Инструкция по применению DEKTOVA
Содержание инструкции
Dectova 10 mg/mL solution for infusion
zanamivir
Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects encountered during
the use of this medicine. See the end of section 4 for information on how to report
adverse effects.
Read this leaflet carefully before this medicine is administered to you 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 or nurse.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet
- 1. What Dectova is and what it is used for
- 2. What you need to know before Dectova is administered to you
- 3. How Dectova is administered
- 4. Possible side effects
- 5. How to store Dectova
- 6. Contents of the pack and other information
1. What Dectova is and what it is used for
Dectova contains zanamivir, which belongs to a group of medicines called antivirals.
Dectova is used to treat severe influenza(influenza A or B virus infection). It is used when
other treatments for influenza are not adequate.
Adults and children from 6 months of age and older can be treated with Dectova.
2. What you need to know before you are given Dectova
Do not use Dectova
- if you are allergicto zanamivir or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Severe allergic or skin reactions
Severe allergic or skin reactions can occur after the administration of Dectova. Symptoms
may include swelling of the skin or throat, difficulty breathing, skin rashes with blisters or
peeling of the skin (see also ‘ Severe allergic or skin reactions’in section 4).
Sudden changes in behaviour, hallucinations and convulsions
During treatment with Dectova, changes in behaviour such as confusion and
unresponsiveness may occur. Some people may also experience hallucinations (seeing, hearing or feeling things that
do not exist) or convulsions that may lead to loss of consciousness. Such symptoms may occur in
people with influenza who are not given Dectova. Therefore, it is not known whether Dectova has
a role in causing such symptoms.
If you are immunocompromised (have a weakened immune system)
If your immune system is not functioning properly, your doctor may monitor you more closely to
ensure that the treatment is working. If necessary, your doctor may switch to an alternative treatment.
If you notice any of the above symptoms:
➔ tell your doctor or nurse immediately
Other medicines and Dectova
Tell your doctor if you are taking or have recently taken or might take any other
medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are
planning to have a baby, ask your doctor for advice before you are given this
medicine.
Driving and using machines
Dectova should not affect your ability to drive or use machines.
Dectova contains sodium
This medicine contains 70.8 mg of sodium (the main component of table salt) in each
vial. This is equivalent to 3.54% of the maximum recommended daily intake of sodium for an
adult.
3. How Dectova is administered
How much Dectova is administered
The doctor will decide the correct dose of Dectova for you. The amount you receive is based on your age,
body weight and the results of blood tests (to check if your kidneys are working properly).
The dose may be increased or decreased depending on how you respond to treatment.
Adults
The recommended dose is 600 mg twice a day for 5 - 10 days.
If your kidneys are not working as well as they should, the doctor will decide to reduce your dose.
Children
The doctor will decide the correct dose of Dectova.
When and how Dectova is administered
Dectova should be administered as soon as possible, usually within 6 days of the onset of
influenza symptoms.
A doctor or nurse will administer Dectova as an infusion (drip) into a vein. It is usually
administered in the arm for about over 30 minutes.
If you have any doubts about the use of Dectova, ask the doctor or nurse who is
administering the medicine.
If you are given too much Dectova
It is unlikely that you will be given an excessive amount of this medicine, but if you believe that
you have been given an excessive dose of Dectova inform your doctor or
nurse immediately.
4. Possible side effects
Like all medicines, Dectova can cause side effects, although not everybody gets them.
Serious allergic and skin reactions can occur with Dectova,but there is not enough
information to estimate how likely they are. Contact your doctor or nurse immediately if you notice
any of the following serious side effects:
- very severe skin reactions such as: o a skin rash, with the formation of blisters that look like small targets (erythema multiforme) o a widespread rash with blisters and peeling of the skin, which occurs particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) o extensive peeling of the skin over a large area of the body (toxic epidermal necrolysis)
- serious allergic reactions, including characteristics such as itchy skin rash, swelling of the face, throat or tongue, difficulty breathing, feeling dizzy and vomiting.
Common side effects
These may affect up to 1in 10people
- diarrhoea
- liver damage (hepatocellular damage)
- skin rash. Common side effects that can be detected by blood tests are:
- increased levels of liver enzymes (increased aminotransferases).
Uncommon side effects
These may affect up to 1in 100people
- itching, irregular skin rash (urticaria). Uncommon side effects that can be detected by blood tests are:
- increased levels of liver or bone enzymes (elevated alkaline phosphatase).
Side effects of unknown frequency
There is not enough information to estimate how likely these side effects are:
- behaving strangely
- seeing, hearing or feeling things that do not exist
- confused thoughts
- convulsions
- being less attentive or not responding to loud noises or being shaken
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the 26ational
reporting system detailed in Appendix V. By reporting side effects you can help to
provide more information on the safety of this medicine.
5. How to store Dectova
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and the vial after Exp.
The vials of Dectova are for single use only. Any unused solution must be discarded.
6. Contents of the pack and other information
What Dectova contains
The active ingredient is zanamivir.
