Prospect: information for the user

Efluelda Tetra, pre-filled syringe suspension

Quadrivalent influenza vaccine (inactivated virus fragments), 60 micrograms HA/strain

This medicine is subject to additional monitoring, which will speed up 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 being vaccinated because 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.
• This vaccine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them
• 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 Efluelda Tetra and what is it used for

2.What you need to know before using Efluelda Tetra

3.How to use Efluelda Tetra

4.Possible adverse effects

5Storage of Efluelda Tetra

6.Contents of the package and additional information

Efluelda Tetra is a vaccine. This vaccine helps to protect people 60 years of age and older from the flu virus. The use of Efluelda Tetra should be based on official recommendations on flu vaccination.

When a person receives Efluelda Tetra, the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease. None of the components of the vaccine can cause flu.

The flu is a contagious respiratory disease caused by the flu virus, which can result in mild to severe illnesses, and serious complications such as pneumonia, which can lead to hospitalization or even death. The flu is a disease that can spread quickly and is caused by different types of strains that can change each year. Due to this potential change in circulating strains annually, as well as the duration of protection expected by the vaccine, annual vaccination is recommended. The highest risk of contracting flu is during the cold months between October and March. If you were not vaccinated in the fall, it is still advisable to get vaccinated in the spring, as you are at risk of contracting the flu until then. Your doctor will be able to recommend the best date for you to get vaccinated.

Efluelda Tetra is designed to protect you from the four flu virus strains contained in the vaccine approximately 2 to 3 weeks after injection. Additionally, if you are exposed to the flu immediately before or after vaccination, you may still develop the disease, as the incubation period of the flu is a few days.

The vaccine will not protect you from the common cold, even if some of the symptoms are similar to those of the flu.

To ensure that Efluelda Tetra is suitable for you, it is essential to inform your doctor or pharmacist if any of the following points affect you. If you do not understand anything, consult your doctor or pharmacist to clarify.

Do not use Efluelda Tetra:

• if you are allergic to:

• the active ingredients, or
• any of the other components of this vaccine (listed in section 6), or
• any of the components that may be present in minimal quantities, such as eggs (ovalbumin, chicken proteins) and formaldehyde.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Efluelda Tetra.

Consult your doctor before vaccinating if you have:

• a weakened immune response (immunodeficiency or taking medications that affect the immune system),
• bleeding problems or easy bruising,
• experienced Guillain-Barré Syndrome (GBS) (severe muscle weakness) after receiving the flu vaccine,
• if you have a disease with high or moderate fever or an acute disease, vaccination should be postponed until you have recovered.

Your doctor will decide if you should receive the vaccine.

You may experience dizziness after, or even before, any injection with a needle. Therefore, inform your doctor or nurse if you fainted with a previous injection.

Like all vaccines, Efluelda Tetra may not protect all people who are vaccinated.

If for any reason, you undergo blood testing a few days after the flu vaccination, please inform your doctor. This is because false-positive results have been observed in some recently vaccinated patients.

Children

This vaccine should not be used in children; it is only for adults aged 60 years or older.

Other medications and Efluelda Tetra

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication or vaccine.

• If Efluelda Tetra is to be administered at the same time as other vaccines, the vaccines must always be administered in different limbs.
• It is worth noting that adverse reactions may be intensified by any co-administration.
• The immune response may decrease in the case of immunosuppressive treatments, such as corticosteroids, cytotoxic medications, or radiation therapy.

Pregnancy and breastfeeding

Efluelda Tetra is only indicated for use in adults aged 60 years or older.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this vaccine. Your doctor/pharmacist will help you decide if you should receive Efluelda Tetra.

Driving and operating machinery

Efluelda Tetra has a negligible or insignificant influence on the ability to drive or operate machinery. However, if you feel unwell or dizzy, it is not recommended to drive.

Efluelda Tetra contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially "sodium-free".

Adults 60 years of age and older receive a dose of 0.7 ml.

How it is administeredEfluelda Tetra

Your doctor, pharmacist, or nurse will administer the recommended dose of the vaccine as an injection into a muscle or under the skin.

If you have any questions about the use of this product, consult your doctor or pharmacist.

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

Allergic reactions

Consult your doctorIMMEDIATELYif you experience:

• Severe allergic reactions:

• that may lead to a medical emergency with low blood pressure, shortness of breath, wheezing or difficulty breathing, rapid heart rate and weak pulse, cold, clammy skin (cold sweat), dizziness, which may lead to collapse (anaphylaxis [including angioedema, e.g. more prominent swelling in the head and neck, including face, lips, tongue, throat or any other part of the body and that may cause difficulty swallowing or breathing]).

