FrancophonIA/ELRC3.0 huggingface dataset:
English: Additionally, resistance to simeprevir was evaluated in HCV genotype 1a and 1b replicon assays using site-directed mutants and chimeric replicons carrying NS3 sequences derived from clinical isolates.
Croatian: Dodatno, rezistencija na simeprevir bila je procijenjena u testovima replikona HCV-a genotipa 1a i 1b koristeći ciljane mutante i kimerne replikone koji su nosili NS3 sekvence derivirane iz kliničkih izolata.
English: In addition, tell your doctor if you take any medicines used to treat irregular heart beat or high blood
Croatian: Dodatno, obavijestite svog liječnika ako uzimate bilo koji lijek za liječenje nepravilnih otkucaja srca
English: When OLYSIO is used with ribavirin, please read the package leaflet for ribavirin for information regarding pregnancy.
Croatian: Kada se OLYSIO uzima s ribavirinom, molimo pročitajte uputu o lijeku za ribavirin radi informacija vezanih uz trudnoću.
English: The recommended co-administered medicinal product(s) and treatment duration for OLYSIO combination therapy are provided in tables 1 and 2.
Croatian: Preporučeni istovremeno primijenjeni lijek(ovi) i trajanje liječenja u kombiniranom liječenju s lijekom OLYSIO prikazani su u tablicama 1 i 2.
English: It is not recommended to co-administer OLYSIO with delavirdine, etravirine or nevirapine.
Croatian: Ne preporučuje se istovremeno primjenjivati OLYSIO s delavirdinom, etravirinom ili nevirapinom.
English: The primary enzyme involved in the biotransformation of simeprevir is CYP3A4 (see section 5.2) and clinically relevant effects of other medicinal products on simeprevir pharmacokinetics via CYP3A4 may occur.
Croatian: Primarni enzim uključen u biotransformaciju simeprevira je CYP3A4 (vidjeti dio 5.2), te se mogu javiti klinički značajni učinci drugih lijekova na farmakokinetiku simeprevira putem CYP3A4.
English: Most of these emerging substitutions have been shown to reduce simeprevir anti-HCV activity in cell culture replicon assays.
Croatian: Većina od tih nastalih supstitucija pokazala je u testu replikona u kulturi stanica da smanjuju anti-HCV aktivnost simeprevira.
English: No dose adjustment is necessary based on race.
Croatian: Nije potrebna prilagodba doze temeljena na rasi.
English: If you develop a photosensitivity reaction during treatment, contact your doctor immediately.
Croatian: Ako Vam se tijekom liječenja razvije reakcija fotoosjetljivosti, odmah se obratite svom liječniku.
English: The pharmacokinetic properties of simeprevir have been evaluated in healthy adult subjects and in adult HCV infected patients.
Croatian: Farmakokinetička svojstva simeprevira bila su procijenjena u zdravih odraslih ispitanika i u odraslih bolesnika inficiranih HCV-om.
English: Female patients of childbearing potential must use an effective form of contraception.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju.
English: The dosing recommendation is applicable to the recommended dose of simeprevir 150 mg once daily.
Croatian: Preporuka za doziranje primjenjiva je na preporučenu dozu za simeprevir od 150 mg jedanput na dan.
English: Discontinue peginterferon alfa and ribavirin (treatment with OLYSIO is complete at week 12)
Croatian: Prekinuti liječenje peginterferonom alfa i ribavirinom (liječenje lijekom OLYSIO završeno je u 12. tjednu)
English: Study C206
Croatian: Ispitivanje C206
English: A trend for a higher incidence of increased bilirubin levels with increasing simeprevir plasma exposure was observed.
Croatian: Uočen je trend veće incidencije povišenih razina bilirubina s povišenjem izloženosti simepreviru u plazmi.
English: If you take more OLYSIO than you should If you take more OLYSIO than you should, talk to your doctor or pharmacist immediately.
Croatian: Ako uzmete više lijeka OLYSIO nego što ste trebali, odmah se obratite liječniku ili ljekarniku.
English: The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Croatian: Doza simeprevira u ovom ispitivanju interakcije bila je 50 mg kada se istovremeno primjenjivao u kombinaciji s darunavirom/ritonavirom, u usporedbi sa 150 mg u skupini koja je liječena samo simeprevirom.
