FrancophonIA/ELRC3.0 huggingface dataset:
English: Opaque polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PE/PVDC) aluminium push-through blister strips of 7 capsules.
Slovenian: Neprozoren pretisni trak iz polivinilklorida/polietilena/polivinilidenklorida (PVC/PE/PVDC) z aluminijastim pokritjem, skozi katerega se potisne kapsulo.
English: - If it is less than 12 hours until your next dose, skip the missed dose.
Slovenian: - Če je do naslednjega odmerka manj kot 12 ur, izpustite pozabljeni odmerek.
English: Simeprevir is not a clinically relevant inhibitor of cathepsin A enzyme activity.
Slovenian: Simeprevir ni klinično pomemben zaviralec encimske dejavnosti
English: While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Slovenian: Čeprav ni pričakovati nobenih sprememb farmakokinetike, se pri vseh antagonistih vitamina K priporoča natančno spremljanje vrednosti INR.
English: The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food.
Slovenian: Priporočeno odmerjanje zdravila OLYSIO je ena 150 mg kapsula enkrat na dan skupaj s hrano.
English: Only grade 1 and 2 events were reported and there were no events leading to discontinuation of any of the study drugs.
Slovenian: Poročani so bili samo neželeni učinki stopnje 1 in 2, od katerih noben primer ni vodil v prekinitev zdravljenja s katerim koli študijskim zdravilom.
English: Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
Slovenian: Celokupno trajanje zdravljenja s peg-IFN-alfa in RBV je bilo odvisno od odziva.
English: Double-blind, randomised, placebo-controlled, except for studies C212 and HPC3011 which were open-label, single arm.
Slovenian: Dvojno slepa, randomizirana, nadzorovana s placebom, z izjemo študij C212 in HPC3011, ki sta bili odprti študiji z eno
English: - The other ingredients are sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) and shellac (E904).
Slovenian: - Druge sestavine zdravila so natrijev lavrilsulfat, magnezijev stearat, koloidni brezvodni silicijev dioksid, premreženi natrijev karmelozat, laktoza monohidrat, želatina, titanov dioksid (E171), črni železov oksid (E172) in šelak (E904).
English: In vitro, simeprevir induced a phototoxic response on BALB/c 3T3 fibroblasts after UVA exposure, in the absence and presence of protein supplements.
Slovenian: In vitro je simeprevir sprožil fototoksičen odziv pri fibroblastih BALB/c 3T3 po izpostavljenosti UVA svetlobi ob dodatku beljakovin ali brez njih.
English: No serious adverse reactions
Slovenian: O resnih neželenih učinkih
English: OLYSIO has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo OLYSIO nima vpliva ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: It is not known whether simeprevir or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se simprevir oziroma njegovi presnovki izločajo v materinem mleku.
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)
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov: - zvečana koncentracija bilirubina v krvi (bilirubin je barvilo, ki nastaja v jetrih)* - povečana občutljivost kože na sončno svetlobo (fotosenzitivnost)
English: The most frequently reported adverse reactions (incidence ≥ 5% following 12 or 24 weeks of treatment) were rash, pruritus, constipation and photosensitivity reaction (see section 4.4).
Slovenian: Najpogosteje poročani neželeni učinki (s pogostnostjo ≥ 5% po 12 ali 24 tednih zdravljenja) so bili izpuščaj, srbenje, zaprtje in fotosenzitivne reakcije (glejte poglavje 4.4).
English: When taking OLYSIO combination treatment, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - notice yellowing of your skin or eyes
Slovenian: Obvestite zdravnika, če se med kombiniranim zdravljenjem z zdravilom OLYSIO pojavijo naslednji simptomi, ki lahko kažejo na poslabšanje jetrne bolezni: - opazite, da so vaša koža ali oči postali rumeni
English: The one patient with on-treatment failure discontinued treatment early due to an adverse event.
Slovenian: En bolnik z neuspehom v času zdravljenja je zdravljenje kmalu zaključil zaradi neželenega učinka.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: During your treatment with OLYSIO, use appropriate sun protection (such as a sun hat, sunglasses and sunscreen).
Slovenian: Med zdravljenjem z zdravilom OLYSIO uporabljajte ustrezna zaščitna sredstva (kot so zaščitno pokrivalo, sončna očala in zaščitne kreme).
