Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IMATINIBMESILAAT SAMENSTELLING overeenkomend met ; IMATINIB
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
L01XE01
IMATINIBMESILAAT COMPOSITION corresponding to ; IMATINIB
Filmomhulde tablet
HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Imatinib
Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-10-13
PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB STADA 600 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product 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. [PRODUCT 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. [Product name] inhibits the growth of these cells. [PRODUCT NAME] IS ALSO A TREATMENT FOR ADULTS FOR: • MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a group of blood diseases Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib STADA 600 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg imatinib (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet [Product name] 600 mg are white to off white, capsule shaped, biconvex film-coated tablets, with a dimension of 16.5x8.0 mm, debossed with H on one side and I1 on the other side, I and 1 separated by a score line. The tablet can be divided into two equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Product 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 (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement The effect of [Product name] on the outcome of bone marrow transplantation has not been determined. [Product name] is indicated for • the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) • the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence shou Baca dokumen lengkap