Efluelda

Package leaflet: Information for the user

Efluelda, suspension for injection in pre-filled syringe

Influenza vaccine (split virion, inactivated), trivalent, 60 micrograms HA/strain
Please read all of this leaflet carefully before you use 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.
• This medicine has been prescribed for you only. Do not pass it on to others.
• If you experience 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 Efluelda is and what it is used for
2. What you need to know before you use 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 people aged 60 years and older from influenza. The use of Efluelda should be based on official recommendations on influenza vaccination.
When Efluelda is administered to a person, the immune system (the body’s natural defence system) will develop its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause influenza.
Influenza is a contagious respiratory illness caused by influenza viruses, which can lead to mild to severe illness and can cause serious complications such as pneumonia, possibly requiring hospitalisation or even resulting in death. Influenza is an illness that can spread rapidly and is caused by different strains that may vary each year. Due to this potential annual variation in circulating strains, as well as the expected duration of vaccine protection, annual vaccination is recommended. The highest risk of contracting influenza occurs during the colder months, from October to March. If you have not received the vaccine in autumn, it is still advisable to get vaccinated by spring, i.e., until the time when there is still a risk of contracting influenza. Your doctor can advise you on the best time to be vaccinated.
Efluelda is intended to protect you against the three virus strains contained in the vaccine within 2–3 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 lasts several days.
The vaccine will not protect you from the common cold, even though some symptoms may resemble those of influenza.

2 What you need to know before you use Efluelda
To ensure Efluelda is suitable for you, it is important that you inform your doctor or pharmacist if any of the following apply to you. If you do not understand something, please ask your doctor or pharmacist for clarification.

Do not use Efluelda:

• If you are allergic to:
  • the active substance(s), or
  • any of the other ingredients of this medicine (listed in section 6), or
  • any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins) and formaldehyde.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Efluelda.
Inform your doctor before vaccination if you:

• have a poor immune response (immunodeficiency or due to use of medicines affecting the immune system),
• have bleeding disorders or bruise easily,
• have 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; in such cases, vaccination should be postponed until after recovery. Your doctor will decide whether you should receive the vaccine.

Fainting may occur during or even before any needle injection. Therefore, inform your doctor or nurse if you have previously fainted after an injection.
As with all vaccines, Efluelda may not fully protect all vaccinated individuals.
Inform your doctor if you need to undergo a blood test within a few days after receiving the influenza vaccine. False positive blood test results have been observed in some patients who were recently vaccinated.

Children
This vaccine must not be used in children and is intended 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 take any other vaccines or medicines.

• If Efluelda is to be administered simultaneously with other vaccines, the vaccines must always be given in different limbs.
• Note that adverse reactions may be intensified by any concomitant administration.
• The immune response may be reduced during immunosuppressive treatment, such as corticosteroids, cytotoxic drugs, or radiotherapy.

Pregnancy and breastfeeding
Efluelda is indicated only for use in adults aged 60 years and older.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor or pharmacist will help you decide whether you should be vaccinated with Efluelda.

Driving and using machines
Efluelda does not affect or has a negligible effect on the ability to drive and use machines. However, if you do not feel well or experience dizziness, driving is not recommended.

Efluelda contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially “sodium-free”.

3 How to use Efluelda
Adults aged 60 years and older receive one 0.5 mL dose.

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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions

Contact your doctor IMMEDIATELY if you experience:

• Severe allergic reaction:
  • which may lead to a medical emergency with low blood pressure, shortness of breath, wheezing or difficulty breathing, rapid heartbeat and weak pulse, cold and clammy skin, dizziness, which may lead to collapse (anaphylaxis, including angioedema, i.e. swelling particularly noticeable in the head and neck area, including face, lips, tongue, throat or any other part of the body, and which may cause difficulty swallowing or breathing).

