Efluelda tetra

Package leaflet: Information for the user

Efluelda Tetra, suspension for injection in prefilled syringe
Tetravalent influenza vaccine (split virion, inactivated),
60 micrograms HA/strain
Please read all of this leaflet carefully before the vaccine is administered, because it contains
important information for the adult patient or child.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific individual only. Do not pass it on to others.
• If you or the vaccinated person experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Efluelda Tetra is and what it is used for

Efluelda Tetra is a vaccine. This vaccine helps protect individuals aged 60 years and older against influenza. The use of Efluelda Tetra vaccine should be based on official recommendations for influenza vaccination.
After administration of Efluelda Tetra vaccine, the immune system (the body's natural defence system) produces its own protection against the disease (antibodies). None of the components of the vaccine can cause influenza.
Influenza is an infectious respiratory disease caused by influenza viruses, ranging in severity from mild to severe, and may lead to serious complications such as pneumonia, which may result in hospitalization or even death. Influenza is a disease that spreads rapidly and is caused by many different virus strains, which may change each year. Due to these possible annual changes in circulating strains and the limited 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. For individuals who have not been vaccinated in the autumn, vaccination during the winter or early spring is still justified, as the risk of influenza infection persists until that time. Your doctor can advise on the optimal timing for vaccination.
The Efluelda Tetra vaccine is intended to protect against the four virus strains contained in the vaccine approximately 2 to 3 weeks after vaccination. Since the incubation period for influenza is several days, it is still possible to develop influenza 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 may resemble those of influenza.

2. Important information before using Efluelda Tetra vaccine

You should inform your doctor or pharmacist if any of the following apply to the person who is to receive the Efluelda Tetra vaccine. If anything is unclear, please ask your doctor or pharmacist for clarification.

When not to use Efluelda Tetra vaccine:

• If the person has a known allergy to:
  • the active substances, or
  • any of the other ingredients of this vaccine (listed in section 6), or
  • any component that may be present in trace amounts, such as egg residue (chicken egg ovalbumin, chicken proteins) or formaldehyde.

Warnings and precautions
Before receiving the Efluelda Tetra vaccine, talk to your doctor, pharmacist, or nurse.
Before vaccination, inform your doctor if the patient has:

• a weakened immune response (due to immunodeficiency or use of medicines affecting the immune system),
• bleeding disorders or a tendency to bruise easily,
• a history of Guillain-Barré syndrome (GBS) (a serious muscle weakness) after receiving an influenza vaccine,
• an illness with high or moderate fever or an acute illness. Vaccination should be postponed until recovery. The doctor will decide whether vaccination should be given.

Fainting may occur after, or even before, any injection. Therefore, inform your doctor or nurse if the person has previously fainted during or after an injection.
As with any vaccine, Efluelda Tetra may not provide complete protection in all vaccinated individuals.
Inform your doctor if blood tests are planned within a few days after influenza vaccination, as false-positive blood test results have been observed in some patients previously vaccinated.

Children
This vaccine should not be used in children. This vaccine is recommended for use in adults aged 60 years and older.

Efluelda Tetra vaccine and other medicines
Tell your doctor or pharmacist about all medicines or vaccines the patient is currently taking, has recently taken, or plans to take.

• If Efluelda Tetra vaccine is administered at the same time as other vaccines, the vaccines should always be given in separate limbs.
• Note that adverse reactions may be increased when vaccines are administered simultaneously.
• When using medicines that reduce immunity, such as corticosteroids, cytotoxic drugs, or radiotherapy, the immune response to vaccination may be weakened.

Pregnancy and breastfeeding
The Efluelda Tetra vaccine is indicated exclusively for use in adults aged 60 years and older.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before receiving this vaccine. The doctor or pharmacist will help decide whether the patient should receive the Efluelda Tetra vaccine.

Driving and operating machinery
The Efluelda Tetra vaccine has no effect or has a negligible effect on the ability to drive and operate machinery.

Efluelda Tetra vaccine contains potassium and sodium
This vaccine contains less than 1 mmol of sodium (23 mg) per dose and is therefore essentially "sodium-free".

3. How to use the Efluelda Tetra vaccine

Adults aged 60 years and older should receive a single dose of 0.7 ml.
How to administer the Efluelda Tetra vaccine
A doctor or nurse will administer the recommended dose of the vaccine as an intramuscular or subcutaneous injection.
If you have any further questions regarding the use of this vaccine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this vaccine may cause adverse reactions, although not everyone experiences them.

