FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine) may decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of Harvoni.
Slovak: Použitie so stredne silnými induktormi P-glykoproteínu (P-gp) Lieky, ktoré sú stredne silnými induktormi P-gp v črevách (napr. oxkarbazepín), môžu znížiť plazmatické koncentrácie ledipasviru a sofosbuviru, a tým viesť k zníženému terapeutickému účinku Harvoni.
English: Of 169 patients with decompensated cirrhosis (pre- or post-transplant CPT B or C), those patients who achieved SVR12 and had post-treatment week 12 laboratory data available (e.g. excluding patients who died, were transplanted, or had missing data at this time-point) were assessed for changes in their MELD and CPT scores.
Slovak: B alebo C pred alebo po transplantácii) sa hodnotili z hľadiska MELD a CPT skóre tí pacienti, ktorí dosiahli SVR12 a boli pre nich k dispozícii laboratórne údaje po 12 týždňoch po ukončení liečby (vylúčení boli napr. pacienti, ktorí zomreli,
English: Ledipasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all ledipasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.
Slovak: Ledipasvir bol plne aktívny proti substitúcii S282T v NS5B súvisiacej s rezistenciou voči sofosbuviru,
English: IMMUNOSUPPRESSANTS Ciclosporing
Slovak: IMUNOSUPRESÍVA cyklosporín g
English: and L31M substitution in genotype 1a conferred high levels of reduced susceptibility to ledipasvir (fold-change in EC50 ranging from 544-fold to 1,677-fold).
Slovak: Cielená mutagenéza substitúcie Y93H u genotypu 1a aj 1b, ako aj substitúcia Q30R a L31M u genotypu 1a viedli k vysokým hodnotám zníženia citlivosti voči ledipasviru (544- až 1677-násobná zmena hodnoty EC50).
English: Patients in the latter treatment arm received placebo (for ledipasvir/sofosbuvir and ribavirin) during the first 12 weeks, followed by active blinded therapy during the subsequent 12 weeks.
Slovak: 12 týždňov placebo (pre ledipasvir/sofosbuvir a ribavirín), potom nasledovala ďalších 12 týždňov aktívna zaslepená liečba.
English: Gender Male Female IL28 genotype CC Non-CC Baseline HCV RNAa
Slovak: Pohlavie Muži Ženy Genotyp IL28 CC
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at doses which cause adverse effects was 16 times (rat) and 71 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Slovak: V štúdiách vykonávaných na hlodavcoch sa nepodarilo zistiť expozíciu sofosbuviru pravdepodobne z dôvodu vysokej esterázovej aktivity; avšak expozícia hlavnému metabolitu GS-331007 pri dávkach, ktoré spôsobujú nežiaduce účinky, bola 16-násobne
English: c. Analysis (by deep sequencing) included NS5A resistance-associated polymorphisms that conferred > 2.5-fold change in EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Slovak: 2,5-násobnej zmene hodnoty EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/l/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T a Y93C/F/H/N/S pre infekciu HCV genotypu 1a a L31I/F/M/V, P32L, P58D, A92K a Y93C/H/N/S pre infekciu HCV genotypu 1b).
English: Additionally a Q30E substitution developed in genotype 1a replicons.
Slovak: v NS5A u genotypov 1a aj 1b. Okrem toho sa vyvinula substitúcia Q30E v replikónoch genotypu 1a.
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)
Slovak: ANTIMYKOBAKTERIÁLNE LIEKY rifampicín (600 mg jedenkrát denne)/ ledipasvir (90 mg jednorazová dávka)d
English: 4.6 Fertility, pregnancy and lactation
Slovak: Fertilita, gravidita a laktácia Ženy vo fertilnom veku / antikoncepcia u mužov a žien
English: HCV replicons with reduced susceptibility to ledipasvir have been selected in cell culture for genotype 1a and 1b.
