FrancophonIA/ELRC3.0 huggingface dataset:
English: The physician in charge of the diabetic care of the patient should be informed when direct acting antiviral therapy is initiated.
Croatian: Liječnik zadužen za praćenje dijabetesa u bolesnika mora biti obaviješten o uvođenju terapije direktno djelujućim antivirotikom.
English: The changes in dasabuvir exposures in subjects with mild, moderate and severe renal impairment are not considered to be clinically significant.
Croatian: Promjene u izloženosti dasabuviru kod bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega se ne smatraju klinički značajnima.
English: Inhibition of P-gp and BCRP is not expected to show clinically relevant increases in exposures of dasabuvir (Table 2).
Croatian: Ne očekuje se da će inhibicija P-gp-a i BCRP-a uzrokovati klinički značajna povećanja izloženosti dasabuviru (Tablica 2).
English: 61% had prior HCV treatment experience before transplant.
Croatian: Šezdeset i jedan posto (61%) ispitanika je prije transplantacije primalo terapiju za HCV.
English: 12 or 24 weeks N = 380 n (%)
Croatian: 12 ili 24 tjedna N = 380 n (%)
English: Dasabuvir exposures increased in a dose proportional manner and accumulation is minimal.
Croatian: Izloženost dasabuviru povećavala se proporcionalno dozi, uz minimalnu kumulaciju.
English: What you need to know before you take Exviera Do not take Exviera:
Croatian: Što morate znati prije nego počnete uzimati lijek Exviera Nemojte uzimati lijek Exviera:
English: Bilirubin elevations were not associated with aminotransferase elevations.
Croatian: Povišenja razina bilirubina nisu bila povezana s povišenjem razina aminotransferaza.
English: Changes in exposures of the metabolite were generally consistent with that observed with dasabuvir except for studies with CYP2C8 inhibitor, gemfibrozil, where the metabolite exposures decreased by up to 95% and CYP3A inducer, carbamazepine, where the metabolite exposures decreased by only up to 39%.
Croatian: Promjene u izloženosti metabolitima su uglavnom bile u skladu s uočenom izloženosti desabuviru, osim u ispitivanjima gemfibrozila, koji je inhibitor CYP2C8, pri čemu se izloženost metabolitima smanjila i do 95%, dok je kod karbamazepina kao induktora CYP3A zabilježeno smanjenje izloženosti metabolitima samo do 39%.
English: Dasabuvir has also been found to inhibit UGT1A4, 1A6 and intestinal UGT2B7 in vitro at in vivo relevant concentrations.
Croatian: Nađeno je da dasabuvir također inhibira UGT1A4, 1A6 i crijevni UGT2B7 in vitro pri in vivo značajnim koncentracijama.
English: Examples of contraindicated inducers are provided below.
Croatian: Primjeri kontraindiciranih induktora navode se u nastavku.
English: Adverse events of anaemia were not seen in the 18 GT1b-infected subjects who did not receive ribavirin.
Croatian: Štetni događaji anemije nisu primijećeni u 18 ispitanika s infekcijom genotipom 1b koji nisu primali ribavirin.
English: Due to high SVR rates in genotype 1b, trends in persistence of treatment-emergent variants in this genotype could not be established.
Croatian: Zbog visokih stopa SVR-a kod genotipa 1b, za taj se genotip nisu mogli utvrditi trendovi postojanosti varijanti nastalih tijekom liječenja.
English: ANTIHYPERLIPIDAEMICS Gemfibrozil
Croatian: ANTIHIPERLIPEMICI Gemfibrozil
English: Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome.
Croatian: Dasabuvir je nenukleozidni inhibitor RNK polimeraze ovisne o HCV RNK, koju kodira gen NS5B, neophodan za replikaciju virusnog genoma.
English: Dasabuvir was the predominant component observed in the milk of lactating rats, without effect on nursing pups.
Croatian: Dasabuvir je bio najzastupljenija komponenta primijećena u mlijeku ženki štakora u laktaciji, ali nije imao učinka na mladunčad koja je sisala.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of multipack of 14 film-coated tablets - without blue box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Unutarnja kutija višestrukog pakiranja s 14 filmom obloženih tableta - bez plavog okvira
English: Enzyme inducers:
Croatian: Induktori enzima:
English: Symptoms include: o Feel sick (nauseous), are sick (vomit) or lose your appetite o Notice yellowing of your skin or eyes o Your urine is darker than normal o Confusion o Notice swelling of your stomach area
Croatian: Simptomi uključuju: o mučninu, povraćanje ili gubitak apetita o opažanje žutila kože ili očiju o mokraća koja je tamnija nego uobičajeno o smetenost o opažanje oticanja u području trbuha
English: In clinical studies
Croatian: U kliničkim ispitivanjima
English: Medicinal products metabolised by glucuronidation Dasabuvir is an inhibitor of UGT1A1 in vivo.
