FrancophonIA/ELRC3.0 huggingface dataset:
English: When taking Viekirax with dasabuvir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems:
Croatian: Dok uzimate lijek Viekirax s dasabuvirom, recite svome liječniku ako primijetite neke od sljedećih simptoma jer oni mogu biti znak pogoršanja jetrenih tegoba:
English: However, no dose-adjustment based on gender is warranted.
Croatian: Međutim nije potrebna prilagodna doze na temelju spola.
English: Viekirax tablets are packed into foil blisters containing 2 tablets.
Croatian: Viekirax tablete zapakirane su u blistere od folije koji sadrže 2 tablete.
English: What Viekirax looks like and contents of the pack
Croatian: Kako Viekirax izgleda i sadržaj pakiranja
English: Viekirax has no or negligible influence on the ability to drive and use machines.
Croatian: Viekirax ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: − Notice swelling of your stomach area
Croatian: − primijećeno oticanje u području trbuha
English: Ribavirin was dosed based on weight (1000 mg - 1200 mg per day).
Croatian: Doza ribavirina je temeljena na težini (1000 mg - 1200 mg na dan).
English: In order to evaluate the recurrence of hepatocellular carcinoma associated withViekirax, 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 Viekirax, nositelj odobrenja mora provesti i dostaviti rezultate prospektivnog ispitivanja sigurnosti, koristeći podatke koji proizlaze iz kohorte dobro definirane skupine bolesnika, na temelju dogovorenog protokola.
English: • sildenafil (when used for the treatment of pulmonary arterial hypertension)
Croatian: • sildenafil (kada se koristi za liječenje plućne arterijske hipertenzije)
English: • Serious allergic reactions, signs may include: o Difficulty breathing or swallowing o Dizziness or light-headedness, which may be due to low blood pressure o Swelling of the face, lips, tongue or throat o Rash and itching of the skin
Croatian: • Ozbiljne alergijske reakcije, znakovi mogu uključivati: o otežano disanje ili gutanje o omaglica ili ošamućenost, koje se mogu javiti uslijed niskog krvnog tlaka o oticanje lica, usana, jezika ili grla o osip ili svrbež kože
English: 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would results in <10% change in ombitasvir exposures, and no change in paritaprevir exposures.
Croatian: Promjena od 10 kg pri tjelesnoj težini od 76 kg (medijan težine u ispitivanjima fazi 3) rezultira u <10% promjene u izloženosti ombitasviru te nema promjene u izloženosti paritapreviru.
English: At least 5 minor metabolites of paritaprevir have been identified in circulation that accounted for approximately 10% of plasma radioactivity.
Croatian: U cirkulaciji je pronađeno najmanje 5 sporednih metabolita paritaprevira, koji su činili približno 10% radioaktivnosti u plazmi.
English: If more than 12 hours have passed since Viekirax is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule.
Croatian: Ako je prošlo više od 12 sati od vremena kada se obično uzima Viekirax, NE smije se uzeti propuštena doza te bolesnik mora uzeti sljedeću dozu prema uobičajenom rasporedu doziranja.
English: Limited data in patients with endstage renal disease indicate no clinically significant changes in exposure also in this patient group.
Croatian: Ograničeni podaci u bolesnika sa završnim stadijem bubrežne bolesti ne ukazuju na postojanje klinički značajnih promjena u izloženosti niti u ovoj skupini bolesnika.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Viekirax.
Croatian: U nekih bolesnika sa šećernom bolesti zabilježene su niske razine šećera u krvi (hipoglikemija) nakon početka liječenja lijekovima kao što je Viekirax.
English: Examples are provided below.
Croatian: Primjeri se navode u nastavku.
English: Ombitasvir and paritaprevir block two proteins essential for the virus to multiply.
Croatian: Ombitasvir i paritaprevir blokiraju dva proteina koji su nužni za umnožavanje virusa.
English: The effects of Viekirax during pregnancy are not known.
Croatian: Učinci lijeka Viekirax u trudnoći nisu poznati.
