Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
IMATINIB MESYLATE
10 Tablets; 30 Tablets
DR. REDDY'S LABORATORIES LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Page 1 REDISTRA (IMATINIB TABLETS 100MG) REDISTRA (IMATINIB TABLETS 400MG) _IMATINIB _(100MG AND 400MG) WHAT IS IN THIS LEAFLET 1. What Redistra is used for 2. How Redistra works 3. Before you use Redistra 4. How to use Redistra 5. While you are using it 6. Side effects 7. Storage and Disposal of Redistra 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT REDISTRA IS USED FOR Redistra is a medicine containing an active substance called imatinib. Redistra is used in the treatment for adult 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. Redistra inhibits the growth of these cells Redistra is also used in the treatment for adult for: • Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Redistra inhibits the growth of these cells in a certain subtype of these diseases • Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Redistra inhibits the growth of these cells in a certain subtype of these diseases. • Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs. • Dermatofibrosarcoma protuberans ( Přečtěte si celý dokument
1 For the use of an oncologist or a hospital or a laboratory only PRESCRIBING INFORMATION REDISTRA (IMATINIB TABLETS 100MG) REDISTRA (IMATINIB TABLETS 400MG) COMPOSITION _REDISTRA (Imatinib Tablets 100 mg) _ Each film coated tablet contains: Imatinib Mesylate Ph.Eur. equivalent to Imatinib 100 mg Colours: Titanium Dioxide, Iron Oxide Yellow, Iron Oxide Red _REDISTRA (Imatinib Tablets 400 mg) _ Each film coated tablet contains: Imatinib Mesylate Ph.Eur. equivalent to Imatinib 400 mg Colours: Titanium Dioxide, Iron Oxide Yellow, Iron Oxide Red PRODUCT DESCRIPTION: _REDISTRA (Imatinib Tablets 100 mg) _ Yellow to brownish orange, round film coated tablets debossed with “1” on one side and score line on the other side. _REDISTRA (Imatinib Tablets 400 mg) _ Yellow to brownish orange, ovaloid film coated tablets debossed with “4” on one side and score line on the other side. CLINICAL INFORMATION THERAPEUTIC INDICATIONS: • Redistra is indicated for the treatment of adult and pediatric patients with newly diagnosed chronic myeloid leukemia (CML) as well as for the treatment of adult and pediatric patients with CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. 2 • adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). • adjuvant treatment of adult patients following resection of GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. • adult and pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (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 hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with F1P1L1-PDGFRα rearrangement. • adult patien Přečtěte si celý dokument