Vaxigriptetra

Leaflet accompanying the packaging: information for the user

VaxigripTetra, suspension for injection in a pre-filled syringe

Tetra-valent influenza vaccine (split virion, inactivated)

Read the leaflet carefully before using the vaccine, as it contains important information for the adult or child 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 adult or child patient experiences any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is VaxigripTetra and what is it used for
• 2. Important information before using 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 is VaxigripTetra and what is it used for

VaxigripTetra is a vaccine. This vaccine, given to adults and children from 6 months of age, helps protect against flu.
After vaccination with VaxigripTetra, the immune system (the body's natural defense system)
produces its own protection against the disease (antibodies). The vaccine given during pregnancy
helps protect pregnant women, as well as the child from birth to under 6 months of age, by transferring protection from mother to child during pregnancy (see also sections 2 and 3).
No component of the vaccine can cause flu.
VaxigripTetra should be used in accordance with official recommendations.
Flu is a disease that can spread quickly and is caused by many different strains of the virus, which can change every 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 is during the cold months between October and March. In the case of adults and children who have 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.
VaxigripTetra is intended to protect adults and children against the four strains of the virus contained in the vaccine about 2-3 weeks after vaccination. Since the incubation period for flu is a few days, in the event of exposure to the flu virus immediately before or after vaccination, it is still possible to get the flu.
The vaccine does not protect against the common cold, although some of its symptoms are similar to those of the flu.

2. Important information before using VaxigripTetra

Tell your doctor or pharmacist if any of the following apply to the adult or child patient who is to receive VaxigripTetra. If you are unsure, ask your doctor or pharmacist to explain.

When not to use VaxigripTetra:

• If the adult or child patient 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 (chicken egg albumin, chicken protein), neomycin, formaldehyde, or octoxynol-9,
• If the adult or child patient has a disease with high or moderate fever or acute disease, vaccination should be postponed until recovery.

Warnings and precautions

Before using VaxigripTetra, talk to your doctor, pharmacist, or nurse.
Before vaccination, tell your doctor if the adult or child patient has:

• Impaired immune response (due to immunodeficiency or taking drugs that affect the immune system),
• Bleeding or bruising easily. The doctor will decide whether the adult or child patient should receive the vaccine.

Fainting can occur (especially in adolescents) after, or even before, any needle injection.
Therefore, tell your doctor or nurse if the patient or their child has experienced fainting during previous injections.
As with any vaccine, VaxigripTetra may not provide full protection for all vaccinated individuals.
Not all children under 6 months of age, born to women vaccinated during pregnancy, will be protected.
Tell your doctor if the adult or child patient is scheduled to have a blood test within a few days after flu vaccination, due to false-positive blood test results observed in some patients previously vaccinated.

Children

VaxigripTetra is not recommended for children under 6 months of age.

VaxigripTetra and other medicines

Tell your doctor or pharmacist about all medicines or vaccines currently being used or recently used by the adult or child patient, as well as any medicines or vaccines planned for use.

• VaxigripTetra can be given at the same time as other vaccines, but in different limbs.
• When using immunosuppressive drugs, such as corticosteroids, cytotoxic drugs, or radiation therapy, the immune response to vaccination may be weakened.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this vaccine.
VaxigripTetra can be given at any stage of pregnancy.
VaxigripTetra can be used during breastfeeding.
The doctor will decide whether to administer VaxigripTetra.

Driving and using machines

VaxigripTetra has no or negligible influence on the ability to drive and use machines.

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, which is essentially "potassium-free" and "sodium-free".

3. How to use VaxigripTetra

Dosage

Adults receive one dose of 0.5 ml.
Use in children
Children from 6 months of age to 17 years of age receive one dose of 0.5 ml.
Children under 9 years of age who have not been previously vaccinated against flu should receive a second dose of 0.5 ml at least 4 weeks later.
In the case of pregnant women, one dose of 0.5 ml given during pregnancy may protect the child from birth to under 6 months of age. For further information, consult your doctor or pharmacist.

How to take VaxigripTetra

Your doctor or nurse will give you the recommended dose of the vaccine as an injection into a muscle or under the skin.

Overdose of VaxigripTetra

In some cases, a higher dose than recommended was accidentally given.
In these cases, when side effects were reported, they were consistent with those described after administration of the recommended dose (see section 4).
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

Seek immediate medical attention if the adult or child patient experiences an allergic reaction (reported as rare: may affect up to 1 in 1,000 people), which can be life-threatening.
Symptoms may include rash, itching, hives, redness, difficulty breathing, wheezing, swelling of the face, lips, throat, or tongue, pale, cool skin, rapid heartbeat, dizziness, weakness, or fainting.

