Siklos

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
31-07-2023
Public Assessment Report Public Assessment Report (PAR)
27-05-2014

Active ingredient:

хидроксикарбамид

Available from:

Theravia

ATC code:

L01XX05

INN (International Name):

hydroxycarbamide

Therapeutic group:

Антинеопластични средства

Therapeutic area:

Анемия, сърповидна клетка

Therapeutic indications:

Шиклоше е показан за профилактика на рецидивиращи болка вазо-окклюзионных на кризите, включително остър синдром на гръдния кош при деца и възрастни пациенти, страдащи от симптоматична за това са сърповидно-клетъчна синдром.

Product summary:

Revision: 24

Authorization status:

упълномощен

Authorization date:

2007-06-29

Patient Information leaflet

                                26
Б. ЛИСТОВКА
27
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
SIKLOS 100 MG ФИЛМИРАНА ТАБЛЕТКА
SIKLOS 1 000 MG ФИЛМИРАНА ТАБЛЕТКА
хидроксикарбамид (hydroxycarbamide)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ ТОВА
ЛЕКАРСТВО,
ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА ЗА ВАС
ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да се
наложи да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар,
фармацевт или
медицинска сестра.
-
Това лекарство е предписано лично на
Вас. Не го преотстъпвайте на други
хора. То може
да им навреди, независимо че
признаците на тяхното заболяване са
същите като Вашите.
-
Ако получите някакви нежелани
реакции, уведомете Вашия лекар,
фармацевт или
медицинска сестра. Това включва и
всички възможни нежелани реакции,
неописани в
тази листовка. Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Siklos и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате Siklos
3.
Как да приемате Siklos
4.
Възможни нежелани реакции
5.
Как да съхранявате Siklos
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА SIKLOS И ЗА КАКВО СЕ
ИЗПОЛЗВА
Siklos се използва, за предотвратяв
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Siklos 100 mg филмиранa таблетка
Siklos 1 000 mg филмиранa таблетка
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Siklos 100 mg филмиранa таблетка
Всяка филмирана таблетка съдържа 100 mg
хидроксикарбамид (hydroxycarbamide).
Siklos 1 000 mg филмиранa таблетка
Всяка филмирана таблетка съдържа 1 000 mg
хидроксикарбамид (hydroxycarbamide).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка (таблетка)
Siklos 100 mg филмиранa таблетка
Почти бяла, с продълговата форма,
филмирана таблетка с делителна черта
за разделяне на
половина от двете страни.
Таблетката може да се раздели на равни
половини. На всяка половина на
таблетката има
изпъкнало релефно означение „H“ от
едната страна.
Siklos 1 000 mg филмиранa таблетка
Почти бяла, с форма на капсула,
филмирана таблетка с по три делителни
черти oт двете страни.
Таблетката може да бъде разделена на
четири равни части. Върху всяка
четвъртина на
таблетката има изпъкнало релефно
означение „Т“ от едната страна.
4.
КЛИНИЧНИ ДАННИ
4.1.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Siklos е показан за профилактика на
рецидивиращи, болезнени,
вазо-оклузив
                                
                                Read the complete document

Similar products

Active ingredient хидроксикарбамид

хидроксикарбамид

ATC code L01XX05

L01XX05

Marketed by Theravia

Theravia

INN (International Name) hydroxycarbamide

hydroxycarbamide

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Patient Information leaflet Patient Information leaflet Spanish 31-07-2023
Summary of Product characteristics Summary of Product characteristics Spanish 31-07-2023
Public Assessment Report Public Assessment Report Spanish 27-05-2014
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Summary of Product characteristics Summary of Product characteristics Czech 31-07-2023
Public Assessment Report Public Assessment Report Czech 27-05-2014
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Public Assessment Report Public Assessment Report Danish 27-05-2014
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Public Assessment Report Public Assessment Report Greek 27-05-2014
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Public Assessment Report Public Assessment Report English 27-05-2014
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