Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dasatinib
Bristol-Myers Squibb Pharmaceuticals Ltd
L01XE06
Dasatinib
20mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5012712003984
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SPRYCEL 20 MG FILM-COATED TABLETS SPRYCEL 50 MG FILM-COATED TABLETS SPRYCEL 70 MG FILM-COATED TABLETS SPRYCEL 80 MG FILM-COATED TABLETS SPRYCEL 100 MG FILM-COATED TABLETS SPRYCEL 140 MG FILM-COATED TABLETS dasatinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects , talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What SPRYCEL is and what it is used for 2. What you need to know before you take SPRYCEL 3. How to take SPRYCEL 4. Possible side effects 5. How to store SPRYCEL 6. Contents of the pack and other information 1. WHAT SPRYCEL IS AND WHAT IT IS USED FOR SPRYCEL contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukaemia (CML) in adults. Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. In people with CML, white cells called granulocytes start growing out of control. SPRYCEL inhibits the growth of these leukaemic cells. SPRYCEL is also used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL), and lymphoid blast CML in adults who are not benefiting from prior therapies. In people with ALL, white cells called lymphocytes multiply too quickly and live too long. SPRYCEL inhibits the growth of these leukaemic cells. If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPRYCEL DO NOT TAKE SPRYCEL if you are ALLERGIC to dasatinib or any of the other ingredients of this med Lestu allt skjalið
OBJECT 1 SPRYCEL 20MG FILM COATED TABLETS Summary of Product Characteristics Updated 14-Jun-2017 | Bristol-Myers Squibb Pharmaceuticals limited 1. Name of the medicinal product SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 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 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate). _Excipient with known effect _ Each film-coated tablet contains 108 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. SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate). _Excipient with known effect _ Each film-coated tablet contains 189 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet). 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, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side. SPRYCEL 70 mg film-coated tablets Whi Lestu allt skjalið