FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
Slovenian: Po enkratnem peroralnem odmerku 200 mg s 14C označenega simeprevirja zdravim osebam so povprečno 91%
English: The safety profile of simeprevir is comparable in patients with HCV genotype 4 infection and HCV genotype 1 infection, when given either in combination with sofosbuvir or in combination with peginterferon alfa and ribavirin.
Slovenian: Varnostni profil simeprevirja pri bolnikih, okuženih s HCV genotipa 4 in HCV genotipa 1, ki so prejemali simeprevir v kombinaciji s sofosbuvirjem ali v kombinaciji s peginterferonom alfa in ribavirinom, je primerljiv.
English: 40 mg omeprazole AUC 1.21 (1.00-1.46) ↑ omeprazole Cmax 1.14 (0.93-1.39) ↑ omeprazole Cmin not studied
Slovenian: AUC omeprazola 1,21 (1,00-1,46) ↑ Cmax omeprazola 1,14 (0,93-1,39) ↑ Cmin omeprazola niso preučevali
English: OLYSIO in combination with peginterferon alfa-2b In the clinical studies, patients randomised to simeprevir in combination with peginterferon alfa-2b and ribavirin obtained numerically lower SVR12 rates and also experienced viral breakthrough and viral relapse more frequently than those treated with simeprevir in combination with peginterferon alfa-2a and ribavirin (see section 5.1).
Slovenian: Bolniki, ki so bili v kliničnih študijah randomiziranih na simeprevir v kombinaciji s peginterferonom alfa-2b in ribavirinom so imeli številčno manjšo pogostnost doseganja SVR12, pogostejši virusni preboj in pogostejšo ponovitev bolezni v primerjavi z bolniki, ki so se zdravili s simeprevirjem v kombinaciji s peginterferonom alfa-2a in ribavirinom (glejte poglavje 5.1).
English: Do not press the capsule from the center of the pocket.
Slovenian: Pritisnite na rob žepka.
English: Patients without cirrhosis N = 155 % (n/N)
Slovenian: Bolniki brez ciroze N = 155 % (n/N)
English: The response rates for patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir are shown in table 13.
Slovenian: Stopnje odziva bolnikov s cirozo ali brez ciroze, ki so 12 tednov prejemali simeprevir + sofosbuvir, so prikazane v preglednici 13.
English: STIMULANTS Methylphenidate
Slovenian: PSIHOSTIMULANSI metilfenidat
English: S-warfarin AUC 1.04 (1.00-1.07) ↔ S-warfarin Cmax 1.00 (0.94-1.06) ↔ S-warfarin Cmin not studied
Slovenian: AUC S-varfarina 1,04 (1,00-1,07) ↔ Cmax S-varfarina 1,00 (0,94-1,06) ↔ Cmin S-varfarina niso preučevali
English: ≥ 1.1 to ≤ 1.5 x ULN
Slovenian: ≥ 1,1 do ≤ 1,5 x ZMN
English: Intravenous: midazolam AUC 1.10 (0.95-1.26) ↑ midazolam Cmax 0.78 (0.52-1.17) ↓ midazolam Cmin not studied
Slovenian: AUC midazolama 1,10 (0,95-1,26) ↑ Cmax midazolama 0,78 (0,52-1,17) ↓ Cmin midazolama niso preučevali
English: Table 2: Recommended treatment duration for OLYSIO combination therapy with peginterferon alfa and ribavirin1 in HCV genotype 1 or 4
Slovenian: Preglednica 2: Priporočeno trajanje zdravljenja z zdravilom OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom1 pri bolnikih, okuženih s HCV genotipa 1 ali 4
English: LIST OF EXCIPIENTS Contains lactose monohydrate
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje laktozo monohidrat.
English: These blood tests help your doctor to - check if the treatment is working for you - check your liver function.
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: CY-2234 Λευκωσία Τηλ: +357 22 207 700
Slovenian: Τηλ: +357 22 207 700
English: Table 13: Treatment outcome in HCV genotype 1 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC3017 and HPC3018) Treatment outcome
Slovenian: Preglednica 13: Izid zdravljenja bolnikov, okuženih s HCV genotipa 1, ki so 12 tednov prejemali simeprevir + sofosbuvir (študiji HPC3017 in HPC3018) Izid zdravljenja
English: ≥ 1.25 to ≤ 2.50 x ULN
Slovenian: ≥ 1,25 do ≤ 2,50 x ZMN
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.
