Imatinib Actavis

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
05-07-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
05-07-2022
Public Assessment Report Public Assessment Report (PAR)
05-07-2022

Active ingredient:

иматиниб

Available from:

Actavis Group PTC ehf

ATC code:

L01EA01

INN (International Name):

imatinib

Therapeutic group:

Protein kinase inhibitors, Antineoplastic agents

Therapeutic area:

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma

Therapeutic indications:

Imatinib Actavis is indicated for the treatment of: , paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with Ph+ CML in blast crisis;, adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy;, adult patients with relapsed or refractory Ph+ ALL as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. Ефект иматиниба на резултата от трансплантация на костен мозък не се определя. Imatinib Actavis is indicated for: , In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. Опит с иматинибом при пациенти с миелодиспластичен синдром/МПЗ, свързани с PDGFR генетични комбинации-много ограничен. Няма контролирани проучвания показват клинична полза или преживяемост при тези заболявания,.

Product summary:

Revision: 13

Authorization status:

Отменено

Authorization date:

2013-04-17

Patient Information leaflet

                                92
Б. ЛИСТОВКА
Лекарствен продукт с невалидно
разрешение за употреба
93
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
ИМАТИНИБ ACTAVIS 50 MG ТВЪРДИ КАПСУЛИ
иматиниб (imatinib)
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 точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Иматиниб Actavis и за
какво се използва
2.
Какво трябва да знаете, преди да
приемете Иматиниб Actavis
3.
Как да приемате Иматиниб Actavis
4.
Възможни нежелани реакции
5.
Как да съхранявате Иматиниб Actavis
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕД
                                
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Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт с невалидно
разрешение за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Иматиниб Actavis 50 mg твърди капсули
Иматиниб Actavis 100 mg твърди капсули
Иматиниб Actavis 400 mg твърди капсули
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Иматиниб Actavis 50 mg твърди капсули
Всяка твърда капсула съдържа 50 mg
иматиниб (imatinib) (под формата на
мезилат).
Иматиниб Actavis 100 mg твърди капсули
Всяка твърда капсула съдържа 100 mg
иматиниб (imatinib) (под формата на
мезилат).
Иматиниб Actavis 400 mg твърди капсули
Всяка твърда капсула съдържа 400 mg
иматиниб (imatinib) (под формата на
мезилат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Твърда капсула (капсула)
Иматиниб Actavis 50 mg твърди капсули
Твърда капсула, размер 3, със
светложълто капаче и светложълто тяло
с надпис „50 mg”, напечатан
с черно мастило.
Иматиниб Actavis 100 mg твърди капсули
Твърда капсула, размер 1, със
светлооранжево капаче и
светлооранжево тяло с надпис „100 mg”,
напечатан с черно мастило.
Иматиниб Actavis 400 mg твърди капсули
Твърда капсула, размер 00, с оранжево,
непрозрачно капаче и тяло с надпис „400
mg”, напечатан с
черно мастило.
4.
КЛИН
                                
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Active ingredient иматиниб

иматиниб

ATC code L01EA01

L01EA01

Marketed by Actavis Group PTC ehf

Actavis Group PTC ehf

INN (International Name) imatinib

imatinib

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