FrancophonIA/ELRC3.0 huggingface dataset:
English: You may need to have additional treatment with other medicines, to take a lower dose of LENVIMA, or to take extra care due to an increased risk of side effects.
Croatian: Možda ćete trebati dodatno liječenje drugim lijekovima, uzimati nižu dozu LENVIME ili biti posebno oprezni zbog povećanog rizika od nuspojava.
English: Approximately half of the events of hepatic failure and one third of the events of the hepatic encephalopathy were reported in patients with disease progression.
Croatian: Približno pola slučajeva zatajenja jetre i jedna trećina epizoda hepatičke encefalopatije zabilježeno je u bolesnika s progresijom bolesti.
English: Of the 392 patients randomised, 76.3% were naïve to prior VEGF/VEGFR-targeted therapies, 49.0% were female, 49.7% were European, and the median age was 63 years.
Croatian: Od 392 randomizirana bolesnika, 76,3% prethodno nikad nije primalo terapije usmjerene na VEGF/VEGFR, 49,0% bile su žene, 49,7% bili su Europljani, a medijan dobi je iznosio 63 godine.
English: Do not take LENVIMA if:
Croatian: Nemojte uzimati LENVIMU:
English: Lenvatinib should be discontinued in the event of nephrotic syndrome.
Croatian: Primjenu lenvatiniba treba prekinuti u slučaju nastanka nefrotskog sindroma.
English: 18th September 2019
Croatian: DATUM REVIZIJE TEKSTA 18. rujna 2019.
English: Median OS was longer by approximately 2.5 months in the lenvatinib compared with the sorafenib arm in both subsets of subjects (with or without post-treatment anticancer therapy).
Croatian: Medijan OS-a bio je duži za približno 2,5 mjeseci u skupini na lenvatinibu u usporedbi sa skupinom na sorafenibu u obje podskupine ispitanika (sa ili bez terapije protiv raka nakon liječenja).
English: These patients also had a higher incidence of renal reactions and arterial thromboembolic events.
Croatian: Ti su bolesnici imali također veću incidenciju bubrežnih nuspojava i arterijskih tromboembolijskih događaja.
English: The majority of Grade 3 to 4 adverse reactions occurred during the first 6 months of treatment except for diarrhoea, which occurred throughout treatment, and weight loss, which tended to be cumulative over time.
Croatian: Većina nuspojava 3. do 4. stupnja nastala je tijekom prvih 6 mjeseci liječenja, osim proljeva koji se javljao tijekom cijelog razdoblja liječenja, te gubitka na tjelesnoj težini koji je imao tendenciju kumulacije tijekom vremena.
English: • bleeding (most commonly nose bleeds, but also other types of bleeding such as blood in the urine, bruising, bleeding from the gums or gut wall)
Croatian: • krvarenja (najčešće iz nosa, ali može uključivati i druge vrste krvarenja, kao što je krv u mokraći, modrice, krvarenje desni ili iz stijenke crijeva)
English: Patients with end-stage renal disease were not studied, therefore the use of lenvatinib in these patients is not recommended.
Croatian: Bolesnici sa završnim stadijem bubrežne bolesti nisu bili ispitani pa se stoga ne preporučuje primjena lenvatiniba u tih bolesnika.
English: • If it is less than 12 hours until your next dose: skip the missed dose.
Croatian: • Ako do sljedeće doze ima manje od 12 sati: preskočite propuštenu dozu.
English: Blood calcium levels should be monitored at least monthly and calcium should be replaced as necessary during lenvatinib treatment.
Croatian: Razine kalcija u krvi treba pratiti najmanje jednom mjesečno, a kalcij prema potrebi nadomještati tijekom liječenja lenvatinibom.
English: Within each frequency category, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: These cases were associated with adverse reactions consistent with the known safety profile of lenvatinib (i.e., renal and cardiac failure), or were without adverse reactions.
Croatian: Ti su slučajevi bili povezani s nuspojavama koje su bile u skladu s poznatim sigurnosnim profilom lenvatiniba (tj. zatajenje bubrega i srca) ili nije bilo nuspojava.
