FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited data on the use of simeprevir in patients older than 65 years.
Slovenian: Podatki o uporabi simeprevirja pri bolnikih, starejših od 65 let, so omejeni.
English: Simeprevir does not affect CYP2C9, CYP2C19 or CYP2D6 in vivo.
Slovenian: Simeprevir in vivo ne vpliva na CYP2C9, CYP2C19 in CYP2D6.
English: Like all medicines, OLYSIO can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Slovenian: Sočasno dajanje z drugimi zdravili proti HCV z neposrednim delovanjem na viruse Zdravilo OLYSIO se sme dajati sočasno z drugimi zdravili z neposrednim delovanjem na viruse le, če se na podlagi razpoložljivih podatkov oceni, da je korist zdravljenja večja od tveganj.
English: Women must use an effective method of contraception during treatment with OLYSIO.
Slovenian: Med zdravljenjem z zdravilom OLYSIO mora jo ženske uporabljati učinkovito metodo kontracepcije.
English: The overall SVR12 rate was similar in patients receiving simeprevir + sofosbuvir with or without ribavirin.
Slovenian: Celokupna stopnja SVR12 je bila pri bolnikih, ki so prejemali simeprevir + sofosbuvir, z ribavirinom ali brez ribavirina, podobna.
English: Treatment regimen with sofosbuvir:
Slovenian: Režimi zdravljenja s sofosbuvirjem:
English: Simeprevir exposure is significantly increased in patients with severe hepatic impairment (see section 5.2).
Slovenian: Izpostavljenost simeprevirju se pomembno zviša pri bolnikih s hudo okvaro jeter (glejte poglavje 5.2).
English: In addition, tell your doctor if you take any medicines used to treat irregular heart beat or high blood
Slovenian: Zdravniku povejte tudi, če jemljete katero koli zdravilo za zdravljenje motenj srčnega ritma ali
English: Genotype 1b N = 81 % (n)
Slovenian: genotip 1b N = 81 % (n)
English: Female patients of childbearing potential must use an effective form of contraception.
Slovenian: Bolnice v rodnem obdobju morajo uporabljati učinkovito obliko kontracepcije.
English: There are no data on the effect of simeprevir on human fertility.
Slovenian: Plodnost O vplivu simeprevirja na plodnost pri ljudeh ni podatkov.
English: No clinically relevant drug-drug interaction is expected.
Slovenian: Klinično pomembnih interakcij med zdraviloma ni pričakovati.
English: Astemizole and terfenadine have the potential for cardiac arrhythmias.
Slovenian: Astemizol in terfenadin lahko povzročata aritmije.
English: Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the
Slovenian: Prilagajanje odmerkov ali začasna prekinitev zdravljenja z zdravili, ki se uporabljajo v kombinaciji z
English: Dosage adjustment or interruption of OLYSIO treatment To prevent treatment failure, the dose of OLYSIO must not be reduced or interrupted.
Slovenian: Prilagajanje odmerkov ali začasna prekinitev zdravljenja z zdravilom OLYSIO Odmerjanja zdravila OLYSIO se ne sme zmanjšati ali prekinjati, da ne bi prišlo do neuspeha zdravljenja.
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: Prilagajanje odmerkov zaviralcev fosfodiesteraze tipa 5 je lahko potrebno pri sočasni uporabi zdravila OLYSIO s sildenafilom ali tadalafilom pri kronični uporabi v odmerkih, ki se uporabljajo pri zdravljenju pljučne arterijske hipertenzije.
English: OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults.
Slovenian: Zdravilo OLYSIO se jemlje skupaj z drugimi zdravili za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa C pri odraslih bolnikih.
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.
Slovenian: Dnevni odmerek ribavirina temelji na telesni masi (< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg) in se daje peroralno v dveh razdeljenih odmerkih s hrano.
English: Includes 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: 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).
Slovenian: Laboratorijske preiskave med zdravljenjem z zdravilom OLYSIO, peginterferonom alfa in ribavirinom Koncentracije HCV RNK je treba spremljati v 4. in 12. tednu zdravljenja ter glede na klinične indikacije (glejte tudi smernice glede trajanja in ukinitve zdravljenja v poglavju 4.2).
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.