Slovak: Replikóny HCV so zníženou citlivosťou voči ledipasviru boli vybraté v bunkovej kultúre pre genotyp 1a a 1b. Znížená citlivosť voči ledipasviru bola spojená s primárnou substitúciou Y93H
English: LIST OF EXCIPIENTS Contains lactose and sunset yellow FCF aluminium lake (E110).
Slovak: Obsahuje laktózu a hlinitý lak oranžovej žlte FCF (E110).
English: The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 5.
Slovak: Hodnoty EC50 ledipasviru a sofosbuviru voči replikónom s úplnou dĺžkou alebo chimérickým replikónom kódujúcim sekvencie NS5A a NS5B z klinických izolátov sú uvedené v tabuľke 5. Prítomnosť 40 % ľudského séra nemala žiadny vplyv na anti-HCV aktivitu sofosbuviru, ale
English: < 12 g/dL despite 4 weeks at reduced dose
Slovak: 12 g/dl napriek
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of ledipasvir by 12-fold against genotype 1a HCV replicons.
Slovak: 12-násobne znížila anti-HCV aktivitu ledipasviru voči replikónom HCV genotypu 1a.
English: Rifabutin Rifapentine
Slovak: rifabutín rifapentín
English: Harvoni contains sunset yellow FCF aluminium lake (E110)
Slovak: Harvoni obsahuje hlinitý lak oranžovej žlte FCF (E110)
English: Simeprevir h
Slovak: simeprevir ↑
English: Table 17: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Slovak: Tabuľka 17: Miery odpovedí (SVR12) u pacientov s infekciou s genotypom 3 (ELEKTRON-2)
English: before taking this medicine.
Slovak: Predtým liečení
English: Table 9: Demographics and baseline characteristics in study ION-1 Patient disposition
Slovak: Tabuľka 9: Demografické a východiskové charakteristiky v štúdii ION-1
English: CPT B
Slovak: CPT Ab
English: Table 13: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Slovak: Tabuľka 13: Miery relapsu ochorenia pre vybrané podskupiny v štúdii ION-2 LDV/SOF
English: Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors.
Slovak: Súbežné podávanie s liekmi, ktoré inhibujú P-gp a/alebo BCRP, môže zvýšiť plazmatické koncentrácie ledipasviru a sofosbuviru bez zvýšenia plazmatickej koncentrácie
English: • Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110”
Slovak: • Ak ste alergický na hlinitý lak oranžovej žlte FCF, nazývaný aj „E110“, povedzte to svojmu lekárovi predtým, ako začnete užívať tento liek.
English: No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
Slovak: U pacientov s dekompenzovanou cirhózou a/alebo u tých, ktorí boli po transplantácii pečene a ktorí dostávali ledipasvir/sofosbuvir s ribavirínom, neboli zistené žiadne nové nežiaduce účinky lieku.
English: Table 4: Adverse drug reactions identified with Harvoni Frequency
Slovak: Tabuľka 4: Nežiaduce účinky lieku identifikované pri liečbe Harvoni
English: Methadone (Methadone maintenance therapy [30 to 130 mg/daily])/ sofosbuvir (400 mg once daily)d
Slovak: (udržiavacia liečba metadónom [30 až 130 mg/denne])/ sofosbuvir (400 mg jedenkrát denne)
English: Site-directed mutagenesis of NS5A RAVs showed that substitutions conferring a fold-change > 100 and ≤ 1,000 in ledipasvir susceptibility are Q30H/R, L31I/M/V, P32L and Y93T in genotype 1a and P58D and Y93S in genotype 1b; and substitutions conferring a fold-change > 1,000 are M28A/G, Q30E/G/K, H58D, Y93C/H/N/S in genotype 1a and A92K and Y93H in genotype 1b.
