País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
dasatinib, Quantity: 50 mg
Bristol-Myers Squibb Australia Pty Ltd
Dasatinib
Tablet, film coated
Excipient Ingredients: magnesium stearate; hyprolose; microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400
Oral
60 tablets
(S4) Prescription Only Medicine
SPRYCEL 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 leukameia with resistance or intolerance to prior therapy including imatinib. - newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukameia integrated with chemotherapy. - Philadelphia chromosome positive acute lymphoblastic leukamia with resistance or intolerance to prior therapy.,SPRYCEL 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, biconvex, oval tablet with "BMS" debossed on one side and "528" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2007-01-15
SPRYCEL ® (SPRY-SELL) _Dasatinib (duh-sat-in-ib)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SPRYCEL ® . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SPRYCEL against the benefits that are expected. This leaflet does not contain everything about SPRYCEL. Your doctor has been provided with full information and can answer any questions you may have. Follow your doctor's advice even if it differs from what is in this leaflet. PLEASE READ THIS LEAFLET CAREFULLY AND KEEP IT IN A SAFE PLACE SO YOU MAY REFER TO IT LATER. WHAT SPRYCEL IS USED FOR SPRYCEL is used to treat adults and children ages 12 months and older with chronic myeloid leukaemia (CML). It is also used to treat adults and children ages 12 months and older who have a particular form of acute lymphoblastic leukaemia (ALL) called Philadelphia chromosome positive or Ph+ ALL. Leukaemia is a cancer of immature white blood cells, which grow in the bone marrow. Under normal circumstances, as these white blood cells mature, they enter the blood stream where they fight infection and maintain the body's immune system. In leukaemia, these immature white blood cells multiply in an uncontrolled manner, occupying the bone marrow space and spilling out into the bloodstream. As a consequence, the production of normal red blood cells (oxygen carrying cells), white blood cells (cells which fight infection), and platelets (cells which help blood to clot) is compromised. Therefore patients with leukaemia are at risk of developing serious anaemia, infections and bleeding. It is intended that SPRYCEL be used in adults with: • Newly diagnosed Ph+ CML in the chronic phase who have not received any prior therapies, OR • Ph+ CML across all phases who are no longer benefiting from other therapies for these diseases (resistance) or in patients who experience severe side effects to other therapies (intolerance), Leia o documento completo
AU_PI_SPRYCEL_V20.0 1 AUSTRALIAN PRODUCT INFORMATION – SPRYCEL ® (DASATINIB) 1 NAME OF THE MEDICINE Dasatinib. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SPRYCEL film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib. Dasatinib is a white to off-white powder. SPRYCEL film-coated tablets contain lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM SPRYCEL film-coated tablets. The 20 mg tablets are white to off-white, biconvex, round tablets with “BMS” debossed on one side and “527” on the other side. The 50 mg tablets are oval shaped and debossed “BMS” on one side and “528” on the other side. The 70 mg tablets are white to off-white, biconvex, round tablets with “BMS” debossed on one side and “524” on the other side. The 100 mg tablets are oval shaped and debossed “BMS 100” on one side and “852” on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS SPRYCEL 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. SPRYCEL 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, SPRYCEL 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. AU_PI_SPRYCEL_V20.0 2 ADULT DOSAGE CML The recommended starting dosage of SPRYCEL for chronic phase CML Leia o documento completo