FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of sofosbuvir was studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir, relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Slovak: 50 ml/min/1,73 m2) a ťažkou poruchou funkcie obličiek (eGFR < 30 ml/min/1,73 m2) a u pacientov s ESRD vyžadujúcich hemodialýzu po podaní jednorazovej 400 mg dávky sofosbuviru v porovnaní s pacientmi s normálnou funkciou obličiek (eGFR >
English: Potential for other medicinal products to affect Epclusa Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP.
Slovak: Sofosbuvir a velpatasvir sú substrátmi liekového transportéra P-gp a BCRP.
English: Use with moderate P-gp inducers and/or moderate CYP inducers Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa.
Slovak: Použitie so stredne silnými induktormi P-gp a/alebo stredne silnými induktormi CYP Lieky, ktoré sú stredne silnými induktormi P-gp a/alebo stredne silnými induktormi CYP (napr. efavirenz, modafinil, oxkarbazepín alebo rifapentín), môžu znížiť plazmatické koncentrácie sofosbuviru alebo velpatasviru so znížením terapeutického účinku Epclusa.
English: Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Slovak: ketokonazol (200 mg dvakrát denne)/ velpatasvir (100 mg jednorazová dávka)d
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑ Velpatasvir
Slovak: 5,5-krát ↑ ≥10-krát ↑ ≥20-krát ↑ ~7-krát ↑ 18-krát ↑
English: (Inhibition of P-gp and CYPs)
Slovak: (inhibícia P-gp a CYP)
English: Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5).
Slovak: Súbežné podávanie takýchto liekov s Epclusa sa neodporúča (pozri časť 4.5).
English: b n = 4 for genotype 2 and n = 2 for genotype 4.
Slovak: 4 pre genotyp 2 a n =
English: Patients who have previously failed therapy with an NS5A-containing regimen Epclusa + ribavirin for 24 weeks may be considered (see section 4.4).
Slovak: Pacienti, u ktorých predtým zlyhal režim liečby obsahujúci NS5A Možno zvážiť Epclusa
English: IMMUNOSUPPRESSANTS Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)f
Slovak: IMUNOSUPRESÍVA cyklosporín (600 mg jednorazová dávka)/sofosbuvir (400 mg jednorazová dávka)f cyklosporín
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks.
Slovak: Pacienti boli randomizovaní v pomere 1:1 na liečbu Epclusa počas 12 týždňov alebo SOF + RBV počas 24 týždňov.
English: Outcome for patients without SVR12 On-treatment virologic failure Relapsea
Slovak: Výsledok pre pacientov bez SVR Virologické zlyhanie počas liečby
English: Potential for Epclusa to affect other medicinal products Velpatasvir is an inhibitor of drug transporter P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3.
Slovak: Resistance Protein), polypeptid transportujúci organické anióny (OATP, organic anion-transporting polypeptide) 1B1 a OATP1B3.
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Slovak: Po jednorazovej 400 mg perorálnej dávke [14C]-sofosbuviru bolo priemerné celkové vylúčenie [14C]-rádioaktivity vyššie ako 92 %, z čoho sa približne 80 % vylúčilo v moči, 14
English: Sofosbuvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study.
Slovak: V pre- a postnatálnej vývojovej štúdii na potkanoch sa u potomstva nepozorovali žiadne účinky na správanie, reprodukciu ani vývoj.
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks.
Slovak: Pacienti boli randomizovaní v pomere 1:1 na liečbu Epclusa počas 12 týždňov alebo SOF + RBV počas 12 týždňov.
English: Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Slovak: Velpatasvir je inhibítor HCV cieleným na bielkovinu HCV NS5A, ktorá je nevyhnutná na replikáciu RNA aj zoskupovanie viriónov HCV. Štúdie in vitro selektívnej rezistencie a skríženej rezistencie naznačujú, že mechanizmus účinku velpatasviru je zacielený na NS5A.
English: Genotypes 2, 4, 5 or 6 Total
Slovak: Genotypy 2, 4, 5 alebo 6
English: Film-coating Polyvinyl alcohol Titanium dioxide Polyethylene glycol Talc
Slovak: Obal tablety polyvinylalkohol oxid titaničitý polyetylénglykol mastenec červený oxid železitý.
