Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
bosutinib (as monohydrate)
Pfizer Europe MA EEIG
L01XE14
bosutinib
Antineoplastic agents, Protein kinase inhibitors
Leukemia, Myeloid
Bosulif is indicated for the treatment of adult patients with:newly‑diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Revision: 24
Authorised
2013-03-27
47 B. PACKAGE LEAFLET 48 PACKAGE LEAFLET: INFORMATION FOR THE USER BOSULIF 100 MG FILM-COATED TABLETS BOSULIF 400 MG FILM-COATED TABLETS BOSULIF 500 MG FILM-COATED TABLETS bosutinib 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bosulif is and what it is used for 2. What you need to know before you take Bosulif 3. How to take Bosulif 4. Possible side effects 5. How to store Bosulif 6. Content of the pack and other information 1. WHAT BOSULIF IS AND WHAT IT IS USED FOR Bosulif contains the active substance bosutinib. It is used to treat adult patients who have a type of leukaemia called Philadelphia chromosome-positive (Ph-positive) Chronic Myeloid Leukaemia (CML) and are newly-diagnosed or for whom previous medicines to treat CML have either not worked or are not suitable. Ph-positive CML is a cancer of the blood which makes the body produce too many of a specific type of white blood cell called granulocytes. If you have any questions about how Bosulif works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE BOSULIF DO NOT TAKE BOSULIF - if you are allergic to bosutinib or any of the other ingredients of this medicine (listed in section 6). - if your doctor has told you that your liver has been damaged and is not working normally. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Bosulif: - IF YOU HAVE, OR HAVE HAD IN THE PAST, LIVER PROBLEMS. Tell your doctor if you have a history of liver problems including hepatitis Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bosulif 100 mg film-coated tablets Each film-coated tablet contains 100 mg bosutinib (as monohydrate). Bosulif 400 mg film-coated tablets Each film-coated tablet contains 400 mg bosutinib (as monohydrate). Bosulif 500 mg film-coated tablets Each film-coated tablet contains 500 mg bosutinib (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Bosulif 100 mg film-coated tablets Yellow oval (width: 5.6 mm; length: 10.7 mm) biconvex, film-coated tablet debossed with “Pfizer” on one side and “100” on the other side. Bosulif 400 mg film-coated tablets Orange oval (width: 8.8 mm; length: 16.9 mm) biconvex, film-coated tablet debossed with “Pfizer” on one side and “400” on the other side. Bosulif 500 mg film-coated tablets Red oval (width: 9.5 mm; length: 18.3 mm) biconvex, film-coated tablet debossed with “Pfizer” on one side and “500” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bosulif is indicated for the treatment of adult patients with: newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML. 3 Posology _Newly-diagnosed CP Ph+ CML_ The recommended dose is 400 mg bosutinib once daily. _CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy_ The recommended dose is 500 mg bosutinib once daily. In clinical trials for both indications, trea Прочетете целия документ