nasal spray suspension
A vaccine against influenza (live attenuated, nasal)
1. What Fluenz Tetra is and what it is used for
Fluenz Tetra is a vaccine that prevents flu. It is used for children and adolescents aged from 24 months up to 18 years. Fluenz Tetra protects against the four virus strains contained in the vaccine and other strains that are closely related to them.
How Fluenz Tetra works
When a person receives the vaccine, the immune system (the body’s natural defense system) will produce its own protection against the flu virus. None of the ingredients in the vaccine can cause the flu.
The Fluenz Tetra vaccine virus is grown in chicken eggs. The vaccine is targeted at four influenza virus strains per year, according to annual recommendations from the World Health Organization.
2. What you need to know before you get Fluenz Tetra
You will not receive Fluenz Tetra:
- if you are allergic to eggs, egg proteins, gentamicin or gelatin, or any of the other ingredients of this vaccine (listed in section 6 “Package contents 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 disease or cancer that affects the immune system.
- if your doctor has informed you that you have a weakened immune system due to an illness, a drug, or any other treatment.
- if you are already taking acetylsalicylic acid (a substance found in many painkillers and antipyretics). This is due to the risk of a very unusual but serious disease (Reyes syndrome).
If any of the above apply to you, tell your doctor, nurse, or pharmacist.
Warnings and cautions
Talk to a doctor, nurse, or pharmacist before vaccination:
- if the baby is under 24 months old. Children under 24 months of age should not be given this vaccine due to the risk of side effects.
- if you have severe asthma or are currently wheezing.
- if you have close contact with someone who has a severely weakened immune system (for example, a bone marrow transplant patient who needs to be isolated).
If any of the above apply to you, talk to your doctor, nurse, or pharmacist before getting vaccinated. He or she will decide if Fluenz Tetra is right 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 be taking other medicines, including over-the-counter medicines.
- Do not give acetylsalicylic acid (a substance that is included in many medicines with analgesic and antipyretic effects) to children under 4 weeks after vaccination with Fluenz Tetra, unless your doctor, nurse, or pharmacist tells you otherwise. It is due to the risk of Reye’s syndrome, a very rare but serious disease that can affect the brain and liver.
- It is not recommended that Fluenz Tetra be co-administered with influenza-specific antiviral medicines, such as oseltamivir and zanamivir. This is because the vaccine may be less effective.
Your doctor, nurse, or pharmacist will decide if Fluenz Tetra can be given at the same time as other vaccines.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, tell your doctor, nurse, or pharmacist before receiving this vaccine. Fluenz Tetra is not recommended for pregnant or lactating women.
Driving and using machines
- Fluenz Tetra has no or negligible effect on the ability to drive and use machines.
3. How Fluenz Tetra is given
Fluenz Tetra is administered under the supervision of a doctor, nurse, or pharmacist.
Fluenz Tetra should 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 receiving Fluenz Tetra. You do not need to inhale actively or inhale air through your nose.
Dosage
The recommended dose of children and adolescents is 0.2 ml Fluenz Tetra, where 0.1 ml given into each nostril. Children who have not previously received a flu vaccine will receive a second follow-up dose after an interval of at least 4 weeks. Follow the instructions of your doctor, nurse, or pharmacist regarding if and when your child should return for the second dose.
If you have any further questions on the use of this product, 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 trials with the vaccine, most side effects were mild and short-lived.
Your doctor, nurse, or pharmacist can give you more information about any side effects of Fluenz Tetra.
Some side effects can be serious
Very rare
(may affect up to 1 user in 10,000)
- Severe allergic reaction: Signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
Tell your doctor immediately or seek emergency medical attention if you experience any of the above side effects.
Other possible side effects are Fluenz Tetra
Very common
(may affect more than 1 user in 10):
- runny or stuffy nose
- decreased appetite
- weakness
Usual
(may affect up to 1 user in 10):
- fever
- muscle aches
- headache
Less common
(may affect up to 1 user in 100):
- rash
- nosebleeds
- allergic reactions
5. How to store Fluenz Tetra
Keep this vaccine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the pipette label after the letters EXP.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze.
Sensitive to light. Store the nasal pipette in the outer carton.
Before use, the vaccine may be removed from the refrigerator for a maximum period of 12 hours at a temperature not exceeding 25 ° C. If the vaccine has not been used after this 12-hour period, it should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substances are:
Reassortant influenza virus * (live, attenuated) of the following four strains **:
| A / Guangdong-Maonan / SWL1536 / 2019 (H1N1) pdm09 – similar strain(A / Hawaii / 66/2019, MEDI 326775) | 10 7.0 ± 0.5 FFU *** |
| A / Hong Kong / 2671/2019 (H3N2) – similar strain (A / Hong Kong / 2671/2019, MEDI 325078) | 10 7.0 ± 0.5 FFU *** |
| B / Washington / 02/2019 – similar strain(B / Washington / 02/2019, MEDI 323797) | 10 7.0 ± 0.5 FFU *** |
| B / Phuket / 3073/2013 – similar strain(B / Phuket / 3073/2013, MEDI 306444) | 10 7.0 ± 0.5 FFU *** |
| ………………………………………….. ………………………………………. | per 0.2 ml dose |
* propagated in fertilized chicken eggs from healthy chicken herds.
** produced in VERO cells by reverse genetic engineering. This product contains genetically modified organisms (GMOs).
*** fluorescent focus units.
This vaccine complies with the recommendation of the WHO (World Health Organization) (Northern Hemisphere) and the EU decision for the 2020/2021 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 the medicine looks like and the contents of the pack
This vaccine is supplied as a nasal spray, suspension, in a single-use nasal pipette (0.2 ml) in pack sizes of 1 or 10. Not all pack sizes may be available in your country.
Manufacturer:
MedImmune Pharma BV,
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
MedImmune, UK Limited,
Plot 6, Renaissance Way,
Boulevard Industry Park,
Speke,
Liverpool, L24 9JW,
UK
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNV AstraZeneca SATel: +32 2 370 48 11 | LithuaniaUAB, AstraZeneca LietuvaTel: +370 5 2660550 |
| BulgariaТП AstraZeneca UK LimitedTel .: +359 2 971 25 33 | Luxembourg / LuxemburgNV AstraZeneca SATel: +32 2 370 48 11 |
| Czech RepublicAstraZeneca Czech Republic sroTel: +420222807111 | HungaryAstraZeneca KftTel .: +36 1 883 6500 |
| DenmarkAstraZeneca A / STel: +45 43 66 64 62 | MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000 |
| GermanyAstraZeneca GmbHTel: +49 41 03 7080 | The NetherlandsAstraZeneca BVTel: +31 79 363 2222 |
| EestiAstraZeneca Eesti OÜTel: +372 6549 600 | NorwayAstraZeneca ASTel: +47 21 00 64 00 |
| GreeceAstraZeneca AE:Ηλ: +30 2 106871500 | AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0 |
| SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 | PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00 |
| FranceAstraZenecaTel: +33 1 41 29 40 00 | PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00 |
| CroatiaAstraZeneca dooTel: +385 1 4628 000 | RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41 |
| IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100 | SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicAstraZeneca AB ozTel: +421 2 5737 7777 |
| ItalyAstraZeneca SpATel: +39 02 98011 | Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010 |
| LatviaSIA AstraZeneca AB LatviaTel: +371 67321747 | United KingdomAstraZeneca UK LtdTel: +44 1582 836 8 |