English: Of the 552 treated patients, the median age was 52 years (range: 19 to 76); 62% of the patients were male; 89% were White, 9% were Asian; 1% were Black; 20% had a baseline body mass index of at least 30 kg/m2; 61% had non-CC IL28B alleles (CT or TT); 70% had baseline HCV RNA levels of at least 800,000 IU/mL, 30% had compensated cirrhosis and 26% were treatment-experienced.
Slovak: U 552 liečených pacientov bol medián veku 52 rokov (rozsah: 19 až 76), 62 % pacientov bolo mužov, 89 % bolo belochov, 9 % bolo aziatov, 1 % bolo černochov, 20 % malo východiskový index telesnej hmotnosti aspoň 30 kg/m2, 61 % malo alely IL28B iné ako CC (CT alebo TT), 70 % malo východiskové hladiny HCV RNA aspoň 800 000 IU/ml, 30 % malo kompenzovanú cirhózu a 26 % bolo už predtým liečených.
English: Haemodialysis is unlikely to result in significant removal of velpatasvir, since velpatasvir is highly bound to plasma protein.
Slovak: Hemodialýza môže efektívne odstrániť metabolit sofosbuviru, GS-331007, prevládajúci v obehu s pomerom vylučovania 53 %. Nie je pravdepodobné, že hemodialýza bude mať za následok významné odstránenie velpatasviru, pretože velpatasvir sa silne viaže na plazmatické bielkoviny.
English: Clinical studies in patients with decompensated cirrhosis - ASTRAL-4 (study 1137) ASTRAL-4 was a randomised, open-label study in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and CPT Class B cirrhosis.
Slovak: ASTRAL-4 bola randomizovaná, otvorená štúdia s pacientmi s infekciou HCV s genotypom 1, 2, 3, 4, 5 alebo 6 a cirhózou podľa CPT triedy B.
English: Patients with decompensated cirrhosis
Slovak: Pacienti s dekompenzovanou cirhózou
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Slovak: PERORÁLNE KONTRACEPTÍVA norgestimát/ etinylestradiol (norgestimát 0,180 mg/ 0,215 mg/0,25 mg/ etinylestradiol
English: Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8).
Slovak: Ak sa tento liek podáva spolu s Epclusa, odporúča sa dôkladné sledovanie (pozri časti 4.4 a digoxín
English: Epclusa is contraindicated with carbamazepine (see section 4.3).
Slovak: Epclusa je kontraindikovaný s karbamazepínom (pozri časť 4.3).
English: The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Slovak: Farmakokinetika velpatasviru sa skúmala s jednorazovou dávkou 100 mg velpatasviru u HCV negatívnych pacientov s ťažkou poruchou funkcie obličiek (eGFR <
English: • light-headedness;
Slovak: • dýchavičnosť,
English: Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
Slovak: Tabuľka 17 uvádza SVR12 pre štúdiu ASTRAL-5 podľa genotypu HCV.
English: 94.3% to 98.9% 85.3% to 97.8% 95.9% to 99.9%
Slovak: % 95,9 % až 99,9 %
English: Epclusa is contraindicated with rifabutin (see section 4.3).
Slovak: Epclusa je kontraindikovaný s rifabutínom (pozri časť 4.3).
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Slovak: ANTIMYKOBAKTERIÁLNE LIEKY rifampicín (600 mg jedenkrát denne)/ sofosbuvir (400 mg jednorazová dávka)d (indukcia P-gp a CYP)
English: In biochemical assays, the ability of the active triphosphate of sofosbuvir (GS-461203) to inhibit recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution was reduced compared to its ability to inhibit wild-type recombinant NS5B polymerase, as indicated by a 8.5- to 24-fold increase in the 50% inhibitory concentration (IC50).
Slovak: V biochemickej analýze sa znížila schopnosť aktívneho trifosfátu sofosbuviru (GS-461203) inhibovať rekombinantnú polymerázu NS5B z genotypov 1b, 2a, 3a a 4a exprimujúcu substitúciu
English: Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p = 0.018) over treatment with SOF+RBV for 12 weeks (treatment difference +5.2%; 95% confidence interval: +0.2% to +10.3%).
