FrancophonIA/ELRC3.0 huggingface dataset:
English: Further, see sections 4.4 and 5.2.
Croatian: Nadalje, vidjeti dijelove 4.4 i 5.2.
English: The mean age was 56 years, with the majority of patients less than 65 years old.
Croatian: Srednja dob bila je 56 godina, dok je većina bolesnika bila mlađa od 65 godina.
English: Your doctor will discuss any change of dose with you.
Croatian: Vaš će liječnik razgovarati s Vama o svim promjenama doze.
English: - Complete biliary obstruction.
Croatian: - Kompletna bilijarna opstrukcija.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}><{mjesec GGGG}>.
English: • fast or irregular heart beat (palpitations)
Croatian: • brzi ili nepravilni otkucaji srca (palpitacije)
English: The study population was predominantly female (91%) and white (94%).
Croatian: Populaciju u ispitivanju činile su pretežno žene (91 %) i bijelci (94 %).
English: Final report: 2023
Croatian: Završno izvješće: 2023.
English: What OCALIVA is and what it is used for
Croatian: Što je OCALIVA i za što se koristi
English: No fertility data is available in humans.
Croatian: Nisu dostupni podaci o plodnosti u ljudi.
English: Clinical signs and symptoms of hepatic decompensation have also been observed.
Croatian: Također su opaženi klinički znakovi i simptomi jetrene dekompenzacije.
English: OCALIVA Titrationc (N = 70)
Croatian: OCALIVA titracijac (N = 70)
English: Depending on your body's response after 6 months your doctor may increase your dose to 10 mg once daily.
Croatian: Ovisno o odgovoru Vašeg organizma nakon 6 mjeseci, Vaš liječnik može povisiti dozu na 10 mg jednaput dnevno.
English: Rationale: to investigate the uncertainties related to the lack of data in a population with more advanced liver disease
Croatian: Obrazloženje: u svrhu ispitivanja neizvjesnosti povezanih s nedostatkom podataka u populaciji s više uznapredovalom bolesti jetre
English: 10 mg twice weekly (at least 3 days apart)
Croatian: 10 mg dvaput tjedno (u razmaku od najmanje 3 dana)
English: For patients experiencing severe intolerability due to pruritus, one or more of the following should be considered:
Croatian: Za bolesnike u kojih se javlja teška nepodnošljivost zbog svrbeža, razmotrite jedno ili više od sljedećeg:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, toksičnosti za plodnost, reproduktivne i razvojne toksičnosti.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Limited data exists in elderly patients.
Croatian: Postoje ograničeni podaci za starije bolesnike.
English: The Fisher's exact test was used to calculate the 95% Confidence Intervals (Cis).
Croatian: Fisherov egzaktni test upotrijebljen je za izračun 95-postotnih intervala pouzdanosti (engl.
English: • pain in the mouth and throat
Croatian: • bol u ustima i grlu
English: Your doctor will do blood tests to monitor the health of your liver when you start treatment and regularly from there on.
Croatian: Vaš će liječnik provesti pretrage krvi kako bi pratio zdravlje jetre kada počnete liječenje te redovito nakon toga.
English: Date of latest renewal: 12 December 2018
Croatian: Datum posljednje obnove odobrenja: 12. prosinca 2018.
English: ALP and total bilirubin were assessed as categorical variables in the primary composite endpoint, as well as continuous variables over time.
Croatian: ALP i ukupni bilirubin ocijenjeni su kao kategoričke varijable u primarnom kompozitnom ishodu te kao kontinuirane varijable tijekom vremena.
English: Elderly (> 65 years)
Croatian: Starije osobe (≥ 65 godina)
English: The highest single dose exposure of obeticholic acid in healthy volunteers has been at the 500 mg dose.
Croatian: Najviša izloženost jednoj dozi obetikolatne kiseline u zdravih dobrovoljaca bila je pri dozi od 500 mg.
