FrancophonIA/ELRC3.0 huggingface dataset:
English: These patients were either newly diagnosed, with CP CML or were resistant or intolerant to prior therapy with chronic, accelerated, or blast phase CML or Ph+ acute lymphoblastic leukaemia (ALL).
Slovenian: Tem bolnikom so bodisi na novo odkrili KML v kronični fazi bodisi so bili neodzivni ali niso prenašali predhodnega zdravljenja KML v kronični, pospešeni ali blastni fazi ali Ph+ akutne limfoblastne levkemije (ALL).
English: Of the 297 (23%) patients with reports of adverse reactions of anaemia, 3 patients discontinued bosutinib due to anaemia.
Slovenian: Od 297 (23 %) bolnikov, pri katerih so poročali o neželenem učinku anemiji, so 3 prekinili z jemanjem bosutiniba zaradi anemije.
English: In the Phase 1/2 clinical study in patients with CML who were resistant or intolerant to prior therapy who started treatment at ≤ 500 mg, 93 (93/558; 16.7%) patients had dose escalations to 600 mg daily.
Slovenian: faze pri bolnikih s KML, ki so bili neodzivni ali niso prenašali predhodnega zdravljenja in so zdravljenje začeli z odmerkom ≤ 500 mg, so pri 93 bolnikih (93/558; 16,7 %) odmerek povečali na 600 mg na dan.
English: Based on non-clinical findings, bosutinib has the potential to impair reproductive function and fertility in humans (see section 5.3).
Slovenian: Predklinični izsledki kažejo, da lahko bosutinib pri ljudeh zmanjša sposobnost razmnoževanja in plodnost (glejte poglavje 5.3.).
English: If cytopoenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment.
Slovenian: Če se ponovno pojavi citopenija, je po izboljšanju treba odmerek dodatno zmanjšati za 100 mg in nadaljevati z zdravljenjem.
English: Dose adjustments
Slovenian: Prilagajanje odmerka
English: In the Phase 3 clinical study in patients with newly-diagnosed CP CML treated with bosutinib 400 mg, there were no patients in the bosutinib treatment group with an increase of > 60 ms from baseline when the QT interval was corrected using Fridericia's formula (QTcF).
Slovenian: V klinični študiji 3. faze pri bolnikih z novo odkrito KML v kronični fazi, ki so se zdravili z bosutinibom 400 mg, v skupini, ki se je zdravila z bosutinibom, ni bilo nobenega bolnika s podaljšanjem > 60 ms v primerjavi z izhodiščem, potem ko so opravili korekcijo intervala QT s Fridericijevo formulo (QTcF).
English: Dose adjustments for adverse reactions
Slovenian: Prilagajanje odmerka zaradi neželenih učinkov
English: In the Phase 1/2 clinical study in patients with CML who were resistant or intolerant to prior therapy, dose escalations from 500 mg to 600 mg once daily with food were allowed in patients who failed to demonstrate complete haematological response (CHR) by Week 8 or complete cytogenetic response (CCyR) by Week 12 and did not have Grade 3 or higher adverse events possibly-related to the investigational product.
Slovenian: faze pri bolnikih s KML, ki so bili neodzivni ali niso prenašali predhodnega zdravljenja, so dovolili povečanje odmerka s 500 mg na 600 mg enkrat na dan s hrano, in sicer pri bolnikih, ki niso dosegli popolnega hematološkega odziva (CHR - Complete Hematologic Response) do 8. tedna ali popolnega citogenetskega odziva (CCyR - Complete Cytogenetic Response) do 12. tedna in niso imeli neželenih učinkov stopnje 3 ali več, ki bi lahko bili povezani s preskušanim zdravilom.
English: The recommended dose is 500 mg once daily for patients whose previous medicines to treat CML have either not worked or are not suitable.
Slovenian: Za bolnike z novo odkrito KML je priporočeni odmerek 400 mg enkrat na dan. Za bolnike, pri katerih predhodna zdravila za zdravljenje KML niso učinkovala ali niso primerna, je priporočeni odmerek 500 mg enkrat na dan.
English: Sprague-Dawley rats, radioactivity was readily excreted into breast milk as early as 0.5 hr after dosing.
Slovenian: C] radioaktivno označenega bosutiniba pri doječih podganah Sprague-Dawley se je radioaktivnost izločila v živalsko mleko že v 0,5 ure po odmerku.