Slovak: 0,018) v porovnaní s liečbou SOF + RBV počas 12 týždňov (rozdiel liečby +5,2
English: Interaction only studied with velpatasvir Expected:
Slovak: Interakcia sa skúmala len s velpatasvirom
English: Norelgestromin Norgestrel
Slovak: ↔ norgestrel etinylestradiol a.
English: Epclusa for 12 weeks
Slovak: Epclusa počas 12 týždňov
English: SOF+RBV 24 weeks (n = 275)
Slovak: SOF + RBV 24 týždňov (275)
English: Effect on velpatasvir exposure not studied.
Slovak: Účinky na expozíciu velpatasviru sa neskúmali.
English: Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
Slovak: Tabuľka 11: SVR12 v štúdii ASTRAL-2 (HCV genotyp 2) Epclusa
English: Epclusa 12 weeks (624) Placebo 12 weeks (116)
Slovak: Placebo 12 týždňov (116)
English: Of the 266 treated patients, the median age was 58 years (range: 23 to 81); 59% of the patients were male; 88% were White, 7% were Black; 33% had a baseline body mass index of at least 30 kg/m2; 62% had non-CC IL28B alleles (CT or TT); 80% had baseline HCV RNA levels of at least 800,000 IU/mL; 14% had compensated cirrhosis and 15% were treatment-experienced.
Slovak: U 266 liečených pacientov bol medián veku 58 rokov (rozsah: 23 až 81), 59 % pacientov bolo mužov, 88 % bolo belochov, 7 % bolo černochov, 33 % malo východiskový index telesnej hmotnosti aspoň 30 kg/m2; 62 % malo alely IL28B iné ako CC (CT alebo TT), 80 % malo východiskové hladiny HCV RNA aspoň 800 000 IU/ml, 14
English: Epclusa is contraindicated with rifampicin (see section 4.3).
Slovak: Epclusa je kontraindikovaný s rifampicínom (pozri časť 4.3).
English: Epclusa 12 weeks
Slovak: Epclusa 12 týždňov
English: ANTICONVULSANTS Phenytoin
Slovak: ANTIKONVULZÍVA fenytoín fenobarbital
English: SOF+RBV 12 weeks (n = 132)
Slovak: SOF + RBV 12 týždňov (132)
English: Without cirrhosis 98% (160/163) With cirrhosis a Five patients with missing cirrhosis status in the SOF+RBV 24 week group were excluded from this subgroup analysis.
Slovak: Piati pacienti v skupine SOF + RBV 24 týždňov s chýbajúcimi informáciami o stave cirhózy boli vylúčení z tejto analýzy podskupín.
English: Patients were randomised in a 1:1:1 ratio to treatment with Epclusa for 12 weeks, Epclusa + RBV for 12 weeks or Epclusa for 24 weeks.
Slovak: Pacienti boli randomizovaní v pomere 1:1:1 na liečbu Epclusa počas 12 týždňov, Epclusa + RBV počas 12 týždňov alebo Epclusa počas 24 týždňov.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Slovak: Ak sa režimy obsahujúce sofosbuvir použili v kombinácii s amiodarónom a inými liekmi, ktoré znižujú srdcovú frekvenciu alebo bez nich, pozorovali sa prípady závažnej bradykardie a srdcovej blokády.
English: 76% of the patients had non-CC IL28B alleles (CT or TT); 56% had baseline HCV RNA levels of at least 800,000 IU/mL, 55% were treatment-experienced; 90% and 95% of patients had CPT Class B
Slovak: (CT or TT), 56 % malo východiskové hladiny HCV RNA aspoň 800 000 IU/ml, 55 % bolo už predtým liečených, na začiatku štúdie malo 90 % pacientov cirhózu podľa CPT triedy
English: Epclusa 12 weeks (n = 277)
Slovak: Epclusa 12 týždňov (277)
English: Of the 106 treated patients, the median age was 57 years (range: 25 to 72); 86% of the patients were male; 51% were white; 45% were black; 22% had a baseline body mass index ≥ 30 kg/m2; 19 patients (18%) had compensated cirrhosis; and 29% were treatment experienced.
