Savene

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-10-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
08-10-2019
Public Assessment Report Public Assessment Report (PAR)
16-08-2011

Active ingredient:

дексразоксан хидрохлорид

Available from:

Clinigen Healthcare B.V.

ATC code:

V03AF02

INN (International Name):

dexrazoxane

Therapeutic group:

Всички други терапевтични продукти

Therapeutic area:

Екстравазиране на диагностични и терапевтични материали

Therapeutic indications:

Savene е показан за лечение на антрациклинова екстравазация.

Product summary:

Revision: 14

Authorization status:

упълномощен

Authorization date:

2006-07-27

Patient Information leaflet

                                23
Б. ЛИСТОВКА
24
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
SAVENE 20 MG/ML ПРАХ И РАЗТВОРИТЕЛ ЗА
КОНЦЕНТРАТ ЗА ИНФУЗИОНЕН РАЗТВОР.
Дексразоксан (Dexrazoxane)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЛАГАТЕ 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
медицинска
сестра.
-
Ако получите някакви нежелани
лекарствени реакции, уведомете Вашия
лекар. Това
включва и всички възможни нежелани
реакции, неописани в тази листовка.
Вижте
точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
:
1.
Какво представлява Savene и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате Savene
3.
Как да използвате Savene
4.
Възможни нежелани реакции
5
Съхранение на Savene
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА SAVENE И ЗА КАКВО СЕ
ИЗПОЛЗВА
Savene съдържа активното вещество
дексразоксан, което действа като
антидот срещу
противораковите лекарства, наречени
антрациклини.
Повечето противоракови лекарства се
прилагат интравенозно (във вената).
Понякога се
получават инцидент
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Savene 20 mg/ml прах и разтворител за
концентрат за инфузионен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки флакон съдържа 500 mg дексразоксан
(dexrazoxane) (589 mg дексразоксанов
хидрохлорид).
Всеки ml съдържа 20 mg дексразоксан след
разтваряне с 25 ml Savene разтворител.
Помощни вещества с известно действие:
Бутилка с разтворител:
Калий 98 mg/500 ml или 5,0 mmol/l
Натрий 1,61 g/500 ml или 140 mmol/l
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Прах и разтворител за концентрат за
инфузионен разтвор
Флакон с прах:
Бял до почти бял лиофилизат.
Бутилка с разтворител:
Бистър изотоничен разтвор (295 mOsml/l, pH
приблизително 7,4).
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Savene е показан при възрастни за лечение
на екстравазация на антрациклини.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Savene трябва да се прилага под
наблюдението на лекар с опит в
приложението на
противоракови лекарствени продукти.
Дозировка
Лечението трябва да се прилага един
път дневно в 3 последователни дни.
Препоръчителната
доза е:
Ден 1:
1 000 mg/m
2
Ден 2:
1 000 mg/m
2
Ден 3:
500 mg/m
2
Първата инфузия трябва да 
                                
                                Read the complete document

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Active ingredient дексразоксан хидрохлорид

дексразоксан хидрохлорид

ATC code V03AF02

V03AF02

Marketed by Clinigen Healthcare B.V.

Clinigen Healthcare B.V.