English: Hepatic decompensation and hepatic failure
Croatian: Hepatička dekompenzacija i zatajenje jetre
English: The median simeprevir EC50 and EC90 values against a HCV genotype 1b replicon were 9.4 nM (7.05 ng/ml) and 19 nM (14.25 ng/ml), respectively.
Croatian: Medijani vrijednosti EC50 i EC90 simeprevira protiv replikona HCV genotipa 1b bili su 9,4 nM (7,05 ng/ml) odnosno 19 nM (14,25 ng/ml).
English: Efficacy in adults with HCV genotype 4
Croatian: Djelotvornost u odraslih s HCV genotipom 4
English: Treatment regimen with sofosbuvir:
Croatian: Režim liječenja sa sofosbuvirom:
English: Simeprevir in vitro was very mildly irritating to the eyes.
Croatian: Simeprevir je in vitro bio vrlo blago nadražujuć za oči.
English: Warnings and precautions related to these medicinal products also apply to their use in OLYSIO combination treatment.
Croatian: Upozorenja i mjere opreza za te lijekove, također su primjenjivi na njihovu primjenu u kombiniranom liječenju s lijekom OLYSIO.
English: Dosage adjustment or interruption of OLYSIO treatment To prevent treatment failure, the dose of OLYSIO must not be reduced or interrupted.
Croatian: Kako bi se spriječio neuspjeh liječenja, doza lijeka OLYSIO ne smije se smanjivati ili prekidati.
English: Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin).
Croatian: Superiorna naspram povijesne kontrolne stope (povijesne SVR stope odobrene kombinacije liječenja antivirusnim lijekovima direktnog djelovanja s peginterferonom alfa i ribavirinom).
English: Dosing of animals resulted in similar (dogs) or lower (rats) exposures than those observed in humans at the recommended dose of 150 mg once daily.
Croatian: Doziranje u životinja rezultiralo je sličnim (u pasa) ili nižim (u štakora) izloženostima u odnosu na one uočene u ljudi pri preporučenoj dozi od 150 mg jedanput na dan.
English: Laboratory testing during treatment with OLYSIO, peginterferon alfa and ribavirin HCV RNA levels should be monitored at weeks 4 and 12 and as clinically indicated (see also guidelines for treatment duration and stopping rules; section 4.2).
Croatian: Laboratorijski nalazi tijekom liječenja lijekom OLYSIO, peginterferonom alfa i ribavirinom Vrijednosti HCV RNK treba pratiti u 4. i 12. tjednu, te kada je to klinički indicirano (vidjeti također smjernice za trajanje i za prestanak primjene liječenja; dio 4.2).
English: Interaction studies have been performed in healthy adults with the recommended dose of 150 mg simeprevir once daily unless otherwise noted.
Croatian: Ispitivanja interakcija provedena su na zdravim odraslim ispitanicima s preporučenom dozom od 150 mg simeprevira jedanput na dan, osim ako nije zabilježeno drugačije.
English: When OLYSIO is used with ribavirin, read the package leaflet for ribavirin for information regarding contraception requirements.
Croatian: Kada se OLYSIO uzima s ribavirinom, pročitajte uputu o lijeku za ribavirin za informacije vezane uz zahtjeve za kontracepciju.
English: Female patients of childbearing potential and male patients with female partners of childbearing potential must use an effective form of contraception during treatment with ribavirin and after completion of ribavirin treatment for a duration as specified in the Summary of
Croatian: Bolesnice reproduktivne dobi i muški bolesnici koji imaju partnerice reproduktivne dobi, moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja ribavirinom i nakon završetka liječenja ribavirinom toliko dugo koliko je navedeno u sažetku opisa svojstava lijeka za ribavirin.
English: Because OLYSIO must be co-administered with other medicinal products, for the treatment of CHC, the contraindications and warnings applicable to those medicinal products also apply to their use in combination treatment with OLYSIO (see section 4.3).
Croatian: Zbog toga što se OLYSIO mora istovremeno primjenjivati s drugim lijekovima za liječenje kroničnog hepatitisa C, kontraindikacije i upozorenja koja su primjenjiva na te lijekove također su primjenjiva na njihovo uzimanje u kombiniranom liječenju s lijekom OLYSIO (vidjeti dio 4.3).