English: Persistent and Intolerable Grade 2 or Grade 3 Toxicitiesa Adverse Reaction Modification
Croatian: Ustrajne i nepodnošljive toksičnosti stupnja 2 ili 3a Nuspojava
English: Because it is not known if LENVIMA can reduce the effect of the oral contraceptive pill, if this is your normal method of contraception you should ensure you also add a barrier method such as the cap or condoms if you have sex during treatment with LENVIMA.
Croatian: Budući da se ne zna može li LENVIMA smanjiti učinak oralnih kontracepcijskih tableta, ako je to metoda kontracepcije koju uobičajeno koristite, morate obavezno dodati mehaničku metodu kontracepcije kao što su cervikalna kapa ili kondomi kada imate spolne odnose tijekom liječenja LENVIMOM.
English: • other types of fistulae (an abnormal connection between different organs in the body or between the skin and an underlying structure such as throat and windpipe).
Croatian: • druge vrste fistula (neprirodan spoj između različitih tjelesnih organa ili između kože i struktura koje ona prekriva, poput grla i dušnika).
English: CI, confidence interval; NE, not estimable.
Croatian: CI, interval pouzdanosti; NP, ne može se procijeniti
English: Second occurrence (same reaction or new reaction)
Croatian: Druga pojava (ista nuspojava ili nova nuspojava)
English: The clinical efficacy and safety of lenvatinib have been evaluated in an international, multicenter, open-label, randomised phase 3 study (REFLECT) in patients with unresectable hepatocellular carcinoma (HCC).
Croatian: Klinička djelotvornost i sigurnost lenvatiniba procijenjena je u međunarodnom, multicentričnom, otvorenom, randomiziranom ispitivanju (REFLECT) faze 3 u bolesnika s neoperabilnim hepatocelularnim karcinomom (HCC).
English: Stratified by region (Region 1: Asia-Pacific; Region 2: Western), macroscopic portal vein invasion or extrahepatic spread or both (yes, no), ECOG PS (0, 1) and body weight (<60 kg, ≥60 kg).
Croatian: b Stratificirano po regiji (Regija 1: Azija-Pacifik; Regija 2: Zapad), makroskopska invazija portalne vene ili širenje izvan jetre ili jedno i drugo (da, ne), ECOG PS (0, 1) i tjelesna težina
English: The SELECT study was a multicentre, randomised, double-blind, placebo-controlled trial that was conducted in 392 patients with radioiodine-refractory differentiated thyroid cancer with independent, centrally reviewed, radiographic evidence of disease progression within 12 months (+1 month window) prior to enrolment.
Croatian: Ispitivanje SELECT bilo je multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno u 392 bolesnika s diferenciranim rakom štitnjače refraktornim na radioaktivni jod i s neovisno, centralno pregledanim radiografskim dokazom progresije bolesti unutar 12 mjeseci (u rasponu od +1 mjesec) prije uključenja.
English: Patients with ≥50% liver occupation, clear invasion into the bile duct or a main branch of the portal vein (Vp4) on imaging were also excluded.
Croatian: Isključeni su i bolesnici s jetrom zahvaćenom ≥ 50%, jasnom invazijom u žučovod ili glavne grane portalne vene (Vp4) na snimci.
English: The degree of tumour invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
Croatian: Stupanj invazije/infiltracije tumora u velike krvne žile (npr. karotidnu arteriju) treba uzeti u obzir zbog mogućeg rizika od teškog krvarenja povezanog sa smanjenjem veličine/nekrozom tumora nakon terapije lenvatinibom.
English: • weigh less than 60 kg
Croatian: • imate tjelesnu težinu manju od 60 kg
English: Continue lenvatinib and initiate antihypertensive therapy, if not already receiving
Croatian: Nastavite s lenvatinibom i uvedite antihipertenzivnu terapiju, ako je bolesnik već ne uzima
English: Patients with hypertension
Croatian: Bolesnici s hipertenzijom
English: Your doctor can give you medicine to reduce these side effects.
