Fluad injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluad injectable suspension in pre-filled syringe

Influenza vaccine (surface antigen, inactivated, with adjuvant)

Read all of this leaflet carefully before you are given 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, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Fluad is and what it is used for

Fluad is a flu vaccine.

When a person is vaccinated, 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 the flu.

Fluad is used to prevent influenza in individuals aged 50 years and older.

The vaccine is directed against the influenza virus strains recommended by the World Health Organization for the 2025/2026 season.

2. What you need to know before receiving Fluad

Do not receive Fluad

• if you are allergic to:

• the active substances or any of the other ingredients of this medicine (listed in section 6).

• egg or chicken proteins (such as ovalbumin), kanamycin and neomycin sulfate, formaldehyde, cetyltrimethylammonium bromide (CTAB), or hydrocortisone, which are residues from the manufacturing process and may be present in minimal amounts.

• If you have previously experienced a severe allergic reaction (e.g., anaphylaxis) to an influenza vaccine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before receiving Fluad.

BEFORE vaccination

• Your doctor or nurse will ensure that appropriate medical treatment and supervision are readily available in case a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) occurs after administration. Such a reaction may occur with Fluad, as with all injectable vaccines.
• You must inform your doctor if you have an illness associated with fever. Your doctor may decide to postpone your vaccination until the fever has resolved.
• You must inform your doctor if your immune system is weakened or if you are receiving treatment that affects it, for example, cancer medication (chemotherapy) or corticosteroids (see section “Other medicines and Fluad”).
• 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 an injection.

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

Children

Fluad is not recommended for use in children.

Other medicines and Fluad

Tell 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.

Pregnancy and breastfeeding

This vaccine is intended for adults aged 50 years and older. It must not be used in women who are or may be pregnant, or during breastfeeding.

Driving and using machines

The effect of Fluad on the ability to drive and operate machinery is none or negligible.

Fluad contains potassium and sodium

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

This vaccine contains potassium, less than 1 mmol (39 mg) per dose; hence, it is essentially “potassium-free”.

3. How Fluad is administered

Your doctor or nurse will administer Fluad as an injection into the muscle of your upper arm (deltoid muscle).

Adults aged 50 years and older:

One dose of 0.5 ml

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Contact your doctor immediately or go to the nearest hospital emergency department if you experience the following serious adverse reactions, as you may require urgent medical attention or hospitalization:

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

The following adverse reactions were reported during clinical trials in adults aged 50 years and older.

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

• Pain or tenderness at the injection site
• Fatigue
• Headache
• Joint pain (arthralgia)¹
• Muscle pain (myalgia)¹

¹ Reported as common in elderly subjects aged 65 years and older.

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

• Redness at the injection site (erythema)
• Hardening of the skin at the injection site (induration)
• Diarrhea
• Chills
• Nausea
• Loss of appetite
• Bruising at the injection site (ecchymosis)
• Influenza-like symptoms²
• Fever (≥38 °C)³

² Reported in elderly subjects aged 65 years and older.
³ Reported as uncommon in elderly subjects aged 65 years and older.

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

• Vomiting
• Swelling of the glands in the neck, armpit, or groin (lymphadenopathy)

Most of the adverse reactions were mild or moderate and resolved within 3 days of onset.

In addition to the adverse reactions listed above, the following adverse reactions have occurred occasionally during general use of the adjuvanted quadrivalent influenza vaccine or Fluad.

• Reduction in the number of certain blood particles called platelets; low levels may cause bruising or excessive bleeding (thrombocytopenia)
• Swelling, pain, and redness at the injection site (injection site cellulitis-like reaction)
• Extensive swelling of the limb where the medicine was injected, lasting for more than one week
• General weakness or lack of energy (asthenia), general feeling of discomfort (malaise)
• Fever (pyrexia)
• Muscle weakness
• Nerve pain (neuralgia), unusual sensations of touch, pain, heat, and cold (paresthesia), seizures (convulsions), neurological disorders that may cause neck stiffness, confusion, numbness, pain, and weakness in the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
• Skin reactions that may spread throughout the body, such as itching of the skin (pruritus, urticaria), redness of the skin (erythema), non-specific rash, severe skin rash (erythema multiforme)
• Swelling more noticeable in the head and neck, including the face, lips, tongue, throat, or any other part of the body (angioedema)
• Swelling of blood vessels that may cause skin rashes (vasculitis) and temporary kidney problems
• Fainting, feeling faint (syncope, presyncope)

Reporting of adverse reactions

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

5. Storage of Fluad

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

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Discard the vaccine if it has been frozen. Keep the prefilled syringe in the outer packaging to protect it from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Fluad

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

*propagated in embryonated chicken eggs obtained from breeding flocks of healthy hens and adjuvanted with MF59C.1

**haemagglutinin

This vaccine complies with the World Health Organization (WHO) recommendation (northern hemisphere) and with the European Union (EU) recommendation for the 2025/2026 season.

• This vaccine contains MF59C.1 as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, enhance, or prolong the protective effects of the vaccine. MF59C.1 is an adjuvant containing per 0.5 ml dose: squalene (9.75 mg), polysorbate 80 (1.175 mg), sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg), and citric acid (0.04 mg).

• The other components are_sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, and water for injections.

Presentation of the product and contents of the pack

Fluad is an injectable suspension in a pre-filled syringe. Fluad is a white, milky suspension. Each pre-filled syringe contains a single dose (0.5 ml) of injectable suspension. Fluad is available in packs containing 1 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, 1105 BJ Amsterdam, The Netherlands

More information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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.

Gently shake before use. After shaking, the vaccine normally appears as a white, milky suspension.

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

If using a pre-filled syringe supplied without a needle, remove the syringe tip cap and attach a needle for administration. A sterile needle of appropriate size for intramuscular injection should be used. For LuerLock syringes, remove the syringe tip cap by unscrewing it counterclockwise. After removing the syringe tip cap, attach a needle to the syringe by screwing it clockwise until it is securely in place. Once the needle is firmly fixed, remove the needle protector and administer the vaccine.