INFLUVAC 0,5 ML Zawiesina do wstrzykiwań w wstrzykiwaczu

Treść ulotki

1. What is Influvac S Tetra and what is it used for
2. What you need to know before you or your child use Influvac S Tetra
3. How to use Influvac S Tetra
4. Possible side effects
5. How to store Influvac S Tetra
6. Content of the pack and other information

Influvac S Tetra, injectable suspension inpre-filled syringes
Influenza vaccine (surface antigen, inactivated)
Season 2025/2026

important information for you or for your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed only for you or your child. Do not give it to other people.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:
1 What Influvac S Tetra is and what it is used for
2 What you need to know before you use Influvac S Tetra
3 How to use Influvac S Tetra
4 Possible side effects
5 How to store Influvac S Tetra
6 Contents of the pack and other information

1. What is Influvac S Tetra and what is it used for

Influvac S Tetra is a vaccine. This vaccine helps to protect you or your child against influenza, particularly in individuals who have a higher risk of associated complications. Influvac S Tetra is indicated for adults and children from 6 months of age. The use of Influvac S Tetra should be based on official recommendations.
When Influvac S Tetra is administered, the immune system (the body's natural defense system) produces its defenses (antibodies) against the disease. None of the components of the vaccine can cause the flu.
Influenza is a disease that can spread rapidly and is caused by different strains of viruses that can change every year. For this reason, you or your child may need to be vaccinated every year. The highest risk of contracting influenza is during the cold months from October to March. If you or your child have not been vaccinated in the autumn, you can still be vaccinated until spring, as you are still at risk of contracting influenza until then. Your doctor will advise you on the best time to get vaccinated.
Influvac S Tetra will protect you or your child against the four strains of viruses contained in the vaccine from 2-3 weeks after vaccination.
The incubation period of influenza is a few days, therefore if you or your child have been exposed to influenza immediately before or immediately after vaccination, you or your child may still develop the disease.
The vaccine will not protect you or your child from the common cold, although some symptoms are similar to those of influenza.
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2. What you need to know before you or your child use Influvac S Tetra

To be sure that Influvac S Tetra is suitable for you or your child, it is important that you inform your doctor, pharmacist or nurse if you or your child have any of the following conditions. If something is not clear, ask your doctor, pharmacist or nurse for an explanation.

Do not use Influvac S Tetra

• if you or your child are allergic (hypersensitive):
• to the active ingredients, or
• to any of the other ingredients of Influvac S Tetra (listed in section 6), or
• to any component that may be present in very small quantities such as eggs (ovalbumin or chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin (an antibiotic used to treat bacterial infections)
• If you or your child have a disease with high fever or an acute infection, vaccination should be postponed until you or your child recover.

Warnings and precautions
Before vaccination, inform your doctor if you or your child have:

• a reduced immune response (immunodeficiency or taking medicines that affect the immune system)
• bleeding problems or a tendency to bruise easily Your doctor will assess whether you or your child should receive the vaccine. Fainting, feeling faint or other stress-related reactions can occur following or even before any injection with a needle. Therefore, inform your doctor or nurse if you or your child have experienced this type of reaction with a previous injection. If, for any reason, you or your child need to have a blood test a few days after the flu vaccine, inform your doctor, as false positive blood test results have been observed in some patients who had been vaccinated shortly before. Like all vaccines, Influvac S Tetra may not fully protect all people who are vaccinated. Other medicines and Influvac S Tetra
• Inform your doctor, pharmacist or nurse if you or your child are taking or have recently taken or may take any other vaccine or medicine, including those that do not require a prescription.
• Influvac S Tetra can be administered simultaneously with other vaccines on different limbs. In this case, it is emphasized that side effects may be more severe.
• The immune response may decrease in case of immunosuppressive treatment, such as with corticosteroids, cytotoxic drugs or radiotherapy. Pregnancy and breastfeedingIf you are pregnant or breastfeeding, if you think you may be pregnant or are planning to have a baby, consult your doctor before taking this medicine.

Influenza vaccines can be used at all stages of pregnancy. More information on safety is available for the second and third trimesters, compared to the first trimester; however, data from worldwide use of influenza vaccines do not indicate that the vaccine can have harmful effects on pregnancy or the baby.
Influvac S Tetra can be used during breastfeeding.
Your doctor, pharmacist or nurse will assess whether you should take Influvac S Tetra. Ask your doctor, pharmacist or nurse for advice before taking any medicine.
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Driving and using machines
Influvac S Tetra does not or negligibly alters the ability to drive vehicles and use machines.

Influvac S Tetra contains sodium and potassium
This medicine contains less than 1 mmol (23mg) of sodium per dose, i.e. essentially ‘sodium-free’.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

3. How to use Influvac S Tetra

Dosage
Adults should be given a dose of 0.5 ml.

Use in children and adolescents
Children from 6 months to 17 years of age should be given a dose of 0.5 ml.
Children under 9 years of age who have not been previously vaccinated against influenza should
be given a second dose after an interval of at least 4 weeks.
For infants and young children under 6 months, the safety and efficacy of Influvac S Tetra
have not yet been established.

Route(s) of administration
Your doctor or nurse will administer the recommended dose of vaccine with an injection into the muscle
or deep under the skin.
If you have any doubts about the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Influvac S Tetra can cause side effects, although not everybody gets them.
manifest.

