstraZeneca d.o.o.

Tel: +385 1 4628 000


contact the local representative of the Marketing


Lietuva

UAB AstraZeneca Lietuva

Tel: +370 5 2660550

Luxembourg/Lu­xemburg

AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11

Magyarország

AstraZeneca Kft.

Tel.: +36 1 883 6500

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000

Nederland

AstraZeneca BV

Tel: +31 79 363 2222

Norge

AstraZeneca AS

Tlf: +47 21 00 64 00

Österreich

AstraZeneca Österreich GmbH

Tel: +43 1 711 31 0

Polska

AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00

Portugal

AstraZeneca Produtos Farmacéuticos, Lda.

Tel: +351 21 434 61 00

Romania

AstraZeneca Pharma SRL

Tel: +40 21 3176041


Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

Island

Vistor hf.

Simi: +354 535 7000

Italia

AstraZeneca S.p.A.

Tel: +39 02 00704500

Knnpog

AXeKTOp OappaKSUTlK^ At5

TqX: +357 22490305

Latvija

SIA AstraZeneca Latvija

Tel: +371 67377100


Slovenija

AstraZeneca UK Limited

Tel: +386 1 51 35 600

Slovenská republika

AstraZeneca AB, o.z.

Tel: +421 2 5737 7777

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010

Sverige

AstraZeneca AB

Tel: +46 8 553 26 000

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836 836


This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Instructions for healthcare professionals

The following information is intended for healthcare professionals only:

Fluenz Tetra is for nasal use only.

  • Do not use with a needle. Do not inject.
  • 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

The drug is classified in the ATC tree:

Frequently Asked Questions

What is Fluenz Tetra and how does it work?

Fluenz Tetra is a live attenuated nasal spray vaccine that protects against influenza. It helps your body build immunity by introducing weakened viruses, prompting an immune response.

Who can receive Fluenz Tetra?

Fluenz Tetra is suitable for healthy children aged 2 to 17 years old. It's important for your child to be within this age range to receive the vaccine.

Is Fluenz Tetra safe for my child?

Yes, Fluenz Tetra is generally safe for healthy children. However, like all vaccines, it may have some side effects. Consult your healthcare provider for more information.

How is Fluenz Tetra administered?

Fluenz Tetra is given as a nasal spray, making it a quick and painless option compared to traditional injections.

When should my child get the Fluenz Tetra vaccine?

It's best to get vaccinated before flu season starts, ideally in early fall. Speak with your healthcare provider about the timing.

Can my child receive Fluenz Tetra if they have allergies?

Children with certain allergies may need to avoid Fluenz Tetra. Discuss your child's medical history with their doctor before vaccination.

What are the common side effects of Fluenz Tetra?

Some common side effects include a runny nose, headache, and tiredness. These symptoms are usually mild and go away quickly.

How long does the immunity from Fluenz Tetra last?

The immunity provided by Fluenz Tetra typically lasts for about one year, which is why annual vaccination is recommended.

Can my child spread the virus after receiving Fluenz Tetra?

It's unlikely for your child to spread the virus after receiving Fluenz Tetra since it's made from weakened viruses. Your child will not cause influenza in others.

What should I do if my child has a fever after getting Fluenz Tetra?

If your child has a mild fever after the vaccination, it's usually not a cause for concern. However, monitor their condition and consult a doctor if it persists or worsens.

Can my child receive other vaccines at the same time as Fluenz Tetra?

In most cases, other vaccines can be administered during the same visit as Fluenz Tetra. Check with your healthcare provider for specific recommendations.

What should I tell my healthcare provider before my child gets Fluenz Tetra?

Inform your healthcare provider about your child's health history, any allergies, and any recent illnesses or medical treatments.

Is there anyone who should avoid getting Fluenz Tetra?

Yes, children with certain conditions such as weakened immune systems or severe allergic reactions to vaccine components should not receive this vaccine.

Can pregnant women receive flu vaccinations like Fluenz Tetra?

Fluenz Tetra is not recommended for pregnant women; however, they can receive inactivated flu vaccines instead.

What happens if my child misses their scheduled dose of Fluenz Tetra?

If your child misses their vaccination appointment, schedule a new one as soon as possible to ensure they are protected against influenza.

Does having flu symptoms mean my child shouldn’t get vaccinated with Fluenz Tetra?

If your child has mild cold symptoms but no fever or severe illness, they can usually still get vaccinated. Consult with their doctor if unsure.

Can my child play sports after receiving the Fluenz Tetra vaccine?

Generally, children can return to normal activities including sports shortly after getting the vaccine unless advised otherwise by their doctor.

How effective is the Fluenz Tetra vaccine compared to other flu vaccines?

Fluenz Tetra has shown effectiveness similar to that of traditional flu shots in preventing illness; however, individual responses may vary.

Where can I get the Fluenz Tetra vaccine for my child?

You can obtain the Fluenz Tetra vaccine at pediatric clinics, family doctors' offices, or health departments that offer immunizations.