Imatinib betapharm 400 mg, filmomhulde tabletten

Страна: Нидерландия

Език: нидерландски

Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активна съставка:

IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk

Предлага се от:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

АТС код:

L01XE01

INN (Международно Name):

IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk

Лекарствена форма:

Filmomhulde tablet

Композиция:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Начин на приложение:

Oraal gebruik

Терапевтична област:

Imatinib

Каталог на резюме:

Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); TALK (E 553 B); TITAANDIOXIDE (E 171);

Дата Оторизация:

1900-01-01

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB BETAPHARM 400 MG FILMOMHULDE TABLETTEN
imatinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] is a medicine containing an active substance called
imatinib. This medicine works by
inhibiting the growth of abnormal cells in the diseases listed below.
These include some types of
cancer.
[INVENTED NAME] IS A TREATMENT FOR ADULTS AND CHILDREN FOR:
•
CHRONIC MYELOID LEUKAEMIA (CML). Leukaemia is a cancer of white blood
cells. These white
cells usually help the body to fight infection. Chronic myeloid
leukaemia is a form of leukaemia
in which certain abnormal white cells (named myeloid cells) start
growing out of control.
•
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE ALL).
Leukaemia is a cancer of white blood cells. These white cells usually
help the body to fight
infection. Acute lymphoblastic leukaemia is a form of leukaemia in
which certain abnormal
white cells (named lymphoblasts) start growing out of control.
[Invented name] inhibits the
growth of these cells.
[INVENTED NAME] IS ALSO A TREATMENT FOR ADULTS FOR:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a
group of b

Данни за продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib betapharm 100 mg filmomhulde tabletten
Imatinib betapharm 400 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Invented name] 100 mg film-coated tablets
Each film-coated tablet contains 100 mg imatinib (as mesilate).
[Invented name] 400 mg film-coated tablets
Each film-coated tablet contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
[Invented name] 100 mg film-coated tablets
White to off-white coloured, round, bevel edged scored tablets with a
dimension of approx. 7.1 mm,
debossed with H on one side and 19 on the other side, 1 and 9
separated by a score line.
The tablet can be divided into equal doses.
[Invented name] 400 mg film-coated tablets
White to off-white coloured, capsule shaped, bevel edged scored, film
coated tablets with a dimension
of approx. 15.0 mm in length and 6.5 mm in width, debossed with H on
one side and 20 on the other
side, 2 and 0 separated by a score line.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Invented name] is indicated for the treatment of
•
adult and 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.
•
adult and paediatric patients with Ph+ CML in chronic phase after
failure of interferon-alpha
therapy, or in accelerated phase or blast crisis.
•
adult and paediatric 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 (HE