FrancophonIA/ELRC3.0 huggingface dataset:
English: • nerve disorder in the arms and/or legs (often causes numbness and pain in the hands and feet)
Croatian: • poremećaj živaca u rukama i/ili nogama (često uzrokuje utrnulost i bol u šakama i stopalima)
English: Transporter substrates
Croatian: Supstrati transportera
English: Majora (MaHR)
Croatian: Značajana (MaHR)
English: • uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris)
Croatian: • neugodan pritisak, osjećaj punoće, stezanje ili bol u sredini prsišta (angina pectoris)
English: Hypertension may contribute to risk of arterial thrombotic events.
Croatian: Hipertenzija može doprinijeti riziku za arterijski trombotski događaje.
English: Do not take Iclusig • if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na ponatinib ili neki drugi sastojak ovog lijeka (popis u dijelu 6).
English: Table 1 Dose modifications for myelosuppression
Croatian: Tablica 1 Prilagodbe doze za mijelosupresiju
English: Patients with severe or very severe hypertriglyceridemia should be appropriately managed to reduce the risk of pancreatitis.
Croatian: Bolesnike s teškom hipertrigliceridemijom treba odgovarajuće liječiti kako bi se smanjio rizik od pankreatitisa.
English: • metabolic disorders caused by the break-down products of dying cancer cells
Croatian: • poremećaji metabolizma uzrokovani razgradnim produktima odumirućih stanica raka
English: • a heart rhythm disorder, abnormal pulse
Croatian: • poremećaj srčanog ritma, abnormalan puls
English: The majority of patients who underwent dose reduction maintained response (MCyR and MMR) for the duration of currently available follow-up.
Croatian: Većina bolesnika kojima je smanjena doza, zadržala je odgovor (MCyR i MMR) u trajanju trenutno dostupnog praćenja.
English: Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, and phototoxicity studies.
Croatian: Iclusig je ocijenjen u studijama sigurnosne farmakologije, toksičnosti ponovljene doze, genotoksičnosti, reproduktivne toksičnosti i fototoksičnosti.
English: The risk of vascular occlusive events is likely to be dose-related.
Croatian: Rizik od događaja vaskularne okluzije je vjerojatno povezan s dozom.
English: Iclusig should be used during pregnancy only when clearly necessary.
Croatian: Iclusig se ne smije primjenjivati za vrijeme trudnoće osim ako to nije neophodno.
English: Frequency categories are very common (≥ 1/10), common (≥1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Croatian: 3. Kategorije učestalosti su vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10) i manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • rash, dry skin
Croatian: • osip, suha koža
English: Age Median, years (range) Gender, n (%) Male Race, n (%) Asian Black/African American White Other ECOG Performance Status, n (%) ECOG=0 or 1 Disease History Median time from diagnosis to first dose, years (range) Resistant to Prior TKI Therapy*, n (%) Prior TKI therapy- number of regimens, n (%)
Croatian: Dob Medijan, godine (raspon) Spol, n(%) Muškarci Rasa, n(%) Azijati Crnci/Afroamerikanci Bjelci Drugi ECOG funkcionalni status, n (%) ECOG=0 ili 1 Povijest bolesti Medijan vremena od postavljanja dijagnoze do prve doze, godine (raspon) Rezistentni na prethodnu TKI terapiju*, n(%) Prethodna TKI terapija- broj režima, n (%)
English: • Instructions on management of adverse events based on monitoring and dose modifications or treatment withdrawal.
Croatian: • Upute za zbrinjavanje štetnih događaja na osnovu praćenja i prilagodba doze ili prestanak liječenja.
English: In the phase 2 trial, dose reductions were recommended following adverse events; in addition in October 2013 new recommendations for prospective dose reduction in all CP-CML patients in the absence of adverse events were introduced in this trial with the aim of reducing the risk of vascular occlusive events.
