FASTURTEC 1,5 MG Порошок и раствор для инфузионного раствора
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Инструкция по применению FASTURTEK
Содержание инструкции
Fasturtec 1.5 mg/ml powder and solvent for concentrate for infusion solution.
rasburicase
Read this leaflet carefully before using 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 hospital pharmacist.
- If any side effects occur, including those not listed in this leaflet, ask your doctor, nurse or hospital pharmacist. See section 4. Contents of this leaflet:
- 1. What Fasturtec is and what it is used for
- 2. What you need to know before using Fasturtec
- 3. How to use Fasturtec
- 4. Possible side effects
- 5. How to store Fasturtec
- 6. Contents of the pack and other information
1. What is Fasturtec and what is it used for
Fasturtec contains the active substance rasburicase.
Rasburicase is used to treat or prevent an increase in uric acid levels in the blood that occurs in
adult, children and adolescent patients (from 0 to 17 years of age) with blood cell disorders (hematological
diseases) who are about to receive or are receiving chemotherapy.
When chemotherapy is administered, cancer cells are destroyed, releasing a large
amount of uric acid into the blood.
Fasturtec works by allowing uric acid to be removed more easily from the body
through the kidneys.
2. What you need to know before you use Fasturtec
Do not use Fasturtec:
- if you are allergic(hypersensitive) to rasburicase, to other uricases or to any of the excipients of this medicine (listed in section 6);
- if you have had in the past hemolytic anemia(a disease caused by the abnormal destruction of red blood cells). Warnings and precautionsTell your doctor, nurse or hospital pharmacist if you have had any type of allergy in the past. Inform your doctor if you have had any allergic reaction to other medicines; Fasturtec can cause allergic reactions, such as severe anaphylaxis including anaphylactic shock (sudden allergic reactions with life-threatening or fatal consequences). Tell your doctor immediatelyif you notice any of the following signs because you may need to stop treatment:
- swelling of the face, lips, tongue or throat
- cough or shortness of breath
- difficulty breathing or swallowing
- rash, sensation of itching or hives (redness like irritation) on the skin
These may be the first signs that a severe allergic reactionis occurring. Therefore,
you may need to stop your treatment with Fasturtec, and need further
treatment.
It is not known whether the possibility of developing an allergic reaction increases if the treatment
with Fasturtec is repeated.
In case of blood disorders such as abnormal decrease of red blood cells (hemolysis) or abnormal levels of
hemoglobin (methemoglobinemia), your doctor will immediately and permanently stop the treatment with Fasturtec.
Other medicines and Fasturtec
Tell your doctor if you are taking or have recently taken any other medicines, including
those available without a prescription.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or think you may be, or if you are breastfeeding.
Driving and using machines
No information is available on the ability to drive and use machines.
Fasturtec contains sodium
This medicine contains up to 10.5 mg of sodium (the main component of table salt) per
vial. This is equivalent to 0.53% of the maximum recommended daily intake with the diet of
an adult.
3. How to use Fasturtec
Fasturtec must be administered to you before or at the start of the chemotherapy cycle.
Fasturtec is injected into a vein slowly, the duration should be approximately 30 minutes.
The dose will be calculated based on body weight.
The recommended dose is 0.20 mg per kg of body weight per day in both children and adults.
The medicine will be given once a day, for a maximum of 7 days.
During treatment with Fasturtec, the doctor will perform blood tests to check the levels of
uric acid and decide how long you should be treated.
The doctor may also perform blood tests to ensure that you do not develop any
blood disorders.
If more Fasturtec than necessary has been administered
In this case, the doctor will carefully monitor the effects on red blood cells and treat any
symptoms that may occur.
If you have any further questions about the use of this medicine, ask your doctor, nurse or hospital pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Fasturtec will be administered together with other medicines that can also cause side effects.
If you suddenly notice:
- swelling of the face, lips, tongue or other parts of the body
- shortness of breath, breathing problems or wheezing
- skin rash, itching or hives Immediately inform the doctor, nurse or hospital pharmacist because thesemay be signs of a serious allergic reaction (anaphylaxis).These events are rare (may affect up to 1 in 1,000 people). Very common side effects (may affect more than 1 in 10 people):
- diarrhoea
- vomiting
- nausea
- headache
- fever Common side effects (may affect up to 1 in 10 people):
- allergic reactions, mainly skin redness and hives. Uncommon side effects (may affect up to 1 in 100 people):
- serious hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock (frequency not known) which can be fatal
- low blood pressure (hypotension)
- wheezing or difficulty breathing (bronchospasm)
- blood disorders such as abnormal decrease in red blood cells (hemolysis), destruction of red blood cells (hemolytic anemia) or abnormal hemoglobin levels (methemoglobinemia).
- seizures (convulsions) Rare (may affect up to 1 in 1,000):
- runny or blocked nose, sneezing, pain or pressure in the face (rhinitis). Frequency not known (frequency cannot be estimated from available data)
- involuntary muscle movements (involuntary muscle contraction) If you experience any of these effects, inform your doctor, nurse or hospital pharmacist. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, please tell your doctor, nurse or hospital pharmacist. You can also report side effects directly through the national 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 Fasturtec
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original packaging, in order to protect from light.
Do not use this medicine if you notice that the solution is not clear and/or contains particles.
6. Contents of the pack and other information
What Fasturtec contains
- The active substance is rasburicase 1.5 mg/ml. Rasburicase is produced by genetic technology from a microorganism called Saccharomyces cerevisiae.
