FrancophonIA/ELRC3.0 huggingface dataset:
English: Sixty-five percent (53/81) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 79%.
Slovenian: Petinšestdeset odstotkov (53/81) bolnikov, okuženih s HCV genotipa 1a s polimorfizmom Q80K, zdravljenih s simeprevirjem, je imelo nezaznavno koncentracijo HCV RNK po 4 tednih, med temi bolniki jih je 79% doseglo
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.
Slovenian: Zdravnika ali farmacevta obvestite zlasti v primeru, da jemljete katero od naslednjih zdravil: - digoksin, dizopiramid, flekainid, meksiletin, propafenon ali kinidin (če zdravilo zaužijete) ali amiodaron za zdravljenje motenj srčnega ritma - klaritromicin, eritromicin (če zdravilo zaužijete ali ga prejmete z injekcijo) ali telitromicin za zdravljenje bakterijskih okužb - varfarin in druge podobne učinkovine, ki jih imenojumo antagonisti vitamina K in se uporabljajo za redčenje krvi.
English: Read the package leaflets for these medicines for their dosage and directions on ‘how to take' them.
Slovenian: Za odmerjanje in navodila za jemanje teh zdravil preberite ustrezno navodilo za uporabo, ki je priloženo vsakemu zdravilu.
English: Treatment-emergent laboratory abnormalities that were observed at a higher incidence in simeprevir-treated patients than in patients treated with placebo, peginterferon alfa and ribavirin are
Slovenian: Z zdravljenjem povzročene nenormalnosti laboratorijskih izvidov, ki so jih z večjo pogostnostjo opažali pri bolnikih, ki so prejemali simeprevir, kot pri bolnikih, ki so prejemali placebo, peginterferon alfa in ribavirin, so navedeni v preglednici 7.
English: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2, 4.8 and 5.2).
Slovenian: Uporaba zdravila OLYSIO pri bolnikih z zmerno do hudo okvaro jeter ni priporočljiva (razreda B ali C po Child-Pughu) (glejte poglavja 4.2, 4.8 in 5.2).
English: Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT and with at least one follow-up HCV RNA assessment.
Slovenian: Pogostnost ponovitve bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno koncentracijo HCV RNK ob dejanskem zaključku zdravljenja in z najmanj eno meritvijo koncentracije HCV RNK v času spremljanja po zaključku zdravljenja.
English: Medicinal products that are affected by the use of simeprevir Simeprevir mildly inhibits the CYP1A2 activity and intestinal CYP3A4 activity, while it does not affect hepatic CYP3A4 activity.
Slovenian: Simeprevir blago zavira delovanje CYP1A2 in delovanje CYP3A4 v črevesju, ne vpliva pa na delovanje CYP3A4 v jetrih.
English: Table 2: Recommended treatment duration for OLYSIO combination therapy with 1 in HCV genotype 1 or 4 Treatment duration
Slovenian: Preglednica 2: Priporočeno trajanje zdravljenja z zdravilom OLYSIO v kombinaciji s pri bolnikih, okuženih s HCV genotipa 1
English: In vitro experiments with human liver microsomes indicated that simeprevir primarily undergoes oxidative metabolism by the hepatic CYP3A4 system.
Slovenian: Poskusi s človeškimi jetrnimi mikrosomi in vitro kažejo, da je simeprevir podvržen predvsem oksidativnemu metabolizmu s sistemom CYP3A4 v jetrih, ni pa mogoče izključiti tudi vpletenosti encimov CYP2C8 in CYP2C19.
English: Elevations in direct and indirect bilirubin have been reported in patients treated with simeprevir and were mostly of mild or moderate severity.
Slovenian: Pri bolnikih, zdravljenih s simeprevirjem, so poročali o zvečanju koncentracije direktnega in indirektnega bilirubina in v večini primerov je bilo zvečanje blago do zmerno.
English: Simeprevir was not genotoxic in a series of in vitro and in vivo tests.
Slovenian: V vrsti testov in vitro in in vivo simeprevir ni bil genotoksičen.
