FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE08
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein-kinaze, ATK oznaka: L01XE08
English: Show them the pack of hard capsules and this package leaflet.
Croatian: Pokažite im pakiranje tvrdih kapsula i ovu uputu o lijeku.
English: Patients who lose MMR must re-initiate treatment within 4 weeks of when loss of remission is known to have occurred.
Croatian: Bolesnici koji izgube MMR moraju ponovo započeti liječenje u roku od 4 tjedna od trenutka saznanja o gubitku remisije.
English: There is a limited amount of data on pregnancies in patients while attempting treatment-free remission (TFR).
Croatian: Postoje ograničeni podaci o trudnoćama u bolesnica tijekom pokušaja ostvarivanja remisije bez liječenja (engl. treatment-free remission, TFR).
English: Tasigna must not be taken in conjunction with food (see sections 4.2 and 4.5) and should be taken 2 hours after a meal.
Croatian: Tasigna se ne smije uzimati zajedno s hranom (vidjeti dijelove 4.2 i 4.5), nego 2 sata nakon obroka.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to nilotinib exposure.
Croatian: S obzirom na to da se ne zna veličina populacije iz koje dolaze dobrovoljno prijavljeni slučajevi, nije uvijek moguće pouzdano procijeniti njihovu učestalost niti odrediti uzročno-posljedičnu vezu s izloženošću nilotinibu.
English: No effects on sperm count/motility or on fertility were noted in male and female rats up to the highest tested dose, approximately 5 times the recommended dosage for humans.
Croatian: Nije zamijećeno djelovanje na broj/pokretljivost sperme ili na plodnost u muških i ženskih štakora čak s najvišim ispitivanim dozama, koje su približno 5 puta veće od preporučene doze za primjenu u ljudi.
English: If a dose is missed the patient should not take an additional dose, but take the usual prescribed next dose.
Croatian: Ako bolesnik propusti uzeti dozu lijeka, ne smije uzimati dodatnu, već samo sljedeću redovnu propisanu dozu lijeka.
English: Since a risk to the newborns/infants cannot be excluded, women should not breast-feed during Tasigna treatment and for 2 weeks after the last dose.
Croatian: S obzirom da se ne može isključiti rizik za novorođenčad/dojenčad, žene ne smiju dojiti tijekom liječenja Tasignom i tijekom 2 tjedna nakon posljednje doze.
English: Nilotinib did not induce teratogenicity, but did show embryo- and foetotoxicity at doses that also showed maternal toxicity.
Croatian: Nilotinib ne inducira teratogenezu, ali je embrio- i fetotoksičan u dozama koje su također izazvale toksičnost u majke.
English: - Women who might get pregnant are advised to use highly effective contraception during treatment and for up to two weeks after ending treatment.
Croatian: - Ženama koje mogu zatrudnjeti savjetuje se korištenje visoko učinkovite kontracepcije tijekom liječenja i do dva tjedna nakon završetka liječenja.
English: If you have questions about how long to take Tasigna, talk to your doctor.
Croatian: Ako imate pitanja o tome koliko dugo ćete uzimati Tasignu, obratite se svom liječniku.
English: If you have any questions about how Tasigna works or why it has been prescribed for you or your child, ask your doctor.
Croatian: Ako imate bilo kakvih pitanja o tome kako Tasigna djeluje ili zašto je propisana Vama ili Vašem djetetu, obratite se svom liječniku.
English: Your doctor will regularly evaluate your treatment and decide whether you should continue to take Tasigna.
Croatian: Liječnik će redovito ocjenjivati Vaše liječenje i odlučiti trebate li nastaviti uzimati Tasignu.
English: Outcomes were reported as recovered.
Croatian: Ishod navedenih slučajeva bio je oporavak.
English: In patients with CML, a change in DNA (genetic material) triggers a signal that tells the body to produce abnormal white blood cells.
Croatian: U bolesnika s KML-om, promjene u DNK-u (genetski materijal) pokreću signal koji kaže tijelu da proizvodi veliki broj abnormalnih bijelih krvnih stanica.