Croatian: U ispitivanju faze 2, smanjenja doze preporučena su nakon pojave štetnih događaja; osim toga u listopadu 2013. u ovom ispitivanju uvedene su nove preporuke za prospektivno smanjenje doze za sve bolesnike u kroničnoj fazi KML bez štetnih događaja s ciljem smanjenja rizika za događaje vaskularne okluzije.
English: Ponatinib did not exhibit genotoxic properties when evaluated in the standard in vitro and in vivo systems.
Croatian: Ponatinib nije iskazao genotoksična svojstva prilikom procjenjivanja u standardnim in vitro i in vivo sustavima.
English: If you forget to take Iclusig
Croatian: Ako ste zaboravili uzeti Iclusig
English: Other covariates that show a statistically significant association with the occurrence of vascular occlusive events in this analysis are medical history of ischemia and age.
Croatian: Druge kovarijable koje pokazuju statistički značajnu povezanost s pojavom događaja vaskularne okluzije u ovoj analizi su ishemija u povijesti bolesti i dob.
English: Iclusig with food and drink Avoid grapefruit products such as grapefruit juice.
Croatian: Izbjegavajte proizvode s grejpfrutom kao što je sok od grejpfruta.
English: First occurrence:
Croatian: Prva pojava:
English: A reduction in dose is therefore expected to reduce the risk of vascular occlusive events, however, the analysis suggested that there may be a ‘carry over' effect of higher doses such that it might take up to several months before a dose reduction manifests in risk reduction.
Croatian: Očekuje se stoga da smanjenje doze smanji rizik za događaje vaskularne okluzije, međutim, analiza ukazuje da je moguć prijenos učinka većih doza takav da bi trebalo nekoliko mjeseci da se smanjenje doze manifestira smanjenjem rizika.
English: Table 4 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥2% of patients in any disease group Laboratory Test
Croatian: Tablica 4 Incidencija klinički značajnih laboratorijskih abnormalnosti stupnja ¾* u ≥2% bolesnika u bilo kojoj skupini bolesti Laboratorijski test
English: See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 Situations where an alternative treatment may be considered.
Croatian: Prije početka liječenja vidjeti dio 4.2 za ocjenu kardiovaskularnog stanja i 4.4 za situacije u kojima treba razmotriti alternativno liječenje.
English: During Iclusig treatment, blood pressure should be monitored and managed at each clinic visit and hypertension should be treated to normal.
Croatian: Tijekom liječenja Iclusigom krvni tlak se mora pratiti i liječiti pri svakoj posjeti klinici, a hipertenzija se mora liječenjem dovesti do normale.
English: At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥50% reduction of CRKL phosphorylation, a biomarker of BCR-ABL inhibition, in peripheral blood mononuclear cells.
Croatian: Pri dozama od 15 mg ili većim, 32 od 34 bolesnika (94%) pokazala su redukciju od ≥50% fosforilacije CRKL, biomarkera za inhibiciju BCR-ABL u mononuklearnim stanicama periferne krvi.
English: What you need to know before you take Iclusig
Croatian: Što morate znati prije nego počnete uzimati Iclusig Nemojte uzimati Iclusig
English: Table 10 shows these data for patients who achieved MCyR and MMR at 45 mg; similar data are available for patients who achieved MCyR and MMR at 30 mg.
Croatian: Tablica 10 pokazuje te podatke za bolesnike koji su postigli MCyR i MMR pri 45 mg; slični su podatci dostupni za bolesnike koji su postigli MCyR i MMR pri 30 mg.
English: Interrupt Iclusig for serious or severe haemorrhage and evaluate.
Croatian: Prekinite davanje Iclusiga kod ozbiljne ili teške hemoragije i načinite procjenu.
English: Compared to patients < 65 years, older patients are more likely to experience adverse reactions.
Croatian: U usporedbi s bolesnicima mlađim od 65 godina, veća je vjerojatnost da će stariji bolesnici imati nuspojave.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use are described below.