English: Dose/Time proportionality
Croatian: Proporcionalnost doze i vremena
English: ALP less than 1.67-times ULN, n (%)
Croatian: ALP manji od 1,67 puta GGN, n (%)
English: Liver-related adverse events have primarily been observed at doses higher than the maximum recommended dose of 10 mg once daily (see section 4.9).
Croatian: Nuspojave povezane s jetrom prije svega su opažene pri dozama višim od najviše preporučene doze od 10 mg jedanput dnevno (vidjeti dio 4.9).
English: As a precautionary measure, you should not take OCALIVA if you are pregnant.
Croatian: Kao mjera opreza, ne smijete uzimati lijek OCALIVA ako ste trudni.
English: The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%).
Croatian: Najčešće prijavljivane nuspojave bile su svrbež (63 %) i umor (22 %).
English: Your doctor may adjust your dose depending on your liver function or if you experience itching that is difficult to tolerate.
Croatian: Liječnik može prilagoditi Vašu dozu ovisno o funkciji jetre ili ako iskusite svrbež koji teško podnosite.
English: All changes were reversible with discontinued dosing, and are consistent with and predict the dose-limiting toxicity in humans (systemic exposure at NOAEL was up to 24-fold higher than that seen at the maximum recommended human dose).
Croatian: Sve promjene bile su reverzibilne s prekidom doziranja te su konzistentne s toksičnosti koja ograničava dozu i predviđaju je (sistemska izloženost pri razini NOAEL bila je do 24 puta viša od one opažene pri maksimalnoj preporučenoj dozi u ljudi).
English: After initiation of therapy, all patients should be monitored for progression of PBC disease with laboratory and clinical assessment to determine whether dosage adjustment is needed.
Croatian: Nakon početka terapije sve je bolesnike potrebno pratiti zbog moguće progresije PBC-a, uz laboratorijsku i kliničku procjenu kako bi se odredilo postoji li potreba za prilagodbom doze.
English: Mean baseline ALP values ranged from 316 U/L to 327 U/L.
Croatian: Srednje početne vrijednosti ALP-a bile su u rasponu od 316 U/L do 327 U/L.
English: Interventional study 747-302:
Croatian: Intervencijsko ispitivanje 747-302:
English: Interventional study 747-401:
Croatian: Intervencijsko ispitivanje 747-401:
English: Approximately 60% of patients had a history of pruritus upon enrollment in the phase III study.
Croatian: Približno 60 % bolesnika imalo je u anamnezi svrbež po uključenju u ispitivanje faze III.
English: FXR is thought to be a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways.
Croatian: Smatra se da je FXR ključni regulator žučnih kiselina, upalnih, fibrotičkih i metaboličkih putova.
English: Method of administration The tablet should be taken orally with or without food.
Croatian: Način primjene Tabletu treba uzeti peroralno s hranom ili bez nje.
English: Contact a doctor or go to a hospital for advice immediately.
Croatian: Odmah se obratite liječniku ili savjet potražite u bolnici.
English: In the case of overdose, patients should be carefully observed and supportive care administered, as appropriate.
Croatian: U slučaju predoziranja, bolesnike treba pažljivo promatrati te, prema potrebi, primijeniti suportivnu skrb.
English: Obeticholic acid is absorbed with peak plasma concentrations (Cmax) occurring at a median time (tmax) of approximately 2 hours.
Croatian: Obetikolatna kiselina se apsorbira s vršnim koncentracijama u plazmi (Cmax) u medijanu vremena (tmax) od približno 2 sata.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „EXP“.
English: Rationale: to investigate the effect of obeticholic acid on clinical outcomes in subjects with PBC
Croatian: Obrazloženje: u svrhu ispitivanja učinka obetikolatne kiseline na kliničke ishode u ispitanika s PBC-om
English: The European Medicines Agency has waived the obligation to submit the results of studies with obeticholic acid in all subsets of the paediatric population in PBC (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja s obetikolatnom kiselinom u svim podskupinama pedijatrijske populacije za PBC (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: An additional third obeticholic acid metabolite, 3-glucuronide is formed but is considered to have minimal pharmacologic activity.