Croatian: Lijekovi koji se metaboliziraju glukoronidacijom Dasabuvir je inhibitor UGT1A1 in vivo.
English: Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2).
Croatian: Interakcije lijekova moraju se pažljivo razmotriti kod bolesnika koji imaju istodobnu infekciju HIV-om (za detalje vidjeti dio 4.5, Tablica 2).
English: Take one tablet in the evening.
Croatian: Uzmite jednu tabletu navečer.
English: The dose of ribavirin was individualized at the discretion of the investigator, with most subjects receiving 600 to 800 mg as a starting dose, and most subjects also receiving 600 to 800 mg per day at the end of treatment.
Croatian: Doza ribavirina prilagođavala se individualno prema odluci ispitivača, pri čemu je većina ispitanika primala dozu od 600 do 800 mg kao početnu dozu, ali je većina ispitanika također primala dozu od 600 do 800 mg na dan i na kraju liječenja.
English: • Check for side effects of Exviera or other antiviral medicines your doctor has prescribed for you to use with Exviera (such as “ombitasvir/paritaprevir/ritonavir” and “ribavirin”).
Croatian: • provjerio imate li nuspojave na lijek Exviera ili druge antivirusne lijekove koje Vam je liječnik propisao uz lijek Exviera (kao što su „ombitasvir/paritaprevir/ritonavir“ i „ribavirin“ ).
English: Medicinal products metabolised by CYP2D6 or CYP1A2
Croatian: Lijekovi koji se metaboliziraju putem CYP2D6 ili CYP1A2
English: Medicines you must not take with Exviera Medicine or active substance
Croatian: Lijekovi koje ne smijete uzimati s lijekom Exviera Lijek ili djelatna tvar
English: No subjects experienced on-treatment virologic failure or relapse.
Croatian: Ni kod jednog ispitanika nije zabilježen virološki neuspjeh niti relaps.
English: Patients who are taking ethinyloestradiol -containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating dasabuvir with ombitasvir/paritaprevir/ritonavir therapy (see sections 4.3 and 4.5).
Croatian: Bolesnice koje uzimaju lijekove koji sadrže etinilestradiol (tj. većina kombiniranih oralnih kontraceptiva ili kontracepcijski vaginalni prstenovi) moraju prijeći na alternativne kontracepcijske metode (npr. kontracepcija samo progestinom ili nehormonalne metode kontracepcije) prije početka liječenja dasabuvirom s ombitasvirom/paritaprevirom/ritonavirom (vidjeti dio 4.3 i 4.5).
English: A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment.
Croatian: Preporučuje se privremeni prekid uzimanja fluvastatina i pitavastatina tijekom liječenja.
English: b. Includes subjects who discontinued due to adverse event, lost to follow-up or subject withdrawal, and subjects with reinfection
Croatian: Uključuje ispitanike koji su prekinuli liječenje zbog štetnog događaja, ispitanike koji su izgubljeni iz praćenja ili koji su se povukli iz ispitivanja te ispitanike kod kojih je došlo do reinfekcije.
English: M1 is mainly cleared through direct biliary excretion with the contribution of UGT-mediated glucuronidation and, to a small extent, oxidative metabolism.
Croatian: M1 se uglavnom izlučuje izravnom bilijarnom ekskrecijom, uz doprinos glukuronidacije posredovane UGTom i u manjoj mjeri oksidativnog metabolizma.
English: The mean baseline haemoglobin level was 12.1 g/dL and the mean decline in haemoglobin at the end of treatment for subjects taking RBV was 1.2 g/dL.
Croatian: Srednja vrijednost početne razine hemoglobina bila je 12,1 g/dl, a srednje sniženje vrijednosti hemoglobina na kraju liječenja u ispitanika koji su uzimali ribavirin iznosilo je 1,2 g/dl.
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2% (5/2,044) and 4.8% (99/2,044) of subjects had ribavirin dose reductions due to adverse reactions.
Croatian: Udio ispitanika koji su trajno obustavili liječenje zbog nuspojava iznosio je 0,2% (5/2044), a u 4,8% (99/2044) ispitanika je zbog nuspojava smanjena doza ribavirina.
English: Patients should be monitored frequently for any changes in renal function or tacrolimus or sirolimus associated adverse reactions.
