Topotecan Teva

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-07-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2018
Public Assessment Report Public Assessment Report (PAR)
06-10-2009

Active ingredient:

топотекан

Available from:

Teva B.V.

ATC code:

L01CE01

INN (International Name):

topotecan

Therapeutic group:

Антинеопластични средства

Therapeutic area:

Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma

Therapeutic indications:

Topotecan monotherapy is indicated for the treatment of: , patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;, patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. , Топотекана в комбинация с цисплатином е показан за пациенти с медиална рецидивиращи на шийката на матката след лъчетерапия и за пациенти със състояние на заболявания на WBI . Пациентите с предварително въздействие на цисплатина, се нуждаят от постоянно безплатно лечение на интервал, за да оправдае лечение с комбинация.

Product summary:

Revision: 8

Authorization status:

Отменено

Authorization date:

2009-09-21

Patient Information leaflet

                                26
Б. ЛИСТОВКА
27
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
ТОПОТЕКАН TEVA 1 MG/1 ML КОНЦЕНТРАТ ЗА
ИНФУЗИОНЕН РАЗТВОР
топотекан (topotecan)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ИЗПОЛЗВАТЕ 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
медицинска
сестра.
-
Ако получите някакви нежелани реакции
, уведомете Вашия лекар или
медицинската
сестра. Това включва и всички възможни
нежелани реакции, неописани в тази
листовка.
Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
:
1.
Какво представлява Топотекан Teva и за
какво се използва
2.
Какво трябва да знаете, преди да
приемете Топотекан Teva
3.
Как да приемате Топотекан Teva
4.
Възможни нежелани реакции
5.
Как да съхранявате Топотекан Teva
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА ТОПОТЕКАН TEVA И ЗА
КАКВО СЕ ИЗПОЛЗВА
Топотекан Teva помага за унищожаване на
туморните клетки.
Топотекан Teva се използва за лечение
на:
-
РАК НА ЯЙЧНИЦИТЕ ИЛИ ДРЕБНОКЛЕТЪЧЕН
РАК НА БЕЛИТЕ ДРОБОВЕ
, който се възвръща след
химиотера
                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
_ _
ПРИЛОЖЕНИЕ І
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Топотекан Teva 1 mg/1 ml концентрат за
инфузионен разтвор
Топотекан Teva 4 mg/4 ml концентрат за
инфузионен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Топотекан Teva 1 mg/1 ml концентрат за
инфузионен разтвор
1 ml от концентрата за инфузионен
разтвор съдържа 1 mg топотекан (topotecan)
(като
хидрохлорид).
Топотекан Teva 4 mg/4 ml концентрат за
инфузионен разтвор
Един ml от концентрата за инфузионен
разтвор съдържа 1 mg топотекан (като
хидрохлорид).
Един флакон от 4 ml концентрат за
инфузионен разтвор съдържа 4 mg
топотекан (като
хидрохлорид).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Концентрат за инфузионен разтвор.
Бистра, бледожълта течност pH = 2,0-2,6.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Монотерапия с топотекан е показана за
лечение на:

пациенти с метастатичен карцином на
яйчника след неуспех на първа линия
или
последваща терапия.

пациенти с рецидив на дребноклетъчен
белодробен карцином (SCLC), при които
повторното приложение на лечението от
първа линия не се счита за подходящо
(вж. точка
5.1).
Топотекан в комбинация с цис
                                
                                Read the complete document

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Active ingredient топотекан

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ATC code L01CE01

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INN (International Name) topotecan

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Patient Information leaflet Patient Information leaflet Spanish 13-07-2018
Summary of Product characteristics Summary of Product characteristics Spanish 13-07-2018
Public Assessment Report Public Assessment Report Spanish 06-10-2009
Patient Information leaflet Patient Information leaflet Czech 13-07-2018
Summary of Product characteristics Summary of Product characteristics Czech 13-07-2018
Public Assessment Report Public Assessment Report Czech 06-10-2009
Patient Information leaflet Patient Information leaflet Danish 13-07-2018
Summary of Product characteristics Summary of Product characteristics Danish 13-07-2018
Public Assessment Report Public Assessment Report Danish 06-10-2009
Patient Information leaflet Patient Information leaflet German 13-07-2018
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Public Assessment Report Public Assessment Report German 06-10-2009
Patient Information leaflet Patient Information leaflet Estonian 13-07-2018
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Public Assessment Report Public Assessment Report Estonian 06-10-2009
Patient Information leaflet Patient Information leaflet Greek 13-07-2018
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Public Assessment Report Public Assessment Report Greek 06-10-2009
Patient Information leaflet Patient Information leaflet English 13-07-2018
Summary of Product characteristics Summary of Product characteristics English 13-07-2018
Public Assessment Report Public Assessment Report English 06-10-2009
Patient Information leaflet Patient Information leaflet French 13-07-2018
Summary of Product characteristics Summary of Product characteristics French 13-07-2018
Public Assessment Report Public Assessment Report French 06-10-2009
Patient Information leaflet Patient Information leaflet Italian 13-07-2018
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Public Assessment Report Public Assessment Report Slovak 06-10-2009
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Public Assessment Report Public Assessment Report Slovenian 06-10-2009
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