English: Rifampicin, a potent CYP3A4 inducer, decreases nilotinib Cmax by 64% and reduces nilotinib AUC by 80%.
Croatian: Rifampicin, snažni induktor CYP3A4, snižava Cmax nilotiniba za 64% i umanjuje AUC nilotiniba za 80%.
English: Clinically relevant or severe abnormalities of routine haematological or biochemistry laboratory values in adult patients are presented in Table 5.
Croatian: Klinički značajne ili teške abnormalnosti rutinskih hematoloških ili biokemijskih laboratorijskih vrijednosti u odraslih bolesnika prikazane su u Tablici 5.
English: Isolated reports of intentional overdose with nilotinib were reported, where an unspecified number of Tasigna hard capsules were ingested in combination with alcohol and other medicinal products.
Croatian: Prijavljeni su izolirani slučajevi namjernog predoziranja nilotinibom u kojima je bio progutan nepoznati broj tvrdih kapsula Tasigne u kombinaciji s alkoholom i drugim lijekovima.
English: Tasigna is a treatment for children and adolescents with CML.
Croatian: Tasigna je lijek za djecu i adolescente s KML-om.
English: Anti-arrhythmic medicinal products and other substances that may prolong the QT interval
Croatian: Antiaritmici i druge tvari koje mogu produžiti QT interval
English: * Percentages are rounded to integer for presentation in this table.
Croatian: *Postotci su zaokruženi na cijeli broj u svrhu navođenja u ovoj tablici.
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a mutagenic potential of nilotinib.
Croatian: Ispitivanja genotoksičnosti u bakterijskim in vitro sistemima te u sisavaca u in vitro i in vivo sistemima sa ili bez metaboličke aktivacije nisu pokazala mutageni potencijal nilotiniba.
English: Similar events were observed in post-marketing reports.
Croatian: Slični su događaji bili uočeni u izvješćima nakon stavljanja lijeka u promet.
English: The following adverse reactions have been derived from post-marketing experience with Tasigna via spontaneous case reports, literature cases, expanded access programmes, and clinical studies other than the global registration trials.
Croatian: Sljedeće nuspojave izvučene su iz razdoblja nakon stavljanja Tasigne u promet putem spontanih prijava, slučajeva iz literature, programa proširenog pristupa i drugih kliničkih ispitivanja izuzev globalnih ispitivanja u svrhu registracije.
English: More than 60% of all patients were Caucasian and 25% of all patients were Asian.
Croatian: Više od 60% bolesnika su bili bijele rase, 25% svih bolesnika su bili azijatskog porijekla.
English: Table 6 Kinase profile of nilotinib (phosphorylation IC50 nM)
Croatian: Tablica 6 Profil učinka nilotiniba na kinaze (IC50 nM za fosforilaciju)
English: Novartis Pharma GmbH Roonstraße 25
Croatian: Novartis Pharma GmbH Roonstrasse 25
English: These tests will monitor: - the amount of blood cells (white blood cells, red blood cells and platelets) in the body to see how Tasigna is tolerated.
Croatian: Tim pretragama će se pratiti: - broj krvnih stanica (bijele krvne stanice, crvene krvne stanice i krvne pločice) u tijelu, kako bi se vidjelo kako podnosite Tasignu.
English: QT prolongation
Croatian: Produženje QT intervala
English: Food may enhance the absorption of Tasigna and therefore increase the amount of Tasigna in the blood, possibly to a harmful level.
Croatian: Hrana može ubrzati apsorpciju Tasigne i tako povećati količinu Tasigne u krvi, moguće i do štetne razine.
English: The juvenile animals did not exert increased sensitivity to nilotinib relative to adults.
Croatian: Mladi štakori nisu imali pojačanu osjetljivost na nilotinib u odnosu na odrasle.
English: You should also tell your doctor if you are already taking Tasigna and you are prescribed a new medicine that you have not taken previously during Tasigna treatment.
Croatian: Također trebate obavijestiti svog liječnika ako već uzimate Tasignu i ako Vam je tijekom liječenja Tasignom propisan novi lijek koji niste prije uzimali.
