Rivastigmine 3M Health Care Ltd

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
18-09-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
18-09-2014
Public Assessment Report Public Assessment Report (PAR)
18-09-2014

Active ingredient:

ривастигмин

Available from:

3M Health Care Limited

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics, , Антихолинэстеразных

Therapeutic area:

Болест на Алцхаймер

Therapeutic indications:

Симптоматично лечение на лека до умерено тежка деменция от Алцхаймер.

Product summary:

Revision: 1

Authorization status:

Отменено

Authorization date:

2014-04-03

Patient Information leaflet

                                43
Б. ЛИСТОВКА
Лекарствен продукт, който вече не е
разрешен за употреба
44
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
РИВАСТИГМИН 3M HEALTH CARE LTD. 4,6 MG/24 ЧАСА
ТРАНСДЕРМАЛЕН ПЛАСТИР
РИВАСТИГМИН 3M HEALTH CARE LTD. 9,5 MG/24 ЧАСА
ТРАНСДЕРМАЛЕН ПЛАСТИР
ривастигмин (rivastigmine)
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
единствено и 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,
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
Ривастигмин 3M Health Care Ltd.
и за какво се използва
2.
Какво трябва да знаете, преди да
приемете Ривастигмин 3M Health Care Ltd.
3.
Как да приемате
Ривастигмин 3M Health Care L
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт, който вече не е
разрешен за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Ривастигмин 3M Health Care Ltd. 4,6 mg/24 часа
трансдермален пластир
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки трансдермален пластир
освобождава 4,6 mg ривастигмин за 24 часа.
Всеки трансдермален
пластир от 4,15 cm
2
съдържа 7,17 mg ривастигмин (rivastigmine).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Трансдермален пластир
Правоъгълни пластири, с размер около
2,5 cm на 1,8 cm със заоблени ъгли. Всеки
пластир се
състои от комбинация от прозрачна,
отделяща се лента, която се
отстранява, функционален слой,
съдържащ лекарството в адхезивна (DIA)
матрица и защитен покриващ слой.
Покриващият слой е
прозрачен до полу
прозрачен, с многократно повтарящ се
надпис "R5".
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Симптоматично лечение на лека до
умерено тежка Алцхаймерова деменция.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Лечението трябва да се започне и да се
следи от лекар с опит в диагностиката
и лечението на
Алцхаймерова деменция. Диагнозата
трябва да се постави съгласно
съвременните препор
                                
                                Read the complete document

Similar products

Active ingredient ривастигмин

ривастигмин

ATC code N06DA03

N06DA03

Marketed by 3M Health Care Limited

3M Health Care Limited

INN (International Name) rivastigmine

rivastigmine

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Spanish 18-09-2014
Public Assessment Report Public Assessment Report Spanish 18-09-2014
Patient Information leaflet Patient Information leaflet Czech 18-09-2014
Summary of Product characteristics Summary of Product characteristics Czech 18-09-2014
Public Assessment Report Public Assessment Report Czech 18-09-2014
Patient Information leaflet Patient Information leaflet Danish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Danish 18-09-2014
Public Assessment Report Public Assessment Report Danish 18-09-2014
Patient Information leaflet Patient Information leaflet German 18-09-2014
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Public Assessment Report Public Assessment Report German 18-09-2014
Patient Information leaflet Patient Information leaflet Estonian 18-09-2014
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Public Assessment Report Public Assessment Report Estonian 18-09-2014
Patient Information leaflet Patient Information leaflet Greek 18-09-2014
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Public Assessment Report Public Assessment Report Greek 18-09-2014
Patient Information leaflet Patient Information leaflet English 18-09-2014
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Public Assessment Report Public Assessment Report English 18-09-2014
Patient Information leaflet Patient Information leaflet French 18-09-2014
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Public Assessment Report Public Assessment Report French 18-09-2014
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Public Assessment Report Public Assessment Report Slovak 18-09-2014
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