Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
BOSUTINIB AS MONOHYDRATE
PFIZER PHARMACEUTICALS ISRAEL LTD
L01XE14
FILM COATED TABLETS
BOSUTINIB AS MONOHYDRATE 100 MG
PER OS
Required
PFIZER INC, USA
BOSUTINIB
Bosulif is indicated for the treatment of adult patients with:• newly diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (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.
2019-10-31
Bosulif 100 mg, 400 mg and 500 mg , PIL, CC 110623 2023-0083371 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only BOSULIF ® 100 MG BOSULIF ® 400 MG BOSULIF ® 500 MG FILM-COATED TABLETS EACH TABLET CONTAINS: BOSUTINIB (AS MONOHYDRATE) 100 MG, 400 MG OR 500 MG Inactive ingredients and allergens: see section 2 under 'Important information about some of this medicine's ingredients' and section 6 "Further information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is not intended for children and adolescents under 18 years old. 1. WHAT IS THIS MEDICINE INTENDED FOR? Bosulif is intended for the treatment of adult patients with: • newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). • chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (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. THERAPEUTIC GROUP: protein kinase enzyme inhibitors. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine(listed in section 6). • You were told by your doctor that your liver has been damaged and is not working normally. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH BOSULIF, TELL THE DOCTOR IF: • YOU HAVE, OR HAVE HAD IN THE PAST, LIVER PROBLEMS. Tell your doctor if you have a history of liver problems including hepati Przeczytaj cały dokument
Bosulif 100 mg, 400 mg and 500 mg, LPD, Israel, CC 110623 2023-0083371 1 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 biconvex, film-coated tablet debossed with “Pfizer” on one side and “100” on the other side. Bosulif 400 mg film-coated tablets Orange oval biconvex, film-coated tablet debossed with “Pfizer” on one side and “400” on the other side. Bosulif 500 mg film-coated tablets Red oval 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). • chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (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. Posology Bosulif 100 mg, 400 mg and 500 mg, LPD, Israel, CC 110623 2023-0083371 2 _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 r Przeczytaj cały dokument