Croatian: Liječnik Vam može dati lijek koji će ublažiti te nuspojave.
English: Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, MATE2-K or the bile salt export pump BSEP.
Croatian: Lenvatinib nije supstrat OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, MATE2-K ili pumpe za izbacivanje žučnhi soli BSEP-a.
English: The choice of antihypertensive treatment should be individualised to the patient's clinical circumstances and follow standard medical practice.
Croatian: Izbor antihipertenzivnog liječenja treba biti prilagođen pojedinom bolesniku prema kliničkim okolnostima, te u liječenju treba slijediti standardnu medicinsku praksu.
English: Symptoms and Management
Croatian: Simptomi i liječenje
English: • Prior treatments: hepatectomy (28%), radiotherapy (11%), loco-regional therapies including transarterial (chemo)embolisation (52%), radiofrequency ablation (21%) and percutaneous ethanol injection (4%)
Croatian: • Prethodna liječenja: hepatektomija (28%), radioterapija (11%), loko-regionalne terapije uključujući transarterijsku (kemo)embolizaciju (52%), radiofrekvencijsku ablaciju (21%) i perkutanu injekciju etanola (4%)
English: In vitro binding of lenvatinib to human plasma proteins is high and ranged from 98% to 99% (0.3 - 30 μg/mL, mesylate).
Croatian: In vitro, lenvatinib se u visokom postotku veže za proteine ljudske plazme i to u rasponu od 98% do 99% (0,3 - 30 μg/ml, mesilat).
English: Further dose adjustments may be necessary based on individual tolerability.
Croatian: Mogu biti potrebne daljnje prilagodbe doze na temelju podnošljivosti u pojedinog bolesnika.
English: Lenvatinib and its metabolites are excreted in rat milk.
Croatian: Lenvatinib i njegovi metaboliti izlučuju se u mlijeku štakora.
English: There have also been reports of overdose with lenvatinib involving single administrations of 6 to 10 times the recommended daily dose.
Croatian: Također su zabilježeni slučajevi predoziranja lenvatinibom koji su uključivali primjenu pojedinačne doze 6 do 10 puta veće od preporučene dnevne doze.
English: In case of suspected overdose, lenvatinib should be withheld and appropriate supportive care given as required.
Croatian: U slučaju sumnje na predoziranje, potrebno je prekinuti primjenu lenvatiniba i po potrebi primijeniti odgovarajuću potpornu njegu.
English: Life-threatening toxicities (Grade 4): Discontinuee a.
Croatian: Po život opasne toksičnosti (stupanj 4): Trajni prekide a.
English: 4.7 Effects on ability to drive and use machines Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Lenvatinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog nuspojava kao što su umor i omaglica.
English: A treatment decision should be made based upon an assessment of the individual patient's benefit/risk.
Croatian: Odluku o liječenju treba temeljiti na procjeni omjera koristi i rizika u pojedinog bolesnika.
English: Cases of fatal intracranial haemorrhage have been reported in some patients with or without brain metastases.
Croatian: Slučajevi smrtonosnog intrakranijalnog krvarenja zabilježeni su u nekih bolesnika s metastazama u mozgu ili bez njih.
English: The positive effect on PFS was seen across the subgroups of age (above or below 65 years), sex, race, histological subtype, geographic region, and those who received 0 or 1 prior VEGF/VEGFR-targeted therapies.
Croatian: Pozitivan učinak na PFS uočen je u različitim podskupinama razdijeljenim prema dobi (iznad i ispod 65 godina), spolu, rasi, histološkom podtipu i geografskoj regiji i onima koji su prethodno primili 0 ili 1 terapiju usmjerenu na VEGF/VEGFR.
English: The analogous median apparent volume of distribution at steady-state (Vz/Fss) was also generally consistent and ranged from 43.2 L to 121 L.
Croatian: Analogni medijan prividnog volumena distribucije u stanju dinamičke ravnoteže (Vz/Fss) također je većinom bio dosljedan i kretao se u rasponu od 43,2 l do 121 l.