English: Body weight is not a significant predictor of ritonavir exposures.
Croatian: Tjelesna težina nije bitan čimbenik za izloženost ritonaviru.
English: Stop taking Viekirax and talk to your doctor or get medical help immediately if any of the following occur:
Croatian: Prekinite uzimanje lijeka Viekirax i obratite se svom liječniku ili odmah potražite medicinsku pomoć ako se bilo što od navedenog pojavi:
English: If you forget to take Viekirax
Croatian: Ako ste zaboravili uzeti Viekirax
English: Concomitant use of fluticasone can increase systemic exposures of fluticasone.
Croatian: Istodobna primjena s flutikazonom može povećati sistemsku izloženost flutikazonu.
English: NA Decrease amlodipine dose by 50% and monitor patients for clinical effects.
Croatian: --NP Preporučuje se smanjenje doze amlodipina za 50% i nadzor bolesnika za kliničke učinke.
English: Ombitasvir is metabolised via amide hydrolysis followed by oxidative metabolism.
Croatian: Ombitasvir se metabolizira hidrolizom amida, nakon koje slijedi oksidativni metabolizam.
English: Changes for ombitasvir, paritaprevir and dasabuvir the same as shown for paracetamol above
Croatian: Promjene za ombitasvir, paritaprevir i dasabuvir su iste kao što je prikazano iznad za paracetamol
English: • If you or your partner becomes pregnant during treatment with Viekirax and ribavirin or in the months that follow, you must contact your doctor immediately.
Croatian: Ako Vi ili Vaša partnerica zatrudnite tijekom liječenja lijekom Viekirax i ribavirinom ili u nekoliko narednih mjeseci nakon prestanka liječenja, odmah se obratite Vašem liječniku.
English: • cisapride
Croatian: • cisaprid
English: GASTROINTESTINAL PRODUCTS (PROPULSIVE) Cisapride
Croatian: GASTROINTESTINALNI LIJEKOVI (PROPULZIVI) cisaprid
English: for many different conditions including serious illnesses and allergies trazodone for anxiety and depression warfarin and other similar medicines called vitamin K antagonists*
Croatian: za liječenje brojnih različitih stanja, uključujući ozbiljne bolesti i alergije trazodon za liječenje tjeskobe i depresije varfarin i drugi slični lijekovi koji se nazivaju antagonisti vitamina K*
English: While no change to the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Croatian: Iako nije očekivana promjena farmakokinetike varfarina, preporučuje se pomni nadzor INR-a kod primjene svih antagonista vitamina K.
English: Women of childbearing potential / contraception in males and females
Croatian: Žene reproduktivne dobi / kontracepcija u muškaraca i žena
English: • indinavir, lopinavir/ritonavir, saquinavir, tipranavir,
Croatian: • indinavir, lopinavir/ritonavir, sakvinavir, tipranavir
English: Such medicinal products include some statins (see Table 2), fexofenadine, repaglinide and angiotensin II receptor antagonists (e.g., valsartan).
Croatian: Ovi lijekovi uključuju neke statine (vidjeti Tablicu 2), feksofenadin, repaglinid i antagoniste receptora angiotenzina II (npr. valsartan).
English: ↑ cisapride
Croatian: ↑ cisaprid
English: The increase in exposure was similar regardless of meal type (e.g., high-fat versus moderate-fat) or calorie content (approximately 600 Kcal versus approximately 1000 Kcal).
Croatian: Povećanje izloženosti bilo je slično, neovisno o vrsti obroka (npr. obrok s visokim udjelom masnoća naspram obroka s umjerenim udjelom masnoća) ili njegovoj kalorijskoj vrijednosti (približno 600 kcal naspram približno 1000 kcal).
English: Metabolism as well as biliary excretion of parent drug contribute to the elimination of paritaprevir.
Croatian: Metabolizam, kao i bilijarna ekskrecija ishodišnog spoja doprinose eliminaciji paritaprevira.