Slovenian: Večina fotosenzitivnih reakcij je bila blagih (stopnja 1), o fotosenzitivnih reakcijah stopnje 2 so poročali pri dveh bolnikih (0,7%), ki sta prejemala zdravljenje
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: Zmerni ali močni zaviralci CYP3A4 pomembno povečajo izpostavljenost simeprevirju v plazmi, zmerni ali močni induktorji CYP3A4 pa pomembno zmanjšajo izpostavljenost simeprevirju v plazmi.
English: Warnings and precautions related to these medicinal products also apply to their use in OLYSIO combination treatment.
Slovenian: Opozorila in varnostni ukrepi povezani s temi zdravili veljajo tudi za uporabo pri zdravljenju v kombinaciji z zdravilom OLYSIO.
English: If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the
Slovenian: Če se pojavijo fotosenzitivnostne reakcije, je treba razmisliti o prenehanju uporabe zdravila OLYSIO, bolnika pa spremljati do izboljšanja.
English: One patient (3.2%) receiving 24 weeks of treatment experienced a grade 4 ‘blood bilirubin increased' event.
Slovenian: Pri enem bolniku (3,2%), ki je prejemal zdravljenje 24 tednov, je prišlo do 'zvečanja koncentracije bilirubina v krvi' stopnje 4.
English: 24 weeks
Slovenian: 12 tednov.
English: If adverse reactions, potentially related to the medicinal products that are used in combination with OLYSIO for the treatment of CHC, require dosage adjustment or interruption of the medicinal product(s), refer to the instructions outlined in the respective Summary of Product Characteristics for
Slovenian: Če se pojavijo neželeni učinki, ki bi bili lahko povezani z uporabo zdravil, ki se uporabljajo v kombinaciji z zdravilom OLYSIO za zdravljenje CHC in zaradi katerih bi bilo treba prilagoditi odmerjanje ali prekiniti zdravljenje s temi zdravili, je treba upoštevati navodila v povzetku glavnih
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.
Slovenian: Odmerjanje pri živalih je pokazalo podobno (psi) ali manjšo (podgane) izpostavljenost kot tisto, ki so jo opažali pri ljudeh pri uporabi priporočenega odmerka 150 mg enkrat na dan.
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.
Slovenian: Mediani vrednosti EC50 in EC90 simeprevirja za replikon virusa hepatitisa C genotipa 1b sta bili 9,4 nM (7,05 ng/ml) in 19 nM (14,25 ng/ml).
English: No dose adjustment is necessary based on race.
Slovenian: Prilagajanje odmerkov glede na raso ni potrebno.
English: Short term monotherapy data of simeprevir from studies C201 (genotype 1) and C202 (genotype 2, 3, 4, 5 and 6) in patients receiving 200 mg once daily simeprevir for 7 days is presented in table 9.
Slovenian: Kratkoročni podatki o zdravljenju s simeprevirjem v monoterapiji v študiji C201 (genotip 1) in C202 (genotip 2, 3, 4, 5 in 6) pri bolnikih, ki so prejemali 200 mg simeprevirja enkrat na dan 7 dni so podani v preglednici 9.
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.
Slovenian: O resnih neželenih učinkih so poročali pri 0,3% bolnikov, ki so prejemali simeprevir (2 fotosenzitivnostna dogodka, ki sta zahtevala hospitalizacijo), in pri nobenem od tistih, ki so prejemali placebo skupaj s peginterferonom alfa in z ribavirinom.
English: Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating OLYSIO combination treatment with sofosbuvir.
Slovenian: Kadar je potrebno sočasno zdravljenje z amiodaronom, je priporočljivo skrbno spremljanje bolnika ob uvedbi kombiniranega zdravljenja z zdravilom OLYSIO in sofosbuvirjem.
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.
Slovenian: Če bolnik pozabi vzeti odmerek zdravila OLYSIO in to opazi v 12 urah od običajnega časa odmerjanja, mu naročite naj čimprej vzame pozabljeni odmerek zdravila OLYSIO s hrano, naslednji odmerek zdravila OLYSIO pa naj vzame po običajnem razporedu.
English: Patients with cirrhosis N = 103 % (n/N)
Slovenian: Bolniki s cirozo N = 103 % (n/N)
English: Maximum plasma concentrations (Cmax) are typically achieved between 4 to
Slovenian: Učinkovina doseže najvišjo koncentracijo v plazmi (Cmax) praviloma 4 do 6 ur po odmerjanju.
