FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Ako se razvije klinički značajna umjerena ili teška nehematološka toksičnost, liječenje bosutinibom mora se prekinuti, a može se nastaviti dozom smanjenom za 100 mg uzetom jedanput dnevno nakon nestanka toksičnosti.
English: The p-values for endpoints other than MMR at 12 months and CCyR by 12 months have not been adjusted for multiple comparisons.
Croatian: Za mjere ishoda koje nisu bile MMR nakon 12 mjeseci i CCyR do 12 mjeseci, p-vrijednosti nisu bile prilagođene za višestruke usporedbe.
English: The secondary efficacy endpoints included MMR by 18 months, duration of MMR, CCyR by 12 months, duration of CCyR, event-free survival (EFS), and overall survival (OS).
Croatian: Sekundarne mjere ishoda djelotvornosti uključivale su MMR do 18 mjeseci, trajanje MMR-a, CCyR do 12 mjeseci, trajanje CCyR-a, preživljenje bez pojave događaja (engl. event-free survival, EFS) i ukupno preživljenje (engl. overall survival, OS).
English: Clinical data are very limited (n = 3) for CML patients with moderate renal impairment receiving an escalated dose of 600 mg bosutinib.
Croatian: Klinički podaci su vrlo ograničeni (n = 3) u bolesnika s KML-om i umjerenim oštećenjem bubrega koji primaju povećanu dozu od 600 mg bosutiniba.
English: Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML.
Croatian: Bosutinib inhibira abnormalnu BCR-ABL kinazu koja pospješuje KML.
English: Dose reduction is recommended for patients with moderate or severe renal impairment (see sections 4.2 and 5.2).
Croatian: Preporučuje se smanjivanje doza u bolesnika s umjerenim ili teškim oštećenjem bubrega (vidjeti dijelove 4.2 i 5.2).
English: The following adverse reactions were reported in patients in bosutinib clinical studies (Table 2).
Croatian: Sljedeće nuspojave prijavljene su u bolesnika tijekom kliničkih ispitivanja bosutiniba (Tablica 2).
English: Incidence at baseline n (%)
Croatian: Incidencija na početku n (%)
English: If you stop taking Bosulif
Croatian: Ako prestanete uzimati Bosulif
English: The antiemetic agent, domperidone, has the potential to increase QT interval (QTc) prolongation and to induce “torsade de pointes”- arrhythmias; therefore, co-administration with domperidone should be avoided.
Croatian: Antiemetik domperidon ima potencijal produljiti QT interval (QTc) i izazvati aritmije "torsade de pointes", stoga je nužno izbjeći istodobnu primjenu domperidona.
English: One patient on bosutinib and 7 patients on imatinib died while on study.
Croatian: Jedan bolesnik liječen bosutinibom i 7 bolesnika liječenih imatinibom umrli su tijekom sudjelovanja u ispitivanju.
English: - Do not use this medicine after the expiry date which is stated on the blister foil and carton after “EXP”.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na foliji blistera i kutiji iza oznake „Rok valjanosti“ ili „EXP“.
English: If a dose is missed by more than 12 hours, take your next dose at your regular time on the following day.
Croatian: Ako je od propuštene doze prošlo više od 12 sati, uzmite sljedeću dozu u predviđeno vrijeme sljedećeg dana.
English: At least 1 adverse reaction of any toxicity grade was reported for 1,240 (97.5%) patients.
Croatian: Najmanje 1 nuspojava bilo kojeg stupnja toksičnosti bila je prijavljena u 1240 (97,5%) bolesnika.
English: Treatment with bosutinib may result in a clinically significant decline in renal function in CML patients.
Croatian: Liječenje bosutinibom može rezultirati klinički značajnim smanjenjem funkcije bubrega u bolesnika s KML-om.
English: Among the 994 patients with diarrhoea, 180 patients (18%) were managed with treatment interruption and of these 170 (94%) were rechallenged with bosutinib.
Croatian: Među 994 bolesnika s proljevom, 180 bolesnika (18%) bilo je zbrinuto prekidom liječenja, a od toga je 170 (94%) ponovno izloženo bosutinibu.
