Fluad tetra suspension inyectable en jeringa precargada

Prospect: information for the user

Fluad Tetra, pre-filled syringe suspension for injection

Influenza vaccine (surface antigen, inactivated, with adjuvant)

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before you receive this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to receive Fluad Tetra

3.How to administer Fluad Tetra

4.Possible adverse effects

5.Storage of Fluad Tetra

6.Contents of the package and additional information

Fluad Tetrais an influenza vaccine.

When a person receives 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 influenzainindividuals aged 50 years and older.

The vaccine is directed against four strains of the influenza virus in accordance with the World Health Organization's recommendations for the 2024/2025 Campaign.

Do not receive Fluad Tetra

• if you are allergic to:

• the active ingredients or any of the other components of this medication (listed in section6).
• egg or chicken proteins (such as ovoalbumin), kanamycin and neomycin sulfate, formaldehyde, cetrimonium bromide (CTAB) and hydrocortisone, which are manufacturing residues that may be present in minimal quantities.

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to receive Fluad Tetra.

BEFORE VACCINATING

• Your doctor or nurse will check the availability of medical treatment and adequate supervision 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 may occur withFluad Tetra, as with all vaccines that are injected.
• You must inform your doctor if you have a disease that is accompanied by fever. Your doctor may decide to postpone your vaccination until the fever has disappeared.
• You must inform your doctor if your immune system is compromised or if you are receiving a treatment that affects it, for example, chemotherapy for cancer or corticosteroids (see section "Other medications andFluad Tetra").
• You must inform your doctor if you have a bleeding disorder or if you bruise easily.
• You may faint after the injection with a needle, or even before, therefore, inform your doctor or nurse if you have fainted previously with any injection.

As with all vaccines,Fluad Tetramay not protect completely all people who are vaccinated.

Children

Fluad Tetra is not recommended for use in children.

Other medications and Fluad Tetra

Inform your doctor or nurse if you are using, have used recently or may have to use any other medication, even those obtained without a prescription, or if you have received recently any other vaccine.

Pregnancy and breastfeeding

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

Driving and operating machinery

The influence of Fluad Tetra on the ability to drive and operate machinery is negligible or insignificant.

Fluad Tetracontains potassium and sodium

This vaccine contains less than 1mmol of sodium (23mg) per dose; this is essentially "sodium-free".

This vaccine contains potassium, less than 1mmol (39mg) per dose; this is essentially "potassium-free".

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

Adults 50 years of age and older:

A dose of 0.5ml

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediately or go to the nearest hospital emergency department if you experience the following severe 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 anaphylactic reaction (a very severe allergic reaction)

The following side effects were 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

1Reported 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 theinjection site (induration)
• Diarrhea
• Chills
• Nausea
• Loss of appetite
• Ecchymosis at the injection site
• Flu-like symptoms2
• Fever (≥38 °C)3

2Reported in elderly subjects aged 65 years and older.

3Reportedas uncommon in elderly subjects aged 65 years and older.

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

• Vomiting
• Swollen lymph nodes in the neck, armpits, or groin (lymphadenopathy)

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

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

• Reduction in the number of a certain type of blood cells called platelets; a low number of these may cause bruising or excessive 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 medication was injected, lasting more than a week.
• General weakness or lack of energy (asthenia), feeling of general indisposition (malaise)
• Fever (pyrexia)
• Muscle weakness
• Pain along the nerves (neuralgia), unusual sensation of touch, pain, heat, and cold (paresthesia), seizures (convulsions), neurological disorders that may cause neck stiffness, confusion, numbness, pain, and weakness of the extremities, 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 (pruritus, urticaria), redness of the skin (erythema), nonspecific rash, severe skin rash (erythema multiforme)
• More noticeable swelling 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 eruptions (vasculitis) and temporary kidney problems
• Fainting, feeling of impending fainting (syncope, presyncope)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in refrigerator (between 2°C and 8°C). Do not freeze. Discard if the vaccine has frozen.

Keep the preloaded syringe in the outer packaging to protect it from light.

Do not use this vaccine after the expiration date that appears on the label and on the box after EXP/CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Fluad Tetra

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

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

**Hemagglutinin

This vaccine meets the recommendation of the World Health Organization (WHO) (Northern Hemisphere) and the EU recommendation for the 2024/2025 campaign.

• 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 dose of 0.5 ml: squalene (9.75 mg), polysorbate 80 (1.175 mg), trioleate of sorbitan (1.175 mg), sodium citrate (0.66 mg), and citric acid (0.04 mg).
• The other components are sodium chloride, potassium chloride, dihydrogen phosphate of potassium, disodium dihydrogen phosphate, magnesium chloride hexahydrate, calcium chloride dihydrate, and water for injection.

Appearance of Fluad Tetra and contents of the package

Fluad Tetra is a pre-filled syringe injectable suspension. Fluad Tetra is a white milky suspension. A syringe contains 0.5 ml of injectable suspension. Fluad Tetra is available in packages containing 1 or 10 pre-filled syringes with or without needles.

Only certain package sizes may be marketed.

Holder of the marketing authorization and manufacturer responsible

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: 07/2024

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

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

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

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

If a pre-filled syringe supplied without a needle is used, the protective cap at the tip of the syringe should be removed and a suitable needle for administration should be placed. In the case of LuerLock syringes, the protective cap at the tip of the syringe should be removed by unscrewing it in the opposite direction to the clock. Once the protective cap at the tip of the syringe has been removed, a needle should be placed in the syringe by screwing it in the direction of the clock until it stops. When the needle is securely in place, the protective cap should be removed from the needle and the vaccine administered.