Package leaflet: Information for the user
Quadrivalent Influenza Vaccine (split virion, inactivated),suspension for injection in pre-filled syringe
Quadrivalent influenza vaccine (split virion, inactivated)
Read all of this leaflet carefully before you or your child are vaccinated because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This vaccine has been prescribed for you or your child only. Do not pass it on to others.
If you or your child get any side effects, talk to your doctor, pharmacist or nurse. Thisincludes any possible side effects not listed in this leaflet. See Section 4.
What is in this leaflet
1.
What Quadrivalent Influenza Vaccine (split virion, inactivated) is and what it is used for2.
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
1.

What Quadrivalent Influenza Vaccine (split virion, inactivated) is and what it is used for

Quadrivalent Influenza Vaccine (split virion, inactivated) is a vaccine. This vaccine administered toyou 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 toprotect her baby from birth to less than 6 months of age through the transmission of protection frommother 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 everyyear. Due to this potential change in circulating strains on a yearly basis, as well as the duration ofprotection intended by the vaccine, vaccination is recommended every year. The greatest risk ofcatching flu is during the cold months between October and March. If you or your child were notvaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you run the riskof 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 childcould 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.
2.

What you need to know before you or your child use Quadrivalent Influenza Vaccine(split virion, inactivated)

To make sure that Quadrivalent Influenza Vaccine (split virion, inactivated) is suitable for you or yourchild, it is important to tell your doctor or pharmacist if any of the points below apply to you or yourchild. If there is anything you do not understand, ask your doctor or pharmacist to explain.
Do not use Quadrivalent Influenza Vaccine (split virion, inactivated)- If you or your child are allergic to:•The active substances, or•
Any of the other ingredients of this vaccine (listed in Section 6), or•Any component that may be present in very small amounts such as eggs (ovalbumin,chicken proteins), neomycin, formaldehyde or octoxinol-9,- If you or your child have an illness with a high or moderate temperature or an acute illness, thevaccination should be postponed until after you or your child have recovered.
Warnings and precautions
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:- A poor immune response (immunodeficiency or taking medicines affecting the immune system),- Bleeding problem or bruising easily.
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 allpersons who are vaccinated.
Not all babies less than 6 months of age born to pregnant women vaccinated during pregnancy will beprotected.
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.
Children
Quadrivalent Influenza Vaccine (split virion, inactivated) is not recommended for use in children below
6 months of age.
Other medicines and Quadrivalent Influenza Vaccine (split virion, inactivated)
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.
Quadrivalent Influenza Vaccine (split virion, inactivated) can be given at the same time as othervaccines by using separate limbs.
The immunological response may decrease in case of immunosuppressant treatment, such as
corticosteroids, cytotoxic drugs or radiotherapy.
Pregnancy and breast-feeding
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).
Driving and using machines
Quadrivalent Influenza Vaccine (split virion, inactivated) has no or negligible influence on the abilityto drive or use machines.
Quadrivalent Influenza Vaccine (split virion, inactivated) contains potassium and sodiumThis 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’.
3.

How to use Quadrivalent Influenza Vaccine (split virion, inactivated)

DosageAdults receive one 0.5 mL dose.
Use in childrenChildren 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 doseof 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.
How Quadrivalent Influenza Vaccine (split virion, inactivated) is given
Your doctor or nurse will administer the recommended dose of the vaccine as an injection into themuscle or under the skin.
If you or your child receive more Quadrivalent Influenza Vaccine (split virion, inactivated) thanyou should
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 theadministration of the recommended dose (see Section 4).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions
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 1in 1,000 people) that can be life threatening.
Symptoms may include rash, itching, hives, redness, difficulty breathing, shortness of breath, swellingof the face, lips, throat, or tongue, cold, clammy skin, palpitations, dizziness, weakness or fainting.

Other side effects reported in adults and elderly
Very common (may affect more than 1 in 10 people):
Headache, muscular pain (myalgia), generally feeling unwell (malaise) (1), pain at the injection
site.
(1) Common in elderly

Common (may affect up to 1 in 10 people):
Fever (2), shivering, reactions at the injection site: redness (erythema), swelling, hardness(induration).
(2) Uncommon in elderly

Uncommon (may affect up to 1 in 100 people):Dizziness (3), diarrhoea, feeling sick (nausea) (4), fatigue, reactions at the injection site: bruising(ecchymosis), itching (pruritus), and warmth.
(3) Rare in adults-(4) Rare in elderly

Hot flush: only seen in the elderly.
Swelling of the glands in the neck, armpit or groin (lymphadenopathy): only seen in adults.