English: • lurasidone
Croatian: • lurasidon
English: Ritonavir acts as a ‘booster' to prolong the action of paritaprevir in the body.
Croatian: Ritonavir djeluje kao „pojačivač“ da bi se djelovanje paritaprevira u tijelu produžilo.
English: Drug interaction studies have only been performed in adults.
Croatian: Pedijatrijska populacija Ispitivanja interakcija lijekova provedena su samo u odraslih.
English: The blood to plasma concentration ratios in humans ranged from 0.6 to 0.8 indicating that ombitasvir and paritaprevir were preferentially distributed in the plasma compartment of whole blood.
Croatian: U ljudi su se omjeri između koncentracije u krvi i koncentracije u plazmi kretali u rasponu od 0,6 do 0,8, što upućuje na to da se ombitasvir i paritaprevir pretežno raspodjeljuju u plazmatski dio pune krvi.
English: INHALED BETA AGONISTS Salmeterol
Croatian: INHALACIJSKI BETA-AGONISTI salmeterol
English: AUC (ng*hr/ml) (% CV)
Croatian: AUC (ng*h/ml) (%CV)
English: Ritonavir is a strong inhibitor of CYP3A.
Croatian: Ritonavir je snažan inhibitor CYP3A.
English: 8 weeks may be considered in previously untreated genotype 1binfected patients with minimal to moderate fibrosis** (see section 5.1, GARNET study)
Croatian: Liječenje u trajanju od 8 tjedana može se razmotriti u prethodno neliječenih bolesnika s infekcijom genotipom 1b i minimalnom do umjerenom fibrozom** (vidjeti dio 5.1, ispitivanje GARNET)
English: While ombitasvir exposures increased in a dose proportional manner, paritaprevir and ritonavir exposures increased in a more than dose proportional manner.
Croatian: Dok se izloženost ombitasviru povećavala proporcionalno dozi, izloženost paritapreviru i ritonaviru povećavala se više nego proporcionalno dozi.
English: Trazodone should be used with caution and a lower dose of trazodone may be considered.
Croatian: Trazodon se mora primjenjivati s oprezom te se moraju razmotriti niže doze trazodona.
English: For dosing recommendations with calcineurin inhibitors see section 4.5.
Croatian: Za preporuke o doziranju s inhibitorima kalcineurina vidjeti dio 4.5.
English: Unchanged parent drug accounted for 88% of total radioactivity recovered in faeces, indicating that biliary excretion is a major elimination pathway for ombitasvir.
Croatian: Nepromijenjeni ishodišni spoj lijeka doprinosi 88% ukupne radioaktivnosti pronađene u fecesu, što upućuje da je bilijarna ekskrecija glavni put eliminacije ombitasvira.
English: V55Ic Y56Hc
Croatian: NS3 V55Ic Y56Hc
English: It is very important that you also read the package leaflets for the other antiviral medicines that you take with Viekirax.
Croatian: Vrlo je važno da pročitate i upute o lijeku za druge antivirusne lijekove koje uzimate s lijekom
English: See the section on contraception below.
Croatian: Pogledajte dio o kontracepciji u nastavku teksta.
English: All 3 (100%) subjects with GT4 infection who were post liver transplant achieved SVR12.
Croatian: Sva 3 (100%) ispitanika s infekcijom genotipom 4 kojima je transplantirana jetra postigla su SVR12.
English: 16 Weeks
Croatian: 16 tjedana
English: Overall, 37 (97.4%) of 38 subjects achieved SVR12.
Croatian: Ukupno je 37 (97,4%) od 38 ispitanika postiglo SVR12.
English: Such medicinal products include sulfasalazine, imatinib and some of the statins (see Table 2).
Croatian: Ovi lijekovi uključuju sulfasalazin, imatinib i neke statine (vidjeti Tablicu 2).
English: The combined action of the three active substances stops the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time.
Croatian: Zajedničkim djelovanjem ove tri djelatne tvari zaustavlja se umnožavanje virusa hepatitisa C i infekcija novih stanica te se virus s vremenom uklanja iz Vaše krvi.
