IMATIQUAL imatinib 100 mg film-coated tablets bottle pack

ประเทศ: ออสเตรเลีย

ภาษา: อังกฤษ

แหล่งที่มา: Department of Health (Therapeutic Goods Administration)

สารออกฤทธิ์:

imatinib mesilate, Quantity: 119.469 mg (Equivalent: imatinib, Qty 100 mg)

มีจำหน่ายจาก:

Teva Pharma Australia Pty Ltd

INN (ชื่อสากล):

imatinib mesilate

แบบฟอร์มเภสัชกรรม:

Tablet, film coated

องค์ประกอบ:

Excipient Ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol

เส้นทางการบริหาร:

Oral

หน่วยในแพ็คเกจ:

500 film-coated tablets, 100 film-coated tablets

ประเภทใบสั่งยา:

(S4) Prescription Only Medicine

ข้อบ่งชี้ในการรักษา:

1) IMATIQUAL (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (CML). 2) IMATIQUAL (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) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy. 4) IMATIQUAL (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) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed. 6) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). 7) IMATIQUAL (imatinib) is indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) 8) IMATIQUAL (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) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

สรุปสินค้า:

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

สถานะการอนุญาต:

Licence status A

วันที่อนุญาต:

2016-06-10