Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
imatinib mesilate, Quantity: 119.5 mg (Equivalent: imatinib, Qty 100 mg)
Cipla Australia Pty Ltd
imatinib mesilate
Capsule
Excipient Ingredients: colloidal anhydrous silica; lactose; magnesium stearate; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate
Oral
48, 96, 120, 24, 180, 60
(S4) Prescription Only Medicine
IMATINIB GH 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) ? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
Visual Identification: Light yellow granules filled in size 3 hard gelatin capsule with brown cap and white 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
2016-12-22
Imatinib GH 1 IMATINIB GH 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 IMATINIB GH? Imatinib GH contains the active ingredient imatinib mesilate. Imatinib GH is used to treat adults who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL). Imatinib GH 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 Imatinib GH? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE IMATINIB GH? Do not use if you have ever had an allergic reaction to Imatinib GH 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 Imatinib GH? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Imatinib GH 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 IMATINIB GH? 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 Imatinib GH? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING IMATINIB GH? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist when you visit that you are using Imatinib GH. • You will ne Baca dokumen lengkap
AUSTRALIAN PRODUCT INFORMATION - IMATINIB GH (IMATINIB CAPSULES) 1 NAME OF THE MEDICINE Imatinib capsules 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 IMATINIB GH 100 MG CAPSULE : Light yellow granules filled in size 3 hard gelatin capsule with brown cap and white body. I MATINIB GH 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 IMATINIB GH 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 and/or metastatic dermatofibrosarcoma protuberans (DFSP). 4.2 Baca dokumen lengkap