Croatian: Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama ekspozicije sličnim razinama ekspozicije u ljudi i s mogućom važnošću za kliničku primjenu, bile su kako je niže opisano:
English: Iclusig use may be resumed at the same, or a reduced dose, after the event is resolved or controlled.
Croatian: Uporaba lijeka Iclusig može se nastaviti pri istoj ili smanjenoj dozi nakon što se štetni događaj povuče ili stavi pod kontrolu.
English: Caution is recommended in patients with a history of pancreatitis or alcohol abuse.
Croatian: Potreban je oprez kod bolesnika s anamnezom pankreatitisa ili zlouporabe alkohola.
English: Table 5 Demographics and disease characteristics
Croatian: Tablica 5 Demografske karakteristike te karakteristike bolesti
English: If abnormal results from blood tests are received, a doctor should be contacted immediately.
Croatian: Ako rezultati krvnih pretraga odstupaju od normalnih vrijednosti, odmah se treba obratiti liječniku.
English: Number of Patients
Croatian: Broj bolesnika
English: Although plasma ponatinib exposures increased to steady-state levels with continuous dosing, a population pharmacokinetic analysis predicts a limited increase in apparent oral clearance within the first two weeks of continuous dosing, which is not considered clinically relevant.
Croatian: Iako se izloženost ponatinibu u plazmi s kontinuiranim doziranjem povećala do razina u stanju dinamičke ravnoteže, populacijska farmakokinetička analiza predviđa ograničeni porast za prividni peroralni klirens unutar prva dva tjedna kontinuiranog doziranja, što se ne smatra klinički relevantnim.
English: However, a thorough QT study has not been performed; therefore a clinically significant effect on QT cannot be excluded.
Croatian: Nisu provedena dodatna ispitivanja utjecaja Inclusiga na QT interval; stoga se klinički značajan učinak na QT interval ne može isključiti.
English: Patient characteristics at entry
Croatian: Karakteristike bolesnika kod ulaska u ispitivanje
English: Renal excretion is not a major route of ponatinib elimination.
Croatian: Izlučivanje putem bubrega nije glavni put eliminacije ponatiniba.
English: Ponatinib is highly bound (>99%) to plasma proteins in vitro.
Croatian: Ponatinib se izrazito veže na proteine plazme (>99%) u in vitro uvjetima.
English: Compared to healthy volunteers with normal liver function, no major differences in ponatinib PK were observed in patients with varying degrees of hepatic impairment.
Croatian: U usporedbi sa zdravim dobrovoljacima s normalnom funkcijom jetre, nisu uočene veće razlike u farmakokinetičkim parametrima ponatiniba u bolesnika s različitim stupnjevima oštećenja jetre.
English: • The active substance is ponatinib.
Croatian: • Djelatna tvar je ponatinib.
English: You should take special care when driving and using machines as patients taking Iclusig may experience visual disturbance, dizziness, sleepiness, and tiredness.
Croatian: Budite posebice oprezni prilikom upravljanja vozilima i strojevima jer bolesnici koji uzimaju Iclusig mogu iskusiti smetnje vida, omaglicu, pospanost i umor.
English: Ponatinib is metabolized by CYP3A4.
Croatian: Ponatinib se metabolizira putem CYP3A4.
English: • rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections.
Croatian: • rifabutin, rifampicin: lijekovi za liječenje tuberkuloze ili određenih drugih infekcija.
English: • increased or reduced sense of touch or sensation, abnormal sensation such as prickling, tingling and itchiness
Croatian: • povećani ili smanjeni osjeti ili samo osjet dodira, neuobičajeni osjeti poput bockanja, trnaca i svrbeža
English: The European Medicines Agency has waived the obligation to submit the results of studies with Iclusig in children from birth to less than 1 year in CML and Ph+ ALL.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Iclusig u djece od rođenja do manje od godine dana s KML i Ph+ALL.
English: • increased tendency to bleed or bruise
Croatian: • povećana sklonost krvarenju ili nastajanju modrica
English: In patients with CML and Ph+ ALL, changes in the DNA trigger a signal that tells the body to produce abnormal white blood cells.