Slovenian: OLYSIO s sildenafilom ali tadalafilom pri kronični uporabi v odmerkih, ki se uporabljajo pri zdravljenju pljučne arterijske hipertenzije.
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) - constipation.
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov: - zvečana koncentracija bilirubina v krvi (bilirubin je barvilo, ki nastaja v jetrih)*
English: Gastrointestinal disorders: very common nausea common constipation constipation constipation
Slovenian: Bolezni prebavil: zelo pogosti navzea pogosti zaprtje zaprtje zaprtje
English: > 3.0 to ≤ 5.0 x ULN 1 (0.3%)
Slovenian: > 3,0 to ≤ 5,0 x ZMN 1 (0,3%)
English: Read the package leaflets for the other medicines used for treating your hepatitis C infection for side effects reported with these medicines.
Slovenian: Za podatke o neželenih učinkih ostalih zdravil za zdravljenje okužbe z virusom hepatitisa C preberite navodila za uporabo teh zdravil.
English: (OATP1B1 inhibition by tacrolimus)
Slovenian: (zaviranje OATP1B1 s takrolimusom)
English: It is not recommended to co-administer OLYSIO with ritonavir.
Slovenian: OLYSIO z ritonavirjem ni priporočljiva.
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Slovenian: Pri bolnikih z okvaro ledvic ali jeter ne prihaja do bistvenih sprememb glede vezave na beljakovine v plazmi.
English: 10 mg rosuvastatin AUC 2.81 (2.34-3.37) ↑ rosuvastatin Cmax 3.17 (2.57-3.91) ↑ rosuvastatin Cmin not studied
Slovenian: AUC rosuvastatina 2,81 (2,34-3,37) ↑ Cmax rosuvastatina 3,17 (2,57-3,91) ↑ Cmin rosuvastatina niso preučevali
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.
Slovenian: Y93C/H) ter na nukleozidne (S282T) in nenukleozidne zaviralce (C316N, M414I/L, P495A) polimeraz, so ostale občutljive na simeprevir in vitro.
English: 3 To prior treatment with peginterferon alfa and ribavirin.
Slovenian: 3 Predhodno zdravljenje s peginterferonom alfa in ribavirinom.
English: Genotype 1, treatment-naïve or treatment-experienced4, HCV/HIV-1 co-infected patients, with compensated cirrhosis or without cirrhosis treatment-naïve patients or prior relapsers without cirrhosis: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV prior non-responder patients (partial and null responders) without cirrhosis and all treatment-naïve and treatment-experienced patients with cirrhosis: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 36 weeks peg-IFN-alfa + RBV
Slovenian: genotip 1, nezdravljeni ali že zdravljeni bolniki4, s sočasno okužbo s HCV/HIV-1 in kompenzirano cirozo ali brez ciroze nezdravljeni bolniki ali bolniki s ponovitvijo bolezni brez ciroze: 12 tednov SMV + peg-IFN-alfa + RBV, nato 12 ali 36 tednov peg-IFN-alfa + RBV3; bolniki brez odziva (z delnim odzivom ali brez odziva) brez ciroze in vsi nezdravljeni ter že zdravljeni bolniki s cirozo: 12 tednov SMV + peg-IFN-alfa + RBV, nato 36 tednov peg-IFN-alfa + RBV
English: Magnesium hydroxide Calcium carbonate
Slovenian: ZDRAVILA Z DELOVANJEM NA PREBAVILA Antacidi aluminijev ali magnezijev hidroksid kalcijev karbonat
English: Interim data from a phase 2 study in 9 HCV infected post-liver transplant patients.
Slovenian: Vmesna analiza podatkov iz študije faze 2 pri 9 bolnikih s presaditvijo jeter,
English: Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin (study HPC2002) Treatment outcome simeprevir + sofosbuvir N = 21 % (n/N)
Slovenian: Preglednica 14: Izid zdravljenja bolnikov, okuženih s HCV genotipa 1, brez ciroze, ki so 12 tednov prejemali simeprevir + sofosbuvir, z ribavirinom ali brez ribavirina (študija HPC2002) Izid zdravljenja simeprevir + sofosbuvir N = 21 % (n/N)
English: Use of a sensitive quantitative HCV RNA assay for monitoring HCV RNA levels during treatment is recommended.
