FrancophonIA/ELRC3.0 huggingface dataset:
English: Includes one prior null responder who experienced relapse after SVR12, who was considered to have an HCV re-infection (based on phylogenetic analyses).
Croatian: Uključuje jednog bolesnika koji prethodno nije odgovorio koji je doživio relaps nakon SVR12, za kojeg se smatralo da je imao reinfekciju HCV-om (temeljeno na filogenetičkoj analizi).
English: SVR: SVR12 for study HPC3007 and SVR24 for study C206.
Croatian: SVR: SVR12 za ispitivanje HPC3007 i SVR24 za ispitivanje C206.
English: Caution is warranted and clinical monitoring of patients is recommended when these calcium channel blockers are given orally.
Croatian: Nalaže se oprez i preporučuje se kliničko praćenje bolesnika kada se ti blokatori kalcijevih kanala primjenjuju peroralno.
English: In these patients the SVR12 rates were 89%, 93%, 75% and 90%, respectively.
Croatian: Kod tih bolesnika stope SVR12 bile su 89%, 93%, 75% odnosno 90%.
English: In dogs, simeprevir was associated with a reversible multifocal hepatocellular necrosis with associated increases in ALT, AST, alkaline phosphatase and/or bilirubin.
Croatian: U pasa, simeprevir je bio povezan s reverzibilnom multifokalnom hepatocelularnom nekrozom s povezanim povišenjima ALT, AST, alkalne fosfataze i/ili bilirubina.
English: There are no data on the effect of simeprevir on human fertility.
Croatian: Ne postoje podaci o učinku simeprevira na plodnost u ljudi.
English: Established and theoretical interactions between simeprevir and selected medicinal products are listed in table 4 (least square mean ratios with 90% confidence intervals (90% CI) are presented, increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Croatian: Ustanovljene i teoretske interakcije između simeprevira i odabranih lijekova navedene su u tablici 4 (prikazani su omjeri srednjih vrijednosti dobivenih metodom najmanjih kvadrata s intervalom pouzdanosti od 90% (90% CI), povišenje je navedeno kao “↑”, sniženje kao “↓”, “nije bilo promjene” kao “↔”).
English: Unchanged simeprevir in faeces accounted for on average 31% of the administered dose.
Croatian: Nepromijenjeni simeprevir u fecesu ubrojan je kao prosjek 31% primijenjene doze.
English: Study HPC3021 N = 40 % (n/N)
Croatian: Ispitivanje HPC3021 N = 40 % (n/N)
English: Simeprevir was not genotoxic in a series of in vitro and in vivo tests.
Croatian: Simeprevir nije bio genotoksičan u serijama in vitro i in vivo ispitivanja.
English: HCV/HIV-1 co-infected patients.
Croatian: HCV/HIV-1 koinficirani bolesnici.
English: Antiretroviral - non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz
Croatian: Antiretrovirusni - ne-nukleozidni inhibitori reverzne transkriptaze (NNRTIs) Efavirenz
English: The one patient with on-treatment failure discontinued treatment early due to an adverse event.
Croatian: Jedan bolesnik s neuspjehon tijekom liječenja prekinuo je liječenje ranije zbog štetnog događaja.
English: Patients had compensated liver disease (including cirrhosis), HCV RNA of at least 10,000 IU/ml, and liver histopathology consistent with CHC (if available).
Croatian: Bolesnici su imali kompenziranu bolest jetre (uključujući cirozu), HCV RNK od najmanje 10 000 IU/ml i histopatologiju jetre u skladu s kroničnim hepatitisom C (ukoliko je dostupna).
English: Studies carried out in rats did not reveal significant findings on fertility, embryo-fetal development or pre- and post-natal development at any of the tested doses (corresponding to a systemic exposure in rats similar or lower than that observed in humans at the recommended dose of 150 mg once daily).
Croatian: Ispitivanja provedena na štakorima nisu otkrila značajne nalaze vezano uz plodnost, embrio-fetalni razvoj ili pre- i post-natalni razvoj pri bilo kojoj ispitivanoj dozi (odgovara sistemskoj izloženosti u štakora sličnoj ili nižoj od one koja je uočena u ljudi pri preporučenoj dozi od 150 mg jedanput na dan).