Slovak: 1000-násobnej zmene citlivosti voči ledipasviru sú Q30H/R, L31I/M/V, P32L a Y93T u genotypu 1a a P58D a Y93S u genotypu 1b; substitúciami vedúcimi k > 1000-násobnej zmene sú M28A/G, Q30E/G/K, H58D, Y93C/H/N/S u genotypu 1a a A92K a Y93H u genotypu 1b.
English: Due date
Slovak: 24 týždňov
English: Treatment-naïve Patients without cirrhosis Patients with cirrhosis Treatment-experienced
Slovak: Pacienti bez cirhózy Pacienti s cirhózou
English: SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a. 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12.
Slovak: Do štúdie bolo zaradených 8 pacientov s infekciou HCV genotypu 4, pričom 8/8 dosiahlo SVR12.
English: Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)
Slovak: takrolimus (5 mg jednorazová dávka)/ sofosbuvir (400 mg jednorazová dávka)
English: Ledipasvir ↑ Cmax 1.81 (1.69, 2.94)
Slovak: Cmax 1,81 (1,69; 2,94) ↑
English: H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)
Slovak: famotidín (40 mg jednorazová dávka)/ ledipasvir (90 mg jednorazová dávka)
English: Medicinal products that are potent P-gp inducers (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
Slovak: Lieky, ktoré sú silnými induktormi P-gp (rifampicín, rifabutín, ľubovník bodkovaný, karbamazepín, fenobarbital a fenytoín), môžu výrazne znížiť plazmatické koncentrácie ledipasviru a sofosbuviru,
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Slovak: 1/100 až < 1/10), menej časté (≥
English: In female rats, the mean number of corpora lutea and implantation sites were slightly reduced at maternal exposures 6-fold the exposure in humans at the recommended clinical dose.
Slovak: U samíc potkanov bol priemerný počet žltých teliesok a miest implantácie mierne nižší pri materských expozíciách, ktoré boli
English: No dose adjustment of Harvoni is required for patients with mild or moderate renal impairment.
Slovak: U pacientov s miernym alebo stredným poškodením obličiek nie je potrebná žiadna úprava dávky Harvoni.
English: In patients with ESRD, relative to patients with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
Slovak: % pri podaní sofosbuviru 1 hodinu pred hemodialýzou a o 60 % pri podaní sofosbuviru 1 hodinu po hemodialýze.
English: Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Slovak: rifampicín (600 mg jedenkrát denne)/sofosbuvir (400 mg jednorazová dávka)
English: (listed in section 6 of this leaflet).
Slovak: (pozri časť 4.3).
English: In phenotypic analyses, post-baseline isolates from patients who harboured NS5A RAVs at failure showed 20- to at least a 243-fold (the highest dose tested) reduced susceptibility to ledipasvir.
Slovak: Izoláty získané po začatí štúdie od pacientov, ktorí v čase virologického zlyhania vykazovali RAV NS5A, mali na základe fenotypových analýz 20- až najmenej
English: d. Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2.
Slovak: 5 na základe biopsie pečene alebo skóre FibroTest > 0,75 a (APRI)
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to ledipasvir.
Slovak: HCV ukázala, že cirhóza nemala žiadny klinicky významný vplyv na expozíciu ledipasviru.
English: b. Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4.
Slovak: F2; 0,59-1,00 = F3-F4.
English: Table 10: Response rates in study ION-1 LDV/SOF
Slovak: Tabuľka 10: Miery odpovede v štúdii ION-1 LDV/SOF
English: Film-coating:
Slovak: Celkové poruchy:
English: 12 weeks (n = 109)
Slovak: (n = 109)
English: SVR Outcome for patients without SVR On-treatment virologic failure a
Slovak: SVR Výsledok pre pacientov bez SVR
English: f. One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis.
Slovak: LLOQ, mal chýbajúce údaje o východiskových hodnotách NS5A a bol z tejto analýzy vylúčený.
