FrancophonIA/ELRC3.0 huggingface dataset:
English: ACID REDUCING AGENTS H2-receptor antagonists Famotidine (20 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Croatian: LIJEKOVI ZA SNIŽAVANJE KISELOSTI Antagonisti H2 receptora Famotidin (20 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)/grazoprevir (100 mg u jednokratnoj dozi)
English: ↔ Cobicistat AUC 1.49 (1.42, 1.57) Cmax 1.39 (1.29, 1.50)
Croatian: ↔ kobicistat AUC 1,49 (1,42; 1,57) Cmax 1,39 (1,29; 1,50)
English: Co-administration of ZEPATIER with strong CYP3A inhibitors increases elbasvir and grazoprevir plasma concentrations, and co-administration is not recommended (see Table 2 and section 4.4).
Croatian: Istodobna primjena lijeka ZEPATIER sa snažnim inhibitorima CYP3A povisuje koncentracije elbasvira i grazoprevira u plazmi i stoga se ne preporučuje (vidjeti Tablicu 2 i dio 4.4).
English: The dose of fluvastatin, lovastatin, or simvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Croatian: Pri istodobnoj primjeni s lijekom ZEPATIER, doza fluvastatina, lovastatina ili simvastatina ne smije biti viša od dnevne doze od 20 mg.
English: • EBR/GZR for 12 or 16 weeks (N=105 and respectively)
Croatian: • EBR/GZR tijekom 12 ili 16 tjedana (N=105 odnosno 105)
English: (8-24 mg/2-6 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: (8-24 mg/2-6 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: How to store ZEPATIER
Croatian: Kako čuvati ZEPATIER
English: • EBR* + GZR* + RBV† for 12 weeks (N=14)
Croatian: • EBR*+GZR*+RBV tijekom 12 tjedana (N=14)
English: • EBR/GZR + RBV† for 12 or 16 weeks (N=104 and respectively)
Croatian: • EBR/GZR+RBV tijekom 12 ili 16 tjedana (N=104 odnosno 106)
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on race/ethnicity (see section 4.4).
Croatian: Te promjene nisu klinički značajne; stoga se ne preporučuje prilagođavati dozu elbasvira/grazoprevira na temelju rase/etničkog podrijetla (vidjeti dio 4.4).
English: Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Croatian: Sevelamer karbonat (2400 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)/grazoprevir (100 mg u jednokratnoj dozi)
English: • EBR/GZR for 12 weeks (N=218)
Croatian: • EBR/GZR tijekom 12 tjedana (N=218)
English: GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
Croatian: GT 1, 4, 6 PN, s cirozom ili bez nje Istodobna HCV/HIV-1 infekcija
English: Proton pump inhibitors Pantoprazole (40 mg once daily)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Croatian: Inhibitori protonske pumpe Pantoprazol (40 mg jedanput na dan)/ elbasvir (50 mg u jednokratnoj dozi)/grazoprevir (100 mg u jednokratnoj dozi)
English: ↔ R-Methadone AUC 1.09 (1.02, 1.17) Cmax 1.03 (0.96, 1.11)
Croatian: ↔ R-metadon AUC 1,09 (1,02; 1,17) Cmax 1,03 (0,96; 1,11)
English: Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Croatian: Darunavir/ritonavir (600 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/elbasvir (50 jedanput na dan)
English: Among genotype 1binfected subjects, NS5A resistance-associated substitutions persisted at detectable levels in 100% (7/7) of subjects at follow-up week 12 and in 100% (3/3) of subjects with follow-up week 24 data.
Croatian: Među ispitanicima s infekcijom genotipom 1b, supstitucije povezane s rezistencijom u NS5A bile su i dalje prisutne u mjerljivim količinama u 100% (7/7) ispitanika u 12. tjednu praćenja te u 100% (3/3) ispitanika u 24. tjednu praćenja.