INN (International Name) dexrazoxane

dexrazoxane

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 08-10-2019
Summary of Product characteristics Summary of Product characteristics Spanish 08-10-2019
Public Assessment Report Public Assessment Report Spanish 16-08-2011
Patient Information leaflet Patient Information leaflet Czech 08-10-2019
Summary of Product characteristics Summary of Product characteristics Czech 08-10-2019
Public Assessment Report Public Assessment Report Czech 16-08-2011
Patient Information leaflet Patient Information leaflet Danish 08-10-2019
Summary of Product characteristics Summary of Product characteristics Danish 08-10-2019
Public Assessment Report Public Assessment Report Danish 16-08-2011
Patient Information leaflet Patient Information leaflet German 08-10-2019
Summary of Product characteristics Summary of Product characteristics German 08-10-2019
Public Assessment Report Public Assessment Report German 16-08-2011
Patient Information leaflet Patient Information leaflet Estonian 08-10-2019
Summary of Product characteristics Summary of Product characteristics Estonian 08-10-2019
Public Assessment Report Public Assessment Report Estonian 16-08-2011
Patient Information leaflet Patient Information leaflet Greek 08-10-2019
Summary of Product characteristics Summary of Product characteristics Greek 08-10-2019
Public Assessment Report Public Assessment Report Greek 16-08-2011
Patient Information leaflet Patient Information leaflet English 08-10-2019
Summary of Product characteristics Summary of Product characteristics English 08-10-2019
Public Assessment Report Public Assessment Report English 16-08-2011
Patient Information leaflet Patient Information leaflet French 08-10-2019
Summary of Product characteristics Summary of Product characteristics French 08-10-2019
Public Assessment Report Public Assessment Report French 16-08-2011
Patient Information leaflet Patient Information leaflet Italian 08-10-2019
Summary of Product characteristics Summary of Product characteristics Italian 08-10-2019
Public Assessment Report Public Assessment Report Italian 16-08-2011
Patient Information leaflet Patient Information leaflet Latvian 08-10-2019
Summary of Product characteristics Summary of Product characteristics Latvian 08-10-2019
Public Assessment Report Public Assessment Report Latvian 16-08-2011
Patient Information leaflet Patient Information leaflet Lithuanian 08-10-2019
Summary of Product characteristics Summary of Product characteristics Lithuanian 08-10-2019
Public Assessment Report Public Assessment Report Lithuanian 16-08-2011
Patient Information leaflet Patient Information leaflet Hungarian 08-10-2019
Summary of Product characteristics Summary of Product characteristics Hungarian 08-10-2019
Public Assessment Report Public Assessment Report Hungarian 16-08-2011
Patient Information leaflet Patient Information leaflet Maltese 08-10-2019
Summary of Product characteristics Summary of Product characteristics Maltese 08-10-2019
Public Assessment Report Public Assessment Report Maltese 16-08-2011
Patient Information leaflet Patient Information leaflet Dutch 08-10-2019
Summary of Product characteristics Summary of Product characteristics Dutch 08-10-2019
Public Assessment Report Public Assessment Report Dutch 16-08-2011
Patient Information leaflet Patient Information leaflet Polish 08-10-2019
Summary of Product characteristics Summary of Product characteristics Polish 08-10-2019
Public Assessment Report Public Assessment Report Polish 16-08-2011
Patient Information leaflet Patient Information leaflet Portuguese 08-10-2019
Summary of Product characteristics Summary of Product characteristics Portuguese 08-10-2019
Public Assessment Report Public Assessment Report Portuguese 16-08-2011
Patient Information leaflet Patient Information leaflet Romanian 08-10-2019
Summary of Product characteristics Summary of Product characteristics Romanian 08-10-2019
Public Assessment Report Public Assessment Report Romanian 16-08-2011
Patient Information leaflet Patient Information leaflet Slovak 08-10-2019
Summary of Product characteristics Summary of Product characteristics Slovak 08-10-2019
Public Assessment Report Public Assessment Report Slovak 16-08-2011
Patient Information leaflet Patient Information leaflet Slovenian 08-10-2019
Summary of Product characteristics Summary of Product characteristics Slovenian 08-10-2019
Public Assessment Report Public Assessment Report Slovenian 16-08-2011
Patient Information leaflet Patient Information leaflet Finnish 08-10-2019
Summary of Product characteristics Summary of Product characteristics Finnish 08-10-2019
Public Assessment Report Public Assessment Report Finnish 16-08-2011
Patient Information leaflet Patient Information leaflet Swedish 08-10-2019
Summary of Product characteristics Summary of Product characteristics Swedish 08-10-2019
Public Assessment Report Public Assessment Report Swedish 16-08-2011
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Summary of Product characteristics Summary of Product characteristics Norwegian 08-10-2019
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Summary of Product characteristics Summary of Product characteristics Icelandic 08-10-2019
Patient Information leaflet Patient Information leaflet Croatian 08-10-2019
Summary of Product characteristics Summary of Product characteristics Croatian 08-10-2019

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