English: Cases of bradycardia have been observed when OLYSIO is used in combination with sofosbuvir and concomitant amiodarone.
Slovenian: Pri uporabi zdravila OLYSIO v kombinaciji s sofosbuvirjem in amiodaronom so opazili primere bradikardije.
English: The safety profile of OLYSIO 150 mg in combination with peginterferon alfa and ribavirin in a phase 3 study conducted in Asian patients in China and South-Korea is comparable to non-Asian patients from a pooled phase 3 population from global studies, except for higher frequencies for ‘blood bilirubin increased' events (see table 8).
Slovenian: Varnostni profil zdravila OLYSIO 150 mg v kombinaciji s peginterferonom alfa in ribavirinom v študiji faze 3 pri bolnikih azijskega porekla na Kitajskem in v Južni Koreji je primerljiv z varnostnim profilom pri bolnikih, ki niso azijskega porekla.
English: A higher incidence of anaemia in patients with advanced fibrosis receiving simeprevir in combination with peginterferon alfa and ribavirin has been reported.
Slovenian: Pri bolnikih z napredovalo fibrozo, ki so prejemali simeprevir v kombinaciji s peginterferonom alfa in ribavirinom, so poročali so o večjem pojavu anemije.
English: Table 23: Treatment outcome in HCV genotype 4 infected patients (study HPC3011)
Slovenian: Preglednica 23: Izidi zdravljenja pri bolnikih, okuženih s HCV genotipa 4 (študija HPC3011) Izid zdravljenja predhodno nezdravljeni bolniki n = 35 % (n/N)
English: The pharmacokinetic properties of simeprevir have been evaluated in healthy adult subjects and in adult HCV infected patients.
Slovenian: Farmakokinetične lastnosti simeprevirja so ocenjevali pri zdravih odraslih in pri odraslih bolnikih, okuženih s HCV. Izpostavljenost simeprevirju v plazmi (AUC) je bila pri bolnikih, okuženih s HCV;
English: These blood tests help your doctor to - check if the treatment is working for you
Slovenian: Pred začetkom zdravljenja in nato redno med zdravljenjem bo zdravnik naročil preiskave krvi, s katerimi bo preveril - ali zdravilo pri vas deluje - delovanje vaših jeter.
English: Prior partial responders N = 10 % (n/N)
Slovenian: delni odgovor po predhodnem zdravljenju n = 10 % (n/N)
English: Pre-treatment testing for NS3 Q80K polymorphism in patients infected with HCV genotype 1a
Slovenian: Testiranje na prisotnost polimorfizma NS3 Q80K pred uvedbo zdravljenja pri bolnikih, okuženih s
English: The safety profile of simeprevir in combination with peginterferon alfa and ribavirin is comparable between HCV genotype 1 infected patients with and without HIV-1 co-infection.
Slovenian: Varnostni profil simeprevirja v kombinaciji s peginterferonom alfa in ribavirinom pri bolnikih, sočasno okuženih s HCV genotipa 1in s sočasno okužbo s HIV-1 je primerljiv z varnostnim profilom pri tovrstnih bolnikih, ki niso okuženi s HIV-1.
English: No dose adjustment of simeprevir is necessary in patients with mild hepatic impairment.
Slovenian: Pri bolnikih z blago okvaro jeter prilagajanje odmerkov simeprevirja ni potrebno.
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.
Slovenian: Po podatkih populacijske farmakokinetične analize bolnikov (n = 21, starost nad 65 let), ki so okuženi s HCV in so prejemali simeprevir, starost (18-73 let) ni klinično pomembno vplivala na farmakokinetiko simeprevirja.
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, rash and pruritus were reported in 21.8% and 21.9% of simeprevir-treated patients, compared to 16.6% and 14.6% in placebo-treated patients, respectively (all grades; pooled phase 3).
Slovenian: Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom: med 12 tedenskim zdravljenjem s simeprevirjem so o izpuščaju in srbenju poročali pri 21,8% in 21,9% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi s 16,6% in 14,6% bolnikov, ki so se zdravili s placebom (vse stopnje, združeni podatki iz študij faze 3).
