What it is and what it is used for

for Influenza vaccine TIV Viatris is a vaccine. This vaccine helps to protect you or your child against influenza (flu), particularly in subjects who run a high risk of associated complications. Influenza vaccine TIV Viatris is indicated in adults and children from 6 months of age. The use of Influenza vaccine TIV Viatris should be based on official recommendations. When a person is given the vaccine Influenza vaccine TIV Viatris, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Therefore, this is why you or your child might need to be vaccinated every year. The greatest risk of catching flu is during the cold months between October and March. If you or your child were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you or your child runs the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated. Influenza vaccine TIV Viatris will protect you or your child against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection. The incubation period for flu is a few days, so if you or your child are exposed to flu immediately before or after your vaccination, you or your child could still develop the illness. The vaccine will not protect you or your child against the common cold, even though some of the symptoms are similar to flu. 2.

What you need to know before you or your child use Influenza vaccine TIV Viatris

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To make sure that Influenza vaccine TIV Viatris is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain. Do not use Influenza vaccine TIV Viatris

• If you or your child are allergic (hypersensitive) to:
• the active substances, or
• any of the other ingredients of Influenza vaccine TIV Viatris (see section 6), or
• any component that may be present in very small amounts such as eggs (ovalbumin or chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin (an antibiotic that is used to treat bacterial infections)
• If you or your child have an illness with a high temperature or acute infection, the vaccination shall be postponed until after you or your child have recovered. Warnings and precautions You or your child should tell your doctor before vaccination if you or your child have:
• a poor immune response (immunodeficiency or taking medicines affecting the immune system)
• a bleeding problem or bruising easily Your doctor will decide if you or your child should receive the vaccine. Fainting, feeling faint or other stress related reactions can occur following, or even before, any needle injection. Therefore tell your doctor or nurse if you have experienced this kind of reaction with a previous injection. If, for any reason, you or your child have a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated. As with all vaccines, Influenza vaccine TIV Viatris may not fully protect all persons who are vaccinated. Other medicines and Influenza vaccine TIV Viatris
• Tell your doctor or pharmacist if you or your child are taking or have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription.
• Influenza vaccine TIV Viatris can be given at the same time as other vaccines by using separate limbs. It should be noted that the side effects may be stronger.
• The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Flu vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of flu vaccines do not indicate that the vaccine would have harmful effects on the pregnancy or the baby. Influenza vaccine TIV Viatris may be used during breast-feeding. Your doctor/pharmacist will be able to decide if you should receive Influenza vaccine TIV Viatris. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Influenza vaccine TIV Viatris has no or negligible influence on the ability to drive or use machines. Influenza vaccine TIV Viatris contains sodium and potassium This medicine contains less than 1 mmol 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".

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How to take it

Influenza vaccine TIV Viatris Dosage Adults receive one 0.5 ml dose. Use in children Children from 6 months to 17 years receive one 0.5 ml dose. Children less than 9 years of age, who have not previously been vaccinated with a seasonal influenza vaccine: a second dose should be given after an interval of at least 4 weeks. For infants less than 6 months of age, the safety and efficacy of Influenza vaccine TIV Viatris have not been established. Route(s) and/or method of administration Your doctor will administer the recommended dose of the vaccine as an injection into the muscle or deep under the skin. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Influenza vaccine TIV Viatris can cause side effects, although not everybody gets them. See your doctor straight away 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 unknown, occurred occasionally during general use of Influenza vaccine TIV Viatris):

• that may lead to medical emergency with low blood pressure, rapid, shallow breathing, rapid heart rate and weak pulse, cold, clammy skin, dizziness, that may lead to collapse (shock)
• swelling most apparent in the head and the neck, including the face, lips, tongue, throat or any other part of the body and which may cause difficulty in swallowing or breathing (angioedema) During clinical trials, the following side effects have been observed. Adults and elderly: Very common: may affect more than 1 in 10 people:
• headache a
• fatigue
• local reaction: vaccination site pain a In elderly adults (≥ 61 years) reported as common Common: may affect up to 1 in 10 people:
• sweating
• muscular pain (myalgia), joint pain (arthralgia)
• generally feeling unwell (malaise), shivering,
• local reactions: redness, swelling, bruising (ecchymosis), hardness (induration) around the area where vaccine is injected. Uncommon: may affect up to 1 in 100 people:
• fever Children (6 months to 17 years of age):