English: A study of [14C] radiolabelled bosutinib in rats demonstrated excretion of bosutinib-derived radioactivity in breast milk (see section 5.3).
Slovenian: radioaktivno označenim bosutinibom je pokazala izločanje radioaktivno označenega bosutiniba v živalsko mleko (glejte poglavje 5.3).
English: In an oral study of bosutinib in dogs, bosutinib did not produce changes in blood pressure, abnormal atrial or ventricular arrhythmias, or prolongation of the PR, QRS, or QTc of the ECG at exposures up to 3-times the human exposure resulting from the clinical dose of 400 mg and 2-times the human exposure resulting from the clinical dose of 500 mg (based on unbound Cmax in the respective species).
Slovenian: V študiji peroralne uporabe bosutiniba na psih bosutinib ni povzročil sprememb v krvnem tlaku, nenormalnih atrijskih ali ventrikularnih aritmij ali podaljšanj intervalov PR, QRS ali QTc na EKG, in sicer pri do 3-kratniku izpostavljenosti pri človeku, ki je posledica kliničnega odmerka 400 mg, in 2-kratniku izpostavljenosti pri človeku, ki je posledica kliničnega odmerka 500 mg (na podlagi nevezane Cmax pri posamezni vrsti).
English: The concomitant use of bosutinib with strong CYP3A inducers (including, but not limited to carbamazepine, phenytoin, rifampicin, St. John's Wort), or moderate CYP3A inducers (including, but not limited to bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided, as a decrease in bosutinib plasma concentration will occur.
Slovenian: Sočasni uporabi bosutiniba skupaj z močnimi induktorji CYP3A (kot so med drugim karbamazepin, fenitoin, rifampicin, šentjanževka) ali zmernimi induktorji CYP3A (kot so med drugim bosentan, efavirenz, etravirin, modafinil, nafcilin) se je treba izogibati, ker zmanjšajo plazemsko koncentracijo bosutiniba.
English: Tell your doctor if you develop abdominal pain or discomfort.
Slovenian: Obvestite zdravnika, če se vam pojavi bolečina ali nelagodje v trebuhu.
English: a p-value based on CMH test stratified by geographical region and Sokal score at randomisation.
Slovenian: vrednost p temelji na testu CMH, stratificiranem po geografski regiji in oceni po Sokalu ob randomizaciji.
English: Following administration of a single oral dose of bosutinib 500 mg (therapeutic dose) and bosutinib 500 mg with ketoconazole 400 mg (to achieve supratherapeutic concentrations of bosutinib) in healthy subjects, the upper bound of the 1-sided 95% confidence interval (CI) around the mean change in QTc was less than 10 ms at all post-dose time points, and no adverse events suggestive of QTc prolongation were observed.
Slovenian: Po uporabi enkratnega peroralnega 500 mg odmerka bosutiniba (terapevtski odmerek) ter 500 mg bosutiniba skupaj s 400 mg ketokonazola (za dosego supraterapevtskih koncentracij bosutiniba) pri zdravih preskušancih je bila zgornja meja enostranskega 95 % intervala zaupanja (IZ) okoli povprečne spremembe QTc manj kot 10 ms pri vseh časovnih točkah po odmerku; poleg tega niso opazili neželenih učinkov, ki bi kazali na podaljšanje QTc.
English: Based on the limited clinical information from the Phase 1/2 study, some evidence of clinical activity was observed in patients with BCR-ABL mutations (see Table 6).
Slovenian: faze so določene znake klinične aktivnosti opazili pri bolnikih z mutacijami BCR-ABL (glejte preglednico 6).
English: Baseline characteristics for the mITT population were well balanced between the 2 treatment groups with respect to age (median age was 52 years for the bosutinib group and 53 years for the imatinib group with 19.5% and 17.4% of patients 65 years of age or older, respectively); gender (women 42.3% and 44.0%, respectively); and race (Caucasian 77.6% and 77.2%, Asian 12.2% and
Slovenian: Izhodiščne značilnosti populacije mITT so bile med 2 skupinama zdravljenja dobro uravnotežene glede starosti (mediana starost je bila 52 let v skupini z bosutinibom in 53 let v skupini z imatinibom, pri čemer je bilo 19,5 % oziroma 17,4 % bolnikov starih 65 let ali več), spola (ženske 42,3 % oziroma 44,0 %) in rase (belci 77,6 % oziroma 77,2 %, azijsko poreklo 12,2 % oziroma 12,4 %, črnci ali Afroameričani 4,1 % oziroma 4,1 % in drugi 5,7 % oziroma 5,8 % ter po 1 neznane rase v vsaki skupini).
