FrancophonIA/ELRC3.0 huggingface dataset:
English: OLYSIO has no or negligible influence on the ability to drive and use machines.
Croatian: OLYSIO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Treatment duration
Croatian: Trajanje liječenja
English: Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna kapsula sadrži 78,4 mg laktoze (u obliku hidrata).
English: Please refer to section 4.5 for information on interactions with medicinal products.
Croatian: Molimo pogledajte dio 4.5 za informacije o interakcijama s lijekovima.
English: Steady-state was reached after 7 days of once daily dosing.
Croatian: Stanje dinamičke ravnoteže bilo je dostignuto nakon 7 dana nakon doziranja jedanput na dan.
English: In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a
Croatian: U Europi, prevalencija je bila niža, 19% (73/377) u bolesnika s HCV genotipom 1a i
English: Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience:
Croatian: - Odmah recite svom liječniku ukoliko uzimate lijek OLYSIO sa sofosbuvirom i bilo kojim lijekom za probleme sa srcem, te ukoliko tijekom liječenja osjetite:
English: What you need to know before you take OLYSIO
Croatian: Što morate znati prije nego počnete uzimati OLYSIO
English: It acts against the virus that causes hepatitis C infection, called ‘hepatitis C virus' (HCV).
Croatian: Ona djeluje protiv virusa koji je uzročnik infekcije hepatitisom C, a koji se zove “virus hepatitisa C“ (HCV).
English: Only grade 1 and 2 events were reported and there were no events leading to discontinuation of any of the study drugs.
Croatian: Bili su prijavljeni samo događaji stupnja 1 i 2 te nije bilo događaja koji bi doveli do prekida uzimanja bilo kojeg od lijekova u ispitivanju.
English: ANTI-INFECTIVES
Croatian: ANTIINFEKTIVI
English: Although causality is difficult to establish due to background advanced liver disease, a potential risk cannot be excluded.
Croatian: Premda je uzročno-posljedičnu vezu teško utvrditi zbog pozadinske uznapredovale bolesti jetre, potencijalni rizik nije moguće isključiti.
English: Women must use an effective method of contraception during treatment with OLYSIO.
Croatian: Žene moraju koristiti učinkovitu metodu kontracepcije tijekom liječenje lijekom OLYSIO.
English: No dose adjustment is necessary based on body weight or body mass index.
Croatian: Nije potrebna prilagodba doze temeljena na tjelesnoj težini ili indeksu tjelesne težine.
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AE14.
Croatian: Farmakoterapijska skupina: Antivirusni lijekovi za sistemsku primjenu, antivirusni lijekovi izravnog učinka, ATK oznaka: J05AE14.
English: In pregnant rats, simeprevir concentrations in placenta, fetal liver and foetus were lower compared to those observed in blood.
Croatian: U skotnih štakorica, koncentracije simeprevira u placenti, fetalnoj jetri i fetusu bile su niže u usporedbi s onima uočenima u krvi.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with OLYSIO, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Croatian: Kako bi se procijenilo ponovno pojavljivanje hepatocelularnog karcinoma povezanog s primjenom lijeka Olysio, nositelj odobrenja mora provesti i dostaviti rezultate prospektivnog ispitivanja sigurnosti, koristeći podatake koji proizlaze iz kohorte dobro definirane skupine bolesnika, na temelju dogovorenog protokola.
English: • Obligation to conduct post-authorisation measures
Croatian: • Obveza provođenja mjera nakon davanja odobrenja>
English: Please refer to sections 4.4 and 4.5 for relevant interactions with antiretroviral agents.
Croatian: Molimo pogledati dijelove 4.4 i 4.5 za odgovarajuće interakcije s antiretrovirusnim lijekovima.
English: The adverse reactions are listed by system organ class (SOC) and frequency: 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
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava (SOC) i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko
English: * In a clinical study in Asian patients from China and South-Korea, increased blood ‘bilirubin' levels were reported in more than 1 in 10 people (very common).
Croatian: * U kliničkom ispitivanju na bolesnicima azijatskog porijekla iz Kine i Južne Koreje, prijavljene su povišene razine “bilirubina“ u krvi u više od 1 na 10 ljudi (vrlo često).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from OLYSIO therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom OLYSIO, uzimajući u obzir korist dojenja za dijete i korist liječenja za majku.
English: Involvement of CYP2C8 and CYP2C19 cannot be excluded.
