Skip to content

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies.Continue

Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)

 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

View Patient Information Leaflet

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine.

This PIL is in PDF format and so you must have a PDF reader installed on your device to read it.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link above. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/13/887/001, EU/1/13/887/002, EU/1/13/887/003, EU/1/13/887/004.



Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)

Package leaflet: Information for the user

Fluenz Tetra nasal spray suspension

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.

Read all of this leaflet carefully before the vaccine is given because it contains important information for you or your child.

  • 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 is in this leaflet:

1. What Fluenz Tetra is and what it is used for
2. What you need to know before you are given Fluenz Tetra
3. How Fluenz Tetra is given
4. Possible side effects
5. How to store Fluenz Tetra
6. Contents of the pack and other information

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

Fluenz Tetra is identical to Fluenz (a nasal influenza vaccine containing three strains), except Fluenz Tetra provides protection against an additional influenza strain.

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 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.

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 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.

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
  • headache

Common

(may affect up to 1 in 10 people):

  • fever
  • muscle aches

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard.

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/Michigan/45/2015 (H1N1)pdm09 - like strain

(A/Slovenia/2903/2015, MEDI 255962) 107.0±0.5 FFU***

A/Hong Kong/4801/2014 (H3N2) - like strain

(A/New Caledonia/71/2014, MEDI 263122) 107.0±0.5 FFU***

B/Brisbane/60/2008 - like strain

(B/Brisbane/60/2008, MEDI 228030) 107.0±0.5 FFU***

B/Phuket/3073/2013 - like strain

(B/Phuket/3073/2013, MEDI 254977) 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 recommendations (World Health Organisation) and EU decision for the 2017/2018 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 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 and Manufacturer

Marketing Authorisation Holder:

AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer:

MedImmune, UK Limited
Plot 6
Renaissance Way
Boulevard Industry Park
Speke
LiverpoolL24 9JW
UK

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
AstraZeneca UK Ltd
Tel: +44 1582 836 836

This leaflet was last revised in 08/2017.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Company Information

AstraZeneca UK Limited

Address : Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU

Telephone : +44 (0)1582 836 000

Fax : +44 (0)1582 838 000

Medical Information Direct Line : 0800 783 0033

Medical Information e-mail :

Customer Care direct line : +44 (0)1582 837 837

Medical Information Fax : +44 (0)1582 838 003

More information about this medicine

Legal categories

  • POM

Active ingredients/generics

  • influenza vaccine

Summaries of Product Characteristics (SPCs):

© 2017 Datapharm Communications Ltd