English: Table 7: Response rates in study ION-3 LDV/SOF
Slovak: Tabuľka 7: Miery odpovede v štúdii ION-3 LDV/SOF
English: IL28CC genotype FibroTest-Determined Metavir score b
Slovak: Skóre Metavir podľa testu FibroTest b
English: Table 6: Demographics and baseline characteristics in study ION-3 Patient disposition
Slovak: Tabuľka 11: Demografické a východiskové charakteristiky v štúdii ION-2 Charakteristika pacientov
English: ↑ Pravastatin
Slovak: ↑ statíny
English: No dose adjustment of Harvoni or ciclosporin is required.
Slovak: Nie je potrebná žiadna úprava dávky Harvoni ani cyklosporínu.
English: a. Six patients (1 in the 12-week, 5 in the 24-week treatment group) with HCV RNA < LLOQ at last measurement prior to transplant, were transplanted prior to SVR12 and were excluded from SVR12 and relapse analyses.
Slovak: LLOQ pri poslednom meraní pred transplantáciou, u ktorých sa transplantácia vykonala pred SVR12, boli vylúčení z analýz SVR12 a relapsu.
English: Elimination Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%).
Slovak: Po jednorazovej 90 mg perorálnej dávke [14C]-ledipasviru bolo priemerné celkové vylúčenie dávky [14C]-rádioaktivity v stolici a moči 87
English: C]-radioactivity ranged between 0.51 and 0.66.
Slovak: 0,51 až 0,66.
English: Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Slovak: 50 ml/min (pozri časť 5.2).
English: Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Slovak: Cmax 1,11 (0,99; 1,24) ↔
English: Patients with a CPT score > 12 were excluded.
Slovak: 12 boli vylúčení.
English: Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
Slovak: Cmax 0,80 (0,69; 0,93)
English: Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
Slovak: Cmax 1,68 (1,54; 1,84) ↑
English: Distribution Ledipasvir is > 99.8% bound to human plasma proteins.
Slovak: % na ľudské plazmatické proteíny.
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone with or without other drugs that lower heart rate.
Slovak: Ak sa Harvoni používa pri súbežnom použití amiodarónu a iných liekov, ktoré znižujú srdcovú frekvenciu, alebo bez nich, pozorujú sa prípady závažnej bradykardie a srdcovej blokády.
English: The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis.
Slovak: Bezpečnosť Harvoni nebola vyhodnotená u pacientov so závažným poškodením obličiek (odhadovaná rýchlosť glomerulárnej filtrácie [eGFR]
English: • digoxin used to treat heart conditions;
Slovak: používaný na liečbu infekcie HIV, • digoxín používaný na liečbu ochorení srdca,
English: Table 12: Response rates in study ION-2 LDV/SOF
Slovak: Tabuľka 12: Miery odpovede v štúdii ION-2 LDV/SOF
English: Pravastating
Slovak: PODANIA
English: Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)
Slovak: cyklosporín (600 mg jednorazová dávka)/ sofosbuvir (400 mg jednorazová dávka)
English: Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Slovak: Cmax 1,08 (0,97; 1,21) ↔
English: Neither ledipasvir nor sofosbuvir are substrates for hepatic uptake transporters, organic cation transporter (OCT) 1, organic anion-transporting polypeptide (OATP) 1B1 or OATP1B3.
Slovak: 1, polypeptidu transportujúceho organické anióny (OATP) 1B1 ani
English: ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC
Slovak: ION-1 bola randomizovaná, otvorená štúdia, ktorá vyhodnocovala 12 a 24 týždňov liečby ledipasvirom/sofosbuvirom s ribavirínom alebo bez ribavirínu u 865 predtým neliečených pacientov s CHC genotypu 1 vrátane pacientov s cirhózou (randomizovaných v pomere 1:1:1:1).
English: Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Slovak: Pozrite si odporúčania týkajúce sa sledovania činnosti obličiek v súhrne charakteristických vlastností lieku pre tenofovir-dizoproxilfumarát, emtricitabín/tenofovirdizoproxilfumarát alebo elvitegravir/kobicistat/emtricitabín/tenofovir-dizoproxilfumarát.