English: Treatment-emergent laboratory abnormalities in amylase and lipase have been observed in patients treated with simeprevir in combination with sofosbuvir (table 6).
Slovenian: Z zdravljenjem povzročene nenormalnosti laboratorijskih izvidov amilaze in lipaze so opazili pri bolnikih, zdravljenih s simeprevirjem v kombinaciji s sofosbuvirjem (preglednica 6).
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).
Slovenian: Substitucije, kot sta D168V ali A in R155K, običajno zmanjšajo občutljivost simeprevirja in vitro (več kot 50-kratno zvečanje EC50), medtem ko druge substitucije, kot so Q80K ali R, S122R in D168E, pomenijo in vitro nizko stopnjo odpornosti (od 2 do 50-kratno zvečanje EC50).
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Slovenian: Za aktivnost, specifično za genotip virusa hepatitisa C (HCV), glejte poglavji 4.4 in 4.5.
English: Monitoring of blood concentrations of sirolimus is recommended.
Slovenian: Priporočeno je spremljanje koncentracije sirolimusa v krvi.
English: Based on the elimination pathway of azithromycin, no drug interactions are expected between azithromycin and simeprevir.
Slovenian: Na osnovi poti izločanja azitromicina se ne pričakuje interakcij med
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).
Slovenian: Če se uporablja kombinacija zdravilo OLYSIO, sofosbuvir, ribavirin in je potrebno ukiniti ribavirin, se zdravljenje lahko nadaljuje samo z zdravilom OLYSIO in sofosbuvirjem (glejte poglavje 5.1).
English: Prior non-responder patients (including partial and null responders)
Slovenian: Bolniki z nezadostnim odzivom (vključno z bolniki z delnim odzivom ali brez odziva)
English: - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
Slovenian: - sildenafil ali tadalafil za zdravljenje pljučne arterijske hipertenzije - midazolam ali triazolam (če ju zaužijete) za zdravljenje nespečnosti ali za lajšanje tesnobe
English: In the event of an overdose with OLYSIO, it is recommended to employ the usual supportive measures and observe the patient's clinical status.
Slovenian: V primeru prevelikega odmerjanja zdravila OLYSIO se priporočajo splošni podporni ukrepi in spremljanje klinične slike
English: Simeprevir inhibits the uptake transporters OATP1B1/3 and NTCP and the efflux transporters P-gp/MDR1, MRP2, BCRP and BSEP.
Slovenian: Simeprevir zavira privzemna prenašalca OATP1B1/3 in NTCP in izlivne prenašalce P-gp/MDR1, MRP2, BCRP in BSEP.
English: The efficacy of simeprevir (150 mg once daily) as part of an interferon-free regimen (sofosbuvir, 400 mg once daily) was evaluated in patients with HCV genotype 1 or 4 infection, who were treatment-naïve or treatment-experienced patients (following prior interferon-based therapy) (table 11).
Slovenian: Učinkovitost simeprevirja (150 mg enkrat na dan) kot del režima odmerjanja brez interferona (sofosbuvir, 400 mg enkrat na dan) so ocenili pri bolnikih, okuženih s HCV genotipa 1 ali 4, ki se predhodno še niso zdravili ali pa so zdravljenje že prejemali (po predhodnem zdravljenju z interferonom) (preglednica 11).
English: No meaningful changes in QTc interval were observed with either the recommended dose of 150 mg once daily or the supratherapeutic dose of
Slovenian: Pomembnih sprememb intervala QTc niso opažali niti pri priporočenem odmerku 150 mg enkrat na dan niti pri supraterapevtskem odmerku 350 mg enkrat na dan.
English: % above 65 yrs Male gender Race White Black/African American Hispanic BMI ≥ 30 kg/m
Slovenian: Starost (leta) mediana (razpon) % nad 65 let Moški Rasa belci črna rasa/afroameričani
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
Slovenian: 12 tednov SMV + peg-IFN-alfa + RBV, nato 12 ali 36 tednov peg-IFN-alfa + RBV kontrolna skupina: 48 tednov placebo + peg-IFN-alfa + RBV
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.
Slovenian: Odpornost na simeprevir so vrednotili tudi s testiranjem replikona HCV genotipa 1a in 1b s pomočjo mutant s točkovno usmerjeno mutacijo in himernih replikonov, ki vsebujejo sekvence za NS3, pridobljene iz kliničnih izolatov.
