देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk
Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)
L01XE01
IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk
Filmomhulde tablet
CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),
Oraal gebruik
Imatinib
Hulpstoffen: CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B);
2015-09-16
PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB DENK 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 Imatinib Denk is and what it is used for 2. What you need to know before you take Imatinib Denk 3. How to take Imatinib Denk 4. Possible side effects 5. How to store Imatinib Denk 6. Contents of the pack and other information 1. WHAT IMATINIB DENK IS AND WHAT IT IS USED FOR Imatinib Denk 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. IMATINIB DENK 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. Imatinib Denk inhibits the growth of these cells. IMATINIB DENK IS ALSO A TREATMENT FOR ADULTS FOR: − MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a group of blood diseases in which some bl पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib Denk 100 mg, filmomhulde tabletten Imatinib Denk 400 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Imatinib Denk 100 mg film-coated tablets: _ Each film-coated tablet contains 100 mg imatinib (as mesilate). _Imatinib Denk 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 Imatinib Denk 100 mg film-coated tablets are round tablets with light brown film coating and a diameter of 8 mm, score on one side. Imatinib Denk 400 mg film-coated tablets are oval tablets with light brown film coating, 17 mm long and 8 mm wide, score on both sides. The tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib Denk 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 Imatinib Denk on the outcome of bone marrow transplantation has not been determined. Imatinib Denk is indicated for ▪ the treatment of adult patients with Kit (CD 117) positive unresectable and/or me पूरा दस्तावेज़ पढ़ें