INFLUVAC 0,5 ML Инъекционная суспензия в преднаполненном шприце
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Инструкция по применению INFLUVAK S
Содержание инструкции
Influvac S, injectable suspension in pre-filled syringe
Influenza vaccine (surface antigen, inactivated)
Season 2025/2026
Read this leaflet carefully before you or your child is vaccinated, as it contains
important information for you and your child.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This vaccine has been prescribed for you or your child. Do not give it to other people.
- If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
1 What Influvac S is and what it is used for
2 What you need to know before Influvac S is used
3 How to use Influvac S
4 Possible side effects
5 How to store Influvac S
6 Contents of the pack and other information
1. What is Influvac S and what it is used for
Influvac S is a vaccine indicated for adults and children starting from 6 months of age. This vaccine
helps to protect you or your child from influenza. The use of Influvac S must be based on
official recommendations.
When a person is administered the Influvac S vaccine, the immune system (the body's natural defense
system) produces protection (antibodies) against the disease. None of the
ingredients in the vaccine can cause influenza.
Influenza is an illness that can spread rapidly and is caused by different strains that
can change every year. For this reason, it may be necessary for you or your child to be
vaccinated every year. The risk of contracting influenza is higher during the cold months, from October to
March. If you or your child have not been vaccinated in autumn, you can still be vaccinated until
spring, as you are still at risk of contracting influenza until then. Your doctor will be able to
advise you on the best time to get vaccinated.
Influvac S will protect you or your child from the three viral strains contained in the vaccine 2 or
3 weeks after the injection.
The incubation period for influenza is a few days, so if you or your child have been exposed to
influenza immediately before or after vaccination, you may still develop the disease.
The vaccine will not protect you or your child from the common cold, even if some symptoms are
similar to those of influenza.
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2. What you need to know before you or your child uses Influvac S
To be sure that Influvac S is suitable for you or your child, it is important to inform your doctor,
pharmacist or nurse if you or your child is in any of the following conditions. If
something is not clear to you, ask for explanations from your doctor, pharmacist or nurse.
Do not use Influvac S
- If you or your child is allergic (hypersensitive) to:
- the active ingredients or
- any of the other ingredients of Influvac S (see section 6) or
- any component that may be present in very small quantities such as eggs (ovalbumin or chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin (an antibiotic used to treat bacterial infections)
Warnings and precautions
You must inform your doctor before vaccination if you or your child has:
- a poor immune response (immunodeficiency or taking medicines that affect the immune system)
- a bleeding problem or easy bruising The doctor will decide whether you or your child should receive the vaccine. If you or your child has an ongoing illness with high fever or an acute infection, vaccination should be postponed until after recovery. After or even before any injection with a needle, fainting, feeling faint or other stress-related reactions may occur. Therefore, inform your doctor or nurse if you have experienced this type of reaction with a previous injection. If, for any reason, you or your child needs to undergo a blood test within a few days of the flu vaccine, inform your doctor. This is because false positive results have been observed in some patients recently vaccinated. As with all vaccines, Influvac S may not fully protect all vaccinated people. Other medicines and Influvac S
- Inform your doctor, pharmacist or nurse if you or your child is taking, has recently taken or may take any other vaccine or medicine, including over-the-counter medicines.
- Influvac S can be administered simultaneously with other vaccines on separate limbs. It is emphasized that side effects may be stronger.
- The immunological response may decrease in case of immunosuppressive treatment, such as that with corticosteroids, cytotoxic drugs or radiotherapy. Pregnancy and breastfeedingIf you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with breast milk, ask your doctor for advice before taking this medicine. Flu vaccines can be used at all stages of pregnancy. More information on safety is available for the second and third trimesters, compared to that available for the first trimester; however, data from worldwide use of flu vaccines do not indicate that the vaccine can have harmful effects on pregnancy or the baby. Influvac S can be used during breastfeeding.
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The doctor, pharmacist or nurse will be able to decide if you should receive Influvac
- S. Ask your doctor, pharmacist or nurse for advice before taking any medicine. Driving and operating machineryInfluvac S does not or negligibly alters the ability to drive vehicles and operate machinery. Influvac S contains sodium and potassiumThis medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’. This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.
3. How to use Influvac S
Dosage
Adults should be administered a dose of 0.5 mL.
