FrancophonIA/ELRC3.0 huggingface dataset:
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%.
Slovak: Osemdesiatdeväť percent (54/61) „naivných“ pacientov a pacientov s recidívou v minulosti bez cirhózy liečených simeprevirom bolo vhodných pre celkovú dĺžku liečby 24 týždňov; u týchto pacientov bol podiel SVR12 87 %.
English: The safety profile of simeprevir in combination with sofosbuvir in patients with HCV genotype 1 infection with or without cirrhosis is based on pooled data from the phase 2 study HPC2002 and the phase 3 studies HPC3017 and HPC3018 which included 472 patients who received simeprevir with sofosbuvir without ribavirin (155, 286 and 31 patients received 8, 12 or 24 weeks of treatment, respectively) and 108 patients who received simeprevir with sofosbuvir and ribavirin (54 patients each received 12 or 24 weeks of treatment).
Slovak: Bezpečnostný profil simepreviru v kombinácii so sofosbuvirom u pacientov infikovaných HCV genotypu 1 s cirhózou alebo bez nej je založený na zlúčených údajoch zo štúdie fázy 2 HPC2002 a zo štúdií fázy 3 HPC3017 a HPC3018, ktoré zahŕňali 472 pacientov, ktorí dostávali simeprevir so sofosbuvirom bez ribavirínu (155, 286 a 31 pacientov dostávalo liečbu 8, 12 alebo 24 týždňov v uvedenom poradí), a 108 pacientov, ktorí dostávali simeprevir so sofosbuvirom a ribavirínom (54
English: HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1 and 5.2).
Slovak: U pacientov koinfikovaných HCV/HIV-1 nie je potrebná úprava dávky OLYSIA (pozri časti 4.8, 5.1 a
English: Most of these emerging substitutions have been shown to reduce simeprevir anti-HCV activity in cell culture replicon assays.
Slovak: V analýze bunkovej kultúry replikónu sa dokázalo, že väčšina týchto vznikajúcich substitúcií znižovala anti-HCV aktivitu simepreviru.
English: OLYSIO in combination with sofosbuvir: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients.
Slovak: Pacienti koinfikovaní HCV/HIV-1 sa majú liečiť rovnako dlho ako pacienti s monoinfekciou HCV.
English: Mild increases in simeprevir concentrations may occur due to mild inhibition of OATP1B1 by sildenafil.
Slovak: Môžu sa objaviť mierne zvýšenia koncentrácií simepreviru z dôvodu inhibície OATP1B1 sildenafilom.
English: Effect on drug levels Least Squares Mean Ratio (90%CI)
Slovak: Pomer priemerných minimálnych štvorcov (90
English: R(-) methadone AUC 0.99 (0.91-1.09) ↔ R(-) methadone Cmax 1.03 (0.97-1.09) ↔ R(-) methadone Cmin 1.02 (0.93-1.12) ↔
Slovak: R(-) metadón AUC 0,99 (0,91-1,09) ↔
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.
Slovak: nukleozidové inhibítory polymerázy (S282T) a nenukleozidové inhibítory polymerázy (C316N, M414I/L, P495A) zostali citlivé na simeprevir in vitro.
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
Slovak: Tabuľka 8: Prípady „zvýšenej hladiny bilirubínu v krvi“ pozorované u pacientov ázijského pôvodu v klinickej štúdii HPC3005 fázy 3 oproti zlúčenej fázy 3 štúdií C208, C216 a HPC3007 u pacientov, ktorí dostávali simeprevir alebo placebo v kombinácii s peginterferónom alfa a ribavirínom (prvých 12 týždňov liečby)
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 +
Slovak: Tabuľka 6: Abnormálne hodnoty laboratórnych vyšetrení amylázy a lipázy vyplývajúce z liečby u pacientov, ktorí dostávali 12 alebo 24 týždňov simeprevir v kombinácii so sofosbuvirom (12 týždňov: zlúčené štúdie HPC2002, HPC3017 a HPC3018; 24 týždňov: štúdia HPC2002)
English: Caution is warranted and clinical monitoring of patients is recommended when these calcium channel blockers are given orally.