English: In a renal impairment study, bosutinib exposures were increased in subjects with moderately and severely impaired renal function.
Slovenian: V študiji okvare ledvic se je pri preskušancih z zmerno in hudo okvaro delovanja ledvic povečevala izpostavljenost bosutinibu.
English: The concomitant use of bosutinib with strong or moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma concentration will occur (see section 4.5).
Slovenian: Sočasni uporabi bosutiniba z močnimi ali zmernimi zaviralci CYP3A se je treba izogibati, ker povečajo plazemsko koncentracijo bosutiniba (glejte poglavje 4.5).
English: The concomitant use of bosutinib with strong or moderate CYP3A inducers should be avoided as a decrease in bosutinib plasma concentration will occur (see section 4.5).
Slovenian: Sočasni uporabi bosutiniba z močnimi ali zmernimi induktorji CYP3A se je treba izogibati, ker zmanjšajo plazemsko koncentracijo bosutiniba (glejte poglavje 4.5).
English: The efficacy results for AP (minimum follow-up 48 months, median treatment duration of 10 months and 17.7% still on-treatment at 48 months) and BP (minimum follow-up 48 months, median treatment duration of 2.8 months and 3.1% still on-treatment at 48 months) Ph+ CML patients are present in Table 5.
Slovenian: Rezultati o učinkovitosti pri bolnikih s Ph+ KML v pospešeni fazi (minimalno obdobje spremljanja 48 mesecev, mediano trajanje zdravljenja 10 mesecev in 17,7 % po 48 mesecih še vedno na zdravljenju) ter pri bolnikih s Ph+ KML v blastni fazi (minimalno obdobje spremljanja 48 mesecev, mediano trajanje zdravljenja 2,8 meseca in 3,1 % po 48 mesecih še vedno na zdravljenju) so predstavljeni v preglednici 5.
English: The maximum toxicity of thrombocytopenia of Grade 3 was experienced in 161 (36%) patients and Grade 4 in 98 (22%) patients.
Slovenian: Do trombocitopenije največje stopnje 3 je prišlo pri 161 (36 %) bolnikih, do stopnje 4 pa pri 98 (22 %) bolnikih.
English: - a marked decrease in the number of granulocytes (a type of white blood cells).
Slovenian: pogosti levkopenija (vključno z zmanjšanjem števila belih krvnih celic)
English: The following adverse reactions were reported in patients in bosutinib clinical studies (Table 2).
Slovenian: V kliničnih študijah z bosutinibom so pri bolnikih poročali o naslednjih neželenih učinkih (preglednica 2).
English: Tell your doctor if you develop any of the following signs and symptoms such as fever, problems with urine such as burning on urination, a new cough, or a new sore throat.
Slovenian: Obvestite zdravnika, če se vam pojavijo naslednji znaki ali simptomi: vročina, težave z uriniranjem, kot je pekoč občutek med uriniranjem, kašelj ali vneto grlo, ki se pojavita na novo.
English: Note: MMR was defined as ≤ 0.1% BCR-ABL/ABL ratio by international scale (corresponding to ≥ 3 log reduction from standardised baseline) with a minimum of 3,000 ABL transcripts assessed by the central laboratory.
Slovenian: Opomba: MMR so opredelili kot razmerje BCR-ABL/ABL ≤ 0,1 % po mednarodni lestvici (kar ustreza zmanjšanju za ≥ 3 log v primerjavi s standardiziranim izhodiščem) z najmanj 3.000 prepisi ABL po oceni osrednjega laboratorija.
English: Liver function abnormalities
Slovenian: Nenormalno delovanje jeter
English: Breast-feeding should be discontinued during treatment with bosutinib.
Slovenian: Med zdravljenjem z bosutinibom je treba prenehati z dojenjem.
English: An in vitro study indicates that drug-drug interactions are unlikely to occur at therapeutic doses as a result of induction by bosutinib on the metabolism of medicinal products that are substrates for CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4.
Slovenian: Študija in vitro je pokazala, da je pri terapevtskih odmerkih majhna verjetnost za medsebojno delovanje z drugimi zdravili, ki bi se pojavilo zaradi z bosutinibom povzročene indukcije metabolizma zdravil, ki so substrati CYP1A2, CYP2B6, CYP2C9, CYP2C19 in CYP3A4.
