FrancophonIA/ELRC3.0 huggingface dataset:
English: Following administration of a single intravenous dose of 120 mg bosutinib to healthy subjects, bosutinib had a mean (% coefficient of variation [CV]) volume of distribution of 2,331 (32) L, suggesting that bosutinib is extensively distributed to extra vascular tissue.
Slovenian: Po dajanju enkratnega intravenskega 120 mg odmerka bosutiniba zdravim preskušancem je povprečni (% koeficient variance [CV]) volumen porazdelitve bosutiniba znašal 2.331 (32) l, kar kaže na to, da se bosutinib v veliki meri porazdeli v ekstravaskularno tkivo.
English: It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy with bosutinib, with particular attention in those patients who have pre-existing renal compromise or in those patients exhibiting risk factors for renal dysfunction, including concomitant use of medicinal products with potential for nephrotoxicity, such as diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Pred začetkom zdravljenja z bosutinibom je pomembno oceniti delovanje ledvic in ga med zdravljenjem pozorno spremljati, zlasti pri bolnikih z obstoječo okvaro ledvic ali bolnikih z dejavniki tveganja za motnjo delovanja ledvic, vključno s sočasno uporabo potencialno nefrotoksičnih zdravil, kot so diuretiki, zaviralci ACE, antagonisti angiotenzinskih receptorjev in nesteroidna protivnetna zdravila (NSAID).
English: Of these patients, 268 (400 mg starting dose) and 248 (500 mg starting dose) are from the 2 Phase 3 studies in previously untreated CML patients, 570 and 63 are from 2 Phase 1/2 studies in previously treated Ph+ leukaemias, and 123 patients from a Phase 4 study in previously treated CML.
Slovenian: Od teh bolnikov jih je 268 (začetni odmerek 400 mg) in 248 (začetni odmerek 500 mg) iz 2 kliničnih študij 3. faze pri predhodno nezdravljenih bolnikih s KML, 570 in 63 jih je iz 2 kliničnih študij 1./2.
English: Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
Slovenian: Preglednica 6 - Odziv glede na status mutacij BCR-ABL ob začetku študije pri KML v kronični fazi (populacija, ki jo je bilo mogoče oceniti): pred zdravljenjem z imatinibom in dasatinibom in/ali nilotinibom (tretja linija)
English: In CML patients at steady state, Cmax (geometric mean, coefficient of variation [CV]%) was 145 (14) ng/mL, and AUCss (geometric mean, CV%) was 2,700 (16) ng•h/mL after daily administration of bosutinib at 400 mg with food.
Slovenian: Pri bolnikih s KML v stanju dinamičnega ravnovesja je Cmax (geometrična sredina, koeficient variacije [KV] %) znašala 145 (14) ng/ml, AUCss (geometrična sredina, KV %) pa je znašala 2.700 (16) ng*h/ml po jemanju bosutiniba 400 mg na dan s hrano.
English: Newly-diagnosed CP Ph+ CML The recommended dose is 400 mg bosutinib once daily.
Slovenian: Novo odkrita Ph+ KML v kronični fazi Priporočeni odmerek je 400 mg bosutiniba enkrat na dan.
English: The primary efficacy endpoint was the proportion demonstrating a major molecular response (MMR) at 12 months (48 weeks) in the bosutinib treatment group compared with that in the imatinib treatment group in the mITT population.
Slovenian: Primarni opazovani dogodek učinkovitosti je bil delež populacije mITT, ki je dosegla pomembni molekularni odziv (MMR - Major Molecular Response) po 12 mesecih (48 tednih) v skupini, ki se je zdravila z bosutinibom, v primerjavi s skupino, ki se je zdravila z imatinibom.
English: In vitro and in vivo studies indicated that bosutinib (parent compound) undergoes predominantly hepatic metabolism in humans.
Slovenian: Študije in vitro ter in vivo so pokazale, da je bosutinib (izhodna spojina) pri ljudeh pretežno podvržen presnovi v jetrih.
English: The median time to first event was 59 days (range: 27 to 505 days), and the median duration per event was 15 days (range: 1 to 913 days).
Slovenian: Mediani čas do prvega dogodka je bil 59 dni (razpon: 27 do 505 dni), mediano trajanje dogodka pa je bilo 15 dni (razpon: 1 do 913 dni).
English: The effect of bosutinib 500 mg administration on corrected QTc was evaluated in a randomised, single-dose, double-blind (with respect to bosutinib), crossover, placebo- and open-label moxifloxacin-controlled study in healthy subjects.
