VAXIGRIP TETRA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet:information for the user

Vaxigrip Tetra, injectable suspension in a pre-filled syringe

Influenza vaccine (tetravalent, inactivated, split virion)

Read all of this leaflet carefully before you or your child are vaccinated 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 or pharmacist.
• This vaccine has been prescribed to you or your child, do not pass it on to others, even if their symptoms are the same, as it may harm them.
• If you or your child experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Vaxigrip Tetra and what is it used for
2. What you need to know before you or your child start using Vaxigrip Tetra
3. How to use Vaxigrip Tetra
4. Possible side effects

5 Storage of Vaxigrip Tetra

1. Package contents and additional information

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

Vaxigrip Tetra is a vaccine.

This vaccine is given to you or your child from 6 months of age and is intended to protect you or your child against influenza.

When Vaxigrip Tetra is injected into a person, the immune system (the body's natural defense system) will produce protection (antibodies) against infection.

When the vaccine is administered during pregnancy, it not only protects the pregnant woman but also protects her baby from birth to 6 months of age through the transmission of protection from mother to baby during pregnancy (see also sections 2 and 3).

None of the components of 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 types of strains that can change each year. Due to this potential change in circulating strains each year, as well as the duration of the protection provided by the vaccine, vaccination is recommended every year. There is a higher risk of getting influenza during the cold months between October and March. If you or your child did not get vaccinated in the fall, it is possible to get vaccinated until spring, since you or your child are at risk of getting infected with influenza during that period. Your doctor will be able to recommend the best date for vaccination.

The goal of Vaxigrip Tetra is to protect you or your child against the four strains of the virus contained in the vaccine after about 2 to 3 weeks of injection. The incubation period of influenza is a few days, so if you or your child are exposed to influenza immediately before or after vaccination, you or your child may develop the disease.

The vaccine will not protect you or your child against the common cold, even if some of the symptoms are similar to influenza.

2. What you need to know before you start using Vaxigrip Tetra

To ensure that Vaxigrip Tetra is suitable for you or your child, it is important that you consult your doctor or pharmacist if any of the points described below apply to you or your child. If there is something you do not understand, consult your doctor or pharmacist to clarify it.

Do not use Vaxigrip Tetra

• If you or your child are allergic to:

• The active substances or
• Any of the other components of this vaccine (listed in section 6), or
• Any of the components that may be present in minimal amounts, such as eggs (ovoalbumin or chicken proteins), neomycin, formaldehyde, or octoxinol-9.

• If you or your child have a disease that is accompanied by high or moderate fever or an acute disease, in this case, vaccination will be delayed until you or your child have recovered.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Vaxigrip Tetra.

Consult your doctor before getting vaccinated if you or your child have:

• A weakened immune system (immunodeficiency or treatment with medications that affect the immune system),
• Bleeding problems or bruising easily.

Your doctor will decide if you or your child should receive the vaccine. Before or after any injection, fainting (especially in adolescents) may occur, so you should inform your doctor or nurse if you or your child have fainted after receiving an injection in the past.

Like all vaccines, Vaxigrip Tetra may not fully protect all people who are vaccinated.

Not all babies under 6 months of age born to women vaccinated during pregnancy will be protected.

If, for any reason, you or your child have a blood test a few days after influenza vaccination, please inform your doctor. This is because false-positive results have been observed in serological tests in some recently vaccinated patients.

Children

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

Use of Vaxigrip Tetrawithother medicines

Tell your doctor or pharmacist if you or your child are using, have recently used, or might use any other medicine or vaccine.

• Vaxigrip Tetra can be administered at the same time as other vaccines, in different limbs.
• The immune response may be reduced in the case of immunosuppressive treatments, such as corticosteroids, cytotoxic medications, or radiation therapy.

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, consult your doctor or pharmacist before using this vaccine.

Vaxigrip Tetra can be used in all stages of pregnancy.

Vaxigrip Tetra can be used during breast-feeding.

Your doctor/pharmacist will be able to decide if you should be vaccinated with Vaxigrip Tetra.

Driving and using machines

Vaxigrip Tetra has a negligible influence on the ability to drive and use machines.

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; that is, it is "essentially potassium-free" and "sodium-free".

3. How to use Vaxigrip Tetra

Dosage

Adults: 1 dose of 0.5 ml.

Use in children

Children from 6 months to 17 years of age receive a dose of 0.5 ml.

If your child is under 9 years of age and has not been previously vaccinated against influenza, a second dose of 0.5 ml should be administered after an interval of at least 4 weeks.

If you are pregnant, a dose of 0.5 ml administered during pregnancy may protect your baby from birth to 6 months of age. For more information, ask your doctor or pharmacist.

How Vaxigrip Tetra is administered

Your doctor or nurse will administer the recommended dose of the vaccine with an injection into the muscle or under the skin.

If you or your child receive more Vaxigrip Tetra than you should

In some cases, more doses than recommended were administered by mistake.

In these cases, when adverse events were reported, they were in line with those described after administration of the recommended dose (see Section 4).

If you have any doubts about the use of this medicine, 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 or go immediately to the Emergency Department of the nearest hospital 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 skin rash, itching, hives, redness, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cool and clammy skin, palpitations, dizziness, weakness, or fainting.

Other side effects reported in adults and the elderly

Very common (may affect more than 1 in 10 people)

• Headache, muscle pain (myalgia), general feeling of being unwell (malaise) (1), pain at the injection site.

