Tavlesse

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
12-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
12-09-2022
Public Assessment Report Public Assessment Report (PAR)
11-02-2020

Active ingredient:

Динатриевая Fostamatinib

Available from:

Instituto Grifols S.A.

ATC code:

B02BX

INN (International Name):

fostamatinib

Therapeutic group:

Други системни кровоостанавливающие

Therapeutic area:

Тромбоцитопения

Therapeutic indications:

Tavlesse е показан за лечение на хронична имунна тромбоцитопении (ITP) при възрастни пациенти, рефрактерных към други методи за лечение.

Product summary:

Revision: 5

Authorization status:

упълномощен

Authorization date:

2020-01-09

Patient Information leaflet

                                33
Б. ЛИСТОВКА
34
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
TAVLESSE 100 MG ФИЛМИРАНИ ТАБЛЕТКИ
TAVLESSE 150 MG ФИЛМИРАНИ ТАБЛЕТКИ
фостаматиниб динатриев хексахидрат
(fostamatinib disodium hexahydrate)
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
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,
фармацевт или
медицинска сестра.

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, фармацевт
или медицинска сестра. Това включва и
всички възможни нежелани реакции,
неописани в
тази листовка. Вижте точк
                                
                                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
TAVLESSE 100 mg филмирани таблетки
TAVLESSE 150 mg филмирани таблетки
2.
КАЧЕСТВЕН
И КОЛИЧЕСТВЕН СЪСТАВ
TAVLESSE 100 mg филмирани таблетки
Всяка филмирана таблетка съдържа 126,2 mg
фостаматиниб динатриев хексахидрат,
еквивалентни на 100 mg фостаматиниб
(fostamatinib)
_Помощно(и) вещество(а) с известно
действие _
Всяка таблетка от 100 mg съдържа 23 mg
натрий (от помощни вещества и
фостаматиниб
динатриев хексахидрат).
TAVLESSE 150 mg филмирани таблетки
Всяка филмирана таблетка съдържа 189,3 mg
фостаматиниб динатриев хексахидрат,
еквивалентни на 150 mg фостаматиниб
(fostamatinib).
_Помощно(и) вещество(а) с известно
действие _
Всяка таблетка от 150 mg съдържа 34 mg
натрий (от помощни вещества и
фостаматиниб
динатриев хексахидрат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Фил
                                
                                Read the complete document

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Active ingredient Динатриевая Fostamatinib

Динатриевая Fostamatinib

ATC code B02BX

B02BX

Marketed by Instituto Grifols S.A.

Instituto Grifols S.A.

INN (International Name) fostamatinib

fostamatinib

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Patient Information leaflet Patient Information leaflet Spanish 12-09-2022
Summary of Product characteristics Summary of Product characteristics Spanish 12-09-2022
Public Assessment Report Public Assessment Report Spanish 11-02-2020
Patient Information leaflet Patient Information leaflet Czech 12-09-2022
Summary of Product characteristics Summary of Product characteristics Czech 12-09-2022
Public Assessment Report Public Assessment Report Czech 11-02-2020
Patient Information leaflet Patient Information leaflet Danish 12-09-2022
Summary of Product characteristics Summary of Product characteristics Danish 12-09-2022
Public Assessment Report Public Assessment Report Danish 11-02-2020
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Public Assessment Report Public Assessment Report German 11-02-2020
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Public Assessment Report Public Assessment Report Estonian 11-02-2020
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Public Assessment Report Public Assessment Report Greek 11-02-2020
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Public Assessment Report Public Assessment Report English 11-02-2020
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Public Assessment Report Public Assessment Report French 11-02-2020
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Summary of Product characteristics Summary of Product characteristics Slovak 12-09-2022
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Patient Information leaflet Patient Information leaflet Croatian 12-09-2022
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