Victrelis

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-07-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
31-07-2018
Public Assessment Report Public Assessment Report (PAR)
31-07-2018

Active ingredient:

Боцепревир

Available from:

Merck Sharp Dohme Ltd

ATC code:

J05AE

INN (International Name):

boceprevir

Therapeutic group:

Антивирусни средства за системно приложение

Therapeutic area:

Хепатит C, хроничен

Therapeutic indications:

Victrelis е показан за лечение на хроничен хепатит C (CHC) генотип-1 инфекция, в комбинация с пегинтерферон алфа и рибавирин при възрастни пациенти с компенсирани чернодробно заболяване, които са нелекуван или които са се провалили предишните терапия.

Product summary:

Revision: 22

Authorization status:

Отменено

Authorization date:

2011-07-18

Patient Information leaflet

                                49
Б. ЛИСТОВКА
Лекарствен продукт с невалидно
разрешение за употреба
50
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
VICTRELIS 200 MG ТВЪРДИ КАПСУЛИ
боцепревир (boceprevir)
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 Victrelis и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Victrelis
3.
Как да приемате Victrelis
4.
Възможни нежелани реакции
5.
Как да съхранявате Victrelis
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА VICTRELIS И ЗА КАКВО СЕ
ИЗПОЛЗВА
КАКВО ПРЕДСТАВЛЯВА VICTRELIS
Victrelis съдържа
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт с невалидно
разрешение за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Victrelis 200 mg твърди капсули
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка твърда капсула съдържа 200 mg
боцепревир (boceprevir).
Помощно вещество с известно действие
Всяка капсула съдържа 56 mg лактоза
монохидрат.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Твърда капсула
Всяка капсула има жълтеникавокафяво,
непрозрачно капаче с лого „MSD”,
отпечатано с
червено мастило, и почти бяло,
непрозрачно тяло с код „314”,
отпечатан с червено мастило.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Victrelis е показан за лечение на хроничен
вирусен хепатит С (CHC) генотип 1 в
комбинация с
пегинтерферон алфа и рибавирин при
възрастни пациенти с компенсирано
чернодробно
заболяване, които не са лекувани преди
това, или не са се повлияли от
предшестващо лечение
(вж. точки 4.4 и 5.1).
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Лечението с Victrelis трябва да се започне
и проследява от лекар, с опит в
лечението на
хроничен хепатит С.
Дозировка
Victrelis трябва да се прилага в
комбинация с пегинтерферон алфа и
риб
                                
                                Read the complete document

Similar products

Active ingredient Боцепревир

Боцепревир

ATC code J05AE

J05AE

Marketed by Merck Sharp Dohme Ltd

Merck Sharp Dohme Ltd

INN (International Name) boceprevir

boceprevir

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Patient Information leaflet Patient Information leaflet Spanish 31-07-2018
Summary of Product characteristics Summary of Product characteristics Spanish 31-07-2018
Public Assessment Report Public Assessment Report Spanish 31-07-2018
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Public Assessment Report Public Assessment Report Czech 31-07-2018
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Victrelis