FLUAD TETRA Injectable Suspension in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Fluad Tetra, Prefilled Syringe Suspension for Injection

Influenza Vaccine (Surface Antigen, Inactivated, with Adjuvant)

This medicine is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you are given 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Fluad Tetra is a vaccine against influenza.

When a person is given 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.

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

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

2. What you need to know before you are given Fluad Tetra

You should not be given Fluad Tetra

• 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), and hydrocortisone, which are residues of the manufacturing process that may be present in minimal amounts.

• If you have had a severe allergic reaction (e.g., anaphylaxis) to a previous influenza vaccine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Fluad Tetra.

BEFOREvaccination

• your doctor or nurse will check that 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) after administration. This reaction can occur with Fluad Tetra, as with all injectable vaccines.
• you should tell your doctor if you have a disease with fever. Your doctor may decide to delay your vaccination until the fever has disappeared.
• you should tell 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 Fluad Tetra").
• you should tell 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 tell your doctor or nurse if you have fainted with any injection before.

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

Children

Fluad Tetra is not recommended for use in children.

Other medicines and Fluad 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 received any other vaccine recently.

Pregnancy and breastfeeding

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

Driving and using machines

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

Fluad Tetra contains potassium and sodium

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 Fluad Tetra is given

Your doctor or nurse will give you Fluad Tetra as an injection into the muscle of the upper arm (deltoid muscle).

Adults aged 50 years and older:

A dose of 0.5 ml

4. Possible side effects

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

Tell your doctor or go to the emergency department of your nearest hospital immediately if you get any of the following serious side effects, as you may need urgent medical attention or hospitalization:

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

The following side effects have been reported during clinical trials in adults aged 50 years and older.

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

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

1 Reported as frequent 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)
• Flu-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 lymph nodes in the neck, armpit, or groin (lymphadenopathy)

Most side effects were mild or moderate and disappeared within 3 days of onset.

In addition to the side effects mentioned, the following side effects have occasionally occurred during general use of Fluad Tetra or a similar vaccine in elderly subjects aged 65 years and older.

• decrease in the number of a certain type of particle in the blood called platelets; a low number of these can cause bruising or bleeding (thrombocytopenia)
• swelling, pain, and redness at the injection site (reaction similar to cellulitis at the injection site)
• extensive swelling of the limb where the medicine was injected, lasting more than one week.
• general weakness or lack of energy (asthenia), feeling unwell (malaise)
• fever (pyrexia)
• muscle weakness
• pain in the nerve pathway (neuralgia), unusual sensation of touch, pain, heat, and cold (paresthesia), seizures (convulsions), neurological disorders that can cause stiffness of the neck, confusion, numbness, pain, and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
• skin reactions that can 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)
• more pronounced swelling of the head and neck, including the face, lips, tongue, throat, or any other part of the body (angioedema)
• swelling of the blood vessels that can cause skin rashes (vasculitis) and temporary kidney problems
• fainting, feeling of being about to faint (syncope, presyncope)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Fluad Tetra

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 if the vaccine 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 which is stated on the label and on the carton after EXP/CAD. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Fluad Tetra

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

*propagated in embryonated chicken eggs from healthy chicken flocks and adjuvanted with MF59C.1

**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.

• This vaccine includes MF59C.1 as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve, or prolong the protective effects of the vaccine. MF59C.1 is an adjuvant that contains 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 ingredients are sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, and water for injections.

Appearance of Fluad Tetra and pack contents

Fluad Tetra is a suspension for injection in a prefilled syringe. Fluad Tetra is a white, cloudy suspension. One syringe contains 0.5 ml of suspension for injection. Fluad Tetra is available in packs containing 1 or 10 prefilled 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, Netherlands

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

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 gently before use. After shaking, the normal appearance of the vaccine is a white, cloudy suspension.

The vaccine should be inspected visually for particulate matter and/or changes in physical appearance before administration. If particulate matter and/or changes in physical appearance are observed, do not administer the vaccine.

If a prefilled syringe is supplied without a needle, remove the protective cap from the tip of the syringe and attach a suitable needle for administration. For LuerLock syringes, remove the protective cap from the tip of the syringe by unscrewing it in an anticlockwise direction. Once the protective cap is removed, attach a needle to the syringe by screwing it in a clockwise direction until it is secure. When the needle is securely attached, remove the needle protector and administer the vaccine.