Contact your 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 side effects
The following side effects have been 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 being unwell (malaise), headache, muscle pain (myalgia)

Common (may affect up to 1 in 10 people)

• Injection site reactions: swelling, bruising, hardening
• Fever, chills (tremor)

Uncommon (may affect up to 1 in 100 people)

• Injection site reactions: itching
• Fatigue, lethargy, feeling unwell (nausea), vomiting, diarrhoea
• 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), flushing, joint pain (arthralgia), dizziness, night sweats, rash, numbness or tingling sensation (paraesthesia), inflammation of the nose (rhinorrhoea), vertigo, excess blood in the white of the eye (ocular hyperaemia)
• Limb pain

Not known (frequency cannot be estimated from the available data)

• Decrease in the number of certain types of blood particles called platelets; low levels may cause excessive bruising or bleeding (thrombocytopenia);
• Swelling of glands in the neck, armpit or groin (lymphadenopathy);
• Neurological disorders which may cause stiff neck, confusion, numbness, pain and weakness in 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, widening of blood vessels (vasodilation);
• Chest pain;
• Wheezing, throat tightness, difficulty breathing (dyspnoea).

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

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 can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Efluelda

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

6. Package contents and other information

What Efluelda contains

• The active substances are: Influenza virus (inactivated split) from the following strains*:

A/Victoria/4897/2022 (H1N1) pdm09 – equivalent strain (A/Victoria/4897/2022, IVR-238)
..................................................................................................................................... 60 micrograms HA**
A/Croatia/10136RV/2023 (H3N2) – equivalent strain (A/Croatia/10136RV/2023, X-425A)
..................................................................................................................................... 60 micrograms HA**
B/Austria/1359417/2021 – equivalent strain (B/Michigan/01/2021, wild type) ......... 60 micrograms HA**
Per 0.5 mL dose
* propagated in embryonated chicken eggs
** haemagglutinin

This vaccine complies with the recommendations of the World Health Organization (WHO) and
(European Union) for the northern hemisphere for the 2025/2026 season.

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

The vaccine may contain traces of certain substances such as egg (ovalbumin, chicken proteins) or formaldehyde (see section 2).

Description of the appearance of Efluelda and contents of the pack
After gentle shaking, the vaccine appears as a colourless opalescent liquid.
Efluelda is an injectable suspension in a 0.5 mL pre-filled syringe (injectable suspension), supplied with or without a separate needle (pack sizes of 1, 5 or 10) or with a safety needle (pack sizes of 1 or 10). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Representative in Italy
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milano
Manufacturer:
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France

This medicinal product is authorised in the EEA Member States under the following names:

Other sources of information
The latest approved information on this product is available by scanning the QR code on the outer packaging with a smartphone or by visiting the following URL: https://efluelda-nh.info.sanofi .

The following information is intended exclusively for healthcare professionals:

As with all injectable vaccines, appropriate medical treatments and supervision must always be readily available in case of an anaphylactic reaction following vaccine administration.
The vaccine should reach room temperature before use.
Shake well before use. Visually inspect before administration.
The vaccine must not be used if extraneous particles are present in suspension.
It must not be mixed with other medicinal products in the same syringe.
This vaccine must not be injected directly into a blood vessel.
See also section 3. How to use Efluelda
˂Preparation for Administration
Instructions for use of the safety needle with the pre-filled syringe with Luer Lock:

Figure A: Safety needle (inside the carrier)	Figure B: Components of the safety needle (ready for use)

Step 1: To attach the needle to the syringe, remove the connector cap to expose the needle connector and gently rotate the needle into the syringe's Luer Lock adapter until slight resistance is felt.
Step 2: Remove the safety needle from its carrier. The needle is covered by the safety shield and the needle cap.

Step 3: A: Remove the safety shield from the needle and orient it toward the syringe barrel at the angle shown. B: Remove the needle cap.
Step 4: At the end of the injection, lock (activate) the safety shield using one of the three (3) one-handed activation techniques illustrated: surface, thumb, or finger activation. Note: activation is confirmed by an audible and/or tactile "click".
Step 5: Visually inspect the activation of the safety shield. The safety shield must be fully locked (activated) as shown in Image C. Image D shows the safety shield NOT fully locked (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by forcing the needle out of the safety shield.

Unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with
local regulations. ˃