English: - The recommended dose of OLYSIO is one capsule (150 milligrams) once a day.
Croatian: - Preporučena doza lijeka OLYSIO je jedna kapsula (150 miligrama) jedanput na dan.
English: Read the package leaflets for these other medicines for information regarding driving and using machines.
Croatian: Pročitajte upute o lijeku za te druge lijekove vezano uz informacije o upravljanju vozilima i strojevima.
English: Race No dose adjustment is necessary based on race (see section 5.2).
Croatian: Rasa Prilagodba doze, na temelju rase, nije potrebna (vidjeti dio 5.2).
English: The doctor will advise you to stop breast-feeding or to stop taking OLYSIO while breast-feeding.
Croatian: Liječnik će Vam savjetovati prekid dojenja ili prekid uzimanja lijeka OLYSIO tijekom dojenja.
English: Female patients of childbearing potential must use an effective form of contraception (see section 4.6).
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju (vidjeti dio 4.6).
English: OLYSIO capsules contain lactose monohydrate.
Croatian: OLYSIO kapsule sadrže laktozu hidrat.
English: OLYSIO has not been studied in HCV infected patients with severe renal impairment (creatinine clearance below 30 ml/min) or end stage renal disease, including patients requiring haemodialysis.
Croatian: OLYSIO nije ispitan u bolesnika zaraženih HCV-om s teškim oštećenjem bubrega (klirens kreatinina ispod 30 ml/min) ili završnim stadijem bubrežne bolesti, uključujući bolesnike kojima je potrebna hemodijaliza.
English: Compared to intake without food, administration of simeprevir with food to healthy subjects increased the AUC by 61% after a high-fat, high-caloric (928 kcal) and 69% after a normal caloric (533 kcal) breakfast, and delayed the absorption by 1 hour and 1.5 hours, respectively.
Croatian: U usporedbi s uzimanjem bez hrane, primjena simeprevira s hranom zdravim je ispitanicima povisila AUC za 61% nakon doručka s visokim udjelom masti i kalorija (928 kcal) i za 69% nakon doručka s normalom količinom kalorija (533 kcal), te je odgodila apsorpciju za 1 sat odnosno za 1,5 sati.
English: No clinically relevant drug-drug interaction is expected.
Croatian: Ne očekuje se klinički značajna interakcija lijek-lijek.
English: In the pooled phase 3 safety data, the majority of the adverse reactions reported during 12 weeks treatment with simeprevir were grade 1 to 2 in severity.
Croatian: U objedinjenim sigurnosnim podacima faze 3, većina nuspojava koje su prijavljene tijekom 12 tjedana liječenja sa simeprevirom bile su težine stupnja 1 do 2.
English: Co-administration with other direct acting antivirals against HCV OLYSIO should only be co-administered with other direct acting antiviral medicinal products if the benefits are considered to outweigh the risks based upon available data.
Croatian: Istodobna primjena s ostalim antiviroticima koji djeluju direktno na HCV OLYSIO se smije primijeniti istodobno s ostalim antivirusnim lijekovima direktnog učinka samo ako se na temelju dostupnih podataka procijeni da korist nadvladava rizik.
English: 6 cells/ml).
Croatian: 6 stanica/ml
English: Age (18-73 years) had no clinically meaningful effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis (n = 21, age above 65 years) of HCV infected patients treated with simeprevir.
Croatian: Dob (18-73 godina) nije klinički značajno utjecala na farmakokinetiku simeprevira, temeljeno na populacijskoj farmakokinetičkoj analizi (n = 21, dob iznad 65 godina) bolesnika inficiranih HCV-om koji su liječeni simeprevirom.
English: If you are not sure, talk to your doctor or pharmacist before taking OLYSIO.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego što uzmete OLYSIO.
English: Substitutions D168V and R155K alone or in combinations with other mutations at these positions emerged most frequently (table 10).
Croatian: Najčešće su nastale supstitucije D168V i R155K same ili u kombinacijama s drugim mutacijama na tim položajima (tablica 10).
