Skilarence

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
27-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
27-09-2022
Public Assessment Report Public Assessment Report (PAR)
27-09-2017

Active ingredient:

диметил фумарат

Available from:

Almirall S.A

ATC code:

L04AX07

INN (International Name):

dimethyl fumarate

Therapeutic group:

Имуносупресори

Therapeutic area:

псориазис

Therapeutic indications:

Skilarence е показан за лечение на умерен до тежък плаков псориазис при възрастни, нуждаещи се от системна лекарствена терапия.

Product summary:

Revision: 11

Authorization status:

упълномощен

Authorization date:

2017-06-23

Patient Information leaflet

                                28
Б. ЛИСТОВКА
29
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
SKILARENCE 30 MG СТОМАШНО-УСТОЙЧИВИ ТАБЛЕТКИ
диметилфумарат
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 или
фармацевт.
-
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 или
фармацевт. Това
включва и всички възможни нежелани
реакции, неописани в тази листовка.
Вижте
точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Skilarence и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Skilarence
3.
Как да приемате Skilarence
4.
Възможни нежелани реакции
5.
Как да съхранявате Skilarence
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА SKILARENCE И ЗА КАКВО СЕ
ИЗПОЛЗВА
КАКВО ПРЕДСТАВЛЯВА SKILARENCE
Skilarence е лекарство, което съдържа
активното вещество диметилфумарат.
Д
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Skilarence 30 mg стомашно-устойчиви таблетки
Skilarence 120 mg стомашно-устойчиви таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Skilarence 30 mg
стомашно-устойчиви таблетки
Всяка стомашно-устойчива таблетка
съдържа 30 mg диметилфумарат.
_Помощно вещество с известно действие
_
Всяка стомашно-устойчива таблетка
съдържа 34,2 mg лактоза (като монохидрат).
Skilarence 120 mg стомашно-устойчиви таблетки
Всяка стомашно-устойчива таблетка
съдържа 120 mg диметилфумарат.
_Помощно вещество с известно действие
_
Всяка стомашно-устойчива таблетка
съдържа 136,8 mg лактоза (като
монохидрат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Стомашно-устойчива таблетка.
Skilarence 30 mg стомашно-устойчиви таблетки
Бяла, филмирана, кръгла,
двойноизпъкнала таблетка с диаметър
приблизително 6,8 mm.
Skilarence 120 mg стомашно-устойчиви таблетки
Синя, филмирана, кръгла,
двойноизпъкнала таблетка с диаметър
приблизително 11,6 mm.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Skilarence е показан за лечение на умерено
тежък до тежък плакатен псориазис при
възрастни,
които се нуждаят от систем
                                
                                Read the complete document

Similar products

Active ingredient диметил фумарат

диметил фумарат

ATC code L04AX07

L04AX07

Marketed by Almirall S.A

Almirall S.A

INN (International Name) dimethyl fumarate

dimethyl fumarate

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Patient Information leaflet Patient Information leaflet Spanish 27-09-2022
Summary of Product characteristics Summary of Product characteristics Spanish 27-09-2022
Public Assessment Report Public Assessment Report Spanish 27-09-2017
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Summary of Product characteristics Summary of Product characteristics Czech 27-09-2022
Public Assessment Report Public Assessment Report Czech 27-09-2017
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