Croatian: Stvara se dodatni treći metabolit obetikolatne kiseline, 3-glukoronid, no smatra se da ima minimalno farmakološko djelovanje.
English: Elevations in alanine amino transferase (ALT) and aspartate aminotransferase (AST) have been observed in patients taking obeticholic acid.
Croatian: Povećanja razina alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST) opažena su u bolesnika koji su uzimali obetikolatnu kiselinu.
English: There is no relevant use of obeticholic acid in the paediatric population in the treatment of primary biliary cholangitis (PBC).
Croatian: Nema relevantne primjene obetikolatne kiseline u pedijatrijskoj populaciji u liječenju primarnog bilijarnog kolangitisa (PBC).
English: Mean reduction in ALP
Croatian: Srednje smanjenje razine ALP-a
English: There are limited pharmacokinetic data in elderly patients (≥ 65 years).
Croatian: Farmakokinetički podaci u starijih bolesnika (≥ 65 godina) su ograničeni.
English: These included increased liver weights, alterations in serum chemistry parameters (ALT, AST, LDH, ALP, GGT, and/or bilirubin), and macroscopic/microscopic alterations.
Croatian: To je uključivalo povećanje težine jetre, promjene biokemijskih parametara seruma (ALT, AST, LDH, ALP, GGT i/ili bilirubin) te makroskopske /mikroskopske promjene.
English: Children and adolescents This medicine is not for use in children or adolescents.
Croatian: Ovaj se lijek ne smije primjenjivati u djece i adolescenata.
English: Patients at an increased risk of hepatic decompensation, including those with laboratory evidence of worsening liver function and /or progression to cirrhosis, should be monitored more closely.
Croatian: Bolesnike s povećanim rizikom od dekompenzacije jetre, uključujući one s laboratorijskim znakovima pogoršanja funkcije jetre i/ili progresije do ciroze, potrebno je pozorno pratiti.
English: Mean reductions in ALP were observed as early as Week 2 and were maintained through Month 12 for patients who were maintained on the same dosage throughout 12 months.
Croatian: Srednja smanjenja razine ALP-a su opažena već u 2. tjednu te su održana do 12. mjeseca za bolesnike koji su održavani na istoj dozi tijekom 12 mjeseci.
English: Following multiple-dose administration of 5, 10, and 25 mg once daily for 14 days, systemic exposures of obeticholic acid increase dose proportionally.
Croatian: Nakon primjene višestrukih doza od 5, 10 i 25 mg jedanput dnevno tijekom 14 dana, sistemske izloženosti obetikolatne kiseline povećavaju se proporcionalno dozi.
English: You can take OCALIVA with or without food.
Croatian: Lijek OCALIVA možete uzimati s hranom ili bez nje.
English: Management strategies include the addition of bile acid binding resins or antihistamines, dose reduction, reduced dosing frequency, and/or temporary dose interruption (see sections 4.2 and 4.8).
Croatian: Strategije zbrinjavanja uključuju dodatak smola koje vežu žučne kiseline ili antihistaminika, smanjenje doze, smanjenje učestalosti doziranja i/ili privremeni prekid doziranja (vidjeti dijelove 4.2 i 4.8).
English: Obeticholic acid is a selective and potent agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed at high levels in the liver and intestine.
Croatian: Obetikolatna kiselina je selektivni i potentni agonist za farnezoid X receptor (FXR), nuklearni receptor koji se eksprimira u visokim razinama u jetri i crijevima.
English: As a precautionary measure, it is preferable to avoid the use of obeticholic acid during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu obetikolatne kiseline tijekom trudnoće.
