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The product code(s) for this leaflet is: PL 46602/0017.
Quadrivalent Influenza vaccine (Split virion, inactivated)
Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe
Quadrivalent influenza vaccine (split virion, inactivated)
1. What Quadrivalent Influenza Vaccine (split virion, inactivated) is and what it is used for
2. What you need to know before you or your child use Quadrivalent Influenza Vaccine (split virion, inactivated)
3. How to use Quadrivalent Influenza Vaccine (split virion, inactivated)
4. Possible side effects
5. How to store Quadrivalent Influenza Vaccine (split virion, inactivated)
6. Contents of the pack and other information
Quadrivalent Influenza Vaccine (split virion, inactivated) is a vaccine. This vaccine administered to you or your child from 6 months of age helps to protect you or your child against influenza (flu).
When a person is given Quadrivalent Influenza Vaccine (split virion, inactivated), the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. When given during pregnancy the vaccine helps to protect the pregnant women but also helps to protect her baby from birth to less than 6 months of age through the transmission of protection from mother to baby during pregnancy (see also Sections 2 and 3).
None of the ingredients in the vaccine can cause flu.
The use of Quadrivalent Influenza Vaccine (split virion, inactivated) should be based on official recommendations.
Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Due to this potential change in circulating strains on a yearly basis, as well as the duration of protection intended by the vaccine, vaccination is recommended every year. The greatest risk of catching flu is during the cold months between October and March. If you or your child were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you run the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.
Quadrivalent Influenza Vaccine (split virion, inactivated) is intended to protect you or your child against the four strains of virus contained in the vaccine about 2 to 3 weeks after the injection. In addition, if you or your child are exposed to flu immediately before or after your vaccination, you or your child could still develop the illness as the incubation period for flu is a few days.
The vaccine will not protect you or your child against the common cold, even though some of the symptoms are similar to flu.
To make sure that Quadrivalent Influenza Vaccine (split virion, inactivated) is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain.
Talk to your doctor, pharmacist or nurse before using Quadrivalent Influenza Vaccine (split virion, inactivated).
You should tell your doctor before vaccination if you or your child have:
Your doctor will decide if you or your child should receive the vaccine.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell your doctor or nurse if you or your child fainted with a previous injection.
As with all vaccines, Quadrivalent Influenza Vaccine (split virion, inactivated) may not fully protect all persons who are vaccinated.
Not all babies less than 6 months of age born to pregnant women vaccinated during pregnancy will be protected.
If, for any reason, you or your child have a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.
Quadrivalent Influenza Vaccine (split virion, inactivated) is not recommended for use in children below 6 months of age.
Tell your doctor or pharmacist if you or your child are receiving, have recently received or might receive any other vaccines or any other medicines.
If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before using this vaccine.
Quadrivalent Influenza Vaccine (split virion, inactivated) can be used in all stages of pregnancy.
Quadrivalent Influenza Vaccine (split virion, inactivated) may be used during breast-feeding.
Your doctor/pharmacist will be able to decide if you should receive Quadrivalent Influenza Vaccine (split virion, inactivated).
Quadrivalent Influenza Vaccine (split virion, inactivated) has no or negligible influence on the ability to drive or use machines.
This medicine contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘potassium-free’ and ‘sodium-free’.
Adults receive one 0.5 mL dose.
Use in children
Children from 6 months to 17 years of age receive one 0.5 mL dose.
If your child is less than 9 years old and has not been previously vaccinated against flu, a second dose of 0.5 mL should be given after at least 4 weeks.
If you are pregnant, one 0.5 mL dose given to you during pregnancy may protect your baby from birth to less than 6 months of age. Ask your doctor or pharmacist for more information.
Your doctor or nurse will administer the recommended dose of the vaccine as an injection into the muscle or under the skin.
In some cases, more than the recommended dose has been inadvertantly administered.
In these cases, when side effects were reported, they were in line with what is described following the administration of the recommended dose (see Section 4).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you or your child experience allergic reactions (reported as rare: may affect up to 1 in 1,000 people) that can be life threatening.
Symptoms may include rash, itching, hives, redness, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold, clammy skin, palpitations, dizziness, weakness or fainting.
Very common (may affect more than 1 in 10 people):
(1) Common in elderly
Common (may affect up to 1 in 10 people):
(2) Uncommon in elderly
Uncommon (may affect up to 1 in 100 people):
(3) Rare in adults (4) Rare in elderly
Rare (may affect up to 1 in 1,000 people):
Very common (may affect more than 1 in 10 people):
(5) Common in children from 9 to 17 years of age
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people) in children from 3 to 8 years of age:
Uncommon (may affect up to 1 in 100 people) in children from 9 to 17 years of age:
Very common (may affect more than 1 in 10 people):
(1) Uncommon in children from 24 to 35 months of age (2) Rare in children less than 24 months of age
(3) Rare in children from 24 to 35 months of age
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
In children from 6 months to 8 years of age who receive 2 doses, side effects are similar after the first and after the second dose. Fewer side effects may happen after the second dose in children from 6 to 35 months of age.
When seen, side effects generally happen in the first 3 days after the vaccination and go away by themselves in 1 to 3 days after they start. The intensity of observed side effects was mild.
Overall, side effects were generally less frequent in elderly than in adults and children.
The following side effects have been reported after administration of Inactivated Influenza Vaccine (Split Virion) BP. These side effects may occur with Quadrivalent Influenza Vaccine (split virion, inactivated):
If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland
Health Products Regulatory Authority (HPRA):
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 label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.
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.
A/Victoria/4897/2022 (H1N1)pdm09-like strain
(A/Victoria/4897/2022, IVR-238)…………..............…. ....................................... 15 micrograms HA**
A/Darwin/9/2021 (H3N2)-like strain
(A/Darwin/9/2021, IVR-228)..................................................................................15 micrograms HA**
B/Austria/1359417/2021-like strain
(B/Michigan/01/2021, wild type) …………………………………………….......15 micrograms HA**
B/Phuket/3073/2013-like strain
(B/Phuket/3073/2013, wild type)…………………………………………………15 micrograms HA**
Per 0.5 mL dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2023/2024 season.
Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9 may be present in very small amounts (see Section 2).
The vaccine, after shaking gently, is a colourless opalescent liquid.
Quadrivalent Influenza Vaccine (split virion, inactivated) is a suspension for injection presented in a pre-filled syringe of 0.5 mL, with attached needle or without needle, in box of 1, 10 or 20. Not all pack sizes may be marketed.
The Marketing Authorisation Holder is:
The distributor is:
United Kingdom:
Ireland:
The Manufacturer is:
This medicinal product is authorised in the Member States of the EEA under the following names:
Member State Name
Austria VaxigripTetra Injektionssuspension in einer Fertigspritze
Lithuania VaxigripTetra injekcinė suspensija užpildytame švirkšte
Bulgaria, Croatia, Cyprus, Estonia, Finland, France, Greece, Iceland, Latvia, Malta, Poland, Portugal, Romania, Slovenia, Sweden, Netherlands VaxigripTetra
Denmark, Norway Vaxigriptetra
Belgium, Luxemburg Vaxigrip Tetra suspension injectable en seringue préremplie
Germany, Italy, Spain, Czech Republic, Slovakia, Hungary Vaxigrip Tetra
Ireland, United Kingdom Quadrivalent Influenza Vaccine (split virion, inactivated)
This leaflet was last revised in 06/2023.