Slovenian: Za spremljanje koncentracije HCV RNK med zdravljenjem je priporočljiva uporaba občutljive kvantitativne metode določanja koncentracije HCV RNK.
English: Mild increases in concentrations of these antihistamines may be expected.
Slovenian: Mogoče je blago zvečanje koncentracij navedenih antihistaminikov.
English: Pre-treatment testing for NS3 Q80K polymorphism in patients infected with HCV genotype 1a OLYSIO in combination with sofosbuvir
Slovenian: Testiranje na prisotnost polimorfizma NS3 Q80K pred uvedbo zdravljenja pri bolnikih, okuženih s HCV genotipa 1a
English: SVR12 rates for selected subgroups METAVIR fibrosis score F0-2 F3-4 F4 IL28B genotype CC CT TT HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a Genotype 1a with Q80K without Q80K Genotype 1b
Slovenian: Stopnje SVR za izbrane podskupine Stopnja fibroze po klasifikaciji METAVIR F0-2 F3-4 F4 genotip IL28B CC CT TT HCV geno/podtip in prisotnost polimorfizma Q80K ob izhodišču pri HCV genotipa 1 genotip 1a s Q80K brez Q80K genotip 1b
English: How to take - The recommended dose of OLYSIO is one capsule (150 milligrams) once a day.
Slovenian: Kako jemati zdravilo - 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 spomnili, da morate vzeti kapsulo.
English: Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa and ribavirin (pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments)
Slovenian: Preglednica 7: Z zdravljenjem povzročene nenormalnosti laboratorijskih izvidov, ki so jih pogosteje opažali pri bolnikih, ki so prejemali simeprevir v kombinaciji s peginterferonom alfa in ribavirinom (združeni podatki iz študij faze 3: študije C208, C216 in HPC3007; prvih 12 tednov zdravljenja) Laboratorijski parameter
English: ANALEPTIC Caffeine 150 mg caffeine AUC 1.26 (1.21-1.32) ↑ caffeine Cmax 1.12 (1.06-1.19) ↔ caffeine Cmin not studied
Slovenian: AUC kofeina 1,26 (1,21-1,32) ↑ Cmax kofeina 1,12 (1,06-1,19) ↔ Cmin kofeina niso preučevali
English: > 1.5 to ≤ 2.0 x ULN 15 (5.2%)
Slovenian: > 1,5 do ≤ 2,0 x ZMN 15 (5,2%)
English: Table 15: Treatment outcome in HCV genotype 1 infected patients with cirrhosis receiving 12 or 24 weeks simeprevir + sofosbuvir, with or without ribavirin (study HPC2002) Treatment outcome
Slovenian: Preglednica 15: Izidi zdravljenja bolnikov, okuženih s HCV genotipa 1, s cirozo, ki so 12 ali 24 tednov prejemali simeprevir + sofosbuvir, z ribavirinom ali brez ribavirina (študija HPC2002) Izid zdravljenja
English: levels were reported in more than 1 in 10 people (very common).
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov:
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.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravljenje z zdravilom OLYSIO, skupaj z drugimi zdravili za zdravljenje kronične okužbe z virusom hepatitisa C, lahko zmanjša sposobnost za upravljanje vozil in strojev.
English: SEDATIVES/ANXIOLYTICS Midazolam
Slovenian: SEDATIVI/ANKSIOLITIKI midazolam peroralni:
English: 0.25 mg digoxin AUC 1.39 (1.16-1.67) ↑ digoxin Cmax 1.31 (1.14-1.51) ↑ digoxin Cmin not studied
Slovenian: AUC digoksina 1,39 (1,16-1,67) ↑ Cmax digoksina 1,31 (1,14-1,51) ↑ Cmin digoksina niso preučevali
English: Antimycobacterials Bedaquiline
Slovenian: Učinkovine za zdravljenje infekcij z mikobakterijani bedakilin
English: OLYSIO helps to fight against hepatitis C infection by preventing HCV from multiplying.
Slovenian: Kako zdravilo OLYSIO deluje Zdravilo OLYSIO pomaga zdraviti okužbo z virusom hepatitisa C tako, da preprečuje razmnoževanje
English: Mild increases in concentrations of PDE-5 inhibitors may be expected.
