Flucelvax suspension for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Flucelvax injectable suspension in pre-filled syringe

Influenza vaccine (surface antigen, inactivated, cell culture-derived)

Read this entire leaflet carefully before you start receiving this medicine, because it contains important information for you.

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

Leaflet Contents

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

1. What Flucelvax is and what it is used for

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

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

Flucelvax is used to prevent influenza in adults and children from 6 months of age.

The vaccine targets three strains of the influenza virus, in accordance with the recommendations of the World Health Organization for the 2025/2026 season.

2. What you need to know before receiving Flucelvax

Do not receive Flucelvax

If you are allergic to:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving Flucelvax.

BEFORE vaccination

• your doctor or nurse will ensure that appropriate medical treatment and adequate supervision are readily available in the rare event of an anaphylactic reaction (a severe allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) following administration. Such a reaction may occur with Flucelvax, as with all injectable vaccines.
• you must inform your doctor if you have an acute illness accompanied by fever. Your doctor may decide to postpone your vaccination until the fever has resolved.
• you must 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”).
• you must inform your doctor if you have a bleeding disorder or bruise easily.
• you may faint after an injection with a needle, or even before; therefore, inform your doctor or nurse if you have previously fainted during or after an injection.

As with all vaccines, Flucelvax may not fully protect all individuals who are vaccinated.

Children under 6 months

This vaccine is not currently recommended for children under 6 months of age, as safety and efficacy have not been established in this age group.

Other medicines and Flucelvax

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, or if you have recently received any other vaccine.

Flucelvax 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 during any trimester of pregnancy.

Breastfeeding

The use of Flucelvax during breastfeeding has not been studied. No effects on breastfed infants are expected. Flucelvax may be administered during breastfeeding.

Driving and using machines

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

Flucelvax contains sodium chloride and potassium chloride

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 “potassium-free”.

3. How Flucelvax is administered

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

Adults and children from 6 months of age

A dose of 0.5 ml.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

Very serious side effects

Contact 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 together with a 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 the 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 administered

Other side effects

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

• Pain at the injection site, bruising, redness, hardening or swelling at the injection site
• Headache
• Muscle pain
• Fatigue
• Loss of appetite
• Irritability (reported only in children aged 6 months to <6 years)
• Drowsiness (reported only in children aged 6 months to <6 years)
• Change in eating habits (reported only in children aged 6 months to <6 years)
• Fever (≥38 °C)
• Diarrhea

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

Bruising at the injection site was common in adults, elderly individuals, and children aged 9 to <18 years.

Headache was common in elderly individuals.

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

Fever was uncommon in adults and elderly individuals, and common in children aged 4 to <18 years.

Common (may affect up to 1 in 10 people)

• Nausea, vomiting, diarrhea
• Joint pain
• Chills

Vomiting was uncommon in elderly patients.

Frequency not known (cannot be estimated from available data)

• Sensation of tingling and numbness (paresthesia)
• Generalized skin reactions including itching, skin blisters (pruritus, urticaria), or nonspecific rash

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flucelvax

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

Do not use this vaccine after the expiry date stated on the label and the carton following CAD/EXP. The expiry date refers to the last day of the month indicated.

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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Flucelvax

• The active substances are inactivated surface antigens of the influenza virus (haemagglutinin and neuraminidase) from 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/District of Columbia/27/2023 (H3N2) (A/Victoria/800/2024, CVR-289) 15 micrograms HA**

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

** haemagglutinin

This vaccine complies with the World Health Organization (WHO) (northern hemisphere) recommendation and with the EU recommendation for the 2025-2026 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 contains sodium chloride and potassium chloride).

Appearance of the product and contents of the pack

Flucelvax is an injectable suspension (injection) in a pre-filled syringe (ready-to-use syringe). Flucelvax is a suspension ranging from clear to slightly opalescent.

Each single syringe contains 0.5 ml of injectable suspension.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Seqirus Netherlands B.V.

Paasheuvelweg 28

1105BJ Amsterdam

The Netherlands

More information about this medicine can be requested from the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this summary: 07/2025

Other sources of information

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

This information is intended for healthcare professionals only:

Appropriate medical treatment and supervision must always be readily available in case of an anaphylactic reaction, which may rarely occur after administration of the vaccine.

Shake well before use. After shaking, the vaccine normally appears as a clear to slightly opalescent suspension.

The vaccine should be inspected visually for foreign particles and discoloration prior to administration. Do not administer the vaccine if foreign particles and/or any change in physical appearance are observed.