English: The recommended dose is 400 mg once daily for patients with newly-diagnosed CML.
Croatian: Preporučena doza je 400 mg jedanput dnevno u bolesnika s novodijagnosticiranim KML-om.
English: - if you notice any of these symptoms: pain in your side, blood in your urine or reduced amount of urine.
Croatian: - ako primijetite bilo koji od sljedećih simptoma: bol u slabinama, krv u mokraći ili smanjenu količinu mokraće.
English: Your doctor should do blood tests to check your liver function prior to your starting treatment with Bosulif and for the first 3 months of treatment with Bosulif, and as clinically indicated.
Croatian: Vaš liječnik mora zatražiti pretrage krvi kako bi provjerio funkcionira li Vaša jetra ispravno prije početka liječenja lijekom Bosulif, za vrijeme prva 3 mjeseca liječenja lijekom Bosulif i kad god je to klinički indicirano.
English: In vitro studies indicate that bosutinib has a low potential to inhibit breast cancer resistance protein (BCRP, systemically), organic anion transporting polypeptide (OATP)1B1, OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2 at clinically relevant concentrations, but may have the potential to inhibit BCRP in the gastrointestinal tract and OCT1.
Croatian: In vitro ispitivanja pokazuju da bosutinib ima niski potencijal za inhibiciju proteina rezistencije raka dojke (BCRP, sistemski), polipeptida koji prenose organske anione (OATP)1B1, OATP1B3, transportera organskih aniona (OAT)1, OAT3, transportera organskih kationa (OCT)2 pri klinički značajnim koncentracijama, ali može imati potencijal inhibirati BCRP u gastrointestinalnom traktu i OCT1.
English: FISH analysis (≥ 200 cells) could be used for post-baseline cytogenetic assessments if ≥ 20 metaphases were not available.
Croatian: FISH analiza (≥ 200 stanica) može se koristiti za citogenetske procjene nakon početka ako nije bilo dostupno ≥ 20 metafaza.
English: 1-sided p-value
Croatian: Jednostrana p-vrijednost
English: The median duration of therapy was 14.1 months (range: 0.3 to 24.7 months), 61.6 months (0.03 to 99.6 months), 11.1 months (range: 0.03 to 123.3 months), 30.2 months (range: 0.3 to 85.6 months), and 5.7 months (range: 0.07 to 17.8 months), respectively.
Croatian: Medijan trajanja terapije bio je 14,1 mjesec (raspon: 0,3 do 24,7 mjeseci), 61,6 mjeseci (0,03 do 99,6 mjeseci), 11,1 mjesec (raspon: 0,03 do 123,3 mjeseca), 30,2 mjeseca (raspon: 0,3 do 85,6 mjeseci), odnosno 5,7 mjeseci (raspon: 0,07 do 17,8 mjeseci).
English: In a rat pre- and postnatal development study, there were reduced number of pups born at ≥ 30 mg/kg/day, and increased incidence of total litter loss and decreased growth of offspring after birth occurred at 70 mg/kg/day.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja štakora zabilježen je smanjen broj mladunčadi okoćene pri ≥ 30 mg/kg/dan te je došlo do povećane incidencije ukupnog gubitka okota i smanjenja rasta mladunčadi nakon okota pri 70 mg/kg/dan.
English: Hypokalaemia or hypomagnesaemia must be corrected prior to bosutinib administration and should be monitored periodically during therapy.
Croatian: Hipokalijemiju ili hipomagnezijemiju se mora korigirati prije primjene bosutiniba te se povremeno mora pratiti tijekom terapije.
English: Patients with uncontrolled or significant cardiovascular disease including QTc prolongation, at baseline, were not included in clinical studies (see sections 5.1 and 5.3).
Croatian: Bolesnici koji su na početku ispitivanja imali nekontroliranu ili značajnu kardiovaskularnu bolest, uključujući produljeni QTc, nisu bili uključeni u klinička ispitivanja (vidjeti dijelove 5.1 i 5.3).