English: Patients should be tested for HBV infection before initiating treatment with bosutinib.
Slovenian: Pred začetkom zdravljenja z bosutinibom je bolnike treba testirati glede okužbe s HBV.
English: In an intravenous study in dogs, transient increases in heart rate and decreases in blood pressure and minimal prolongation of the QTc (< 10 msec) were observed at exposures ranging from approximately 6-times to 20-times the human exposure resulting from the clinical dose of 400 mg and 4-times to 15-times the human exposure resulting from the clinical dose of 500 mg (based on unbound Cmax in the respective species).
Slovenian: V študiji intravenskega odmerjanja na psih so opazili prehodno pospešeno bitje srca in znižanje krvnega tlaka ter minimalno podaljšanje QTc (< 10 ms), in sicer pri približno 6-kratniku do 20-kratniku izpostavljenosti pri človeku, ki je posledica kliničnega odmerka 400 mg, in 4-kratniku do 15-kratniku izpostavljenosti pri človeku, ki je posledica kliničnega odmerka 500 mg (na podlagi nevezane Cmax pri posamezni vrsti).
English: In a study of the central nervous system (CNS), bosutinib treated rats displayed decreased pupil size and impaired gait.
Slovenian: V študiji osrednjega živčnega sistema (OŽS) so pri podganah, ki so prejemale bosutinib, opazili zmanjšano velikost zenic in motnje hoje.
English: There were 570 patients treated with bosutinib in this trial including CP CML patients previously treated with only 1 prior TKI (imatinib), CP CML patients previously treated with imatinib and at least 1 additional TKI (dasatinib and/or nilotinib), CML patients in accelerated or blast phase previously treated with at least 1 TKI (imatinib) and patients with Ph+ ALL previously treated with at least 1 TKI (imatinib).
Slovenian: V preskušanju je 570 bolnikov prejemalo bosutinib; v to število so bili vključeni bolniki s KML v kronični fazi, ki so bili predhodno zdravljeni z 1 TKI (imatinib), bolniki s KML v kronični fazi, ki so bili predhodno zdravljeni z imatinibom in vsaj še 1 dodatnim TKI (dasatinib in/ali nilotinib), bolniki s KML v pospešeni ali blastni fazi, ki so bili predhodno zdravljeni z 1 TKI (imatinib) in bolniki s Ph+ ALL, ki so bili predhodno zdravljeni z vsaj 1 TKI (imatinib).
English: For patients previously treated with both imatinib and at least 1 additional TKI, the endpoints include the cumulative MCyR rate, time to and duration of MCyR, and time to and duration of CHR. For patients with AP and BP CML previously treated with at least 1 prior TKI (imatinib), the endpoints were cumulative overall haematological response (OHR) and time to and duration of OHR.
Slovenian: Za bolnike, ki so bili predhodno zdravljeni z imatinibom in vsaj še 1 dodatnim TKI, so opazovani dogodki vključevali kumulativno stopnjo MCyR, čas do nastopa in trajanje MCyR ter čas do nastopa in trajanje CHR. Za bolnike s KML v pospešeni ali blastni fazi, ki so bili predhodno zdravljeni z vsaj 1 TKI (imatinib), so opazovani dogodki vključevali kumulativni celokupni hematološki odziv (OHR - Overall Haematologic Response) ter čas do nastopa in trajanje OHR.
English: Abbreviations: AP=accelerated phase; BP=blast phase; Ph+=Philadelphia chromosome-positive; CP=chronic phase; CML=chronic myelogenous leukaemia; K-M=Kaplan-Meier; N/n=number of patients; N/A=not applicable; N/R=not reached as of minimum follow-up; N/E=not estimable; CI=confidence interval; MCyR=major cytogenetic response; CCyR=complete cytogenetic response; OHR=overall haematological response; CHR=complete haematological response.
Slovenian: Okrajšave: Ph+ = prisotnost kromosoma Philadelphia, KML = kronična mieloična levkemija, K-M = KaplanMeier, n = število bolnikov, N/A = navedba smiselno ni potrebna (not applicable), N/R = ni bilo doseženo po najkrajšem obdobju spremljanja (not reached), N/E = ni mogoče oceniti (not estimable), IZ = interval zaupanja, MCyR = pomembni citogenetski odziv, CCyR = popolni citogenetski odziv, OHR = celokupni hematološki odziv, CHR = popolni hematološki odziv.
