SUPEMTEK 0.5 ML Преднаполненный инъекционный раствор в ручке
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Инструкция по применению SUPEMTEK TETRA
Содержание инструкции
Supemtek Tetra
injectable solution in pre-filled syringe
Quadrivalent influenza vaccine (recombinant, prepared in cell culture)
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, nurse or pharmacist.
- This vaccine has been prescribed only for you. Do not give it to other people.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Supemtek Tetra is and what it is used for
- 2. What you need to know before you receive Supemtek Tetra
- 3. How Supemtek Tetra is administered
- 4. Possible side effects
- 5. How to store Supemtek Tetra
- 6. Contents of the pack and other information
1. What is Supemtek Tetra and what is it used for
Supemtek Tetra is a vaccine for adults and children aged 9 years and over. This vaccine
helps to protect you from influenza. Supemtek Tetra does not contain eggs, due to the technology
used in production.
When a person is given Supemtek Tetra, the body's natural defense system (the immune system) develops its own protection against the influenza virus.
None of the ingredients in the vaccine can cause influenza.
As with all vaccines, Supemtek Tetra may not fully protect all vaccinated people.
When to get vaccinated against influenza
Influenza is an illness that can spread very rapidly.
- It is caused by different strains that can change every year. This is why you should get vaccinated every year.
- The greatest risk of contracting influenza is during the cold months, between October and March.
- If you have not been vaccinated in autumn, it is still reasonable to get vaccinated until spring, as there is a risk of contracting influenza until that period. Your doctor will be able to recommend the best time to get vaccinated.
2. What you need to know before you receive Supemtek Tetra
Do not use Supemtek Tetraif you are allergic to:
- the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
- octylphenol ethoxylate, a residue from the manufacturing process.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive Supemtek Tetra.
As with all vaccines, Supemtek Tetra may not fully protect all vaccinated people.
Before receiving the vaccine, tell your doctor, nurse or pharmacist if:
- you have an acute illnessassociated with fever. Vaccination may be delayed until the fever has gone.
- you have a weakened immune response(immunodeficiency or are taking medicines that affect the immune system such as anticancer drugs, i.e. chemotherapy, or corticosteroids).
- you have a bleeding problemor a tendency to bruise.
- you have faintedafter an injection in the past. Fainting can occur after or even before an injection. If you have any of the conditions described above (or if you have any doubts), talk to your doctor, pharmacist or nurse before receiving Supemtek Tetra.
Other medicines and Supemtek Tetra
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, or if you have recently received any other vaccine.
Supemtek Tetra can be given at the same time as other vaccines, choosing different limbs.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before receiving this vaccine. Your doctor/pharmacist will help you decide whether or not to receive Supemtek Tetra.
Driving and using machines
Supemtek Tetra does not alter, or only negligibly alters, the ability to drive and use machines.
However, be careful when driving or using machines if your reaction ability is reduced due to some of the effects mentioned in section 4 (Possible side effects).
Supemtek Tetra contains sodium and polysorbate 20
This vaccine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
This medicine contains 0.0275 mg of polysorbate 20 (E432) per 0.5 mL dose. Polysorbates can cause allergic reactions.
3. How Supemtek Tetra is administered
Supemtek Tetra will be administered to you by a doctor, nurse or pharmacist in the form of
an intramuscular injection into the upper arm (deltoid muscle).
Adults and children aged 9 years and over:
A dose of 0.5 mL.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
experiences them.
The following side effects have been reported with Supemtek Tetra:
Very rare serious side effects
Contact your doctor or healthcare professional immediately, or go immediately to the nearest
emergency room if you experience severe allergic reactions (anaphylactic reaction). These
can be potentially life-threatening.
Symptoms may include:
- difficulty breathing, shortness of breath
- swelling of the face, lips, throat or tongue
- cold, clammy skin
- palpitations
- feeling dizzy, weak, fainting
- skin rash or itching
Contact your doctor or healthcare professional immediately, or go immediately to the nearest
emergency room if you experience any of the following side effects:
- stiff neck, confusion, numbness, pain and weakness in the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (Guillain-Barré syndrome).
Other side effects
Very common (may affect more than 1 in 10 people)
- headache
- feeling tired (fatigue)
- muscle pain
- joint pain
- pain at the injection site
- injection site pain Muscle pain and joint pain are common in adults aged 50 years and over.
Common (may affect up to 1 in 10 people)
- feeling unwell (nausea)
- redness, swelling, hardening and bruising around the area where the vaccine is injected
- fever, shaking chills Fever is rare in adults aged 50 years and over. Bruising has been reported in children/adolescents aged 9 to 17 years.
Uncommon (may affect up to 1 in 100 people)
- asthma
- cough
- pain in the mouth and throat
- diarrhoea, vomiting, abdominal discomfort and decreased appetite
- itching
- skin irritation
- skin rash
- flu-like symptoms
- itching where the vaccine is injected Itching is rare in adults aged 50 years and over. Skin irritation and rash have not been reported in adults aged 50 years and over. Flu-like symptoms have not been reported in adults aged 18 to 49 years. Vomiting, decreased appetite, abdominal discomfort and asthma have not been reported in adults aged 18 years and over.