Croatian: Umiješanost CYP2C8 i CYP2C19 ne može se isključiti.
English: Renal clearance plays an insignificant role in its elimination.
Croatian: Bubrežni klirens ne igra značajnu ulogu u njegovoj eliminaciji.
English: Therefore, it is not expected that renal impairment will have a clinically relevant effect on the exposure to simeprevir.
Croatian: Stoga se ne očekuje da će oštećenje bubrega imati klinički značajan učinak na izloženost simepreviru.
English: Increase in sofosbuvir exposure observed in the pharmacokinetic substudy is not clinically relevant.
Croatian: Povišenje izloženosti sofosbuviru koje je uočeno u farmakokinetičkom podispitivanju nije klinički značajno.
English: PHOSPHODIESTERASE TYPE 5 INHIBITORS Sildenafil
Croatian: INHIBITORI FOSFODIESTERAZE TIPA 5 Sildenafil
English: Patients with mild to moderate rashes should be monitored for possible progression of rash, including the development of mucosal signs or systemic symptoms.
Croatian: Bolesnike s blagim do umjerenim osipima treba pratiti radi moguće progresije osipa, uključujući razvoj znakova na sluznici ili sistemskih simptoma.
English: Do not take OLYSIO if this applies to you.
Croatian: Nemojte uzimati OLYSIO ako se navedeno odnosi na Vas.
English: * Skin rash may affect more than 1 in 10 people (very common) when OLYSIO is used in combination with sofosbuvir for 24 weeks.
Croatian: * Kožni osip se može javiti u više od 1 na 10 osoba (vrlo često) kada se OLYSIO primjenjuje u kombinaciji sa sofosbuvirom kroz 24 tjedna.
English: Patients should be informed of the risk of photosensitivity reactions and on the importance of applying appropriate sun protective measures during treatment with OLYSIO.
Croatian: Bolesnike se mora informirati o riziku za reakcije fotoosjeljivosti, te o važnosti da se tijekom liječenja lijekom OLYSIO primjenjuju prikladne mjere za zaštitu od sunca.
English: Studies in animals have shown reproductive effects (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivne učinke (vidjeti dio 5.3).
English: OLYSIO must be taken orally once a day with food (see section 5.2).
Croatian: OLYSIO se mora uzeti peroralno jedanput na dan, s hranom (vidjeti dio 5.2).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za
English: The European Medicines Agency has deferred the obligation to submit the results of studies with simeprevir in one or more subsets of the paediatric population from 3 years to less than 18 years of age in the treatment of chronic viral hepatitis C (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja simeprevira u jednoj ili više podskupina pedijatrijske populacije od 3 godine do manje od 18 godina starosti u liječenju kroničnog virusnog hepatitis C (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
Croatian: Supstitucije uočene samo u kombinacijama s drugim nastalim supstitucijama na jednom ili više NS3 položaja 80, 122,
English: This is important because it is not known whether simeprevir can pass into breast milk.
Croatian: To je važno zato što nije poznato može li simeprevir prijeći u majčino mlijeko.
English: There were no adverse effects of simeprevir on vital functions (cardiac, respiratory and central
Croatian: Nije bilo štetnih učinaka simeprevira na vitalne funkcije (srčani, dišni i središnji živčani sustav) u
English: % above 65 yrs Male gender Race White Black/African American Hispanic BMI ≥ 30 kg/m
Croatian: % iznad 65 godina Muški spol Rasa bijela crna/Afroamerikanci azijati Hispanci
English: 12 weeks N = 286
Croatian: 12 tjedana N = 286
English: If pregnancy occurs during this period, you must contact your doctor straight away.
Croatian: Ukoliko dođe do trudnoće tijekom ovog razdoblja, morate se odmah obratiti svom liječniku.
English: Concentrations of digoxin should be monitored and used for titration of digoxin dose to obtain the desired clinical effect.
Croatian: Treba pratiti koncentracije digoksina u serumu i koristiti ih za titraciju doze digoksina, da bi se dobio željeni klinički učinak.
English: Eighty-eight percent (n = 93) of the patients were on HIV therapy, most commonly with 2 NRTIs + raltegravir.
Croatian: Osamdeset i osam posto (n = 93) bolesnika bilo je na HIV terapiji, najčešće s 2 NRTI + raltegravirom.
