IMATINIB DR.REDDY'S imatinib (as mesilate) 50mg capsule blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

imatinib mesilate, Quantity: 59.735 mg (Equivalent: imatinib, Qty 50 mg)

제공처:

Dr Reddys Laboratories Australia Pty Ltd

INN (국제 이름):

imatinib mesilate

약제 형태:

Capsule, hard

구성:

Excipient Ingredients: purified water; titanium dioxide; sodium lauryl sulfate; iron oxide yellow; sodium stearylfumarate; Gelatin; crospovidone; propylene glycol; butan-1-ol; isopropyl alcohol; Shellac; iron oxide red; ethanol absolute; ammonia

관리 경로:

Oral

패키지 단위:

30

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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)

제품 요약:

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

승인 상태:

Licence status A

승인 날짜:

2016-08-11