Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
dasatinib, Quantity: 50 mg
Teva Pharma Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; lactose monohydrate; hyprolose; titanium dioxide; hypromellose; triacetin
Oral
60
(S4) Prescription Only Medicine
Dasatinib is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,Dasatinib is indicated for the treatment of paediatric patients with: ? Ph+ CML in the chronic phase. ? newly diagnosed Ph+ ALL in combination with chemotherapy.
Visual Identification: White to off-white, oval film-coated tablets with bevelled,edges and debossed 50 on one side of the tablet.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-03-18
DASATINIB-TEVA V2.0 1 AUSTRALIAN PRODUCT INFORMATION – DASATINIB-TEVA (DASATINIB) 1 NAME OF THE MEDICINE Dasatinib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DASATINIB-TEVA film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib. Dasatinib is a white to off-white powder. DASATINIB-TEVA film-coated tablets contain lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM DASATINIB-TEVA film-coated tablets. The 20 mg tablets are white to off white, round film-coated tablets with bevelled edges and debossed “20” on one side of the tablet. The 50 mg tablets are white to off white, oval film-coated tablets with bevelled edges and debossed ˝50˝ on one side of the tablet. The 70 mg tablets are white to off white, round film-coated tablets with bevelled edges and debossed ˝70˝ on one side of the tablet. The 100 mg tablets are white to off white, oval film-coated tablets with bevelled edges and debossed ˝100˝ on one side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DASATINIB-TEVA is indicated for the treatment of adults aged 18 years or over with: • newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase. • chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. • newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. • Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy. DASATINIB-TEVA is indicated for the treatment of paediatric patients with: • Ph+ CML in the chronic phase. • newly diagnosed Ph+ ALL in combination with chemotherapy. 4.2 D OSE AND METHOD OF ADMINISTRATION To achieve the recommended dose, DASATINIB-TEVA is available as 20 mg, 50 mg, 70 mg and 100 mg film-coated tablets. Dose increase or reduction is recommended based on patient response and tolerability Läs hela dokumentet