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).
Slovenian: V primerjavi z zdravimi osebami z normalnim delovanjem jeter je bila povprečna vrednost AUC simeprevirja v stanju dinamičnega ravnovesja 2,4-krat večja pri osebah brez okužbe s HCV, ki so imele zmerno okvaro jeter (razreda B po Child-Pughu), in 5,2-krat večja pri osebah brez okužbe s HCV in s hudo okvaro jeter (razreda C po Child-Pughu).
English: Monitoring of blood concentrations of tacrolimus is recommended.
Slovenian: Priporočeno je spremljanje koncentracije takrolimusa v krvi.
English: The emerging NS3 amino acid substitutions were similar to those observed in patients who did not achieve SVR following treatment with simeprevir in combination with peginterferon alfa and ribavirin.
Slovenian: Pojav substitucije aminokislin NS3 je bil podoben tistemu, ki so ga opazili pri bolnikih, ki niso dosegli SVR po zdravljenju s simeprevirjem v kombinaciji s peginterferonom alfa in ribavirinom.
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.
Slovenian: Prilagajanje odmerkov ni potrebno pri sočasni uporabi zdravila OLYSIO s sildenafilom, vardenafilom ali tadalafilom v odmerkih, ki so indicirani za zdravljenje erektilne disfunkcije.
English: Simeprevir does not induce CYP1A2 or CYP3A4 in vitro.
Slovenian: Simeprevir in vitro ne inducira CYP1A2 ali CYP3A4.
English: Bilirubin elevations were generally not associated with elevations in liver transaminases and bilirubin levels normalised after end of treatment.
Slovenian: Zvečanje koncentracije bilirubina na večinoma ni bilo povezano z zvečanjem koncentracij jetrnih aminotransferaz, vrednosti pa so se po zaključku zdravljenja normalizirale.
English: There are no safety and efficacy data of OLYSIO in patients over the age of 75 years.
Slovenian: Podatkov o varnosti in učinkovitosti uporabe zdravila OLYSIO pri bolnikih, starejših od 75 let, ni.
English: In studies HPC3017 (OPTIMIST-1) and HPC3018 (OPTIMIST-2), patients received simeprevir + sofosbuvir for 8 weeks (HPC3017 only) or 12 weeks (HPC3017 and HPC3018) (see table 11).
Slovenian: V študijah HPC3017 (OPTIMIST-1) in HPC3018 (OPTIMIST-2) so bolniki prejemali simeprevir + sofosbuvir 8 tednov (samo študija HPC3017) ali 12 tednov (HPC3017 in HPC3018) (glejte preglednico 11).
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: Variante virusa s substitucijami aminokislin, ki povzročajo zmanjšano občutljivost na zaviralce NS5A (L31F/V, Y93C/H) ter na nukleozidne (S282T) in nenukleozidne zaviralce (C316N, M414I/L, P495A) polimeraz, so ostale občutljive na simeprevir in vitro.
English: Race No dose adjustment is necessary based on race (see section 5.2).
Slovenian: Prilagajanje odmerkov glede na rasno pripadnost ni potrebno (glejte poglavje 5.2).
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.
Slovenian: Klinične študije, v katerih so preučevali interval QT Vpliv 7-dnevnega odmerjanja simeprevirja v odmerku 150 mg enkrat na dan in v odmerku 350 mg enkrat na dan na interval QT so ocenjevali v randomizirani, dvojno slepi, s placebom in aktivno nadzorovani (s 400 mg moksifloksacina, enkrat na dan), štirikratno navzkrižni študiji pri 60 zdravih preiskovancih.
English: - This medicine does not require any special temperature storage conditions.
Slovenian: - Za shranjevanje zdravila ni posebnih temperaturnih omejitev.
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).
Slovenian: Pri 2% oziroma 0,3% bolnikov, ki so prejemali simeprevir, so poročali o zvečani koncentraciji bilirubina v krvi stopnje 3 oziroma 4 (združeni podatki iz študij faze 3).
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12.
Slovenian: Delež bolnikov, zdravljenih s simeprevirjem, s koncentracijo HCV RNK < 25 i.e./ml, zaznavno po 4 tednih, je bil 14% (70/509), 67% jih je doseglo SVR12.
English: None of the patients experienced grade 3 or 4 pruritus; none of the patients discontinued treatment due to pruritus.