English: Table 3: Adverse reactions identified with ZEPATIER Frequency
Croatian: Tablica 3: Nuspojave zabilježene kod primjene lijeka ZEPATIER* Učestalost
English: Table 9: SVR in genotype 1b †-infected subjects Baseline Characteristics
Croatian: Tablica 9: SVR u ispitanika s infekcijom genotipom 1b Početne značajke
English: • EBR/GZR* for 12 weeks (N=316)
Croatian: • EBR/GZR* tijekom 12 tjedana (N=316)
English: • EBR/GZR for 12 weeks (N=201)
Croatian: • EBR/GZR tijekom 12 tjedana (N=201)
English: Among genotype 1a-infected subjects, the median age was 54 years (range: 19 to 76); 71 % were male; 71 % were White; 22 % were Black or African American; 9% were Hispanic or Latino; 74% were treatment-naïve subjects; 26% were treatment-experienced subjects; mean body mass index was 27 kg/m2; 75 % had baseline HCV RNA levels greater than 800,000 IU/mL; 23 % had cirrhosis; 72% had non-C/C IL28B alleles (CT or TT); 30 % had HCV/HIV-1 co-infection.
Croatian: Među ispitanicima s infekcijom genotipom 1a, medijan dobi iznosio je 54 godine (raspon: 19 do 76); 71% ispitanika bili su muškarci; 71% bili su bijelci; 22% bili su crnci ili Afroamerikanci; 9% bili su hispanoameričkog ili latinoameričkog podrijetla; 74% ispitanika prethodno nije bilo liječeno, dok je njih 26% prethodno primalo liječenje; srednja vrijednost indeksa tjelesne mase iznosila je 27 kg/m 75% ispitanika je na početku ispitivanja imalo vrijednost HCV RNK iznad 800 000 IU/ml; 23% imalo je cirozu; 72% imalo je alele IL28B koji nisu bili genotipa C/C (CT ili TT), a njih 30% imalo je istodobnu HCV/HIV-1 infekciju.
English: Among genotype 1b/1 other-infected subjects, the median age was 55 years (range: 22 to 82); 61% were male; 60 % were White; 20% were Black or African American; 6% were Hispanic or Latino; 82% were treatment-naïve subjects; 18% were treatment-experienced subjects; mean body mass index was 26 kg/m2; 64 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 71% had non-C/C IL28B alleles (CT or TT); 18 % had HCV/HIV-1 co-infection.
Croatian: Među ispitanicima s infekcijom genotipom 1b/1 drugo, medijan dobi iznosio je 55 godina (raspon: 22 do 82); 61% ispitanika bili su muškarci; 60% bili su bijelci; 20% bili su crnci ili Afroamerikanci; 6% bili su hispanoameričkog ili latinoameričkog podrijetla; 82% ispitanika prethodno nije bilo liječeno, dok je njih 18% prethodno primalo liječenje; srednja vrijednost indeksa tjelesne mase iznosila je 26 kg/m2; 64% ispitanika je na početku ispitivanja imalo vrijednost HCV RNK iznad 800 000 IU/ml; 22% imalo je cirozu; 71% imalo je alele IL28B koji nisu bili genotipa C/C (CT ili TT), a njih 18% imalo je istodobnu HCV/HIV-1 infekciju.
English: Diabetics may experience improved glucose control potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral (DAA) treatment.
Croatian: Nakon uvođenja liječenja HCV infekcije direktno djelujućim antivirotikom (DAA), bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on sex (see section 4.4).
Croatian: Te promjene nisu klinički značajne; stoga se ne preporučuje prilagođavati dozu elbasvira/grazoprevira na temelju spola (vidjeti dio 4.4).
English: Tenofovir disoproxil fumarate (300 mg once daily)/ elbasvir (50 mg once daily)
Croatian: Tenofovirdizoproksilfumarat (300 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)
English: †Reference sequences for NS5A at amino acid 31 are L (genotype 1a and genotype 1b) and M (genotype 4a and 4d).