Slovak: Vyžaduje sa opatrnosť a odporúča sa klinické monitorovanie pacientov,
English: Only grade 1 and 2 events were reported and there were no events leading to discontinuation of any of the study drugs.
Slovak: stupňa závažnosti a žiadne prípady neviedli k ukončeniu niektorého zo skúšaných liekov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/924/001 (7 capsules)
Slovak: EU/1/14/924/001 (7 kapsúl)
English: Outcome for patients without SVR12 On-treatment failure2
Slovak: Výsledok pre pacientov bez SVR12
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).
Slovak: 3 uskutočnenej u pacientov ázijského pôvodu v Číne a v Južnej Kórei je porovnateľný s profilom u pacientov neázijského pôvodu zo zlúčených údajov z medzinárodných štúdií fázy 3, okrem vyššej frekvencie prípadov „zvýšenej hladiny bilirubínu v krvi” (pozri tabuľku 8).
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).
Slovak: 400 mg jedenkrát denne) bola hodnotená u pacientov infikovaných HCV genotypu 1 alebo 4, ktorí neboli doteraz liečení alebo u pacientov už liečených (po predchádzajúcej liečbe interferónom) (tabuľka 11).
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 (see section 4.4).
Slovak: nauzea, vyrážka, pruritus, dyspnoe, zvýšenie hladiny bilirubínu v krvi a fotosenzitívna reakcia (pozri časť 4.4).
English: Consider starting with the lowest dose of the PDE-5 inhibitor and increase as needed, with clinical monitoring as appropriate.
Slovak: Zvážte začať liečbu s najnižšou dávkou inhibítora PDE-5
English: Effect of baseline HCV polymorphisms on treatment response Analyses were conducted to explore the association between naturally-occurring baseline NS3/4A amino acid substitutions (polymorphisms) and treatment outcome.
Slovak: Vykonali sa analýzy na zistenie súvislosti medzi prirodzene sa vyskytujúcimi východiskovými NS3/4A substitúciami aminokyselín (polymorfizmus) a výsledkom liečby.
English: Each capsule contains simeprevir sodium equivalent to 150 milligrams of simeprevir.
Slovak: Jedna kapsula obsahuje simeprevir sodný, čo zodpovedá 150 miligramom simepreviru.
English: NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules
Slovak: NÁZOV LIEKU OLYSIO 150 mg tvrdé kapsuly
English: Gastrointestinal disorders: very common nausea common constipation constipation constipation
Slovak: nauzea časté zápcha zápcha zápcha
English: Pooled phase 3 studies simeprevir + peginterferon alfa + ribavirin N = 152 n (%)
Slovak: Zlúčená fáza 3 štúdií simeprevir + peginterferón alfa + ribavirín N =
English: How OLYSIO works
Slovak: Ako OLYSIO účinkuje
English: LIST OF EXCIPIENTS Contains lactose monohydrate
Slovak: Obsahuje monohydrát laktózy.
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
Slovak: „naivní“ pacienti alebo pacienti s recidívou v minulosti bez cirhózy: 12 týždňov SMV + peg-IFN-alfa + RBV, za ktorými nasledovalo 12 alebo 36 týždňov peg-IFN-alfa + RBV3; nuloví respondenti v minulosti (čiastoční a nuloví respondenti) bez cirhózy a všetci „naivní“ pacienti a pacienti po predchádzajúcej liečbe s cirhózou: 12 týždňov SMV + peg-IFN-alfa + RBV, za ktorými nasledovalo 36 týždňov peg-IFN-alfa + RBV
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
Slovak: Tabuľka 15: Výsledok liečby u pacientov infikovaných HCV genotypu 1 s cirhózou, ktorí dostávali 12 alebo 24 týždňov simeprevir + sofosbuvir, s ribavirínom alebo bez ribavirínu (štúdia HPC2002)
English: Laboratory abnormalities
Slovak: Abnormálne hodnoty laboratórnych vyšetrení
English: (OATP1B1/3, P-gp and CYP3A inhibition by ciclosporin)
Slovak: (inhibícia OATP1B1/3, P-gp a CYP3A cyklosporínom)
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.
