INFLUVAC TETRA

Package leaflet: Information for the user

Influvac Tetra, suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen), inactivated
Season 2025/2026
Please read all of this leaflet carefully before this vaccine is administered to an adult or child, as it contains important information for the patient.

• Keep this leaflet as 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 adult or child only. Do not pass it on to others.
• If any adverse reactions occur in the adult or child, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

Influvac Tetra is a vaccine. This vaccine helps protect adults and children from influenza (flu), particularly those at risk of developing flu-related complications. Influvac Tetra is indicated for adults and children aged 6 months and older.
Use of the Influvac Tetra vaccine should follow official recommendations.
After vaccination with Influvac Tetra, the body's immune system (the body's natural defence system) produces its own protection (antibodies) against the disease. None of the vaccine components cause influenza.
Influenza is an illness that can spread rapidly. It is caused by various strains of virus, which may change each year. For this reason, annual vaccination of adults and children may be necessary. The highest risk of contracting influenza occurs during the colder months between October and March. If an adult or child has not been vaccinated in the autumn, vaccination may still be given until spring, as the risk of influenza remains elevated until then. Your doctor will determine the best time for vaccination.
Influvac Tetra protects adults and children against the four virus strains contained in the vaccine approximately 2 to 3 weeks after vaccination.
The incubation period of influenza in the body is several days; therefore, if an adult or child is exposed to the virus shortly before or immediately after vaccination, there remains a possibility of developing influenza.
The vaccine does not protect adults or children against the common cold, even though some of its symptoms may resemble those of influenza.

2. What you need to know before using Influvac Tetra

Inform your doctor, pharmacist, or nurse if any of the following apply to the adult or child who is to receive the vaccine. If in doubt, ask your doctor, pharmacist, or nurse for advice.

When not to use Influvac Tetra

• if the adult or child has a known allergy (hypersensitivity) to:
  • the active substances or
  • any of the other ingredients of Influvac Tetra (see section 6) or
  • any component that may be present in trace amounts, such as egg (chicken egg ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin (an antibiotic used to treat bacterial infections)
• if the adult or child has a disease accompanied by high fever or an acute infection, vaccination should be postponed until recovery.

Warnings and precautions

Before administering Influvac Tetra, inform your doctor if the adult or child has:

• a weakened immune response (due to immunodeficiency or use of medications affecting the immune system)
• bleeding disorders or a tendency to bruise easily.

Your doctor will decide whether the adult or child can be vaccinated.
Fainting, feeling faint or weak, or other stress-related reactions may occur before or after any injection. If such a reaction occurred previously in the adult or child after vaccination, they should inform their doctor or nurse.
Inform your doctor if blood tests are planned for the adult or child within a few days after influenza vaccination. In some patients, false-positive blood test results have been observed shortly after influenza vaccination.
As with any vaccine, Influvac Tetra may not fully protect all vaccinated individuals.

Influvac Tetra and other medicines

• Tell your doctor, pharmacist, or nurse about all vaccines or medicines currently being taken or recently taken by the adult or child, as well as any medicines they plan to take, including those obtained without a prescription.
• Influvac Tetra may be administered simultaneously with other vaccines, but each vaccine should be given in a different limb. This may increase the frequency of adverse reactions.
• Immune response may be reduced when administered concurrently with immunosuppressive medications such as corticosteroids, cytotoxic drugs, or radiotherapy.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before receiving this vaccine.
Influenza vaccines may be used at any stage of pregnancy. More extensive safety data are available for the second and third trimesters compared to the first trimester; however, worldwide data on influenza vaccination do not indicate any harmful effects on the fetus or mother.
Influvac Tetra may be used during breastfeeding.
Your doctor, pharmacist, or nurse will decide whether vaccination with Influvac Tetra is appropriate for a pregnant woman. Always consult your doctor, pharmacist, or nurse before using any medicine.

Driving and using machines

Influvac Tetra has no effect or a negligible effect on the ability to drive and operate machinery.

Influvac Tetra contains sodium and potassium

The vaccine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is considered "sodium-free".
The vaccine contains less than 1 mmol of potassium (39 mg) per dose, meaning it is considered "potassium-free".

