Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Dasatinib
KRKA, d.d., Novo mesto
L01XE06
Dasatinib
140 milligram(s)
Film-coated tablet
dasatinib
Not marketed
2020-04-03
PACKAGE LEAFLET: INFORMATION FOR THE USER DASATINIB KRKA 20 MG FILM-COATED TABLETS DASATINIB KRKA 50 MG FILM-COATED TABLETS DASATINIB KRKA 70 MG FILM-COATED TABLETS DASATINIB KRKA 80 MG FILM-COATED TABLETS DASATINIB KRKA 100 MG FILM-COATED TABLETS DASATINIB KRKA 140 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 Dasatinib Krka is and what it is used for 2. What you need to know before you take Dasatinib Krka 3. How to take Dasatinib Krka 4. Possible side effects 5. How to store Dasatinib Krka 6. Contents of the pack and other information 1. WHAT DASATINIB KRKA IS AND WHAT IT IS USED FOR Dasatinib Krka contains the active substance dasatinib. This medicine is used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents and children at least 1 year of age. In people with ALL, white cells called lymphocytes multiply too quickly and live too long. Dasatinib Krka inhibits the growth of these leukaemic cells. If you have any questions about how Dasatinib Krka works or why this medicine has been prescribed for you, ask your doctor. Dasatinib which is contained in Dasatinib Krka is also authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DASATINIB KRKA DO NOT TAKE DASATINIB KRKA - if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6). IF YOU COU Belgenin tamamını okuyun
Health Products Regulatory Authority 23 August 2023 CRN00DMCC Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dasatinib Krka 140 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 140 mg of dasatinib. Excipient(s) with known effect Each film-coated tablet contains 184 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). White to off-white, biconvex, round film-coated tablet with a diameter of approximately 11.7 mm, with "D7SB" debossed on one side and "140" on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dasatinib Krka is indicated for the treatment of adult patients with: -Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. Dasatinib Krka is indicated for the treatment of paediatric patients with: -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. Posology _Adult patients_ The recommended starting dose for Ph+ ALL is 140 mg once daily (see section 4.4). _Paediatric population _ Dosing for children and adolescents is on the basis of body weight (see Table 1). Dasatinib is administered orally once daily in the form of either dasatinib film-coated tablets or dasatinib powder for oral suspension. The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary. The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients. Dose increase or reduction is recommended based on individual patient response and tolerability. There is no experience with Dasatinib Krka treatment in children under 1 year of age. Dasatinib film-coated tablets and dasatinib powder for oral suspension are not bioequivalent. Patients who are able to swallow tablets and who de Belgenin tamamını okuyun