EFLUELDA 60 MICROGRAMS Инъекционная суспензия в преднаполненном шприце

Содержание инструкции

1. Possible side effects
2. How to store Efluelda
3. Content of the pack and other information

Efluelda, injectable suspension in pre-filled syringe
Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain
Medicinal product subject to additional monitoring. This will allow the rapid identification of new

information on safety. You can contribute by reporting any adverse effects you experience
while taking this medicinal product. See the end of section 4 for information on how to
report adverse effects.

Read this leaflet carefully before using this medicine as 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 get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What is Efluelda 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

1What is Efluelda and what it is used for
Efluelda is a vaccine. This vaccine helps to protect people aged 60 years and over from influenza.
The use of Efluelda should be based on official recommendations on influenza vaccination.
When Efluelda is given 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 cause mild to severe illness and can cause serious complications such as pneumonia, which may require hospitalisation or even death. Influenza is an illness that can spread rapidly and is
caused by different strains that can vary each year. Due to this potential annual variation of circulating strains, as well as the expected duration of vaccine protection, it is recommended to
be vaccinated every year. The highest risk of contracting influenza occurs during the cold months
between October and March. If you have not received the vaccine in autumn, it is still advisable to get vaccinated in spring, i.e. until the time when you are still at risk of contracting influenza. Your
doctor will be able to advise you on the best time to get vaccinated.
Efluelda is intended to protect you from the three strains of virus contained in the vaccine 2-3 weeks
after the injection. In addition, if you are exposed to influenza immediately before or after vaccination,
you may still develop the disease because the incubation period of influenza lasts a few
days.
The vaccine will not protect you from the common cold, even if some symptoms are similar to influenza.

2What you need to know before you use Efluelda
To make sure that Efluelda is suitable for you, it is important that you tell your doctor or pharmacist if any
of the following points apply to you. If you do not understand something, do not hesitate to ask
your doctor or pharmacist for an explanation.

Do not use Efluelda:

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

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

• a poor immune response (immunodeficiency or due to the use of medicines that affect the immune system),
• bleeding problems or a tendency to bruise easily,
• developed Guillain-Barré syndrome (GBS) (severe muscle weakness) after receiving an influenza vaccine,
• a disease with high or moderate fever or an acute illness; in this case, vaccination should be postponed until recovery. The doctor will decide whether you should receive the vaccine.

Following, or even before, any injection with a needle, fainting may occur. Therefore, inform your
doctor or nurse if you have experienced fainting with a previous injection.
As with all vaccines, Efluelda may not fully protect all vaccinated people.
Tell your doctor if, for any reason, you need to undergo a blood test a few days after
influenza vaccination. This is because false positive blood test results have been observed
in some patients who had been recently vaccinated.

Children
This vaccine should not be used in children, but should only be used in adults aged 60 years and over.

Other medicines and Efluelda
Tell 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 at the same time as other vaccines, the vaccines should always be administered using different limbs.
• It should be noted that adverse reactions may be intensified by any concomitant administration.
• The immune response may decrease in case of immunosuppressive treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.

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

Driving and operating machinery
Efluelda does not impair or negligibly impairs the ability to drive vehicles and operate machinery. However,
if you feel unwell or dizzy, it is not advisable to drive.

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

3How to useEfluelda
Adults aged 60 years and over receive a dose of 0.5 mL.

How Efluelda is administered
The 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 using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions
Contact your doctor IMMEDIATELYif you experience:

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

Contact your doctor if 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 side effects reported
The following side effects have been reported in adults aged 60 years or older:
Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

• Reactions at the injection site: swelling, bruising, hardening,
• Fever, chills (tremor)

Uncommon (may affect up to 1 in 100 people)

• Reactions at the injection site: itching
• Fatigue, lethargy, feeling sick (nausea), vomiting, diarrhea
• Cough, muscle weakness, indigestion (dyspepsia), sore 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 (paresthesia), inflammation of the nose (rhinorrhea), vertigo, excess blood in the white of the eye (ocular hyperemia)
• Pain in the limbs.

Not known (frequency cannot be estimated from available data)

• Reduced number of certain types of blood particles called platelets; a low number of them can cause excessive bruising or bleeding (thrombocytopenia);
• Swelling of the glands in the neck, armpit or groin (lymphadenopathy);
• Neurological disorders that can cause stiff neck, confusion, numbness, pain and weakness of 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) that can cause skin rashes and, in very rare cases, temporary kidney problems, widening of blood vessels (vasodilation);
• Chest pain;
• Wheezing, constriction of the throat, difficulty breathing (dyspnea).

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you 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 which is stated on the label and the package after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Store the syringe in the outer packaging to
protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Efluelda contains

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

A/Victoria/4897/2022 (H1N1) pdm09–strain equivalent (A/Victoria/4897/2022, IVR-238)
..................................................................................................................................... 60 micrograms HA**
A/Croatia/10136RV/2023 (H3N2)–strain equivalent (A/Croatia/10136RV/2023, X-425A)
..................................................................................................................................... 60 micrograms HA**
B/Austria/1359417/2021–strain equivalent (B/Michigan/01/2021, wild type) ......... 60 micrograms HA**
Per dose of 0.5 mL
* propagated in fertilised hen’s eggs
** haemagglutinin
This vaccine is in accordance with the recommendations of the World Health Organization (WHO) and
(Northern Hemisphere) and the decision of the European Union for the 2025/2026 season.
The other ingredients are: a buffer solution containing sodium chloride, monobasic sodium phosphate, disodium
phosphate, water for injections and octoxinol-9.
The vaccine may contain residues of certain substances, such as eggs (ovalbumin, chicken proteins) or
formaldehyde (see section 2).

Description of the appearance of Efluelda and contents of the pack
The vaccine, after being gently shaken, appears as a colourless, opalescent liquid.
Efluelda is an injectable suspension in a pre-filled syringe of 0.5 mL (injectable suspension), with or without
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 for Italy
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milan
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 Member States of the EEA under the following names:

Other sources of information
The latest approved information on this product is available by scanning the QR code, present
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 treatment and medical supervision must always be
readily available in the event of an anaphylactic reaction following vaccine administration.
The vaccine must reach room temperature before use.
Shake before use. Inspect visually before administration.
The vaccine should not be used if there are foreign particles in suspension.
It should not be mixed with other medicinal products in the same syringe.
This vaccine should not be injected directly into a blood vessel.
See also section 3. How to use Efluelda

˂Preparation for Administration
Instructions for use of the pre-filled syringe safety needle with Luer Lock:

I Figure A: Safety needle (inside the casing)	Figure B: Components of the safety needle (ready for use)
A g e n c y

Step 1: To connect the needle to the syringe, remove the cap of the connector to expose the connector or of the needle and gently rotate the needle into the Luer Lock adapter of the syringe until you feel slight resistance.
c a Step 2: Remove the safety needle from the casing. The needle is covered by the safety shield and the needle cap.
Step 3: A: Remove the safety shield from the needle and direct it towards the body of the syringe as shown in the angle. B: Pull off the needle cap.	l F a r m
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”.	n a d e
i l a Step 5: Visually inspect the activation of the safety shield. The t safety shield must be completely locked (activated) as shown in Image C.

Caution: Do not attempt to unlock (deactivate) the safety device by forcibly removing the needle
from the safety shield.
Unused medicine and waste materials derived from such medicine should be disposed of in accordance with
current local regulations. ˃