3. How to use Influvac Tetra

Dosage
Adults should receive one 0.5 ml dose.
Use in children and adolescents
Children aged 6 months to 17 years should receive one 0.5 ml dose.
Children under 9 years of age who have not previously been vaccinated with seasonal influenza vaccine: a second 0.5 ml dose should be administered after an interval of at least 4 weeks.
Children under 6 months of age: safety and efficacy of Influvac Tetra have not been established.
Method and route of administration
The vaccine will be administered by a doctor or nurse intramuscularly or deep subcutaneously.
If you have any doubts regarding the use of the vaccine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, Influvac Tetra can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in an adult or child, contact a doctor immediately – immediate medical intervention may be required:
Severe allergic reactions (frequency unknown, occurred sporadically during administration of the trivalent vaccine Influvac)

• possibly requiring immediate medical assistance, manifesting as low blood pressure, rapid shallow breathing, rapid heartbeat with weak pulse, cold and clammy skin, dizziness which may lead to fainting (shock)
• swelling most pronounced in the head and neck area, affecting face, lips, tongue, throat or other parts of the body, which may cause difficulty in swallowing or breathing (angioedema)

During clinical trials with Influvac Tetra vaccine, the following adverse reactions were observed:
Adults and elderly individuals:
Very common: may occur in more than 1 in 10 people

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

In elderly individuals (aged ≥61 years), reported as common

Common: may occur in up to 1 in 10 people

• sweating
• muscle pain, joint pain
• malaise, chills
• local reactions: redness, swelling, bruising, induration at the injection site

Uncommon: may occur in up to 1 in 100 people

• fever

Children (aged 6 months to 17 years):
Adverse reactions observed in children aged 6 months to 35 months:
Very common: may occur in more than 1 in 10 people

• drowsiness
• sweating
• loss of appetite
• diarrhoea, vomiting
• irritability
• fever
• local reactions: pain, redness

Common: may occur in up to 1 in 10 people

• local reactions: swelling, induration, bruising

Adverse reactions observed in children aged 3–5 years:
Very common: may occur in more than 1 in 10 people

• drowsiness
• loss of appetite
• irritability
• local reactions: pain at injection site, redness, swelling, induration at injection site

Common: may occur in up to 1 in 10 people

• sweating
• diarrhoea, vomiting
• fever
• local reaction: bruising

Adverse reactions observed in children aged 6–17 years:
Very common: may occur in more than 1 in 10 people

• headache
• nausea, abdominal pain, diarrhoea, vomiting
• muscle pain
• fatigue, general malaise
• local reactions: pain at injection site, redness, swelling, induration at injection site

Common: may occur in up to 1 in 10 people

• sweating
• joint pain
• fever
• chills
• local reaction: bruising

All age groups
In all age groups, most of the above-mentioned adverse reactions usually occurred within the first 3 days after vaccination and resolved spontaneously within 1 to 3 days of onset. Generally, these were mild adverse reactions.
In addition to the above-mentioned adverse reactions, the following reactions have been observed sporadically during use of the trivalent Influvac vaccine.
Frequency unknown

• skin reactions which may affect the entire body, including itching, urticaria or rash
• vasculitis which may cause skin rash and, in very rare cases, transient disturbances in kidney function
• nerve pain (neuralgia), abnormal sensation to touch, pain, heat and cold (paresthesia), seizures associated with fever, neurological disorders which may lead to neck stiffness, disorientation, numbness, pain and weakness of limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
• temporary decrease in platelet count; low platelet levels may lead to increased tendency to bruise and bleed (transient thrombocytopenia), temporary enlargement of cervical, axillary or inguinal lymph nodes (transient lymphadenopathy).

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 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 may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Influvac Tetra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the syringe after
EXP. The expiry date refers to the last day of the stated month. The batch number is shown on
the carton and syringe after Lot.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep in the original 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Influvac Tetra contains
The active substances are:
Inactivated influenza virus surface antigens (haemagglutinin and neuraminidase)
corresponding to 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/Austria/1359417/2021, BVR-26)
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
** haemagglutinin
This vaccine is in accordance with the recommendations of the World Health Organization (WHO)
(for the northern hemisphere) and EU recommendations for the 2025/2026 season.
Other ingredients of the vaccine are: potassium chloride, potassium dihydrogen phosphate,
disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride
hexahydrate, water for injections.

What Influvac Tetra looks like and contents of the pack
The Influvac Tetra vaccine contains 0.5 ml of a colourless, clear suspension for injection in a prefilled syringe (Type I glass) with or without needle. Each prefilled syringe is for single use only.
Pack sizes of 1 or 10 prefilled 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
Olst, 8121AA
The Netherlands

For further information, contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

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

The following information is intended exclusively for healthcare professionals or medical personnel:

As with all injectable vaccines, appropriate medical treatment and supervision must be readily available to manage potential anaphylactic reactions following vaccination.

The vaccine should be brought to room temperature. Shake well before use.
Inspect visually prior to administration.
Do not use the vaccine if particulate matter or discoloration is present in the suspension.
Do not mix with other medicinal products in the same syringe.
The vaccine must not be administered intravascularly.

The preferred sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is sufficient) in children aged 6 to 35 months, or the deltoid muscle in children aged 36 months and older and in adults.

Traceability
To improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

See also section 3: How to use Influvac Tetra