English: NS5B transient replicons Median (range)
Slovak: Nestále replikóny NS5B
English: If you forget to take Harvoni It is important not to miss a dose of this medicine.
Slovak: Je dôležité nevynechať žiadnu dávku tohto lieku.
English: After a single 90 mg dose of [14C]-ledipasvir in healthy subjects, the blood to plasma ratio of [
Slovak: [14C]-ledipasviru zdravým osobám bol pomer [14C]-rádioaktivity v krvi oproti plazme v rozsahu medzi
English: R-methadone ↔ Cmax 0.99 (0.85, 1.16)
Slovak: Cmax 0,99 (0,85; 1,16)
English: 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Slovak: Po podaní jednorazovej dávky 400 mg sofosbuviru sa 4-hodinovou hemodialýzou odstránilo 18
English: Change in CPT: 59% (79/133) and 34% (45/133) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 39 patients who had CPT C cirrhosis at baseline, 56% (22/39) had CPT B cirrhosis at post-treatment week 12; of the 99 patients who had CPT B cirrhosis at baseline, 29% (27/92) had CPT A cirrhosis at post-treatment week 12.
Slovak: Zmena skóre CPT: 59 % (79/133) a 34 % (45/133) pacientov malo zlepšené alebo nezmenené skóre CPT od východiskových hodnôt 12 týždňov po ukončení liečby, v uvedenom poradí.
English: Among the 8 patients who had no NS5A RAVs at failure, 7 patients received 8 weeks of treatment (n = 3 with ledipasvir/sofosbuvir; n = 4 with ledipasvir/sofosbuvir + ribavirin) and 1 patient received ledipasvir/sofosbuvir for 12 weeks.
Slovak: 3 s ledipasvirom/sofosbuvirom, n = 4 s ledipasvirom/sofosbuvirom a ribavirínom) a 1 pacient dostával ledipasvir/sofosbuvir po dobu 12 týždňov.
English: No dose adjustment of Harvoni or tacrolimus is required.
Slovak: Nie je potrebná žiadna úprava dávky Harvoni ani takrolimusu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/958/001
Slovak: EU/1/14/958/001
English: Change in MELD score: 53% (72/135) and 21% (28/135) had an improvement or no change of MELD score from baseline to post-treatment week 4, respectively; of the 35 patients whose MELD score was ≥ 15 at baseline, 63% (22/35) had a MELD score < 15 at post-treatment week 12.
Slovak: % (28/135) pacientov malo zlepšené alebo nezmenené skóre MELD od východiskových hodnôt do 4 týždňov po ukončení liečby, v uvedenom poradí.
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Slovak: %, 0 % a 2 % v prípade pacientov dostávajúcich kombinovanú liečbu ledipasvirom/sofosbuvirom a ribavirínom po dobu 8, 12 a 24 týždňov, v uvedenom poradí.
English: Gilead Sciences Ltd. Tel: + 353 214 825999
Slovak: Tel: + 353 214 825999
English: Relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
Slovak: 80 ml/min/1,73 m2) bola hodnota AUC0-inf pre sofosbuvir vyššia o 61 %, 107 %
English: Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
Slovak: U pacientov infikovaných HCV boli hodnoty AUC0-24 a Cmax pre ledipasvir v porovnaní so zdravými osobami (n =
English: Interactions between Harvoni and other medicinal products Table 3 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined equivalence boundaries).