English: Men being treated with bosutinib are advised to seek advice on conservation of sperm prior to treatment because of the possibility of decreased fertility due to therapy with bosutinib.
Croatian: Muškarcima koji su liječeni bosutinibom savjetuje se da potraže savjet oko pohranjivanja sperme prije početka liječenja zbog mogućeg smanjenja plodnosti uslijed terapije bosutinibom.
English: Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
Croatian: U nekim je slučajevima došlo do akutnog zatajenja jetre ili fulminantnog hepatitisa što je dovelo do transplantacije jetre ili smrtnog ishoda (vidjeti dio 4.4).
English: There are limited amount of data in pregnant women from the use of bosutinib.
Croatian: Ograničeni su podaci o primjeni bosutiniba u trudnica.
English: - if you have or have had pancreas problems.
Croatian: - ako imate ili ste imali probleme s gušteračom.
English: Treatment with bosutinib may be associated with fluid retention including pericardial effusion, pleural effusion, pulmonary oedema and/or peripheral oedema.
Croatian: Liječenje bosutinibom može biti povezano sa zadržavanjem tekućine, uključujući perikardijalni izljev, pleuralni izljev, plućni edem i/ili periferni edem.
English: Cytochrome P-450 (CYP)3A inhibitors
Croatian: Inhibitori citokroma P450 (CYP)3A
English: Statistically significant comparison at the pre-specified significance level; based on CMH test stratified by geographical region and Sokal score at randomisation.
Croatian: Statistički značajna usporedba na unaprijed određenoj razini značajnosti; na temelju CMH testa raslojenog prema geografskom području i rezultatu prema Sokalu pri randomizaciji.
English: Ph+ CP CML with prior imatinib treatment only
Croatian: Ph+ CP KML s prethodnim liječenjem samo imatinibom
English: Carcinogenicity Bosutinib was not carcinogenic in the 2-year rat carcinogenicity study.
Croatian: Bosutinib nije bio kancerogen u dvogodišnjem ispitivanju kancerogenosti provedenom na štakorima.
English: Ph+ CP CML with prior treatment with imatinib and dasatinib or nilotinib
Croatian: Ph+ CP KML s prethodnim liječenjem imatinibom i dasatinibom ili nilotinibom
English: In the event that you have moderate or severe kidney problems, your doctor will reduce your dose by 100 mg once daily for moderate kidney problems and by an additional 100 mg once daily for severe kidney problems.
Croatian: U slučaju umjerenih ili teških problema s bubrezima, Vaš liječnik će Vam smanjiti dozu uzetu jednom dnevno za 100 mg kod umjerenih problema s bubrezima i za dodatnih 100 mg jednom dnevno kod teških problema s bubrezima.
English: At least 1 Grade 3 or Grade 4 adverse reaction was reported for 814 (63.9%) patients.
Croatian: Najmanje jedna nuspojava 3. stupnja ili 4. stupnja prijavljena je u 814 (63,9%) bolesnika.
English: No metabolism of bosutinib was observed with CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A5.
Croatian: Metabolizam bosutiniba nije zapažen s enzimima CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ili 3A5.
English: Rare side effects (may affect up to 1 in 1,000 people): - severe skin disorder (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative (scaly, peeling) rash.
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - teški kožni poremećaji (multiformni eritem, Stevens-Johnsonov sindrom, toksična epidermalna nekroliza) nastali zbog alergijske reakcije, eksfolijativni (ljuskav, koji se ljušti) osip
English: These medicines should be avoided during your treatment with Bosulif.
Croatian: Te lijekove treba izbjegavati za vrijeme Vašeg liječenja lijekom Bosulif.
English: This finding was in a study of bosutinib in combination with letrozole in a patient with metastatic breast cancer.
Croatian: Ti su nalazi dobiveni u ispitivanju bosutiniba u kombinaciji s letrozolom u bolesnice s metastatskim rakom dojke.
English: A total of 1,272 leukaemia patients received at least 1 dose of single-agent bosutinib.