Slovak: (klírens kreatinínu pod 30 ml/min) alebo s ochorením obličiek v koncovom štádiu, vrátane pacientov na dialýze.
English: nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol levels - ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant failures - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
Slovak: - atazanavir, darunavir, delavirdín, efavirenz, etravirín, fosamprenavir, indinavir, lopinavir, nelfinavir, nevirapín, ritonavir, sachinavir alebo tipranavir na liečbu infekcie HIV - atorvastatín, lovastatín, pitavastatín, pravastatín, rosuvastatín alebo simvastatín na zníženie hladín cholesterolu - cyklosporín, sirolimus alebo takrolimus na zníženie vašej imunitnej odpovede alebo na zabránenie odvrhnutia transplantovaného orgánu
English: patients, with compensated cirrhosis or without cirrhosis
Slovak: s kompenzovanou cirhózou alebo bez cirhózy
English: SVR12 rates for selected subgroups METAVIR fibrosis score F0-2
Slovak: Skóre fibrózy METAVIR F0-2
English: - Keep this medicine out of the sight and reach of children.
Slovak: Ako uchovávať OLYSIO - Tento liek uchovávajte mimo dohľadu a dosahu detí.
English: ≥ 1.1 to ≤ 1.5 x ULN
Slovak: 1,1 až ≤ 1,5 x ULN
English: Talk to your doctor or pharmacist about all your medical conditions before taking OLYSIO in particular if: - you have hepatitis C that is not ‘genotype 1' or ‘genotype 4';
Slovak: - máte hepatitídu C, ktorá nie je „genotypu 1“ alebo „genotypu 4“;
English: The response rates for patients with cirrhosis (METAVIR score F4) receiving 12 or 24 weeks of simeprevir + sofosbuvir are shown in table 15.
Slovak: Miera odpovede pacientov s cirhózou (skóre METAVIR F4), ktorí dostávali 12 alebo 24 týždňov simeprevir
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
Slovak: F3-4 F4 IL28B genotyp CC CT TT HCV geno/subtyp a prítomnosť polymorfizmu Q80K u HCV genotypu 1a Genotyp 1a s Q80K bez Q80K Genotyp 1b 1 p <
English: C2121 N = 106
Slovak: C2121
English: OLYSIO in combination with peginterferon alfa and ribavirin Simeprevir efficacy in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with hepatitis C genotype 1a with the NS3 Q80K polymorphism at baseline compared to patients with hepatitis C genotype 1a without the Q80K polymorphism (see section 5.1).
Slovak: Účinnosť simepreviru v kombinácii s peginterferónom alfa a ribavirínom je výrazne znížená u pacientov infikovaných hepatitídou C genotypu 1a s východiskovým polymorfizmom NS3 Q80K v porovnaní s pacientmi s hepatitídou
English: Pre-treatment testing for NS3 Q80K polymorphism in patients infected with HCV genotype 1a OLYSIO in combination with sofosbuvir
Slovak: Testovanie polymorfizmu NS3 Q80K pred začiatkom liečby u pacientov infikovaných HCV genotypu 1a
English: The 63 enrolled patients had a median age of 51 years (range 24 to 68 years; with 2% above 65 years); 54% were male; 43% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.01 log10 IU/ml; 37% had cirrhosis; 30% had HCV genotype 4a, and 56% HCV genotype 4c or 4d; 79% had non-CC IL28B alleles (CT or TT); 52% were treatment-naïve, and 48% were treatment-experienced.