Croatian: Bolesnike treba često kontrolirati kako bi se uočile bilo kakve promjene bubrežne funkcije ili nuspojave povezane s primjenom takrolimusa ili sirolimusa.
English: Overall SVR12
Croatian: Ukupan SVR12
English: Prior HCV Treatment: naïve, n (%)
Croatian: Prethodno liječenje HCV-a: neliječeni, n (%)
English: Exviera tablets are beige, ovaloid film-coated tablets, of dimensions of 14.0 mm x 8.0 mm, marked with “AV2”.
Croatian: Exviera tablete su bež, ovalne, filmom obložene tablete veličine 14,0 mm x 8,0 mm, s oznakom „AV2“.
English: Clinical Comments twice daily1
Croatian: Klinička napomena dvaput na dan1
English: Food increased the exposure (AUC) of dasabuvir by up to 30% relative to the fasting state.
Croatian: U odnosu na primjenu natašte, hrana je povećala izloženost (AUC) dasabuviru do 30%.
English: Beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm and debossed on one side with ‘AV2'.
Croatian: Bež, ovalne, filmom obložene tablete dimenzija 14,0 mm x 8,0 mm i s utisnutim „AV2“ s jedne strane.
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines.
Croatian: Bolesnici istodobno inficirani HBV-om/HCV-om izloženi su riziku od reaktivacije HBV-a te ih stoga treba pratiti i liječiti sukladno važećim kliničkim smjernicama.
English: In the 8.5% of subjects who had ribavirin dose adjustments during therapy, the SVR rate (98.5%) was comparable to subjects who maintained their starting ribavirin dose throughout treatment.
Croatian: U 8,5% ispitanika kojima je doza ribavirina prilagođena tijekom terapije, stopa SVR-a (98,5%) bila je usporediva s onom postignutom u ispitanika koji su tijekom čitavog liječenja primali početnu dozu ribavirina.
English: 5 subjects required erythropoietin, all of whom initiated ribavirin at the starting dose of 1000 to 1200 mg daily.
Croatian: U 5 ispitanika je bila potrebna primjena eritropoetina, s tim da je u svih njih početna doza ribavirina bila 1000 do 1200 mg na dan.
English: • Hepatic laboratory testing including direct bilirubin levels should be performed at baseline, during the first 4 weeks of starting treatment and as clinically indicated thereafter.
Croatian: • Potrebno je provoditi laboratorijske pretrage jetrenih parametara, uključujući razine direktnog bilirubina, na početku liječenja, tijekom prva 4 tjedna liječenja te sukladno kliničkoj potrebi nakon toga.
English: Dasabuvir was absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Croatian: Dasabuvir se apsorbirao nakon peroralne primjene uz srednju vrijednost tmax od približno 4 do 5 sati.
English: • Confirm if your treatment has worked and if you are free of the hepatitis C virus.
Croatian: • potvrdio da je liječenje bilo učinkovito i da u Vašem tijelu nema više virusa hepatitisa C
English: AMINOSALICYLATE Sulfasalazine
Croatian: AMINOSALICILATI Sulfasalazin
English: Increase in paritaprevir exposures may be due to inhibition of OATPs by atazanavir.
Croatian: povećanje razine izloženosti paritaprevir u moglo bi biti posljedica inhibicije OATP-a koju uzrokuje atazanavir.
English: • Dehydration
Croatian: • dehidracija.
English: Genotype 1b N=7 % (n)
Croatian: Genotip 1b N=7 % (n)
English: Exviera works by stopping the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time.
Croatian: Exviera djeluje tako da spriječava umnožavanje virusa hepatitisa C i infekciju novih stanica čime s vremenom uklanja virus iz krvi.
English: If statin treatment is required during the treatment period, a switch to dose reduced pravastatin or rosuvastatin is possible.
Croatian: Ako je tijekom liječenja potrebno liječenje statinima, moguć je prelazak na manju dozu pravastatina ili rosuvastatina.
English: There was 1 relapse in the 12-week arm and 1 on-treatment virologic failure in the 24-week arm.
Croatian: Zabilježen je 1 relaps u skupini liječenoj 12 tjedana i 1 virološki neuspjeh tijekom liječenja u skupini koja je terapiju primala 24 tjedna.
English: The overall safety profile in subjects with severe renal impairment was similar to that seen in prior Phase 3 studies in subjects without severe renal impairment, except that a greater proportion of subjects required intervention due to ribavirin-associated decreases in serum haemoglobin.
Croatian: Cjelokupni sigurnosni profil u ispitanika s teškim oštećenjem funkcije bubrega bio je sličan onome opaženom u prethodnim ispitivanjima faze 3 u ispitanika bez teškog oštećenja funkcije bubrega, osim što je većem udjelu ispitanika bila potrebna intervencija zbog sniženja serumskih vrijednosti hemoglobina povezanih s djelovanjem ribavirina.
