Інструкція із застосування FLUKELVAX
Зміст інструкції
Flucelvax injectable suspension in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, produced in cell cultures)
Read this leaflet carefully before you receive this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Flucelvax is and what it is used for
- 2. What you need to know before you receive Flucelvax
- 3. How Flucelvax is administered
- 4. Possible side effects
- 5. How to store Flucelvax
- 6. Contents of the pack and other information
1. What is Flucelvax and what is it used for
Flucelvax is a vaccine against influenza. Flucelvax is produced in cell cultures and therefore does not
contain egg components.
Following administration of the vaccine, the immune system (the body's natural defense system) produces antibodies against the influenza virus. None of the components of the vaccine can cause
influenza.
Flucelvax is used to prevent influenza in adults and children starting from 6 months of age.
The vaccine has been formulated against the three strains of influenza virus based on the recommendations
of the World Health Organization for the 2025/2026 season.
2. What you need to know before you receive Flucelvax
Do not useFlucelvax
if you are allergic to:
- the active ingredients or any of the other ingredients of this medicine (listed in section 6).
- beta-propiolactone, cetyltrimethylammonium bromide or polysorbate 80; these substances are residues of the manufacturing process present in trace amounts.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive Flucelvax.
BEFORE receiving the vaccine
- The doctor or nurse will ensure that appropriate treatment and medical supervision are readily available in the rare event of an anaphylactic reaction (a very serious allergic reaction, with symptoms such as difficulty breathing, dizziness, weak and rapid pulse and skin rash) occurring after administration. This reaction may occur with Flucelvax as with all injected vaccines.
- Tell your doctor if you have an acute illness associated with fever. Your doctor may decide to postpone vaccination until the fever has subsided.
- Tell your doctor if your immune system is compromised or if you are receiving treatment that affects your immune system, e.g. cancer drugs (chemotherapy) or corticosteroids (see section “Other medicines and Flucelvax”).
- Tell your doctor if you have bleeding problems or bruise easily.
- Fainting can occur after or even before an injection with a needle; therefore, inform your doctor or nurse if you have already fainted on previous occasions during injections.
As with all vaccines, it is possible that Flucelvax may not fully protect all
vaccinated people.
Children under 6 months of age
This vaccine is not currently recommended in children under 6 months of age as the
safety and efficacy in this age group have not been established.
Other medicines and Flucelvax
Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines or if you have recently received
any other vaccine.
Flucelvax can be given at the same time as other vaccines.
Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you are pregnant, suspect you may be pregnant or are planning a pregnancy. Influenza
vaccines can be given at any stage of pregnancy.
Breastfeeding
Use during breastfeeding has not been studied. No effects on breastfed infants are expected. Flucelvax can be given during breastfeeding.
Driving and using machines
Flucelvax has no or negligible effect on the ability to drive and operate machines.
Flucelvax contains sodium chloride and potassium chloride
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
This vaccine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium-free’.
3. How Flucelvax is administered
Flucelvax is administered to you by a doctor or nurse as an injection into the muscle
of the upper arm (deltoid muscle) or into the muscle of the upper and outer
thigh in young children, depending on the size of the muscle.
Adults and children aged 6 months or older:
A dose of 0.5 mL
If your child is under 9 years of age and has not been previously vaccinated against influenza,
a second dose must be administered after at least 4 weeks.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during clinical studies and general use:
Very serious side effects
Tell your doctor immediately or go to the nearest hospital emergency room if you experience
symptoms of the following side effect, as you may need urgent medical attention or hospitalisation:
- Difficulty breathing, dizziness, weak and rapid pulse, and skin rash, which are symptoms of anaphylaxis (a very serious allergic reaction)
Serious side effects
Tell your doctor immediately if any of the following side effects occur,
as you may need medical attention:
- Feeling of weakness, difficulty moving, or numbness or tingling in the limbs. These may be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by the immune system.