Seek medical attention immediately if you or your child experience any of the following side effects – you
or your child may need urgent medical treatment.
Serious allergic reactions (frequency not known, occurred occasionally during the general use of the trivalent influenza vaccine Influvac S)

• which can lead to a medical emergency with low blood pressure, rapid and shallow breathing, increased heart rate and weak pulse, cold and clammy skin, dizziness, which can lead to collapse (shock)
• more noticeable swelling in the head and neck, including the face, lips, tongue, throat or any other part of the body, which can cause difficulty swallowing or breathing (angioedema).

The following side effects have been observed during a clinical study with Influvac S Tetra:

Adults and the elderly
Very common: may affect more than 1 in 10 people:

• headache
• fatigue
• local reaction: pain at the injection site

Common: may affect up to 1 in 10 people:

• sweating

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• muscle pain (myalgia), joint pain (arthralgia)
• general feeling of discomfort, chills
• local reactions: redness, swelling, bruising (ecchymosis), hardening of the skin at the injection site.

Uncommon: may affect up to 1 in 100 people:

• fever

Children (from 6 months to 17 years of age)
Side effects that may occur in children from 6 to 35 months of age:
Very common: may affect more than 1 in 10:

• sleepiness
• sweating
• loss of appetite
• diarrhea, vomiting
• irritability/agitation
• fever
• local reactions: pain, redness

Common: may affect up to 1 in 10:

• local reactions: swelling, hardening, ecchymosis

Side effects that may occur in children from 3 to 5 years of age:
Very common: may affect more than 1 in 10:

• sleepiness
• loss of appetite
• irritability/agitation
• local reactions: pain at the injection site, redness, swelling, hardening of the skin at the injection site

Common: may affect up to 1 in 10:

• sweating
• diarrhea, vomiting
• fever
• local reactions: bruising (ecchymosis)

Side effects that may occur in children from 6 to 17 years of age:
Very common: may affect more than 1 in 10:

• headache
• nausea, abdominal pain, diarrhea, vomiting
• muscle pain (myalgia)
• fatigue, general feeling of discomfort
• local reactions: pain at the injection site, redness, swelling, hardening of the skin at the injection site

Common: may affect up to 1 in 10:

• sweating
• joint pain (arthralgia)
• fever
• chills
• local reactions: bruising (ecchymosis)

All age groups
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For all age groups, most of the above reactions usually occurred within the first 3
days after vaccination, and resolved spontaneously within 1-3 days of onset. The intensity of
these reactions was generally mild.
In addition to the above side effects, occasionally during the general use of the trivalent influenza vaccine
Influvac S, the following side effects have occurred:
Frequency not known:

• skin reactions that can spread all over the body such as itching (urticaria) or rash
• inflammation of the blood vessels which can cause redness of the skin (vasculitis) and in very rare cases temporary kidney problems
• nerve pain (neuralgia), abnormalities in the perception of touch, pain, heat and cold (paresthesia), convulsions associated with fever, neurological disorders that can cause stiff neck, confusion, numbness, pain and weakness in the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
• temporary reduction in the number of a type of blood particles called platelets; a low number of platelets can cause bruising or excessive bleeding (transient thrombocytopenia); temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy)

Reporting of side effects
If you or your child gets any side effect, talk to your doctor, pharmacist or nurse. This includes any side effects
not listed in this leaflet. You can also report side effects directly
to 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 Influvac S Tetra

Keep this medicine out of the sight and reach of children.
Do not use Influvac S Tetra after the expiry date stated on the pack after EXP. The expiry date
refers to the last day of that month.
Store Influvac S Tetra in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original package 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 Influvac S Tetra contains
The active ingredients are:
Surface antigens (haemagglutinin and neuraminidase) (inactivated) of influenza viruses of the following strains*:

• A/Victoria/4897/2022 (H1N1)pdm09-equivalent strain (A/Victoria/4897/2022, IVR-238)
• A/Croatia/10136RV/2023 (H3N2)-equivalent strain (A/Croatia/10136RV/2023, X-425A) 15 micrograms HA **

15 micrograms HA **

• B/Austria/1359417/2021-equivalent strain (B/Austria/1359417/2021, BVR-26) 15 micrograms HA **
• B/Phuket/3073/2013-equivalent strain (B/Phuket/3073/2013, wild type) 15 micrograms HA ** per a 0.5 ml dose

* propagated in fertilised hen eggs from healthy chicken farms
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** haemagglutinin
This vaccine is in accordance with the recommendations of the World Health Organization (WHO) (northern
hemisphere) and the recommendations of the European Union for the 2025/2026 season.
The other components are: potassium chloride, dipotassium hydrogen phosphate, disodium phosphate dihydrate, sodium chloride,
calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.

Description of the appearance of Influvac S Tetra and content of the pack
Influvac S Tetra is an injectable suspension presented in pre-filled glass syringes (with / without needle)
containing 0.5 ml of a clear and colourless injectable liquid. Each syringe can only be used once.
Pack of 1 or 10 syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturer
Abbott Biologicals B.V.
Veerweg 12
NL - 8121 AA Olst
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) under the following denominations:

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The following information is intended for healthcare professionals only:
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.
Allow the vaccine to reach room temperature before use. Shake before use.
Examine visually before administration.
Do not use the vaccine if there are foreign particles in the suspension.
Do not mix other medicines within the same syringe.
The vaccine must not be injected directly into a blood vessel.
The preferred injection sites for intramuscular injection are the anterolateral portion of the thigh (or the deltoid if the muscle
mass is adequate) in children from 6 months to 35 months of age, or the deltoid muscle in children from 36 months of
age and in adults.
Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the medicinal
product administered must be clearly recorded.
See also section 3: How to use Influvac S Tetra
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