English: Dasabuvir is an inhibitor of BCRP in vivo.
Croatian: Dasabuvir je inhibitor BCRP-a in vivo.
English: Potential for dasabuvir 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 dasabuvira na farmakokinetiku drugih lijekova U in vivo ispitivanjima interakcije lijekova ocjenjivo se neto učinak kombiniranog liječenja,
English: 12 weeks N = 509 n (%)
Croatian: 12 tjedana N = 509 n (%)
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,
English: For dosing recommendations with HIV antiviral medicinal products, refer to sections 4.4 and 4.5.
Croatian: Za preporuke o doziranju antivirusnih lijekova za HIV vidjeti dijelove 4.4 i 4.5.
English: Enzyme inducers
Croatian: Induktori enzima
English: Dasabuvir M1 AUC values were 6% lower, 10% lower, and 13% lower, respectively.
Croatian: Vrijednosti AUC-a za M1 dasabuvira bile susnižene redom za 6%, 10% i 13%.
English: 10 of 34 subjects (29.4%) dose modified ribavirin due to decrease in haemoglobin and 2.9% (1/34) had an interruption of ribavirin.
Croatian: U 10 od 34 ispitanika (29,4%) je prilagođena doza ribavirina zbog smanjenja vrijednosti hemoglobina te je u 2,9% (1/34) prekinuto liječenje ribavirinom.
English: Tell your doctor or pharmacist before taking Exviera if you are also using hormonal contraceptives.
Croatian: Recite svom liječniku ili ljekarniku prije nego uzmete lijek Exviera ako uzimate hormonske kontraceptive.
English: Dasabuvir is predominantly metabolised by CYP2C8 and to a lesser extent by CYP3A.
Croatian: Dasabuvir se najvećim dijelom metabolizira posredstvom CYP2C8, a u manjoj mjeri posredstvom CYP3A.
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when dasabuvir is used with ribavirin.
Croatian: Moraju se poduzeti iznimne mjere opreza kako bi se izbjegla trudnoća u bolesnica i partnerica bolesnika muškoga spola kada se dasabuvir primjenjuje u kombinaciji s ribavirinom.
English: dasabuvir + ombitasvir/paritaprevir/ritonavir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim.
Croatian: Dasabuvir + ombitasvir/paritaprevir/ritonavir primjenjivali su se u višestrukim dozama u svim ispitivanjima interakcija lijekova osim u ispitivanju interakcije s karbamazepinom, gemfibrozilom, ketokonazolom i sulfametoksazol/trimetoprimom.
English: Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Croatian: Exviera je indicirana u kombinaciji s drugim lijekovima za liječenje odraslih bolesnika s kroničnim hepatitisom C (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Coadministration with ethinyloestradiol may lead to increased risk of ALT elevations (see sections 4.3 and 4.4).
Croatian: Istodobna primjena s etinilestradiolom može povećati rizik od povišene razine ALT-a (vidjeti dijelove 4.3 i 4.4).
English: Dasabuvir retained full activity against replicons containing substitutions S282T in the nucleoside binding site, M423T in the lower thumb site, and P495A/S, P496S or V499A in the upper thumb site.
Croatian: Dasabuvir je zadržao punu djelotvornost protiv replikona koji su imali supstituciju S282T na mjestu vezivanja nukleozida, supstituciju M432T u donjoj „palac“ („thumb“) domeni te supstituciju P495A/S, P496S ili V499A u gornjoj „thumb“ domeni.
English: One subject experienced relapse at Post-Treatment Week 4, 2 subjects prematurely discontinued study drug and 1 subject had missing SVR12 data.
Croatian: 4. tjednu nakon završetka liječenja, 2 su ispitanika prijevremeno prekinula liječenje ispitivanim lijekom, a za 1 bolesnika nedostajali su podaci o SVR12.
English: Cross-resistance
Croatian: Križna rezistencija
English: Compared to subjects without cirrhosis, in subjects with compensated cirrhosis there was an increased rate of indirect hyperbilirubinemia when ribavirin was part of the regimen.
Croatian: U odnosu na ispitanike bez ciroze, u ispitanika s kompenziranom cirozom učestalost indirektne hiperbilirubinemije bila je povećana kada je ribavirin bio uključen u liječenje.
English: Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with dasabuvir.
Croatian: Pročitajte sažetak opisa svojstava lijeka za lijekove koji se primjenjuju u kombinaciji s dasabuvirom.