English: If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the
Croatian: Ako se pojave reakcije fotoosjetljivosti, u obzir se mora uzeti prekid primjene lijeka OLYSIO, a bolesnike treba pratiti dok ne
English: In 32 out of 48 patients (67%) with emerging single D168V and in 34 out of 66 (52%) patients with emerging single R155K, the respective emerging variants were no longer detected at end of the studies.
Croatian: U 32 od 48 bolesnika (67%) s nastalom samom D168V supstitucijom i u 34 od 66 (52%) bolesnika s nastalom samom R155K supstitucijom, dotične nastale varijante nisu više bile detektabilne na kraju ispitivanja.
English: The pharmacokinetics of simeprevir in children aged below 18 years have not been investigated.
Croatian: Farmakokinetika simeprevira u djece starosti ispod 18 godina nije bila ispitana.
English: There is no specific antidote for overdose with OLYSIO.
Croatian: Ne postoji specifični antidot za predoziranje lijekom OLYSIO.
English: - OLYSIO contains the active substance ‘simeprevir'.
Croatian: - OLYSIO sadrži djelatnu tvar “simeprevir“.
English: Re-evaluation of HCV RNA is recommended in case of HCV RNA ≥ 25 IU/ml after previous undetectable HCV RNA to confirm HCV RNA levels prior to discontinuing HCV treatment.
Croatian: Ponovna procjena HCV RNK preporučena je u slučaju HCV RNK ≥ 25 IU/ml nakon prethodno nedetektabilne HCV RNK kako bi se potvrdile razine HCV RNK prije prekida liječenja HCV-a.
English: - being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver).
Croatian: - osjetljivost na sunčevu svjetlost (fotoosjetljivost) - povišene razine “bilirubina“ u Vašoj krvi (bilirubin je pigment kojeg stvara jetra).
English: In these patients the SVR12 rates were 96%, 94%, 100% and 68%,
Croatian: Kod tih bolesnika stope SVR12 bile su 96%, 94%, 100%
English: 12 weeks OLYSIO + sofosbuvir (without ribavirin) may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see sections 4.4 and 5.1)
Croatian: + sofosbuvir (bez ribavirina) može se uzeti u obzir u bolesnika za koje je procijenjeno da imaju nizak rizik za kliničku progresiju bolesti i koji imaju naknadne mogućnosti ponovnog liječenja (vidjeti dijelove 4.4 i 5.1)
English: Mild increases in concentrations of these antiarrhythmics may be expected when these medicinal products are administered orally.
Croatian: Mogu se očekivati blagi porasti koncentracija ovih antiaritmika kada se ovi lijekovi primjenjuju peroralno.
English: Common: may affect up to 1 in 10 people: - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver)* - being sensitive to sunlight (photosensitivity)
Croatian: Često: mogu se javiti u do 1 na 10 osoba: - povišene razine “bilirubina“ u Vašoj krvi (bilirubin je pigment kojeg stvara jetra)* - osjetljivost na sunčevu svjetlost (fotoosjetljivost)
English: Maximum plasma concentrations (Cmax) are typically achieved between 4 to
Croatian: Maksimalne koncentracije u plazmi (Cmax) obično se postižu unutar 4 do 6 sati nakon doze.
English: OLYSIO should only be used during pregnancy or in women of childbearing potential if the benefit justifies the risk.
Croatian: Tijekom trudnoće i u žena reproduktivne dobi OLYSIO se smije uzimati jedino ako korist primjene opravdava rizik.
English: Asian patients
Croatian: Bolesnici azijatskog porijekla
English: As liver function may change during treatment with OLYSIO, close monitoring of International Normalised Ratio (INR) values is recommended.
Croatian: Budući da tijekom liječenja lijekom OLYSIO može doći do promjene u funkciji jetre, preporučuje se pomno praćenje vrijednosti međunarodnog normaliziranog omjera (INR).
English: Table 12: Demographics and baseline characteristics (studies HPC3017 and HPC3018) HPC3017 N = 310
Croatian: Tablica 12: Demografske i početne karakteristike (ispitivanja HPC3017 i HPC3018) HPC3017 N = 310
English: One patient in the 12-week treatment group (0.3%) and none of the patients in the 24-week treatment group discontinued treatment due to adverse reactions.