Slovenian: Pričakovati je mogoče blago zvečanje koncentracije zaviralcev fosfodiesteraze tipa 5.
English: It is not recommended to co-administer OLYSIO with clarithromycin or telithromycin.
Slovenian: OLYSIO s klaritromicinom ali telitromicinom ni priporočljiva.
English: Treatment-naïve patients N = 53 % (n/N)
Slovenian: Predhodno nezdravljeni bolniki N = 53 % (n/N)
English: ≥ 1.1 to ≤ 1.5 x ULN 13 (4.5%)
Slovenian: ≥ 1,1 do ≤ 1,5 x ZMN 13 (4,5%)
English: Table 6: Treatment-emergent laboratory abnormalities in amylase and lipase in patients receiving 12 or 24 weeks of simeprevir in combination with sofosbuvir (12 weeks: pooled studies HPC2002, HPC3017 and HPC3018; 24 weeks: study HPC2002) Laboratory parameter WHO toxicity range1 12 weeks simeprevir +
Slovenian: Preglednica 6: Z zdravljenjem povzočene nenormalnosti laboratorijskih izvidov amilaze in lipaze pri bolnikih, ki so 12 ali 24 tednov prejemali zdravljenje s simeprevirjem v kombinaciji s sofosbuvirjem (12 tednov: združene študije HPC2002, HPC3017 in HPC3018; 24 tednov: študija HPC2002)
English: Table 8: ‘Blood bilirubin increased' events observed in Asian patients from the phase 3 study HPC3005 versus the pooled phase 3 studies C208, C216 and HPC3007 receiving simeprevir or placebo in combination with peginterferon alfa and ribavirin (first 12 weeks of treatment) Blood bilirubin increased
Slovenian: Preglednica 8: ‘Zvečanje koncentracije bilirubina v krvi ' pri bolnikih azijskega porekla v študiji faze 3 HPC3005 v primerjavi z združenimi podatki študij faze 3 C208, C216 in HPC3007 pri bolnikih, ki so prejemali simeprevir ali placebo v kombinaciji s peginterferonom alfa in ribavirinom (prvih 12 tednov zdravljenja)
English: 4 Includes relapsers, partial and null responders to prior treatment with peginterferon and ribavirin.
Slovenian: 4 Vključuje bolnike s ponovitvijo bolezni, bolnike z delnim odzivom ali brez odziva na predhodno zdravljenje z peginterferonom in ribavirinom.
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 SVR12.
English: Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by diltiazem and verapamil.
Slovenian: Zaradi blagega zaviranja CYP3A4 z amlodipinom in zmernega zaviranja CYP3A4 z diltiazemom in verapamilom se lahko pričakuje zvečanje koncentracij simeprevirja.
English: 4 simeprevir-treated patients who experienced relapse after SVR12.
Slovenian: Vključuje tudi podatke 4 bolnikov, ki so prejemali simeprevir in pri katerih je prišlo do ponovitve bolezni po doseženem SVR12.
English: Treatment discontinuation in patients with inadequate on-treatment virologic response OLYSIO in combination 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: Blood bilirubin increased
Slovenian: Zvišanje koncentracije bilirubina
English: Prior relapsers
Slovenian: Izhodiščne koncentracije
English: Mild increases in concentrations of amiodarone may be expected when amiodarone is administered orally.
Slovenian: Pri peroralni uporabi je mogoče pričakovati blago zvečanje koncentracije amiodarona.
English: Simvastatin 40 mg simvastatin AUC 1.51 (1.32-1.73) ↑ simvastatin Cmax 1.46 (1.17-1.82) ↑ simvastatin Cmin not studied simvastatin acid AUC 1.88 (1.63-2.17) ↑ simvastatin acid Cmax 3.03 (2.49-3.69) ↑ simvastatin acid Cmin not studied
Slovenian: AUC simvastatina 1,51 (1,32-1,73) ↑ Cmax simvastatina 1,46 (1,17-1,82) ↑ Cmin simvastatina niso preučevali AUC simvastatinske kisline 1,88 (1,63-2,17) ↑ Cmax simvastatinske kisline 3,03 (2,49-3,69) ↑ Cmin simvastatinske kisline niso preučevali
English: Prior relapsers Prior partial responders Prior null responders
Slovenian: ponovitev bolezni delni odziv brez odziva
English: Mild increased or decreased plasma concentrations of sirolimus may occur.
