Influvac suspension for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Influvac suspension for injection in a pre-filled syringe

Influenza vaccine (inactivated surface antigen)

2025/2026 campaign

Read all of this leaflet carefully before you or your child are vaccinated, because 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, 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 adverse reactions, consult your doctor, pharmacist or nurse. This includes any adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Influvac is and what it is used for

2. What you need to know before you or your child are given Influvac

3. How to use Influvac

4. Possible side effects

5. How to store Influvac

6. Contents of the pack and other information

1. What Influvac is and what it is used for

Influvac is a vaccine for adults and children from 6 months of age. This vaccine helps protect you or your child against the influenza virus. The use of Influvac should be based on official recommendations.

When the Influvac vaccine is administered to a person, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. None of the components of the vaccine can cause influenza.

Influenza is an illness that can spread rapidly and is caused by different strains that may change each year. For this reason, you or your child may need to be vaccinated every year. The highest risk of contracting influenza occurs during the colder months, between October and March. If you or your child were not vaccinated in the autumn, it is still reasonable to get vaccinated until spring, as you or your child remain at risk of catching influenza until then. Your doctor can advise you on the best time to be vaccinated.

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

The incubation period for influenza is a few days, so if you or your child are exposed to the influenza virus immediately before or after vaccination, it is possible that you or your child may still develop the disease.

The vaccine will not protect you or your child against the common cold, even though some of its symptoms may be similar to those of influenza.

2. What you need to know before you or your child use Influvac

To ensure that Influvac is suitable for you or your child, it is important that you consult your doctor, pharmacist, or nurse if any of the following 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

• If you or your child are allergic (hypersensitive) to:
  • the active substances, or
  • any of the other components of Influvac (see section 6), or
  • any of the components that may be present in very small amounts, such as eggs (ovalbumin or chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin (an antibiotic used to treat bacterial infections).

Warnings and precautions

Before vaccination, you must inform your doctor if you or your child have:

• a weakened immune response (immunodeficiency or use of medicines affecting the immune system).
• a bleeding disorder or bruise easily.

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

If you or your child have an illness with high fever or an acute infection, vaccination should be postponed until you or your child have recovered.

Fainting (syncope), dizziness, or other stress-related reactions may occur after or even before an injection with a needle. Therefore, you should inform your doctor or nurse if you have experienced or have previously experienced such reactions with an injection.

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

Like all vaccines, Influvac may not fully protect all individuals who are vaccinated.

Other medicines and Influvac

• Inform your doctor, pharmacist, or nurse if you or your child are using, have recently used, or might need to use any other vaccines or medicines, including those obtained without a prescription.
• Influvac can be administered at the same time as other vaccines, but in different limbs. Note that adverse effects could be more intense.
• The immune response may be reduced during immunosuppressive treatment, such as corticosteroids, cytotoxic medicines, or radiotherapy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor for advice before using this medicine.

Inactivated influenza vaccines can be used at all stages of pregnancy.

More safety data are available for the second and third trimesters compared to the first trimester. However, data on the use of influenza vaccines worldwide do not indicate that the vaccine may have harmful effects on pregnancy or the baby.

Influvac can be used during breastfeeding.

Your doctor, pharmacist, or nurse will decide whether you should receive Influvac.

Consult your doctor, pharmacist, or nurse before taking any medicine.

Driving and using machines

The influence of Influvac on the ability to drive or use machines is none or negligible.

Influvac contains sodium and potassium

This medicine contains less than 1 mmol of sodium (23 mg) 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

Posology

Adults should receive a single 0.5 ml dose.

Use in children and adolescents

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

Children under 9 years of age who have not previously been vaccinated against seasonal influenza: a second dose should be administered after an interval of at least 4 weeks.

The safety and efficacy of Influvac in infants under 6 months of age has 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 further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Influvac can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you or your child experience any of the following adverse effects; you or your child may require urgent medical attention.

Severe allergic reactions (frequency not known, occasionally reported during general use of Influvac):

• leading to medical emergencies due to circulatory system failure to maintain adequate blood flow to the various organs (shock) in rare cases,
• with marked swelling of the head and neck, including face, lips, tongue, throat, or any other part of the body (angioedema) in very rare cases.

The following adverse effects have been observed during clinical trials with Influvac and/or Influvac Tetra. Their frequency has been estimated as:

• very common (may affect more than 1 in 10 people);
• common (may affect up to 1 in 10 people);
• uncommon (may affect up to 1 in 100 people);
• frequency not known (adverse effects derived from post-marketing experience; cannot be estimated from the available data).

In all age groups, most of the previously mentioned reactions usually occur within the first 3 days after vaccination and resolve spontaneously within 1 to 3 days after onset. In general, the intensity of these reactions was mild.

Reporting of adverse reactions

If you or your child experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Influvac

Keep out of the sight and reach of children.

Do not use Influvac after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store Influvac in a refrigerator (between 2°C - 8°C). Do not freeze.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Influvac

The active substances are:

Influenza virus surface antigens (haemagglutinin and neuraminidase) from the following strains*:

• Strain similar to A/Victoria/4897/2022 (H1N1) pdm09
  (A/Victoria/4897/2022, IVR-238).......15 micrograms HA**

• Strain similar to A/Croatia/10136RV/2023 (H3N2)
  (A/Croatia/10136RV/2023, X-425A).......................15 micrograms HA**

• Strain similar to B/Austria/1359417/2021
  (B/Austria/1359417/2021, BVR-26)…........15 micrograms HA**

per 0.5 ml dose

• grown in embryonated hens' eggs from healthy chickens

** haemagglutinin

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 and contents of the pack

Influvac is an injectable suspension supplied in pre-filled glass syringes (with or without needle), with a plunger stopper (bromobutyl rubber), containing 0.5 ml of clear, colourless injectable liquid. Each syringe is for single use only.

Pack containing 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
The Netherlands

Further information on this medicine is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 Madrid
Spain

This medicine 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 reviewed in: July 2025

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

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 an anaphylactic reaction following vaccine administration.

Allow the vaccine to reach room temperature before use.

Shake well before use.

Inspect visually before administration.

Do not use the vaccine if the colour has changed or if foreign particles in suspension are observed.

Do not mix with other medicines in the same syringe.

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

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

Traceability

To improve traceability of biological medicines, the name and batch number of the administered medicine should be clearly recorded.

See also section 3: How to use Influvac