English: In vitro experiments with human Caco-2 cells indicated that simeprevir is a substrate of P-gp.
Slovenian: In vitro testiranja na človeških celicah Caco-2 so pokazala, da je simeprevir substrat P-glikoproteina
English: In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a
Slovenian: V Evropi je bila prevalenca manjša, 19% (73/377) pri bolnikih s HCV genotipa 1a in 0,3% (3/877) pri bolnikih s HCV
English: The safety and efficacy of OLYSIO in children aged below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila OLYSIO pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 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: Table 12: Demographics and baseline characteristics (studies HPC3017 and HPC3018) HPC3017 N = 310
Slovenian: Preglednica 12: Demografske in izhodiščne značilnosti (študiji HPC3017 in HPC3018) HPC3017 N = 310
English: Studies carried out in rats did not reveal significant findings on fertility, embryo-fetal development or pre- and post-natal development at any of the tested doses (corresponding to a systemic exposure in rats similar or lower than that observed in humans at the recommended dose of 150 mg once daily).
Slovenian: Rezultati študij na podganah ne kažejo pomembnega vpliva na plodnost, razvoj zarodka oziroma ploda in na prenatalni ter postnatalni razvoj pri nobenem od testiranih odmerkov (glede na sistemsko izpostavljenost pri podganah, ki je bila podobna ali manjša kot izpostavljenost pri ljudeh pri uporabi priporočenega odmerka 150 mg enkrat na dan).
English: OLYSIO has not been studied in HCV infected patients with severe renal impairment (creatinine clearance below 30 ml/min) or end stage renal disease, including patients requiring haemodialysis.
Slovenian: Zdravila OLYSIO niso proučevali pri bolnikih, okuženih s HCV in hudo okvaro ledvic (očistek kreatinina manj kot 30 ml/min) ali končno ledvično odpovedjo, vključno z bolniki, ki potrebujejo hemodializo.
English: OLYSIO must be used in combination with other medicinal products for the treatment of CHC (see section 5.1).
Slovenian: Zdravilo OLYSIO je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje CHC (glejte poglavje 5.1).
English: No dose adjustment is necessary based on gender.
Slovenian: Prilagajanje odmerkov na podlagi spola ni potrebno.
English: If you are pregnant, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali
English: In a phase 3 study conducted in China and South-Korea, the mean plasma exposure of simeprevir in Asian HCV infected patients was 2.1-fold higher compared to non-Asian HCV infected patients in a pooled phase 3 population from global studies.
Slovenian: V študiji faze 3, izvedeni na Kitajskem in v Južni Koreji, je bila povprečna izpostavljenost simeprevirju pri bolnikih azijskega porekla, okuženih s HCV, 2,1-krat večja kot pri populaciji bolnikov v združenih globalnih študijah faze 3, okuženimi s HCV, ki niso bili azijskega porekla.
English: All patients receiving OLYSIO combination treatment with sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they
Slovenian: Vse bolnike, ki prejemajo zdravilo OLYSIO in sofosbuvir v kombinaciji z amiodaronom (z ali brez drugih zdravil, ki zmanjšujejo srčno frekvenco) je treba opozoriti na simptome bradikardije in srčnega bloka in jim svetovati naj v primeru pojava teh simptomov takoj poiščejo zdravniško pomoč.
English: Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
Slovenian: Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
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).
Slovenian: Pri zdravih odraslih osebah, ki so prejele enkraten odmerek do 600 mg ali pa so 5 dni enkrat na dan prejemale odmerke do 400 mg, in pri odraslih bolnikih z okužbo s HCV, ki so 4 tedne prejemali odmerek 200 mg enkrat na dan, so se neželeni učinki ujemali s tistimi, ki so jih opažali v kliničnih študijah pri uporabi priporočenega odmerka (glejte poglavje 4.8).
English: Viral breakthrough rates were 24% (11/45), 20% (5/25) and 11% (4/36) in patients with genotype 4a, 4d and 4/other, respectively.
Slovenian: Stopnje virusnega preboja so bile 24% (11/45) pri bolnikih z genotipom 4a, 20% (5/25) pri bolnikih z genotipom 4d in 11% (4/36) pri bolnikih z ostalimi podtipi genotipa 4.