Croatian: U bolesnika s KML i Ph+ALL, opisana promjena u DNK djeluje kao okidač koji navodi tijelo da stvara nenormalne bijele krvne stanice.
English: Preliminary data from the phase 2 trial are available on the maintenance of response (MCyR and MMR) in all CP-CML patients who underwent dose reduction for any reason.
Croatian: Dostupni su preliminarni podatci iz ispitivanja faze 2 o održavanju odgovora (MCyR i MMR) u svih bolesnika u kroničnoj fazi KML kojima je iz bilo kojeg razloga smanjena doza.
English: The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is ongoing.
Croatian: Antileukemična aktivnost lijeka Iclusig također je procijenjena u ispitivanju faze 1 povišenja doze koja je uključivala 65 bolesnika s KML i Ph+ALL; ispitivanje je u tijeku.
English: In this kind of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, the Philadelphia chromosome.
Croatian: Kod ove vrste leukemije dolazi do preslagivanja dijela DNK (genetski materijal) i stvaranja nenormalnog kromosoma, Philadelphia kromosoma.
English: • carbamazepine: a medicine to treat epilepsy, euphoric/depressive stages and certain pain conditions.
Croatian: • karbamazepin: lijek za liječenje epilepsije, euforičnih/depresivnih stanja i određenih bolnih stanja.
English: Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase
Croatian: Tablica 2 Prilagodba doze u slučaju pankreatitisa i povišenja serumske lipaze/amilaze Pankreatitis 2. stupnja i/ili asimptomatsko povišenje lipaze/amilaze
English: An integrated population pharmacokinetic analysis completed for ponatinib suggests that age may be predictive of variability for ponatinib apparent oral clearance (CL/F).
Croatian: Integrirana populacijska farmakokinetska analiza provedena za ponatinib upućuje na to da dob može predskazivati varijabilnost za prividni peroralni klirens ponatiniba (CL/F).
English: Formal studies of ponatinib with anti-clotting medicinal products have not been conducted.
Croatian: Formalna ispitivanja ponatiniba s lijekovima protiv zgrušavanja nisu provedena.
English: AST increased
Croatian: Povišena AST
English: The carboxylic acid and the N-desmethyl metabolite comprise 58% and 2% of the circulating levels of ponatinib, respectively.
Croatian: Karboksilna kiselina i N-desmetil metabolit čine 58% odnosno 2% cirkulirajuće razine ponatiniba.
English: Ponatinib is metabolized to an inactive carboxylic acid by esterases and/or amidases, and metabolized by CYP3A4 to an N-desmethyl metabolite that is 4 times less active than ponatinib.
Croatian: Ponatinib se metabolizira u inaktivnu karboksilnu kiselinu putem esteraza i/ili amidaza i metabolizirati putem CYP3A4 u N-desmetil metabolit koji je 4 puta manje aktivan od ponatiniba.
English: If a dose reduction is considered, the following factors should be to taken into account in the individual benefit-risk assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1).
Croatian: Ako se razmatra smanjenje doze, u individualnoj procjeni koristi i rizika moraju se u obzir uzeti sljedeći čimbenici:kardiovaskularni rizik, nuspojave liječenja ponatinibom, vrijeme do citogenetičkog odgovora i razine BCR-ABL transkripta (vidjeti dijelove 4.4 i 5.1).
English: Vascular occlusion (see section 4.2 and 4.4).
Croatian: Vaskularna okluzija (vidjeti dio 4.2 i 4.4)
English: Caution should be exercised with concurrent use of Iclusig and moderate and strong CYP3A inhibitors and moderate and strong CYP3A inducers (see section 4.5).
Croatian: Potreban je oprez s istovremenom primjenom lijeka Iclusig i umjerenih i jakih inhibitora CYP3A te umjerenih i jakih induktora CYP3A (vidjeti dio 4.5).
