国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
imatinib mesilate, Quantity: 478 mg (Equivalent: imatinib, Qty 400 mg)
Cipla Australia Pty Ltd
imatinib mesilate
Capsule
Excipient Ingredients: magnesium stearate; lactose; colloidal anhydrous silica; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate
Oral
120, 96, 30, 180, 24, 48
(S4) Prescription Only Medicine
? treatment of patients with chronic myeloid leukaemia (CML) ? treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) ? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
Visual Identification: Light yellow granules filled in size 00EL hard gelatin capsules with brown cap and brown body.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-05-20
Cipla Imatinib Adult 1 CIPLA IMATINIB ADULT CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING CIPLA IMATINIB ADULT? Cipla Imatinib Adult contains the active ingredient imatinib mesilate. Cipla Imatinib Adult is used to treat adults who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL). Cipla Imatinib Adult is also used to treat adults for myelodysplastic/myeloproliferative diseases (MDS/MPD), aggressive systemic mastocytosis (ASM), hypereosinophilic syndrome (HES) and or chronic eosinophilic leukaemia (CEL) and for dermatofibrosarcoma protuberans (DFSP). For more information, see Section 1. Why am I using Cipla Imatinib Adult? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CIPLA IMATINIB ADULT? Do not use if you have ever had an allergic reaction to Cipla Imatinib Adult or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Cipla Imatinib Adult? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Cipla Imatinib Adult and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CIPLA IMATINIB ADULT? For CML, the usual dose for an adult is 400 to 600 mg each day. For Ph-positive ALL the usual dose is 600 mg each day. For MDS/MPD, the starting dose is 400 mg. For ASM and HES/CEL, the usual starting dose is 400 mg. For some patients, the starting dose may be 100 mg. For DFSP, the starting dose is 800 mg per day. More instructions can be found in Section 4. How do I use Cipla Imatinib Adult? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CIPLA IMATINIB ADULT? TH 完全なドキュメントを読む
AUSTRALIAN PRODUCT INFORMATION - CIPLA IMATINIB ADULT (IMATINIB CAPSULES) 1 NAME OF THE MEDICINE Australian approved name: imatinib mesilate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gelatin capsule contains 100 mg or 400 mg of imatinib (equivalent to 119.50 mg or 478 mg imatinib mesilate, respectively). Excipients with known effects Each 100 mg capsule contains 39.91 mg of lactose Each 400 mg capsule contains 159.64 mg of lactose For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Capsule CIPLA IMATINIB ADULT 100 MG CAPSULE : Light yellow granules filled in size 3 hard gelatin capsule with brown cap and white body. CIPLA IMATINIB ADULT 400 MG CAPSULE: Light yellow granules filled in size 00EL hard gelatin capsule with brown cap and brown body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CIPLA IMATINIB ADULT is indicated for the: • treatment of patients with chronic myeloid leukaemia (CML). • treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. • treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. • treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet‐derived growth factor receptor (PDGFR) gene re‐ arrangements, where conventional therapies have failed. • treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed. • treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). • treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) • adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST (see Dosage and Administration and Clinical Trials) • treatment of adult patients with unresectable, recurrent 完全なドキュメントを読む