English: Simeprevir-resistant variants studied remained susceptible to representative HCV nucleoside and non-nucleoside polymerase inhibitors, and NS5A inhibitors.
Croatian: Ispitivane varijante rezistentne na simeprevir i dalje su ostale osjetljive na tipične predstavnike HCV nukelozidnih i ne-nukleozidnih ihhibitora polimeraza i NS5A inhibitore.
English: Simeprevir is not a clinically relevant inhibitor of cathepsin A enzyme activity.
Croatian: Simeprevir nije klinički značajan inhibitor enzimske aktivnosti katepsina A.
English: Close monitoring is recommended if this medicinal product is administered with OLYSIO in combination with sofosbuvir (see section 4.4).
Croatian: Preporuča se pomno praćenje ukoliko se ovaj lijek primijenjuje s lijekom OLYSIO u kombinaciji sa sofosbuvirom (vidjeti dio 4.4).
English: If a dose of OLYSIO is missed by more than 12 hours after the usual dosing time, the patient should not take the missed dose of OLYSIO and should resume dosing of OLYSIO with food at the regularly
Croatian: Ako se propusti doza lijeka OLYSIO više od 12 sati od uobičajenog vremena doziranja, bolesnik ne smije uzeti propuštenu dozu lijeka OLYSIO, a s doziranjem lijeka OLYSIO mora nastaviti s hranom,
English: Grade 2 and 3 adverse reactions were reported in 3.5% (n = 10) and 0.3% (n = 1) of patients, respectively, receiving 12 weeks simeprevir with sofosbuvir; no grade 4 adverse reactions were reported.
Croatian: Nuspojave 2. i 3. stupnja bile su prijavljene u 3,5% (n = 10) odnosno 0,3% (n = 1) bolesnika koja su primala 12 tjedana simeprevir sa sofosbuvirom; nije bilo prijavljenih nuspojava 4. stupnja.
English: HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1
Croatian: Istodobna infekcija HCV-om/virusom humane imunodeficijencije tipa 1 (HIV-1) Nije potrebna prilagodba doze za lijek OLYSIO u bolesnika s koinfekcijom HCV-om i HIV-om-1 (vidjeti dijelove 4.8, 5.1 i 5.2).
English: - If you are a man, your female partner must not become pregnant during your treatment and
Croatian: - Ako ste muškarac, Vaša partnerica ne smije zatrudniti tijekom Vašeg liječenja i nekoliko mjeseci nakon toga.
English: Dose adjustment of the PDE-5 inhibitor may be required when OLYSIO is co-administered with sildenafil or tadalafil administered chronically at doses used for the treatment of pulmonary arterial hypertension.
Croatian: Prilagodba doze PDE-5 inhibitora može biti potrebna kada se lijek OLYSIO primjenuje istovremeno sa sildenafilom ili tadalafilom kronično pri dozama za liječenje plućne arterijske hipertenzije.
English: In study C208, all patients received peginterferon alfa-2a; in study C216, 69% of the patients received peginterferon alfa-2a and 31% received peginterferon alfa-2b.
Croatian: U ispitivanju C208, svi bolesnici primali su peginterferon alfa-2a; u ispitivanju C216, 69% bolesnika primalo je peginterferon alfa-2a i 31% primalo je peginterferon alfa-2b.
English: There are no data to support the co-administration of OLYSIO and telaprevir or boceprevir.
Croatian: Ne postoje podaci koji bi poduprli istodobnu primjenu lijeka OLYSIO i telaprevira ili boceprevira.
English: Ribavirin use and prior treatment status (treatment-naïve and prior null responders) did not impact treatment outcome.
Croatian: Primjena ribavirina i status prethodnog liječenja (bolesnici koji prethodno nisu bili liječeni i bolesnici bez prethodnog odgovora) nisu imali utjecaj na ishod liječenja.
English: When used together with other medicines to treat chronic hepatitis C infection, OLYSIO helps to clear HCV from
Croatian: Kada se uzima zajedno s drugim lijekovima za liječenje kronične infekcije virusom hepatitisa C, OLYSIO pomaže odstranjenju HCV-a iz Vašeg tijela.