English: If you experience itching that is difficult to tolerate, talk to your doctor.
Croatian: Ako se pojavi svrbež koji teško podnosite, obratite se svom liječniku.
English: Responders, n (%) Corresponding 95% CI p-valued
Croatian: Bolesnici s odgovorom na liječenje, n (%) Odgovarajući 95-postotni CI p-vrijednostd
English: At month 3, 9 (38%) OCALIVA-treated patients achieved a response to the composite endpoint, compared to 1 (4%) placebo-treated patient.
Croatian: U 3. je mjesecu 9 (38 %) bolesnika liječenih lijekom OCALIVA postiglo odgovor na kompozitni ishod u usporedbi s jednim (4 %) bolesnikom koji je liječen placebom.
English: These events have occurred as early as within the first month of treatment.
Croatian: Ovi su se događaji javili tijekom prvih mjeseci liječenja.
English: Responses occurred as early as 2 weeks and were dose dependent (OCALIVA 5 mg compared with 10 mg at 6 months, p=0.0358).
Croatian: Odgovori su se javili već u 2. tjednu te su bili ovisni o dozi (OCALIVA od 5 mg u usporedbi s 10 mg u 6. mjesecu liječenja, p=0,0358).
English: Urinary excretion is less than 3%.
Croatian: Izlučivanje putem mokraće manje je od 3 %.
English: After administration of radiolabeled obeticholic acid, greater than 87% is excreted in faeces.
Croatian: Nakon primjene radioaktivno obilježene obetikolatne kiseline više od 87 % izlučuje se putem stolice.
English: • dry skin, redness of the skin (eczema)
Croatian: • suha koža, crvenilo kože (ekcem)
English: Child-Pugh Class B or C or Decompensated Cirrhotic
Croatian: Child-Pugh stadij B ili C ili dekompenzirana ciroza
English: The levels of some medicines such as theophylline (a medicine to help breathing) or tizanidine (a medicine to relieve the stiffness and restriction of muscles) may be increased and need to be monitored by your doctor while taking OCALIVA.
Croatian: Razine nekih lijekova kao što je teofilin (lijek koji olakšava disanje) ili tizanidin (lijek za ublažavanje ukočenosti i ograničene pokretljivosti mišića) mogu se povisiti te ih Vaš liječnik treba nadgledati dok uzimate lijek OCALIVA.
English: Animal studies do not indicate any direct or indirect effects on fertility or reproduction (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju ni na kakve izravne ili neizravne učinke na plodnost ili reprodukciju (vidjeti dio 5.3).
English: Repeated doses of 250 mg have been administered for 12 consecutive days and some subjects experienced pruritus and reversible transaminase liver elevations.
Croatian: Ponovljene doze od 250 mg primijenjene su tijekom 12 uzastopnih dana te su neki ispitanici imali svrbež i reverzibilna povišenja jetrenih transaminaza.
English: Human plasma protein binding of obeticholic acid and its conjugates is greater than 99%.
Croatian: Vezanje obetikolatne kiseline i njenih konjugata na proteine u ljudskoj plazmi veće je od 99 %.
English: It is not known if this medicine passes into human milk.
Croatian: Nije poznato prelazi li lijek u majčino mlijeko u ljudi.
English: Prior to initiation of treatment with obeticholic acid the patient's hepatic status must be known.
Croatian: Prije početka liječenja obetikolatnom kiselinom mora biti poznat status jetrene funkcije bolesnika.
English: Consider discontinuing treatment with obeticholic acid for patients who continue to experience persistent, intolerable pruritus.
Croatian: Razmotrite prekid liječenja obetikolatnom kiselinom za bolesnike u kojih se i dalje javlja perzistentni nepodnošljivi svrbež.
English: The most common adverse reaction leading to discontinuation was pruritus.
Croatian: Najčešća nuspojava koja je dovela do prekida liječenja bila je svrbež.