Rare (may affect up to 1 in 1,000 people)
- feeling dizzy
- hives Feeling dizzy and hives have not been reported in adults aged 18 to 49 years. Feeling dizzy is uncommon in children/adolescents aged 9 to 17 years.
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 Supemtek Tetra
Keep this vaccine out of the sight and reach of children.
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 use this vaccine after the expiry date which is stated on the label and the packaging after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Supemtek Tetra contains
One dose (0.5 mL) contains:
the active substances are haemagglutinin (HA) proteins of influenza virus, of the following strains*:
Type A/xxxxxx (H1N1) virus ......................................... 45 micrograms HA
Type A/xxxxxx (H3N2) virus ......................................... 45 micrograms HA
Type B/xxxxxx virus ....................................................... 45 micrograms HA
Type B/xxxxxx virus ....................................................... 45 micrograms HA
* produced using recombinant DNA technology, using a baculovirus expression system in a continuous insect cell line derived from Sf9 cells of lafigma, Spodoptera
frugiperda.
This vaccine complies with the recommendation of the World Health Organization (WHO) (northern hemisphere) and with the EU recommendation for the {year/year} season.
The other ingredients are: polysorbate 20 (E432), sodium chloride, monobasic sodium phosphate, dibasic sodium
phosphate, water for injections (see section 2).
Description of the appearance of Supemtek Tetra and contents of the pack
Supemtek Tetra is an injectable solution in a pre-filled syringe (injection) (ready-to-use syringe).
Supemtek Tetra is a clear and colourless solution.
Each pre-filled syringe contains a single dose (0.5 mL) of injectable solution.
Supemtek Tetra is available in packs containing 1, 5 or 10 pre-filled syringes without a needle or
with a separate needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France
Manufacturer
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d'Incarville
B P 101
27100 Val de Reuil
France
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:
| België/ Belgique /Belgien Sanofi Belgium Tel./Tel.: +32 02 710.54.00 | Lietuva o Swixx Biopharma UAB Tel: +370 5 236 91 40 |
| България Swixx Biopharma EOOD Тел.: +359 (0) 2 4942 480 | c Luxembourg/Lussemburgo Sanofi Belgium Tél/Tel: +32 2 710.54.00 |
| Česká republika Sanofi s.r.o. Tel: +420 233 086 111 | a Magyarország m sanofi-aventis zrt Tel: +36 1 505 0055 |
| Danmark Sanofi A/S Tel: +45 4516 7000 | r Malta Sanofi S.r.l. Tel: +39 02 39394275 |
| Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 54 54 010 Tel. aus dem Ausland: +49 69 305 21 130 | a Nederland F Sanofi B.V. Tel: +31 20 245 4000 |
| Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 | l Norge Sanofi-aventis Norge AS Tlf: + 47 67 10 71 00 |
| Ελλάδα ΒΙΑΝΕΞ Α.Ε. Τηλ: +30.210.8009111 | e d Österreich Sanofi-Aventis GmbH Tel: +43 (1) 80185-0. |
| España sanofi-aventis, S.A. Tel: +34 93 485 94 00 | Polska a Sanofi sp. z o. o. Tel: +48 22 280 00 00 |
| n France Sanofi Winthrop Industrie a Tél: 0800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23 | Portugal Sanofi – Produtos Farmacêuticos, Lda. Tel: + 351 21 35 89 400 |
| i Hrvatska l Swixx Biopharma d.o.o. Tel: +385 1 2078 500 | România Sanofi Romania SRL Tel: +40(21) 317 31 36 |
| a Ireland t sanofi-aventis Ireland T/A SANOFI Tel: + 353 (0) 1 4035 600 | Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 00 |
| I Ísland Vistor Sími: +354 535 7000 | Slovenská republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 600 |
| a i Italia Sanofi S.r.l. Tel: 800536389 | Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 |
| z Κύπρος n C.A. Papaellinas Ltd. Τηλ: +357 22 741741 | Sverige Sanofi AB Tel: +46 8-634 50 00 |
| e Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50 |
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 for healthcare professionals only:
Appropriate medical treatment and monitoring must always be readily available in the
event of a rare anaphylactic event following vaccine administration.
Perform a visual inspection of the vaccine for particles and discolouration before
administration. Do not administer the vaccine if any foreign particles and/or changes in physical appearance are observed.
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- Страна регистрации
- Форма выпускаPre-filled pen injectable solution, 0.5 ML
- Код АТХJ07BB02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги SUPEMTEK 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 SUPEMTEK TETRA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог SUPEMTEK TETRA в Испания
Аналог SUPEMTEK TETRA в Польша
Аналог SUPEMTEK TETRA в Украина
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Часто задаваемые вопросы
SUPEMTEK TETRA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество SUPEMTEK TETRA — influenza, inactivated, split virus or surface antigen. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
SUPEMTEK TETRA производится компанией SANOFI WINTHROP INDUSTRIE. 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 SUPEMTEK 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 SUPEMTEK 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.
