Інструкція із застосування FLUAD
Зміст інструкції
Fluad injectable suspension in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, adjuvated)
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 you experience any side effects, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Fluad is and what it is used for
- 2. What you need to know before you receive Fluad
- 3. How Fluad is administered
- 4. Possible side effects
- 5. How to store Fluad
- 6. Contents of the pack and other information
1. What is Fluad and what is it used for
Fluad is a vaccine against influenza.
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.
Fluad is used to prevent influenza in adults aged 50 years and over.
The vaccine has been formulated against influenza virus strains based on the recommendations
of the World Health Organization for the 2025/2026 season.
2. What you need to know before you receive Fluad
Do not use Fluad:
- If you are allergic
- to the active ingredients or to any of the other ingredients of this medicine (listed in section 6)
- to egg or chicken proteins (such as albumin), kanamycin and neomycin sulfate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and hydrocortisone; these substances are residues of the manufacturing process present in trace amounts.
- If you have had a severe allergic reaction (e.g., anaphylaxis) to a previous influenza vaccination.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive Fluad.
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) after administration. This reaction may occur with Fluad as with
all vaccines that are injected.
- Tell your doctor if you have an illness associated with fever. The 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, such as cancer drugs (chemotherapy) or corticosteroids (see section “Other medicines and Fluad”).
- Tell your doctor if you have bleeding problems or if you 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 Fluad will not fully protect all people
vaccinated.
Children
The use of Fluad is not indicated in children.
Other medicines and Fluad
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.
Pregnancy and breastfeeding
This vaccine is intended for adults aged 50 years or older. It should not be used in women
who are or may become pregnant and during breastfeeding.
Driving and operating machinery
Fluad does not or negligibly alters the ability to drive and operate machinery.
Fluad contains potassium and sodium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically “sodium-free”.
This vaccine contains less than 1 mmol (39 mg) of potassium per dose, i.e. it is practically “potassium-free”.
3. How Fluad is administered
Fluad is administered to you by a doctor or nurse as an injection into the muscle of the
upper arm (deltoid muscle).
Adults aged 50 years or older
A dose of 0.5 mL
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.
Immediately inform your doctor or go to the nearest hospital emergency room if
you experience the following serious side effect; urgent medical attention
or hospitalisation may be necessary:
- Difficulty breathing, dizziness, weak and rapid pulse, and skin rash, which are symptoms of anaphylaxis (a very serious allergic reaction)
The following side effects have been reported during clinical studies in adults aged 50 years or
older.
Very common (may affect more than 1 in 10 people):
- Pain or tenderness at the injection site
- Fatigue
- Headache
- Joint pain (arthralgia)
- Muscle pain (myalgia) reported with common frequency in elderly subjects aged 65 years or older
Common (may affect up to 1 in 10 people):
- Redness at the injection site (erythema)
- Hardening of the skin at the injection site
- Diarrhoea
- Chills
- Nausea
- Loss of appetite
- Bruising at the injection site (ecchymosis)
- Flu-like symptoms
- Fever (≥ 38 °C) reported in elderly subjects aged 65 years or older reported with uncommon frequency in elderly subjects aged 65 years or older
Uncommon (may affect up to 1 in 100 people):
- Vomiting
- Swelling of the lymph nodes in the neck, armpits or groin (lymphadenopathy)
Most side effects were mild or moderate in severity and resolved within 3 days
of onset.
In addition to the side effects described above, the following side effects have occurred
occasionally during the general use of quadrivalent adjuvanted influenza vaccine or Fluad:
- reduction in the number of certain blood particles called platelets; a low number of platelets may increase bruising or bleeding (thrombocytopenia)
- swelling, pain and redness at the injection site (cellulite-like reaction at the injection site)
- extensive swelling of the limb in which the injection was given lasting more than a week
- general weakness or lack of energy (asthenia), general feeling of being unwell (malaise)
- fever (pyrexia)
- muscle weakness
- pain along the course of a nerve (neuralgia), abnormalities in the perception of touch, pain, heat and cold (paresthesia), convulsions, neurological disorders that can cause stiffness of the neck, confusion, numbness, pain and weakness in the limbs, loss of balance, loss of reflexes, paralysis of parts of the body or of the whole body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
- skin reactions that can spread throughout the body including itchy skin (pruritus, urticaria), redness of the skin (erythema), non-specific rash, severe skin rash (erythema multiforme)
- more noticeable swelling of the head and neck, including face, lips, tongue, throat, or any other part of the body (angioedema)
- swelling of blood vessels that can cause skin rashes (vasculitis) and temporary kidney problems
- fainting, feeling like you are going to faint (syncope, presyncope)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Fluad
Keep this vaccine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Discard the vaccine if it has been frozen.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Do not use this vaccine after the expiry date which is stated on the label and the carton after
“EXP/Scad”. The expiry date refers to the last day of that month.
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 Fluad contains
- The active ingredient is comprised of influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, derived from the following strains*:
| n | Per una dose da 0,5 mL |
| a A/Victoria/4897/2022 (H1N1)pdm09-strain i equivalent (A/Victoria/4897/2022, IVR-238) | 15 micrograms HA** |
| l A/Croatia/10136RV/2023 (H3N2)-strain a equivalent (A/Croatia/10136RV/2023, X-425A) | 15 micrograms HA** |
| t B/Austria/1359417/2021‐strain equivalent (B/Austria/1359417/2021, BVR-26) | 15 micrograms HA** |
The vaccine is in accordance with the recommendation of the World Health Organization (WHO)
(northern hemisphere) and the EU recommendation for the 2025/2026 Season.
- MF59C.1 is included in this vaccine as an adjuvant. Adjuvants are substances that are included in some vaccines to accelerate, enhance and/or prolong the protective effect of the vaccine. MF59C.1 is an adjuvant containing per 0.5 mL dose: squalene (9.75 mg), polysorbate 80 (1.175 mg), sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg) and citric acid (0.04 mg).
- The other components are sodium chloride, potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
Description of the appearance of Fluad and contents of the pack
Fluad is an injectable suspension in pre-filled syringes. Fluad is a milky white suspension.
Each pre-filled syringe contains a single dose (0.5 mL) of injectable suspension. Fluad is
available in packs of 1 or 10 pre-filled syringes with or without needles.
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
Vifor Pharma België NV
Tel. +32 3 218 20 70
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
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
Lietuva
Seqirus Netherlands B.V. Nyderlandai
Tel: +31 (0) 20 204 6900
Luxembourg/Luxemburg
Vifor Pharma België NV
Tel. +32 3 218 20 70
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
Ísland
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
Slovenská republika
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 medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu
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The following information is intended exclusively for healthcare professionals:
Appropriate medical treatment and supervision must always be readily available, in the
rare event of anaphylactic reactions occurring following vaccine administration.
Shake gently before use. After shaking, the vaccine normally appears
as a milky white suspension.
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 is present,
do not administer the vaccine.
When using a pre-filled syringe supplied without a needle, remove the syringe cap and attach a needle for administration. Use a sterile needle of the appropriate size for intramuscular injection. For Luer Lock syringes, remove the cap by twisting it counterclockwise. After removing the cap, attach a needle to the syringe by screwing it clockwise until it is tight. Once the needle is attached, remove the needle shield and 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 FLUADЛікарська 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 FLUAD в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог FLUAD у Іспанія
Аналог FLUAD у Польща
Аналог FLUAD у Україна
Лікарі онлайн щодо FLUAD
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на FLUAD 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
FLUAD не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у FLUAD — influenza, inactivated, split virus or surface antigen. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
FLUAD 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 FLUAD 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 FLUAD 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.
