English: Up to 0.32 m
Croatian: Do 0,32 m
English: Time since TFR (weeks)
Croatian: Vrijeme od TFR-a (tjedni)
English: For a dose of 400 mg once daily (see dose adjustments below), 200 mg hard capsules are available.
Croatian: Za dozu od 400 mg jedanput na dan (vidjeti prilagođavanje doze ispod), dostupne su tvrde kapsule od 200 mg.
English: Median duration of treatment was 561 days for CP patients and 264 days for AP patients (see Table 10).
Croatian: Medijan trajanja liječenja bio je 561 dan za bolesnike u kroničnoj fazi i 264 dana za bolesnike u ubrzanoj fazi (vidjeti Tablicu 10).
English: Tasigna hard capsules contain lactose.
Croatian: Tasigna tvrde kapsule sadrže laktozu.
English: There was no evidence of carcinogenicity upon administration of nilotinib at 5, 15 and 40 mg/kg/day.
Croatian: Nije bilo dokaza karcinogenosti uslijed primjene nilotiniba u dozi od 5, 15 i 40 mg/kg/dan.
English: Tasigna demonstrated efficacy in patients harboring a variety of BCR-ABL mutations associated with imatinib resistance, except T315I.
Croatian: Tasigna je pokazala djelotvornost u bolesnika koji su razvili različite Bcr-Abl mutacije povezane s rezistencijom na imatinib, osim T315I.
English: In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, which are medicines against heartburn.
Croatian: Osim toga, obavijestite svojeg liječnika ili ljekarnika prije nego što uzmete Tasignu ako uzimate bilo koje antacide, odnosno lijekove protiv žgaravice.
English: The absolute bioavailability of nilotinib has not been determined.
Croatian: Apsolutna bioraspoloživost nilotiniba nije utvrđena.
English: Progression to accelerated phase (AP) or blast crisis (BC) on treatment is defined as the time from the date of randomisation to the first documented disease progression to accelerated phase or blast crisis or CML-related death.
Croatian: Progresija do ubrzane faze ili blastične krize pri terapiji definira se kao vrijeme od datuma randomizacije do prve dokumentirane progresije bolesti do ubrzane faze ili blastične krize ili smrti povezane s KML-om.
English: Table 9 Best CCyR rate
Croatian: Tablica 9 Najbolja stopa CCyR
English: Chronic phase
Croatian: Kronična faza
English: Repeated-dose toxicity studies in dogs of up to 4 weeks' duration and in cynomolgus monkeys of up to 9 months' duration revealed the liver as the primary target organ of toxicity of nilotinib.
Croatian: Ispitivanja toksičnosti ponovljenih doza u pasa u trajanju do 4 tjedna i u cinomolgus majmuna do 9 mjeseci pokazala su da je jetra primarni ciljni organ toksičnosti nilotiniba.
English: Randomisation was stratified by Sokal risk score at the time of diagnosis.
Croatian: Randomizacija je bila stratificirana po pokazatelju rizika prema Sokalu u vrijeme postavljanja dijagnoze.
English: H2 blockers should be taken approximately 10 hours before and approximately 2 hours after you take Tasigna; - antacids such as those containing aluminium hydroxide, magnesium hydroxide and simethicone, which neutralise high acidity in the stomach.
Croatian: Blokatore H2 receptora potrebno je uzimati približno 10 sati prije i približno 2 sata nakon uzimanja Tasigne; - antacidi kao što su oni koji sadrže aluminij hidroksid, magnezij hidroksid i simetikon, koji neutraliziraju visoku kiselost želuca.
English: If clinically significant moderate or severe non-haematological toxicity develops, dosing should be interrupted, and patients should be monitored and treated accordingly.
Croatian: Ako se razvije klinički značajna umjerena ili teška nehematološka toksičnost, doziranje treba prekinuti, a bolesnike pratiti i odgovarajuće liječiti.
English: Bioavailability/bioequivalence studies
Croatian: Ispitivanja bioraspoloživosti/bioekvivalencije
English: The MMR rate at 12, 24, 36, 48, 60 and 72 months is presented in Table 7.