English: Simeprevir is extensively bound to plasma proteins ( 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Croatian: Simeprevir se opsežno veže na proteine plazme (> 99,9%), primarno na albumin te u manjoj mjeri na alfa-1-kiseli glikoprotein.
English: In vitro, simeprevir induced a phototoxic response on BALB/c 3T3 fibroblasts after UVA exposure, in the absence and presence of protein supplements.
Croatian: In vitro, simeprevir je inducirao fototoksični odgovor na BALB/c 3T3 fibroblaste nakon UVA izloženosti, u odsutnosti ili prisutnosti proteinskih suplemenata.
English: Antibiotics - macrolides (systemic administration) Azithromycin
Croatian: Antibiotici - makrolidi (sistemska primjena) Azitromicin
English: Astemizole and terfenadine have the potential for cardiac arrhythmias.
Croatian: Astemizol i terfenadin imaju potencijal izazivanja srčanih aritmija.
English: If the capsule shell is indented or bent - without being broken or opened - the capsule can still
Croatian: Ako je ovojnica kapsule udubljena ili savijena - bez da se razlomila ili otvorila- kapsula se
English: This interaction study has been performed with a dose higher than the recommended dose for simeprevir assessing the maximal effect on the co-administered drug.
Croatian: Ovo ispitivanje interakcije bilo je provedeno s dozom koja je viša od preporučene doze za simeprevir procjenjujući maksimalni učinak na istovremeno primijenjeni lijek.
English: Based on the elimination pathway of azithromycin, no drug interactions are expected between azithromycin and simeprevir.
Croatian: Temeljeno na putevima eliminacije azitromicina, ne očekuju se interakcije između azitromicina i simeprevira.
English: This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite
Croatian: Navedeno je od posebnog značaja ako je praćeno bilo kojim od sljedećih simptoma: - ako osjećate mučninu, povraćanje ili gubitak apetita
English: Simeprevir was not irritating to rabbit skin, and is not likely to cause skin sensitisation.
Croatian: Simeprevir nije bio iritans za kožu zeca i nije vjerojatno da će uzrokovati preosjetljivost
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e., treatment stopping rules) are presented in table 3.
Croatian: Pragovi HCV RNK, koji zahtijevaju prekid liječenja (tj. pravila za prestanak liječenja) prikazani su u tablici 3.
English: Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Croatian: Izniman oprez mora se posvetiti izbjegavanju trudnoće u bolesnica i partnerica muških bolesnika.
English: Therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients (see section 4.6).
Croatian: Stoga je potreban krajnji oprez kako bi se izbjegla trudnoća u bolesnica i partnerica muških bolesnika (vidjeti dio 4.6).
English: C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
Croatian: C-simeprevira zdravim ispitanicima, prosječno je 91% od ukupne radioaktivnosti otkriveno u fecesu.
English: The presence of 50% human serum reduced simeprevir replicon activity by 2.4-fold.
Croatian: Prisutnost 50%-tnog ljudskog seruma smanjila je aktivnost simeprevira protiv replikona za 2,4 puta.
English: White gelatin capsule of approximately 22 mm in length, marked with “TMC435 150” in black ink.
Croatian: Bijela želatinska kapsula duljine približno 22 mm, označena s “TMC435 150” crnom tintom.
English: These blood tests help your doctor to - check if the treatment is working for you
Croatian: Krvne pretrage pomažu Vašem liječniku - provjeriti je li liječenje za Vas učinkovito - provjeriti funkciju Vaše jetre.
English: In the event of an overdose with OLYSIO, it is recommended to employ the usual supportive measures and observe the patient's clinical status.
Croatian: U slučaju predoziranja lijekom OLYSIO, preporučuje se provesti uobičajene suportivne mjere i promatrati bolesnikov klinički status.
English: Opaque polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PE/PVDC) aluminium push-through blister strips of 7 capsules.
Croatian: Neprozirni polivinilklorid/polietilen/polivinilideneklorid (PVC/PE/PVDC) aluminij blisteri kroz koje se može protisnuti kapsula, sa 7 kapsula.
English: The majority of the adverse reactions reported were grade 1 in severity.
Croatian: Većina prijavljenih nuspojava bila je 1. stupnja težine.
English: The terminal elimination half-life of simeprevir was 10 to 13 hours in healthy subjects and 41 hours in HCV infected patients receiving 200 mg simeprevir.