English: • checks of the serum protein known as lipase A serum protein called lipase will be checked every 2 weeks for the first 2 months, then periodically.
Croatian: • provjera razine proteina zvanog serumska lipaza Serumska lipaza provjeravat će se svaka 2 tjedna tijekom prva 2 mjeseca i potom povremeno.
English: BP-CML/Ph+ ALL (N=94)
Croatian: BP-KML/Ph+ ALL (N=94)
English: Inform your doctor immediately if pancreas inflammation occurs.
Croatian: Odmah obavijestite svog liječnika ako se pojavi upala gušterače.
English: Iclusig is associated with pancreatitis.
Croatian: Liječenje lijekom Iclusig je povezano s pankreatitisom.
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median durations of MCyR and MMR had not yet been reached.
Croatian: U vrijeme podnošenja ažuriranog izvješća s praćenjem svih uključenih bolesnika tijekom najmanje 27 mjeseci, medijan trajanja MCyR i MMR još nije bio dosegnut.
English: The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients who received 30 mg, 45 mg, or 60 mg Iclusig once daily.
Croatian: Učinak lijeka Iclusig na produljenje QT intervala procijenjen je u 39 bolesnika s leukemijom koji su primali 30 mg, 45 mg ili 60 mg lijeka Iclusig jednom dnevno.
English: Women of childbearing potential/Contraception in males and females Women of childbearing age being treated with Iclusig should be advised not to become pregnant and men being treated with Iclusig should be advised not to father a child during treatment.
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Ženama reproduktivne dobi koje se liječe lijekom Iclusig treba savjetovati da ne zatrudne, a muškarcima koji se liječe lijekom Iclusiga također treba savjetovati da ne začnu dijete tijekom liječenja.
English: Therefore, ponatinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) or BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine) and may increase their therapeutic effect and adverse reactions.
Croatian: Stoga ponatinib može smanjiti plazmatske koncentracije istovremeno primijenjenih supstrata P-gp (poput digoksina, dabigatrana, kolhicina, pravastatina) ili BCRP (poput metotreksata, rosuvastatina, sulfasalazina) i može povećati njihov terapijski učinak i nuspojave.
English: The Marketing Authorisation Holder shall ensure that in each Member State where ICLUSIG is marketed all physicians who are expected to prescribe ICLUSIG are provided with the Healthcare Professional
Croatian: Nositelj odobrenja mora osigurati da u svakoj državi članici u kojoj se ICLUSIG stavlja u promet, svi liječnici za koje se predviđa da će propisivati ICLUSIG dobiju brošuru za zdravstvene radnike.
English: • pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels.
Croatian: • pravastatin, rosuvastatin: lijekovi za snižavanje povišenih razina kolesterola.
English: How to take Iclusig
Croatian: Kako uzimati Iclusig
English: Following single and multiple 45 mg doses of Iclusig, the terminal elimination half-life of ponatinib was 22 hours, and steady state conditions are typically achieved within 1 week of continuous dosing.
Croatian: Nakon pojedinačne i višestruke doze Iclusiga od 45 mg, terminalni poluvijek eliminacije ponatiniba iznosio je 22 sata, a stanje dinamičke ravnoteže se postiže unutar tjedan dana neprekidnog doziranja.
English: A complete blood count should be performed every 2 weeks for the first 3 months and then monthly or as clinically indicated.
Croatian: Kompletnu krvnu sliku treba kontrolirati svaka 2 tjedna tijekom prva 3 mjeseca liječenja te zatim jednom mjesečno ili kada je klinički indicirano.
English: • chest pain not in connection with the heart
Croatian: • bol u prsištu koja nije povezana sa srcem
English: In a patient suspected of developing an arterial or venous occlusive event, Iclusig should be immediately interrupted.
Croatian: U bolesnika kod kojih se sumnja na razvoj arterijskog ili venskog okluzijskog događaja, primjena Iclusig se mora odmah prekinuti.