English: Vardenafil
Slovenian: amiodaron
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).
Slovenian: Pri bolnikih, okuženih s HCV in z zmerno ali hudo okvaro jeter (razreda B ali C po Child-Pughu), varnosti in učinkovitosti simeprevirja niso ugotovili.
English: No dose adjustment of simeprevir is required in elderly patients (see section 4.2).
Slovenian: Pri starostnikih ni potrebno prilagajati odmerkov simeprevirja (glejte poglavje 4.2).
English: The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje
English: Simeprevir is primarily metabolised by the liver.
Slovenian: Simeprevir se presnavlja predvsem v jetrih.
English: - The recommended dose of OLYSIO is one capsule (150 milligrams) once a day.
Slovenian: - Priporočeni odmerek zdravila OLYSIO je ena kapsula (150 miligramov) enkrat na dan. - Na pretisnem traku so natisnjene okrajšave imen dni v tednu - tako se boste vsak dan lažje
English: There are no virologic treatment stopping rules that apply to the combination of OLYSIO with sofosbuvir.
Slovenian: Ukinitev zdravljenja pri bolnikih nezadostnim virološkim odzivom Zdravilo OLYSIO v kombinaciji s sofosbuvirjem Smernic za ukinitev zdravljenja z zdravilom OLYSIO v kombinaciji s sofosbuvirjem ni.
English: Table 20: Treatment outcome in treatment-experienced 1 HCV genotype 1 infected patients
Slovenian: Preglednica 20: Izidi zdravljenja pri že zdravljenih bolnikih 1, okuženih s HCV genotipa 1
English: Hepatic uptake of simeprevir is mediated by OATP1B1/3.
Slovenian: Privzem simeprevirja v jetrih je povezan s prenašalcem OATP1B1/3.
English: Nifedipine
Slovenian: fenitoin
English: It is not recommended to co-administer OLYSIO with ritonavir.
Slovenian: Sočasna uporaba zdravila OLYSIO z ritonavirjem ni priporočljiva.
English: Consult the Summary of Product Characteristics of the co-prescribed medicinal products before starting therapy with OLYSIO.
Slovenian: Glejte tudi povzetek glavnih značilnosti zdravila za zdravila, ki se uporabljajo v kombinaciji z zdravilom OLYSIO.
English: Rash has been observed with OLYSIO combination treatment (see section 4.8).
Slovenian: Pri kombiniranem zdravljenju z zdravilom OLYSIO so poročali o izpuščaju (glejte poglavje 4.8).
English: Population pharmacokinetic estimates of exposure of simeprevir were comparable between Caucasian and Black/African American HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Slovenian: Po ocenah populacijske farmakokinetike je izpostavljenost simeprevirju, pri bolnikih z okužbo s HCV, zdravljenih s simeprevirjem v kombinaciji s peginterferonom alfa in ribavirinom, pri pripadnikih bele ali črne rase oziroma Afroameričanih, primerljiva.
English: Mild increases in concentrations of
Slovenian: lahko pride do blagega zvečanja koncentracij
English: In study HPC3007, 80% (24/30) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism at baseline were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 58%.
Slovenian: V študiji HPC3007 je bilo 80% (24/30) bolnikov, okuženih s HCV genotipa 1 s polimorfizmom Q80K na začetku zdravljenja, zdravljenih s simeprevirjem, primernih za skupno trajanje zdravljenja 24 tednov.