- The other excipients of the powder are: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium monobasic phosphate dihydrate.
- The other excipients of the solvent are: poloxamer 188 and water for injections. Description of the appearance of Fasturtec and contents of the packFasturtec is supplied as a powder for concentrate for solution for infusion (sterile concentrate powder) with solvent. The powder is a whole or broken granule (pellet) of white or off-white colour. The solvent is a clear and colourless liquid. Pack of 3 vials of 1.5 mg of rasburicase and 3 ampoules of 1 ml of solvent. The powder is supplied in clear glass vials of 2 ml or 3 ml with a rubber stopper and the solvent in a clear glass ampoule of 2 ml. Pack of 1 vial of 7.5 mg of rasburicase and 1 ampoule of 5 ml of solvent. The powder is supplied in clear glass vials of 10 ml with a rubber stopper and the solvent in a clear glass ampoule of 5 ml. Not all pack sizes may be marketed. Marketing Authorisation HolderSanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France ManufacturersSanofi S.r.l. Via Valcanello, 4 03012 Anagni (FR) Italy For further information on this medicinal product, contact the local representative of the marketing authorisation holder: België/Belgique/BelgienSanofi Belgium Tél/Tel: +32 (0)2 710 54 00 Lietuva
БългарияLuxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111
Magyarország
sanofi-aventis zrt.
Tel.: +36 1 505 0050
Danmark
Sanofi- A/S
Tlf: +45 45 16 70 00
Malta
Sanofi S.r.l.
Tel: + 39 02 39394275
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 04 36 996
Tel. aus dem Ausland: +49 69 305 70 13
Nederland
Sanofi B.V.
Tel: +31 (0)20 245 4000
EestiNorge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00
Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00
Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0
España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00
Polska
Sanofi sp. z o.o
Tel.: +48 22 280 00 00
France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23
Portugal
Sanofi - Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400
HrvatskaRomânia
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36
Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00
Slovenija
Ísland
Vistor hf.
Sími: +354 535 7000
Slovenská republika
Italia
sanofi S.r.l.
Tel: 800536389
Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300
ΚύπροςSverige
Sanofi AB
Tel: +46 (0)8 634 50 00
Latvija
Altre fonti di informazioni
More detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/ .
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The following information is exclusivelyfor healthcare professionals:
See section 3 “How to use Fasturtec” and the practical information on preparation and
handling provided below.
Fasturtec must be reconstituted with the entire volume of the solvent provided (for example, the 1.5 mg rasburicase vial must be reconstituted with the 1 ml solvent ampoule; the 7.5 mg rasburicase vial must be reconstituted with the 5 ml solvent ampoule). Reconstitution leads to a solution
with a concentration of 1.5 mg/ml to be further diluted with sodium chloride 9 mg/ml (0.9%).
Reconstitution of the solution:
Add the contents of one solvent ampoule to a vial containing rasburicase and mix
by gently rotating it in controlled and validated aseptic conditions.
Do not shake.
Examine visually before use. Only clear and colourless solutions, free of particles, should be used.
For single use only, any unused solution must be discarded.
The solvent does not contain preservatives, so the reconstituted solution must be diluted in
controlled and validated aseptic conditions.
Dilution before infusion:
The volume of reconstituted solution required depends on the patient's weight. More ampoules may be needed to obtain the amount of rasburicase required for a dose. The volume of
reconstituted solution required, taken from one or more ampoules, must be further diluted with a
solution of sodium chloride 9 mg/ml (0.9 %) to obtain a total volume of 50 ml. The
concentration of rasburicase in the final solution for infusion depends on the patient's body weight.
The reconstituted solution does not contain preservatives, so the diluted solution must be infused
immediately.
Infusion:
The infusion of the final solution must be carried out in 30 minutes.
Sample handling:
If it is necessary to check the patient's uric acid level, a strict
sample handling procedure must be followed to reduce any ex vivodegradation. Blood must be
collected in previously frozen tubes containing the heparin anticoagulant. Samples must be
immersed in an ice/water bath. Plasma samples must be prepared
immediately by centrifugation in a pre-cooled centrifuge (4°C). Finally, the
plasma must be kept in an ice/water bath and analysed for uric acid within 4 hours.
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- Страна регистрации
- Форма выпускаPowder and solvent for intravenous infusion solution, 1,5 MG
- Код АТХV03AF07
- 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 FASTURTEKФорма выпуска: Hard capsule, 15 MGДействующее вещество: Кальция фолинатПроизводитель: LANOVA FARMACEUTICI S.R.L.Отпускается по рецептуФорма выпуска: Tablet, 15 MGДействующее вещество: Кальция фолинатПроизводитель: SANDOZ S.P.A.Отпускается по рецептуФорма выпуска: Powder for injectable solution, 25 MGДействующее вещество: calcium levofolinateПроизводитель: TEVA B.V.Отпускается по рецепту
Аналоги FASTURTEK в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог FASTURTEK в Испания
Аналог FASTURTEK в Польша
Аналог FASTURTEK в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
FASTURTEK требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество FASTURTEK — Расбуриказа. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
FASTURTEK 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 FASTURTEK 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 FASTURTEK 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 (Расбуриказа) включают KALKIFOLIN, KALKIO FOLINATO SANDOTS, KALKIO LEVOFOLINATO TEVA JENERIKS. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