Slovak: U 106 liečených pacientov bol medián veku 57 rokov (rozsah: 25 až 72), 86 % pacientov bolo mužov, 51 % bolo belochov, 45 % bolo černochov, 22 % malo východiskový index telesnej hmotnosti ≥ 30 kg/m2; 19 pacientov (18
English: Safety data are limited in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Slovak: 30 ml/min/1,73 m2) a s ESRD, u ktorých sa vyžaduje hemodialýza, sú obmedzené.
English: Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p < 0.001) compared to treatment with SOF+RBV for 24 weeks (treatment difference +14.8%; 95% confidence interval: +9.6% to +20.0%).
Slovak: 0,001) v porovnaní s liečbou SOF + RBV počas 24 týždňov (rozdiel liečby +14,8
English: Genotype 3 HCV-infected adults - ASTRAL-3 (study 1140) ASTRAL-3 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 24 weeks of treatment with SOF+RBV in patients with genotype 3 HCV infection.
Slovak: ASTRAL-3 bola randomizovaná, otvorená štúdia, ktorá hodnotila 12 týždňov liečby Epclusa v porovnaní s 24 týždňami liečby SOF + RBV u pacientov s infekciou HCV s genotypom
English: Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Slovak: Tabuľka 12: SVR12 v štúdii ASTRAL-3 (HCV genotyp 3) Epclusa
English: The overall SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed Epclusa treatment and relapsed and two did not meet virologic failure criteria.
Slovak: Z troch pacientov, ktorí nedosiahli SVR12, jeden dokončil liečbu liekom Epclusa a mal relaps a dvaja nesplnili kritériá virologického zlyhania.
English: Epclusa 12 weeks (n = 624)
Slovak: Epclusa 12 týždňov (624)
English: Ribavirin was discontinued in 15% of patients treated with Epclusa + RBV for 12 weeks due to adverse events.
Slovak: Z dôvodu nežiaducich udalostí sa liečba ribavirínom ukončila u 15 % pacientov, ktorí sa liečili Epclusa + RBV počas 12 týždňov.
English: Patient populationa
Slovak: Starší pacienti
English: ANTIFUNGALS Ketoconazole
Slovak: ANTIKOAGULANCIÁ dabigatranetexilát
English: Genotype 2 HCV-infected adults - ASTRAL-2 (study 1139) ASTRAL-2 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF+RBV in patients with genotype 2 HCV infection.
Slovak: ASTRAL-2 bola randomizovaná, otvorená štúdia, ktorá hodnotila 12 týždňov liečby Epclusa v porovnaní s 12 týždňami liečby SOF + RBV u pacientov s infekciou HCV s genotypom
English: Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
Slovak: Lieky, ktoré sú silnými induktormi P-glykoproteínu (P-gp) a/alebo silnými induktormi cytochrómu P450 (CYP)
English: Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
Slovak: Tabuľka 14 zobrazuje SVR12 pre štúdiu ASTRAL-4 podľa genotypu HCV.
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with Epclusa (n=59) for 12 weeks, and compared to patients without renal impairment in the sofosbuvir/velpatasvir Phase 2/3 trials.
Slovak: Farmakokinetika sofosbuviru, GS-331007 a velpatasviru sa skúmala u pacientov infikovaných HCV s ESRD vyžadujúcim dialýzu liečených liekom Epclusa (n =
English: Epclusa 12 weeks (n = 134)
Slovak: Epclusa 12 týždňov (134)
English: Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Slovak: Antacidá napr. hydroxid hlinitý alebo horečnatý; uhličitan vápenatý
English: In the pooled analysis of the Phase 3 studies, 380/1,023 (37%) patients' virus had baseline NS5A RAVs.
Slovak: V súhrnnej analýze štúdie 3. fázy malo vírus 380/1 023 (37
English: Epclusa 24 weeks (n = 90)
Slovak: Epclusa 24 týždňov (90)
English: No dose adjustment of Epclusa or pravastatin is required.