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Side effects that occurred in children 6 to 35 months of age: Very common: may affect more than 1 in 10 people:

• drowsiness
• sweating
• appetite loss
• diarrhoea, vomiting
• irritability/fussiness
• fever
• local reactions: pain, redness Common: may affect up to 1 in 10 people:
• local reaction: swelling, induration, ecchymosis Side effects that occurred in children 3 – 5 years of age: Very common: may affect more than 1 in 10 people:
• drowsiness
• appetite loss
• irritability/fussiness
• local reactions: vaccination site pain, redness, swelling, hardness (induration) around the area where the vaccine is injected Common: may affect up to 1 in 10 people:
• sweating
• diarrhoea, vomiting
• fever
• local reaction: bruising (ecchymosis)

Possible side effects

that occurred in children 6 – 17 years of age: Very common: may affect more than 1 in 10 people:

• headache
• nausea, abdominal pain, diarrhoea, vomiting
• muscular pain (myalgia)
• fatigue, generally feeling unwell (malaise)
• local reactions: vaccination site pain, redness, swelling, hardness (induration) around the area where the vaccine is injected Common: may affect 1 in 10 people:
• sweating
• joint pain (arthralgia)
• fever
• shivering
• local reaction: bruising (ecchymosis) All age groups For all age groups, most reactions mentioned above usually occurred within the first 3 days following vaccination, resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was generally mild. Next to the above side effects, the following side effects occurred occasionally during general use of the trivalent influenza vaccine: Unknown frequency:
• • skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash
• • blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases in temporary kidney problems
• • pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and cold (paraesthesia), fits (convulsions) associated with fever, neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of

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•

part or all the body (encephalomyelitis, neuritis, Guillain-Barré Syndrome)

• temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia); temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy)

Reporting of side effects If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

How to store it

Influenza vaccine TIV Viatris Keep out of the sight and reach of children. Do not use Influenza vaccine TIV Viatris after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store Influenza vaccine TIV Viatris in a refrigerator (2°C – 8°C). Do not freeze. Store the product in the original package in order 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. These measures will help to protect the environment.

Contents of the pack and other information

What Influenza vaccine TIV Viatris contains The active substances are: Influenza virus surface antigens (haemagglutinin and neuraminidase) of 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 15 micrograms HA ** (A/Croatia/10136RV/2023, X-425A)
• B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) 15 micrograms HA ** per 0.5 ml dose
• propagated in fertilised hens'eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2025/2026 season. The other ingredients are: potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections. What Influenza vaccine TIV Viatris looks like and contents of the pack Influenza vaccine TIV Viatris is a suspension for injection presented in prefilled glass syringe (with or without needle) containing 0.5 ml of a colourless clear injection fluid. Each syringe can only be used once. Pack size of 1 or 10. Not all pack sizes may be marketed. Marketing Authorisation Holder: Viatris Products Limited, Station Close,

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Potters Bar, EN6 1TL, United Kingdom. Registration number: PLGB 46302/0251 Manufacturer: Abbott Biologicals B.V. Veerweg 12 NL – 8121 AA Olst The Netherlands This leaflet was last revised in October 2025.

—————————————————————————————————————–The following information is intended for medical or healthcare professionals only: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. The vaccine should be allowed to reach room temperature. Shake before use. Inspect visually prior to administration. Do not use the vaccine if foreign particles are present in the suspension. Do not mix with other medicinal products in the same syringe. The vaccine is not to be injected directly into any blood vessel. The preferred sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults. See also section 3: How to use Influenza vaccine TIV Viatris

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