Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
DASATINIB
TARO INTERNATIONAL LTD, ISRAEL
L01XE06
FILM COATED TABLETS
DASATINIB 140 MG
PER OS
Required
SYNTHON HISPANIA S.L., SPAIN
DASATINIB
Dasatinib Taro 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.
2021-10-18
Page 1 of 7 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only DASATINIB TARO 20 MG DASATINIB TARO 50 MG DASATINIB TARO 70 MG DASATINIB TARO 80 MG DASATINIB TARO 100 MG DASATINIB TARO 140 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 80 mg, dasatinib 100 mg, dasatinib 140 mg Inactive ingredients and allergens: see section 2 under 'Important information about some of this medicine's ingredients' and section 6 'Further information'. 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. Dasatinib Taro is not intended for use in children and adolescents under 18 years of age. There is limited experience with use of Dasatinib Taro in this age group. 1. WHAT IS THE MEDICINE INTENDED FOR? Dasatinib Taro is intended for the treatment of adults: • Newly diagnosed patients suffering from Philadelphia chromosome-positive chronic myeloid leukaemia (CML), at the chronic phase. • Patients with chronic myeloid leukaemia (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 leukaemia (ALL) and patients with lymphoid blast-phase chronic myeloid leukaemia (CML) with resistance or intolerance to prior treatment. THERAPEUTIC GROUP: protein kinase inhibitors 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 the medicine contains, which are listed in Lue koko asiakirja
Page 1 of 34 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DASATINIB TARO 20 mg , 50 mg, 70 mg, 80 mg, 100 mg, 140 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg dasatinib (as monohydrate). Excipients with known effect Each DASATINIB TARO 20 mg contains 27.67 mg of lactose monohydrate. Each DASATINIB TARO 50 mg contains 69.18 mg of lactose monohydrate. Each DASATINIB TARO 70 mg contains 96.85 mg of lactose monohydrate. Each DASATINIB TARO 80 mg contains 110.69 mg of lactose monohydrate. Each DASATINIB TARO 100 mg contains 138.36 mg of lactose monohydrate. Each DASATINIB TARO 140 mg contains 193.7 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). DASATINIB TARO 20 mg: white to off-white, biconvex, round film-coated tablet with a diameter of approximately 6 mm, with "D7SB" debossed on one side and "20" on the other side. DASATINIB TARO 50 mg: white to off-white, biconvex, oval film-coated tablet with a length of approximately 11.0 mm and a width of approximately 6.0 mm, with "D7SB" debossed on one side and "50" on the other side. DASATINIB TARO 70 mg: white to off-white, biconvex, round film-coated tablet with a diameter of approximately 9 mm, with "D7SB" debossed on one side a "70" on the other side. DASATINIB TARO 80 mg: white to off-white, biconvex, triangular film-coated tablet with a length of approximately 10 mm and a width of approximately 11 mm, with "D7SB" debossed one side and "80" on the other side. DASATINIB TARO 100 mg: white to off-white, biconvex, oval film-coated tablet with a length of approximately 15 mm and a width of approximately 7 mm, with "D7SB" debossed on one side and "100" on the other side. DASATINIB TARO 140 mg: white to off-white, biconvex, round film-coated tablet with a diameter of approximately 12 mm, with "D7SB" debossed on one side and "140" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDI Lue koko asiakirja