English: 12 or 24 weeks SMV + sofosbuvir, with or without ribavirin patients without cirrhosis: 8 or 12 weeks SMV + sofosbuvir; patients with cirrhosis:
Slovenian: Bolniki brez ciroze: 8 ali 12 tednov SMV + sofosbuvir; Bolniki s cirozo: 12 tednov SMV + sofosbuvir 12 tednov SMV + sofosbuvir
English: Table 10: Treatment-emergent amino-acid substitutions in pooled phase 2 and phase 3 studies: patients who did not achieve SVR with 150 mg simeprevir in combination
Slovenian: Preglednica 10: Z zdravljenjem povzročene substitucije aminokislin po združenih podatkih študij faze 2b in faze 3: bolniki, ki niso dosegli SVR s 150 mg odmerkom simeprevirja v kombinaciji s peginterferonom alfa in ribavirinom nove substitucije aminokislin v proteinu NS3
English: Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL)
Slovenian: Preglednica 9: Protivirusno delovanje 200 mg simeprevirja v monoterapiji (študiji C201 in
English: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2 and 4.4).
Slovenian: Uporaba zdravila OLYSIO pri bolnikih z zmerno ali hudo okvaro jeter ni priporočljiva (razreda B ali C po Child-Pughu) (glejte poglavji 4.2 in 4.4).
English: It is not recommended to co-administer OLYSIO with a ledipasvir-containing medicinal product.
Slovenian: Sočasna uporaba zdravila OLYSIO z zdravili, ki vsebujejo ledipasvir, ni priporočljiva.
English: (OATP1B1/3, BCRP transporter inhibition)
Slovenian: (zaviranje OATP1B1 s takrolimusom)
English: Significant decrease in plasma concentrations of simeprevir are expected.
Slovenian: Pričakovano je pomembno zmanjšanje koncentracije simeprevirja v plazmi.
English: A trend for a higher incidence of increased bilirubin levels with increasing simeprevir plasma exposure was observed.
Slovenian: Z zvečanjem izpostavljenosti simeprevirju v plazmi so opazili tudi zvišanje koncentracije bilirubina.
English: No dose adjustment of OLYSIO is required in patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic prilagajanje odmerkov zdravila OLYSIO ni potrebno.
English: Excipient of OLYSIO capsules
Slovenian: Pomožna snov v kapsulah zdravila OLYSIO
English: DATE OF REVISION OF THE TEXT
Slovenian: Priporočilo glede sočasne uporabe
English: In these patients the SVR12 rates were 96%, 94%, 100% and 68%,
Slovenian: Pri teh bolnikih je bila stopnja SVR12 94%.
English: In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the NS3 Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with
Slovenian: Pri bolnikih s cirozo, okuženih s HCV genotipa 1a, se lahko pred uvedbo zdravljenja z zdravilom OLYSIO v kombinaciji s sofosbuvirjem razmisli o testiranju na prisotnost polimorfizma NS3 Q80K
English: Seventy-nine percent (404/509) of simeprevir-treated patients had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 90%.
Slovenian: Devetinsedemdeset odstotkov (404/509) bolnikov, ki so prejemali simeprevir, je imelo po 4 tednih nezaznavno koncentracijo HCV RNK.
English: Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin
Slovenian: Preglednica 5: Neželeni učinki, ugotovljeni s simeprevirjem v kombinaciji s sofosbuvirjem ali s simeprevirjem v kombinaciji s peginterferonom alfa in ribavirinom simeprevir + peginterferon alfa + ribavirin n = 781
English: placebo + peginterferon + ribavirin N = 264 % (n/N)
Slovenian: placebo +peginterferon alfa + ribavirin N = 264 % (n/N)
English: Antiretroviral - nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTIs) No dose adjustment is required.
Slovenian: Protiretrovirusna zdravila - nukleozidni ali nukleotidni zaviralci reverzne transkriptaze
English: Driving and using machines
Slovenian: Za podatke glede vožnje in upravljanja s stroji preberite
English: None of the patients discontinued treatment due to ‘blood bilirubin increased'.
Slovenian: Noben bolnik pa ni prekinil zdravljenja zaradi 'zvečanja
English: Table 20 shows the response rates in treatment-experienced patients with HCV genotype 1 infection.
Slovenian: V preglednici 20 so prikazane stopnje posameznih odzivov pri že zdravljenih bolnikih, okuženih s HCV genotipa 1.