English: Interaction with CYP1A2 substrates with narrow therapeutic index Obeticholic acid may increase the exposure to concomitant medicinal products that are CYP1A2 substrates.
Croatian: Interakcije sa supstratima CYP1A2 uskog terapijskog indeksa Obetikolatna kiselina može povećati izloženost istodobno primijenjenim lijekovima koji su supstrati CYP1A2.
English: Dosing frequency should be reduced for patients who progress to advanced disease (i.e. from Child-Pugh Class A to Child-Pugh Class B or C) (see sections 4.2 and 5.2).
Croatian: Učestalost doziranja treba biti smanjena u bolesnika u kojih bolest progredira do uznapredovalog stadija (tj. od Child-Pugh stadija A do Child-Pugh stadija B ili C) (vidjeti dijelove 4.2 i 5.2).
English: • thyroid hormone irregularity
Croatian: • nepravilnosti hormona štitnjače
English: Population pharmacokinetic analysis, developed using data from patients up to 65 years old, indicated that age is not expected to significantly influence obeticholic acid clearance from the circulation.
Croatian: Analiza populacijske farmakokinetike, razvijena korištenjem podataka od bolesnika starosti do 65 godina, ukazuje da se ne očekuje da će dob značajno utjecati na klirens obetikolatne kiseline iz cirkulacije.
English: Child-Pugh Class A
Croatian: Child-Pugh stadij
English: What OCALIVA is and what it is used for What you need to know before you take OCALIVA How to take OCALIVA
Croatian: Što je OCALIVA i za što se koristi Što morate znati prije nego počnete uzimati lijek OCALIVA
English: - Film-coat: Polyvinyl alcohol, part hydrolysed (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172).
Croatian: - Film-ovojnica: poli(vinilni alkohol), djelomično hidroliziran (E1203), titanijev dioksid (E171), makrogol 3350 (E1521), talk (E553b), žuti željezov oksid (E172).
English: There are no data on the use of obeticholic acid in pregnant women.
Croatian: Nema podataka o primjeni obetikolatne kiseline u trudnica.
English: Patients were included in the trial if the alkaline phosphatase (ALP) was greater than or equal to 1.67 times upper limit of normal (ULN) and/or if total bilirubin was greater than 1 x ULN but less 2 x ULN.
Croatian: Bolesnici su bili uključeni u ispitivanje ako je razina alkalne fosfataze (ALP) bila veća od ili jednaka 1,67 puta gornja granica normale (GGN) i/ili ako je ukupni bilirubin bio veći od 1 × GGN, no manji od 2 x GGN.
English: In particular, tell your doctor if you are taking so-called bile acid binding resins (cholestyramine, colestipol, colesevelam) used to lower blood cholesterol levels as they may lessen the effect of OCALIVA.
Croatian: Posebice recite svom liječniku ako uzimate takozvane smole koje vežu žučne kiseline (kolestiramin, kolestipol, kolesevelam) koje se uzimaju za snižavanje razina kolesterola u krvi jer one mogu smanjiti učinak lijeka OCALIVA.
English: This medicine is used to treat adult patients with a type of liver disease known as primary biliary cholangitis (also known as primary biliary cirrhosis), either by itself or together with another medicine, ursodeoxycholic acid.
Croatian: Ovaj se lijek koristi za liječenje odraslih bolesnika s jednom vrstom bolesti jetre koja se naziva primarni bilijarni kolangitis (također poznat i kao primarna bilijarna ciroza), bilo samostalno ili zajedno s drugim lijekom, ursodeoksikolatnom kiselinom.
English: Therapeutic monitoring of CYP1A2 substrates with narrow therapeutic index (e.g. theophylline and tizanidine) is recommended.
Croatian: Preporučuje se terapijsko praćenje supstrata CYP1A2 uskog terapijskog indeksa (primjerice, teofilina i tizanidina).