English: Kaplan-Meier Curve of Progression-Free Survival - DTC
Croatian: Slika 1 Kaplan-Meierova krivulja preživljenja bez progresije bolesti - DTC
English: Number of capsules
Croatian: Broj kapsula
English: The median time to first onset was 11.9 weeks.
Croatian: Medijan vremena do prve pojave bio je 11,9 tjedana.
English: Resolves to Grade 0, 1 or See detailed guidance in Table 4 in section 4.4.
Croatian: Detaljne smjernice vidjeti u tablici 4 u dijelu 4.4.
English: Hypertension includes: hypertension, hypertensive crisis, increased diastolic blood pressure , , orthostatic hypertension, and increased blood pressure.
Croatian: Hipertenzija uključuje: hipertenziju, hipertenzivnu krizu, povišen dijastolički krvni tlak, ortostatsku hipertenziju i povišen krvni tlak.
English: M2' and M3', the major metabolites in human faeces, were formed from M2 and lenvatinib, respectively, by aldehyde oxidase.
Croatian: M2' i M3', glavni metaboliti u ljudskoj stolici, nastali su iz M2 odnosno lenvatiniba djelovanjem aldehid oksidaze.
English: Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia.
Croatian: Primjenu lenvatiniba treba privremeno prekinuti ili prilagoditi dozu prema potrebi, ovisno o težini, prisutnosti promjena u EKG-u i ustrajnosti hipokalcemije.
English: The highest doses of lenvatinib studied clinically were 32 mg and 40 mg per day.
Croatian: Najviše klinički ispitane doze lenvatiniba bile su 32 mg i 40 mg na dan.
English: In plasma samples collected up to 24 hours after administration, lenvatinib constituted 97% of the radioactivity in plasma radiochromatograms while the M2 metabolite accounted for an additional 2.5%.
Croatian: U uzorcima plazme prikupljenima do 24 sata nakon primjene, lenvatinib je činio 97% radioaktivnosti u radiokromatogramima plazme, dok je metabolit
English: A clinical drug-drug interaction (DDI) study in cancer patients showed that plasma concentrations of midazolam (a sensitive CYP3A and Pgp substrate) were not altered in the presence of lenvatinib.
Croatian: Kliničko ispitivanje interakcija lijek-lijek (engl. drug-drug interaction, DDI) u bolesnika s karcinomom pokazalo je da se koncentracije midazolama u plazmi (supstrat osjetljiv na CYP3A i Pgp) nisu mijenjale u prisutnosti lenvatiniba.
English: Radioiodine-refractory was defined as one or more measurable lesions either with a lack of iodine uptake or with progression in spite of radioactive-iodine (RAI) therapy, or having a cumulative activity of RAI of >600 mCi or 22 GBq with the last dose at least 6 months prior to study entry.
Croatian: Refraktornost na radioaktivni jod bila je definirana kao jedna ili više mjerljivih lezija bez unosa joda ili s progresijom unatoč terapiji radioaktivnim jodom (RAI) ili kumulativna aktivnost RAI od >600 mCi ili 22 GBq sa zadnjom dozom najmanje 6 mjeseci prije ulaska u ispitivanje.
English: Patients in the placebo arm could opt to receive lenvatinib treatment at the time of confirmed disease progression.
Croatian: Bolesnici u skupini koja je primala placebo mogli su se odlučiti za liječenje lenvatinibom u vrijeme kada je potvrđena progresija bolesti.
English: Hepatic encephalopathyl,‡,†
Croatian: hepatička encefalopatijal,‡,†
English: Men had a higher incidence (26.5%) of dysphonia than women (12.3%), decreased weight and decreased platelet count.
Croatian: U muškaraca je bila veća incidencija (26,5%) disfonije nego u žena (12,3%), smanjene tjelesne težine i smanjenog broja trombocita.
English: LENVIMA can also be used on its own to treat liver cancer (hepatocellular carcinoma) in adults who have not previously been treated with another anticancer medicine that travels through the bloodstream.