Croatian: Ukupno 1272 bolesnika s leukemijom primilo je najmanje jednu dozu bosutiniba kao jedinog lijeka.
English: If cytopoenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment.
Croatian: Ako se citopenija ponovno pojavi, smanjiti dozu za dodatnih 100 mg kad dođe do oporavka i nastaviti liječenje.
English: Pfizer ApS Tlf: +45 44 20 11 00
Croatian: Danmark Pfizer ApS Tlf: +45 44 20 11 00
English: Seventy-five percent of the dose was recovered within 96 hours.
Croatian: U roku od 96 sati nađeno je sedamdesetpet posto doze.
English: After 500 mg bosutinib daily with food, Cmax was 200 (6) ng/mL and AUCss was 3,640 (12) ng•h/mL.
Croatian: Nakon svakodnevne primjene 500 mg bosutiniba s hranom, Cmax je iznosio 200 (6) ng/ml, a AUCss je iznosio 3640 (12) ng•h/ml.
English: In a mass-balance study with oral bosutinib, an average of 94.6% of the total dose was recovered in 9 days; faeces (91.3%) was the major route of excretion, with 3.29% of the dose recovered in urine.
Croatian: U ispitivanju masene bilance nakon peroralne primjene bosutiniba, prosječno 94,6% od ukupne doze nađeno je u roku od 9 dana, glavni put ekskrecije bio je feces (91,3%), a 3,29% doze nađeno je u urinu.
English: Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
Croatian: Tablica 6 - Odgovor prema statusu mutacije BCR-ABL-a na početku u procjenjivoj populaciji s CP KML-om: prije toga liječeni imatinibom i dasatinibom i /ili nilotinibom (treća linija)
English: Discontinuations due to suboptimal response or treatment failure as assessed by the investigator occurred for 2.0% of patients in the bosutinib-treated group compared to 6.3% of patients in the imatinib-treated group.
Croatian: Do prekida primjene lijeka zbog suboptimalnog odgovora ili neuspješnog liječenja prema procjeni ispitivača došlo je u 2,0% bolesnika u skupini liječenoj bosutinibom, u usporedbi sa 6,3% bolesnika u skupini liječenoj imatinibom.
English: Monitoring for an effect on the QTc is advisable and a baseline electrocardiogram (ECG) is recommended prior to initiating therapy with bosutinib and as clinically indicated.
Croatian: Preporučuje se praćenje učinka na QTc i preporučeno je snimanje ishodišnog elektrokardiograma (EKG-a) prije početka terapije bosutinibom te kad god je to klinički indicirano.
English: In vitro studies with human liver microsomes indicated that the major cytochrome P450 isozyme involved in the metabolism of bosutinib is CYP3A4 and drug interaction studies have shown that ketoconazole and rifampicin had marked effect on the pharmacokinetics of bosutinib (see section 4.5).
Croatian: In vitro ispitivanja na mikrosomima ljudske jetre pokazuju da je CYP3A4 bio glavni izoenzim citokroma P450 uključen u metabolizam bosutiniba, a ispitivanja interakcije lijekova pokazala su da ketokonazol i rifampicin imaju značajni učinak na farmakokinetiku bosutiniba (vidjeti dio 4.5).
English: - if you have diarrhoea and vomiting.
Croatian: - ako imate proljev i povraćate.
English: In a study in liver impaired subjects, an increasing frequency of QTc prolongation > 450 ms with declining hepatic function was observed.
Croatian: U ispitivanju na ispitanicima s oštećenjem jetre zapaženo je povećavanje učestalosti produljenja QTc-a > 450 ms s pogoršavanjem jetrene funkcije.
English: A 200 mg dose of bosutinib administered with food was evaluated in a cohort of 18 hepatically impaired subjects (Child-Pugh classes A, B, and C) and 9 matched healthy subjects.
Croatian: Doza od 200 mg bosutiniba primijenjena s hranom procijenjena je u kohorti od 18 ispitanika s oštećenjem jetre (Child-Pugh stadiji A, B i C) i 9 odgovarajućih zdravih ispitanika.
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.