English: In juvenile rats, mortality related to inflammatory effects was observed in animals treated with 3 mg/kg/day, and reductions in body weight gain were observed at doses of 0.75, 1.5 and 3 mg/kg/day during the pre weaning and early post weaning treatment phases.
Croatian: U mladih štakora, smrtnost povezana s upalnim učincima zabilježena je u životinja liječenih s 3 mg/kg/dan, a smanjenje u dobivanju na tjelesnoj težini zabilježeno je pri dozama 0,75; 1,5 i 3 mg/kg/dan tijekom faza liječenja u razdoblju prije prestanka sisanja i ranom razdoblju poslije prestanka sisanja.
English: Iclusig is indicated in adult patients with
Croatian: Iclusig je indiciran za liječenje odraslih bolesnika s:
English: For patients whose adverse reactions are resolved or attenuated in severity, Iclusig may be restarted and escalation of the dose back to the daily dose used prior to the adverse reaction may be considered, if clinically appropriate.
Croatian: Za bolesnike čije su se nuspojave povukle ili je njihova težina oslabila, Iclusig se može ponovno početi davati i može se razmotriti povećanje doze natrag na dnevnu dozu od prije nuspojave ako je to klinički opravdano.
English: • Recommendation to consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days).
Croatian: • Preporuka za razmatranje prekida davanja ponatiniba ako se potpuni hematološki odgovor ne javi za 3 mjeseca (90 dana).
English: • the number of white blood cells called neutrophils is reduced.
Croatian: • ako je smanjen broj bijelih krvnih stanica (leukocita) zvanih neutrofili.
English: Therefore, clinical medicinal product interactions are unlikely to occur as a result of ponatinib-mediated inhibition of substrates for these transporters.
Croatian: Stoga nisu vjerojatne kliničke interakcije lijekova koje će se javljati kao rezultat inhibicije supstrata ovih transportera ponatinibom.
English: Iclusig therapy should be prescribed by a doctor experienced in leukaemia treatment.
Croatian: Terapiju lijekom Iclusig treba propisati liječnik iskusan u liječenju leukemije.
English: Isolated reports of unintentional overdose with Iclusig were reported in clinical trials.
Croatian: Prijavljeni su izolirani slučajevi nenamjernog predoziranja lijekom Iclusig u kliničkim ispitivanjima.
English: Men receiving treatment with Iclusig are advised not to father a child during treatment.
Croatian: Muškarcima koji primaju Iclusig savjetuje se da ne začinju dijete tijekom liječenja.
English: • Information on important adverse reactions for which monitoring and/or dose adjustment are recommended as outlined in the SmPC: pancreatitis, increased amylase and lipase levels, myelosuppression, liver function test abnormalities, haemorrhage, cardiac failure/left ventricular dysfunction, vascular occlusive events and hypertension.
Croatian: • Informacije o važnim nuspojavama za koje se preporučuje praćenje i/ili prilagodba doze kako je navedeno u Sažetku opisa svojstava lijeka: pankreatitis, povišene razine amilaze i lipaze, mijelosupresija, poremećene vrijednosti testova jetrene funkcije, hemoragija, zatajenje srca/disfunkcija lijeve klijetke, događaji vaskularne okluzije i hipertenzija.
English: Patients aged 65 and over are more likely to be affected by side effects.
Croatian: Vjerojatnije je da će bolesnici od 65 godina i stariji biti zahvaćeni nuspojavama.
English: In addition, the pharmacokinetic-pharmacodynamic models show no exposure-effect relationship, with an estimated QTcF mean change of -6.4 ms (upper confidence interval -0.9 ms) at Cmax for the 60 mg group.
Croatian: Pored toga, farmakokinetički-farmakodinamički modeli nisu pokazali odnos izloženosti-učinka s procijenjenom prosječnom promjenom QTcF od -6,4 ms (gornji interval pouzdanosti -0,9 ms) pri Cmax za skupinu od 60 mg.