Minjuvi

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
31-10-2023
Public Assessment Report Public Assessment Report (PAR)
08-09-2021

Active ingredient:

Tafasitamab

Available from:

Incyte Biosciences Distribution B.V.

ATC code:

L01FX12

INN (International Name):

tafasitamab

Therapeutic group:

Антинеопластични средства

Therapeutic area:

Lymphoma, Large B-Cell, Diffuse

Therapeutic indications:

Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Product summary:

Revision: 4

Authorization status:

упълномощен

Authorization date:

2021-08-26

Patient Information leaflet

                                25
Б. ЛИСТОВКА
26
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
MINJUVI 200 MG ПРАХ ЗА КОНЦЕНТРАТ ЗА
ИНФУЗИОНЕН РАЗТВОР
тафазитамаб (tafasitamab)
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. Можете да
дадете своя принос, като
съобщите всяка нежелана реакция,
която сте получили. За начина на
съобщаване на нежелани
реакции вижте края на точка 4.
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
фармацевт.
•
Ако получите някакви нежелани
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 MINJUVI и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате MINJUVI
3.
Как да използвате MINJUVI
4.
Възможни нежелани реакции
5.
Как да съхранявате MINJUVI
6.
Съдържание на опаковката и
допълнителна информаци
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. От
медицинските специалисти се
изисква да съобщават всяка подозирана
нежелана реакция. За начина на
съобщаване на
нежелани реакции вижте точка 4.8.
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
MINJUVI 200 mg прах за концентрат за
инфузионен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Един флакон прах съдържа 200 mg
тафазитамаб (tafasitamab).
След реконституиране всеки ml разтвор
съдържа 40 mg тафазитамаб.
Тафазитамаб е хуманизирано
CD19-специфично моноклонално антитяло
от подклас
имуноглобулин G (IgG), произведено в
клетки на бозайник (яйчник на китайски
хамстер) чрез
рекомбинантна ДНК технология.
Помощно вещество с известно действие
Всеки флакон MINJUVI съдържа 7,4 mg натрий.
За пълния списък на помощните
вещества
вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Прах за концентрат за инфузионен
разтвор (прах за концентрат)
Бял до леко жълтеникав лиофилизиран
прах.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
MINJUVI е показан в комбинация с
леналидомид, последвана от
монотерап
                                
                                Read the complete document

Similar products

Active ingredient Tafasitamab

Tafasitamab

ATC code L01FX12

L01FX12

Marketed by Incyte Biosciences Distribution B.V.

Incyte Biosciences Distribution B.V.

INN (International Name) tafasitamab

tafasitamab

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 31-10-2023
Summary of Product characteristics Summary of Product characteristics Spanish 31-10-2023
Public Assessment Report Public Assessment Report Spanish 08-09-2021
Patient Information leaflet Patient Information leaflet Czech 31-10-2023
Summary of Product characteristics Summary of Product characteristics Czech 31-10-2023
Public Assessment Report Public Assessment Report Czech 08-09-2021
Patient Information leaflet Patient Information leaflet Danish 31-10-2023
Summary of Product characteristics Summary of Product characteristics Danish 31-10-2023
Public Assessment Report Public Assessment Report Danish 08-09-2021
Patient Information leaflet Patient Information leaflet German 31-10-2023
Summary of Product characteristics Summary of Product characteristics German 31-10-2023
Public Assessment Report Public Assessment Report German 08-09-2021
Patient Information leaflet Patient Information leaflet Estonian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Estonian 31-10-2023
Public Assessment Report Public Assessment Report Estonian 08-09-2021
Patient Information leaflet Patient Information leaflet Greek 31-10-2023
Summary of Product characteristics Summary of Product characteristics Greek 31-10-2023
Public Assessment Report Public Assessment Report Greek 08-09-2021
Patient Information leaflet Patient Information leaflet English 31-10-2023
Summary of Product characteristics Summary of Product characteristics English 31-10-2023
Public Assessment Report Public Assessment Report English 08-09-2021
Patient Information leaflet Patient Information leaflet French 31-10-2023
Summary of Product characteristics Summary of Product characteristics French 31-10-2023
Public Assessment Report Public Assessment Report French 08-09-2021
Patient Information leaflet Patient Information leaflet Italian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Italian 31-10-2023
Public Assessment Report Public Assessment Report Italian 08-09-2021
Patient Information leaflet Patient Information leaflet Latvian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Latvian 31-10-2023
Public Assessment Report Public Assessment Report Latvian 08-09-2021
Patient Information leaflet Patient Information leaflet Lithuanian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 31-10-2023
Public Assessment Report Public Assessment Report Lithuanian 08-09-2021
Patient Information leaflet Patient Information leaflet Hungarian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 31-10-2023
Public Assessment Report Public Assessment Report Hungarian 08-09-2021
Patient Information leaflet Patient Information leaflet Maltese 31-10-2023
Summary of Product characteristics Summary of Product characteristics Maltese 31-10-2023
Public Assessment Report Public Assessment Report Maltese 08-09-2021
Patient Information leaflet Patient Information leaflet Dutch 31-10-2023
Summary of Product characteristics Summary of Product characteristics Dutch 31-10-2023
Public Assessment Report Public Assessment Report Dutch 08-09-2021
Patient Information leaflet Patient Information leaflet Polish 31-10-2023
Summary of Product characteristics Summary of Product characteristics Polish 31-10-2023
Public Assessment Report Public Assessment Report Polish 08-09-2021
Patient Information leaflet Patient Information leaflet Portuguese 31-10-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 31-10-2023
Public Assessment Report Public Assessment Report Portuguese 08-09-2021
Patient Information leaflet Patient Information leaflet Romanian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Romanian 31-10-2023
Public Assessment Report Public Assessment Report Romanian 08-09-2021
Patient Information leaflet Patient Information leaflet Slovak 31-10-2023
Summary of Product characteristics Summary of Product characteristics Slovak 31-10-2023
Public Assessment Report Public Assessment Report Slovak 08-09-2021
Patient Information leaflet Patient Information leaflet Slovenian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 31-10-2023
Public Assessment Report Public Assessment Report Slovenian 08-09-2021
Patient Information leaflet Patient Information leaflet Finnish 31-10-2023
Summary of Product characteristics Summary of Product characteristics Finnish 31-10-2023
Public Assessment Report Public Assessment Report Finnish 08-09-2021
Patient Information leaflet Patient Information leaflet Swedish 31-10-2023
Summary of Product characteristics Summary of Product characteristics Swedish 31-10-2023
Public Assessment Report Public Assessment Report Swedish 08-09-2021
Patient Information leaflet Patient Information leaflet Norwegian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 31-10-2023
Patient Information leaflet Patient Information leaflet Icelandic 31-10-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 31-10-2023
Patient Information leaflet Patient Information leaflet Croatian 31-10-2023
Summary of Product characteristics Summary of Product characteristics Croatian 31-10-2023
Public Assessment Report Public Assessment Report Croatian 08-09-2021

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