Croatian: Jedan bolesnik u skupini s 12-tjednim liječenjem (0,3%) i niti jedan bolesnik u skupini s 24-tjednim liječenjem nije prekinuo liječenje zbog nuspojava.
English: In vitro experiments with human Caco-2 cells indicated that simeprevir is a substrate of P-gp.
Croatian: In vitro eksperimenti s humanim Caco-2 stanicama ukazuju na to da je simeprevir supstrat P-gp-a.
English: Treatment stopping rules for HCV therapy were used to ensure that patients with inadequate on-treatment virologic response discontinued treatment in a timely manner.
Croatian: Pravila za kraj liječenja za HCV terapiju su se koristila kako bi se osiguralo da bolesnici s neodgovarajućim virološkim odgovorom tijekom liječenja prekinu liječenje u zadanom vremenskom okviru.
English: - Do not use this medicine after the expiry date which is stated on the carton and blister packaging after EXP.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blister pakiranju iza oznake Rok valjanosti odnosno EXP.
English: The effect of simeprevir 150 mg once daily and 350 mg once daily for 7 days on the QT interval was evaluated in a randomised, double-blind, placebo- and positive-controlled (moxifloxacin 400 mg once daily), 4-way cross-over study in 60 healthy subjects.
Croatian: Učinak simeprevira od 150 mg jedanput na dan i 350 mg jedanput na dan tijekom 7 dana na QT interval bilo je procijenjeno u randomiziranom, dvostruko slijepom, s placebom i pozitivnom kontrolom kontroliranom (moksifloksacin 400 mg jedanput na dan), 4- smjernom ukriženom ispitivanju u 60 zdravih ispitanika.
English: Most photosensitivity reactions in simeprevir-treated patients were of mild or moderate severity (grade 1 or 2); 0.3% of the simeprevir-treated patients experienced serious reactions leading to hospitalisation (see section 4.4).
Croatian: Većina reakcija fotoosjetljivosti kod bolesnika liječenih simeprevirom bile su blage ili umjerene težine (stupanj 1 ili 2); 0,3% bolesnika liječenih simeprevirom doživjelo je ozbiljne reakcije koje su dovele do hospitalizacije (vidjeti dio 4.4).
English: Two patients had HIV virologic failure defined as confirmed HIV-1 RNA ≥ 200 copies/ml after previous < 50 copies/ml; these failures occurred 36 and 48 weeks after end of simeprevir treatment.
Croatian: Dva bolesnika imala su HIV virološki neuspjeh definiran kao potvrđena HIV-1 RNK ≥ 200 kopija/ml nakon prethodne < 50 kopija/ml; ovaj neuspjeh se pojavio 36 i 48 tjedana nakon kraja liječenja simeprevirom.
English: The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food.
Croatian: Preporučeno doziranje lijeka OLYSIO je jedna kapsula od 150 mg jedanput na dan, uzeta s hranom.
English: The mean absolute bioavailability of simeprevir following a single oral 150 mg dose of simeprevir in fed conditions is 62%.
Croatian: Srednja vrijednost apsolutne bioraspoloživosti simeprevira nakon jedne peroralne doze od 150 mg simeprevira u stanju sitosti je 62%.
English: If a dose of OLYSIO is missed, and the patient notices within 12 hours of the usual dosing time, the patient should take the missed dose of OLYSIO with food as soon as possible and then take the next dose of OLYSIO at the regularly scheduled time.
Croatian: Ako se propusti doza lijeka OLYSIO, a bolesnik to primijeti unutar 12 sati od uobičajenog vremena doziranja, bolesnik propuštenu dozu lijeka OLYSIO mora uzeti što je prije moguće s hranom, a sljedeću dozu lijeka OLYSIO uzeti prema uobičajenom rasporedu.
English: Inhibitors of OATP1B1/3 such as eltrombopag or gemfibrozil may result in increases in simeprevir plasma concentrations.
Croatian: Inhibitori OATP1B1/3 poput eltrombopaga ili gemfibrozila mogu dovesti do povišenja koncentracija simeprevira u plazmi.
