FLUCELVAX TETRA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Flucelvax Tetra injectable suspension in pre-filled syringe

Vaccine against influenza (surface antigen, inactivated, prepared in cell cultures)

Read all of this leaflet carefully before you start receiving this medicine 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.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Flucelvax Tetra and what is it used for
2. What you need to know before you receive Flucelvax Tetra
3. How Flucelvax Tetra is administered
4. Possible side effects
5. Storage of Flucelvax Tetra
6. Contents of the pack and further information

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

Flucelvax Tetra is a vaccine against influenza. 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 components of the vaccine can cause influenza.

Flucelvax Tetra is used to prevent influenza in adults and children from 2 years of age.

The vaccine is directed against four strains of the influenza virus, following the recommendations of the World Health Organization for the 2024/2025 campaign.

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

You should not receive Flucelvax Tetra

If you are allergic to:

• the active substances or any of the other components of this vaccine (listed in section 6).
• beta-propiolactone, cetrimonium bromide, or polysorbate 80, which are residues from the manufacturing process that may be present in minimal amounts.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you receive Flucelvax Tetra.

BEFORE vaccination

• your doctor or nurse will check that medical treatment and adequate supervision are readily available in the rare event of an anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) after administration. This reaction can occur with Flucelvax Tetra, as with all injectable vaccines.
• you should 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 should inform your doctor if your immune system is compromised or if you are receiving treatment that affects it, for example, cancer medication (chemotherapy) or corticosteroids (see section "Other medicines and Flucelvax Tetra").
• you should inform your doctor if you have a bleeding problem or if you bruise easily.
• you may faint after injection with a needle, or even before, so inform your doctor or nurse if you have fainted previously with any injection.

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

Children under 2 years

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

Other medicines and Flucelvax Tetra

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines, including those obtained without a prescription, or if you have recently received 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 plan 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 effect on breastfed infants is expected. Flucelvax Tetra can be administered during breastfeeding.

Driving and using machines

Flucelvax Tetra has no or negligible influence on the ability to drive and use machines.

Flucelvax Tetra contains sodium and potassium

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

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

3. How Flucelvax Tetra is administered

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 small children, depending on muscle size.

Adults and children from 2 years of age

A dose of 0.5 ml.

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

4. Possible side effects

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

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

Very serious side effects

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

• Difficulty breathing, dizziness, weak and rapid pulse, along with skin rash, which are symptoms of an anaphylactic reaction (a very severe allergic reaction)

Serious side effects

Tell 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 can be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by the body's immune system
• Extensive swelling of the limb where the vaccine was injected

Other side effects

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

• Pain at the injection site, bruising, redness, and swelling or hardness at the injection site
• Headache
• Muscle pain
• Fatigue
• Loss of appetite
• Irritability (reported only in children from 2 to <6 years)< li>
• Somnolence (reported only in children from 2 to <6 years)< li>

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

Bruising at the injection site was common in adults, elderly, and children from 9 to <18 years.< p>

Headache was common in the elderly.

Loss of appetite was common in adults, elderly, and children from 9 to <18 years.< p>

Common (may affect up to 1 in 10 people)

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

Vomiting was uncommon in elderly patients

Fever was uncommon in adults and elderly

Frequency not known (cannot be estimated from the available data)

• Paresthesia (tingling or numbness sensation)
• Generalized skin reactions including itching, hives, or non-specific skin rash

Reporting of side effects

If you 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 Pharmacovigilance System for Human Use Medicines at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flucelvax Tetra

Keep this medicine 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 CAD/EXP. The expiry date is the last day of the month shown.

Store in a 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Flucelvax Tetra

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

Strain similar to A/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 complies with the recommendation of the World Health Organization (WHO) (northern hemisphere) and with the EU recommendation for the 2024/2025 season.

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

Appearance and packaging of the product

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

Flucelvax Tetra is a transparent to slightly opalescent suspension.

Each individual syringe contains 0.5 ml of injectable suspension.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Seqirus Netherlands B.V.

Paasheuvelweg 28

1105BJ Amsterdam

Netherlands

You can request more information about this medicine from the local representative of the marketing authorization holder:

Seqirus Spain, S.L., Barcelona

Tel: 937 817 884

Date of last revision of this leaflet: 07/2024

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

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This information is intended only for healthcare professionals:

Medical treatment and adequate supervision should always be readily available in case of an anaphylactic episode, which can rarely occur after vaccine administration.

Shake before use. After shaking, the normal appearance of the vaccine is a transparent to slightly opalescent suspension.

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