Slovenian: Lahko pride do blagega zvečanja ali zmanjšanja koncentracije sirolimusa v plazmi.
English: ciclosporin AUC 1.19 (1.13-1.26) ↑ ciclosporin Cmax 1.16 (1.07-1.26) ↑ ciclosporin Cmin not studied simeprevir AUC 5.81 (3.56-9.48) ↑5 simeprevir Cmax 4.74 (3.12-7.18) ↑5 simeprevir Cmin not studied5
Slovenian: AUC ciklosporina 1,19 (1,13-1,26) ↑ Cmax ciklosporina 1,16 (1,07-1,26) ↑ Cmin ciklosporina niso preučevali AUC simeprevirja 5,81 (3,56-9,48) ↑5 Cmax simeprevirja 4,74 (3,12-7,18) ↑5 Cmin simeprevirja niso preučevali5
English: NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules
Slovenian: IME ZDRAVILA OLYSIO 150 mg trde kapsule
English: DXM AUC 1.08 (0.87-1.35) ↑ DXM Cmax 1.21 (0.93-1.57) ↑ DXM Cmin not studied dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔ dextrorphan Cmin not studied
Slovenian: AUC dekstrometorfana 1,08 (0,87-1,35) ↑ Cmax dekstrometorfana 1,21 (0,93-1,57) ↑ Cmin dekstrometorfana niso preučevali AUC dekstrorfana 1,09 (1,03-1,15) ↔ Cmax dekstrorfana 1,03 (0,93-1,15) ↔ Cmin dekstrorfana nisi preučevali
English: patients, with compensated cirrhosis or without cirrhosis treatment-naïve patients or prior relapsers: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV3; prior non-responder patients (partial and null responders): 12 weeks SMV + peg-IFN-alfa + RBV, followed by 36 weeks peg-IFN-alfa + RBV
Slovenian: genotip 4, nezdravljeni ali že zdravljeni bolniki4 s kompenzirano cirozo ali brez ciroze nezdravljeni bolniki ali bolniki s ponovitvijo bolezni: 12 tednov SMV + peg-IFN-alfa + RBV, nato 12 ali 36 tednov peg-IFN-alfa + RBV3; bolniki brez odziva (z delnim odzivom ali brez odziva): 12 tednov SMV + peg-IFN-alfa + RBV, nato 36 tednov peg-IFN-alfa + RBV
English: 7 The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic study in opioid-dependent adults on stable methadone maintenance therapy.
Slovenian: Medsebojno delovanje med simeprevirjem in tem zdravilom so ocenjevali v farmakokinetični študiji pri odraslih,
English: Sustained virologic response (SVR) was the primary endpoint in all studies and was defined as HCV RNA less than the lower limit of quantification (LLOQ) detectable or undetectable 12 weeks (SVR12) or 24 weeks (SVR24) after the planned end of treatment (studies C206, C208, C212, C216, HPC2002, HPC3007 and HPC3011) or after the actual end of treatment (studies HPC2014, HPC3017, HPC3018 and HPC3021) (LLOQ of 25 IU/ml and limit of detection of 15 IU/ml, except in studies HPC2014 and HPC3021 where LLOQ and limit of detection were 15 IU/ml).
Slovenian: Trajni virološki odziv (SVR- sustained virologic response) je bil primarni opazovani dogodek v vseh študijah, opredeljen kot koncentracija HCV RNK manj kot spodnja meja kvantifikacije (LLOQ-lower limit of quantification), zaznavna ali nezaznavna 12 tednov (SVR12) ali 24 tednov (SVR24) po načrtovanem zaključku zdravljenja (študije C206, C208, C212, C216, HPC2002, HPC3007 in
English: 100 mg patient individualised dose4
Slovenian: IMUNOSUPRESIVI ciklosporin 100 mg odmerek, prilagojen posameznemu bolniku4
English: The safety and efficacy of simeprevir have not been established in HCV infected patients with moderate or severe hepatic impairment (Child-Pugh class 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: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class 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: 6 Comparison based on historic controls.
Slovenian: okuženih s HCV. 6 Primerjava s podatki zgodovinskih kontrol.
English: When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, patients should be tested for the presence of virus with the NS3 Q80K polymorphism before starting treatment (see section 4.4).