Croatian: Terminalno poluvrijeme eliminacije simeprevira bilo je 10 do 13 sati u zdravih ispitanika i 41 sat u HCV-om inficiranih bolesnika koji su primili 200 mg simeprevira.
English: Plasma Cmax and the area under the plasma concentration time curve (AUC) increased more than dose proportional after multiple doses between 75 mg and 200 mg once daily, with accumulation occurring following repeated dosing.
Croatian: Cmax u plazmi i područje ispod krivulje koncentracija-vrijeme u plazmi (AUC) povisili su se više od proporcionalno dozi nakon višestrukih doza između 75 mg i 200 mg jedanput na dan, s kumulacijom koja se javila nakon ponovljenog doziranja.
English: The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people:
Croatian: Sljedeće nuspojave mogu se javiti uz OLYSIO kada se uzima u kombinaciji sa sofosbuvirom: Često: mogu se javiti u do 1 na 10 osoba:
English: Cisapride has the potential to cause cardiac arrhythmias.
Croatian: Cisaprid ima potencijal za izazivanje srčanih aritmija.
English: - If you are a woman, you must not become pregnant during treatment and for several
Croatian: - Ako ste žena, ne smijete zatrudniti tijekom liječenja i nekoliko mjeseci nakon toga.
English: These increases in bilirubin levels were not associated with any adverse liver safety finding.
Croatian: Ova povišenja razina bilirubina nisu bila povezana s bilo kojim od štetnih sigurnosnih nalaza za jetru.
English: Bilirubin elevations were generally not associated with elevations in liver transaminases and bilirubin levels normalised after end of treatment.
Croatian: Povišenja bilirubina općenito nisu bila povezana s povišenjem transaminaza u jetri i razine bilirubina su se normalizirale nakon završetka liječenja.
English: This medicinal product may pose a risk to the environment (see section 5.3).
Croatian: Ovaj lijek može predstavljati rizik za okoliš (vidjeti dio 5.3).
English: The safety and efficacy of OLYSIO in children aged below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka OLYSIO u djece u dobi manjoj od 18 godina nisu još ustanovljene.
English: Table 21 shows the SVR rates for selected subgroups for study HPC3007.
Croatian: Tablica 21 prikazuje stope SVR za odabrane podskupine za ispitivanje HPC3007.
English: Consider starting with the lowest dose of the PDE-5 inhibitor and increase as needed, with clinical monitoring as appropriate.
Croatian: Razmotrite započinjanje s najnižom dozom PDE-5 inhibitora i povisite ju po potrebi, uz prikladno kliničko praćenje.
English: OLYSIO combination treatment with sofosbuvir may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone, a medicine used to treat irregular heart beat.
Croatian: Kombinirano liječenje lijekom OLYSIO sa sofosbuvirom može rezultirati usporavanjem frekvencije srca (pulsa) zajedno s drugim simptomima kada se uzima s amiodaronom, lijekom koji se koristi za liječenje nepravilnih otkucaja srca.
English: Metabolites identified in faeces were formed via oxidation at the macrocyclic moiety or aromatic moiety or both and by O-demethylation followed by oxidation.
Croatian: Metaboliti identificirani u fecesu bili su formirani putem oksidacije napola makrociklički, a napola aromatički ili oboje te O-demetilacijom nakon koje je slijedila oksidacija.
English: Treatment regimen not containing sofosbuvir:
Croatian: Režim liječenja koji ne sadrži sofosbuvir:
English: The efficacy of OLYSIO has not been studied in patients with HCV genotypes 2, 3, 5 or 6; therefore OLYSIO should not be used in these patients (see section 5.1).
Croatian: Djelotvornost lijeka OLYSIO nije bila ispitana u bolesnika s HCV genotipovima 2, 3, 5 ili 6; stoga se OLYSIO ne smije primjenjivati u tih bolesnika (vidjeti dio 5.1).
English: Includes 4 simeprevir-treated patients who experienced relapse after SVR12.
Croatian: Uključuje 4 bolesnika liječena simeprevirom koji su doživjeli relaps nakon SVR12.
English: Phase 3 study in Asian patients
Croatian: Ispitivanje faze 3 u bolesnika azijatskog porijekla
English: Viral breakthrough rates were 24% (11/45), 20% (5/25) and 11% (4/36) in patients with genotype 4a, 4d and 4/other, respectively.
Croatian: Stope virološkog proboja bile su 24% (11/45), 20% (5/25) i 11% (4/36) u bolesnika s genotipom 4a, 4d odnosno 4/drugo.