Each mL of Dectova contains 10 mg of zanamivir (as hydrate). Each vial contains 200 mg of
zanamivir (as hydrate) in 20 mL.
The other excipients are sodium chloride, water for injections.
Description of the appearance of Dectova and contents of the pack
Dectova is a clear, colorless solution for infusion. It is supplied in a transparent glass
vial of 26 mL with a rubber stopper and an aluminum seal with a plastic ‘flip-off’ cap.
Each pack contains 1 vial.
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
GlaxoSmithKline Manufacturing S.p.A
Strada Provinciale Asolana, 90
43056 San Polo di Torrile
Parma
Italy
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00
Lietuva
GlaxoSmithKline Trading Services Limited
Tel: +370 80000334
България
GlaxoSmithKline Trading Services Limited
Teл.: +359 80018205
Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00
Česká republika
GlaxoSmithKline, s.r.o.
Tel: + 420 222 001 111
[email protected]
Magyarország
GlaxoSmithKline Trading Services Limited
Tel.: +36 80088309
Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]
Malta
GlaxoSmithKline Trading Services Limited
Tel: +356 80065004
Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
[email protected]
Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100
Eesti
GlaxoSmithKline Trading Services Limited
Tel: +372 8002640
Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00
Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]
España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]
Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000
France
Laboratoire GlaxoSmithKline
Tél: + 33 (0)1 39 17 84 44
[email protected]
Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]
Hrvatska
GlaxoSmithKline Trading Services Limited
Tel: +385 800787089
România
GlaxoSmithKline Trading Services Limited
Tel: +40 800672524
Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000
Slovenija
GlaxoSmithKline Trading Services Limited
Tel: +386 80688869
Ísland
Vistor hf.
Sími: +354 535 7000
Slovenská republika
GlaxoSmithKline Trading Services Limited
Tel: +421 800500589
Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
Κύπρος
GlaxoSmithKline Trading Services Limited
Τηλ: +357 80070017
Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]
Latvija
GlaxoSmithKline Trading Services Limited
Tel: +371 80205045
United Kingdom (Northern Ireland)
GlaxoSmithKline Trading Services Limited
Tel: + 44 (0)800 221441
[email protected]
An authorisation has been granted in “exceptional circumstances” for this medicinal product.
This means that complete information on this medicinal product is not yet available.
The European Medicines Agency will review any new information on this
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/
The following information is only for healthcare professionals:
7. INFORMATION FOR HEALTHCARE PROFESSIONALS
Preparation of Dectova
- The volume of Dectova and the total volume for the infusion will depend on the patient's age, weight and renal function (see section 4.2 of the SmPC).
- The dose may be infused as supplied or diluted in 9 mg/mL (0.9%) sodium chloride solution for injectable preparations to achieve a concentration of 0.2 mg/mL or higher.
- Each vial is for single use only; once the seal has been broken, any remaining volume must be discarded.
How to prepare the infusion for intravenous administration
- Use aseptic techniques throughout the dose preparation.
- Calculate the required dose and volume of Dectova.
- Decide on the volume of 9 mg/mL (0.9%) sodium chloride solution for injectable preparations to be used for the infusion.
- Using a sterile needle and syringe, withdraw and discard a volume of 9 mg/mL (0.9%) sodium chloride solution for injectable preparations (equal to the volume of Dectova) from the infusion bag.
- Infusion bags may include an additional amount of 9 mg/mL (0.9%) sodium chloride solution for injectable preparations, which may also be removed if deemed necessary.
- Using a sterile needle and syringe, withdraw the volume of Dectova from the vial and add it to the infusion bag.
- Discard any unused portion of the vial.
- The infusion bag should be gently manipulated to ensure thorough mixing.
- If refrigerated, the infusion bag should be removed from the refrigerator and brought to room temperature before use.
- Страна регистрации
- Форма выпускаInfusion solution, 10 MG/ML
- Код АТХJ05AH01
- 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 DEKTOVAФорма выпуска: Inhalation powder, 5 MG/ALVEOLOДействующее вещество: ЗанамивирПроизводитель: GLAXOSMITHKLINE S.P.A.Отпускается по рецептуФорма выпуска: Hard capsule, 30 MGДействующее вещество: озельтамивирПроизводитель: ACTAVIS GROUP PTC EHFОтпускается по рецептуФорма выпуска: Hard capsule, 75 MGДействующее вещество: озельтамивирПроизводитель: ROCHE REGISTRATION GMBHОтпускается по рецепту
Аналоги DEKTOVA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог DEKTOVA в Испания
Аналог DEKTOVA в Польша
Аналог DEKTOVA в Украина
Врачи онлайн по DEKTOVA
Обсудите применение DEKTOVA и возможные следующие шаги — по оценке врача.
Получите рецепт на DEKTOVA 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
DEKTOVA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество DEKTOVA — Занамивир. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
DEKTOVA производится компанией GLAXOSMITHKLINE TRADING SERVICES 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 DEKTOVA 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 DEKTOVA 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 (Занамивир) включают RELENTSA, EBILFUMIN, TAMIFLU. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















