Efluelda

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: information for the user

Efluelda, suspension for injection in a pre-filled syringe,

Trivalent influenza vaccine (split virion), inactivated,

60 micrograms HA/dose

This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after administration of the medicinal product. To find out how to report adverse reactions, see section 4.

Read the leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for you. Do not pass it on to others.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Efluelda and what is it used for
• 2. Important information before using Efluelda vaccine
• 3. How to use Efluelda vaccine
• 4. Possible side effects
• 5. How to store Efluelda vaccine
• 6. Contents of the pack and other information

1. What is Efluelda and what is it used for

Efluelda is a vaccine. This vaccine helps protect people aged 60 and over against flu.
The use of Efluelda vaccine should be based on official recommendations regarding influenza vaccinations.
After administration of Efluelda vaccine, the immune system (the body's natural defense system) produces its own protection against the disease (antibodies). None of the vaccine components can cause flu.
Flu is an infectious disease of the respiratory system caused by influenza viruses, ranging from mild to severe and can lead to serious complications, such as pneumonia, which can result in hospitalization and even death. Flu is a disease that can spread quickly and is caused by many different virus strains that can change each year. Due to this possible annual change in circulating strains, as well as the duration of protection provided by the vaccine, it is recommended to get vaccinated every year. The greatest risk of getting the flu occurs during the cold months between October and March. If a person has not been vaccinated in the fall, it is still justified to get vaccinated during the spring, as there is still a risk of getting the flu. The doctor will be able to recommend the best time to get vaccinated.
The Efluelda vaccine is intended to protect against the three virus strains contained in the vaccine, approximately 2 to 3 weeks after vaccination. Since the incubation period of the flu is several days,

it is still possible to get the flu if exposed to the influenza virus shortly before or after vaccination.
The vaccine does not protect against the common cold, although some of its symptoms are similar to the flu.

2. Important information before using Efluelda vaccine

Tell your doctor or pharmacist if any of the following statements apply to the person who is to receive the Efluelda vaccine. If anything is unclear, ask your doctor or pharmacist to explain.

When not to use Efluelda vaccine:

• If the person is allergic to:
• active substances, or
• any of the other ingredients of this vaccine (listed in section 6), or
• any ingredient that may be present in very small amounts, such as egg residue (egg albumen, chicken proteins) and formaldehyde.

Warnings and precautions

Discuss with your doctor, pharmacist, or nurse before using Efluelda vaccine.
Before vaccination, tell your doctor if the patient has:

• weakened immune response (due to immune deficiency or taking drugs that affect the immune system),
• bleeding or bruising easily,
• previously had Guillain-Barré Syndrome (GBS) (severe muscle weakness) after receiving an influenza vaccine,
• a disease with high or moderate fever or acute illness. Vaccination should be postponed until recovery. The doctor will decide whether to administer the vaccine.

Fainting can occur after, or even before, any needle injection. Therefore, inform your doctor or nurse if the person has fainted during previous injections.
As with any vaccine, Efluelda may not provide complete protection for all vaccinated individuals.
Tell your doctor if the patient is scheduled to have a blood test within a few days after influenza vaccination, due to false-positive blood test results observed in some patients who have been vaccinated.

Use in children

This vaccine should not be used in children. The use of this vaccine is recommended for adults aged 60 and over.

Efluelda vaccine and other medicines

Tell your doctor or pharmacist about all medicines or vaccines the patient is currently taking or has recently taken, as well as any medicines or vaccines the patient plans to take.

• When administering Efluelda vaccine at the same time as other vaccines, the vaccines should always be administered in different limbs.
• Note that concurrent administration of vaccines may result in increased side effects.
• When using drugs or therapies that lower immunity, such as corticosteroids, cytotoxic drugs, or radiation therapy, the immune response to vaccination may be weakened.

Pregnancy and breastfeeding

Efluelda vaccine is indicated for use only in adults aged 60 and over.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this vaccine. The doctor or pharmacist will help decide whether the patient should receive the Efluelda vaccine.

Driving and using machines

Efluelda vaccine has no or negligible influence on the ability to drive and use machines. However, it is not recommended to drive if the patient feels unwell or has dizziness.

Efluelda vaccine contains sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose, which means the vaccine is considered "sodium-free".

3. How to use Efluelda vaccine

Adults aged 60 and over receive one dose of 0.5 ml.

How Efluelda vaccine 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 further questions about the use of this vaccine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions

IMMEDIATELYcontact your doctor if the patient experiences:

• Severe allergic reactions:
• which may require medical attention, with low blood pressure, difficulty breathing, wheezing, rapid heartbeat, and weak pulse, cool, moist skin, dizziness, which can lead to fainting (anaphylaxis [including angioedema, i.e., swelling most noticeable in the face, lips, tongue, throat, or other parts of the body, which can cause difficulty swallowing or breathing]).