English: There were no grade 3 or 4 photosensitivity reactions reported and none of the patients discontinued treatment due to photosensitivity reactions.
Croatian: Nisu bile prijavljene reakcije fotoosjetljivosti 3. ili 4. stupnja i niti jedan bolesnik nije prekinuo liječenje zbog reakcija fotoosjetljivosti.
English: Simeprevir must be taken with food (see section 4.2).
Croatian: Simeprevir se mora uzeti s hranom (vidjeti dio 4.2).
English: What OLYSIO contains - The active substance is simeprevir.
Croatian: Što OLYSIO sadrži - Djelatna tvar je simeprevir.
English: Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event.
Croatian: Od 3 bolesnika s neuspjehom tijekom liječenja, 2 bolesnika su doživjela virološki proboj i jedan bolesnik je ranije prekinuo liječenje zbog štetnog događaja.
English: Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease, which is essential for viral replication.
Croatian: Simeprevir je specifični inhibitor NS3/4A serin proteaze HCV-a, koja je esencijalna za replikaciju virusa.
English: Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
Croatian: Cjelokupno trajanje liječenja s peg-IFN-alfa i RBV bilo je vođeno odgovorom.
English: Elevations in amylase and lipase were transient and mostly of mild or moderate severity.
Croatian: Povišenja amilaze i lipaze bila su prolazna i većinom blage ili umjerene težine.
English: Therefore, in patients who are at high risk for hepatic decompensation or hepatic failure, liver function tests should be monitored before and as clinically indicated during OLYSIO combination therapy.
Croatian: Stoga se u bolesnika koji imaju visok rizik od hepatičke dekompenzacije ili zatajenja jetre trebaju pratiti funkcionalni testovi jetre prije i, kao što je klinički indicirano, za vrijeme kombiniranog liječenja lijekom OLYSIO.
English: Read the package leaflets for these medicines for their dosage and directions on ‘how to take' them.
Croatian: Pročitajte upute o lijeku za te lijekove vezano uz doziranje i uputstva o tome ‘kako uzimati' te lijekove.
English: Following a single oral administration of 200 mg
Croatian: Nakon jedne peroralne primjene 200 mg
English: Relapsers after prior interferon-based therapy.
Croatian: Bolesnici s relaspom nakon prethodne terapije temeljene na interferonu.
English: It is not known whether simeprevir or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se simeprevir ili njegovi metaboliti u majčino mlijeko.
English: If you are not sure what to do, contact your doctor or pharmacist.
Croatian: Ako niste sigurni što treba učiniti, obratite se svom liječniku ili ljekarniku.
English: The type of food does not affect exposure to
Croatian: Vrsta hrane ne utječe na izloženost simepreviru.
English: - If it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.
Croatian: - Ukoliko do slijedeće doze ima više od 12 sati, uzmite zaboravljenu dozu što je prije moguće s hranom.
English: The Q80K polymorphism was not observed in patients with genotype 4 infection.
Croatian: Q80K polimorfizam nije zapažen u bolesnika s infekcijom genotipom 4.
English: All patients receiving OLYSIO combination treatment with sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they
Croatian: Svi bolesnici koji primaju kombinirano liječenje lijekom OLYSIO sa sofosbuvirom u kombinaciji s amiodaronom s ili bez drugih lijekova koji snižavaju frekvenciju srca trebaju također biti upozoreni na simptome bradikardije i srčanog zastoja, te im se treba savjetovati da hitno potraže medicinski savjet
English: Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Croatian: Procjena rizika za okoliš (ERA) Simeprevir je klasificiran kao PBT (postojana, bioakumulativna i toksična) tvar (vidjeti dio 6.6).
English: Table 4: Interactions and dose recommendation with other medicinal products Recommendation for co-administration
Croatian: Tablica 4: Interakcije i preporuke za doziranje s drugim lijekovima
English: Johnson & Johnson d.o.o.
Croatian: Johnson & Johnson S.E. d.o.o.
English: May include few patients with HCV non-genotype 1a/1b.
Croatian: Može uključivati nekoliko bolesnika s HCV-om koji nije genotipa 1a/1b.
English: None of the patients discontinued treatment due to ‘blood bilirubin increased'.
Croatian: Niti jedan bolesnik nije prekinuo liječenje zbog ‘povišenog bilirubina u krvi'.