natgillin/translations-raw huggingface dataset:
A 2-arm, Phase 3, open-label, multicentre superiority trial was conducted to investigate the efficacy and safety of bosutinib 400 mg once daily alone compared with imatinib 400 mg once daily alone in adult patients with newly-diagnosed Ph+ CP CML. 
Izvedli so odprto, multicentrično preskušanje superiornosti z dvema skupinama, v katerem so preučevali učinkovitost in varnost samega bosutiniba 400 mg enkrat na dan v primerjavi s samim imatinibom 400 mg enkrat na dan pri odraslih bolnikih z novo odkrito Ph+ KML v kronični fazi.
Bosutinib 400 mg study 
Študija z bosutinibom 400 mg
Heart problems. 
Srčne bolezni
Whereas, in the Phase 3 study in patients with newly-diagnosed CP CML treated with bosutinib 400 mg, dose escalations by 100 mg increments to a maximum of 600 mg once daily with food were permitted if the patient failed to demonstrate breakpoint cluster region-Abelson (BCR-ABL) transcripts ≤ 10% at Month 3, did not have a Grade 3 or 4 adverse reaction at the time of escalation, and all Grade 2 non-haematological toxicities were resolved to at least Grade 1. 
V študiji 3. faze pri bolnikih z novo odkrito KML v kronični fazi, ki so se zdravili z bosutinibom 400 mg, pa so dovolili povečanje odmerka v korakih po 100 mg do največ 600 mg enkrat na dan s hrano, če pri bolniku po 3 mesecih niso dokazali prepisov gena ''Breakpoint Cluster RegionAbelson'' (BCR-ABL) ≤ 10 %, če v času povečanja ni imel neželenih učinkov stopnje 3 ali 4 in če so vse nehematološke toksičnosti izzvenele do vsaj stopnje 1.
If transaminase elevations ≥ 3 × ULN occur concurrently with bilirubin elevations > 2 × ULN and alkaline phosphatase < 2 × ULN, bosutinib should be discontinued (see section 4.4). 
Če pride do povečanja vrednosti transaminaz ≥ 3-kratnik ZMN ob sočasnem povečanju vrednosti bilirubina > 2-kratnik ZNM in alkalne fosfataze za < 2-kratnik ZMN, je treba zdravljenje z bosutinibom prekiniti (glejte poglavje 4.4).
Doses less than 300 mg/day have been used in patients; however, efficacy has not been established. 
Pri bolnikih so uporabljali tudi odmerke, manjše od 300 mg na dan, vendar učinkovitosti niso dokazali.
What Bosulif contains - The active substance is bosutinib. 
Kaj vsebuje zdravilo Bosulif - Učinkovina je bosutinib.
Bosutinib should be administered with caution to patients who have a history of or predisposition for QTc prolongation, who have uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia, or who are taking medicinal products that are known to prolong the QTc (e.g., anti-arrhythmic medicinal products and other substances that may prolong QTc [see section 4.5]). 
Bosutinib je treba uporabljati previdno pri bolnikih z anamnezo ali predispozicijo za podaljšanje QTc, pri bolnikih z nenadzorovano ali klinično pomembno srčno boleznijo (vključno z nedavnim miokardnim infarktom, kongestivnim srčnim popuščanjem, nestabilno angino pektoris ali klinično pomembno bradikardijo) ali pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšujejo QTc (npr. antiaritmiki in druge učinkovine, ki lahko podaljšajo QTc [poglavje 4.5]).
Elevated liver transaminases: If elevations in liver transaminases > 5 × institutional upper limit of normal (ULN) occur, bosutinib should be interrupted until recovery to ≤ 2.5 × ULN and may be resumed at 400 mg once daily thereafter. 
Povečane vrednosti jetrnih transaminaz: Če pride do povečanja vrednosti jetrnih transaminaz, ki presega 5-kratnik zgornje meje normale (ZMN), je treba zdravljenje z bosutinibom prekiniti, dokler ne pride do izboljšanja na ≤ 2,5-kratnik ZMN; nato se sme zdravljenje nadaljevati z odmerkom 400 mg enkrat na dan.
Tell your doctor if you develop any of the following signs and symptoms of fluid retention during Bosulif treatment such as swelling of the ankles, feet or legs; difficulty breathing chest pain or a cough (these may be signs of fluid retention in the lungs or chest). 
Obvestite zdravnika, če se vam pojavijo naslednji znaki in simptomi zastajanja tekočine med zdravljenjem z zdravilom Bosulif: otekanje gležnjev, stopal ali nog, težko dihanje, bolečine v prsnem košu ali kašelj (to so lahko znaki zastajanja tekočine v pljučih ali prsnem košu).