English: Bilirubin elevations occurred after initiation of treatment, peaked by study Week 1, and generally resolved with ongoing therapy.
Croatian: Povišenja razina bilirubina nastupila su nakon uvođenja liječenja, vršnu vrijednost dosegla su do 1. tjedna ispitivanja, a obično bi se povukla s nastavkom terapije.
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Croatian: Za aktivnost protiv pojedinih genotipova virusa hepatitisa C (HCV) vidjeti dijelove 4.4 i 5.1.
English: Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Croatian: Bolesnike i njegovatelje treba uputiti da obavijeste liječnika koji je propisao lijek o bilo kakvim promjenama u ponašanju ili raspoloženju te bilo kakvim suicidalnim mislima.
English: Sixty four of 68 (94.1%) subjects achieved SVR12.
Croatian: Od ukupno 68 ispitanika, njih 64 (94,1%) postiglo je SVR12.
English: Medicinal products renally excreted via transport proteins Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate).
Croatian: Lijekovi koji se izlučuju putem prijenosnih proteina u bubrezima Dasabuvir ne inhibira prijenosnik organskih aniona (OAT1) in vivo što je pokazao izostanak interakcije s tenofovirom (supstrat za OAT1).
English: In subjects receiving dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue and nausea.
Croatian: U ispitanika koji su primali dasabuvir i ombitasvir/paritaprevir/ritonavir s ribavirinom, najčešće prijavljivane nuspojave (prijavljene u više od 20% ispitanika) bile su umor i mučnina.
English: Contraindicated enzyme inducers are provided in section 4.3.
Croatian: Kontraindicirani induktori enzima navedeni su u dijelu 4.3.
English: Deferasirox may increase dasabuvir exposures and should be used with caution.
Croatian: Deferasiroks može povisiti izloženost dasabuviru i potrebno ga je primjenjivati s oprezom.
English: Clinical trials in treatment-naïve adults
Croatian: Klinička ispitivanja u prethodno neliječenih odraslih ispitanika
English: Cirrhosis was not a risk factor for elevated ALT (see section 4.4).
Croatian: Ciroza nije bila faktor rizika za povišene razine ALT-a (vidjeti dio 4.4)
English: ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 857 days) and most resolved with ongoing therapy.
Croatian: Povišenja razine ALT-a su u pravilu bila asimptomatska, obično su se javljala tijekom prva 4 tjedna liječenja (u prosjeku nakon 20 dana, s rasponom od 8 do 57 dana) i većinom su se normalizirala s nastavkom liječenja.
English: Co-administration of dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine).
Croatian: Istodobna primjena dasabuvira s lijekovima koji se prvenstveno metaboliziraju posredstvom UGT1A1 povećava koncentraciju tih lijekova u plazmi; preporučuje se rutinski klinički nadzor za lijekove uskog terapijskog indeksa (npr. levotiroksin).
English: • If you have moderate to severe liver problems other than hepatitis C.
Croatian: • ako osim hepatitisa C imate druge umjerene do teške jetrene tegobe
English: None of the subjects with hyperbilirubinemia had concomitant elevations of aminotransferases.
Croatian: Ni u jednog ispitanika s hiperbilirubinemijom nije zabilježeno istodobno povišenje aminotransferaza.
English: See also Table 2 for specific advice on rosuvastatin which has been evaluated in a drug interaction study.
Croatian: Također vidjeti Tablicu 2 za određene preporuke za rosuvastatin koji je ocijenjen u ispitivanjima interakcija.
English: The safety of dasabuvir in children and adolescents aged < 18 years has not yet been established.
Croatian: Sigurnost primjene dasabuvira u djece i adolescenata mlađih od 18 godina nije još ustanovljena.
English: The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Croatian: Ova kombinacija predstavlja povećani rizik od hiperbilirubinemije (uključujući okularni ikterus), posebice kada je ribivarin sastavni dio režima liječenja hepatitisa C.
English: For subjects who received ribavirin, the ribavirin dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg.
Croatian: Kod ispitanika koji su primali ribavirin, doza ribavirina iznosila je 1000 mg na dan u ispitanika tjelesne težine manje od 75 kg odnosno 1200 mg na dan u ispitanika tjelesne težine od 75 kg ili više.
English: Exviera contains the active substance dasabuvir.
Croatian: Exviera sadrži djelatnu tvar dasabuvir.
English: Dasabuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Croatian: Dasabuvir nije bio genotoksičan u nizu in vitro ili in vivo testova, uključujući test mutagenosti na bakterijama, test kromosomskih aberacija na limfocitima iz ljudske periferne krvi te in vivo mikronukleusni test na štakorima.