Efluelda solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efluelda injectable suspension in pre-filled syringe

Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain

Read the entire leaflet carefully before being vaccinated, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed only for you; do not give it to others, even if they have the same symptoms as you, as it could harm them.
• 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 Efluelda is and what it is used for
2. What you need to know before using Efluelda
3. How to use Efluelda
4. Possible side effects
5. How to store Efluelda
6. Contents of the pack and other information

1. What Efluelda is and what it is used for

Efluelda is a vaccine. This vaccine helps protect individuals aged 60 years and older against influenza virus. The use of Efluelda should be based on official recommendations for influenza vaccination.

When a person receives Efluelda, 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 influenza.

Influenza is a contagious respiratory illness caused by the influenza virus, which can result in mild to severe illness, and serious complications such as pneumonia, potentially leading to hospitalization or even death. Influenza is a disease that can spread rapidly and is caused by different strains that may change each year. Due to these potential annual changes in circulating strains, as well as the duration of protection provided by the vaccine, annual vaccination is recommended. The highest risk of contracting influenza occurs during the colder months between October and March. If you were not vaccinated in the autumn, it is still advisable to get vaccinated until spring, as you remain at risk of contracting influenza until then. Your doctor can advise you on the best time to be vaccinated.

Efluelda is designed to protect you against the three virus strains contained in the vaccine approximately 2 to 3 weeks after injection. Additionally, if you are exposed to influenza immediately before or after vaccination, you may still develop the disease, as the incubation period of influenza is several days.

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

2. What you need to know before using Efluelda

To ensure that Efluelda is suitable for you, it is important that you inform your doctor or pharmacist if any of the following apply to you. If there is anything you do not understand, consult your doctor or pharmacist for clarification.

Do not use Efluelda:

• if you are allergic to:

• the active substances, or

• any of the other components of this vaccine (listed in section 6), or

• any of the components that may be present in minimal amounts, such as eggs (ovalbumin, chicken proteins) and formaldehyde.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Efluelda.

Consult your doctor before vaccination if you:

• have a weakened immune response (immunodeficiency or are taking medicines that affect the immune system),
• have bleeding problems or bruise easily,
• experienced Guillain-Barré Syndrome (GBS) (severe muscle weakness) after receiving an influenza vaccine,
• have an illness with high or moderate fever or an acute illness; vaccination should be postponed until you have recovered.

Your doctor will decide whether you should receive the vaccine.

Fainting may occur after, or even before, any injection with a needle. Therefore, inform your doctor or nurse if you have previously fainted after an injection.

Like all vaccines, Efluelda may not fully protect all individuals who are vaccinated.

If, for any reason, you undergo a blood test within a few days of influenza vaccination, please inform your doctor. This is because false positive results in serological tests have been observed in some recently vaccinated patients.

Children

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

Other medicines and Efluelda

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines or vaccines.

• If Efluelda is to be administered at the same time as other vaccines, the vaccines must always be given in different limbs.
• It should be noted that adverse reactions may be intensified by any co-administration.
• The immune response may be reduced in cases of immunosuppressive treatments, such as corticosteroids, cytotoxic drugs, or radiotherapy.

Pregnancy and breastfeeding

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

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

Driving and using machines

Efluelda has no or negligible influence on the ability to drive or use machines. However, if you feel unwell or dizzy, driving is not advisable.

Efluelda contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to use Efluelda

Adults aged 60 years and older receive a dose of 0.5 ml.

How Efluelda is administered

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

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

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.

Allergic reactions

Consult your doctor IMMEDIATELY if you experience:

• Severe allergic reactions:

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

Consult a doctor if you experience:

• Allergic reactions such as skin reactions that may 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):

• Injection site reactions: pain, redness (erythema)
• General feeling of discomfort (malaise), headache, muscle pain (myalgia)

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

• Injection site reactions: swelling, bruising, hardness (induration)
• Fever, chills (shivering)

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

• Injection site reactions: pruritus
• Fatigue, lethargy, feeling of illness (nausea), vomiting, diarrhoea
• Cough, muscle weakness, indigestion (dyspepsia), throat inflammation (oropharyngeal pain)

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

• Abnormal lack of energy (asthenia), flushing, joint pain (arthralgia), dizziness, night sweats, rash, numbness or tingling sensation (paraesthesia), nasal inflammation (rhinorrhea), vertigo, excess blood in the white of the eye (ocular hyperaemia)
• Pain in the limbs

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

• Reduction in the number of certain types of blood particles called platelets; a low number of these may result in excessive bruising or bleeding (thrombocytopenia)
• Swelling of glands in the neck, armpit or groin (lymphadenopathy)
• Neurological disorders which may result in 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 and transverse myelitis, brachial neuritis, Guillain-Barré syndrome), facial paralysis (Bell's palsy), vision disorders due to dysfunction of the optic nerves (optic neuritis/neuropathy), seizures (including febrile seizures), fainting (syncope) shortly after vaccination
• Inflammation of blood vessels (vasculitis) which may cause skin rashes and, in very rare cases, temporary kidney problems, blood vessel dilation (vasodilation)
• Chest pain
• Wheezing, sensation of throat tightness, difficulty breathing (dyspnoea)

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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efluelda

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

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

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Efluelda

• The active substances are: Inactivated, split influenza viruses from the following strains *:

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

Strain similar to A/Croatia/10136RV/2023 (H3N2): (X-425A)…….…60 micrograms HA **

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

Per 0.5 ml dose

• Grown in embryonated hens' eggs

** haemagglutinin

This vaccine complies with WHO (World Health Organization) (Northern Hemisphere) recommendations and with the EU decision for the 2025/2026 season.

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

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

Appearance of Efluelda and contents of the pack

After gently shaking, the vaccine is an opalescent, colourless liquid.

Efluelda is a 0.5 ml injectable suspension supplied in a pre-filled syringe (Injectable suspension) with or without needle (pack sizes of 1, 5 or 10) or with safety needle (pack sizes of 1 or 10). Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation 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 authorised in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: July 2025

Other sources of information

The most up-to-date approved information about this medicine is available by scanning with your mobile phone (smartphone) the QR code included on the packaging or at the following internet address: https://efluelda-nh.info.sanofi

This information is intended for healthcare professionals only:

As with all injectable vaccines, appropriate medical treatment and supervision must be readily available in case an anaphylactic reaction occurs following vaccine administration.

The vaccine should reach room temperature before use.

Shake well before use. Visually inspect prior to administration.

The vaccine must not be used if foreign particles are present in the suspension.

Do not mix with other medicines in the same syringe.

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

See also Section 3. How to use Efluelda

?Preparation for administration

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

Disposal of unused vaccines and all materials that have come into contact with them must be carried out in accordance with local regulations.