IMATINIB SANDOZ imatinib 400mg tablet divisible blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

imatinib, Quantity: 400 mg (Equivalent: imatinib mesilate, Qty 478 mg)

Διαθέσιμο από:

Sandoz Pty Ltd

INN (Διεθνής Όνομα):

imatinib mesilate

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; iron oxide red; macrogol 4000; iron oxide yellow

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30 Tablets, 28 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

IMATINIB SANDOZ 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 adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)

Περίληψη προϊόντος:

Visual Identification: Very dark yellow to brownish orange, ovaloid biconvex with bevelled edges. Debossed with "400" on one side and score on the other and "SL" on each side of the score.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2015-11-11