Slovak: Nie je potrebná žiadna úprava dávky Epclusa ani pravastatínu.
English: SVR with Y93H 95% CI
Slovak: SVR s Y93H
English: Table 18: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Velpatasvir Compared to Subjects with Normal Renal Function
Slovak: Tabuľka 18: Účinky rôznych stupňov poruchy funkcie obličiek na expozície (AUC) sofosbuviru,
English: No dose adjustment of Epclusa or atorvastatin is required.
Slovak: Nie je potrebná žiadna úprava dávky Epclusa ani atorvastatínu.
English: c Administered as Epclusa.
Slovak: Podávané ako Epclusa.
English: Outcome for patients without SVR12 Ontreatment virologic failure
Slovak: Výsledok pre pacientov bez SVR12
English: Cobicistat
Slovak: ANTIMYKOTIKÁ
English: Genotype 2, 4, and 6 HCV-infected patients had a higher prevalence of NS5A RAVs (70%, 63% and 52%, respectively) compared to genotype 1 (23%), genotype 3 (16%), and genotype 5 (18%) HCV-infected patients.
Slovak: %, 63 % a 52 %, v uvedenom poradí) v porovnaní s pacientmi infikovanými HCV s genotypom 1 (23
English: Epclusa + RBV 12 weeks (n = 87)
Slovak: Epclusa + RBV 12 týždňov (87)
English: Cirrhotic (n = 80)
Slovak: S cirhózou (n =
English: GS-331007 is efficiently removed by haemodialysis with an extraction coefficient of approximately 53%.
Slovak: GS-331007 sa účinne odstraňoval hemodialýzou s koeficientom extrakcie približne 53 %. Po podaní jednorazovej dávky 400 mg sofosbuviru sa 4-hodinovou hemodialýzou odstránilo 18
English: H2-receptor antagonists Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Slovak: Antagonisti H2-receptorov famotidín (40 mg jednorazová dávka)/sofosbuvir/ velpatasvir (400/100 mg jednorazová dávka)c famotidín podávaný súbežne s Epclusad cimetidíne nizatidíne ranitidíne
English: Table 14: SVR12 in study ASTRAL-4 by HCV genotype
Slovak: Tabuľka 14: SVR12 v štúdii ASTRAL-4 podľa genotypu HCV Epclusa
English: CPT Class C cirrhosis
Slovak: ČÍSLO VÝROBNEJ ŠARŽE Č. šarže
English: Non-Cirrhotic (n = 197)
Slovak: Bez cirhózy (n =
English: Renal impairment No dose adjustment of Epclusa is required for patients with mild or moderate renal impairment.
Slovak: U pacientov s ľahkou alebo stredne ťažkou poruchou funkcie obličiek sa nevyžaduje úprava dávky Epclusa.
English: Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Slovak: rosuvastatín (10 mg jednorazová dávka)/ velpatasvir (100 mg jedenkrát denne)d
English: Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Slovak: Jadro tablety kopovidón mikrokryštalická celulóza sodná soľ kroskarmelózy magnéziumstearát.
English: Ritonavir
Slovak: rosuvastatín
English: Genotype 3 infected patients with the NS5A RAV Y93H at baseline had a lower SVR12 rate than patients without Y93H after treatment with Epclusa for 12 weeks, as summarised in Table 7.
Slovak: Východiskové RAV nemali žiadny významný dopad na miery SVR12 u pacientov infikovaných HCV s genotypom 1, 2, 4, 5 a 6 podľa zhrnutia v tabuľke 6. Pacienti infikovaní genotypom 3 s RAV NS5A Y93H na začiatku štúdie mali nižšiu mieru SVR12 ako pacienti bez Y93H po liečbe Epclusa počas 12 týždňov podľa zhrnutia v tabuľke 7.
English: No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Slovak: Nie je potrebná žiadna úprava dávky Epclusa ani atazanaviru (zosilneného ritonavirom) alebo emtricitabínu/tenofovirdizoproxilfumarátu.