Slovenian: Kadar se odločate za zdravilo OLYSIO skupaj s peginterferonom alfa in ribavirinom, je treba bolnike s HCV genotipa 1 pred začetkom zdravljenja testirati na prisotnost polimorfizma NS3 Q80K (glejte poglavje 4.4).
English: • Risk Management Plan (RMP)
Slovenian: Ocena tveganja za okolje (ERA)
English: Ritonavir1 100 mg twice daily simeprevir AUC 7.18 (5.63-9.15) ↑ simeprevir Cmax 4.70 (3.84-5.76) ↑ simeprevir Cmin 14.35 (10.29-20.01) ↑
Slovenian: AUC simeprevirja 7,18 (5,63-9,15) ↑ Cmax simeprevirja 4,70 (3,84-5,76) ↑ Cmin simeprevirja 14,35 (10,29-20,01) ↑
English: 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 0.80 - 1.25 range.
Slovenian: Smer puščice (↑ = zvečanje, ↓ = zmanjšanje, ↔ = ni spremembe) za vsak farmakokinetični parameter temelji na 90% intervalu zaupanja za razmerje geometrične sredine, ki je v okviru razpona 0,80 - 1,25 (↔) ali pod (↓) oziroma nad (↑) njim.
English: Treatment-naïve patients N = 35 % (n/N)
Slovenian: predhodno nezdravljeni bolniki n = 35 % (n/N)
English: Oral: midazolam AUC 1.45 (1.35-1.57) ↑ midazolam Cmax 1.31 (1.19-1.45) ↑ midazolam Cmin not studied
Slovenian: AUC midazolama 1,45 (1,35-1,57) ↑ Cmax midazolama 1,31 (1,19-1,45) ↑
English: (intestinal CYP3A4 enzyme and P-gp transporter inhibition)
Slovenian: (zaviranje CYP3A4 in prenašalca P-gp v črevesju)
English: - Keep this leaflet.
Slovenian: - kožni izpuščaj*
English: Alkaline phosphatase
Slovenian: ANALEPTIKI kofein
English: > 2.5 to ≤ 5.0 x ULN
Slovenian: > 2,5 do ≤ 5,0 x ZMN
English: > 2.0 to ≤ 5.0 x ULN 13 (4.5%)
Slovenian: > 2,0 do ≤ 5,0 x ZMN 13 (4,5%)
English: St John's wort (Hypericum perforatum)
Slovenian: OLYSIO s pegastim badljem ni priporočljiva šentjanževka (Hypericum perforatum)
English: 1 Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable) HCV RNA at actual EOT.
Slovenian: 1 Ponovitev bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno (ali nepotrjeno zaznavno) koncentracijo HCV RNK ob zaključku zdravljenja.
English: 2 SVR: SVR12 for study HPC3007 and SVR24 for study C206.
Slovenian: 1 predhodno zdravljeni s peginterferonom alfa in ribavirinom 2 SVR: SVR12 za študijo HPC3007 in SVR24 za študijo C206 3 p < 0,001
English: Concentrations of ledipasvir and simeprevir are increased when simeprevir is co-administered with ledipasvir.
Slovenian: Pri sočasni uporabi ledipasvirja in simeprevirja se plazemske koncentracije obeh učinkovin povečajo.
English: Moderate or strong inhibitors of CYP3A4 significantly increase the plasma exposure of simeprevir, and moderate or strong inducers of CYP3A4 significantly reduce plasma exposure of simeprevir.
Slovenian: CYP3A4 pomembno povečajo izpostavljenost simeprevirju v plazmi, zmerni ali močni induktorji
English: It is not recommended to co-administer OLYSIO with systemic erythromycin.
Slovenian: OLYSIO s sistemskim eritromicinom ni priporočljiva.
English: Genotype 1a and 1b isolates with a baseline Q80K polymorphism resulted in median FC in simeprevir EC50 of 11 (N = 33) and 8.4 (N = 2), respectively.
Slovenian: Pri izolatih genotipa 1a in 1b z izhodiščnim polimorfizmom Q80K je prišlo do mediano 11-kratnega (N = 33)
English: > 2.50 to ≤ 5.00 x ULN
Slovenian: > 2,50 do ≤ 5,00 x ZMN
English: NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg capsules simeprevir
Slovenian: IME ZDRAVILA OLYSIO 150 mg kapsule simeprevir