Zurampic

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
06-07-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
06-07-2017
Public Assessment Report Public Assessment Report (PAR)
09-03-2016

Active ingredient:

lesinurad

Available from:

Grünenthal GmbH

ATC code:

M04AB05

INN (International Name):

lesinurad

Therapeutic group:

Препарати против изгаряне

Therapeutic area:

Hyperuricemia

Therapeutic indications:

Zurampic, в комбинация с инхибитор на ксантин оксидаза, е показан при възрастни за комбинирана обработка на hyperuricaemia при подагра пациенти (с или без тофите), които не са постигнали целта серумните нива на пикочната киселина с подходяща доза на ксантин оксидаза инхибитор сам.

Product summary:

Revision: 4

Authorization status:

Отменено

Authorization date:

2016-02-18

Patient Information leaflet

                                26
Б. ЛИСТОВКА
27
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
ZURAMPIC 200 MG ФИЛМИРАНИ ТАБЛЕТКИ
лезинурад (lesinurad)
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. Можете да
дадете своя принос като
съобщите всяка нежелана реакция,
която сте получили. За начина на
съобщаване на нежелани
реакции вижте края на точка 4.
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
лекарствени 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 Zurampic и за какво се
използва
2.
Какво трябва да знаете, преди
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. От
медицинските специалисти се
изисква да съобщават всяка подозирана
нежелана реакция. За начина на
съобщаване на
нежелани реакции вижте точка 4.8.
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Zurampic 200 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка филмирана таблетка съдържа 200 mg
лезинурад (lesinurad).
Помощно вещество с известно действие:
Всяка таблетка съдържа 52,92 mg лактоза
(като
монохидрат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка (таблетка)
Овални, сини таблетки с размери 5,7 x 12,9
mm.
Таблетките са гравирани с “LES200” от
едната страна.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Zurampic, в комбинация с инхибитор на
ксантин оксидазата, е показан при
възрастни за
допълващо лечение на хиперурикемия
при пациенти с подагра (със или без
тофи), които не са
достигнали таргетни серумни нива на
пикочната киселина със съответна доза
инхибитор на
ксантин оксидазата, приеман
самостоятелно.
4.
                                
                                Read the complete document

Similar products

Active ingredient lesinurad

lesinurad

ATC code M04AB05

M04AB05

Marketed by Grünenthal GmbH

Grünenthal GmbH

INN (International Name) lesinurad

lesinurad

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Patient Information leaflet Patient Information leaflet Spanish 06-07-2017
Summary of Product characteristics Summary of Product characteristics Spanish 06-07-2017
Public Assessment Report Public Assessment Report Spanish 09-03-2016
Patient Information leaflet Patient Information leaflet Czech 06-07-2017
Summary of Product characteristics Summary of Product characteristics Czech 06-07-2017
Public Assessment Report Public Assessment Report Czech 09-03-2016
Patient Information leaflet Patient Information leaflet Danish 06-07-2017
Summary of Product characteristics Summary of Product characteristics Danish 06-07-2017
Public Assessment Report Public Assessment Report Danish 09-03-2016
Patient Information leaflet Patient Information leaflet German 06-07-2017
Summary of Product characteristics Summary of Product characteristics German 06-07-2017
Public Assessment Report Public Assessment Report German 09-03-2016
Patient Information leaflet Patient Information leaflet Estonian 06-07-2017
Summary of Product characteristics Summary of Product characteristics Estonian 06-07-2017
Public Assessment Report Public Assessment Report Estonian 09-03-2016
Patient Information leaflet Patient Information leaflet Greek 06-07-2017
Summary of Product characteristics Summary of Product characteristics Greek 06-07-2017
Public Assessment Report Public Assessment Report Greek 09-03-2016
Patient Information leaflet Patient Information leaflet English 06-07-2017
Summary of Product characteristics Summary of Product characteristics English 06-07-2017
Public Assessment Report Public Assessment Report English 09-03-2016
Patient Information leaflet Patient Information leaflet French 06-07-2017
Summary of Product characteristics Summary of Product characteristics French 06-07-2017
Public Assessment Report Public Assessment Report French 09-03-2016
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Public Assessment Report Public Assessment Report Lithuanian 09-03-2016
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Summary of Product characteristics Summary of Product characteristics Hungarian 06-07-2017
Public Assessment Report Public Assessment Report Hungarian 09-03-2016
Patient Information leaflet Patient Information leaflet Maltese 06-07-2017
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Public Assessment Report Public Assessment Report Maltese 09-03-2016
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Public Assessment Report Public Assessment Report Dutch 09-03-2016
Patient Information leaflet Patient Information leaflet Polish 06-07-2017
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Public Assessment Report Public Assessment Report Polish 09-03-2016
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Public Assessment Report Public Assessment Report Portuguese 09-03-2016
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Public Assessment Report Public Assessment Report Romanian 09-03-2016
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Summary of Product characteristics Summary of Product characteristics Slovak 06-07-2017
Public Assessment Report Public Assessment Report Slovak 09-03-2016
Patient Information leaflet Patient Information leaflet Slovenian 06-07-2017
Summary of Product characteristics Summary of Product characteristics Slovenian 06-07-2017
Public Assessment Report Public Assessment Report Slovenian 09-03-2016
Patient Information leaflet Patient Information leaflet Finnish 06-07-2017
Summary of Product characteristics Summary of Product characteristics Finnish 06-07-2017
Public Assessment Report Public Assessment Report Finnish 09-03-2016
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Public Assessment Report Public Assessment Report Swedish 09-03-2016
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Summary of Product characteristics Summary of Product characteristics Icelandic 06-07-2017
Patient Information leaflet Patient Information leaflet Croatian 06-07-2017
Summary of Product characteristics Summary of Product characteristics Croatian 06-07-2017
Public Assessment Report Public Assessment Report Croatian 09-03-2016

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