English: Prior relapsers N = 22 % (n/N)
Slovenian: ponovitev bolezni po predhodnem zdravljenju n = 22 % (n/N)
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, photosensitivity reactions were reported in 4.7% of simeprevir-treated patients compared to 0.8% in placebo-treated patients (all grades; pooled phase 3).
Slovenian: Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom: med 12-tedenskim zdravljenjem s simeprevirjem so o fotosenzitivnih reakcijah poročali pri 4,7% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 0,8% bolnikov, zdravljenih s placebom (vse stopnje, združeni podatki iz študij faze 3).
English: Mechanism of action
Slovenian: Navodilo za uporabo
English: PHOSPHODIESTERASE TYPE 5 INHIBITORS Sildenafil
Slovenian: Stopnja fibroze po klasifikaciji METAVIR
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli od neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: Compared to healthy subjects with normal renal function (classified using the Modification of Diet in Renal Disease [MDRD] eGFR formula; eGFR ≥ 80 ml/min), the mean steady-state AUC of simeprevir was 1.62-fold higher (90% confidence interval: 0.73-3.6) in subjects with severe renal impairment (eGFR below 30 ml/min).
Slovenian: Povprečna vrednost AUC simeprevirja v stanju dinamičnega ravnovesja je bila pri bolnikih s hudo okvaro ledvic (z ocenjeno glomerulno filtracijo (eGFR) manj kot 30 ml/min) za 1,62-krat večja (90% IZ: 0,73-3,6) kot pri zdravih osebah z normalno ledvično funkcijo (opredeljeni s formulo za ocenjeno glomerulno filtracijo po metodi Modification of Diet in Renal Disease [MDRD] kot eGFR ≥ 80 ml/min), Ker se lahko pri bolnikih z okužbo s HCV in hudo okvaro ledvic izpostavljenost poveča, je pri predpisovanju simeprevirja tem bolnikom potrebna previdnost.
English: When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, testing for NS3 Q80K polymorphism should be performed before starting treatment (see section 4.4).
Slovenian: Kadar se odločate za zdravljenje z zdravilom OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom pri bolnikih s HCV genotipa 1a, jih je treba pred uvedbo zdravljenja testirati na prisotnost polimorfizma NS3 Q80K (glejte
English: Please refer to section 4.5 for information on interactions with medicinal products.
Slovenian: Za interakcije z drugimi zdravili glejte poglavje 4.5.
English: Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT.
Slovenian: Pogostnost ponovitve bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno koncentracijo HCV RNK ob dejanskem zaključku zdravljenja.
English: (CYP3A4 enzyme induction)
Slovenian: (indukcija CYP3A4)
English: Renal elimination of simeprevir is negligible.
Slovenian: Izločanje učinkovine skozi ledvice je nepomembno.
English: OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.4 and 5.2).
Slovenian: Uporaba zdravila OLYSIO pri bolnikih z zmerno do hudo okvaro jeter ni priporočljiva (razreda B ali C po Child-Pughu) (glejte poglavji 4.4 in 5.2).
English: (CYP3A4 enzyme induction [etravirine or nevirapine] or inhibition [delavirdine])
Slovenian: (indukcija [etravirin in nevirapin] CYP3A4 ali
English: It is not recommended to co-administer OLYSIO with efavirenz as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovenian: OLYSIO z efavirenzom ni priporočljiva, saj lahko povzroči izgubo terapevtskega učinka zdravila OLYSIO.
English: Close monitoring is recommended if this medicinal product is administered with OLYSIO in combination with sofosbuvir (see section 4.4).
Slovenian: Kadar se amidaron uporablja v kombinaciji z zdravilom OLYSIO in sofosbuvirjem je priporočljivo skrbno spremljanje bolnika (glejte poglavje 4.4).
English: It is not recommended to co-administer OLYSIO with systemic dexamethasone as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovenian: Sočasna uporaba zdravila OLYSIO s sistemsko obliko deksametazona ni priporočljiva, saj lahko povzroči izgubo terapevtskega učinka zdravila OLYSIO.