Croatian: Porast jetrenih transaminaza: ako se javi porast jetrenih transaminaza > 5 × institucionalne gornje granice normale (GGN), liječenje bosutinibom mora se prekinuti do oporavka na ≤ 2,5 × GGN, a može se nastaviti nakon toga s 400 mg jedanput dnevno.
English: Infections Bosutinib may predispose patients to bacterial, fungal, viral, or protozoan infections.
Croatian: Bosutinib može uzrokovati povećanu sklonost bolesnika bakterijskim, gljivičnim, virusnim ili protozoalnim infekcijama.
English: If a strong or moderate CYP3A inhibitor must be administered during bosutinib treatment, an interruption of bosutinib therapy or a dose reduction in bosutinib should be considered.
Croatian: Ako se tijekom liječenja bosutinibom mora primijeniti snažni ili umjereni inhibitor CYP3A, mora se razmotriti prekid terapije bosutinibom ili smanjenje doze bosutiniba.
English: Treatment with bosutinib is associated with diarrhoea and vomiting; therefore, patients with recent or ongoing clinically significant gastrointestinal disorder should use this medicinal product with caution and only after a careful benefit-risk assessment as respective patients were excluded from the clinical studies.
Croatian: Liječenje bosutinibom povezano je s proljevom i povraćanjem, stoga bolesnici s nedavnim ili trenutačnim klinički značajnim gastrointestinalnim poremećajem moraju koristiti ovaj lijek uz oprez i to samo nakon pažljive procjene omjera koristi i rizika jer su takvi bolesnici bili isključeni iz kliničkih ispitivanja.
English: Based on a population pharmacokinetic analysis increasing exposure (AUC) in patients with moderate and severe renal impairment at initiation of treatment during studies was observed (see sections 4.2 and
Croatian: Temeljem farmakokinetičke analize populacije, tijekom ispitivanja zapaženo je povećanje izloženosti lijeku (AUC) na početku liječenja bolesnika s umjerenim i teškim oštećenjem bubrega (vidjeti dijelove 4.2 i
English: Stomach/intestinal disorders.
Croatian: Poremećaji želuca/crijeva.
English: In in vitro studies, bosutinib inhibits proliferation and survival of established CML cell lines, Ph+ ALL cell lines, and patient-derived primary primitive CML cells.
Croatian: U in vitro ispitivanjima bosutinib inhibira proliferaciju i preživljenje odabranih staničnih linija KMLa, staničnih linija Ph+ ALL i primarnih primitivnih stanica KML-a dobivenih od bolesnika.
English: Repeated-dose toxicity
Croatian: Toksičnost ponovljenih doza
English: Dehydration, Hyperkalaemia, Hypophosphataemia Nervous system disorders Very common Headache Common
Croatian: Dehidracija, hiperkalijemija, hipofosfatemija Poremećaji živčanog sustava Vrlo često
English: Women of childbearing potential should be advised to use effective contraception during treatment with bosutinib and for at least 1 month after the last dose and to avoid becoming pregnant while receiving bosutinib.
Croatian: Žene reproduktivne dobi potrebno je savjetovati da koriste učinkovitu kontracepciju tijekomliječenja bosutinibom i do najmanje mjesec dana nakon zadnje doze te da izbjegavaju trudnoću tijekom liječenja bosutinibom.
English: Caution is recommended in patients with previous history of pancreatitis.
Croatian: Preporučuje se oprez u bolesnika koji u anamnezi imaju pankreatitis.
English: Caution should be exercised in patients with recent or ongoing clinically significant gastrointestinal disorder (see section 4.4).
Croatian: Nužan je oprez u bolesnika s nedavnim ili trenutačnim klinički značajnim gastrointestinalnim poremećajem (vidjeti dio 4.4).
English: Breast-feeding should be discontinued during treatment with bosutinib.
Croatian: Dojenje se mora prekinuti za vrijeme liječenja bosutinibom.
English: Includes patients (N) with a valid baseline assessment.
Croatian: Uključuje bolesnike (N) s važećom početnom procjenom.
