Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
imatinib mesilate, Quantity: 119.469 mg (Equivalent: imatinib, Qty 100 mg)
Teva Pharma Australia Pty Ltd
imatinib mesilate
Tablet, film coated
Excipient Ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol
Oral
500 film-coated tablets, 100 film-coated tablets
(S4) Prescription Only Medicine
1) IMATINIB-TEVA (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (CML). 2) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. 3) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy. 4) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements, where conventional therapies have failed. 5) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed. 6) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). 7) IMATINIB-TEVA (imatinib) is indicated for the Treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) 8) IMATINIB-TEVA (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST. 9) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
Visual Identification: Imatinib tablets 100 mg are dark yellow to brownish orange round film coated tablets debossed with IT and 1 divided by score line on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-06-10
Imatinib-Teva ® CMI Version 1.0 1 IMATINIB-TEVA ® _FILM-COATED TABLETS _ _contains the active ingredient imatinib (as mesilate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about imatinib. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.TEVA.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide. If you have any concerns about this medicine, ask your doctor or pharmacist. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IMATINIB IS USED FOR Imatinib 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). CML and ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells. Imatinib kills the abnormal cells while leaving normal cells alone. Imatinib is also used to treat adults for: MYELODYSPLASTIC / MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. 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. DERMATOFIBROSARCOMA PROTUBERANS (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of c Perskaitykite visą dokumentą
Teva Pharma Australia Pty Limited Version 7 1 AUSTRALIAN PI – IMATINIB-TEVA ® (IMATINIB (AS MESILATE)) FILM COATED TABLETS 1 NAME OF THE MEDICINE The active ingredient is Imatinib (as mesilate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION IMATINIB-TEVA tablets contain either 100 mg or 400 mg of imatinib (as mesilate) as the active ingredient. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM IMATINIB-TEVA 100 mg film-coated tablet: contains 100mg of imatinib equivalent to 119.5mg imatinib (as mesilate) in a dark yellow to brownish orange round film coated tablet debossed with IT and 1 divided by score line on one side. IMATINIB-TEVA 400 mg film-coated tablet: contains 400mg of imatinib equivalent to 477.9mg imatinib (as mesilate) in a dark yellow to brownish orange oblong film coated tablet debossed with IT and 4 divided by score line on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Imatinib-Teva 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 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 Ad Perskaitykite visą dokumentą