Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Dasatinib 50mg;
Bristol-Myers Squibb (NZ) Limited
Dasatinib 50 mg
50 mg
Film coated tablet
Active: Dasatinib 50mg Excipient: Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white YS-1-18177-A
Blister pack, Al/Al, 60 tablets
Prescription
Prescription
Siegfried Evionnaz SA
· SPRYCEL® (dasatinib) is indicated for the treatment of adults aged 18 years or over with newly diagnosed chronic myeloid leukaemia (CML). · SPRYCEL® (dasatinib) is indicated for the treatment of adults aged 18 years or over with chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. · SPRYCEL® (dasatinib) is indicated for the treatment of paediatric patients with Philadelphia chromosome positive chronic myeloid leukaemia (CML) in the chronic phase
Package - Contents - Shelf Life: Blister pack, Al/Al - 60 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 60 tablets - 36 months from date of manufacture stored at or below 30°C
2006-05-18
SPRYCEL ® 1 SPRYCEL ® (SPRY-SELL) _Dasatinib (duh-sat-in-ib) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SPRYCEL P ® P . 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 or Ph+ ALL who are no longer benefiting from other therapies for these diseases (resistance) or in patients who experience severe side effects to other therapies (int Les hele dokumentet
Sprycel v 22.0 1 DATA SHEET 1 PRODUCT NAME SPRYCEL® 20 mg film-coated tablets SPRYCEL® 50 mg film-coated tablets SPRYCEL® 70 mg film-coated tablets SPRYCEL® 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 27 mg of lactose monohydrate. SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 67.5 mg of lactose monohydrate. SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 94.5 mg of lactose monohydrate. SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 135.0 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM SPRYCEL 20 mg film-coated tablets White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side. SPRYCEL 50 mg film-coated tablets White to off-white, oval shaped film-coated tablet with "BMS" debossed on one side and "528" on the other side. SPRYCEL 70 mg film-coated tablets White to off-white, biconvex, round, film-coated tablet with "BMS" debossed on one side and "524" on the other side. SPRYCEL 100 mg film-coated tablets White to off-white, oval shaped film-coated tablet with "BMS 100" debossed on one side and "852" on the other side. Sprycel v 22.0 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPRYCEL is indicated for the treatment of adults aged 18 years or over with: • newly diagnosed chronic myeloid leukaemia (CML). • chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. • Philadelphia c Les hele dokumentet