Slovak: (pričom 90 % interval spoľahlivosti [IS] pomeru priemerných hodnôt zistených geometrickou metódou najmenších štvorcov [GLSM] bol v rámci „↔“, presahoval „↑“ alebo nedosahoval „↓“
English: Simeprevir ↔ Cmax 0.96 (0.71, 1.30)
Slovak: Cmax 0,96 (0,71; 1,30)
English: Norgestrel ↔ Cmax 1.18 (0.99, 1.41) ↑ AUC 1.19 (0.98, 1.45) ↑ Cmin 1.23 (1.00, 1.51)
Slovak: Cmax 1,18 (0,99; 1,41) ↑
English: If you take Harvoni you may get one or more of the side effects below:
Slovak: Keď užívate Harvoni, môže sa u vás vyskytnúť jeden alebo viacero z vedľajších účinkov uvedených nižšie: Veľmi časté vedľajšie účinky (môžu postihnúť viac než 1 z 10 osôb)
English: The improvement in CPT scores observed was driven largely by improvements in total bilirubin and albumin.
Slovak: (27/92) pacientov 12 týždňov po ukončení liečby cirhózu CPT A. Pozorované zlepšenie skóre CPT bolo dôsledkom do značnej miery zlepšených hodnôt celkového bilirubínu a albumínu.
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)
Slovak: HIV ANTIVIROTIKÁ: INHIBÍTORY REVERZNEJ TRANSKRIPTÁZY efavirenz/ emtricitabín/ tenofovir-dizoproxilfumarát (600 mg/ 200 mg/ 300 mg/ jedenkrát denne)/ ledipasvir (90 mg jedenkrát denne)c/ sofosbuvir (400 mg jedenkrát denne)c, d efavirenz ↔
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)
Slovak: HIV ANTIVIROTIKÁ: INHIBÍTORY HIV PROTEÁZY atazanavir posilnený ritonavirom (300 mg/ 100 mg jedenkrát denne)/ ledipasvir (90 mg jedenkrát denne)c/ sofosbuvir (400 mg jedenkrát denne)c, d atazanavir ↔
English: Ledipasvir ↑ Cmax 1.45 (1.34, 1.56) ↑ AUC 1.39 (1.28, 1.49) ↑ Cmin 1.39 (1.29, 1.51)
Slovak: AUC 1,39 (1,28; 1,49) ↑
English: Simeprevir ↑ Cmax 2.61 (2.39, 2.86)
Slovak: Cmax 2,61 (2,39; 2,86) ↑
English: Harvoni is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
Slovak: fenobarbitalom a fenytoínom, silnými črevnými induktormi P-gp (pozri časť 4.3).
English: ↑ Digoxin ↔ Ledipasvir
Slovak: ↔ dolutegravir ↔ ledipasvir
English: ↑ Rosuvastatin
Slovak: ↑ rosuvastatín
English: 84 (3 bottles of 28) film-coated tablets.
Slovak: LIEKOVÁ FORMA A OBSAH 28 filmom obalených tabliet 84 (3 fľaše po 28) filmom obalených tabliet
English: Lansoprazole e
Slovak: Relapsb Inéc
English: Ritonavir ↔ Cmax 0.86 (0.79, 0.93)
Slovak: Cmax 0,86 (0,79; 0,93) ↔
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Slovak: Inhibítory protónovej pumpy omeprazol (20 mg jedenkrát denne)/ ledipasvir (90 mg jednorazová dávka)
English: HMG-CoA REDUCTASE INHIBITORS Rosuvastating
Slovak: HMG-CoA rosuvastatín g
English: c/ sofosbuvir (400 mg once daily)
Slovak: sofosbuvir (400 mg jednorazová dávka)
English: Prior HCV therapy
Slovak: Predchádzajúca liečba HCV
English: Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in post-liver transplant patients with compensated liver disease (SOLAR-1), none (n = 8) of the patients with baseline NS5A RAVs conferring a ledipasvir fold-change of > 100 relapsed.
Slovak: Po 12-týždňovej liečbe ledipasvirom/sofosbuvirom s ribavirínom nedošlo u pacientov po transplantácii pečene s kompenzovaným ochorením pečene (SOLAR-1) k relapsu ochorenia ani u jedného
English: Genotype 1a a
Slovak: Belosi Genotyp 1a a