Imatinib-RZ imatinib (as mesilate) 50mg capsule blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

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

から入手可能:

Dr Reddys Laboratories Australia Pty Ltd

INN（国際名）:

imatinib mesilate

医薬品形態:

Capsule, hard

構図:

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

投与経路:

Oral

パッケージ内のユニット:

30

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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)

製品概要:

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

認証ステータス:

Licence status A

承認日:

2016-08-11