English: Mild increased or decreased plasma
Slovenian: Lahko pride do blagega zvečanja ali zmanjšanja koncentracije
English: Prior null responders N = 28 % (n/N)
Slovenian: Bolniki brez odziva na predhodno zdravljenje N = 28 % (n/N)
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).
Slovenian: Pri 0,3% bolnikov, ki so prejemali simeprevir, se je pojavila huda reakcija, ki je vodila v hospitalizacijo (glejte poglavje 4.4).
English: Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or
Slovenian: Vključuje bolnike s ponovitvijo bolezni, bolnike z delnim odzivom ali brez odziva na predhodno zdravljenje z interferonom (pegiliranim ali nepegiliranim), z ribavirinom ali brez ribavirina.
English: The presence of Q80K at baseline was associated with lower SVR rates in HCV genotype 1a patients treated with simeprevir in combination with peginterferon alfa and ribavirin (tables 19, 21, 22).
Slovenian: Prisotnost polimorfizma Q80K ob izhodišču je bila povezana z manjšo pogostnostjo doseganja SVR pri bolnikih s HCV genotipa 1a, ki so prejemali simeprevir v kombinaciji s peginterferonom alfa in
English: Prior relapsers N = 15 % (n/N)
Slovenian: Predhodno nezdravljeni bolniki N = 53 % (n/N)
English: Efficacy in treatment-naïve patients with HCV genotype 1 infection In studies C208 (QUEST-1) and C216 (QUEST-2), treatment-naïve patients received simeprevir (150 mg once daily) + peginterferon alfa + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa + ribavirin (see tables 17 and 18).
Slovenian: V študijah C208(QUEST-1) in C216 (QUEST-2) so predhodno nezdravljeni bolniki 12 tednov prejemali simeprevir (150 mg enkrat na dan) + peginterferon alfa + ribavirin, nato pa dodatnih 12 ali 36 tednov peginterferon alfa + ribavirin (glejte preglednici 17 in 18).
English: Significant increases in plasma concentrations of simeprevir are expected.
Slovenian: Pričakovano je pomembno zvečanje koncentracije simeprevirja v plazmi.
English: Eighty-nine percent (54/61) of the simeprevir-treated treatment-naïve patients and prior relapsers without cirrhosis were eligible for 24 weeks of treatment; in these patients the SVR12 rate was 87%.
Slovenian: Devetinosemdeset odstotkov (54/61) bolnikov, ki so prejemali simeprevir, niso imeli ciroze in predhodno niso bili zdravljeni, je bilo primernih za 24-tedensko zdravljenje.
English: 600 mg once daily efavirenz AUC 0.90 (0.85-0.95) ↔ efavirenz Cmax 0.97 (0.89-1.06) ↔ efavirenz Cmin 0.87 (0.81-0.93) ↔ simeprevir AUC 0.29 (0.26-0.33) ↓ simeprevir Cmax 0.49 (0.44-0.54) ↓ simeprevir Cmin 0.09 (0.08-0.12) ↓
Slovenian: AUC escitaloprama 1,00 (0,97-1,03) ↔ Cmax escitaloprama 1,03 (0,99-1,07) ↔ Cmin escitaloprama 1,00 (0,95-1,05) ↔ AUC simeprevirja 0,75 (0,68-0,83)  Cmax simeprevirja 0,80 (0,71-0,89)  Cmin simeprevirja 0,68 (0,59-0,79) 
English: HPC3011 (RESTORE; Phase 3)
Slovenian: C212 (faza 3)
English: It is not recommended to co-administer OLYSIO with rifabutin or rifapentine as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovenian: Sočasna uporaba zdravila OLYSIO z rifabutinom ali rifapentinom ni priporočljiva, saj lahko zmanjša terapevtski učinek zdravila OLYSIO.
English: It is not recommended to co-administer OLYSIO with these anticonvulsants as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovenian: Sočasna uporaba navedenih antikonvulzivov z zdravilom OLYSIO ni priporočljiva, saj lahko povzroči izgubo terapevtskega učinka zdravila OLYSIO.