English: MMR was defined as ≤ 0.1% BCR-ABL/ABL ratio by international scale (corresponding to ≥ 3 log reduction from standardised baseline) with a minimum of 3,000 ABL transcripts as assessed by the central laboratory.
Slovenian: MMR so opredelili kot razmerje BCR-ABL/ABL ≤ 0,1 % po mednarodni lestvici (kar ustreza zmanjšanju za ≥ 3 log v primerjavi s standardiziranim izhodiščem) z najmanj 3.000 prepisi ABL po oceni osrednjega laboratorija.
English: Years 2 (Month 24) and 5 (60 months) for CP treated with imatinib only and Years 1 (Month 12) and 4 (48 months) for CP treated with imatinib and at least 1 other TKI, AP, and BP.
Slovenian: Po 2 letih (24 mesecih) in 5 letih (60 mesecih) pri kronični fazi, zdravljeni samo z imatinibom, in po 1 letu (12 mesecih) in 4 letih (48 mesecih) pri kronični fazi, zdravljeni z imatinibom in vsaj še 1 drugim TKI, pri pospešeni fazi in blastni fazi.
English: Minimum follow-up time (time from last patient first dose to data snapshot date) of 60 months for CP treated with imatinib only and, 48 months for CP treated with imatinib and at least 1 other TKI, AP and BP.
Slovenian: Najkrajše obdobje spremljanja (čas od uporabe prvega odmerka pri zadnjem bolniku do datuma zajema podatkov) je znašalo 60 mesecev pri kronični fazi, zdravljeni samo z imatinibom, ter 48 mesecev pri kronični fazi, zdravljeni z imatinibom in vsaj še 1 drugim TKI, pri pospešeni fazi in pri blastni fazi.
English: • CP, accelerated phase (AP), and blast phase (BP) 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.
Slovenian: • s Ph+ KML v kronični fazi, pospešeni fazi in blastni fazi, ki so bili predhodno zdravljeni z enim ali več zaviralci tirozin-kinaze (TKI(s) - Tyrosine Kinase Inhibitor(s)) in pri katerih zdravljenje z imatinibom, nilotinibom ali dasatinibom ni primerno.
English: When a single oral dose of bosutinib (400 mg) was co-administered with multiple-oral doses of lansoprazole (60 mg) in a study of 24 healthy fasting subjects, bosutinib Cmax and AUC decreased to 54% and 74%, respectively, of the values seen when bosutinib (400 mg) was given alone.
Slovenian: Pri sočasni uporabi enkratnega peroralnega odmerka bosutiniba (400 mg) z večkratnimi peroralnimi odmerki lansoprazola (60 mg) v študiji pri 24 zdravih preskušancih, ki so zdravili vzeli na tešče, sta se Cmax in AUC bosutiniba zmanjšali na 54 % in 74 % v primerjavi z vrednostmi, ko je bil bosutinib (400 mg) uporabljen samostojno.
English: Uncommon Pericarditis
Slovenian: občasni perikarditis
English: Of the 197 (15%) patients with reports of adverse reactions of neutropenia, 15 patients discontinued bosutinib due to neutropenia.
Slovenian: Od 197 (15 %) bolnikov, pri katerih so poročali o neželenem učinku nevtropeniji, jih je 15 prekinilo z jemanjem bosutiniba zaradi nevtropenije.
English: In vitro studies indicate that clinical drug-drug interactions are unlikely to occur at therapeutic doses as a result of inhibition by bosutinib on the metabolism of medicinal products that are substrates for CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5.
Slovenian: Študije in vitro so pokazale, da je pri terapevtskih odmerkih majhna verjetnost za medsebojno delovanje z drugimi zdravili, ki bi se pojavilo zaradi z bosutinibom povzročenega zaviranja metabolizma zdravil, ki so substrati CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4/5.
English: Acute kidney injury, Renal failure, Renal impairment General disorders and administration site conditions Very common Pyrexia, Asthenia, Oedema (including Face oedema, Localised oedema, Oedema peripheral), Fatigue (including Malaise)
Slovenian: Bolezni sečil pogosti akutna poškodba ledvic, odpoved ledvic, okvara ledvic Splošne težave in spremembe na mestu aplikacije zelo pogosti pireksija, astenija, edem (vključno z edemom obraza, lokaliziranim edemom, perifernim edemom), utrujenost (vključno s splošnim slabim počutjem)
English: These represent an evaluation of the adverse reaction data from 1,272 patients with either newly-diagnosed CP CML or with chronic, accelerated, or blast phase CML resistant or intolerant to prior therapy or Ph+ ALL who have received at least 1 dose of single-agent bosutinib.
Slovenian: Ti predstavljajo oceno podatkov o neželenih učinkih, zbranih pri 1.272 bolnikih z bodisi novo odkrito KML v kronični fazi ali bolnikih s KML v kronični, pospešeni ali blastni fazi, ki so bili neodzivni ali pa niso prenašali predhodnega zdravljenja, ali bolnikih s Ph+ ALL; vsi ti bolniki so prejeli vsaj 1 odmerek bosutiniba kot samostojno zdravilo.
English: Nine (0.8%) patients experienced QTcF increase from baseline exceeding 60 ms.
Slovenian: Pri 9 bolnikih (0,8 %) je prišlo do podaljšanja QTcF za več kot 60 ms glede na izhodišče.
English: Increasing exposure (area under curve [AUC]) in patients with moderate and severe renal impairment during studies was observed.
Slovenian: Med študijami so pri bolnikih z zmerno in hudo okvaro ledvic opazili povečanje izpostavljenosti (površina pod krivuljo [AUC - Area Under Curve]).
English: However, bosutinib did not demonstrate a potential for phototoxicity of the skin or eyes in pigmented rats exposed to bosutinib in the presence of UV radiation at bosutinib exposures up to 3-times and 2-times the human exposure resulting from the clinical dose of 400 or 500 mg, respectively (based on unbound Cmax in the respective species).
Slovenian: Vendar pa bosutinib ni pokazal potenciala za fototoksičnost na koži ali očeh pri pigmentiranih podganah, ki so bile bosutinibu izpostavljene v prisotnosti UV sevanja, pri stopnji izpostavljenosti, ki je bila do 3-kratnik izpostavljenosti pri človeku, ki je posledica kliničnega odmerka 400 mg, in 2-kratnik izpostavljenosti pri človeku, ki je posledica kliničnega odmerka 500 mg (na podlagi nevezane Cmax pri posamezni vrsti).
English: Abbreviations: BCR-ABL=breakpoint cluster region-Abelson; CP=chronic phase; CML=chronic myelogenous leukaemia; MCyR=major cytogenetic response; N/n=number of patients; Resp=responders; Eval=evaluable.
Slovenian: Okrajšave: BCR-ABL = Breakpoint Cluster Region-Abelson, CP = kronična faza, KML = kronična mieloična levkemija, MCyR = pomembni citogenetski odziv, n = število bolnikov.
English: The median time to MMR for responders was 24.7 weeks versus 36.3 weeks for the bosutinib treatment and imatinib treatment groups, respectively, in the mITT population.
Slovenian: Mediani čas do MMR pri odzivnih bolnikih v populaciji mITT je bil 24,7 tedna v skupini, ki se je zdravila z bosutinibom, v primerjavi s 36,3 tedna v skupini, ki se je zdravila z imatinibom.
English: Sample size (N) includes patients with a valid baseline haematological ass essment.
Slovenian: Velikost vzorca (n) vključuje bolnike z veljavno hematološko oceno na začetku študije.
English: • newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
Slovenian: • z novo odkrito kronično mieloično levkemijo s prisotnim kromosomom Philadelphia (Ph+ KML) v kronični fazi,
English: Note: Baseline mutations were identified before the patient's first dose of study drug.
Slovenian: Datum zajema podatkov: 2. oktober 2015 Opomba: Mutacije ob izhodišču so ugotovili, preden je bolnik prejel prvi odmerek preučevanega zdravila.
English: The descriptions included below are based on the safety population of 1,272 patients who received at least 1 dose of bosutinib for either newly-diagnosed CP CML or were resistant or intolerant to prior therapy with CP, AP, or BP CML, or Ph+ ALL.
Slovenian: Spodaj vključeni opisi temeljijo na populaciji 1.272 bolnikov za oceno varnosti, ki so prejeli vsaj 1 odmerek bosutiniba bodisi za novo odkrito KML v kronični fazi ali za KML v kronični, pospešeni ali blastni fazi, ki so bili neodzivni ali niso prenašali predhodnega zdravljenja, ali za Ph+ ALL.
English: Ask your doctor for advice before taking Bosulif if you are pregnant or might become pregnant.
Slovenian: Če ste noseči ali bi lahko zanosili, vprašajte zdravnika za nasvet, preden začnete jemati zdravilo Bosulif.