Croatian: Stopa MMR-a u 12., 24., 36., 48., 60. i 72. mjesecu prikazana je u Tablici 7.
English: Since nilotinib and its metabolites are not renally excreted, a decrease in total body clearance is not anticipated in patients with renal impairment.
Croatian: Budući da se nilotinib i njegovi metaboliti ne izlučuju putem bubrega, ne očekuje se pad ukupnog tjelesnog klirensa u bolesnika s oštećenjem bubrega.
English: The MCyR rate in 321 CP patients was 51%.
Croatian: Stopa MCyR-a u 321 bolesnika u kroničnoj fazi bila je 51%.
English: Animal studies did not show an effect on fertility in male and female rats (see section 5.3).
Croatian: Ispitivanja u životinja nisu pokazala učinak na plodnost muških i ženskih štakora (vidjeti dio 5.3).
English: If you are taking any of these, your doctor might prescribe other alternative medicines.
Croatian: Ako uzimate neki od navedenih lijekova, liječnik Vam može propisati neki drugi lijek.
English: Table 10 Duration of exposure with nilotinib
Croatian: Tablica 10 Trajanje izloženosti nilotinibu
English: If you are pregnant or think that you may be, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.
Croatian: Ako ste trudni ili mislite da ste možda trudni, obavijestite svog liječnika koji će s Vama procijeniti možete li uzimati ovaj lijek tijekom Vaše trudnoće.
English: After a single dose of radiolabelled nilotinib in healthy subjects, more than 90% of the dose was eliminated within 7 days, mainly in faeces (94% of the dose).
Croatian: Nakon jednokratne doze radiooznačenog nilotiniba u zdravih ispitanika, više od 90% doze eliminiralo se unutar 7 dana, prvenstveno stolicom (94% doze).
English: Of these patients 30/36 (83%) were treatment resistant not intolerant.
Croatian: Od ovih bolesnika, u njih 30/36 (83%) razvila se rezistencija na liječenje, ali ga podnose.
English: Resistant (n=226)
Croatian: Rezistencija (n=226)
English: Hypokalaemia or hypomagnesaemia must be corrected prior to Tasigna administration and should be monitored periodically during therapy.
Croatian: Hipokalijemija ili hipomagnezijemija moraju se korigirati prije primjene Tasigne i trebaju se periodički pratiti tijekom liječenja.
English: Reproductive toxicity and fertility studies
Croatian: Ispitivanja reproduktivne toksičnosti i plodnosti
English: The median TFS has not yet been reached (Figure 5); 74 of 126 patients (58.7%) did not have a TFS event.
Croatian: Medijan TFS-a nije još dostignut (Slika 5); 74 od 126 bolesnika (58,7%) nije imalo TFS događaj.
English: No patient had a LVEF of <45% during treatment nor an absolute reduction in LVEF of more than
Croatian: Tijekom liječenja, niti jedan bolesnik nije imao LVEF <45% niti potpuno smanjenje LVEF za više od 15%.
English: 150 mg twice a day.
Croatian: 150 mg dva puta na dan.
English: Overall, 73% of patients were imatinib-resistant, while 27% were imatinib-intolerant.
Croatian: Ukupno gledajući, u 73% bolesnika bila je prisutna rezistencija na imatinib, a u 27% bolesnika intolerancija na imatinib.
English: 200 mg twice a day.
Croatian: 200 mg dva puta na dan.
English: Resistant (n=109)
Croatian: Rezistencija (n=109)
English: Based on a reduction in body weight in both genders and a delayed preputial separation in males (which may be associated with the reduction in weight), the No-Observed-Effect-Level in juvenile rats was considered to be 6 mg/kg/day.
Croatian: Na temelju sniženja tjelesne težine u oba spola i odgođenog odvajanja prepucija u mužjaka (što može biti povezano sa sniženjem tjelesne težine), doza od 6 mg/kg/dan se smatrala dozom bez opaženog učinka (No-Observed-Effect-Level) u mladih štakora.
English: In vitro, nilotinib is a relatively strong inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1, with Ki value being lowest for CYP2C9 (Ki=0.13 microM).
