Vaxigrip Tetra: detailed information

Package leaflet: Information for the user

Vaxigrip Tetra, suspension for injection in a pre-filled syringe

Quadrivalent influenza vaccine (inactivated, split virion)
Please read all of this leaflet carefully before you or your child receive this vaccine because it contains important information for you and your child.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This vaccine has been prescribed for you or your child only. Do not give it to others.
If you or your child experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Vaxigrip Tetra is and what it is used for
What you need to know before you or your child receive Vaxigrip Tetra
How to use Vaxigrip Tetra
Possible side effects
How to store Vaxigrip Tetra
Contents of the pack and other information

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

Vaxigrip Tetra is a vaccine. This vaccine, administered to you or your child from the age of 6 months, helps protect you or your child against influenza.
When Vaxigrip Tetra is administered, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. When administered during pregnancy, the vaccine helps protect pregnant women, but also helps protect their baby from birth up to the age of 6 months through the transfer of protection from mother to baby during pregnancy (see also sections 2 and 3).
None of the components contained in the vaccine can cause influenza.
The use of Vaxigrip Tetra should be based on official recommendations.
Influenza is a disease that can spread rapidly and is caused by different strains, which may change every year. Due to these potential annual changes in circulating strains, as well as the duration of protection induced by the vaccine, vaccination is recommended every year. The highest risk of contracting influenza occurs during the colder months between October and March. If you or your child have not been vaccinated in the autumn, it is still reasonable to proceed with vaccination until the spring season, as you or your child remain at risk of contracting influenza until that time of year. Your doctor will be able to advise you on the best time for vaccination.
Vaxigrip Tetra is indicated to protect you or your child against the four virus strains contained in the vaccine, starting about 2-3 weeks after vaccination. Moreover, if you or your child have been exposed to influenza immediately before or after being vaccinated, you or your child may still contract the disease, as the incubation period of influenza is several days.
The vaccine will not protect you or your child against the common cold, even though some of its symptoms may resemble those of influenza.

2. What you should know before you or your child receive Vaxigrip Tetra

To ensure that Vaxigrip Tetra is an appropriate vaccine for you or your child, it is important to inform your doctor or pharmacist if you or your child are in any of the conditions listed below. If any information is unclear, please ask your doctor or pharmacist for clarification.

Do not use Vaxigrip Tetra
if you or your child are allergic:

to the active substances, or
to any of the other components of this vaccine (listed in section 6), or
to 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 a high or moderate fever or an acute illness, vaccination should be postponed until you or your child have recovered.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Vaxigrip Tetra.
Inform your doctor before vaccination if you or your child have:
A weakened immune response (immunodeficiency or treatment with medicines affecting the immune system),
A condition causing easy bruising or bleeding problems.
Your doctor will decide whether you or your child should receive the vaccine.
Fainting can occur (particularly in adolescents) following, or even before, any needle injection. Therefore, inform your doctor or nurse if you or your child have previously fainted after an injection.
As with all vaccines, Vaxigrip Tetra may not fully protect all vaccinated individuals.
Not all infants under 6 months of age born to women who were vaccinated during pregnancy will be protected.
If, for any reason, you or your child undergo a blood test a few days after influenza vaccination, inform your doctor. This is important because false positive blood test results have been observed in some patients recently vaccinated.

Children
The use of Vaxigrip Tetra is not recommended in children under 6 months of age.

Other medicines and Vaxigrip Tetra
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other vaccines or medicines.
Vaxigrip Tetra may be administered simultaneously with other vaccines, provided the injections are given in different limbs.
The immune response may be reduced during treatment with immunosuppressive medicines such as corticosteroids, cytotoxic drugs, or radiotherapy.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before receiving this vaccine.
Vaxigrip Tetra may be used during all stages of pregnancy.
Vaxigrip Tetra may be used during breastfeeding.
Your doctor/pharmacist will decide whether you should be vaccinated with Vaxigrip Tetra.

Driving and using machines
Vaxigrip Tetra does not affect, or affects only negligibly, the ability to drive vehicles or operate machinery.

Vaxigrip Tetra contains potassium and sodium
This medicine contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "potassium-free" and "sodium-free".

