Vaxigriptetra

Package leaflet: Information for the user

VaxigripTetra, suspension for injection in pre-filled syringe
Tetravalent influenza vaccine (split virion), inactivated
Please read all of this leaflet carefully before the vaccine is administered, because it
contains important information for the adult or child receiving the vaccine.

• 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 for a specific individual only. Do not pass it on to others.
• If any side effects occur in the adult or child, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What VaxigripTetra is and what it is used for
2. What you need to know before receiving VaxigripTetra
3. How to use VaxigripTetra
4. Possible side effects
5. How to store VaxigripTetra
6. Contents of the pack and other information

1. What VaxigripTetra is and what it is used for

VaxigripTetra is a vaccine. This vaccine is given to adults and children from 6 months of age to help protect against influenza (flu).
After receiving VaxigripTetra vaccine, the immune system (the body’s natural defence system) produces its own protection against the disease (antibodies). Vaccination during pregnancy helps protect pregnant women as well as their infants from birth up to less than 6 months of age by transferring protection from mother to child during pregnancy (see also sections 2 and 3).
None of the components of the vaccine can cause influenza.
The use of VaxigripTetra vaccine should follow official recommendations.
Influenza is an illness that can spread quickly and is caused by many different strains of virus which may change each year. Because of these possible annual changes in circulating strains and also due to the limited duration of protection provided by the vaccine, annual vaccination is recommended. The highest risk of contracting influenza occurs during the colder months, from October to March. For adults and children who were not vaccinated in the autumn, vaccination during the winter or early spring is still justified, as there remains a risk of influenza infection until that time. Your doctor can advise on the best time to be vaccinated.
VaxigripTetra vaccine is intended to protect adults and children 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 be similar to those of influenza.

2. Important information before using VaxigripTetra vaccine

Inform your doctor or pharmacist if any of the following apply to the adult or child who is to receive the VaxigripTetra vaccine. If anything is unclear, please ask your doctor or pharmacist for clarification.

When not to use VaxigripTetra:

• If the adult or child has a known allergy to:
  • The active substances, or
  • Any of the other ingredients of this vaccine (listed in section 6), or
  • Any component which may be present in trace amounts, such as egg residue (ovalbumin, chicken proteins), neomycin, formaldehyde, or octoxynol-9,
• If the adult or child has a current illness with high or moderate fever or an acute illness, vaccination should be postponed until recovery.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving the VaxigripTetra vaccine.
Inform your doctor if the adult or child has:

• A weakened immune response (due to immunodeficiency or medications affecting the immune system),
• Bleeding disorders or a tendency to bruise easily. The doctor will decide whether the adult or child should receive the vaccine.

Fainting may occur (particularly in adolescents) during or even before any injection.
Therefore, inform your doctor or nurse if you or your child has previously fainted following an injection.
As with any vaccine, VaxigripTetra may not protect all individuals who receive it.
Not all children under six months of age, born to women vaccinated during pregnancy, will be protected.
Inform your doctor if the adult or child is scheduled for blood tests within a few days after influenza vaccination, due to observed false-positive blood test results in some patients previously vaccinated.

Children
The use of VaxigripTetra vaccine is not recommended in children under 6 months of age.

VaxigripTetra and other medicines
Tell your doctor or pharmacist about any medicines or vaccines the adult or child is currently taking, has recently taken, or plans to take.

• VaxigripTetra may be administered simultaneously with other vaccines, but in separate limbs.
• If immunosuppressive medicines such as corticosteroids, cytotoxic drugs, or radiotherapy are being used, the immune response to vaccination may be reduced.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, or suspects she may be pregnant, she should consult her doctor or pharmacist before receiving this vaccine.
VaxigripTetra vaccine may be given during any stage of pregnancy.
VaxigripTetra vaccine may be used during breastfeeding.
The doctor decides on the appropriateness of administering the VaxigripTetra vaccine.

Driving and operating machinery
VaxigripTetra vaccine has no effect or negligible effect on the ability to drive and operate machinery.