Croatian: In vitro je nilotinib relativno snažan inhibitor CYP3A4, CYP2C8, CYP2C9, CYP2D6 i UGT1A1, uz najnižu Ki vrijednost za CYP2C9 (Ki=0,13 mikroM).
English: The highest prior imatinib dose was 600 mg/day in 74% of all patients, with 40% of patients receiving imatinib doses 800 mg/day.
Croatian: Najveća prethodna doza imatiniba bila je 600 mg/dan u 74% svih bolesnika, a 40% bolesnika primao je doze imatiniba 800 mg/dan.
English: Contains lactose - see the package leaflet for further information.
Croatian: Sadrži laktozu - za dodatne informacije vidjeti uputu o lijeku.
English: If a woman who is being treated with nilotinib is considering pregnancy, treatment discontinuation may be considered based on the eligibility criteria for discontinuing treatment as described in sections 4.2 and 4.4.
Croatian: Ako žena liječena nilotinibom razmatra trudnoću, može se uzeti u obzir prekid liječenja temeljem kriterija koji trebaju biti ispunjeni za prekid liječenja kako je opisano u dijelovima 4.2 i 4.4.
English: If any of these apply to you or your child, tell your doctor.
Croatian: Ako se bilo što od navedenog odnosi na Vas ili Vaše dijete, obavijestite svog liječnika.
English: Hypophosphataemia (including blood phosphorus decreased)
Croatian: Hipofosfatemija (uključujući sniženje fosfora u krvi)
English: Eligibility for discontinuation of treatment
Croatian: Ispunjavanje uvjeta za prekid liječenja
English: None of the metabolites contribute significantly to the pharmacological activity of nilotinib.
Croatian: Niti jedan od metabolita ne utječe značajno na farmakološku aktivnost nilotiniba.
English: Cumulative incidence of MMR, %
Croatian: Kumulativna incidencija MMR-a, %
English: The rates of response for the two treatment arms are reported in Table 12.
Croatian: Stope odgovora u oba kraka liječenja prikazane su u Tablici 12.
English: The blood-to-plasma ratio of nilotinib is 0.71.
Croatian: Omjer nilotiniba u krvi i plazmi je 0,71.
English: Tasigna may be given in combination with haematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) if clinically indicated.
Croatian: Tasigna se može primijeniti u kombinaciji s hematopoetskim faktorima rasta kao što su eritropoetin ili faktor stimulacije granulocitnih kolonija (G-CSF) ako je klinički indicirano.
English: Pancreatitis, gastritis, sensitivity of teeth
Croatian: Pankreatitis, gastritis, osjetljivost zuba
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Women of childbearing potential have to use highly effective contraception during treatment with nilotinib and for up to two weeks after ending treatment.
Croatian: Žene reproduktivne dobi moraju koristiti visoko učinkovite mjere kontracepcije tijekom liječenja nilotinibom i do dva tjedna nakon završetka liječenja.
English: This study suggests that a clinically meaningful drug-drug interaction between nilotinib and warfarin is less likely up to a dose of 25 mg of warfarin.
Croatian: Ovo ispitivanje ukazuje da je značajna interakcija između nilotiniba i varfarina manje vjerojatna do doze od 25 mg varfarina.
English: The long-term effects of treating children with Tasigna for long periods of time are not known.
Croatian: Dugoročni učinci liječenja djece Tasignom tijekom duljih razdoblja nisu poznati.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Croatian: Vaše stanje da bi utvrdio ima li liječenje željeni učinak.
English: Nilotinib was shown to absorb light in the UV-B and UV-A range, is distributed into the skin and showed a phototoxic potential in vitro, but no effects have been observed in vivo.
Croatian: Nilotinib apsorbira svjetlo u UV-B i UV-A rasponu, distribuira se u kožu te pokazuje fototoksični potencijal in vitro, bez zabilježenog učinka in vivo.
English: However, it is recommended that patients experiencing dizziness, fatigue, visual impairment or other undesirable effects with a potential impact on the ability to drive or use machines safely should refrain from these activities as long as the undesirable effects persist (see section 4.8).