- Extensive swelling of the limb where the injection was given
Other side effects
Very common (may affect more than 1 in 10 people)
- Pain at the injection site, bruising, redness and hardening or swelling at the injection site.
- Headache
- Muscle pain
- Fatigue
- Loss of appetite
- Irritability (reported only in children aged between 6 months and < 6 years)
- Drowsiness (reported only in children aged between 6 months and < 6 years)
- Change in eating habits (reported only in children aged between 6 months and < 6 years)
- Fever (≥ 38 °C)
- Diarrhoea Hardening or swelling at the injection site, headache, muscle pain and fatigue were common in the elderly. Bruising at the injection site was common in adults, the elderly and children aged between 9 and < 18 years. Headache was common in the elderly. Loss of appetite was common in adults, the elderly and children aged between 9 and < 18 years. Fever was uncommon in adults and the elderly and common in children aged between 4 and < 18 years.
Common (may affect up to 1 in 10 people)
- Nausea, vomiting
- Joint pain
- Chills Vomiting was uncommon in the elderly.
Not known (frequency cannot be estimated from available data)
- Feeling of numbness and tingling (paresthesia)
- Generalised skin reactions, including itching, skin bumps (itching, urticaria) or unspecified rash
Reporting of side effects
in Appendix V. By reporting side
effects you can help provide more information on the safety of this
medicine.
5. How to store Flucelvax
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the label and on the packaging after
EXP / Scad. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Flucelvax contains
- The active ingredient is comprised of surface antigens of the influenza virus (haemagglutinin and neuraminidase), inactivated, derived from equivalent strains*:
A/Wisconsin/67/2022 (H1N1)pdm09-equivalent strain (A/Georgia/12/2022, CVR-167)
15 micrograms HA**
A/District of Columbia/27/2023 (H3N2)-equivalent strain (A/Victoria/800/2024, CVR-289)
15 micrograms HA**
B/Austria/1359417/2021-equivalent strain (B/Singapore/WUH4618/2021, wild type)
15 micrograms HA**
per a 0.5 mL dose
……………………………………….
* propagated in Madin Darby Canine Kidney (MDCK) cells (these are the specific cell cultures in which the influenza virus is grown)
** HA=haemagglutinin
The vaccine is in accordance with the recommendation of the World Health Organization (WHO)
(Northern Hemisphere) and the EU decision for the 2025/2026 Season.
- The other ingredients are sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, monobasic potassium phosphate and water for injections (see section 2 Flucelvax contains sodium and potassium).
Description of the appearance of Flucelvax and contents of the pack
Flucelvax is an injectable suspension (injection) in a pre-filled syringe (ready-to-use syringe).
Flucelvax is a solution from clear to slightly opalescent.
A single syringe contains 0.5 mL of injectable suspension.
Flucelvax is available in packs containing 1 pre-filled syringe with or without a needle or 10 pre-filled
syringes with or without a needle.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105 BJ Amsterdam
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
België/Belgique/Belgien
Seqirus Netherlands B.V.Nederland/Netherlands
Tel: +31 (0) 20 204 6900
България
Seqirus Netherlands B.V. Нидерландия
Тел.: +31 (0) 20 204 6900
Česká republika
Seqirus Netherlands B.V. Nizozemsko
Tel: +31 (0) 20 204 6900
Danmark
Seqirus Netherlands B.V. Holland
Tlf: +31 (0) 20 204 6900
Deutschland
Seqirus GmbH
Tel: : 0800 360 10
Eesti
Seqirus Netherlands B.V. Holland
Tel: +31 (0) 20 204 6900
Ελλάδα
WIN MEDICA Α.Ε.