English: Table 1: Dosage Regimen by PBC Patient Population Staging/Classification Non-Cirrhotic or
Croatian: Režim doziranja u populaciji bolesnika s PBC-om Stadij/Klasifikacija Bez ciroze ili
English: The systemic exposure of obeticholic acid, its active conjugates, and endogenous bile acids is increased in patients with moderate and severe hepatic impairment (Child-Pugh Class B and C, respectively) when compared to healthy controls.
Croatian: Sistemska izloženost obetikolatne kiseline, njezinih aktivnih konjugata i endogenih žučnih kiselina povišena je u bolesnika s umjerenim i teškim oštećenjem jetre (odnosno Child-Pugh stadijem B i C) u usporedbi sa zdravim kontrolnim ispitanicima.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Croatian: POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: f The mean baseline total bilirubin value was 0.65 mg/dL, and was within the normal range (i.e., less than or equal to the ULN) in 92% of the enrolled patients.
Croatian: f Srednja početna vrijednost ukupnog bilirubina bila je 0,65 mg/dl te je bila unutar normalnog raspona (tj. manja od ili jednaka GGN-u) u 92 % uključenih bolesnika.
English: International normalised ratio (INR) is decreased following co-administration of warfarin and obeticholic acid.
Croatian: International Normalized Ratio, INR) snižen je nakon istodobne primjene varfarina i obetikolatne kiseline.
English: The recommended dose is one 5 mg film-coated tablet once daily by mouth.
Croatian: Preporučena doza je jedna filmom obložena tableta od 5 mg, jedanput dnevno, kroz usta.
English: Your doctor will determine whether you should discontinue breast-feeding or discontinue/abstain from OCALIVA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Croatian: Vaš će liječnik odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom OCALIVA uzimajući u obzir korist dojenja za dijete i korist liječenja za vas.
English: Co-administration with food does not alter the extent of absorption of obeticholic acid.
Croatian: Istodobna primjena s hranom ne mijenja opseg apsorpcije obetikolatne kiseline.
English: Your doctor may need to monitor how well your blood clots when taking medicines such as warfarin (a medicine to help your blood flow) with OCALIVA.
Croatian: Vaš će liječnik možda trebati nadgledati koliko dobro se vaša krv zgrušava dok uzimate lijekove kao što je varfarin (lijek koji razrjeđuje krv) s lijekom OCALIVA.
English: The conjugates can be deconjugated in the ileum and colon by intestinal microbiota, leading to the conversion to obeticholic acid that can be reabsorbed or excreted in faeces, the principal route of elimination.
Croatian: Konjugati se mogu dekonjugirati u ileumu i kolonu crijevnom mikrobiotom, što dovodi do konverzije obetikolatne kiseline koja se može ponovno apsorbirati ili izlučiti u stolicu, što je primarni put eliminacije.
English: * Adverse reactions are defined as events occurring at a rate of greater than or equal to 5% of patients on obeticholic acid treatment arm and at an incidence greater than or equal to 1% higher than in the placebo treatment arm.
Croatian: * Nuspojave su definirane kao događaji koji su se javili u 5 % ili više bolesnika u skupini liječenoj obetikolatnom kiselinom s incidencijom koja je za 1 % ili više veća od one u skupini koja je primala placebo.
English: No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid.
Croatian: Nije potrebna prilagodba doze UDCA-a koja se primjenjuje istodobno u bolesnika koji primaju obetikolatnu kiselinu.
English: Obeticholic acid is metabolised in the liver and intestines.
Croatian: Obetikolatna se kiselina metabolizira u jetri i crijevima.
English: Mean baseline total bilirubin values ranged from 10 μmol/L to 12 μmol/L across treatment arms, with 92% of patients within normal range.
Croatian: Srednje početne vrijednosti ukupnog bilirubina bile su u rasponu od 10 μmol/l do 12 μmol/l u svim terapijskim skupinama, s 92 % bolesnika unutar normalnog raspona.