Croatian: LENVIMA se može također primjenjivati sama za liječenje raka jetre (hepatocelularni karcinom) u odraslih koji nisu prethodno liječeni drugim lijekom protiv raka, koji se krvotokom raspodjeljuje po čitavom tijelu.
English: Women of childbearing potential must use highly effective contraception while taking lenvatinib and for one month after stopping treatment (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti visoko učinkovitu kontracepciju dok uzimaju lenvatinib i tijekom 1 mjeseca nakon prekida liječenja (vidjeti dio 4.6).
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances.
Croatian: PRES je neurološki poremećaj koji se može manifestirati glavoboljom, napadajem, letargijom, smetenošću, promijenjenom mentalnom funkcijom, sljepoćom i drugim vidnim ili neurološkim poremećajima.
English: Patients with HCC should be monitored for worsening liver function including hepatic encephalopathy.
Croatian: Potrebno je pratiti bolesnike sa HCC-om da ne dođe do pogoršanja funkcije jetre, uključujući hepatičku encefalopatiju.
English: Neutropenia includes neutropenia and decreased neutrophil count decreased.
Croatian: Neutropenija uključuje neutropeniju i smanjeni broj neutrofila.
English: The overall survival analysis was confounded by the fact that placebo-treated subjects with confirmed disease progression had the option to cross over to open-label lenvatinib.
Croatian: Na analizu ukupnog preživljenja utjecao je jedan zbunjujući čimbenik, a taj je činjenica da su ispitanici s potvrđenom progresijom bolesti koji su primali placebo imali mogućnost prijeći na otvoreno liječenje lenvatinibom.
English: Patients were excluded who had prior systemic anticancer therapy for advanced/unresectable HCC or any prior anti-VEGF therapy.
Croatian: Isključeni su bolesnici koji su prethodno primali sistemsku terapiju protiv raka za uznapredovali/neoperabilni HCC ili bilo koju prethodnu anti-VEGF terapiju.
English: These in vivo metabolic routes align with the data provided in the in vitro studies using human biomaterials.
Croatian: Ovi in vivo metabolički putevi sukladni su podacima dobivenima in vitro u ispitivanjima na ljudskom biološkom materijalu.
English: There is no specific antidote for overdose with lenvatinib.
Croatian: Ne postoji posebni antidot za predoziranje lenvatinibom.
English: Data from a human mass balance/excretion study indicate lenvatinib is extensively metabolised in humans.
Croatian: Podaci iz ispitivanja masene bilance/izlučivanja u ljudi pokazuju da se lenvatinib u ljudi opsežno metabolizira.
English: Systolic BP ≥140 mmHg up to <160 mmHg or diastolic BP ≥90 mmHg up to <100 mmHg
Croatian: Sistolički krvni tlak ≥140 mmHg do <160 mmHg ili dijastolički krvni tlak ≥90 mmHg do <100 mmHg
English: In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg.
Croatian: U bolesnika se medijan prividnog volumena distribucije (Vz/F) prve doze kretao u rasponu od 50,5 l do 92 l i većinom je bio dosljedan u svim doznim skupinama od 3,2 mg do 32 mg.
English: Lenvatinib may adversely affect the wound healing process as for other agents of the same class.
Croatian: Lenvatinib može štetno utjecati na cijeljenje rana kao i drugi lijekovi istoga razreda.
English: To dissolve them, pour a tablespoon of water or apple juice into a small glass and put the capsules into the liquid without breaking or crushing them.
Croatian: Za otapanje, ulijte žlicu vode ili soka od jabuke u malu čašu i stavite kapsule u tekućinu bez lomljenja ili drobljenja.
English: If patients have severe renal impairment, the initial dose of lenvatinib should be adjusted (see sections 4.2 and 5.2).
Croatian: Ako bolesnici imaju teško oštećenje funkcije bubrega, potrebno je prilagoditi početnu dozu lenvatiniba (vidjeti dijelove 4.2 i 5.2).
