Flucelvax

Package leaflet: Information for the user

Flucelvax suspension for injection in a pre-filled syringe

Influenza vaccine (surface antigen, inactivated, produced in cell cultures)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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 components.
After administration of the vaccine, the immune system (the body's natural defence system) produces antibodies against the influenza virus. None of the vaccine components can cause influenza.
Flucelvax is used to prevent influenza in adults and children from the age of 6 months.
The vaccine has been formulated to target the three influenza virus strains according to the recommendations of the World Health Organization for the 2025/2026 season.

2. What you need to know before receiving Flucelvax

Do not use Flucelvax
if you are allergic:

• to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• to beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80; these substances are residual traces from the manufacturing process.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Flucelvax.
BEFORE receiving the vaccine:

• Your doctor or nurse will ensure that appropriate medical treatment and 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) following administration. Such a reaction may occur with Flucelvax, as with all injectable vaccines.
• Inform your doctor if you have an acute illness associated with fever. Your doctor may decide to postpone vaccination until the fever has resolved.
• Inform your doctor if your immune system is weakened or if you are receiving treatment that affects the immune system, e.g. anticancer drugs (chemotherapy) or corticosteroids (see section “Other medicines and Flucelvax”).
• Inform your doctor if you have bleeding disorders or bruise easily.
• Fainting may occur during or even before an injection with a needle; therefore, inform your doctor or nurse if you have previously fainted during injections.

As with all vaccines, Flucelvax may not fully protect all vaccinated individuals.
Children under 6 months of age
This vaccine is not currently recommended for children under 6 months of age, as safety and efficacy in this age group have not been established.
Other medicines and Flucelvax
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, or if you have recently received any other vaccine.
Flucelvax may be administered concurrently with other vaccines.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Influenza vaccines may be administered during any trimester of pregnancy.
Breastfeeding
Use during breastfeeding has not been studied. Effects on breastfed infants are not expected. Flucelvax may be administered during breastfeeding.
Driving and using machines
Flucelvax does not affect or has a negligible effect on the ability to drive vehicles and operate machinery.
Flucelvax contains sodium chloride and potassium chloride
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
This vaccine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium-free’.

3. How Flucelvax is administered

Flucelvax is administered to you by a doctor or nurse as an injection into the muscle of the upper arm (deltoid muscle) or into the upper and outer part of the thigh muscle in young children, depending on muscle size.
Adults and children aged 6 months and older:
One 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 should be administered at least 4 weeks after the first dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during clinical studies and general use:

Very serious side effects
Immediately inform your doctor or go to the nearest hospital emergency department if you experience
symptoms of the following side effect, as you may require urgent medical treatment or hospitalisation:

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

Serious side effects
Immediately inform your doctor if you experience any of the following side effects, as you may require
medical intervention:

• Feeling weak, difficulty moving, or experiencing numbness or tingling in the limbs. These may be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by the 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 injection site, bruising, redness, hardening or swelling at 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)
• Changes in eating habits (reported only in children aged 6 months to < 6 years)
• Fever (≥ 38 °C)
• Diarrhoea
  Hardening or swelling at injection site, headache, muscle pain and fatigue were common in elderly people. Bruising at injection site was common in adults, elderly people and children aged 9 to < 18 years. Headache was common in elderly people. Loss of appetite was common in adults, elderly people and children aged 9 to < 18 years. Fever was uncommon in adults and elderly people and common in children aged 4 to < 18 years.

Common (may affect up to 1 in 10 people)

• Nausea, vomiting
• Joint pain
• Chills
  Vomiting was uncommon in elderly people.

Not known (frequency cannot be estimated from the available data)

• Sensation of numbness and tingling (paraesthesia)
• Generalised skin reactions, including itching sensation, skin bumps (pruritus, urticaria) or non-specific rash

Reporting of side effects
in Annex V. By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Flucelvax

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 the carton after
EXP / 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 pre-filled 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Flucelvax contains

• The active substance consists of inactivated influenza virus surface antigens (haemagglutinin and neuraminidase), derived from the following equivalent strains*:

A/Wisconsin/67/2022 (H1N1)pdm09-equivalent strain (A/Georgia/12/2022, CVR-167)
15 micrograms HA**
A/District of Columbia/27/2023 (H3N2)-equivalent strain (A/Victoria/800/2024, CVR-289)
15 micrograms HA**
B/Austria/1359417/2021-equivalent strain (B/Singapore/WUH4618/2021, wild type)
15 micrograms HA**
per 0.5 mL dose
……………………………………….
* propagated in Madin Darby Canine Kidney (MDCK) cells (these are specific cell cultures
in which the influenza virus is grown)
** HA = haemagglutinin
The vaccine complies with the World Health Organization (WHO) recommendations (northern hemisphere)
and the EU decision for the 2025/2026 season.

