INFLUVAC SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

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

Contents of the package leaflet:

1. What is Influvac and what is it used for
2. What you need to know before you or your child use Influvac
3. How to use Influvac
4. Possible side effects
5. Storage of Influvac

1. Contents of the pack and further information

1. What is Influvac and what is it 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 flu 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 defense system) will produce 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 every year. For this reason, you or your child may need to be vaccinated every year. The greatest risk of getting the flu occurs during the cold months, between October and March. If you or your child were not vaccinated in the fall, it is still reasonable to be vaccinated until the spring, as you or your child are at risk of getting the flu until then. Your doctor can recommend the best time to be vaccinated.

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

The incubation period for the flu is a few days, so if you or your child are exposed to the flu virus immediately before or after being vaccinated, it is possible to develop the disease.

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

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 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

• 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 quantities, such as eggs (ovoalbumin or chicken proteins), formaldehyde, cetrimide, 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 system (immunodeficiency or use of medications that affect the immune system).
• a bleeding problem or bruise easily.

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

If you or your child have a disease accompanied by high fever or an acute infection, vaccination should be postponed until you or your child have recovered.

After or even before injection with a needle, fainting (fainting), dizziness, or other stress-related reactions may occur. Therefore, you should inform your doctor or nurse if you experience or have experienced this type of reaction previously with an injection.

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

Like all vaccines, Influvac may not completely protect all people who are vaccinated.

Other medicines and Influvac

• Tell your doctor, pharmacist, or nurse if you or your child are using, have recently used, or may need to use other vaccines or medications, including those purchased without a prescription.
• Influvac can be administered at the same time as other vaccines, but in different limbs. It should be noted that side effects could 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, consult your doctor for advice before using this medication.

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 global use of influenza vaccines do not indicate that the vaccine can have harmful effects on pregnancy or the baby.

Influvac can be used during breastfeeding.

Your doctor, pharmacist, or nurse can decide if you should receive Influvac.

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

Driving and using machines

The influence of Influvac on the ability to drive or use machines is nil or insignificant.

Influvac 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

Dosage

Adults receive a single dose of 0.5 ml.

Use in children and adolescents

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

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

The safety and efficacy of Influvac have not been established for infants under 6 months of age.

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 on the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Influvac can cause side effects, although not everyone gets them.

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

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

• that caused medical emergency due to insufficient circulation to maintain adequate blood flow to different organs (shock) in rare cases,
• with very evident inflammation of the head and neck, including face, lips, tongue, throat, or any other part of the body (angioedema) in very rare cases.

During clinical trials with Influvac and/or Influvac Tetra, the following side effects were observed. 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); and
• frequency not known (side effects derived from post-marketing experience; cannot be estimated from available data).

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

Reporting of side effects

If you or your child experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Influvac

Keep out of sight and reach of children.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container contents and additional information

Influvac composition

The active ingredients are:

Influenza virus surface antigens (hemagglutinin and neuraminidase), of 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 chicken eggs from healthy chickens

** hemagglutinin

This vaccine complies with the World Health Organization (WHO) recommendation (Northern Hemisphere) and with the European Union recommendation for the 2025/2026 campaign.

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 container contents

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

Container with 1 or 10 syringes.

Not all formats may be marketed.

Marketing authorization 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 from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized 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:July 2025

Detailed and updated 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 an anaphylactic reaction following administration of the vaccine.

The vaccine should be allowed to reach room temperature.

Shake before use.

Inspect visually before administration.

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

Do not mix with other medicinal products 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 the muscle mass is adequate) in children from 6 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 must be clearly recorded.

See also section 3: How to use Influvac