3. How to use Vaxigrip Tetra

Dosage
Adults should receive a single dose of 0.5 mL.
Use in children
Children from 6 months to 17 years of age should receive a dose of 0.5 mL.
If your child is under 9 years of age and has not previously been vaccinated against influenza, a second dose of 0.5 mL of vaccine should be administered after an interval of at least 4 weeks.
If you are pregnant, administering a 0.5 mL dose during pregnancy may protect your baby from birth up to 6 months of age. Please consult your doctor or pharmacist for further information.
How Vaxigrip Tetra is administered
The doctor or nurse will administer the recommended dose of vaccine by intramuscular or subcutaneous injection.
If you or your child receive more Vaxigrip Tetra than you should
In some cases, more than the recommended dose has been inadvertently administered. In such cases, any reported side effects were consistent with those described after administration of the recommended dose (section 4).
Contact your doctor or pharmacist if you have any further questions regarding the use of this medicine.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody will get them.

Allergic reactions
Seek immediate medical advice from your doctor or healthcare professional, or go immediately to the nearest hospital emergency department if you or your child experience:
Allergic reactions (reported as rare: may affect up to 1 in 1,000 people) which 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 and clammy skin, palpitations, dizziness, weakness or fainting.

Other side effects reported in adults and elderly people
Very common (may affect more than 1 in 10 people):

Headache, muscle pain (myalgia), general feeling of being unwell, pain at injection site. Common in elderly subjects.

Common (may affect up to 1 in 10 people):

Fever, chills, injection site reactions: redness (erythema), swelling, hardness (induration). Uncommon in elderly subjects.

Uncommon (may affect up to 1 in 100 people):

Dizziness, diarrhoea, feeling unwell (nausea), fatigue, injection site reactions: bruising (ecchymosis), hives (pruritus) and warmth. Rare in adults. Rare in elderly subjects.
Hot flushes: observed only in elderly subjects.
Swelling of glands in the neck, armpits or groin (lymphadenopathy): observed only in adults.

Rare (may affect up to 1 in 1,000 people):

Abnormal sensations of touch, pain, heat and cold (paraesthesia), drowsiness, increased sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), influenza-like illness.
Joint pain (arthralgia), discomfort at injection site: observed only in adults.

Other side effects reported in children aged 3 to 17 years
Very common (may affect more than 1 in 10 people):

Headache, muscle pain (myalgia), general feeling of being unwell, chills, injection site reactions: pain, swelling, redness (erythema), hardness (induration).

Common (may affect up to 1 in 10 people):

Fever, bruising (ecchymosis) at injection site.

Uncommon (may affect up to 1 in 100 people) in children aged 3 to 8 years:

Temporary reduction in the number of certain blood particles called platelets; a low number of these particles may cause bruising or excessive bleeding (transient thrombocytopenia): observed only in one 3-year-old child.
Unusual crying, irritability.
Dizziness, diarrhoea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, warmth at injection site.

Uncommon (may affect up to 1 in 100 people) in children aged 9 to 17 years:

Diarrhoea, itching at injection site.

Other side effects reported in children aged 6 to 35 months
Very common (may affect more than 1 in 10 people):

Vomiting, muscle pain (myalgia), irritability, loss of appetite, general feeling of being unwell (malaise), fever.
Reaction at injection site: pain/tenderness, redness (erythema).
Headache: observed only in children from 24 months of age.
Drowsiness, unusual crying: observed only in children under 24 months of age.

Common (may affect up to 1 in 10 people):

Chills: observed in children from 24 months of age.
Reaction at 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):

Influenza-like illness, reaction at injection site: rash, itching (urticaria).

In children aged 6 months to 8 years who received two doses, side effects were similar after the first and second dose. Fewer side effects may occur after the second dose in children aged 6 to 35 months.
When they occur, side effects usually appear within the first 3 days after vaccination and resolve spontaneously within 1–3 days after administration. The intensity of the observed side effects has been mild.
Overall, side effects have generally been less frequent in the elderly than in adults and children.