VaxigripTetra contains potassium and sodium
This medicine contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially "potassium-free" and "sodium-free".

3. How to use VaxigripTetra

Dosage
Adults should receive one 0.5 ml dose.
Use in children
Children from the age of 6 months up to the age of 17 years should receive one 0.5 ml dose.
Children below 9 years of age who have not previously been vaccinated against influenza should be given a second 0.5 ml dose at least 4 weeks apart.
In pregnant women, one 0.5 ml dose administered during pregnancy may protect the infant from birth up to less than six months of age. For further information, consult your doctor or pharmacist.
How to use VaxigripTetra
Your doctor or nurse will administer the recommended dose of the vaccine as an intramuscular or subcutaneous injection.
Use of a higher than recommended dose of VaxigripTetra vaccine
In some cases, a higher than recommended dose has been accidentally administered.
In such cases, any reported adverse reactions were consistent with those described after administration of the recommended dose (see section 4).
If you have any further doubts concerning the use of this vaccine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this vaccine may cause adverse reactions, although not everyone will experience them.

Allergic reactions
Contact a doctor or healthcare professional immediately or go to the nearest emergency room if the adult or child experiences allergic reactions (reported as rare: may affect up to 1 in 1,000 people), which may be life-threatening.
Symptoms may include rash, itching, hives, redness, difficulty breathing, shortness of breath, swelling of the face, lips, throat or tongue, cold and clammy skin, palpitations, dizziness, weakness or fainting.

Other adverse reactions reported in adults and elderly people
Very common (may affect more than 1 in 10 people):

• Headache, muscle pain, general malaise, pain at injection site.

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

• Fever, chills, injection site reactions: redness (erythema), swelling, hardening.

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

• Dizziness, diarrhoea, feeling sick (nausea), fatigue, injection site reactions: bruising (discoloration), itching (pruritus) and warmth.

Rare in adults
Rare in elderly people

• Hot flushes: observed only in elderly people.
• Enlargement of lymph nodes in the neck, armpit or groin (lymphadenopathy): observed only in adults.

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

• Sensory disturbances involving touch, pain, heat and cold (paraesthesia), somnolence, excessive sweating, unusual tiredness or weakness (asthenia), influenza-like symptoms.
• Joint pain, discomfort at injection site: observed only in adults.

Other adverse reactions reported in children aged 3 to 17 years
Very common (may affect more than 1 in 10 people):

• Headache, muscle pain, general malaise, chills, injection site reactions: pain, swelling, redness (erythema), hardening.

Common in children aged 9 to 17 years
Common (may affect up to 1 in 10 people):

• Fever, bruise at injection site (discoloration).

Uncommon (may affect up to 1 in 100 people) in children aged 3 to 8 years:

• Temporary decrease in the number of certain types of blood cells called platelets; low levels may cause excessive bruising or bleeding (transient thrombocytopenia): reported in one 3-year-old child.
• Irritability, restlessness.
• Dizziness, diarrhoea, vomiting, abdominal pain, joint pain, fatigue, warmth at injection site.

Uncommon (may affect up to 1 in 100 people) in children aged 9 to 17 years:

• Diarrhoea, itching (pruritus) at injection site.

Other adverse reactions reported in children from completion of 6 months of age up to completion of 35 months of age
Very common (may affect more than 1 in 10 people):

• Vomiting, muscle pain, irritability, loss of appetite, general malaise, fever.
• Injection site reactions: pain/tenderness, redness (erythema).
• Headache: observed only in children below 24 months of age.
• Somnolence, unusual crying: observed only in children below 24 months of age.

Uncommon in children aged 24 months to completion of 35 months
Rare in children below 24 months of age
Rare in children aged 24 months to completion of 35 months

• Chills: observed only in children aged 24 months and older.
• Injection site reactions: hardening, swelling, bruising at injection site (discoloration).

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

• Diarrhoea, hypersensitivity.

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

• Influenza-like illness, injection site reactions: rash, itching (pruritus).