English: In healthy adult subjects receiving single doses up to 600 mg or once daily doses up to 400 mg for 5 days, and in HCV infected adult patients receiving 200 mg once daily for 4 weeks, adverse reactions were consistent with those observed in clinical studies at the recommended dose (see section 4.8).
Croatian: U zdravih odraslih ispitanika koji su primali jednu dozu do 600 mg ili doze do 400 mg jedanput na dan tijekom 5 dana, i u odraslih bolesnika inficiranih HCV-om koji su primali 200 mg jedanput na dan tijekom 4 tjedna, nuspojave su bile konzistentne s onima koje su uočene u kliničkim ispitivanjima pri preporučenoj dozi (vidjeti
English: No dose adjustment is required when OLYSIO is co-administered with doses of sildenafil, vardenafil, or tadalafil indicated for the treatment of erectile dysfunction.
Croatian: Nije potrebna prilagodba doze kada se OLYSIO primjenjuje istovremeno sa sildenafilom, vardenafilom ili tadalafilom koji su indicirani za liječenje erektilne disfunkcije.
English: In patients receiving 24 weeks simeprevir with sofosbuvir, no grade 2 or 3 adverse reactions were reported; one patient (3.2%) experienced a grade 4 adverse reaction (‘blood bilirubin increased').
Croatian: U bolesnika koji su primali 24 tjedna simeprevir sa sofosbuvirom, nije bilo prijavljenih nuspojava 2. ili 3. stupnja; jedan bolesnik (3,2%) imao je nuspojavu 4. stupnja (“povišen bilirubin u krvi”).
English: Compared to healthy subjects with normal hepatic function, the mean steady-state AUC of simeprevir was 2.4-fold higher in non-HCV infected subjects with moderate hepatic impairment (Child-Pugh B) and 5.2-fold higher in non-HCV infected subjects with severe hepatic impairment (Child-Pugh C).
Croatian: U usporedbi sa zdravim ispitanicima s normalnom funkcijom jetre, srednja vrijednost AUC-a simeprevira u stanju dinamičke ravnoteže bila je 2,4-puta viša u bolesnika koji nisu inficirani HCVom s umjerenim oštećenjem jetre (Child-Pugh B) i 5,2-puta viša u bolesnika koji nisu inficirani HCVom sa teškim oštećenjem jetre (Child-Pugh C).
English: Simeprevir exposure is significantly increased in patients with severe hepatic impairment (see section 5.2).
Croatian: Izloženost simepreviru značajno je povišena u bolesnika s teškim oštećenjem jetre (vidjeti dio 5.2).
English: There are no virologic treatment stopping rules that apply to the combination of OLYSIO with sofosbuvir.
Croatian: Ne postoje pravila za prekid virološkog liječenja koja su primjenjiva na kombinaciju lijeka OLYSIO sa sofosbuvirom.
English: Renal elimination of simeprevir is negligible.
Croatian: Eliminacija simeprevira bubregom je zanemariva.
English: OLYSIO is supplied in push-through blister strips of 7 capsules.
Croatian: OLYSIO se isporučuje u blisterima kroz koje se može protisnuti kapsula, s po 7 kapsula.
English: Table 21: SVR12 rates for selected subgroups (study HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
Croatian: Tablica 21: Stope SVR12 za odabrane podskupine (ispitivanje HPC3007) placebo + peginterferon + ribavirin % (n/N)
English: Co-administration of OLYSIO with ciclosporin is not recommended as this leads to significantly higher exposure of simeprevir (see section 4.5).
Croatian: Istodobna primjena lijeka OLYSIO s ciklosporinom ne preporučuje se jer dovodi do značajno višoj izloženosti simepreviru (vidjeti dio 4.5).
English: Genotype 1b N = 81 % (n)
Croatian: Genotip 1b N = 81 % (n)
English: or amiodarone to treat irregular heart beat - clarithromycin, erythromycin (when taken by mouth or given by injection) or telithromycin to treat bacterial infections - warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Croatian: ili amiodaron za liječenje nepravilnih otkucaja srca - klaritromicin, eritromicin (kada se uzima kroz usta ili primjenjuje injekcijom) ili telitromicin za liječenje bakterijskih infekcija - varfarin i drugi slični lijekovi pod nazivom antagonisti vitamina
English: The overall SVR12 rate was similar in patients receiving simeprevir + sofosbuvir with or without ribavirin.
