Stalevo

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
23-02-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
23-02-2023
Public Assessment Report Public Assessment Report (PAR)
13-10-2011

Active ingredient:

l-dopa, карбидопа, энтакапон

Available from:

Orion Corporation

ATC code:

N04BA03

INN (International Name):

levodopa, carbidopa, entacapone

Therapeutic group:

Антипаркинсонови лекарства

Therapeutic area:

Паркинсонова болест

Therapeutic indications:

От село Сталево е показан за лечение на възрастни пациенти с болестта на Паркинсон и край на доза моторни колебания не стабилизира на леводопа / допа-декарбоксилаза (DDC)-инхибитор лечение.

Product summary:

Revision: 29

Authorization status:

упълномощен

Authorization date:

2003-10-17

Patient Information leaflet

                                42
Б. ЛИСТОВКА
43
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
STALEVO 50 MG/12,5 MG/200 MG ФИЛМИРАНИ ТАБЛЕТКИ
леводопа/карбидопа/ентакапон
(levodopa/carbidopa/entacapone)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ ТОВА
ЛЕКАРСТВО,
ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА ЗА ВАС
ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да имате
нужда да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар или
фармацевт.
-
Това лекарство е предписано
единствено и лично на Вас. Не го
преотстъпвайте на други
хора. То може да им навреди, независимо
че признаците на тяхното заболяване
са
същите както 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 Stalevo и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Stalevo
3.
Как да приемате Stalevo
4.
Възможни нежелани реакции
5.
Как да съхранявате Stalevo
6.
Съдържание на опаковката и
допълнителна информация
1_._
КАКВО ПРЕДСТАВЛЯВА STALEVO И ЗА КАКВО СЕ
ИЗПОЛЗВА
Stalevo съдържа три активни вещества
(леводопа, карбидоп
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Stalevo 50 mg/12,5 mg/200 mg филмирани таблетки
Stalevo 75 mg/18,75 mg/200 mg филмирани таблетки
Stalevo 100 mg/25 mg/200 mg филмирани таблетки
Stalevo 125 mg/31,25 mg/200 mg филмирани таблетки
Stalevo 150 mg/37,5 mg/200 mg филмирани таблетки
Stalevo 175 mg/43,75 mg/200 mg филмирани таблетки
Stalevo 200 mg/50 mg/200 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
50 mg/12,5 mg/200 mg
Всяка таблетка съдържа 50 mg леводопа
(levodopa), 12,5 mg карбидопa (carbidopa) и 200 mg
eнтакапон (entacapone).
Помощно вещество с известно действие:
Всяка таблетка съдържа 1,2 mg захароза.
75 mg/18,75 mg/200 mg
Всяка таблетка съдържа 75 mg леводопа
(levodopa), 18,75 mg карбидопa (carbidopa) и 200 mg
eнтакапон (entacapone).
Помощно вещество с известно действие
Всяка таблетка съдържа 1,4 mg захароза.
100 mg/25 mg/200 mg
Всяка таблетка съдържа 100 mg леводопа
(levodopa), 25 mg карбидопa (carbidopa) и 200 mg
eнтакапон (entacapone).
Помощно вещество с известно действие
Всяка таблетка съдържа 1,6 mg захароза.
125 mg/31,25 mg/200 mg
Всяка таблетка съдържа 125 mg леводопа
(levodopa), 31,25 mg карбидопa (carbidopa) и 200 mg
eнтакапон (entacapone).
Помощно вещество с известно действие
Всяка таблетка съдържа 1,6 mg захароза.
150 mg/37,5 mg/200 mg
Всяка таблетка съдържа 150 mg леводопа
(levodopa), 37,5 mg ка
                                
                                Read the complete document

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Active ingredient l-dopa, карбидопа, энтакапон

l-dopa, карбидопа, энтакапон

ATC code N04BA03

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Marketed by Orion Corporation