English: Treatmentexperienced (n = 69)
Slovak: (n = 69)
English: Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 5-fold higher than the human exposure at the recommended clinical dose.
Slovak: V pre- a postnatálnej vývojovej štúdii na potkanoch pri expozíciách AUC približne 5-násobne vyšších ako je ľudská expozícia pri odporúčanej klinickej dávke nemal velpatasvir žiadne účinky na správanie, reprodukciu ani vývoj potomstva.
English: Total (n = 328)
Slovak: (n = 210)
English: (eGFR ≥50
Slovak: Stredná PFO (eGFR ≥
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Slovak: HIV ANTIVIROTIKÁ: INHIBÍTORY INTEGRÁZY raltegravir (400 mg dvakrát denne)g + emtricitabín/tenofovirdizoproxilfumarát (200/300 mg jedenkrát denne)/sofosbuvir/ velpatasvir (400/100 mg jedenkrát denne)c, d raltegravir
English: ↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Slovak: Nie je potrebná žiadna úprava dávky Epclusa ani darunaviru (zosilneného ritonavirom) alebo emtricitabínu/tenofovirdizoproxilfumarátu.
English: Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Slovak: efavirenz/emtricitabín/ tenofovirdizoproxilfumarát (600/200/300 mg jedenkrát denne)/sofosbuvir/ velpatasvir (400/100 mg jedenkrát denne)c, d efavirenz
English: c n = 4 for genotype 2, n = 2 for genotype 4 and n = 1 for genotype 6.
Slovak: 4 pre genotyp 2, n =
English: Lansoprazolee Rabeprazolee Pantoprazolee Esomeprazolee
Slovak: RASLINNÉ LIEKY ľubovník bodkovaný
English: The pharmacokinetic properties of sofosbuvir, GS-331007 and velpatasvir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration of Epclusa, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 1 hour post-dose.
Slovak: Farmakokinetické vlastnosti sofosbuviru, GS-331007 a velpatasviru sa hodnotili u zdravých dospelých jedincov a u pacientov s chronickou hepatitídou C.
English: Co-administration with such medicinal products is not recommended with Epclusa (see section 4.4).
Slovak: Epclusa s takýmito liekmi sa neodporúča (pozri časť 4.4).
English: The resistance associated variants (RAVs) selected in 2 or more genotypes were F28S, L31I/V and Y93H.
Slovak: F28S, L31I/V a Y93H.
English: No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
Slovak: Nie je potrebná žiadna úprava dávky lieku Epclusa ani raltegraviru alebo emtricitabínu/tenofovirdizoproxilfumarátu.
English: Table 13: SVR12 for selected subgroups in study ASTRAL-3 (HCV genotype 3)
Slovak: SVR12 pre vybrané podskupiny sú uvedené v tabuľke 13. Tabuľka 13: SVR12 pre vybrané podskupiny v štúdii ASTRAL-3 (HCV genotyp 3) Epclusa 12 týždňov
English: Clinical studies in patients without cirrhosis and patients with compensated cirrhosis Genotype 1, 2, 4, 5 and 6 HCV-infected adults - ASTRAL-1 (study 1138) ASTRAL-1 was a randomised, double-blind, placebo-controlled study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of placebo in patients with genotype 1, 2, 4, 5, or 6 HCV infection.
Slovak: ASTRAL-1 bola randomizovaná, dvojito zaslepená, placebom kontrolovaná štúdia, ktorá hodnotila 12 týždňov liečby Epclusa v porovnaní s 12 týždňami podávania placeba u pacientov s infekciou HCV s genotypom 1, 2, 4, 5 alebo 6.
English: 86% (6/7)c a n = 4 for genotype 2 and n = 4 for genotype 4.
Slovak: % (6/7)c a. n =
English: Following a single dose of 100 mg [14C]-velpatasvir, the majority (> 98%) of radioactivity in plasma was parent drug.
Slovak: Po jednorazovej dávke 100 mg [14C]-velpatasviru tvorilo väčšinu (>
English: • The active substances are sofosbuvir and velpatasvir.
Slovak: Liečivá sú sofosbuvir a velpatasvir.