Product Information for the User

Flucelvax Tetra Pre-filled Syringe Suspension

Influenza Vaccine (Surface Antigen, Inactivated, Prepared in Cell Cultures)

Read this entire product information carefully before starting to receive this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

1. What is Flucelvax Tetra and how is it used

2. What you need to know before starting to receive Flucelvax Tetra

3. How to administer Flucelvax Tetra

4. Possible adverse effects

5. Storage of Flucelvax Tetra

6. Contents of the package and additional information

Flucelvax Tetra is an influenza vaccine. Flucelvax Tetra is prepared in cell cultures and therefore does not contain egg.

When a person receives the vaccine, the immune system (the body's natural defense system) will produce its own protection against the influenza virus. None of the vaccine components can cause influenza.

Flucelvax Tetra is used to prevent influenza in adults and children aged 2 years and older.

The vaccine is directed against four influenza virus strains following the recommendations of the

World Health Organization for the 2024/2025 Campaign.

Do not receive Flucelvax Tetra

If you are allergic to:

• the active ingredients or any of the other components of this vaccine (listed in section 6).
• beta-propiolactone, cetiltrimetilamonio bromide, or polisorbate 80, which are manufacturing residues that may be present in minimal quantities.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Flucelvax Tetra.

BEFORE VACCINATING

• Your doctor or nurse will check the availability of medical treatment and adequate supervision in the rare case of anaphylactic reaction (a severe allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) after administration. This reaction may occur with Flucelvax Tetra, as with all injected vaccines.
• You must inform your doctor if you have an acute illness with fever. Your doctor may decide to postpone your vaccination until the fever has disappeared.
• You must inform your doctor if your immune system is compromised or if you are receiving a treatment that affects it, for example, chemotherapy or corticosteroids (see section “Other medicines and Flucelvax Tetra”).
• You must inform your doctor if you have a bleeding disorder or if you bruise easily.
• You may faint after the injection with a needle, or even before, therefore, inform your doctor or nurse if you have fainted previously with any injection.

As with all vaccines, Flucelvax Tetra may not protect completely all people who are vaccinated.

Children under 2 years

This vaccine is not currently recommended for children under 2 years, as its safety and efficacy have not been established in this age group.

Other medicines and Flucelvax Tetra

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription, or if you have received recently any other vaccine.

Flucelvax Tetra can be administered at the same time as other vaccines.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor. Influenza vaccines can be administered in any trimester of pregnancy.

Breastfeeding

The use of Flucelvax Tetra during breastfeeding has not been studied. No effects are expected in breastfed infants. Flucelvax Tetra can be administered during breastfeeding.

Driving and operating machinery

The influence of Flucelvax Tetra on the ability to drive and operate machinery is negligible or insignificant.

Flucelvax Tetra contains sodium and potassium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free.”

This vaccine contains potassium, less than 1 mmol (39 mg) per dose; it is essentially

Your doctor or nurse will administer Flucelvax Tetra as an injection into the muscle of the upper arm (deltoid muscle) or into the muscle of the upper and outer thigh in young children, depending on the muscle size.

Adults and children 2 years of age and older

A dose of 0.5 ml.

If your child is under 9 years of age and has never been vaccinated against the flu, a second dose should be administered at least 4 weeks later.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported during clinical studies and general use:

Very serious side effects

Consult your doctor immediately or go to the nearest hospital emergency department if you experience the following side effect – you may need urgent medical attention or hospitalization:

• Difficulty breathing, dizziness, weak and rapid pulse, and skin rash, which are symptoms of anaphylaxis (a severe allergic reaction)

Severe side effects

Inform your doctor immediately if you experience any of the following side effects – you may need medical attention:

• You feel weak, have difficulty moving, or experience numbness or tingling in your limbs. These may be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by the body's own immune system
• Extensive swelling of the limb where the injection was given

Other side effects

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

• Pain, redness, swelling, or hardness at the injection site
• Headache
• Muscle pain
• Fatigue
• Loss of appetite
• Irritability (reported only in children aged 2 to <6)
• Drowsiness (reported only in children aged 2 to <6)

In elderly patients, the following side effects were common: hardness or swelling at the injection site, headache, muscle pain, and fatigue.

Cardinal signs at the injection site were common in adults, elderly patients, and children aged 9 to <18

Headache was common in elderly patients.

Loss of appetite was common in adults, elderly patients, and children aged 9 to <18

Common(may affect up to 1 in 10 people)

• Nausea, vomiting, diarrhea
• Joint pain
• Chills
• Changes in eating habits (reported only in children aged 2 to <6)
• Fever (> 38 °C)

Vomiting was uncommon in elderly patients

Fever was uncommon in adults and elderly patients

Unknown frequency(cannot be estimated from available data)

• Prickling or tingling sensation (paresthesia)
• Generalized skin reactions, including itching, skin blisters (pruritus, urticaria), or non-specific skin rash

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use atwww.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this vaccine after the expiration date that appears on the label and on the box after CAD/EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the pre-filled syringe in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Flucelvax Tetra

• The active ingredients are inactivated surface antigens of the influenza virus (hemagglutinin and neuraminidase) from the following strains*:

Strain similar toA/Wisconsin/67/2022 (H1N1)pdm09(A/Georgia/12/2022 CVR-167)

15 micrograms HA**

Strain similar to A/Massachusetts/18/2022 (H3N2) (A/Sydney/1304/2022, wild type)

15 micrograms HA**

Strain similar to B/Austria/1359417/2021(Singapore/WUH4618/2021, wild type)

15 micrograms HA**

Strain similar to B/Phuket/3073/2013 (B/Singapore/INFTT-16-0610/2016, wild type)

15 micrograms HA**

per 0.5 ml dose

……………………………………….

* propagated in Madin Darby Canine Kidney (MDCK) cells (a special cell culture in which the influenza virus grows)

** hemagglutinin

This vaccine meets the World Health Organization (WHO) recommendation (northern hemisphere) and the EU recommendation for the 2024/2025 campaign.

• The other components are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injection(see section 2: Flucelvax Tetra contains sodium and potassium).

Appearance of the product and contents of the package

Flucelvax Tetra is a pre-filled injectable suspension (injection) in a pre-filled syringe (pre-filled syringe ready for use).

Flucelvax Tetra is a transparent to slightly opalescent suspension.

Each individual syringe contains 0.5 ml of injectable suspension.

Flucelvax Tetra is available in packages of 1 pre-filled syringe with or without needle or 10 pre-filled syringes with or without needles.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Seqirus Netherlands B.V.

Paasheuvelweg 28

1105BJ Amsterdam

Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Seqirus Spain, S.L., Barcelona

Tel: 937 817 884

Date of the last review of this leaflet: 07/2024

Other sources of information

Detailed information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

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This information is intended solely for healthcare professionals:

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic episode, which may rarely occur after administering the vaccine.

Shake before use. After shaking, the normal appearance of the vaccine is a

transparent to slightly opalescent suspension.

The vaccine should be visually inspected for foreign particles or color changes before administration. If foreign particles and/or any physical appearance changes are observed, do not administer the vaccine.