Fluad

Package leaflet: Information for the user

Fluad suspension for injection in pre-filled syringe

Influenza vaccine (surface antigen, inactivated, adjuvanted)
Please read this leaflet carefully before using 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 Fluad is and what it is used for
2. What you need to know before receiving Fluad
3. How Fluad is given
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 an influenza vaccine.
After administration of the vaccine, the immune system (the body's natural defence system) produces antibodies against the influenza virus. None of the components of the vaccine can cause influenza.
Fluad is used to prevent influenza in adults aged 50 years and older.
The vaccine has been formulated to target 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 Fluad

Do not use Fluad:

• If you are allergic
  • to the active substances or to any of the other ingredients of this medicine (listed in section 6)
  • to egg or chicken proteins (such as ovalbumin), kanamycin and neomycin sulfate, formaldehyde, cetrimonium bromide (CTAB), and hydrocortisone; these substances are residuals from the manufacturing process present in trace amounts.
• If you have previously experienced a severe allergic reaction (e.g., anaphylaxis) after a previous influenza vaccination.

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

• The doctor or nurse will ensure that appropriate medical treatment and supervision are rapidly available in the rare event of an anaphylactic reaction (a very severe allergic reaction, with symptoms such as breathing difficulties, dizziness, weak and rapid pulse, and

skin rash) following administration. Such a reaction may occur with Fluad, as with
all injectable vaccines.

• Inform your doctor if you have a fever-associated illness. 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, for example, anticancer drugs (chemotherapy) or corticosteroids (see section “Other medicines and Fluad”).
• Inform your doctor if you have bleeding disorders or bruise easily.
• Fainting may occur during or shortly after injection with a needle; therefore, inform the doctor or nurse if you have previously fainted after receiving injections.

As with all vaccines, Fluad may not fully protect all vaccinated individuals.
Children
Fluad is not indicated for use in children.
Other medicines and Fluad
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.
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
Fluad does not affect or affects negligibly the ability to drive and use machines.
Fluad contains potassium and sodium
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 Fluad is administered

Fluad is administered to you by a doctor or nurse as an injection into the muscle of the upper arm (deltoid muscle).
Adults aged 50 years and older
One 0.5 mL dose

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Immediately contact your doctor or go to the nearest hospital emergency department if you experience the following serious side effect; urgent medical treatment or hospitalization may be required:

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

The following side effects were reported during clinical studies 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)
• Muscle pain (myalgia), 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
• Diarrhea
• Chills
• Nausea
• Loss of appetite
• Bruising at the injection site (ecchymosis)
• Influenza-like symptoms
• Fever (≥ 38 °C), reported in elderly subjects aged 65 years and older; 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, armpits, or groin (lymphadenopathy)

Most of the reported side effects were mild or moderate in severity and resolved within 3 days of onset.
In addition to the side effects listed above, the following side effects have been reported occasionally during general use of the adjuvanted quadrivalent influenza vaccine or Fluad:

• Reduction in the number of certain blood particles called platelets; low platelet count may increase bruising or bleeding (thrombocytopenia)
• Swelling, pain, and redness at the injection site (injection site reaction resembling cellulitis)
• Extensive swelling of the limb where the injection was given, lasting longer than one week
• General weakness or lack of energy (asthenia), general feeling of being unwell (malaise)
• Fever (pyrexia)
• Muscle weakness
• Pain along the course of a nerve (neuralgia), disturbances in the perception of touch, pain, heat, and cold (paraesthesia), seizures, neurological disorders that may cause neck stiffness, confusion, numbness, pain and weakness in the limbs, loss of balance, loss of reflexes, or paralysis of parts of the body or the entire body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
• Skin reactions that may spread over the entire body, including skin itching (pruritus, urticaria), skin redness (erythema), non-specific rash, severe skin rash (erythema multiforme)
• Swelling particularly affecting the head and neck, including 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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluad

Keep this vaccine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Discard the vaccine if it has been frozen.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Do not use this vaccine after the expiry date stated on the label and carton after "EXP/Scad". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Fluad contains

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

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

• MF59C.1 is included in this vaccine as an adjuvant. Adjuvants are substances included in some vaccines to accelerate, enhance, and/or prolong the protective effect 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, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.

Description of the appearance of Fluad and contents of the pack
Fluad is an injectable suspension in pre-filled syringes. 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 of 1 or 10 pre-filled syringes, with or without needles.
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 on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Vifor Pharma België NV Seqirus Netherlands B.V. Nyderlandai
Tel. +32 3 218 20 70 Tel: +31 (0) 20 204 6900

България Luxembourg/Luxemburg
Seqirus Netherlands B.V. Нидерландия Vifor Pharma België NV
Тел.: +31 (0) 20 204 6900 Tel. +32 3 218 20 70

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 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 medicinal product 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 case of rare
anaphylactic reactions following vaccine administration.
Shake gently before use. After shaking, the vaccine normally appears as a white, milky suspension.
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 changes in physical
appearance are observed.
When using a pre-filled syringe supplied without a needle, remove the syringe cap and attach a
needle for administration. Use a sterile needle of appropriate size for intramuscular injection. For
Luer Lock syringes, remove the syringe cap by unscrewing it counterclockwise. After removing the
cap, attach a needle to the syringe by screwing it on clockwise until securely fixed. Once the needle is
secured, remove the needle protector and administer the vaccine.