English: Grade 4*
Croatian: 4. stupnja*
English: Based on a population pharmacokinetic analysis of patients receiving up to 24 mg lenvatinib once daily, age, sex, weight, and race (Japanese vs. other, Caucasian vs. other) had no significant effects on clearance (see section 4.2).
Croatian: Na temelju analize populacijske farmakokinetike u bolesnika koji su primali do 24 mg lenvatiniba jedanput na dan, dob, spol, tjelesna težina i rasa (Japanci naspram drugih, bijelci naspram drugih) nisu imali značajne učinke na klirens (vidjeti dio 4.2).
English: Based on AUC(0 - inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Croatian: Na temelju vrijednosti AUC(0 - inf), na lenvatinib je otpalo 60% radioaktivnosti u plazmi i 64% radioaktivnosti u krvi.
English: In vitro, the lenvatinib blood-to-plasma concentration ratio ranged from 0.589 to 0.608 (0.110 μg/mL, mesylate).
Croatian: In vitro, omjer koncentracije lenvatiniba u krvi i plazmi bio je u rasponu od 0,589 do 0,608 (0,110 μg/ml, mesilat).
English: A statistically significant prolongation in PFS was demonstrated in lenvatinib-treated patients compared with those receiving placebo (p<0.0001) (see figure 1).
Croatian: Dokazano je statistički značajno produljenje preživljenja bez progresije bolesti (PFS) u bolesnika liječenih lenvatinibom u usporedbi s onima koji su primali placebo (p<0,0001) (vidjeti sliku 1).
English: LENVIMA blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow.
Croatian: LENVIMA blokira djelovanje proteina koji se zovu receptori tirozin kinaze i uključeni su u rast stanica i razvoj novih krvnih žila koje stanice opskrbljuju kisikom i hranjivim tvarima i pomažu njihov rast.
English: In patients with solid tumours administered single and multiple doses of lenvatinib once daily, exposure to lenvatinib (Cmax and AUC) increased in direct proportion to the administered dose over the range of 3.2 to 32 mg once-daily.
Croatian: U bolesnika sa solidnim tumorima koji su primali jednu i više doza lenvatiniba jedanput na dan, izloženost lenvatinibu (Cmax i AUC) povećavala se izravno proporcionalno primijenjenoj dozi u rasponu od 3,2 do 32 mg jedanput na dan.
English: • painful infection or irritation near the anus
Croatian: • bolna infekcija ili nadraženost u blizini čmara
English: LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1).
Croatian: LENVIMA je indicirana kao monoterapija za liječenje odraslih bolesnika s uznapredovalim ili neoperabilnim hepatocelularnim karcinomom (HCC) koji prethodno nisu primili sistemsku terapiju (vidjeti dio 5.1).
English: If the submission of a PSUR and the update of an RMP coincide, they can be submitted at the same time.
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: There was a higher incidence of decreased neutrophil count in patients with HCC (8.7% on lenvatinib than in other nonHCC tumour types (1.4%)), which was not associated with infection, sepsis or bacterial peritonitis.
Croatian: U bolesnika sa HCC-om bila je veća incidencija smanjenog broja neutrofila (u 8,7% bolesnika koji su primali lenvatinib u odnosu na druge vrste tumora koji nisu HCC (1,4%)), koja nije bila povezana s infekcijom, sepsom ili bakterijskim peritonitisom.
English: • Do not breast-feed if you are taking LENVIMA.
Croatian: • Nemojte dojiti ako uzimate LENVIMU.
English: The daily dose is to be modified as needed according to the dose/toxicity management plan.
Croatian: Dnevnu dozu treba prilagoditi po potrebi u skladu s planom upravljanja omjerom doze/toksičnosti.
English: The median half-life was comparable in subjects with mild, moderate, and severe hepatic impairment as well as those with normal hepatic function and ranged from 26 hours to 31 hours.
Croatian: Medijan poluvijeka bio je usporediv u ispitanika s blagim, umjerenim i teškim oštećenjem funkcije jetre, kao i u onih s normalnom funkcijom jetre, i kretao se u rasponu od 26 sati do 31 sat.