In children aged from completion of 6 months to 8 years who receive 2 doses, adverse reactions after the first and second dose are similar. Fewer adverse reactions may occur after administration of the second dose in children aged from completion of 6 months to completion of 35 months.

Observed adverse reactions usually occurred within the first 3 days after vaccination and resolved spontaneously within 1 to 3 days of onset. Observed adverse reactions were generally mild in nature.

Generally, adverse reactions occurred less frequently in elderly people than in adults and children.

The adverse reactions listed below were reported after administration of Vaxigrip vaccine. They may also occur after administration of VaxigripTetra:

• Pain along nerves (neuralgia), seizures, neurological disorders which may cause neck stiffness, disorientation, numbness, pain and weakness in limbs, loss of balance, loss of reflexes, paralysis of part or whole body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
• Vasculitis, which may lead to skin rashes and, very rarely, transient kidney function disorders.
• Transient thrombocytopenia, lymphadenopathy, paraesthesia in age groups other than those described above for these adverse reactions.

Reporting of adverse reactions
If any adverse reactions occur in an adult or child, including any adverse reactions 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Tel.: +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 VaxigripTetra 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. 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 in use. This will help
protect the environment.

6. Contents of the pack and other information

What VaxigripTetra contains

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

A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238)
............................................................................................................................. 15 micrograms HA**
A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A)
…………………………………………………………………………………. 15 micrograms HA**
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)
............................................................................................................................. 15 micrograms HA**
B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type)
............................................................................................................................. 15 micrograms HA**
per 0.5 ml dose
* Propagated in embryonated chicken eggs from healthy flocks
** 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, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.

Some components such as eggs (chicken egg albumin, chicken proteins), neomycin, formaldehyde, or octoxynol-9 may be present in very small amounts (see section 2).

What VaxigripTetra looks like and contents of the pack

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

VaxigripTetra is a suspension for injection supplied in 0.5 ml pre-filled syringes, with or without attached needle (packs of 1, 10 or 20) or with a separate needle in a protective shield (packs of 1 or 10). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder in Poland:

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France

Manufacturer:

< Sanofi Winthrop Industrie - 1541 avenue Marcel Mérieux - 69280 Marcy l’Etoile - France
Sanofi Winthrop Industrie - Voie de l’Institut - Parc Industriel d’Incarville – B.P 101 - 27100 Val de Reuil - France >

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

• Austria: VaxigripTetra Injektionssuspension in einer Fertigspritze.
• Lithuania: VaxigripTetra injekcinė suspensija užpildytame švirkšte.
• Bulgaria, Croatia, Cyprus, Estonia, Finland, France, Greece, Iceland, Latvia, Malta, Poland, Portugal, Romania, Slovenia, Sweden, Netherlands: VaxigripTetra.
• Denmark, Norway: Vaxigriptetra.
• Belgium, Luxembourg: Vaxigrip Tetra suspension injectable en seringue préremplie.
• Germany, Italy, Spain, Czech Republic, Slovakia, Hungary: Vaxigrip Tetra.
• Ireland, United Kingdom (Northern Ireland): Quadrivalent influenza vaccine (split virion, inactivated).

Further information

Up-to-date information on this product is available by scanning with a smartphone the QR code provided on the outer carton, or at the following URL: https://vaxigriptetra-nh.info.sanofi

Information intended exclusively for medical professionals:

As with all injectable vaccines, appropriate medical treatment and supervision must be available
in case 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 injected directly into blood vessels.
See also section 3. How to use VaxigripTetra

Instructions for use of the needle in safety shield with cartridge-syringe with Luer tip
Lock:
Figure A: Needle in safety shield (in housing)	Figure B: Components of the needle safety shield (ready for use)

Step 1: To attach the needle to the syringe, remove the hub cap from the needle hub 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 cover. The needle is protected by a safety shield and a protective cap.
Step 3: A: Slide the safety shield away from the needle towards 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 check 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 or remove the needle from the safety shield.
Any unused remnants of the medicinal product or waste materials should be disposed of in accordance with local regulations.
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