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

Description of the appearance of Flucelvax and contents of the pack
Flucelvax is an injectable suspension (injection) in a pre-filled syringe (ready-to-use syringe).
Flucelvax is a solution ranging from clear to slightly opalescent.
A single syringe contains 0.5 mL of injectable suspension.
Flucelvax is available in packs containing 1 pre-filled syringe with or without needle, or 10 pre-filled syringes with or without needle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105 BJ Amsterdam
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Seqirus Netherlands B.V. Nederland/Netherlands Seqirus Netherlands B.V. Nyderlandai
Tel: +31 (0) 20 204 6900 Tel: +31 (0) 20 204 6900

България Luxembourg/Luxemburg
Seqirus Netherlands B.V. Нидерландия Seqirus Netherlands B.V. Netherlands
Тел.: +31 (0) 20 204 6900 Tél/Tel: +31 (0) 20 204 6900

Česká republika Magyarország
Seqirus Netherlands B.V. Nizozemsko Seqirus Netherlands B.V. Hollandia
Tel: +31 (0) 20 204 6900 Tel.: +31 (0) 20 204 6900

Danmark Malta
Seqirus Netherlands B.V. Holland Seqirus Netherlands B.V. In-Netherlands
Tlf: +31 (0) 20 204 6900 Tel: +31 (0) 20 204 6900

Deutschland Nederland
Seqirus GmbH Seqirus Netherlands B.V. Amsterdam
Tel: 0800 360 10 Tel: +31 (0) 20 204 6900

Eesti Norge
Seqirus Netherlands B.V. Holland Seqirus Netherlands B.V. Nederland
Tel: +31 (0) 20 204 6900 Tlf: +31 (0) 20 204 6900

Ελλάδα Österreich
WIN MEDICA Α.Ε. Vifor Pharma Österreich GmbH
Τηλ: +30 210 7488821 Tel: +43 (1) 41 64 7770

España Polska
Seqirus Spain, S.L., Barcelona Seqirus Netherlands B.V. Holandia
Tel: 937 817 884 Tel.: +31 (0) 20 204 6900

France Portugal
Vifor France Seqirus Netherlands B.V. Países Baixos
Tel: 0800 400 160 Tel: +31 (0) 20 204 6900

Hrvatska România
Seqirus Netherlands B.V. Nizozemska Seqirus Netherlands B.V. Olanda
Tel: +31 (0) 20 204 6900 Tel: +31 (0) 20 204 6900

Ireland Slovenija
Seqirus Netherlands B.V., The Netherlands Seqirus Netherlands B.V. Nizozemska
Tel: +31 (0) 20 204 6900 Tel: +31 (0) 20 204 6900

Ísland Slovenská republika
Seqirus Netherlands B.V. Holland Seqirus Netherlands B.V. Holandsko
Sími: +31 (0) 20 204 6900 Tel: +31 (0) 20 204 6900

Italia Suomi/Finland
Seqirus S.r.l. Siena Seqirus Netherlands B.V. Alankomaat
Tel: +39 0577 096400 Puh/Tel: +31 (0) 20 204 6900

Κύπρος Sverige
Seqirus Netherlands B.V. Ολλανδία Seqirus Netherlands B.V. Nederländerna
Τηλ: +31 (0) 20 204 6900 Tel: +31 (0) 20 204 6900

Latvija
Seqirus Netherlands B.V. Nīderlande
Tel: +31 (0) 20 204 6900

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

The following information is intended exclusively for healthcare professionals:

Appropriate medical treatment and supervision must always be readily available in the rare event of anaphylactic reactions following vaccine administration.
Shake well before use. After shaking, the vaccine normally appears as a suspension ranging from clear to slightly opalescent.
Visually inspect the vaccine for the presence of particulate matter and discoloration prior to administration. Do not administer the vaccine if foreign particulate matter and/or physical changes in appearance are present.