Simulect

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
12-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
12-10-2023
Public Assessment Report Public Assessment Report (PAR)
31-10-2008

Active ingredient:

базиликсимаб

Available from:

Novartis Europharm Limited

ATC code:

L04AC02

INN (International Name):

basiliximab

Therapeutic group:

Имуносупресори

Therapeutic area:

Graft Rejection; Kidney Transplantation

Therapeutic indications:

Simulect е показан за профилактика на острата орган отхвърляне в de-novo алогенни бъбречна трансплантация при възрастни и педиатрични пациенти (1-17 години). Той ще се използва паралелно с микроемулсия циклоспорина и кортикостероиди въз основа на имуносупресия при пациенти с панел реактивни антитела по-малко от 80%, или в троен ремонт иммуносупрессивной терапия, съдържащи циклоспорин микроемулсия, глюкокортикоиди и Азатиоприн или микофенолата мофетил.

Product summary:

Revision: 28

Authorization status:

упълномощен

Authorization date:

1998-10-09

Patient Information leaflet

                                42
Б. ЛИСТОВКА
43
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
SIMULECT 20 MG ПРАХ И РАЗТВОРИТЕЛ ЗА
ИНЖЕКЦИОНЕН ИЛИ ИНФУЗИОНЕН РАЗТВОР
базиликсимаб (basiliximab)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ВИ БЪДЕ ПРИЛОЖЕНО 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,
медицинска сестра
или фармацевт.
-
Ако получите някакви нежелани
реакции, уведомете Вашия лекар,
медицинска сестра
или фармацевт. Това включва и всички
възможни нежелани реакции, неописани
в тази
листовка. Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Simulect и за какво се
използва
2.
Какво трябва да знаете,
преди да Ви бъде приложен Simulect
3.
Как се прилага Simulect
4.
Възможни нежелани реакции
5.
Как да съхранявате Simulect
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА SIMULECT И ЗА КАКВО СЕ
ИЗПОЛЗВА
Simulect принадлежи към група лекарства,
наречени имуносупресори. Прилага се в
болниците
на възрастни, юноши и деца, които са
претърпели бъбречна трансплантация.
Имуносупресорите намаляват отговор
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Simulect 20 mg прах и разтворител за
инжекционен или инфузионен разтвор
Simulect 20 mg прах за инжекционен или
инфузионен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки флакон съдържа 20 mg базиликсимаб
(basiliximab)*.
Един ml от приготвения разтвор съдържа
4 mg базиликсимаб.
* рекомбинантно химерично мишe-човешко
моноклонално антитяло, насочено срещу
α-
веригата на рецептора за интерлевкин-2
(CD25 антиген), получено в миша миеломна
клетъчна
линия чрез рекомбинантна ДНК
технология.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Simulect 20 mg прах и разтворител за
инжекционен или инфузионен разтвор
Прах и разтворител за инжекционен или
инфузионен разтвор
Бял прах
Simulect 20 mg прах за инжекционен или
инфузионен разтвор
Прах за инжекционен или инфузионен
разтвор
Бял прах
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ
ПОКАЗАНИЯ
Simulect е показан за профилактика на
остро отхвърляне на орган при
_de novo_
алогенна
бъбречна трансплантация при
възрастни пациенти и деца (1-17 години)
(вж. точка 4.2).
Предназначен е за едновременна
употреба с имуноспупресия, базира
                                
                                Read the complete document

Similar products

Active ingredient базиликсимаб

базиликсимаб

ATC code L04AC02

L04AC02

Marketed by Novartis Europharm Limited

Novartis Europharm Limited

INN (International Name) basiliximab

basiliximab

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 12-10-2023
Summary of Product characteristics Summary of Product characteristics Spanish 12-10-2023
Public Assessment Report Public Assessment Report Spanish 31-10-2008
Patient Information leaflet Patient Information leaflet Czech 12-10-2023
Summary of Product characteristics Summary of Product characteristics Czech 12-10-2023
Public Assessment Report Public Assessment Report Czech 31-10-2008
Patient Information leaflet Patient Information leaflet Danish 12-10-2023
Summary of Product characteristics Summary of Product characteristics Danish 12-10-2023
Public Assessment Report Public Assessment Report Danish 31-10-2008
Patient Information leaflet Patient Information leaflet German 12-10-2023
Summary of Product characteristics Summary of Product characteristics German 12-10-2023
Public Assessment Report Public Assessment Report German 31-10-2008
Patient Information leaflet Patient Information leaflet Estonian 12-10-2023
Summary of Product characteristics Summary of Product characteristics Estonian 12-10-2023
Public Assessment Report Public Assessment Report Estonian 31-10-2008
Patient Information leaflet Patient Information leaflet Greek 12-10-2023
Summary of Product characteristics Summary of Product characteristics Greek 12-10-2023
Public Assessment Report Public Assessment Report Greek 31-10-2008
Patient Information leaflet Patient Information leaflet English 12-10-2023
Summary of Product characteristics Summary of Product characteristics English 12-10-2023
Public Assessment Report Public Assessment Report English 31-10-2008
Patient Information leaflet Patient Information leaflet French 12-10-2023
Summary of Product characteristics Summary of Product characteristics French 12-10-2023
Public Assessment Report Public Assessment Report French 31-10-2008
Patient Information leaflet Patient Information leaflet Italian 12-10-2023
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Public Assessment Report Public Assessment Report Italian 31-10-2008
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Public Assessment Report Public Assessment Report Latvian 31-10-2008
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Public Assessment Report Public Assessment Report Lithuanian 31-10-2008
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Public Assessment Report Public Assessment Report Hungarian 31-10-2008
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Public Assessment Report Public Assessment Report Maltese 31-10-2008
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Summary of Product characteristics Summary of Product characteristics Dutch 12-10-2023
Public Assessment Report Public Assessment Report Dutch 31-10-2008
Patient Information leaflet Patient Information leaflet Polish 12-10-2023
Summary of Product characteristics Summary of Product characteristics Polish 12-10-2023
Public Assessment Report Public Assessment Report Polish 31-10-2008
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Summary of Product characteristics Summary of Product characteristics Portuguese 12-10-2023
Public Assessment Report Public Assessment Report Portuguese 31-10-2008
Patient Information leaflet Patient Information leaflet Romanian 12-10-2023
Summary of Product characteristics Summary of Product characteristics Romanian 12-10-2023
Public Assessment Report Public Assessment Report Romanian 31-10-2008
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Summary of Product characteristics Summary of Product characteristics Slovak 12-10-2023
Public Assessment Report Public Assessment Report Slovak 31-10-2008
Patient Information leaflet Patient Information leaflet Slovenian 12-10-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 12-10-2023
Public Assessment Report Public Assessment Report Slovenian 31-10-2008
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Summary of Product characteristics Summary of Product characteristics Finnish 12-10-2023
Public Assessment Report Public Assessment Report Finnish 31-10-2008
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Public Assessment Report Public Assessment Report Swedish 31-10-2008
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