English: Due to the long elimination half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on OLYSIO combination treatment with sofosbuvir.
Croatian: Zbog dugog poluvremena eliminacije amiodarona, treba se provoditi i prikladno praćenje bolesnika koji su prekinuli liječenje amiodaronom unatrag nekoliko mjeseci i kojima će biti započeto kombinirano liječenje lijekom OLYSIO sa sofosbuvirom.
English: When taking OLYSIO combination treatment, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - notice yellowing of your skin or eyes
Croatian: Kada uzimate kombinirano liječenje lijekom OLYSIO, recite svom liječniku ako imate sljedeće simptome, jer oni mogu biti znak pogoršanja problema s jetrom: - ako primijetite da su vam požutjeli koža ili oči - ako vam je mokraća tamnije boje od uobičajene - ako primijetite oticanje u području trbuha.
English: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgija
English: As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by
Croatian: Budući da se simeprevir u visokoj mjeri veže na proteine plazme, nije vjerojatno da će se značajno
English: peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin); SMV = simeprevir.
Croatian: peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (doziranje ribavirina dvaput dnevno na temelju tjelesne težine, prema sažetku opisa svojstava lijeka za ribavirin); SMV = simeprevir.
English: The daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food; also refer to the Summary of Product Characteristics of ribavirin.
Croatian: Dnevna doza ribavirina temelji se na tjelesnoj težini (< 75 kg = 1,000 mg i ≥ 75 kg = 1,200 mg) i primjenjuje se peroralno u dvije podijeljene doze uz obrok; također vidjeti sažetak opisa svojstava lijeka za ribavirin.
English: There are no safety and efficacy data of OLYSIO in patients over the age of 75 years.
Croatian: Ne postoje podaci o sigurnosti i djelotvornosti za OLYSIO u bolesnika starijih od 75 godina.
English: In vitro experiments with human liver microsomes indicated that simeprevir primarily undergoes oxidative metabolism by the hepatic CYP3A4 system.
Croatian: In vitro eksperimenti s mikrosomima ljudske jetre ukazuju na to da simeprevir primarno prolazi oksidativni metabolizam putem jetrenog CYP3A4 sustava.
English: In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic
Croatian: In vitro kombinacija simeprevira s interferonom, ribavirinom, NS5A ili NS5B inhibitorima rezultirala je aditivnim ili sinergističkim učincima.
English: Simeprevir does not affect CYP2C9, CYP2C19 or CYP2D6 in vivo.
Croatian: Simeprevir ne utječe na CYP2C9, CYP2C19 ili CYP2D6 in vivo.
English: If treatment with OLYSIO is discontinued because of adverse reactions or inadequate on-treatment virologic response, OLYSIO treatment must not be reinitiated.
Croatian: Ukoliko se liječenje lijekom OLYSIO prekine zbog nuspojava ili neadekvatnog virološkog odgovora tijekom liječenja, liječenje lijekom OLYSIO se ne smije ponovno započeti.
English: The clinical relevance of this difference in viral breakthrough rates is
Croatian: Klinički značaj ove razlike u stopama virološkog proboja nije poznat.
English: - If it is less than 12 hours until your next dose, skip the missed dose.
Croatian: - Ukoliko do slijedeće doze ima manje od 12 sati, preskočite zaboravljenu dozu.
English: OATP1B1/3 and MRP2 are involved in the transport of bilirubin into and out of hepatocytes.
Croatian: OATP1B1/3 i MRP2 su uključeni u transport bilirubina u i iz hepatocita.
English: In rodents, simeprevir elicited toxic effects in the liver, pancreas and gastrointestinal systems.
Croatian: U glodavaca, simeprevir je izazvao toksične učinke na jetri, pankreasu i probavnom sustavu.
English: Double-blind, randomised, placebo-controlled, except for studies C212 and HPC3011 which were open-label, single arm.
Croatian: Dvostruko slijepo, randomizirano, placebom kontrolirano, osim za ispitivanja C212 i HPC3011 koja su bila otvorena ispitivanja u jednoj skupini bolesnika.