English: Viekirax may increase the plasma exposure to medicinal products that are sensitive for changed intestinal P-gp activity (such as dabigatran etexilate).
Croatian: Viekirax može povisiti plazmatsku izloženost lijekovima koji su osjetljivi na promjenu aktivnosti crijevnog P-gp-a (poput dabigatraneteksilata).
English: -have diabetes.
Croatian: - imate šećernu bolest.
English: Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4)
Croatian: Hemoglobin <100-80 g/l (2. stupanj) <80-65 g/l (3. stupanj) <65 g/l (4. stupanj)
English: Potential for Viekirax to affect the pharmacokinetics of other medicinal products In vivo drug interaction studies evaluated the net effect of the combination treatment, including ritonavir.
Croatian: Mogući utjecaj lijeka Viekirax na farmakokinetiku drugih lijekova Ispitivanja interakcija lijekova in vivo su ocijenila neto učinak kombiniranog liječenja, uključujući ritonavir.
English: In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1).
Croatian: U ispitivanju nakon transplantacije jetre, doza ribavirina je individualizirana i većina ispitanika je primala 600 do 800 mg na dan (vidjeti dio 5.1).
English: See also Table 2 for specific advice on raltegravir and buprenorphine, which have been evaluated in drug interaction studies.
Croatian: Vidjeti također Tablicu 2 za posebne napomene o primjeni raltegravira i buprenorfina koji su ocijenjeni u ispitivanjima interakcija lijekova.
English: Thirty-nine of the 50 subjects who received ribavirin required interruption of ribavirin, and 11 of these subjects were also treated with erythropoietin.
Croatian: Od ukupno 50 ispitanika koji su primali ribavirin, u njih 39 bilo je potrebno prekinuti liječenje ribavirinom, a 11 od njih bilo je liječeno i eritropoetinom.
English: • pimozide
Croatian: • pimozid
English: SVR12 % (n/N) Outcome for subjects without SVR12
Croatian: SVR12 % (n/N) Ishodi za ispitanike bez SVR12
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 18% to 21% higher ombitasvir exposures, and 37% to 39% higher paritaprevir exposures than non-Asian subjects.
Croatian: Na temelju analize farmakokinetike populacije iz kliničkih ispitivanja faze 3, Azijati su imali 18% do 21% višu izloženost ombitasviru i 37% do 39% višu izloženost paritapreviru od onih koji nisu Azijati.
English: There are very limited data from the use of Viekirax in pregnant women.
Croatian: Vrlo je malo podataka o primjeni lijeka Viekirax u trudnica.
English: It is not known whether paritaprevir /ritonavir or ombitasvir and their metabolites are excreted in human breast milk.
Croatian: Nije poznato izlučuju li se paritaprevir/ritonavir ili ombitasvir i njihovi metaboliti u majčino mlijeko.
English: Ritonavir is an in vitro inhibitor of OCT1, but the clinical relevance is unknown.
Croatian: Ritonavir je in vitro inhibitor OCT1 ali njegov klinički značaj nije poznat.
English: In Phase 3 clinical trials, 1075 subjects (including 181 with compensated cirrhosis) with genotype 1 HCV infection received the recommended regimen (see section 4.2).
Croatian: U kliničkim ispitivanjima faze 3, 1075 ispitanika (uključujući 181 ispitanika s kompenziranom cirozom) s infekcijom HCV-om genotipa 1 primalo je preporučeni režim liječenja (vidjeti dio 4.2).
English: Because of the potential for adverse reactions from the medicinal product in breastfed infants, a decision must be made whether to discontinue breast-feeding or discontinue treatment with Viekirax, taking into account the importance of the therapy to the mother.
Croatian: Budući da lijek može uzrokovati nuspojave u dojenčadi, mora se donijeti odluka hoće li se prekinuti dojenje ili obustaviti liječenje lijekom Viekirax, uzimajući u obzir važnost terapije za majku.