Slovak: zaregistrovaných pacientov malo medián veku 51 rokov (v rozmedzí od 24 do 68 rokov s 2 % nad 65 rokov); 54 % boli muži; 43 % malo BMI ≥ 30 kg/m2; medián východiskovej hladiny HCV RNA bol 6,01 log10 IU/ml; 37 % malo cirhózu; 30 % malo HCV genotypu 4a, a 56 % HCV genotypu 4c alebo 4d; 79 % malo non-CC
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
Slovak: 150 mg kofeín AUC 1,26 (1,21-1,32)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains simeprevir sodium equivalent to 150 mg simeprevir.
Slovak: Každá tvrdá kapsula obsahuje simeprevir sodný, čo zodpovedá 150 mg simepreviru.
English: 2 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT.
Slovak: 2 Miera virologickej recidívy je vypočítaná s menovateľom pacientov s nedetekovateľnou HCV
English: Nisoldipine
Slovak: Nisoldipín
English: ANTICOAGULANTS Warfarin and other vitamin K antagonists warfarin 10 mg:
Slovak: warfarín 10 mg:
English: In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated patients (all grades; pooled phase 3).
Slovak: % pacientov liečených simeprevirom v porovnaní so 7,6 % u pacientov, ktorí dostávali placebo (všetky stupne; zlúčená fáza 3).
English: sofosbuvir N = 286 n (%)
Slovak: N = 286 n (%)
English: (OATP1B1 inhibition by tacrolimus)
Slovak: (inhibícia OATP1B1 takrolimom)
English: Table 22 shows the response rates in HCV genotype 1 infected patients with HIV-1 co-infection.
Slovak: Tabuľka 22 znázorňuje podiely odpovedí u pacientov infikovaných HCV genotypu 1 koinfikovaných HIV-1.
English: ≥ 1.1 to ≤ 1.5 x ULN 13 (4.5%)
Slovak: 1,1 až ≤ 1,5 x ULN 13 (4,5
English: Hyperbilirubinemia Grade 1
Slovak: Hyperbilirubinémia
English: S-warfarin AUC 1.04 (1.00-1.07) ↔ S-warfarin Cmax 1.00 (0.94-1.06) ↔ S-warfarin Cmin not studied
Slovak: S-warfarín Cmax 1,00 (0,94-1,06)
English: Oral: 0.075 mg/kg Intravenous:
Slovak: 0,075 mg/kg
English: Treatment discontinuation in patients with inadequate on-treatment virologic response OLYSIO in combination with sofosbuvir
Slovak: Ukončenie liečby u pacientov s nedostatočnou virologickou odpoveďou
English: 1 In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 4.4).
Slovak: U pacientov s HCV genotypu 1a s cirhózou sa môže zvážiť testovanie na prítomnosť polymorfizmu Q80K pred začiatkom liečby OLYSIOM v kombinácii so sofosbuvirom (pozri časť 4.4).
English: 4 Includes relapsers, partial and null responders to prior treatment with peginterferon and ribavirin.
Slovak: Zahŕňa pacientov srecidívou, čiastočných a nulových respondentov v minulosti na liečbe s peginterferónom a ribavirínom.
English: 1 Treatment-experienced to prior treatment with peginterferon and ribavirin.
Slovak: Pacienti po predchádzajúcej liečbe s peginterferónom a ribavirínom.
English: Hepatobiliary disorders: common blood bilirubin increased* blood bilirubin increased* blood bilirubin increased* Skin and subcutaneous tissue disorders: very common rash*
Slovak: Poruchy pečene a žlčových ciest: časté zvýšená hladina bilirubínu v krvi*
English: Genotype 1, treatment-naïve or null responders3, with compensated cirrhosis or without cirrhosis
Slovak: Genotyp 1, „naivní“ pacienti alebo nuloví respondenti3, s kompenzovanou cirhózou alebo bez cirhózy
English: > 3.0 to ≤ 5.0 x ULN 1 (0.3%)
Slovak: 3,0 až ≤ 5,0 x ULN 1 (0,3
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) ↑
Slovak: Ritonavir1 100 mg dvakrát denne simeprevir AUC 7,18 (5,63-9,15)
English: 2 Relapsers after prior interferon-based therapy.