The following side effects have been reported after administration of Vaxigrip. These side effects may also occur with Vaxigrip Tetra:

Pain along the course of a nerve (neuralgia), seizures, neurological disorders which may cause stiff neck, confusion, numbness, pain and weakness of limbs, loss of balance, loss of reflexes, total or partial paralysis of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
Inflammation of blood vessels (vasculitis) which may cause skin rashes and, in very rare cases, temporary kidney problems.
Transient thrombocytopenia, lymphadenopathy, paraesthesia in age groups different from those described above for these side effects.

Reporting of side effects
If you or your child experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vaxigrip Tetra

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date 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 packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vaxigrip Tetra contains
The active substances are: Influenza virus ("split" inactivated) from the following strains*:
A/Victoria/4897/2022 (H1N1)pdm09 – equivalent strain (A/Victoria/4897/2022, IVR-238)
………………………………………………………………………………… 15 micrograms HA**
A/Croatia/10136RV/2023 (H3N2) – equivalent strain (A/Croatia/10136RV/2023, X-
425A)……………………………………………………………………………… 15 micrograms HA**
B/Austria/1359417/2021 – equivalent strain (B/Michigan/01/2021, wild
type)……………………………………………………………………………… 15 micrograms HA**
B/Phuket/3073/2013 – equivalent strain (B/Phuket/3073/2013, wild
type)…………………………………………………………………………… 15 micrograms HA**
Per 0.5 mL dose
* Grown in embryonated hens' eggs from healthy chicken flocks
** Haemagglutinin
The composition of this vaccine is in accordance with WHO (World Health Organization) recommendations (Northern Hemisphere) and EU decisions adopted for the 2025/2026 season.
The excipients are: a buffer solution containing sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium hydrogen phosphate, and water for injections.
Some components such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxynol-9 may be present in very small amounts (see section 2).

Description of the appearance of Vaxigrip Tetra and contents of the pack
After gentle shaking, the vaccine appears as a colourless, opalescent liquid.
Vaxigrip Tetra is an injectable suspension supplied in a 0.5 mL pre-filled syringe, with or without a pre-attached needle (packs of 1, 10 or 20 units) or with a safety needle (packs of 1 or 10 units). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder in Italy is:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Representative for Italy
Sanofi S.r.l.
Viale L. Bodio, 37/B
20158 Milano
Italy
The Manufacturers are:
Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
Sanofi Aventis Zrt. - Campona utca 1. (Harbor Park) - 1225 Budapest - Hungary

This medicinal product is authorised in the European Union Member States under the following names:

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, Luxembourg: Vaxigrip Tetra suspension injectable en seringue préremplie.
Germany, Italy, Spain, Czech Republic, Slovakia, Hungary: Vaxigrip Tetra.
Ireland, United Kingdom (Northern Ireland): Quadrivalent influenza vaccine (split virion, inactivated).

The most up-to-date information on this product is available by scanning the QR code on the outer packaging with a smartphone or by visiting the following URL: https://vaxigriptetra-nh.info.sanofi

The following information is intended exclusively for healthcare professionals:
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of an anaphylactic reaction following administration of the vaccine.
The vaccine should be brought to room temperature before use.
Shake well before use. Visually inspect before administration.
The vaccine must not be used if foreign particulate matter is observed in the suspension.
The vaccine must not be mixed in the same syringe with other medicinal products.
This vaccine must not be injected directly into a blood vessel.
See also section 3. How to use Vaxigrip Tetra
< Preparation for administration
Instructions for use of the safety needle on the pre-filled syringe with Luer Lock:

Figure A: Safety needle (inside the housing)	Figure B: Components of the safety needle (ready for use)

Step 1: To attach the needle to the syringe, remove the cap from the connector to expose the needle hub and gently twist the needle into the syringe's Luer Lock adapter until slight resistance is felt.
Step 2: Remove the safety needle from its carrier. The needle is covered by the safety shield and the needle cap.

Step 3: A: Remove the safety shield from the needle and orient it toward the syringe barrel at the angle shown. B: Remove the needle cap.
Step 4: At the end of the injection, lock (activate) the safety shield using one of the three (3) illustrated single-handed activation techniques: surface, thumb, or finger. Note: activation is confirmed by an audible and/or tactile "click".
Step 5: Visually inspect the activation of the safety shield. The safety shield must be fully closed (activated), as shown in Image C. Image D shows that the safety shield is NOT fully closed (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by forcing the needle out of the safety shield.

Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.