Leaflet: Information for the user

Influvac Tetra pre-filled syringe suspension

Inactivated surface antigen influenza vaccine

Season 2024/2025

Read this leaflet carefully before you or your child is vaccinated, as it contains important information for you and your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or your child only. Do not give it to anyone else.
• If you or your child experience any side effects, consult your doctor, pharmacist or nurse. Even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Influvac Tetra is a vaccine. This vaccine helps you or your child to protect against the flu, especially in those people who are at a high risk of complications related to it. Influvac Tetra is indicated for adults and children from 6 months of age. The use of Influvac Tetra should be based on official recommendations.

When a person receives the Influvac Tetra vaccine, their immune system (natural defense system of the body) will manufacture its own protection (antibodies) against the disease. None of the components of the vaccine can cause the flu.

The flu is a disease that can spread quickly and is caused by different types of strains that can change each year. This is why it is necessary for you or your child to be vaccinated every year. The highest risk of catching the flu is during the cold months between October and March. If you or your child did not get vaccinated in the fall, it is still reasonable to get vaccinated in the spring, as you or your child is still at risk of catching the flu until then. Your doctor will recommend the best time to be vaccinated.

Influvac Tetra will protect you or your child against the four virus strains contained in the vaccine approximately 2 or 3 weeks after the injection.

The incubation period of the flu is a few days, so if you or your child are exposed to the flu immediately before or after being vaccinated, you or your child could still develop the disease.

The vaccine will not protect you or your child against the common cold, even though some of the symptoms are similar to the flu.

To ensure that Influvac Tetra is suitable for you or your child, it is essential to consult with your doctor, pharmacist, or nurse if any of the points described below affect you or your child. If you do not understand anything, tell 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 (ovalbumin or chicken proteins), formaldehyde, cetrimonium bromide, polisorbate 80, or gentamicin (an antibiotic used to treat bacterial infections)
• If you or your child has a disease with high temperature or an acute infection, vaccination should be postponed until you have recovered.

Warnings and precautions

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

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

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

After or even before any needle injection, dizziness, feeling of dizziness, or other reactions related to stress may appear. Therefore, 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 the flu vaccination, please inform your doctor. This is because false positive results in blood tests have been observed in a few patients who were recently vaccinated.

Like all vaccines, Influvac Tetra does not entirely protect all people who are vaccinated.

Other medicines and Influvac Tetra

• Inform your doctor, pharmacist, or nurse if you or your child are using, have recently used, or may need to use any other vaccine or any other medication, including over-the-counter medications.
• Influvac Tetra can be used at the same time as other vaccines, but in different limbs. The adverse effects may be more intense.
• The immune response may decrease in 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 intend to become pregnant,ask your doctor before taking thismedicine.

Influenza vaccines can be used in all stages of pregnancy. There is more safety data available in the second and third trimesters, compared to the first trimester; however, global data on the use of influenza vaccines do not indicate any adverse effects in 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 operating machinery

The influence of Influvac Tetra on the ability to drive and operate machinery is negligible or insignificant.

Influvac Tetra contains sodium and potassium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is, it is essentially “sodium-free”.

This medicine contains potassium, less than 1 mmol (39 mg) per dose, that is, it is essentially “potassium-free”.

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, who have not been previously vaccinated with a seasonal flu vaccine: a second dose should be administered after a minimum interval of 4 weeks.

For babies 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.

Like all medicines, Influvac Tetra can cause side effects, although not everyone will 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 flu vaccine):

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

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

Adults and elderly people:

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

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

aNotified as common 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, inflammation, purpura, induration around the vaccine administration area.

Rare: may affect up to 1 in 100 people:

• fever.

Children (6 months to 17 years):

Side effects that occur in children aged 6 to 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: inflammation, induration, purpura

Side effects that occur in children aged 3 to 5 years:

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

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

Common: may affect up to 1 in 10 people:

• sweating
• diarrhea, vomiting
• fever
• local reaction: purpura.

Side effects that occur in children aged 6 to 17 years:

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

• headache
• nausea, abdominal pain, diarrhea, vomiting
• muscle pain (myalgia)
• fatigue, general feeling of being unwell

• local reactions: pain at the vaccination site, redness, inflammation, induration around the area where the vaccine was injected.

Common: may affect up to 1 in 10 people:

• sweating
• joint pain (arthralgia)
• fever
• chills
• local reaction: purpura.

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 onset. The intensity of these reactions was generally mild.

Unknown frequency:

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

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

Do not use Influvac Tetra after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Store the product in the original packaging to protect from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

What Influvac Tetra contains

The active substances are:

Surface antigens (inactivated) of the following influenza virus strains:

This vaccine meets the World Health Organization (WHO) recommendation (northern hemisphere) and the European Union recommendation for the 2024/2025 campaign.

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

Appearance of Influvac Tetra and contents of the pack

Influvac Tetra is a ready-to-use injectable suspension presented in pre-filled syringes (with/without needle) containing 0.5 ml of transparent and colourless liquid for injection. Each syringe is for single use.

Available in packs of 1 or 10 syringes.

Only some pack sizes may have been marketed.

Marketing authorisation holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer responsible for the medicinal product:

Abbott Biologicals B.V.

Veerweg 12

NL - 8121 AA Olst

Netherlands

Further information on this medicinal product can be obtained by contacting 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 2024

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

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

The vaccine should reach room temperature. Shake before use.

Inspect visually before administration.

Do not use the vaccine if you observe any foreign particles in suspension.

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

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

The recommended injection sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle 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 adults.

Traceability

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

See also section 3: How to use Influvac Tetra