English: Other substitutions such as Q80G or L, S122G, N or T did not reduce simeprevir activity (FC in EC50 ≤ 2).
Slovenian: Druge substitucije, kot so Q80G ali L in S122G, N ali T, niso zmanjšale delovanje simeprevirja (sprememba EC50 za ≤ 2-krat).
English: rash*, pruritus*
Slovenian: izpuščaj*, srbenje *
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).
Slovenian: Ker je treba zdravilo OLYSIO uporabljati sočasno z drugimi zdravili za zdravljenje CHC, veljajo kontraindikacije in opozorila pri teh zdravilih tudi za uporabo kombinacije z zdravilom OLYSIO (glejte poglavje 4.3).
English: May include few patients with HCV non-genotype 1a/1b.
Slovenian: Lahko vključuje nekaj bolnikov z virusom hepatitisa C, ki niso genotipa 1a ali 1b.
English: OLYSIO in combination with peginterferon alfa and ribavrin It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR), therefore discontinuation of treatment is recommended in these patients.
Slovenian: Zdravilo OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom Ker je malo verjetno, da bodo bolniki z nezadostnim virološkim odzivom dosegli trajni virološki odziv (SVR - sustained virologic response), je priporočljivo, da tem bolnikom zdravljenje ukinete.
English: Relapsers after prior interferon-based therapy.
Slovenian: Ponovitev bolezni po predhodnem zdravljenju na osnovi interferona.
English: If the capsule shell has been broken or opened, some medicine may be lost and you should take a new capsule.
Slovenian: Če je kapsula zlomljena ali odprta del zdravila lahko manjka, zato take kapsule ne smete uporabiti in morate vzeti novo.
English: Inhibitors of OATP1B1/3 such as eltrombopag or gemfibrozil may result in increases in simeprevir plasma concentrations.
Slovenian: Zaviralci OATP1B1/3, kot sta eltrombopag ali gemfibrozil, lahko povzročita zvečanje koncentracije simeprevirja v plazmi.
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
Slovenian: Bolnice, ki so v rodni dobi, in bolniki s partnerkami v rodni dobi morajo uporabljati učinkovito metodo kontracepcije v času zdravljenja in po zaključku zdravljenja z ribavirinom še tako dolgo, kot je opredeljeno v Povzetku glavnih značilnosti zdravila za ribavirin.
English: Treatment regimen not containing sofosbuvir:
Slovenian: Režimi zdravljenja brez sofosbuvirja:
English: Table 21: SVR12 rates for selected subgroups (study HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
Slovenian: Preglednica 21: Stopnje SVR12 za izbrane podskupine (študija HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
English: Open-label, randomised, except for studies HPC3018 and HPC3021 which were single arm, and study HPC2014 which
Slovenian: Odprte, randomizirane študije, razen študij HPC3018 in HPC3021, ki sta bili enokraki, in študije HPC2014, ki je bila
English: Elevations in amylase and lipase were transient and mostly of mild or moderate severity.
Slovenian: Zvečanje koncentracij amilaze in lipaze je bilo prehodno in večinoma blago do zmerno.
English: Patients should be informed of the risk of photosensitivity reactions and on the importance of applying appropriate sun protective measures during treatment with OLYSIO.
Slovenian: Med zdravljenjem z zdravilom OLYSIO morajo biti bolniki seznanjeni glede tveganja za pojav fotosenzitivnostne reakcije in pomembnosti uporabe ustreznih sredstev za zaščito pred sončnimi žarki.
English: It is not recommended to co-administer OLYSIO with delavirdine, etravirine or nevirapine.
Slovenian: OLYSIO z delavirdinom, etravirinom ali nevirapinom ni priporočljiva.
English: Combination treatment of OLYSIO with other medicinal products for the treatment of CHC may affect a patient's ability to drive and use machines.
Slovenian: Kombinirano zdravljenje z zdravilom OLYSIO in drugimi zdravili za zdravljenje CHC, lahko zmanjša bolnikovo sposobnost vožnje in upravljanja s stroji.
English: Simeprevir was not irritating to rabbit skin, and is not likely to cause skin sensitisation.
