natgillin/translations-raw huggingface dataset:
The median duration of therapy in study B2225 was 6.2 months, with a maximum duration of 24.3 months.
71 studiul B2225 a fost 6, 2 luni, cu o durată maximă de 24, 3 luni.
Absorption Mean absolute bioavailability for imatinib is 98%.
Absorbţie Biodisponibilitatea absolută medie este de 98%.
The effect of prior gastrointestinal surgery on drug absorption has not been investigated.
Efectul unei intervenţii chirurgicale gastro- intestinale în antecedente asupra absorbţiei medicamentului nu a fost investigat.
69 Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/ 5.
In vitro, imatinibul s- a dovedit a fi un inhibitor competitiv al substraturilor marker pentru CYP2C9, CYP2D6 şi CYP3A4/ 5.
70 5.3 Preclinical safety data
5. 3 Date preclinice de siguranţă
Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
73 transaminazelor şi o uşoară scădere a concentraţiilor colesterolului, trigliceridelor, proteinelor totale şi albuminei la ambele specii.
71 In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/ kg/ day resulted in a statistically significant reduction in the longevity of males at 60 mg/ kg/ day and females at ≥ 30 mg/ kg/ day.
Într- un studiu de 2 ani privind carcinogenitatea la şobolani, administrarea imatinibului în doze de 15, 30 şi 60 mg/ kg şi zi a determinat o scădere semnificativă statistic a longevităţii masculilor la doze de 60 mg/ kg şi zi şi a femelelor la ≥ 30 mg/ kg şi zi.
Papilloma/ carcinoma of the preputial/ clitoral gland were noted from 30 mg/ kg/ day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/ day or 800 mg/ day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/ m2/ day.
74 Papilomul/ carcinomul glandei prepuţiale/ clitorale au fost observate începând de la doze de 30 mg/ kg şi zi, reprezentând aproximativ de 0, 5 sau 0, 3 ori expunerea zilnică umană (pe baza ASC) la 400 mg pe zi, respectiv 800 mg pe zi şi de 0, 4 ori expunerea zilnică la copii (pe baza ASC) la 340 mg/ m2 şi zi.
Iron oxide, red (E172) Iron oxide, yellow (E172) Macrogol Talc Hypromellose
Oxid roşu de fer (E172) Oxid galben de fer (E172) Macrogol Talc Hipromeloză
72 6.4 Special precautions for storage
6. 4 Precauţii speciale pentru păstrare
6.5 Nature and contents of container
75 6. 5 Natura şi conţinutul ambalajului
PVC/ alu blisters
Blistere din PVC/ aluminiu
11.11.2003 Date of first renewal:
11. 11. 2003 Data primei reînnoiri:
Very dark yellow to brownish-orange, ovaloid, biconvex film-coated tablet with bevelled edges, debossed with “ NVR” on one side and “ SL” on the other side.
Comprimat filmat de culoare galben foarte închis până la portocaliu- maroniu, oval, biconvex, cu margini rotunjite, inscripţionat prin debosare cu „ NVR ” pe o faţă şi cu „ SL ” pe cealaltă faţă.
74 4.2 Posology and method of administration
77 4. 2 Doze şi mod de administrare
Dose increases from 340 mg/ m2 daily to 570 mg/ m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemia- related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any 75 time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/ or cytogenetic response.
Pacienţii trebuie atent monitorizaţi după creşterea dozei având în
Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.
78 vedere potenţialul de creştere a incidenţei reacţiilor adverse la doze mai mari.
76 If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
79 întrerupt până când concentraţiile plasmatice ale bilirubinei revin la valori < 1, 5 x LSSVN şi concentraţiile plasmatice ale transaminazelor revin la valori < 2, 5 x LSSVN.