Use in children and adolescents
Children from 6 months to 17 years of age should be administered a dose of 0.5 mL.
Children under 9 years of age, who have not been previously vaccinated with a seasonal influenza
vaccine, should be administered a second dose after an interval of at least
4 weeks. The safety and efficacy of Influvac S in infants under 6 months of age has not been
established.
Route(s) of administration
The doctor or nurse will administer the recommended dose of vaccine by injection into the
muscle or deep under the skin.
If you have any doubts about the use of this product, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, Influvac S can cause side effects, although not everybody gets them.
li manifestino.
Seek medical attention immediately if you or your child experiences any of the following
side effects: you or your child may need urgent medical treatment.
Serious allergic reactions (frequency unknown, have occurred occasionally during the general use of
Influvac S):
- which can lead to a medical emergency with the circulatory system's inability to maintain adequate blood flow to different organs (shock) in rare cases,
- noticeable swelling in the head and neck, including face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases.
During clinical studies with Influvac S and/or with the quadrivalent influenza vaccine Influvac S
Tetra, the following side effects have been observed. Their frequencies have been estimated as
follows:
- very common (may affect more than 1 in 10 people);
- common (may affect up to 1 in 10 people);
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- uncommon (may affect up to 1 in 100); and
- not known (adverse reactions derived from post-marketing experience; frequency cannot be defined based on available data).
| Side effects | Adults and the elderly | c Children | ||
| 18 years and over | From 6 to 35 months | a From 3 to 5 years | From 6 to 17 years | |
| Headache | Very common * | Very common | ||
| Sleepiness | Very common | Very common | ||
| Sweating | Common | Very common | m Common | Common |
| Loss of appetite | Very common | Very common | ||
| Nausea | r | Very common | ||
| Abdominal pain | Very common | |||
| Diarrhea | Very common | a Common | Very common | |
| Vomiting | Very common | Common | Very common | |
| Irritability/agitation | Very common | F Very common | ||
| Muscle pain (myalgia) | Common | Very common | ||
| Joint pain (arthralgia) | Common | l e | Common | |
| Fatigue | Very common | Very common | ||
| Fever | Uncommon | d Very common | Common | Common |
| Feeling unwell generally (malaise) | Common | Very common | ||
| Chills | Common | a | Common | |
| Pain at the injection site | n Very common | Very common | Very common | Very common |
| Redness | Common | Very common | Very common | Very common |
| Swelling | a Common | Common | Very common | Very common |
| Hardening | Common | Common | Very common | Very common |
| Bruising (ecchymosis) | i Common | Common | Common | Common |
| For all age groups: Not known (cannot be estimated based on available data) i z n e | l Skin reactions that can spread throughout the body including skin itching (pruritus, urticaria), rash | |||
| a t Inflammation of blood vessels that can cause skin rashes (vasculitis) and, in very rare cases, temporary kidney problems | ||||
| I Nerve pain (neuralgia), abnormalities in the perception of touch, pain, heat and cold (paresthesia), seizures associated with fever, neurological disorders that can cause stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain Barré syndrome) | ||||
| Temporary reduction in the number of some types of blood particles called platelets; a low number of these particles can cause bruising or excessive bleeding (transient thrombocytopenia); temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy) | ||||
| *Common in the elderly (≥ 61 years) | ||||
For all age groups, most of the reactions listed above usually occurred within
the first 3 days after vaccination and resolved spontaneously within 1-3 days
from onset. The intensity of these reactions was generally mild.
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Reporting of side effects
If you or your child experiences any side effect, including those not listed in
this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects
directly through the website https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Influvac S
Keep this medicine out of the sight and reach of children.
Do not use Influvac S after the expiry date which is stated on the pack after “Scad.”. The expiry date refers to the last day of that month.
Store Influvac S in a refrigerator (2°C-8°C). Do not freeze.