Consult a doctorif you experience:

• Allergic reactions such as skin reactions that can spread throughout the body including itching, hives, rash.

These side effects are rare (may affect up to 1 in 1,000 people).

Other reported adverse effects

The following adverse effects were reported in adults aged 60 years and older.

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

• Reactions at the injection site: pain, redness (erythema)
• General feeling of discomfort (malaise), headache, muscle pain (myalgia)

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

• Reactions at the injection site: swelling, bruises, hardness (induration)
• Fever, chills (shivering)

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

• Reactions at the injection site: pruritus
• Fatigue, lethargy, feeling of illness (nausea), vomiting, diarrhea
• Cough, muscle weakness, indigestion (dyspepsia), inflammation of the throat (oropharyngeal pain)

Rare (may affect up to 1 in 1,000 people):

• Abnormal lack of energy (asthenia), redness, joint pain (arthralgia), dizziness, night sweats, rash, numbness or tingling (paresthesia), inflammation of the nose (rhinorrhea), vertigo, excessive blood in the white of the eye (ocular hyperemia)
• Arm or leg pain

Frequency not known: the frequency cannot be estimated from the available data:

• Reduction in the number of certain types of blood cells called platelets; a low number of these may result in excessive bruising or bleeding (thrombocytopenia)
• Swelling of the lymph nodes in the neck, armpit or groin (lymphadenopathy)
• Neurological disorders that may result in neck stiffness, confusion, numbness, pain and weakness in the arms or legs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis and transverse myelitis, brachial neuritis, Guillain-Barré syndrome), facial paralysis (Bell's palsy), vision disorders due to dysfunction of the optic nerves (neuritis/optic neuropathy), seizures (including febrile seizures), fainting (syncope) shortly after vaccination
• Inflammation of blood vessels (vasculitis) that may cause skin rashes and, in very rare cases, temporary kidney problems, dilation of blood vessels (vasodilation)
• Chest pain
• Wheezing, sensation of throat constriction, difficulty breathing (dyspnea).

Most adverse effects generally occurred within 3 days after vaccination and resolved within 3 days. The intensity of these adverse effects was mild to moderate.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date appearing on the label and the packaging after CAD. The expiration date is the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Store the syringe in the outer packaging to protect it from light.

Drugs should not be disposed of through drains or in the trash. Deposit the containers and drugs that you do not need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and drugs that you do not need. In this way, you will help to protect the environment.

Composition of Efluelda Tetra

The active principles are: Inactivated, fragmented influenza virus of the following strains *:

• Strain similar to A/Victoria/4897/2022 (H1N1)pdm09: (IVR-238).…. 60 micrograms HA**

• Strain similar to A/Thailand/8/2022 (H3N2): A/California/122/2022 (SAN-022)……60 micrograms HA **

• Strain similar to B/Austria/1359417/2021: B/Michigan/01/2021 …………………………………………………………60 micrograms HA**

• B/Phuket/3073/2013…………………………………...60 micrograms HA**

Per 0.7 ml dose

* grown in embryonated chicken eggs

** hemagglutinin

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

The other components are: A buffer solution containing sodium chloride, sodium phosphate monobasic, sodium phosphate dibasic, water for injection and octoxinol-9.

Some components, such as eggs (ovalbumin, chicken proteins) or formaldehyde, may be present in very small quantities (see Section 2).

Appearance of Efluelda Tetra and contents of the package

The vaccine, after shaking it carefully, is an opalescent, colorless liquid.

EflueldaTetra is a 0.7 ml injectable suspension presented in a pre-filled syringe with or without a needle (in packs of 1, 5 or 10) or with a safety needle (in packs of 1 or 10).

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

The manufacturer is:

Sanofi Winthrop Industrie

Voie de l’Institut - Parc Industriel d’Incarville

B.P 101

27100 Val de Reuil

France

Local representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Date of the last review of this leaflet:06/2024

Other sources of information

The latest approved information on this medicinal product is available by scanning the QR code included in the carton or at the following internet address:https://efluelda-nh.info.sanofi

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This information is intended solely for healthcare professionals:

As with all injectable vaccines, medical treatment and appropriate supervision should be available in the event of an anaphylactic episode following administration of the vaccine.

The vaccine should reach room temperature before use.

Shake before use.The vaccine should not be used if it presents foreign particles in the suspension.

Do not mix with other medicinal products in the same syringe.

This vaccine should not be injected directly into any blood vessel.

See also Section 3. How to use Efluelda Tetra

?Preparation for administration

Instructions for use of the safety needle with the Luer Lock syringe:

The disposal of unused vaccines and all materials that have come into contact with them will be carried out in accordance with local regulations.?