Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
imatinib mesilate, Quantity: 59.735 mg (Equivalent: imatinib, Qty 50 mg)
Dr Reddys Laboratories Australia Pty Ltd
imatinib mesilate
Capsule, hard
Excipient Ingredients: sodium stearylfumarate; Gelatin; sodium lauryl sulfate; titanium dioxide; purified water; iron oxide yellow; crospovidone; propylene glycol; butan-1-ol; isopropyl alcohol; Shellac; iron oxide red; ethanol absolute; ammonia
Oral
30
(S4) Prescription Only Medicine
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 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). ? 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)
Visual Identification: light yellow to orange opaque Size '4' hard gelatin capsule imprinted with "RDY" on cap and "50" on body with red ink.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-08-11
IMATINIB-DRLA 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-DRLA? IMATINIB-DRLA contains the active ingredient imatinib. IMATINIB-DRLA is used to treat leukaemia and some other forms of cancer. For more information, see Section 1. Why am I using IMATINIB-DRLA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE IMATINIB-DRLA? 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 IMATINIB-DRLA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with IMATINIB-DRLA 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-DRLA? • Your doctor will advise on the appropriate dose for your condition. • IMATINIB-DRLA is usually taken as a single dose each day, although twice daily dosing may be recommended by your doctor • Take IMATINIB-DRLA with food and a large glass of water • Capsules should be taken whole. If you have trouble swallowing, capsules may be opened and poured into a glass of water or apple juice and swallowed. More instructions can be found in Section 4. How do I use IMATINIB-DRLA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING IMATINIB-DRLA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using IMATINIB-DRLA. • Follow your doctor’s instructions carefully and keep all appointments to ensure your treatment is working. • Make sure you use a method of contraception to prevent pregnancy during treatment and for 15 days after ending treatment. Advise your doctor if you become pregnant. • Wear Read the complete document
AUSTRALIAN PRODUCT INFORMATION – IMATINIB-DRLA (IMATINIB MESILATE) CAPSULES 1 NAME OF THE MEDICINE Imatinib (as mesilate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gelatine capsule contains 50mg, 100 mg or 400 mg of imatinib (equivalent to 59.7mg, 119.5 mg or 478 mg imatinib mesilate, respectively). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM IMATINIB-DRLA 50 mg capsules are off-white to brownish yellow colour granular powder filled in light yellow to orange yellow opaque Size ‘4’ Hard Gelatin capsule imprinted with ‘RDY’ on cap and ‘50’ on body with red ink. IMATINIB-DRLA 100 mg capsules are off-white to brownish yellow colour granular powder filled in orange to grayish-orange opaque Size ‘1’ Hard Gelatin capsule imprinted with ‘RDY’ on cap and ‘100’ on body with red ink. IMATINIB-DRLA 400 mg capsules are off-white to brownish yellow color granular powder filled in very dark yellow to brownish-orange opaque Size '00' Hard Gelatin capsule imprinted with 'RDY' on cap and '400' on body with red ink. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS IMATINIB-DRLA 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 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 gast Read the complete document