Keep the product in the original packaging to protect it 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. Package Contents and Other Information
What Influvac S contains
The active ingredients are:
Surface antigens (haemagglutinin and neuraminidase) of influenza viruses of the following strains*:
- A/Victoria/4897/2022 (H1N1)pdm09-equivalent strain (A/Victoria/4897/2022, IVR-238) 15 micrograms HA**
- A/Croatia/10136RV/2023 (H3N2)-equivalent strain (A/Croatia/10136RV/2023, X-425A) 15 micrograms HA**
- B/Austria/1359417/2021-equivalent strain (B/Austria/1359417/2021, BVR-26) 15 micrograms HA** per 0.5 mL dose
* propagated in fertilised hen eggs from healthy poultry farms
** haemagglutinin
This vaccine complies with the recommendation of the World Health Organization (WHO)
(northern hemisphere) and with the European Union recommendation for the 2025/2026 season.
The other components are: potassium chloride, dipotassium hydrogen phosphate, disodium phosphate dihydrate,
sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.
Description of the appearance of Influvac S and contents of the pack
Influvac S is an injectable suspension contained in a pre-filled glass syringe (with or without a needle)
with a plunger stopper (bromobutyl rubber) containing 0.5 mL of a clear and
colourless injectable liquid. Each syringe is for single use only.
Available in packs of 1 or 10 units.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
NL - 8121 AA Olst
Netherlands
For all information about the medicinal product, please contact the local representative of the Marketing
Authorisation Holder.
This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
| Austria | d Influvac Tri- Injektionssuspension in einer Fertigspritze, (Influenza-Impfstoff aus inaktivierten Oberflächenantigenen) |
| Belgium | a Influvac suspensie voor injectie in een voorgevulde spuit Griepvaccin (oppervlakte-antigenen, geïnactiveerd) |
| Bulgaria | n Инфлувак инжекционна суспензия в предварително напълнена спринцовка Bаксина срещу грип (повърхностен антиген, инактивиранa) |
| Croatia | a i Influvac suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv influence (površinski antigen), inaktivirano |
| Cyprus, Malta | l a Influvac sub-unit, suspension for injection (influenza vaccine, surface antigen, inactivated) |
| Czech Republic, Denmark, Estonia, Finland, Germany, a Iceland, Norway, Poland, Portugal, Slovakia, Sweden | t Influvac I |
| i z France | INFLUVAC, suspension injectable en seringue préremplie vaccin grippal inactivé à antigènes de surface |
| n Greece | Influvac sub-unit |
| Hungary | Influvac szuszpenziós injekció előretöltött fecskendőben |
| e g Ireland | Influvac sub-unit, suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated) |
| Italy | Influvac S |
| A Latvia | Influvac suspensija injekcijām pilnšļircē |
| Lithuania | Influvac injekcinė suspensija užpildytame švirkšte |
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| Luxembourg | Influvac suspension injectable en seringue préremplie Vaccin contre la grippe (antigènes de surface, inactivés) |
| Netherlands | o Influvac, suspensie voor injectie in voorgevulde spuit 0,5 ml |
| Romania | c Influvac suspensie injectabilă în seringă preumplută |
| Slovenia | a Influvac suspenzija za injiciranje v napolnjeni injekcijski brizgi |
| Spain | Influvac suspensión inyectable en jeringa precargada |
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The following information is only for healthcare professionals:
As with all injectable vaccines, appropriate medical treatment and supervision must always be
readily available in the event of an anaphylactic reaction following vaccine administration.
Allow the vaccine to reach room temperature. Shake before use.
Inspect visually prior to administration.
Do not use the vaccine if the colour has changed or if there are foreign particles in the suspension.
Do not mix with other medicinal products within the same syringe.
The vaccine should not be injected directly into a blood vessel.
The preferred sites for intramuscular injection are the anterolateral portion of the thigh (or the deltoid
muscle if the muscle mass is adequate) in children from 6 months to 35 months of age, or the deltoid
muscle in children from 36 months of age and in adults.
Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the
medicinal product administered must be clearly recorded.
See also section 3: How to use Influvac S.
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- Страна регистрации
- Форма выпускаInjectable suspension in pre-filled syringe, 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 INFLUVAK SФорма 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 INFLUVAK S в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог INFLUVAK S в Испания
Аналог INFLUVAK S в Польша
Аналог INFLUVAK S в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
INFLUVAK S не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество INFLUVAK S — influenza, inactivated, split virus or surface antigen. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
INFLUVAK S производится компанией Viatris Healthcare Limited. 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 INFLUVAK S 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 INFLUVAK S 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.