Slovenian: Učinek uporabe 500 mg bosutiniba na QTc so ocenili v randomizirani, dvojno slepi (glede na bosutinib), navzkrižni, s placebom ter moksifloksacinom (uporabljenim odprto) nadzorovani študiji z enkratnim odmerkom pri zdravih preskušancih.
English: Automated machine-read QTc prolongation without accompanying arrhythmia has been observed.
Slovenian: Opazili so podaljšanje QTc brez spremljajoče aritmije, ocenjeno z avtomatskim čitalcem.
English: Time to OHR for responders only, weeks (95% CI)
Slovenian: čas do OHR, samo pri odzivnih bolnikih, tedni (95 % IZ)
English: The median duration of an event was 18 days (range: 1 to 775 days), and 15 days (range: 1 to 803 days) for ALT and AST, respectively.
Slovenian: Mediano trajanje dogodka je znašalo 18 dni (razpon: 1 do 775 dni) za ALT in 15 dni (razpon: 1 do 803 dni) za AST.
English: If clinically significant moderate or severe non-haematological toxicity develops, bosutinib should be interrupted, and may be resumed at a dose reduced by 100 mg taken once daily after the toxicity has resolved.
Slovenian: Če pride do klinično pomembne zmerne ali hude nehematološke toksičnosti, je treba zdravljenje z bosutinibom prekiniti; ko toksični učinki izzvenijo, se sme zdravljenje nadaljevati z odmerkom, zmanjšanim za 100 mg, enkrat na dan.
English: A delayed increase in heart rate was observed.
Slovenian: Opazili so zapoznelo pospešeno bitje srca.
English: The t½ of bosutinib increased in hepatic impaired patients as compared to the healthy subjects.
Slovenian: Vrednost t1/2 bosutiniba se je pri bolnikih z okvaro jeter v primerjavi z zdravimi preskušanci povečala.
English: Hold bosutinib until ANC  1.0 × 109/L and platelets 9/L.
Slovenian: Zdravljenje z bosutinibom prekinite, dokler ni ANC  1,0 x 10
English: Tell your doctor if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the QT interval”, or if you faint (loss of consciousness) or have an irregular heart beat while taking Bosulif.
Slovenian: Težave s srcem: Obvestite zdravnika, če imate težave s srcem, kot je nepravilnost električne aktivnosti, ki se imenuje “podaljšanje intervala QT“ ali če med jemanjem zdravila Bosulif omedlite (izgubite zavest) ali imate nereden srčni utrip.
English: MCyR attained or maintained Resp/Eval b
Slovenian: MCyR dosežen ali ohranjen odzivni bolniki/je mogoče oceniti b (%) n = 112
English: Of the 994 (78%) patients that experienced diarrhoea, 10 patients discontinued bosutinib due to this event.
Slovenian: Od 994 (78 %) bolnikov, ki so imeli diarejo, je 10 bolnikov zaradi diareje prekinilo zdravljenje z bosutinibom.
English: Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Slovenian: Pri bolnikih s klinično pomembnimi srčnimi boleznimi je potrebna previdnost (glejte poglavje 4.4).
English: Complete cytogenetic response 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.
Slovenian: Popolni citogenetski odziv so opredelili kot odsotnost Ph+ metafaz pri analizi proganja kromosomov ≥ 20 metafaz, ki so jih pridobili iz aspirata kostnega mozga, ali MMR, če ustrezna citogenetska ocena ni bila na voljo.
English: Dose and method of administration
Slovenian: Odmerek in način uporabe
English: Following administration of single or multiple doses of bosutinib (400 or 500 mg) to humans, the major circulating metabolites appeared to be oxydechlorinated (M2) and N-desmethylated (M5) bosutinib, with bosutinib N-oxide (M6) as a minor circulating metabolite.
Slovenian: Po zaužitju enkratnega ali večkratnih odmerkov bosutiniba (400 ali 500 mg) pri ljudeh so bili poglavitni presnovki v obtoku oksidekloriniran (M2) in N-demetiliran (M5) bosutinib, skupaj z bosutinib N-oksidom (M6) kot manj pomembnim presnovkom v obtoku.
English: Diarrhoea: For NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade 3-4 diarrhoea, bosutinib should be interrupted and may be resumed at 400 mg once daily upon recovery to grade ≤ 1 (see section 4.4).
Slovenian: Diareja: Če se pojavi diareja stopnje 3-4 po merilih NCI za poenoteno terminologijo neželenih dogodkov (NCI CTCAE - National Cancer Institute Common Terminology Criteria for Adverse Events), je treba zdravljenje z bosutinibom prekiniti; ko pride do izboljšanja na stopnjo ≤ 1, se sme zdravljenje nadaljevati z odmerkom 400 mg enkrat na dan (glejte poglavje 4.4).
