Инструкция по применению FLUKELVAX TETRA
Содержание инструкции
Flucelvax Tetra injectable suspension in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, produced in cell cultures)
Read this leaflet carefully before receiving 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 those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Flucelvax Tetra is and what it is used for
- 2. What you need to know before you receive Flucelvax Tetra
- 3. How Flucelvax Tetra is administered
- 4. Possible side effects
- 5. How to store Flucelvax Tetra
- 6. Contents of the pack and other information
1. What is Flucelvax Tetra and what is it used for
Flucelvax Tetra is a vaccine against influenza. Flucelvax Tetra 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 vaccine components can cause
influenza.
Flucelvax Tetra is used to prevent influenza in adults and children from 6 months of age.
The vaccine has been formulated against the four strains of influenza virus based on the recommendations
of the World Health Organization for the 2024/2025 season.
2. What you need to know before you receive Flucelvax Tetra
Do not useFlucelvax Tetra
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 Tetra.
BEFORE receiving the vaccine
- Your 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 Tetra 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 Tetra”).
- 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 during previous injections.
As with all vaccines, it is possible that Flucelvax Tetra may not fully protect all
vaccinated individuals.
Children under 6 months of age
This vaccine is not currently recommended in children under 6 months of age because the
safety and efficacy in this age group have not been established.
Other medicines and Flucelvax Tetra
Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription or if you have recently received
any other vaccine.
Flucelvax Tetra 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 Tetra can be given during breastfeeding.
Driving and using machines
Flucelvax Tetra has no or negligible effect on the ability to drive and use
machines.
Flucelvax Tetracontainssodium and potassium
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 Tetra is administered
Flucelvax Tetra 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 everyone will experience them.
The following side effects have been reported during clinical studies and general use:
Very serious side effects
Immediately inform your doctor 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 hospitalization:
- Difficulty breathing, dizziness, weak and rapid pulse, and skin rash, which are symptoms of anaphylaxis (a very serious allergic reaction)
Serious side effects
Immediately inform your doctor 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 or tenderness 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)
- Changes in eating habits (reported only in children aged between 6 months and < 6 years)
- Fever (≥ 38 °C)
- Diarrhea 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)
- Generalized skin reactions, including itching, skin bumps (itching, urticaria) or unspecified rash
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system detailed in Annex V. By reporting side effects
you can help provide more information on the safety of this medicine.
5. How to store Flucelvax Tetra
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 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 waste water 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 Tetra 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/Massachusetts/18/2022 (H3N2)-equivalent strain (A/Sydney/1304/2022, wild type)
15 micrograms HA**
B/Austria/1359417/2021-equivalent strain (B/Singapore/WUH4618/2021, wild type)
15 micrograms HA**
B/Phuket/3073/2013-equivalent strain (B/Singapore/INFTT-16-0610/2016, 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 2024/2025 Season.
- The other ingredients are sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, monopotassium phosphate and water for injections (see section 2 Flucelvax Tetra contains sodium and potassium).
Description of the appearance of Flucelvax Tetra and contents of the pack
Flucelvax Tetra is an injectable suspension (injection) in a pre-filled syringe (ready-to-use syringe).
Flucelvax Tetra is a solution from clear to slightly opalescent.
A single syringe contains 0.5 mL of injectable suspension.
Flucelvax Tetra 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
1105BJ Amsterdam
Netherlands
For further information on this medicine, 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 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
Seqirus Netherlands B.V. Netherlands
Tél: +31 (0) 20 204 6900
Hrvatska
Seqirus Netherlands B.V. Nizozemska
Tel: +31 (0) 20 204 6900
Ireland
Seqirus UK Limited Maidenhead
Tel: +44 1628 641 500
Ísland
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
Valneva Austria GmbH, Wien
Tel: +43 1 20620 2020
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. Holland
Sími: +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
Seqirus Netherlands B.V. Holandsko
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 medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.
---------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Appropriate treatment and medical supervision must always be readily available in the rare event of anaphylactic reactions following vaccination.
Shake before use. After shaking, the vaccine normally appears as a clear to slightly opalescent suspension.
Visually inspect the vaccine for particulate matter and discoloration before administration. If foreign particulate matter and/or a change in physical appearance is observed, do not administer the vaccine.

- Страна регистрации
- Форма выпускаInjectable suspension, 0.5 ML
- Код АТХJ07BB02
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги FLUKELVAX TETRAФорма выпуска: Injectable suspension, 0.5 mLДействующее вещество: influenza, inactivated, split virus or surface antigenПроизводитель: SEQIRUS NETHERLANDS B.V.Отпускается без рецептаФорма выпуска: Injectable suspension in pre-filled syringe, 60 Microgrammi/HaДействующее вещество: influenza, inactivated, split virus or surface antigenПроизводитель: SANOFI WINTHROP INDUSTRIEОтпускается без рецептаФорма выпуска: Injectable suspension in pre-filled syringe, 60 MICROGRAMSДействующее вещество: influenza, inactivated, split virus or surface antigenПроизводитель: SANOFI WINTHROP INDUSTRIEОтпускается без рецепта
Аналоги FLUKELVAX TETRA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог FLUKELVAX TETRA в Испания
Аналог FLUKELVAX TETRA в Польша
Аналог FLUKELVAX TETRA в Украина
Врачи онлайн по FLUKELVAX TETRA
Обсудите применение FLUKELVAX TETRA и возможные следующие шаги — по оценке врача.
Получите рецепт на FLUKELVAX TETRA онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
FLUKELVAX TETRA не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество FLUKELVAX TETRA — influenza, inactivated, split virus or surface antigen. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
FLUKELVAX TETRA производится компанией SEQIRUS NETHERLANDS B.V.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения FLUKELVAX TETRA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить FLUKELVAX TETRA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (influenza, inactivated, split virus or surface antigen) включают KELLDEMIK, EFLUELDA TETRA, EFLUELDA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















