Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Dasatinib
Zentiva k.s.
L01XE06
Dasatinib
Film-coated tablet
dasatinib
Not marketed
2022-11-04
PACKAGE LEAFLET: INFORMATION FOR THE USER MUBUCHO 16 MG FILM-COATED TABLETS MUBUCHO 40 MG FILM-COATED TABLETS MUBUCHO 55 MG FILM-COATED TABLETS MUBUCHO 63 MG FILM-COATED TABLETS MUBUCHO 79 MG FILM-COATED TABLETS MUBUCHO 111 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 Mubucho is and what it is used for 2. What you need to know before you take Mubucho 3. How to take Mubucho 4. Possible side effects 5. How to store Mubucho 6. Contents of the pack and other information 1. WHAT MUBUCHO IS AND WHAT IT IS USED FOR Mubucho contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children at least 1 year of age. 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. Mubucho inhibits the growth of these leukaemic cells. Mubucho is also used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents and children at least 1 year of age, 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. Mubucho inhibits the growth of these leukaemic cells. If you have any questions about how Mubucho works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUBU Lue koko asiakirja
Health⎯Products⎯Regulatory⎯Authority 06⎯January⎯2023 CRN00D6HT Page⎯1⎯of⎯29 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mubucho⎯40⎯mg⎯film-coated⎯tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each⎯film-coated⎯tablet⎯contains⎯39.5⎯mg⎯dasatinib⎯(anhydrous). Excipient⎯with⎯known⎯effect:⎯Each⎯film-coated⎯tablet⎯contains⎯53⎯mg⎯lactose⎯monohydrate. For⎯the⎯full⎯list⎯of⎯excipients,⎯see⎯section⎯6.1. 3 PHARMACEUTICAL FORM Film-coated⎯tablet. White⎯to⎯off-white,⎯round⎯film-coated⎯tablets⎯with⎯"39.5"⎯embossed⎯on⎯one⎯side⎯with⎯the diameter⎯of⎯7⎯mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mubucho ⎯is⎯indicated⎯for⎯the⎯treatment⎯of⎯paediatric⎯patients⎯with: Newly⎯diagnosed⎯Philadelphia⎯chromosome⎯positive⎯(Ph+)⎯chronic⎯myelogenous⎯leukaemia⎯(CML)⎯in⎯the⎯chronic⎯ phase⎯(CML-CP). Chronic,⎯accelerated⎯or⎯blast⎯phase⎯CML⎯with⎯resistance⎯or⎯intolerance⎯to⎯prior⎯therapy⎯including⎯imatinib. Ph+⎯acute⎯lymphoblastic⎯leukaemia⎯(ALL)⎯and⎯lymphoid⎯blast⎯CML⎯with⎯resistance⎯or intolerance⎯to⎯prior⎯therapy. Mubucho⎯is⎯indicated⎯for⎯the⎯treatment⎯of⎯paediatric⎯patients⎯with: Newly⎯diagnosed⎯Ph+⎯CML⎯in⎯chronic⎯phase⎯(Ph+⎯CML-CP)⎯or⎯Ph+⎯CML-CP⎯resistant⎯or intolerant⎯to⎯prior⎯therapy⎯ including⎯imatinib. Newly⎯diagnosed⎯Ph+⎯ALL⎯in⎯combination⎯with⎯chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy⎯should⎯be⎯initiated⎯by⎯a⎯physician⎯experienced⎯in⎯the⎯diagnosis⎯and⎯treatment⎯of⎯patients⎯with⎯leukaemia. MUBUCHO HAS A HIGHER BIOAVAILABILITY THAN OTHER DASATINIB-CONTAINING PRODUCTS AND CANNOT BE USED INTERCHANGEABLY WITH OTHER DASATINIB FORMULATIONS (SEE SECTION 4.4).⎯The dose⎯of⎯Mubucho⎯have⎯been⎯reduced⎯by 21%⎯compared⎯to⎯other⎯ dasatinib⎯produc Lue koko asiakirja