The most frequent adverse reactions reported for  20% of patients were diarrhoea (78.1%), nausea (40.8%), thrombocytopenia (34.9%), abdominal pain (34.0%), vomiting (33.0%), rash (31.5%), anaemia (25.6%), pyrexia (21.8%), fatigue (21.4%), and ALT increased (25.0%). 
Najpogostejši neželeni učinki, o katerih so poročali pri  20 % bolnikov, so bili diareja (78,1 %), navzea (40,8 %), trombocitopenija (34,9 %), bolečine v trebuhu (34,0 %), bruhanje (33,0 %), izpuščaj (31,5 %), anemija (25,6 %), pireksija (21,8 %), utrujenost (21,4 %) in povečane vrednosti ALT (25,0 %).
The primary efficacy endpoint of the study was the major cytogenetic response (MCyR) rate at Week 24 in patients with imatinib-resistant CP CML previously treated with only 1 prior TKI (imatinib). 
Primarni opazovani dogodek učinkovitosti je bil pomembni citogenetski odziv (MCyR - Major Cytogenetic Response) ob 24. tednu pri bolnikih s KML v kronični fazi, neodzivnih na imatinib, ki so bili predhodno zdravljeni le z 1 TKI (imatinib).
Film coating 
filmska obloga
Tell your doctor if you develop any of the following signs and symptoms such as abnormal bleeding or bruising without having an injury. 
Obvestite zdravnika, če se vam pojavijo naslednji znaki in simptomi: nenormalne krvavitve ali nastajanje modric brez predhodne poškodbe.
How to take Bosulif 
Kako jemati zdravilo Bosulif
In clinical studies, patients with uncontrolled or significant cardiac disease (e.g., recent myocardial infarction, congestive heart failure or unstable angina) were excluded. 
Bolniki z nenadzorovano ali klinično pomembno boleznijo srca (npr. nedavni miokardni infarkt, kongestivno srčno popuščanje ali nestabilna angina pektoris) so bili iz kliničnih študij izključeni.
Pericardial effusion, Electrocardiogram QTc prolonged (including Long 
Srčne bolezni pogosti perikardialni izliv, podaljšanje intervala QTc na elektrokardiogramu (vključno s sindromom dolgega QTc)
Of the 445 (35%) patients with reports of adverse reactions of thrombocytopenia, 41 (9%) patients discontinued treatment with bosutinib due to thrombocytopenia. 
Od 445 (35 %) bolnikov, pri katerih so poročali o neželenem učinku trombocitopeniji, jih je 41 (9 %) prekinilo z jemanjem bosutiniba zaradi trombocitopenije.
The Grade 3 or Grade 4 adverse reactions reported for  5% of patients were thrombocytopenia (20.3%), anaemia (10.2%), neutropenia (10.5%), ALT increased (12.7%), diarrhoea (9.6%), rash (5.0%), lipase increased (8.2%), and AST increased (5.8%). 
Neželeni učinki stopnje 3 ali 4, o katerih so poročali pri  5 % bolnikov, so bili trombocitopenija (20,3 %), anemija (10,2 %), nevtropenija (10,5 %), povečane vrednosti ALT (12,7 %), diareja (9,6 %), izpuščaj (5,0 %), povečane vrednosti lipaze (8,2 %) in povečane vrednosti AST (5,8 %).
No evidence of leukaemia (NEL): Meets all other criteria for CHR except may have thrombocytopenia (platelets greater than or equal to 20,000/mm and less than 100,000/mm 3) and/or neutropenia (ANC greater than or equal to 0.5×10 
Ni nobenega dokaza za levkemijo: izpolnjena so vsa druga merila za CHR, z izjemo tega, da je lahko prisotna trombocitopenija (število trombocitov večje od ali enako 20.000/mm in manjše od 100.000/mm
Tell your doctor right away if you have any of these symptoms: bleeding, fever or easy bruising (you might have blood or lymphatic system disorder). 
Bolezni krvi: Nemudoma obvestite zdravnika, če se vam pojavi kateri izmed naslednjih simptomov: krvavitev, vročina ali modrice (morda imate motnje krvi ali limfatičnega sistema).
Based on CMH test stratified by geographical region and Sokal score at randomisation. 
Na podlagi testa CMH, stratificiranega po geografski regiji in oceni po Sokalu ob randomizaciji.
This medicine has not been studied in children and adoloscents. 
Zdravila Bosulif pri otrocih in mladostnikih niso preučevali.
Complete cytogenetic response by Month 12, a secondary endpoint, was defined as the absence of Ph+ metaphases in chromosome banding analysis of ≥ 20 metaphases derived from bone marrow aspirate or MMR if an adequate cytogenetic assessment was unavailable. 
Popolni citogenetski odziv po 12 mesecih, sekundarni opazovani dogodek, so opredelili kot odsotnost Ph+ metafaz v analizi proganja kromosomov ≥ 20 metafaz, pridobljenih iz aspirata kostnega mozga, ali MMR, če ustrezna citogenetska analiza ni bila na voljo.