English: (see section 4.4).
Croatian: (vidjeti dio 4.4).
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4)
Croatian: ALT >5-20 × GGN* (3. stupanj) >20 × GGN (4. stupanj)
English: No increase in incidence of ALT elevations was observed with other types of estrogens commonly used for hormone replacement therapy (e.g. oestradiol and conjugated estrogens).
Croatian: Nije zabilježena povećana incidencija povišenja razina ALT-a s ostalim tipovima estrogena koji se većinom koriste za hormonsku nadomjesnu terapiju (npr. estradiol i konjugirani estrogeni).
English: C24:= concentration at 24 hours following single dose of cyclosporine, tacrolimus or sirolimus.
Croatian: 6. C24:= koncentracija 24 sata nakon primjene jedne doze ciklosporina, takrolimusa ili sirolimusa.
English: When starting coadministration with Viekirax, give one fifth of the total daily dose of ciclosporin once daily with Viekirax.
Croatian: Kada se započinje istodobna primjena s lijekom Viekirax, primijeniti jednu petinu ukupne dnevne doze ciklosporina jedanput na dan s lijekom Viekirax.
English: Rilpivirine should be used cautiously, in the setting of repeated ECG monitoring.
Croatian: Rilpivirin se mora primjenjivati s oprezom, uz redovito praćenje EKG-a.
English: Some patients have reported feeling very tired when taking Viekirax with other medicines for their hepatitis C infection.
Croatian: Neki bolesnici su se osjećali vrlo umorno tijekom liječenja lijekom Viekirax s ostalim lijekovima za infekciju HCV-om.
English: Treatment outcome
Croatian: Ishod liječenja
English: Viekirax should be used in combination with other medicinal products for the treatment of HCV (see Table 1).
Croatian: Viekirax se mora uzimati u kombinaciji s drugim lijekovima za liječenje HCV-a (vidjeti Tablicu 1).
English: In Part 1b, SVR12 was achieved by 22/22 (100%) subjects (95% CI: 85.1%, 100%).
Croatian: U dijelu 1b, SVR12 postigla su 22/22 (100%) ispitanika (95% CI: 85,1%; 100%).
English: Do not give Viekirax to children and adolescents under 18 years of age.
Croatian: Viekirax se ne smije davati djeci i adolescentima mlađima od 18 godina.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP FOLIJA NA BLISTERU
English: What you need to know before you take Viekirax 3.
Croatian: Što morate znati prije nego počnete uzimati Viekirax
English: The absolute bioavailability of ombitasvir and paritaprevir was approximately 50% when administered with food as Viekirax.
Croatian: Apsolutna bioraspoloživost ombitasvira i paritaprevira bila je približno 50% nakon primjene s hranom u obliku lijeka Viekirax.
English: All other double substitutions of Y93H in combination with substitutions at positions 28, 31, or 58 reduced the activity of ombitasvir by more than 400-fold.
Croatian: Sve ostale dvostruke supstitucije Y93H u kombinaciji sa supstitucijama na položajima 28, 31 ili 58 smanjile su aktivnost ombitasvira više od 400 puta.
English: ↑ pravastatin 1.37
Croatian: ↑ amlodipin 1,26
English: In the presence of ombitasvir, paritaprevir exposures were minimally affected (5% to 27% change) while dasabuvir exposures increase by approximately 30%.
Croatian: U prisutnosti ombitasvira, izloženost paritapreviru se minimalno promijenila (promjena od 5 do 27%) dok se izloženost dasabuviru povećala za otprilike 30%.
English: In vitro interaction data
Croatian: Podaci o in vitro interakcijama
English: As the incidence of such elevations was 26% among women taking a concomitant ethinyloestradiol-containing medicinal product, such medicinal products are contraindicated with Viekirax with or without dasabuvir.
Croatian: S obzirom da je incidencija povišenja bila 26% u žena koje su istodobno uzimale lijekove koje sadrže etinilestradiol, ti lijekovi su kontraindicirani s lijekom Viekirax s dasabuvirom ili bez njega.