Slovenian: Simeprevir ni dražil kože pri kuncih in verjetno ne povzroča senzitizacije kože.
English: Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event.
Slovenian: Med 3 bolniki z neuspehom v času zdravljenja sta imela 2 bolnika virusni preboj, en bolnik pa je zdravljenje kmalu
English: In 32 out of 48 patients (67%) with emerging single D168V and in 34 out of 66 (52%) patients with emerging single R155K, the respective emerging variants were no longer detected at end of the studies.
Slovenian: Pri 32 od 48 bolnikov (pri 67%), pri katerih je prišlo do enojne substitucije D168V, in pri 34 od 66 bolnikov (pri 52%), pri katerih je prišlo do enojne substitucije R155K, so bile ob koncu študije koncentracije te variante virusa nezaznavne.
English: In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis
Slovenian: V študijo HPC3017 so vključili bolnike brez ciroze, v študijo HPC3018 pa bolnike s
English: If treatment with OLYSIO is discontinued because of adverse reactions or inadequate on-treatment virologic response, OLYSIO treatment must not be reinitiated.
Slovenian: Če je treba zdravljenje z zdravilom OLYSIO prekiniti zaradi neželenih učinkov ali nezadostnega virološkega odziva v času zdravljenja, zdravila OLYSIO ne smete ponovno uvesti.
English: The long-term clinical impact of the emergence or persistence of simeprevir-resistance-associated
Slovenian: Dolgoročni klinični pomen pojavljanja oziroma vztrajanja substitucij, ki povzročajo odpornost na
English: - If you are a woman, you must not become pregnant during treatment and for several
Slovenian: - Če ste ženska, ne smete zanositi med zdravljenjem in še nekaj mesecev po zaključku zdravljenja.
English: Consider starting with the lowest dose of the PDE-5 inhibitor and increase as needed, with clinical monitoring as appropriate.
Slovenian: Razmisliti velja o začetku zdravljenja z najnižjim odmerkom zaviralca fosfodiesteraze tipa 5 in zviševanju odmerka po potrebi skupaj z ustreznim kliničnim spremljanjem bolnika.
English: Genotype 1a N = 116 % (n)
Slovenian: genotip 1a N = 116 % (n)
English: Ribavirin use and prior treatment status (treatment-naïve and prior null responders) did not impact treatment outcome.
Slovenian: Uporaba ribavirina in status pred zdravljenjem (predhodno nezdravljeni in bolniki brez odziva na zdravljenje) nista vplivala na izid zdravljenja.
English: - ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant
Slovenian: - ciklosporin, sirolimus ali takrolimus za zaviranje imunskega odgovora ali preprečevanje
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.
Slovenian: V študiji C208 so vsi bolniki prejemali peginterferon alfa-2a; v študij C216 je 69% bolnikov prejemalo peginterferon alfa-2a in
English: Substitutions D168V and R155K alone or in combinations with other mutations at these positions emerged most frequently (table 10).
Slovenian: Najpogosteje je prišlo do substitucij D168V in R155K, bodisi samostojno ali v kombinaciji z drugimi mutacijami na teh položajih (preglednica 10).
English: Grade 1
Slovenian: stopnja 3
English: OATP1B1/3 and MRP2 are involved in the transport of bilirubin into and out of hepatocytes.
Slovenian: Prenašalca OATP1B1/3 in MRP2 sta vpletena tudi v transport bilirubina v hepatocite in iz njih.
English: Co-administration of OLYSIO with substances that moderately or strongly induce or inhibit cytochrome P450 3A (CYP3A4) is not recommended as this may lead to significantly lower or higher
Slovenian: Sočasna uporaba zdravila OLYSIO z zdravili, ki zmerno ali močno inducirajo ali zavirajo citokrom P450 3A (CYP3A4), ni priporočljiva, saj lahko bistveno zmanjša oziroma poveča
English: During the first 12 weeks of treatment, the most frequently reported adverse reactions (incidence ≥ 5%) were nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction
Slovenian: V prvih 12 tednih zdravljenja so najpogosteje (pri ≥ 5%) poročali o naslednjih neželenih učinkih: navzea, izpuščaj, srbenje, dispneja, zvečanje koncentracije bilirubina v krvi in fotosenzitivnostna
English: Therefore, co-administration of OLYSIO with substances that moderately or strongly inhibit or induce CYP3A4 is not recommended.