English: (Cyprus Branch) Tηλ+357 22 817690
Croatian: Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ+357 22 817690
English: If you are taking any of them, tell your doctor.
Croatian: Ako uzimate bilo koji od navedenih lijekova, obavijestite svog liječnika.
English: In clinical studies, patients with uncontrolled or significant cardiac disease (e.g., recent myocardial infarction, congestive heart failure or unstable angina) were excluded.
Croatian: Iz kliničkih ispitivanja isključeni su bolesnici s nekontroliranom ili značajnom srčanom bolešću (npr. nedavni infarkt miokarda, kongestivno zatajenje srca ili nestabilna angina).
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.
Croatian: Obavijestite svog liječnika ako imate srčani poremećaj kao što je poremećaj provođenja električnih impulsa pod nazivom “produljenje QT intervala”, ili ako se onesvijestite (gubitak svijesti) ili ako imate nepravilne otkucaje srca dok uzimate Bosulif.
English: In healthy subjects given a single intravenous dose of 120 mg bosutinib, the mean (%CV) terminal elimination half-life was 35.5 (24) hours, and the mean (%CV) clearance was 61.9 (26) L/h.
Croatian: U zdravih ispitanika koji su intravenski primili jednu dozu od 120 mg bosutiniba, srednja vrijednost (% CV) terminalnog poluvijeka eliminacije bila je 35,5 (24) sata, a srednja vrijednost (% CV) klirensa 61,9 (26) l/h.
English: Doses less than 300 mg/day have been used; however, efficacy has not been established.
Croatian: Doze manje od 300 mg/dan su primjenjivane, ali njihova djelotvornost još nije utvrđena.
English: The tablet film-coating contains polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) and iron oxide yellow (E172, for Bosulif 100 mg and 400 mg) or iron oxide red (E172, for Bosulif 400 mg and 500 mg).
Croatian: Film ovojnica tablete sadrži poli(vinilni alkohol), titanijev dioksid (E171), makrogol 3350, talk (E553b) i žuti željezov oksid (E172, za Bosulif 100 mg i 400 mg) ili crveni željezov oksid (E172, za Bosulif 400 mg i 500 mg).
English: Bosulif contains the active substance bosutinib.
Croatian: Bosulif sadrži djelatnu tvar bosutinib.
English: Patients receiving bosutinib should have liver function tests prior to treatment initiation and monthly for the first 3 months of treatment, and as clinically indicated.
Croatian: Bolesnici koji primaju bosutinib moraju napraviti testove jetrene funkcije prije početka liječenja, zatim svaki mjesec tijekom prva 3 mjeseca liječenja i kad god je to klinički indicirano.
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).
Croatian: Odmah obavijestite svog liječnika ako imate bilo koji od sljedećih simptoma: krvarenje, vrućicu ili lako stvaranje modrica (možda imate poremećaj krvi ili limfnog sustava).
English: At Months 3, 6, and 9, the proportion of patients with MMR was higher in the bosutinib treatment group compared to the imatinib treatment group (Table 4).
Croatian: U 3., 6. i 9. mjesecu udio bolesnika s MMR-om bio je veći u skupini koja je liječena bosutinibom nego u skupini koja je liječena imatinibom (Tablica 4).
English: Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.
Croatian: U nekim je slučajevima došlo do akutnog zatajenja jetre ili fulminantnog hepatitisa što je dovelo do transplantacije jetre ili smrtnog ishoda.
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).
Croatian: Važno je procijeniti funkciju bubrega prije početka liječenja i pažljivo je pratiti tijekom terapije bosutinibom, uz poseban oprez u bolesnika s postojećim oštećenjem bubrega ili u bolesnika koji imaju faktore rizika za disfunkciju bubrega, uključujući istodobnu primjenu lijekova s potencijalom nefrotoksičnosti poput diuretika, inhibitora angiotenzin konvertirajućeg enzima (ACE inhibitora), antagonista angiotenzinskih receptora i nesteroidnih protuupalnih lijekova (NSAIL).
English: 112 film-coated tablets.
Croatian: 112 filmom obloženih tableta.