Rare (may affect up to 1 in 1,000 people):
Anomalies in the perception of touch, pain, heat and cold (paraesthesia), sleepiness, increased
sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), flu-like illness.
Joint pain (arthralgia), discomfort at the injection site: only seen in adults.
Other side effects reported in children from 3 to 17 years of age
Very common (may affect more than 1 in 10 people):
Headache, muscular pain (myalgia), generally feeling unwell (malaise), shivering (5), reactions
at the injection site: pain, swelling, redness (erythema) (5), hardness (induration) (5).
(5) Common in children from 9 to 17 years of age

Common (may affect up to 1 in 10 people):
Fever, bruising (ecchymosis) at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 3 to 8 years of age:
Temporary reduction in the number of certain types of particles in the blood called platelets; alow number of these can result in excessive bruising or bleeding (transient thrombocytopaenia):
only seen in one child of 3 years of age.
Moaning, restlessness.
Dizziness, diarrhoea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, warmth atthe injection site.
Uncommon (may affect up to 1 in 100 people) in children from 9 to 17 years of age:
Diarrhoea, itching (pruritus) at the injection site.
Other side effects reported in children from 6 to 35 months of age
Very common (may affect more than 1 in 10 people):
Vomiting (1), muscular pain (myalgia) (2), irritability (3), appetite lost (3), generally feeling unwell(malaise) (2), fever.
(1) Uncommon in children from 24 to 35 months of age(3) Rare in children from 24 to 35 months of age-(2) Rare in children less than 24 months of age

Reactions at the injection site: pain/tenderness, redness (erythema).
Headache: only seen in children from 24 months of age.
Drowsiness, unusual crying: only seen in children less than 24 months of age.

Common (may affect up to 1 in 10 people):
Shivering: only seen in children 24 months and older.
Reactions at the injection site: hardness (induration), swelling, bruising (ecchymosis).
Uncommon (may affect up to 1 in 100 people):
Diarrhoea, hypersensitivity.
Rare (may affect up to 1 in 1,000 people):-Flu-like illness, reactions at the injection site: rash, pruritus (itching).

In children from 6 months to 8 years of age who receive 2 doses, side effects are similar after the firstand 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 bythemselves 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):
Pain situated on the nerve route (neuralgia), fits (convulsions), neurological disorders that may
result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, lossof reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barrésyndrome).
Blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in
temporary kidney problems.
Transient thrombocytopenia, lymphadenopathy, paraesthesia in other age groups than thosedescribed above for these side effects.
Reporting of side effects
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 informationon the safety of this medicine.
United Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme atwww.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple AppStore.
Ireland
Health Products Regulatory Authority (HPRA): HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
5.

How to store Quadrivalent Influenza Vaccine (split virion, inactivated)

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 toprotect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how tothrow away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Quadrivalent Influenza Vaccine (split virion, inactivated) contains-The active substances are: Influenza virus (inactivated, split) of the following strains*:

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 (NorthernHemisphere) and EU decision for the 2023/2024 season.
The other ingredients are: a buffer solution containing sodium chloride, potassium chloride,
disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.
Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol9 may be present in very small amounts (see Section 2).
What Quadrivalent Influenza Vaccine (split virion, inactivated) looks like and contents of thepack
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 allpack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
FranceThe distributor is:
United Kingdom:
Sanofi410 Thames Valley Park Drive
Reading
Berkshire
RG6 1PT
UKTel: 0800 035 2525
Ireland:sanofi-aventis Ireland T/A SANOFICitywest Business Campus
Dublin 24Ireland
Tel: +353 (0) 1 4035 600
The Manufacturer is:
Sanofi Pasteur - 1541 avenue Marcel Mérieux - 69280 Marcy l'Etoile - France
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val de Reuil - France
Sanofi Aventis Zrt. - Campona utca 1. (Harbor Park) - 1225 Budapest - Hungary
This medicinal product is authorised in the Member States of the EEA under the following
names:
Member State

Name

Austria

VaxigripTetra Injektionssuspension ineiner Fertigspritze

Lithuania

VaxigripTetra injekcinė suspensijaužpildytame 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 injectableen seringue préremplie

Germany, Italy, Spain, Czech Republic,
Slovakia, Hungary
Ireland, United Kingdom

Vaxigrip Tetra
Quadrivalent Influenza Vaccine (splitvirion, inactivated)

This leaflet was last revised in 06/2023.
----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily
available in case of an anaphylactic reaction following the administration of the vaccine.
The vaccine should be allowed to reach room temperature before use.
Shake before use. Inspect visually prior to administration.
The vaccine should not be used if foreign particles are present in the suspension.
It should not be mixed with other medicinal products in the same syringe.
This vaccine is not to be injected directly into a blood vessel.
See also Section 3. How to use Quadrivalent Influenza Vaccine (split virion, inactivated)