Contact your doctor if the patient experiences:

• Allergic reactions such as skin reactions that can affect the whole body, including itching, hives, rash. These side effects are rare (may affect up to 1 in 1000 people).

Other reported side effects

The following side effects have been reported in adults aged 60 and over.
Very common (may affect more than 1 in 10 people):

• Injection site reactions: pain, redness (erythema)
• General malaise (fatigue), headache, muscle pain

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

• Injection site reactions: swelling, bruising, induration
• Fever, chills

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

• Injection site reactions: itching
• Fatigue, lethargy, nausea, vomiting, diarrhea
• Cough, muscle weakness, indigestion, pharyngitis (sore throat)

Rare (may affect up to 1 in 1000 people):

• Lack of energy (weakness), redness, joint pain, dizziness, night sweats, rash, numbness or tingling (paresthesia), rhinitis (nasal congestion), dizziness (balance disorders), excessive blood in the white of the eye (conjunctival congestion)
• Limb pain

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

• Decreased number of certain types of blood cells called platelets; their low level can cause excessive bruising or bleeding (thrombocytopenia)
• Enlargement of lymph nodes in the neck, armpit, or groin (lymphadenopathy)
• Neurological disorders that can cause neck stiffness, disorientation, numbness, pain, and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalitis and transverse myelitis, brachial neuritis, Guillain-Barré syndrome), facial paralysis (Bell's palsy), vision disorders caused by dysfunction of the optic nerves (optic neuritis), seizures (including febrile seizures), fainting soon after vaccination
• Vasculitis, which can lead to skin rashes and, in very rare cases, to transient kidney function disorders, vasodilation
• Chest pain
• Wheezing, throat constriction, difficulty breathing (dyspnea)

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Efluelda vaccine

Store the vaccine out of sight and reach of children.
Do not use this vaccine after the expiry date stated on the label and carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Store the pre-filled syringe in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Efluelda vaccine contains

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

A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238)
.....................................................................................................................................60 micrograms HA**
A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A)
.................................................................................................................................... 60 micrograms HA**
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)
................................................................................................................................... 60 micrograms HA**
in a dose of 0.5 ml
*
propagated in chicken embryos
**
haemagglutinin
The vaccine is in line with the recommendations of the World Health Organization (WHO) for the Northern Hemisphere and with the recommendations of the European Union for the 2025/2026 season.
The other ingredients are: buffer solution containing sodium chloride, sodium phosphate monobasic, sodium phosphate dibasic, water for injections, and octoxynol-9.
Some ingredients such as egg residues (egg albumen, chicken proteins) or formaldehyde may be present in very small amounts (see section 2).

What Efluelda vaccine looks like and contents of the pack

After gentle agitation, the vaccine is a colorless, opalescent liquid.
Efluelda is a suspension for injection in a pre-filled syringe (injection suspension) of 0.5 ml, with a needle or without a needle (in packs of 1, 5, or 10) or with a needle in a protective shield (in packs of 1 or 10). Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Importer:
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d'Incarville
B.P 101
27100 Val de Reuil
France

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

Date of last revision of the leaflet:July 2025

Currently approved information about this product is available or at the following URL: https://efluelda-nh.info.sanofi >
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Information intended for healthcare professionals only:

As with all injectable vaccines, it is necessary to ensure adequate treatment and medical supervision in case of anaphylactic reaction after administration of the vaccine.
Before administration, the vaccine should be at room temperature.
Shake before use. Check visually before administration.
The vaccine should not be used if particles are present in the suspension.
The vaccine should not be mixed with other medicinal products in the same syringe.
The vaccine should not be injected directly into blood vessels.
See also section 3. How to use Efluelda vaccine
˂Preparation for administration
Instructions for using the protective shield needle with the pre-filled syringe with Luer Lock tip:

Figure A: Protective shield needle (in housing)	Figure B: Protective shield needle components (ready for use)

Step 1: To attach the needle to the syringe, remove the needle hub cap to expose the needle hub and gently screw the needle into the Luer Lock adapter of the syringe until a slight resistance is felt.
Step 2: Remove the needle housing. The needle is protected by a protective shield and a protective cap.
Step 3: A: Move the protective shield away from the needle in the direction of the syringe body at the shown angle. B: Remove the protective cap.
Step 4: After injection, lock (activate) the protective shield using one of the three (3) presented one-handed techniques: activation on a flat surface, with the thumb, or with the index finger. Note: Activation is confirmed by an audible and/or palpable "click".
Step 5: Visually check the operation of the protective shield. The protective shield should be fully locked (activated), as shown in Figure C. Figure D shows that the protective shield is NOT fully locked (not activated).

Warning: Do not attempt to unlock (deactivate) the safety device by pushing the needle out of the protective shield.

Any unused product or waste material should be disposed of in accordance with local requirements.˃