Allergic reactions
IMMEDIATELY contact a doctor if the patient experiences:

• Severe allergic reactions:
  • possibly requiring medical assistance, 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 fainting (anaphylaxis [including angioedema, i.e. swelling most commonly affecting the head and neck, including face, lips, tongue, throat or other body parts, which may cause difficulty in swallowing or breathing]).

Contact a doctor if the patient experiences:

• Allergic reactions such as skin reactions affecting the whole body, including itching, urticaria (hives), rash. These adverse reactions are rare (may affect up to 1 in 1,000 people).

Other adverse reactions
The following adverse reactions 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 malaise (fatigue), headache, muscle pain

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

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

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

• Injection site reactions: itching
• Fatigue, drowsiness, nausea, vomiting, diarrhoea
• Cough, muscle weakness, indigestion, sore throat (pain in mouth and throat)

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

• Lack of energy (weakness), redness, joint pain, central dizziness, night sweats, rash, numbness or tingling sensation (paresthesia), nasal inflammation (rhinitis), dizziness (balance disturbances), excess blood in the white part of the eye (ocular hyperemia)
• Limb pain

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

• Decreased number of certain types of blood cells called platelets; low levels may lead to excessive bruising or bleeding (thrombocytopenia)
• Enlargement of lymph nodes in the neck, armpit or groin (lymphadenopathy)
• Neurological disorders which may cause neck stiffness, disorientation, numbness, pain and weakness in limbs, loss of balance, loss of reflexes, paralysis of part or entire body (encephalomyelitis and transverse myelitis, brachial neuritis, Guillain-Barré syndrome), facial paralysis (Bell's palsy), vision disturbances due to optic nerve dysfunction (optic neuritis/neuropathy), seizures (convulsions, including febrile convulsions), fainting shortly after vaccination
• Vasculitis (inflammation of blood vessels), which may lead to skin rashes and, in very rare cases, transient kidney function disorders, blood vessel dilation
• Chest pain
• Wheezing, throat tightness, difficulty breathing (dyspnoea)

Most adverse reactions usually occurred within 3 days after vaccination and resolved within 3 days. The severity of these adverse reactions was generally mild to moderate.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Efluelda Tetra vaccine

Keep the vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the label and packaging following "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the pre-filled syringe in the outer packaging to protect from light.
Medicines should not be disposed of via sewage 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 Tetra vaccine contains

• The active substances are: Inactivated, split influenza virus 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**
B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type)
….…………………………………….. .............................................................. 60 micrograms HA**
per 0.7 ml dose
* propagated in embryonated chicken eggs
** hemagglutinin

The vaccine is in accordance 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.

Other components are: buffer solution containing sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate, water for injections, and octoxynol-9.

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

What Efluelda Tetra looks like and contents of the pack

After gentle shaking, the vaccine is a colourless, opalescent liquid.

Efluelda Tetra is an injection suspension in a pre-filled syringe with or without needle (pack sizes of 1, 5 or 10) or with needle in a protective shield (pack sizes of 1 or 10).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer

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

Other sources of information
Currently approved information about this product is available by scanning with a smartphone the QR code
provided on the cardboard box or at the following URL:
https://eflueldatetra-nh.info.sanofi/

Information intended exclusively for healthcare professionals:

As with all injectable vaccines, appropriate medical treatment and supervision must be available
in the event of an anaphylactic reaction following vaccination.
The vaccine should reach room temperature before administration.
Shake well before use. Visually inspect the vaccine before administration.
The vaccine must not be used if particulate matter is present in the suspension.
The vaccine must not be mixed with other medicinal products in the same syringe.
The vaccine must not be administered directly into blood vessels.
See also section 3. How to use Efluelda Tetra
˂Preparation for administration
Instructions for use of the safety-protected needle with the ampoule-syringe with Luer Lock tip:

Figure A: Needle in protective shield (in housing)	Figure B: Components of the needle protective shield (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 syringe's Luer Lock adapter until slight resistance is felt.
Step 2: Remove the needle housing. The needle is protected by a safety shield and a protective cap.
Step 3: A: Retract the safety shield away from the needle toward the syringe barrel at the angle shown. B: Remove the protective cap.
Step 4: After injection, lock (activate) the safety shield using one of the three (3) illustrated 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 inspect the function of the safety shield. The safety shield should be fully locked (activated), as shown in Figure C. Figure D shows the safety shield is NOT fully locked (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by pushing the needle out of the safety shield.

Any unused remnants of the medicinal product or its waste should be disposed of in accordance with local regulations.