INFLUVAC TETRA Injectable Suspension in Pre-filled Syringe

2. What you need to know before you or your child starts using Influvac Tetra

To ensure that Influvac Tetra is suitable for you or your child, it is important to consult with your doctor, pharmacist, or nurse if any of the following points apply to you or your child. If there is anything you do not understand, ask your doctor, pharmacist, or nurse to explain it to you.

Do not use Influvac Tetra

• If you or your child is allergic (hypersensitive) to:
• • the active ingredients, or
  • any of the other components of Influvac Tetra (listed in section 6), or
  • any component that may be present in small amounts, such as eggs (ovoalbumin or chicken proteins), formaldehyde, cetrimide, polysorbate 80, or gentamicin (an antibiotic used to treat bacterial infections)
• If you or your child has a high fever or an acute infection, vaccination should be postponed until you or your child has recovered.

Warnings and precautions

You or your child should tell your doctor before vaccination if you or your child has:

• a poor immune response (immunodeficiency or taking medications that affect the immune system)
• a bleeding or bruising problem

Your doctor will decide if you or your child should receive the vaccine.

After or even before any injection with the needle, fainting, dizziness, or other stress-related reactions may occur. Therefore, you should inform your doctor or nurse if you or your child has experienced this type of reaction previously with an injection.

If, for any reason, you or your child has a blood test a few days after influenza vaccination, please inform your doctor. This is because false-positive blood test results have been observed in a few patients who have been recently vaccinated.

Like all vaccines, Influvac Tetra does not completely protect all vaccinated individuals.

Other medications and Influvac Tetra

• Tell your doctor, pharmacist, or nurse if you or your child is using, has recently used, or may need to use any other vaccine or any other medication, including medications without a prescription.
• Influvac Tetra can be used at the same time as other vaccines, but in different limbs. Side effects may be more intense.
• The immune response may be reduced in the case of immunosuppressive treatment, such as corticosteroids, cytotoxic medications, or radiation therapy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor before taking this medication.

Influenza vaccines can be used in all stages of pregnancy. More safety data are available for the second and third trimesters compared to the first trimester; however, worldwide data on the use of influenza vaccines do not indicate any adverse effect on pregnancy or the baby attributable to the vaccine.

Influvac Tetra can be used during breastfeeding.

Your doctor, pharmacist, or nurse will decide if you should receive Influvac Tetra. Consult your doctor, pharmacist, or nurse before taking any medication.

Driving and using machines

The influence of Influvac Tetra on the ability to drive and use machines is zero or insignificant.

Influvac Tetra contains sodium and potassium

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

This medication contains potassium, less than 1 mmol (39 mg) per dose, i.e., it is essentially "potassium-free".

3. How to use Influvac Tetra

Dosage

Adults receive a dose of 0.5 ml.

Use in children and adolescents

Children from 6 months to 17 years receive a dose of 0.5 ml.

Children under 9 years of age who have not been previously vaccinated with a seasonal influenza vaccine: a second dose should be administered after a minimum interval of 4 weeks.

For infants under 6 months, the safety and efficacy of Influvac Tetra have not been established.

Route(s) and/or method of administration

Your doctor or nurse will administer the recommended dose of the vaccine by intramuscular or deep subcutaneous injection.

If you have any other questions about the use of this product, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Influvac Tetra can cause side effects, although not all people experience them.

Consult your doctor immediately if you or your child experiences any of the following side effects – you or your child may need urgent medical attention.

Severe allergic reactions (frequency not known, which occurred occasionally during the general use of the trivalent influenza vaccine):

• that may require medical assistance with a drop in blood pressure, rapid and shallow breathing, rapid heart rate and weak pulse, cool and sweaty skin, dizziness that can cause collapse (shock)
• very noticeable inflammation of the head and neck, including the face, lips, tongue, throat, or any other part of the body that can cause difficulty swallowing or breathing (angioedema).

During clinical trials with Influvac Tetra, the following side effects were observed:

Adults and elderly:

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

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

a Reported as frequent in elderly adults (≥61 years)

Common: may affect up to 1 in 10 people:

• sweating
• muscle pain (myalgia), joint pain (arthralgia)
• feeling unwell in general (malaise), chills
• local reactions: redness, swelling, bruising (ecchymosis), hardening (induration) around the vaccine administration area.

Uncommon: may affect up to 1 in 100 people:

• fever.

Children (6 months to 17 years):

Side effects that occur in children between 6 and 35 months:

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

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

Common: may affect up to 1 in 10 people:

• local reactions: swelling, hardening, bruising (ecchymosis)

Side effects that occur in children between 3 and 5 years:

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

• drowsiness
• loss of appetite
• irritability/agitation
• local reactions: pain at the injection site, redness, swelling, hardening around the area where the vaccine was injected.

Common: may affect up to 1 in 10 people:

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

Side effects that occur in children between 6 and 17 years:

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

• headache
• nausea, abdominal pain, diarrhea, vomiting
• muscle pain (myalgia)
• fatigue, general malaise

• local reactions: pain at the injection site, redness, swelling, hardening around the area where the vaccine was injected.

Common: may affect up to 1 in 10 people:

• sweating
• joint pain (arthralgia)
• fever
• shivering
• local reaction: bruising (ecchymosis).

All age groups

For all age groups, most of the reactions shown above usually occurred within the first 3 days after vaccination and resolved spontaneously between the first and third day after the start. The intensity of these reactions was generally mild.

Frequency not known:

• skin reactions that can spread throughout the body, including itching of the skin (pruritus, urticaria), rash
• inflammation of the blood vessels that can cause a skin rash (vasculitis) and, in very rare cases, temporary kidney problems
• pain located at the nerve endings (neuralgia), abnormal sensation of touch, pain, heat, and cold (paresthesia), seizures (convulsions) related to fever, neurological disorders that can lead to stiff neck, confusion, tingling, pain, and weakness in the limbs, loss of balance, loss of reflexes, paralysis of a part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
• temporary reduction in the number of certain types of blood particles called platelets; a low number of these can cause excessive bruising or bleeding (transient thrombocytopenia); temporary inflammation of the glands in the neck, armpit, or groin (transient lymphadenopathy).

Reporting of side effects

If you or your child experiences any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Influvac Tetra

Keep this medication out of sight and reach of children.

Do not use Influvac Tetra after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Store Influvac Tetra in the refrigerator (2°C – 8°C). Do not freeze.

Keep the product in its original packaging to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the pack and additional information

What Influvac Tetra contains

The active substances are:

Influenza virus surface antigens (inactivated) (hemagglutinin and neuraminidase) of the following strains*:

This vaccine complies with the World Health Organization (WHO) recommendation (northern hemisphere) and with the European Union recommendation for the 2025/2026 season.

The other components are: potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and water for injections.

Appearance of Influvac Tetra and pack contents

Influvac Tetra is an injectable suspension presented in glass pre-filled syringes (with/without needle) containing 0.5 ml of clear and colorless liquid for injection. Each syringe is for single use.

Pack with 1 or 10 syringes.

Only some pack sizes may be marketed.

Marketing authorisation holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer responsible for batch release:

Abbott Biologicals B.V.

Veerweg 12

NL - 8121 AA Olst

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

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:

This leaflet was last revised in: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic reaction following administration of the vaccine.

The vaccine should reach room temperature. Shake before use.

Inspect visually before administration.

Do not use the vaccine if foreign particles are observed in suspension.

Do not mix with other medicinal products in the same syringe.

The vaccine must not be administered directly into any blood vessel.

Recommended injection sites are the anterolateral aspect of the thigh (or the deltoid muscle if 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 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