Other side effects reported in adults and the elderly

Very common (may affect more than 1 in 10 people)

• Headache, muscle pain, general feeling of being unwell, pain at the injection site. Common in the elderly Common (may affect up to 1 in 10 people)
• Fever, chills, reactions at the injection site: redness (erythema), swelling, hardness. Less common in the elderly Less common (may affect up to 1 in 100 people)
• Dizziness, diarrhea, feeling sick (nausea), tiredness, reactions at the injection site: bruising (ecchymosis), itching (pruritus), and redness. Rare in adults Rare in the elderly
• Hot flushes: observed only in the elderly.
• Enlarged lymph nodes in the neck, armpits, or groin (lymphadenopathy): observed only in adults.

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

• Numbness or tingling (paresthesia), sleepiness, excessive sweating, unusual tiredness or weakness (asthenia), flu-like symptoms.
• Joint pain, discomfort at the injection site: observed only in adults.

Other side effects reported in children from 3 to 17 years of age

Very common (may affect more than 1 in 10 people)

• Headache, muscle pain, general feeling of being unwell, chills, reactions at the injection site: pain, swelling, redness (erythema), hardness. Common in children from 9 to 17 years of age Common (may affect up to 1 in 10 people)
• Fever, bruising at the injection site (ecchymosis).

Less common (may affect up to 1 in 100 people) in children from 3 to 8 years of age

• Temporary decrease in the number of certain types of blood cells called platelets; their low level can cause excessive bruising or bleeding (transient thrombocytopenia): reported in one 3-year-old child.
• Fussiness, irritability.
• Dizziness, diarrhea, vomiting, abdominal pain, joint pain, tiredness, redness at the injection site.

Less common (may affect up to 1 in 100 people) in children from 9 to 17 years of age

• Diarrhea, itching (pruritus) at the injection site.

Other side effects reported in children from 6 months to 35 months of age

Very common (may affect more than 1 in 10 people):

• Vomiting, muscle pain, irritability, loss of appetite, general feeling of being unwell, fever. Less common in children from 24 months to 35 months of age Rare in children under 24 months of age Rare in children from 24 months to 35 months of age
• Reactions at the injection site: pain/tenderness, redness (erythema).
• Headache: observed only in children under 24 months of age.
• Sleepiness, unusual crying: observed only in children under 24 months of age.

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

• Chills: observed only in children 24 months of age and older
• Reactions at the injection site: hardness, swelling, bruising at the injection site (ecchymosis).

Less common (may affect up to 1 in 100 people):

• Diarrhea, hypersensitivity.

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

• Flu-like illness, reactions at the injection site: rash, itching (pruritus).

In children from 6 months to 8 years of age who receive 2 doses, side effects after the first and second doses are similar. Fewer side effects may occur after the second dose in children from 6 months to 35 months of age.
Observed side effects usually occurred within the first 3 days after vaccination and resolved on their own within 1 to 3 days of occurrence. Observed side effects were generally mild.
Side effects usually occurred less frequently in the elderly than in adults and children.
The following side effects have been reported after administration of Vaxigrip. They may also occur after administration of VaxigripTetra:

• Pain felt along the nerves (neuralgia), seizures (convulsions), 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 myelitis, neuritis, Guillain-Barré syndrome).
• Vasculitis, which can lead to skin rashes and, in very rare cases, to temporary kidney function disorders.
• Transient thrombocytopenia, lymphadenopathy, paresthesia in age groups other than those described above for these side effects.

Reporting side effects

If the adult or child patient experiences 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 medicine.

5. How to store VaxigripTetra

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 carton 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 VaxigripTetra 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)
............................................................................................................................. 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**
in a 0.5 ml dose
* grown in chicken embryos from healthy flocks
** hemagglutinin
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.

• Other ingredients are: buffer solution containing sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.

Certain ingredients, such as eggs (chicken egg albumin, chicken protein), 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 colorless, opalescent liquid.
VaxigripTetra is a suspension for injection in a pre-filled syringe of 0.5 ml, with a attached needle or without a needle (in packs of 1, 10, or 20) or with a separate needle in a protective shield (in packs of 1 or 10). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder in Poland is:
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France
The manufacturer is:
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:

• 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).

Date of last revision of the leaflet:May 2025

Other sources of information

Currently approved information on this product is available by scanning the QR code on the carton or at the following URL: https://vaxigriptetra-nh.info.sanofi
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Information intended for healthcare professionals only:

As with all injectable vaccines, appropriate medical treatment and supervision should be available in case of anaphylactic reactions following 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 VaxigripTetra

Instructions for using the safety needle shield with the pre-filled syringe with Luer Lock tip
Lock:
Rycina A: Safety needle shield (in housing)	Rycina B: Components of the safety needle 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 Luer Lock adapter of the syringe until a slight click is felt.
Step 2: Remove the needle shield. The needle is protected by a safety shield and a protective cap.
Step 3: A: Slide the safety 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 safety shield using one of the three (3) one-handed techniques shown: 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 safety shield. The safety shield should be fully locked (activated), as shown in Figure C. Figure D shows that the safety shield is NOT fully locked (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by pushing the needle back into the safety shield.
Any unused product or waste material should be disposed of in accordance with local regulations.>
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