Τηλ: +30 210 7488821
España
Seqirus Spain, S.L., Barcelona
Tel: 937 817 884
France
Vifor France
Tel: 0800 400 160
Hrvatska
Seqirus Netherlands B.V. Nizozemska
Tel: +31 (0) 20 204 6900
Ireland
Seqirus Netherlands B.V., The Netherlands
Tel: +31 (0) 20 204 6900
Ísland
Seqirus Netherlands B.V. Holland
Sími: +31 (0) 20 204 6900
Lietuva
Seqirus Netherlands B.V. Nyderlandai
Tel: +31 (0) 20 204 6900
Luxembourg/Luxemburg
Seqirus Netherlands B.V. Netherlands
Tél/Tel: +31 (0) 20 204 6900
Magyarország
Seqirus Netherlands B.V. Hollandia
Tel.: +31 (0) 20 204 6900
Malta
Seqirus Netherlands B.V. In-Netherlands
Tel: +31 (0) 20 204 6900
Nederland
Seqirus Netherlands B.V. Amsterdam
Tel: +31 (0) 20 204 6900
Norge
Seqirus Netherlands B.V. Nederland
Tlf: +31 (0) 20 204 6900
Österreich
Vifor Pharma Österreich GmbH
Tel: +43 (1) 41 64 7770
Polska
Seqirus Netherlands B.V. Holandia
Tel.: +31 (0) 20 204 6900
Portugal
Seqirus Netherlands B.V. Países Baixos
Tel: +31 (0) 20 204 6900
România
Seqirus Netherlands B.V. Olanda
Tel: +31 (0) 20 204 6900
Slovenija
Seqirus Netherlands B.V. Nizozemska
Tel: +31 (0) 20 204 6900
Slovenská republika
Seqirus Netherlands B.V. Holandsko
Tel: +31 (0) 20 204 6900
Italia
Seqirus S.r.l. Siena
Tel: +39 0577 096400
Κύπρος
Seqirus Netherlands B.V. Ολλανδία
Τηλ: +31 (0) 20 204 6900
Latvija
Seqirus Netherlands B.V. Nīderlande
Tel: +31 (0) 20 204 6900
Suomi/Finland
Seqirus Netherlands B.V. Alankomaat
Puh/Tel: +31 (0) 20 204 6900
Sverige
Seqirus Netherlands B.V. Nederländerna
Tel: +31 (0) 20 204 6900
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
Appropriate treatment and medical supervision must always be readily available in the rare event of
anaphylactic reactions occurring following vaccine administration.
Shake before use. After shaking, the vaccine normally appears as a suspension from clear to
slightly opalescent.
Visually inspect the vaccine for the presence of particulate matter and colour change before
administration. If foreign particulate matter and/or a change in physical appearance are present, do not
administer the vaccine.

- Країна реєстрації
- Лікарська формаInjectable suspension in pre-filled syringe, 0.5 ml
- Код АТХJ07BB02
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до FLUKELVAXЛікарська форма: Injectable suspension, 0.5 mLДіюча речовина: influenza, inactivated, split virus or surface antigenВиробник: SEQIRUS NETHERLANDS B.V.Рецепт не потрібенЛікарська форма: Injectable suspension in pre-filled syringe, 60 Microgrammi/HaДіюча речовина: influenza, inactivated, split virus or surface antigenВиробник: SANOFI WINTHROP INDUSTRIEРецепт не потрібенЛікарська форма: Injectable suspension in pre-filled syringe, 60 MICROGRAMSДіюча речовина: influenza, inactivated, split virus or surface antigenВиробник: SANOFI WINTHROP INDUSTRIEРецепт не потрібен
Аналоги FLUKELVAX в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог FLUKELVAX у Іспанія
Аналог FLUKELVAX у Польща
Аналог FLUKELVAX у Україна
Лікарі онлайн щодо FLUKELVAX
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на FLUKELVAX онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
FLUKELVAX не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у FLUKELVAX — influenza, inactivated, split virus or surface antigen. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
FLUKELVAX виробляється компанією SEQIRUS NETHERLANDS B.V.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування FLUKELVAX з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати FLUKELVAX у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (influenza, inactivated, split virus or surface antigen) включають KELLDEMIK, EFLUELDA TETRA, EFLUELDA. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