Slovak: 2 Pacienti s recidívou v minulosti na liečbe s interferónom.
English: How to take OLYSIO
Slovak: Čo je OLYSIO
English: > 2.5 to ≤ 5.0 x ULN
Slovak: 2,5 až ≤ 5,0 x ULN
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).
Slovak: detekovateľná alebo nedetegovateľná 12 týždňov (SVR12) alebo 24 týždňov (SVR24) po plánovanom ukončení liečby (štúdie C206, C208, C212, C216, HPC2002, HPC3007 a HPC3011) alebo po skutočnom ukončení liečby (štúdia HPC2014, HPC3017, HPC3018 a HPC3021)
English: Patients with HCV genotype 1a predominantly had emerging R155K alone or in combination with amino acid substitutions at NS3 positions 80, 122 and/or 168, while patients with HCV genotype 1b had most often an emerging D168V substitution (table 10).
Slovak: pozíciách 80, 122 a/alebo 168, zatiaľ čo pacienti s HCV genotypu 1b mali najčastejšie vznikajúcu substitúciu D168V (tabuľka 10).
English: 0.25 mg digoxin AUC 1.39 (1.16-1.67) ↑ digoxin Cmax 1.31 (1.14-1.51) ↑ digoxin Cmin not studied
Slovak: 0,25 mg digoxín AUC 1,39 (1,16-1,67)
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 sofosbuvir (see section 5.1).
Slovak: U pacientov infikovaných HCV genotypu 1a s cirhózou sa môže zvážiť testovanie na prítomnosť polymorfizmu Q80K pred začatím liečby OLYSIOM v kombinácii so sofosbuvirom (pozri časť 5.1).
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 these medicinal products.
Slovak: Ak je z dôvodu nežiaducich reakcií, potenciálne súvisiacich s liekmi užívanými v kombinácii s OLYSIOM na liečbu CHC, potrebná úprava dávky alebo prerušenie liečby liekom (liekmi),
English: Simeprevir in combination with peginterferon alfa and ribavirin The efficacy of simeprevir in combination with peginterferon alfa and ribavirin was evaluated in patients with HCV genotype 1 or 4 infection, with or without HIV-1 co-infection, who were treatment-naïve or treatment-experienced (following prior interferon-based therapy) (tables 17 and
Slovak: Účinnosť simepreviru v kombinácii s peginterferónom alfa a ribavirínom bola hodnotená u pacientov infikovaných HCV genotypu 1 alebo 4, ktorí boli alebo neboli koinfikovaní HIV-1, a ktorí boli
English: Viral relapse3
Slovak: Virologická recidíva3
English: Erythromycin 500 mg three times a day erythromycin AUC 1.90 (1.53-2.36) ↑ erythromycin Cmax 1.59 (1.23-2.05) ↑ erythromycin Cmin 3.08 (2.54-3.73) ↑ simeprevir AUC 7.47 (6.41-8.70) ↑ simeprevir Cmax 4.53 (3.91-5.25) ↑ simeprevir Cmin 12.74 (10.19-15.93) ↑
Slovak: Erytromycín 500 mg trikrát denne erytromycín AUC 1,90 (1,53-2,36) ↑ erytromycín Cmax 1,59 (1,23-2,05)
English: (strong CYP3A4 induction)
Slovak: (silná indukcia CYP3A4)
English: No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh class A).
Slovak: U pacientov s ľahkou poruchou funkcie pečene (Childova-Pughova trieda A) sa nevyžaduje úprava dávky OLYSIA.