Five bosutinib patients and 7 imatinib patients transformed to AP CML or BP CML. 
Pri 5 bolnikih na bosutinibu in 7 bolnikih na imatinibu je prišlo do transformacije v pospešeno ali blastno fazo KML.
The maximum toxicity of diarrhoea was Grade 1 or 2 in 88% of patients, Grade 3 in 12% of patients; 1 patient (< 1%) experienced a Grade 4 event. 
Pri 88 % bolnikov je diareja dosegla največjo toksičnost stopnje 1 ali 2, pri 12 % bolnikov stopnje 3; pri 1 bolniku (< 1 %) pa stopnje 4.
Recent or ongoing clinically significant gastrointestinal disorder In clinical studies, patients with recent or ongoing clinically significant gastrointestinal disorder (e.g., severe vomiting and/or diarrhoea) were excluded. 
Nedavne ali obstoječe klinično pomembne bolezni prebavil Bolniki z nedavno ali obstoječo klinično pomembno boleznijo prebavil (npr. hudo bruhanje in/ali diareja) so bili iz kliničnih študij izključeni.
Tell your doctor if you develop any of the following signs and symptoms: an increase in the number of stools (bowel movements) per day over normal, an increase in episodes of vomiting, blood in your vomit, stools (bowel movements) or urine, or have black stools (tarry black bowel movements). 
Obvestite zdravnika, če se vam pojavijo naslednji znaki in simptomi: povečano število odvajanj blata na dan (čez normalno mero), povečanje števila epizod bruhanja, kri v izbruhku, blatu ali urinu, črno (katranasto) blato.
Treatment with bosutinib may result in a clinically significant decline in renal function in CML patients. 
Pri bolnikih s KML lahko zdravljenje z bosutinibom povzroči klinično pomembno poslabšanje delovanja ledvic.
Includes patients (N) with a valid baseline assessment. 
Vključuje bolnike (n) z veljavno oceno na začetku študije.
The maximum toxicity of Grade 3 neutropenia was experienced in 90 (46%) patients and of Grade 4 in 44 (22%) patients. 
Do nevtropenije največje stopnje 3 je prišlo pri 90 (46 %) bolnikih, do stopnje 4 pa pri 44 (22 %) bolnikih.
Tell your doctor if you have a history of liver problems including hepatitis (liver infection or inflammation) of any kind, or a history of any of the following signs and symptoms of liver problems: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area. 
Obvestite zdravnika, če ste kdaj imeli težave z jetri, vključno s hepatitisom (okužba ali vnetje jeter) katerekoli vrste, ali če ste kdaj imeli naslednje znake in simptome težav z jetri: srbenje, rumeno obarvanje očesnih beločnic ali kože, temen urin ter bolečino ali nelagodje v desnem zgornjem predelu trebuha.
The concomitant use of bosutinib with strong CYP3A inhibitors (including, but not limited to itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, nefazodone, mibefradil, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, grapefruit products including grapefruit juice) or moderate CYP3A inhibitors (including, but not limited to fluconazole, ciprofloxacin, erythromycin, diltiazem, verapamil, amprenavir, atazanavir, darunavir/ritonavir, fosamprenavir, aprepitant, crizotinib, imatinib) should be avoided, as an increase in bosutinib plasma concentration will occur. 
Sočasni uporabi bosutiniba skupaj z močnimi zaviralci CYP3A (kot so med drugim itrakonazol, ketokonazol, posakonazol, vorikonazol, klaritromicin, telitromicin, nefazodon, mibefradil, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, sakvinavir, boceprevir, telaprevir, izdelki iz grenivke, vključno z grenivkinim sokom) ali zmernimi zaviralci CYP3A (kot so med drugim flukonazol, ciprofloksacin, eritromicin, diltiazem, verapamil, amprenavir, atazanavir, darunavir/ritonavir, fosamprenavir, aprepitant, krizotinib, imatinib) se je treba izogibati, ker povečajo plazemsko koncentracijo bosutiniba.
Subjects with moderate and severe renal impairment had an increase in AUC over healthy volunteers of 35% and 60%, respectively. 
Pri preskušancih z zmerno okvaro ledvic se je vrednost AUC povečala za 35 %, pri preskušancih s hudo okvaro ledvic pa za 60 % v primerjavi z zdravimi prostovoljci.
In the Phase 3 study in patients with newly-diagnosed CP CML who started bosutinib treatment at 400 mg, a total of 46 patients (17.2%) received dose escalations to 500 mg. 
V študiji 3. faze pri bolnikih z novo odkrito KML v kronični fazi, ki so zdravljenje z bosutinibom začeli z odmerkom 400 mg, so pri skupno 46 bolnikih (17,2 %) odmerek povečali na 500 mg.
Caution should be exercised in patients with recent or ongoing clinically significant gastrointestinal disorder (see section 4.4). 
Pri bolnikih z nedavno ali obstoječo klinično pomembno boleznijo prebavil je potrebna previdnost (glejte poglavje 4.4).
The efficacy results for Ph+ CP CML patients previously treated with imatinib and at least 1 additional TKI (minimum follow-up 48 months, median treatment duration of 9 months and 24.4% still on-treatment at 48 months) and the results for Ph+ CP CML patients previously treated with only imatinib (minimum follow-up 60 months, median treatment duration of 26 months and 40.5% still on-treatment at 60 months) are presented in Table 5. 
Rezultati o učinkovitosti pri bolnikih s Ph+ KML v kronični fazi, ki so bili predhodno zdravljeni z imatinibom in vsaj še enim dodatnim TKI (minimalno obdobje spremljanja 48 mesecev, mediano trajanje zdravljenja 9 mesecev in 24,4 % po 48 mesecih še vedno na zdravljenju) ter pri bolnikih s Ph+ KML v kronični fazi, ki so bili predhodno zdravljeni le z imatinibom (minimalno obdobje spremljanja 60 mesecev, mediano trajanje zdravljenja 26 mesecev in 40,5 % po 60 mesecih še vedno na zdravljenju) so predstavljeni v preglednici 5.
This is because Bosulif could cause hepatitis B to become active again, which can be fatal in some cases. 
- Če ste kdaj bili ali ste morda sedaj okuženi z virusom hepatitisa B. Zdravilo Bosulif lahko namreč povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
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). 
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).
Of the 297 (23%) patients with reports of adverse reactions of anaemia, 3 patients discontinued bosutinib due to anaemia. 
Od 297 (23 %) bolnikov, pri katerih so poročali o neželenem učinku anemiji, so 3 prekinili z jemanjem bosutiniba zaradi anemije.
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. 
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.
Based on non-clinical findings, bosutinib has the potential to impair reproductive function and fertility in humans (see section 5.3). 
Predklinični izsledki kažejo, da lahko bosutinib pri ljudeh zmanjša sposobnost razmnoževanja in plodnost (glejte poglavje 5.3.).
If cytopoenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment. 
Če se ponovno pojavi citopenija, je po izboljšanju treba odmerek dodatno zmanjšati za 100 mg in nadaljevati z zdravljenjem.
Dose adjustments 
Prilagajanje odmerka
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). 
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).
Dose adjustments for adverse reactions 
Prilagajanje odmerka zaradi neželenih učinkov
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. 
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.
The recommended dose is 500 mg once daily for patients whose previous medicines to treat CML have either not worked or are not suitable. 
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.
Sprague-Dawley rats, radioactivity was readily excreted into breast milk as early as 0.5 hr after dosing. 
C] radioaktivno označenega bosutiniba pri doječih podganah Sprague-Dawley se je radioaktivnost izločila v živalsko mleko že v 0,5 ure po odmerku.
A study of [14C] radiolabelled bosutinib in rats demonstrated excretion of bosutinib-derived radioactivity in breast milk (see section 5.3). 
radioaktivno označenim bosutinibom je pokazala izločanje radioaktivno označenega bosutiniba v živalsko mleko (glejte poglavje 5.3).
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). 
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).
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. 
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.
Tell your doctor if you develop abdominal pain or discomfort. 
Obvestite zdravnika, če se vam pojavi bolečina ali nelagodje v trebuhu.
a p-value based on CMH test stratified by geographical region and Sokal score at randomisation. 
vrednost p temelji na testu CMH, stratificiranem po geografski regiji in oceni po Sokalu ob randomizaciji.
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. 
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.
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). 
faze so določene znake klinične aktivnosti opazili pri bolnikih z mutacijami BCR-ABL (glejte preglednico 6).
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 
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).
In a renal impairment study, bosutinib exposures were increased in subjects with moderately and severely impaired renal function. 
V študiji okvare ledvic se je pri preskušancih z zmerno in hudo okvaro delovanja ledvic povečevala izpostavljenost bosutinibu.
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). 
Sočasni uporabi bosutiniba z močnimi ali zmernimi zaviralci CYP3A se je treba izogibati, ker povečajo plazemsko koncentracijo bosutiniba (glejte poglavje 4.5).
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). 
Sočasni uporabi bosutiniba z močnimi ali zmernimi induktorji CYP3A se je treba izogibati, ker zmanjšajo plazemsko koncentracijo bosutiniba (glejte poglavje 4.5).
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. 
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.
The maximum toxicity of thrombocytopenia of Grade 3 was experienced in 161 (36%) patients and Grade 4 in 98 (22%) patients. 
Do trombocitopenije največje stopnje 3 je prišlo pri 161 (36 %) bolnikih, do stopnje 4 pa pri 98 (22 %) bolnikih.