Croatian: Cjelokupna stopa SVR12 bila je slična u bolesnika koji su primali simeprevir + sofosbuvir s ili bez ribavirina.
English: Serious adverse reactions were reported in 0.3% of simeprevir-treated patients (2 photosensitivity events requiring hospitalisation) and in none of the patients receiving placebo with peginterferon alfa and ribavirin.
Croatian: Ozbiljne nuspojave bile su prijavljene u 0,3% bolesnika liječenih simeprevirom (2 događaja fotoosjetljivosti koja su zahtijevala hospitalizaciju) i niti u jednog bolesnika koji je primao placebo s peginterferonom alfa i ribavirinom.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on OLYSIO combination treatment with sofosbuvir when other alternative antiarrhythmic treatments are
Croatian: Slučajevi su potencijalno opasni po život, stoga se amiodaron treba primijeniti u bolesnika koji se liječe kombinacijom lijekova OLYSIO sa sofosbuvirom, samo kada se druga, alternativna liječenja antiaritmicima ne podnose ili su kontraindicirana.
English: When administered to lactating rats, simeprevir was detected in plasma of suckling rats likely due to excretion of simeprevir via milk.
Croatian: Kada je primijenjen štakoricama koje doje, simeprevir je detektiran u plazmi dojenih štakora vjerojatno radi ekskrecije simeprevira putem mlijeka.
English: Caution is warranted and therapeutic drug monitoring for amiodarone and/or clinical monitoring (ECG etc.) when orally administered are recommended.
Croatian: Potreban je oprez i terapijsko praćenje lijeka za amiodaron i/ili kliničko praćenje (EKG itd.) kada je preporučena peroralna primijena.
English: Caution is warranted when this medicinal product with narrow therapeutic index is co-administered with OLYSIO via the oral route.
Croatian: Nalaže se oprez kada se ovaj lijek s uskim terapijskim indeksom primjenjuje istovremeno s lijekom OLYSIO peroralnim putem.
English: Substitutions such as D168V or A, and R155K were usually associated with large reductions in susceptibility to simeprevir in vitro (FC in EC50 > 50), whereas other substitutions such as Q80K or R, S122R, and D168E displayed in vitro low level resistance (FC in EC50 between 2 and 50).
Croatian: Supstitucije poput D168V ili A i R155K bile su obično povezane sa velikim smanjenjima osjetljivosti na simeprevir in vitro (promjena EC50 > 50 puta), dok su druge supstitucije poput Q80K ili R, S122R i D168E pokazale nisku razinu rezistencije in vitro (promjena EC50 između 2 i 50 puta).
English: OLYSIO in combination with sofosbuvir: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients.
Croatian: OLYSIO u kombinaciji sa sofosbuvirom: Bolesnike s koinfekcijom HCV-om i HIV-om-1 potrebno je liječiti jednako dugo kao i bolesnike s monoinfekcijom HCV-om.
English: OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients (see sections 4.2, 4.4 and 5.1).
Croatian: OLYSIO je indiciran u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa C u odraslih bolesnika (vidjeti dijelove 4.2, 4.4 i 5.1).
English: No serious adverse reactions
Croatian: Nisu bile prijavljene ozbiljne nuspojave.
English: In study HPC2014 (OSIRIS), patients received simeprevir + sofosbuvir for 8 weeks (patients without cirrhosis) or 12 weeks (patients with or without cirrhosis) (see table 11).
Croatian: U ispitivanju HPC2014 (OSIRIS), bolesnici su primali simeprevir + sofosbuvir tijekom 8 tjedana (bolesnici bez ciroze) ili 12 tjedana (bolesnici s ili bez ciroze) (vidjeti tablicu 11).
English: It is not recommended to co-administer OLYSIO with systemic itraconazole, ketoconazole or posaconazole.
Croatian: Ne preporučuje se istovremeno primjenjivati OLYSIO sa sistemskim itrakonazolom, ketokonazolom ili posakonazolom.
English: In 2% and 0.3% of the simeprevir-treated patients grade 3 or 4 ‘blood bilirubin increased' was reported, respectively (pooled phase 3 studies).