English: Ledipasvir 30 mg once daily ledipasvir AUC 1.92 (1.77-2.07) ↑ ledipasvir Cmax 1.81 (1.69-2.94) ↑ ledipasvir Cmin not studied simeprevir AUC 2.69 (2.44-2.96) ↑ simeprevir Cmax 2.61 (2.34-2.86) ↑ simeprevir Cmin not studied
Slovak: Ledipasvir 30 mg jedenkrát denne ledipasvir AUC 1,92 (1,77-2,07) ↑ ledipasvir Cmax 1,81 (1,69-2,94)
English: All grades Grade 3
Slovak: Stupeň 3 Stupeň 4
English: simeprevir + sofosbuvir
Slovak: + sofosbuvir
English: Tabulated list of adverse reactions
Slovak: Súhrn nežiaducich reakcií v tabuľkách
English: Lovastatin
Slovak: Omeprazol
English: Mūkusalas iela 101
Slovak: Mūkusalas iela 101 Rīga, LV-1004
English: Viral relapse2
Slovak: Virologická recidíva2
English: (OATP1B1/3 transporter and/or CYP3A4 enzyme inhibition)
Slovak: (inhibícia transportéra OATP1B1/3 a/alebo enzýmu CYP3A4)
English: It is not recommended to co-administer OLYSIO with these anticonvulsants as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovak: Súbežné podávanie OLYSIA s týmito antikonvulzívami sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
English: Table 20: Treatment outcome in treatment-experienced1 HCV genotype 1 infected patients
Slovak: Tabuľka 22: Výsledok liečby u pacientov infikovaných HCV genotypu 1 koinfikovaných
English: > 1.5 to ≤ 2.5 x ULN
Slovak: 1,5 až ≤ 2,5 x ULN
English: N = 7 % (n/N)
Slovak: 7 % (n/N)
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).
Slovak: 1 Keď sa zvažuje liečba OLYSIOM v kombinácii s peginterferónom alfa a ribavirínom u pacientov s HCV genotypu 1a, pred začiatkom liečby sa má uskutočniť testovanie na polymorfizmus NS3 Q80K (pozri časť 4.4).
English: Press edge of pocket
Slovak: Stlačte okraj vrecka
English: It is not recommended to co-administer OLYSIO with systemic dexamethasone as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovak: Súbežné podávanie OLYSIA so systémovým dexametazónom sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
English: (OATP1B1 transporter and/or CYP3A4 enzyme inhibition)
Slovak: (inhibícia transportéra OATP1B1 a/alebo enzýmu CYP3A4)
English: Genotype 1, treatment-naïve patients, with compensated cirrhosis or without cirrhosis
Slovak: Genotyp 1, „naivní“ pacienti, s kompenzovanou cirhózou alebo bez cirhózy
English: Intravenous: midazolam AUC 1.10 (0.95-1.26) ↑ midazolam Cmax 0.78 (0.52-1.17) ↓ midazolam Cmin not studied
Slovak: Intravenózny: midazolam AUC 1,10 (0,95-1,26)
English: > 2.0 to ≤ 5.0 x ULN 13 (4.5%)
Slovak: 2,0 až ≤ 5,0 x ULN 13 (4,5
English: 10 mg rosuvastatin AUC 2.81 (2.34-3.37) ↑ rosuvastatin Cmax 3.17 (2.57-3.91) ↑ rosuvastatin Cmin not studied
Slovak: ↑ rosuvastatín Cmax 3,17 (2,57-3,91)
English: CC
Slovak: C.
English: > 1.5 to ≤ 2.0 x ULN 15 (5.2%)
Slovak: 2,0 x ULN 15 (5,2
English: (intestinal CYP3A4 enzyme and P-gp transporter inhibition)
Slovak: (inhibícia črevného enzýmu CYP3A4 a transportéra P-gp)
English: HPC3011 N = 107
Slovak: HPC3011
English: Oral: midazolam AUC 1.45 (1.35-1.57) ↑ midazolam Cmax 1.31 (1.19-1.45) ↑ midazolam Cmin not studied
Slovak: Perorálny: midazolam AUC 1,45 (1,35-1,57)
English: Altered plasma concentrations of simeprevir are expected.
Slovak: Očakáva sa zmena plazmatickej koncentrácie simepreviru.
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.
Slovak: Súbežné podávanie OLYSIA s rifabutínom alebo rifapentínom sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku