국가: 이스라엘
언어: 영어
출처: Ministry of Health
DASATINIB
BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL
L01XE06
FILM COATED TABLETS
DASATINIB 100 MG
PER OS
Required
BRISTOL MYERS SQUIBB COMPANY, USA
DASATINIB
DASATINIB
Treatment of adult patients with : * Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. * Chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate. * Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
2015-06-30
Sprycel-20,50,70,100 mg-tablets_PL_MoH_Dec2021 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only SPRYCEL 20 mg Film-coated tablets SPRYCEL 50 mg Film-coated tablets SPRYCEL 70 mg Film-coated tablets SPRYCEL 100 mg Film-coated tablets The active ingredient and its quantity: Each film-coated tablet contains: dasatinib 20 mg, dasatinib 50 mg, dasatinib 70 mg, dasatinib 100 mg For the list of inactive ingredients, please see section 6 and 'Important information about some of this medicine’s ingredients ' in section 2. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. SPRYCEL is not intended for use in children and adolescents under 18 years of age. There is limited experience with use of SPRYCEL in this age group. 1. WHAT IS THE MEDICINE INTENDED FOR? SPRYCEL is a medicine intended for the treatment of adults: Newly diagnosed patients suffering from Philadelphia chromosome-positive chronic myeloid leukemia (CML), at the chronic phase. Patients with chronic myeloid leukemia (CML) at the chronic, accelerated or blast phase with resistance or intolerance to prior treatment, including prior treatment with imatinib mesilate. Patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) and patients with lymphoid blast-phase chronic myeloid leukemia (CML) with resistance or intolerance to prior treatment. Therapeutic group: protein kinase inhibitors. Sprycel-20,50,70,100 mg-tablets_PL_MoH_Dec2021 2. BEFORE USING THE MEDICINE Do not use the medicine if: You are sensitive (allergic) to the active ingredient (dasatinib) or to any of the other ingredients of the medicine (see section 전체 문서 읽기
1 1. NAME OF THE MEDICINAL PRODUCT SPRYCEL 20 mg , 50 mg, 70 mg,100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg , 50 mg, 70 mg, 100 mg dasatinib (as monohydrate). Excipients with known effect Each Sprycel 20mg film-coated tablet contains 27 .0 mg of lactose monohydrate. Each Sprycel 50mg film-coated tablet contains 67.5 mg of lactose monohydrate. Each Sprycel 70mg film-coated tablet contains 94.5 mg of lactose monohydrate. Each Sprycel 100mg film-coated tablet contains 135.0 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 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, biconvex, oval film-coated tablet with “BMS 100” debossed on one side and “852” on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPRYCEL is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. Posology The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily. The recommended starting dose f 전체 문서 읽기