(1) Common in the elderly

Common (may affect up to 1 in 10 people)

• Fever (2), chills, reactions at the injection site: redness (erythema), swelling, hardness (induration).

(2) Uncommon in the elderly

Uncommon (may affect up to 1 in 100 people)

• Dizziness (3), diarrhea, feeling sick (nausea) (4), fatigue, reactions at the injection site: bruising (ecchymosis), itching (pruritus), and heat.

(3) Rare in adults (4) Rare in the elderly

• Hot flushes: only observed in the elderly.
• Swelling of the lymph nodes in the neck, armpit, or groin (lymphadenopathy): only observed in adults.

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

• Abnormal sensations, such as tingling or numbness (paresthesia), drowsiness, increased sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), flu-like illness.
• Joint pain (arthralgia), reactions at the injection site: only observed 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, muscle pain (myalgia), general feeling of being unwell (malaise), chills (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 at the injection site (ecchymosis).

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

• Temporary decrease in the number of certain blood cells called platelets; when the number is low, it can lead to excessive bruising in the skin or bleeding (transient thrombocytopenia): only observed in a 3-year-old child
• Crying, irritability
• Dizziness, diarrhea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, heat at the injection site.

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

• Diarrhea, itching at the injection site (pruritus).

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), muscle pain (myalgia) (2), irritability (3), loss of appetite (3), general feeling of being unwell (malaise) (2), fever.

(1) Uncommon in children from 24 to 35 months of age (2) Rare in children under 24 months of age

(3) Rare in children from 24 to 35 months of age.

• Reactions at the injection site: pain/pain on palpation, redness (erythema).
• Headache: only observed in children from 24 months of age onwards.
• Drowsiness, abnormal crying: only observed in children under 24 months of age.

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

• Chills: only observed in children from 24 months of age onwards.
• Reactions at the injection site: hardness (induration), swelling, bruising (ecchymosis)

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

• Diarrhea, hypersensitivity.

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

• Flu-like illness, reactions at the injection site: rash, itching (pruritus).

In children from 6 months to 8 years of age who receive 2 doses, the side effects are similar after both the first and second doses. Some side effects may occur after the administration of the second dose in children from 6 months to 35 months of age.

These side effects, when observed, usually occurred within the first 3 days following vaccination and disappeared on their own within 1 to 3 days after starting. Most of these side effects were mild.

In general, side effects were less frequent in the elderly than in adults and children.

The following side effects have been observed after administering Vaxigrip. These side effects may also occur with Vaxigrip Tetra:

• Pain along the nerve pathway (neuralgia), seizures (convulsions), neurological disorders that can result in stiffness in the neck, confusion, numbness, pain, and weakness of the limbs, loss of balance, loss of reflexes, paralysis of a part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
• Inflammation of blood vessels (vasculitis) that can lead to skin rashes and, in very rare cases, temporary kidney problems.
• Transient thrombocytopenia, lymphadenopathy, paresthesia in other age groups different from those described above for these side effects.

Reporting of side effects

If you or your child experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vaxigrip Tetra

Keep this medicine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the syringe in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Vaxigrip Tetra Composition

• The active ingredients are: Influenza virus (fractionated, inactivated) of the following strains*:

• Strain similar to A/Victoria/4897/2022 (H1N1)pdm09: (IVR-238)........15 micrograms HA**
• Strain similar to A/Croatia/10136RV/2023 (H3N2): (X-425)..............15 micrograms HA**
• Strain similar to B/Austria/1359417/2021: B/Michigan/01/2021 ..…....15 micrograms HA**
• B/Phuket/3073/2013..............................................................................15 micrograms HA**

Per 0.5 ml dose

• grown in embryonated chicken eggs from healthy chickens

** hemagglutinin

This vaccine complies with the recommendations of the World Health Organization (Northern Hemisphere) and the decision of the European Union for the 2025-2026 campaign.

• The other components are a buffer solution containing sodium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride, and water for injectable preparations.

Some components such as eggs (ovoalbumin, chicken proteins), neomycin, formaldehyde, or octoxinol-9 may be present in very small quantities (see section 2).

Product Appearance and Container Content

After careful shaking, the vaccine is a slightly whitish and opalescent liquid.

Vaxigrip Tetra is presented in a pre-filled syringe containing 0.5 ml of injectable suspension, with a fixed needle or without a needle (packs of 1, 10, or 20) or with a safety needle (in packs of 1 or 10).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer:

The manufacturer responsible for batch release is:

Sanofi Winthrop Industrie

1541 avenue Marcel Mérieux

69280 Marcy l’Etoile

France

or

Sanofi Winthrop Industrie

Voie de l’Institut – Parc Industriel d’Incarville

B.P 101

27100 Val de Reuil

France

or

SANOFI-AVENTIS ZRT

Campona U.1 (Harbor Park )

Budapest 1225

Hungary

Local Representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of thisleaflet: May 2025

Other sources of information

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://vaxigriptetra-nh.info.sanofi

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This information is intended only for doctors or healthcare professionals:

As with all injectable vaccines, medical treatment and appropriate supervision should be available in case of an anaphylactic episode following administration of the vaccine.

The vaccine should reach room temperature before use.

Shake before use.

The vaccine should not be used if it contains foreign particles in the suspension.

It should not be mixed with other medicines in the same syringe.

This vaccine should not be injected directly into any blood vessel.

See also section 3. How to use Vaxigrip Tetra.

Instructions for using the safety needle with the pre-filled Luer Lock syringe:

The disposal of unused vaccines and all materials that have come into contact with them will be carried out in accordance with local regulations.