Croatian: U 2% odnosno 0,3% bolesnika liječenih simeprevirom bio je prijavljen ‘povišen bilirubin u krvi' stupnja 3 ili 4 (objedinjena ispitivanja faze 3).
English: Pharmacokinetic parameters of simeprevir were comparable between patients with HCV genotype 1 infection with or without HIV-1 co-infection.
Croatian: Farmakokinetički parametri simeprevira bili su usporedivi među bolesnicima s HCV infekcijom genotipom 1 sa ili bez HIV-1 koinfekcije.
English: If other medicinal products used in combination with OLYSIO for the treatment of CHC are permanently discontinued for any reason, OLYSIO must also be discontinued.
Croatian: Ukoliko se drugi lijekovi primijenjeni u kombinaciji s lijekom OLYSIO za liječenje kroničnog hepatitisa C trajno prekinu uzimati iz bilo kojeg razloga, uzimanje lijeka OLYSIO također se mora prekinuti.
English: Combination treatment of OLYSIO with other medicines used for treating your chronic hepatitis C infection may affect your ability to drive and use machines.
Croatian: Kombinirano liječenje lijekom OLYSIO s drugim lijekovima za liječenje kronične infekcije hepatitisom C može utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking OLYSIO.
Croatian: Ako se bilo što od gore navedenog odnosi naVas (ili niste sigurni), obratite se svom liječniku ili ljekarniku prije nego što uzmete OLYSIO.
English: Note, substitutions at NS3 position 43 and 156 associated with reduced simeprevir activity in vitro were not observed at
Croatian: Napomena, supstitucije na NS3 položajima 43 i 156 povezane sa smanjenom aktivnošću simeprevira in vitro nisu bile uočene u vrijeme neuspjeha liječenja.
English: The persistence of simeprevir-resistant NS3 amino acid substitutions was assessed following treatment failure.
Croatian: Ustrajnost supstitucija aminokiselina NS3 proteaze koje uzrokuju rezistenciju na simeprevir bila je procijenjena nakon neuspjeha liječenja.
English: Most of the photosensitivity reactions were of mild severity (grade 1); grade 2 photosensitivity reactions were reported in two patients (0.7%) receiving 12 weeks of treatment.
Croatian: Većina reakcija fotoosjetljivosti bila je blaga s obzirom na težinu (1. stupnja); reakcije fotoosjetljivosti 2. stupnja bile su prijavljene u dva bolesnika (0,7%) koji su primali liječenje tijekom 12 tjedana.
English: Variants carrying amino-acid substitutions conferring reduced susceptibility to NS5A inhibitors (L31F/V, Y93C/H), nucleoside polymerase inhibitors (S282T) and non-nucleoside polymerase inhibitors (C316N, M414I/L, P495A) remained susceptible to simeprevir in vitro.
Croatian: Varijante koje nose supstitucije aminokiselina koje uzrokuju smanjenu osjetljivost na NS5A inhibitore (L31F/V, Y93C/H), nukleozidne inhibitore polimeraze (S282T) i ne-nukleozidne inhibitore polimeraze (C316N, M414I/L, P495A) ostale su osjetljive na simeprevir in vitro.
English: When ribavirin is added to the combination of OLYSIO and sofosbuvir, and ribavirin needs to be discontinued, treatment of OLYSIO with sofosbuvir without ribavirin can be continued (see section 5.1).
Croatian: Kada je ribavirin dodan uz kombinaciju lijeka OLYSIO i sofosbuvira, te ribavirin treba prekinuti uzimati, liječenje lijekom OLYSIO i sofosbuvirom bez ribavirina može se nastaviti (vidjeti
English: The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic study in opioid-dependent adults on stable methadone maintenance therapy.
Croatian: Interakcija između simeprevira i lijeka bila je procijenjena u farmakokinetičkom ispitivanju u odraslih ovisnih o opioidima koji su na stabilnoj metadonskoj terapiji održavanja.
English: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV control group: 48 weeks placebo + peg-IFN-alfa + RBV
Croatian: 12 tjedana SMV + peg-IFN-alfa + RBV, nakon čega je slijedilo 12 ili 36 tjedana peg-IFN-alfa + RBV kontrolna skupina: 48 tjedana placebo + peg-IFN-alfa + RBV