Orion Corporation

INN (International Name) levodopa, carbidopa, entacapone

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Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Spanish 23-02-2023
Public Assessment Report Public Assessment Report Spanish 13-10-2011
Patient Information leaflet Patient Information leaflet Czech 23-02-2023
Summary of Product characteristics Summary of Product characteristics Czech 23-02-2023
Public Assessment Report Public Assessment Report Czech 13-10-2011
Patient Information leaflet Patient Information leaflet Danish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Danish 23-02-2023
Public Assessment Report Public Assessment Report Danish 13-10-2011
Patient Information leaflet Patient Information leaflet German 23-02-2023
Summary of Product characteristics Summary of Product characteristics German 23-02-2023
Public Assessment Report Public Assessment Report German 13-10-2011
Patient Information leaflet Patient Information leaflet Estonian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Estonian 23-02-2023
Public Assessment Report Public Assessment Report Estonian 13-10-2011
Patient Information leaflet Patient Information leaflet Greek 23-02-2023
Summary of Product characteristics Summary of Product characteristics Greek 23-02-2023
Public Assessment Report Public Assessment Report Greek 13-10-2011
Patient Information leaflet Patient Information leaflet English 23-02-2023
Summary of Product characteristics Summary of Product characteristics English 23-02-2023
Public Assessment Report Public Assessment Report English 13-10-2011
Patient Information leaflet Patient Information leaflet French 23-02-2023
Summary of Product characteristics Summary of Product characteristics French 23-02-2023
Public Assessment Report Public Assessment Report French 13-10-2011
Patient Information leaflet Patient Information leaflet Italian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Italian 23-02-2023
Public Assessment Report Public Assessment Report Italian 13-10-2011
Patient Information leaflet Patient Information leaflet Latvian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Latvian 23-02-2023
Public Assessment Report Public Assessment Report Latvian 13-10-2011
Patient Information leaflet Patient Information leaflet Lithuanian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 23-02-2023
Public Assessment Report Public Assessment Report Lithuanian 13-10-2011
Patient Information leaflet Patient Information leaflet Hungarian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 23-02-2023
Public Assessment Report Public Assessment Report Hungarian 13-10-2011
Patient Information leaflet Patient Information leaflet Maltese 23-02-2023
Summary of Product characteristics Summary of Product characteristics Maltese 23-02-2023
Public Assessment Report Public Assessment Report Maltese 13-10-2011
Patient Information leaflet Patient Information leaflet Dutch 23-02-2023
Summary of Product characteristics Summary of Product characteristics Dutch 23-02-2023
Public Assessment Report Public Assessment Report Dutch 13-10-2011
Patient Information leaflet Patient Information leaflet Polish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Polish 23-02-2023
Public Assessment Report Public Assessment Report Polish 13-10-2011
Patient Information leaflet Patient Information leaflet Portuguese 23-02-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 23-02-2023
Public Assessment Report Public Assessment Report Portuguese 13-10-2011
Patient Information leaflet Patient Information leaflet Romanian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Romanian 23-02-2023
Public Assessment Report Public Assessment Report Romanian 13-10-2011
Patient Information leaflet Patient Information leaflet Slovak 23-02-2023
Summary of Product characteristics Summary of Product characteristics Slovak 23-02-2023
Public Assessment Report Public Assessment Report Slovak 13-10-2011
Patient Information leaflet Patient Information leaflet Slovenian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 23-02-2023
Public Assessment Report Public Assessment Report Slovenian 13-10-2011
Patient Information leaflet Patient Information leaflet Finnish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Finnish 23-02-2023
Public Assessment Report Public Assessment Report Finnish 13-10-2011
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Summary of Product characteristics Summary of Product characteristics Swedish 23-02-2023
Public Assessment Report Public Assessment Report Swedish 13-10-2011
Patient Information leaflet Patient Information leaflet Norwegian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 23-02-2023
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Summary of Product characteristics Summary of Product characteristics Icelandic 23-02-2023
Patient Information leaflet Patient Information leaflet Croatian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Croatian 23-02-2023

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Stalevo