Slovenian: Zato sočasna uporaba zdravila OLYSIO z učinkovinami, ki zmerno ali močno zavirajo ali inducirajo CYP3A4, ni priporočljiva.
English: There is no specific antidote for overdose with OLYSIO.
Slovenian: Za preveliko odmerjanje zdravila OLYSIO ni specifičnega antidota.
English: Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
Slovenian: Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italija
English: 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, odvisnih od opioidov, na stabilnem metadonskem vzdrževalnem zdravljenju.
English: Patients had compensated liver disease (including cirrhosis), HCV RNA of at least 10,000 IU/ml, and liver histopathology consistent with CHC (if available).
Slovenian: Bolniki so imeli kompenzirano bolezen jeter (vključno s cirozo), koncentracijo HCV RNK najmanj 10.000 i.e./ml in histopatološki izvid jetrne biopsije skladen z diagnozo kroničnega hepatitisa C (če je bil na voljo).
English: The planned total duration of HCV treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12.
Slovenian: Načrtovano skupno trajanje zdravljenja HCV je bilo 24 tednov, če so bili doseženi naslednji od odziva odvisni in v protokolu določeni kriteriji: zaznavna koncentracija HCV RNK < 25 i.e./ml ali nezaznavna po 4. tednu IN nezaznavna koncentracija HCV RNK po 12. tednu.
English: The contraindications and warnings regarding pregnancy and contraception requirements applicable to the co-administered medicinal products also apply to their use in OLYSIO combination treatment.
Slovenian: Kontraindikacije in opozorila glede nosečnosti in zahteve po kontracepcije pri uporabi sočasnih zdravil veljajo tudi za zdravljenje v kombinaciji z zdravilom OLYSIO.
English: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Slovenian: Imetnik dovoljenja za promet z zdravilom Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgija
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).
Slovenian: Zdravilo OLYSIO je indicirano v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C (CHC - chronic hepatitis C) pri odraslih bolnikih (glejte poglavja 4.2, 4.4 in 5.1).
English: OLYSIO helps to fight against hepatitis C infection by preventing HCV from multiplying.
Slovenian: Zdravilo OLYSIO pomaga zdraviti okužbo z virusom hepatitisa C tako, da preprečuje razmnoževanje HCV.
English: In these patients the SVR12 rates were 89%, 93%, 75% and 90%, respectively.
Slovenian: Med temi bolniki jih je 89%, 93%, 75% oziroma 90% doseglo SVR12.
English: In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic
Slovenian: In vitro je kombinacija simeprevirja z interferonom, ribavirinom, zaviralci NS5A ali NS5B delovala aditivno ali sinergistično.
English: Following a single oral administration of 200 mg
Slovenian: Po enkratnem peroralnem odmerjanju 200 mg s
English: If pregnancy occurs during this period, you must contact your doctor straight away.
Slovenian: Če v tem obdobju zanosite, morate takoj obvestiti zdravnika.
English: Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Slovenian: Preglednica 11: Študije s simeprevirjem in sofosbuvirjem: populacija in povzetek načrta
English: Cisapride has the potential to cause cardiac arrhythmias.
Slovenian: Cisaprid lahko povzroča aritmije.
English: Rash may become severe.
Slovenian: Izpuščaj lahko postane hud.
English: In study HPC3021 (PLUTO), patients received simeprevir + sofosbuvir for 12 weeks (see table 11).
Slovenian: V študiji HPC3021 (PLUTO) so bolniki 12 tednov prejemali simeprevir + sofosbuvir (glejte preglednico 11).
English: Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Slovenian: Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italija
English: In case of severe rash, OLYSIO and other co-administered medicinal products for the treatment of CHC should be discontinued and the patients should be monitored until the symptoms have resolved.
Slovenian: Če se pojavi hud izpuščaj je treba zdravljenje z zdravilom OLYSIO in drugimi sočasnimi zdravili za zdravljenje CHC ukiniti, bolnike pa skrbno spremljati dokler simptomi ne izginejo.