Croatian: Međutim, preporučuje se da bolesnici s omaglicom, umorom, poremećajima vida ili drugim nuspojavama koje mogu utjecati na sposobnost sigurnog upravljanja vozilom ili rada sa strojevima prestanu s tim aktivnostima sve dok traju nuspojave (vidjeti dio 4.8).
English: Patients with BCR-ABL levels ≤10% at 3 months of treatment show a greater overall survival at 72 months compared to those who did not achieve this molecular response level (94.5% vs. 77.1% respectively [p=0.0005]).
Croatian: Bolesnici s razinama BCR-ABL ≤10% nakon 3 mjeseca liječenja imaju veće ukupno preživljavanje u 72. mjesecu u usporedbi s onima koji nisu postigli tu razinu molekularnog odgovora (94,5% u odnosu na 77,1% [p=0,0005]).
English: It is unknown whether nilotinib is excreted in human milk.
Croatian: Nije poznato izlučuje li se nilotinib u majčino mlijeko u ljudi.
English: For patients who fail to achieve MMR after three months of treatment re-initiation, BCR-ABL kinase domain mutation testing should be performed.
Croatian: U bolesnika koji nisu postigli MMR tri mjeseca nakon ponovnog započinjanja liječenja potrebno je obaviti testiranje na mutaciju kinazne domene BCR-ABL.
English: - if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the QT interval”.
Croatian: - ako patite od srčanog poremećaja, kao što je poremećaj provođenja električnih impulsa pod nazivom „produženje QT intervala“.
English: Patients should be tested for HBV infection before initiating treatment with nilotinib.
Croatian: Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja nilotinibom.
English: It may increase the amount of Tasigna in the blood, possibly to a harmful level.
Croatian: To može povećati količinu Tasigne u krvi, moguće do razine koja Vam može naškoditi.
English: - Obligation to conduct post-authorisation measures
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
English: Median duration of therapy in days (25th-75th percentiles)
Croatian: Medijan trajanja liječenja u danima (25.-75. percentila)
English: The median highest prior imatinib dose had been 600 mg/day.
Croatian: Medijan najveće prethodne doze imatiniba bio je 600 mg/dan.
English: During treatment with Tasigna - if you faint (loss of consciousness) or have an irregular heart beat while taking this medicine, tell your doctor immediately as this may be a sign of a serious heart condition.
Croatian: Tijekom liječenja Tasignom - ako se onesvijestite (izgubite svijest) ili imate nepravilne otkucaje srca dok uzimate ovaj lijek, odmah obavijestite svog liječnika, jer to može biti znak ozbiljne srčane bolesti.
English: The KM estimate of median treatment-free survival (TFS) has not yet been reached (Figure 4); 99 of 190 patients (52.1%) did not have a TFS event.
Croatian: KM procjena medijana preživljenja bez liječenja (engl. treatment-free survival, TFS) nije još dostignuta (Slika 4); 99 od 190 bolesnika (52,1%) nije imalo TFS događaj.
English: If you stop taking Tasigna
Croatian: Ako prestanete uzimati Tasignu
English: Resistance to imatinib included failure to achieve a complete haematological response (by 3 months), cytogenetic response (by 6 months) or major cytogenetic response (by 12 months) or progression of disease after a previous cytogenetic or haematological response.
Croatian: Rezistencija na imatinib uključivala je neuspjeh u postizanju kompletnog hematološkog odgovora (do 3. mjeseca), citogenetskog odgovora (do 6. mjeseca) ili velikog citogenetskog odgovora (do 12. mjeseca), ili progresiju bolesti nakon prethodnog citogenetskog ili hematološkog odgovora.
English: The cardiovascular status of patients should be evaluated and cardiovascular risk factors monitored and actively managed during nilotinib therapy according to standard guidelines.
Croatian: Potrebno je ocijeniti kardiovaskularni status bolesnika i pratiti čimbenike kardiovaskularnog rizika te ih aktivno zbrinjavati tijekom terapije nilotinibom u skladu sa standardnim smjernicama.