Slovenian: Pri nobenem bolniku se ni pojavilo srbenje stopnje 3 ali 4 in noben bolnik ni zaradi srbenja prekinil zdravljenja.
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 “↔”).
Slovenian: V preglednici 4 so navedene dokazane in teoretične interakcije med simeprevirjem in izbranimi zdravili (navedena so razmerja geometričnega povprečja najmanjših kvadratov z 90-odstotnim intervalom zaupanja (90% IZ), pri čemer je povečanje ali zvišanje koncentracije označeno z znakom "↑", zmanjšanje ali znižanje z znakom "↓", stanje brez spremembe pa je označeno z znakom "↔").
English: Most of these emerging substitutions have been shown to reduce simeprevir anti-HCV activity in cell culture replicon assays.
Slovenian: Za večino navedenih substitucij, ki so se pojavile, so s testi replikonov v celičnih kulturah dokazali, da zmanjšujejo delovanje simeprevirja proti HCV.
English: Do not drive or use machines if you feel faint or have problems with your vision.
Slovenian: Če ste omotični ali imate težave z vidom, ne vozite in ne upravljajte strojev.
English: Therefore, in patients who are at high risk for hepatic decompensation or hepatic failure, liver function tests should be monitored before and as clinically indicated during OLYSIO combination therapy.
Slovenian: Zato je treba pri bolnikih z velikim tveganjem za dekompenzacijo in odpoved jeter spremljati teste delovanja jeter pred in med (kot je klinično indicirano) kombiniranim zdravljenjem z zdravilom OLYSIO.
English: Simeprevir in vitro was very mildly irritating to the eyes.
Slovenian: Simeprevir je in vitro povzročil zelo blago draženje oči.
English: OLYSIO in combination with sofosbuvir: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients.
Slovenian: Uporaba zdravila OLYSIO v kombinaciji s sofosbuvirjem: bolnike s sočasno okužbo s HCV/HIV-1 je treba zdraviti enako dolgo kot bolnike, ki so okuženi samo s HCV.
English: OLYSIO must not be administered as monotherapy and must be prescribed in combination with other medicinal products for the treatment of CHC.
Slovenian: Zdravilo OLYSIO je treba predpisati v kombinaciji z drugimi zdravili za zdravljenje CHC.
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.
Slovenian: Zdravila, ki vplivajo na izpostavljenost simeprevirju Poglavitni encim, ki sodeluje pri biotransformaciji simeprevirja, je CYP3A4 (glejte poglavje 5.2), zato lahko zaradi vpliva na CYP3A4 pride do klinično pomembnih učinkov drugih zdravil na farmakokinetiko simeprevirja.
English: As exposure may be increased in HCV infected patients with severe renal impairment, caution is recommended when prescribing simeprevir to these patients (see section 4.2).
Slovenian: Izpostavljenost se lahko poveča pri bolnikih, okuženih s HCV in s hudo okvaro jeter, zato je pri predpisovanju zdravila OLYSIO tem bolnikom priporočljiva previdnost (glejte poglavje 5.2).
English: In a biochemical assay, simeprevir inhibited the proteolytic activity of recombinant genotype 1a and 1b HCV NS3/4A proteases, with median Ki values of 0.5 nM and 1.4 nM, respectively.
Slovenian: V biokemičnem testu je simeprevir zaviral proteolitično aktivnost rekombinantnih proteaz HCV NS3/4A genotipa 1a in 1b z medianima vrednostima inhibicijske konstante Ki 0,5 nM in 1,4 nM.
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
Slovenian: Če se bolnik na pozabljeni odmerek zdravila OLYSIO spomni po več kot 12 urah od običajnega časa odmerjanja, naj ne vzame pozabljenega odmerka zdravila OLYSIO, ampak naj nadaljuje z odmerjanjem zdravila OLYSIO skupaj s hrano po običajnem razporedu.
English: Median simeprevir FC values against baseline isolates of genotype 4a, genotype 4d and genotype 4other were 0.5 (N = 38), 0.4 (N = 24), and 0.8 (N = 29), respectively.
Slovenian: Mediane vrednosti količnika spremembe aktivnosti simeprevirja proti izhodiščnim izolatom genotipa 4a, genotipa 4 in drugih genotipov 4, so bile 0,5 (N = 38), 0,4 (N = 24) oziroma 0,8 (N = 29).