English: The safety and efficacy of simeprevir have not been established in HCV infected patients with moderate or severe hepatic impairment (Child-Pugh B or C).
Croatian: Sigurnost i djelotvornost simeprevira nisu bile ustanovljene u bolesnika inficiranih HCV-om s umjerenim ili teškim oštećenjem jetre (Child-Pugh B ili C).
English: Co-administration of OLYSIO with substances that moderately or strongly induce or inhibit cytochrome P450 3A (CYP3A4) is not recommended as this may lead to significantly lower or higher
Croatian: Istovremena primjena lijeka OLYSIO s tvarima koje umjereno ili jako induciraju ili inhibiraju citokrom P450 3A (CYP3A4) se ne preporučuje jer može dovesti do značajno niže odnosno više
English: OLYSIO helps to fight against hepatitis C infection by preventing HCV from multiplying.
Croatian: OLYSIO pomaže u borbi protiv infekcije hepatitisom C, sprečavanjem umnožavanja HCV-a.
English: 150 mg simeprevir 12 weeks % (n/N)
Croatian: 150 mg simeprevira 12 tjedana % (n/N)
English: Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse
Croatian: Ispitivanje HPC3007: uključuje 5 bolesnika liječenih simeprevirom koji su doživjeli relaps nakon SVR12.
English: These HCV protease inhibitors are anticipated to be cross-resistant, and co-administration is not recommended (see also section 4.5).
Croatian: Za te inhibitore proteaze HCV-a očekuje se da će biti križno rezistentni, te se istovremena primjena ne preporučuje (također vidjeti dio 4.5).
English: Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
Croatian: Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
English: The most frequently reported adverse reactions (incidence ≥ 5% following 12 or 24 weeks of treatment) were rash, pruritus, constipation and photosensitivity reaction (see section 4.4).
Croatian: Najčešće prijavljene nuspojave (incidencija ≥ 5% nakon 12 ili 24 tjedna liječenja) bile su osip, pruritus, konstipacija i reakcija fotoosjetljivosti (vidjeti dio 4.4).
English: There are limited data on the safety and efficacy of OLYSIO in patients older than 65 years.
Croatian: Postoje ograničeni podaci o sigurnosti i djelotvornosti lijeka OLYSIO u bolesnika starijih od 65 godina.
English: Alternative therapy should be considered for patients infected with HCV genotype 1a with the Q80K polymorphism or in cases where testing is not accessible.
Croatian: Drugi izbor liječenja mora se uzeti u obzir za bolesnike inficirane HCV-om genotipa 1a, s polimorfizmom Q80K ili u slučajevima kada ispitivanje nije dostupno.
English: Simeprevir does not induce CYP1A2 or CYP3A4 in vitro.
Croatian: Simeprevir ne inducira CYP1A2 ili CYP3A4 in vitro.
English: Human experience of overdose with simeprevir is limited.
Croatian: Iskustvo u ljudi s predoziranjem simeprevirom je ograničeno.
English: Genotype 1a N = 116 % (n)
Croatian: Genotip 1a N = 116 % (n)
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Croatian: Za specifično djelovanje na virus hepatitisa C (HCV) ovisno o genotipu, vidjeti dijelove 4.4 i 5.1.
English: One patient (3.2%) receiving 24 weeks of treatment experienced a grade 4 ‘blood bilirubin increased' event.
Croatian: Jedan bolesnik (3,2%) koji je liječen tijekom 24 tjedna imao je događaj ‘povišen bilirubin u krvi' 4. stupnja.
English: In a phase 3 study conducted in China and South-Korea, the mean plasma exposure of simeprevir in Asian HCV infected patients was 2.1-fold higher compared to non-Asian HCV infected patients in a pooled phase 3 population from global studies.
Croatian: U ispitivanju faze 3 provedenom u Kini i Južnoj Koreji, srednja izloženost simepreviru u plazmi bolesnika azijatskog porijekla zaraženih HCV-om bila je 2,1 puta viša u usporedbi s bolesnicima koji nisu azijatskog porijekla zaraženih HCV-om iz objedinjenih globalnih ispitivanja faze 3.