IMATINIB DR.REDDY'S imatinib (as mesilate) 100mg capsule blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

imatinib mesilate, Quantity: 119.47 mg (Equivalent: imatinib, Qty 100 mg)

Dostopno od:

Dr Reddys Laboratories Australia Pty Ltd

INN (mednarodno ime):

imatinib mesilate

Farmacevtska oblika:

Capsule, hard

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

60

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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)

Povzetek izdelek:

Visual Identification: orange to grayish-orange opaque Size '1' hard gelatin capsule imprinted with "RDY" on cap and "100" 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

Status dovoljenje:

Licence status A

Datum dovoljenje:

2016-08-11