English: 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.
Slovenian: 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.
English: Bosutinib 400 mg study
Slovenian: Študija z bosutinibom 400 mg
English: Heart problems.
Slovenian: Srčne bolezni
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Doses less than 300 mg/day have been used in patients; however, efficacy has not been established.
Slovenian: Pri bolnikih so uporabljali tudi odmerke, manjše od 300 mg na dan, vendar učinkovitosti niso dokazali.
English: What Bosulif contains - The active substance is bosutinib.
Slovenian: Kaj vsebuje zdravilo Bosulif - Učinkovina je bosutinib.
English: 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]).
Slovenian: 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]).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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%).
Slovenian: 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 %).
English: 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).
Slovenian: 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).
English: Film coating
Slovenian: filmska obloga
English: Tell your doctor if you develop any of the following signs and symptoms such as abnormal bleeding or bruising without having an injury.
Slovenian: Obvestite zdravnika, če se vam pojavijo naslednji znaki in simptomi: nenormalne krvavitve ali nastajanje modric brez predhodne poškodbe.
English: How to take Bosulif
Slovenian: Kako jemati zdravilo Bosulif
English: In clinical studies, patients with uncontrolled or significant cardiac disease (e.g., recent myocardial infarction, congestive heart failure or unstable angina) were excluded.
Slovenian: 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.
English: Pericardial effusion, Electrocardiogram QTc prolonged (including Long
Slovenian: Srčne bolezni pogosti perikardialni izliv, podaljšanje intervala QTc na elektrokardiogramu (vključno s sindromom dolgega QTc)
English: Of the 445 (35%) patients with reports of adverse reactions of thrombocytopenia, 41 (9%) patients discontinued treatment with bosutinib due to thrombocytopenia.
Slovenian: Od 445 (35 %) bolnikov, pri katerih so poročali o neželenem učinku trombocitopeniji, jih je 41 (9 %) prekinilo z jemanjem bosutiniba zaradi trombocitopenije.
English: 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%).
Slovenian: 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 %).
English: 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
Slovenian: 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
English: 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).
Slovenian: Bolezni krvi: Nemudoma obvestite zdravnika, če se vam pojavi kateri izmed naslednjih simptomov: krvavitev, vročina ali modrice (morda imate motnje krvi ali limfatičnega sistema).
English: Based on CMH test stratified by geographical region and Sokal score at randomisation.
Slovenian: Na podlagi testa CMH, stratificiranega po geografski regiji in oceni po Sokalu ob randomizaciji.
English: This medicine has not been studied in children and adoloscents.
Slovenian: Zdravila Bosulif pri otrocih in mladostnikih niso preučevali.
English: 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.
Slovenian: 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.
English: Five bosutinib patients and 7 imatinib patients transformed to AP CML or BP CML.
Slovenian: Pri 5 bolnikih na bosutinibu in 7 bolnikih na imatinibu je prišlo do transformacije v pospešeno ali blastno fazo KML.
English: 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.
Slovenian: Pri 88 % bolnikov je diareja dosegla največjo toksičnost stopnje 1 ali 2, pri 12 % bolnikov stopnje 3; pri 1 bolniku (< 1 %) pa stopnje 4.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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.
English: Treatment with bosutinib may result in a clinically significant decline in renal function in CML patients.
Slovenian: Pri bolnikih s KML lahko zdravljenje z bosutinibom povzroči klinično pomembno poslabšanje delovanja ledvic.
English: Includes patients (N) with a valid baseline assessment.
Slovenian: Vključuje bolnike (n) z veljavno oceno na začetku študije.
English: The maximum toxicity of Grade 3 neutropenia was experienced in 90 (46%) patients and of Grade 4 in 44 (22%) patients.
Slovenian: Do nevtropenije največje stopnje 3 je prišlo pri 90 (46 %) bolnikih, do stopnje 4 pa pri 44 (22 %) bolnikih.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Subjects with moderate and severe renal impairment had an increase in AUC over healthy volunteers of 35% and 60%, respectively.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Caution should be exercised in patients with recent or ongoing clinically significant gastrointestinal disorder (see section 4.4).
Slovenian: Pri bolnikih z nedavno ali obstoječo klinično pomembno boleznijo prebavil je potrebna previdnost (glejte poglavje 4.4).
English: 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.
Slovenian: 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.
English: This is because Bosulif could cause hepatitis B to become active again, which can be fatal in some cases.
Slovenian: - 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.