País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
imatinib mesilate, Quantity: 478 mg (Equivalent: imatinib, Qty 400 mg)
Pharmacor Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc
Oral
30
(S4) Prescription Only Medicine
Gilmat is indicated for the:,? treatment of patients with chronic myeloid leukaemia (CML) ? treatment of adult and paediatric 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 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).
Visual Identification: White to off-white coloured capsule shaped bevel edged scored film coated tablet debossed with H on one side and 20 on the other side, 2 and 0 separated by a score line.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2017-11-14
Gilmat® (V – 03) 1 GILMAT® imatinib mesilate 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 GILMAT? Gilmat contains the active ingredient imatinib mesilate. Gilmat is used to treat adults and children/adolescents who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL). Gilmat is also used to treat adults for: myelodysplastic /myeloproliferative diseases (MDS/MPD); Hypereosinophilic syndrome (HES) and or chronic eosinophilic leukaemia (CEL); gastro-intestinal stromal tumours (GIST); dermatofibrosarcoma protuberans (DFSP). For more information, see Section 1. Why am I using Gilmat? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GILMAT? Do not use if you have ever had an allergic reaction to imatinib 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 Gilmat? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Gilmat 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 GILMAT? Follow all directions given to you by your doctor and pharmacist carefully. More instructions can be found in Section 4. How do I use Gilmat? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GILMAT? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using Gilmat. - Make sure you follow your doctor's instructions carefully and keep all appointments. - Make sure you use a method of contraception to prevent pregnancy during treatment with Gilmat and for 15 days after ending treatment. - Tell your doctor immediately if you become pregnant while Llegiu el document complet
Gilmat (V – 03) Page 1 of 54 AUSTRALIAN PRODUCT INFORMATION GILMAT (IMATINIB) TABLETS 1 NAME OF THE MEDICINE Imatinib as the mesilate salt (alpha crystals). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg or 400 mg of imatinib (equivalent to 119.5 mg or 478 mg imatinib mesilate, respectively). Excipients with known effect: none For the full list of excipients, see Section 6.1 List of Excipients 3 PHARMACEUTICAL FORM Gilmat 100 mg film-coated tablet: contains 100 mg imatinib (as mesilate) in a white to off-white coloured, round, bevel edged scored tablets debossed with H on one side and 19 on the other side, 1 and 9 separated by a score line. Gilmat 400 mg film-coated tablet: contains 400 mg imatinib (as mesilate) in a white to off-white coloured, capsule shaped, bevel edged scored, film coated tablets debossed with H on one side and 20 on the other side, 2 and 0 separated by a score line. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gilmat is indicated for the: • treatment of patients with chronic myeloid leukaemia (CML) • treatment of adult and paediatric 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 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) Gilmat (V – 03) Page 2 of 54 • 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 pa Llegiu el document complet