English: - have liver disease other than hepatitis C; -have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Croatian: - imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pobliže pratiti.
English: In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
Croatian: Među ispitanicima koji su primali preporučeni režim, njih je 97% postiglo ukupan SVR (među njima je 181 bolesnik s kompenziranom cirozom postigao 97% SVR-a), dok je u 0,5% ispitanika nastupio virološki proboj, a 1,2% ispitanika doživjelo je relaps nakon liječenja.
English: In contrast, the rate of ALT elevations in subjects using other types of oestrogens as typically used in hormonal replacement therapy (i.e., oral and topical oestradiol and conjugated oestrogens) was similar to the rate observed in subjects who were not using oestrogen-containing products (approximately 1% in each group).
Croatian: Nasuprot tome, stopa porasta razina ALT-a kod ispitanica koje su koristile druge tipove estrogena koji se uglavnom koriste u hormonskoj nadomjesnoj terapiji (tj. oralni i topikalni estradiol i konjugirani estrogeni) bila je slična stopi zabilježenoj kod ispitanica koje nisu koristile lijekove koji sadrže estrogen (približno 1% u svakoj skupini).
English: In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
Croatian: U prisutnosti dasabuvira, izloženost paritapreviru se povećala za 50 do 65%, dok nije bilo promjene u izloženosti ombitasviru.
English: The safety and efficacy of Viekirax in children less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Viekirax u djece mlađe od 18 godina nisu ustanovljene.
English: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System (except GARNET which used COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
Croatian: COBAS TaqMan HCV testom (verzija 2.0), namijenjenim za uporabu sa sustavom High Pure System (osim u ispitivanju GARNET, u kojem se koristio COBAS AmpliPrep ili COBAS TaqMan HCV Test, verzija 2.0).
English: ↔ dasabuvir sirolimus is used together with Viekirax + dasabuvir, administer sirolimus 0.2 mg twice a week (every 3 or 4 days on the same two days each week).
Croatian: Ako se sirolimus primjenjuje zajedno s lijekom Viekirax + dasabuvirom, sirolimus treba davati u dozi od 0,2 mg dvaput tjedno (svaka 3 ili 4 dana, ista dva dana svakog tjedna).
English: Contraceptive medicines that contain ethinyloestradiol cannot be used in combination with Viekirax.
Croatian: Kontraceptivi koji sadrže etinilestradiol ne smiju se uzimati u kombinaciji s lijekom Viekirax.
English: Inhibition of these transporters is not expected to show clinically relevant increases in exposures of ombitasvir and dasabuvir.
Croatian: Ne očekuje se da će inhibicija ovih prijenosnika uzrokovati klinički značajno povećanje izloženosti ombitasviru i dasabuviru.
English: The activity of ombitasvir was attenuated 11- to 13-fold in the presence of 40% human plasma.
Croatian: Aktivnost ombitasvira bilo je 11 do 13 puta slabije u prisutnosti 40% ljudske plazme.
English: These metabolites are not expected to have antiviral activity or off-target pharmacologic activity.
Croatian: Ne očekuje se da će ti metaboliti imati antivirusnu aktivnost niti da će biti farmakološki aktivni izvan ciljnih mjesta.
English: GLUCOCORTICOIDS (INHALED) Fluticasone
Croatian: GLUKOKORTIKOIDI (INHALACIJSKI) flutikazon
English: The use of Viekirax in children and adolescents has not yet been studied.
Croatian: Primjena lijeka Viekirax u djece i adolescenata još nije ispitana.
English: Transient elevations in total bilirubin >3 x ULN (mostly indirect) occurred in 17 (27.0%) subjects; 15 of these subjects were receiving atazanavir.
Croatian: U 17 ispitanika (27,0%) je zabilježeno prolazno povišenje ukupnog bilirubina >3 x GGN (većinom indirektnog), a 15 od tih ispitanika je uzimalo atazanavir.