Croatian: Referentne sekvence za NS5A na aminokiselini 31 su L (genotip 1a i genotip 1b) i M (genotip 4a i 4d).
English: GT 1, 4, 6 TE with or without cirrhosis, and with or without HCV/HIV-1 co-infection
Croatian: GT 1, 4, 6 PL, s cirozom ili bez nje te s istodobnom HCV/HIV-1 infekcijom ili bez nje
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 50 % and 30 % higher, respectively, in females compared to males.
Croatian: Prema populacijskim farmakokinetičkim analizama, procjenjuje se da je AUC elbasvira 50% veći, a AUC grazoprevira 30% veći u žena nego u muškaraca.
English: Among genotype 1a-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 31% (4/13) of subjects.
Croatian: Među ispitanicima s infekcijom genotipom 1a, supstitucije povezane s rezistencijom u NS3 bile su i dalje prisutne u mjerljivim količinama u 31% (4/13) ispitanika u 24. tjednu praćenja.
English: • EBR* + GZR* for 12 weeks (N=122)
Croatian: • EBR*+GZR* tijekom 12 tjedana (N=122)
English: In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Croatian: Kod replikona genotipa 4, pojedinačne supstitucije D168A/V u proteinu NS3 smanjile su antivirusnu aktivnost grazoprevira od 110 do 320 puta.
English: Table 11: SVR in genotype 4-infected subjects Baseline Characteristics
Croatian: Tablica 11: SVR u ispitanika s infekcijom genotipom 4 Početne značajke
English: Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Croatian: Lopinavir/ritonavir (400 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/elbasvir (50 mg jedanput na dan)
English: Among genotype 1b-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 50% (1/2) of subjects.
Croatian: Među ispitanicima s infekcijom genotipom 1b, supstitucije povezane s rezistencijom u NS3 bile su i dalje prisutne u mjerljivim količinama u 50% (1/2) ispitanika u 24. tjednu praćenja.
English: In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
Croatian: Kod replikona genotipa 1b, pojedinačne supstitucije L31F i Y93H u proteinu NS5A smanjile su antivirusnu aktivnost elbasvira 17 puta.
English: Among genotype 4-infected subjects, the median age was 51 years (range: 28 to 75); 66 % were male; 88 % were White; 8 % were Black or African American; 11% were Hispanic or Latino; 77% were treatment-naïve subjects; 23% were treatment-experienced subjects; mean body mass index was 25 kg/m2; 56 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 73% had non-C/C IL28B alleles (CT or TT); 40 % had HCV/HIV-1 co-infection.
Croatian: Među ispitanicima s infekcijom genotipom 4, medijan dobi iznosio je 51 godinu (raspon: 28 do 75); 66% ispitanika bili su muškarci; 88% bili su bijelci; 8% bili su crnci ili Afroamerikanci; 11% bili su hispanoameričkog ili latinoameričkog podrijetla; 77% ispitanika prethodno nije bilo liječeno, dok je njih 23% prethodno liječeno; srednja vrijednost indeksa tjelesne mase iznosila je 25 kg/m ispitanika je na početku ispitivanja imalo vrijednost HCV RNK iznad 800 000 IU/ml; 22% imalo je cirozu; 73% imalo je alele IL28B koji nisu bili genotipa C/C (CT ili TT), a njih 40% imalo je istodobnu HCV/HIV-1 infekciju.
English: ↔ Elbasvir AUC 1.66 (1.35, 2.05) Cmax 1.67 (1.36, 2.05) C24 1.82 (1.39, 2.39)
Croatian: AUC 1,66 (1,35; 2,05) Cmax 1,67 (1,36; 2,05) C24 1,82 (1,39; 2,39)
English: Table 10: SVR in genotype 1a-infected subjects Baseline Characteristics
Croatian: Tablica 10: SVR u ispitanika s infekcijom genotipom 1a Početne značajke
English: Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
Croatian: Raltegravir (400 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)
English: ↔ Buprenorphine AUC 0.98 (0.81, 1.19) Cmax 0.90 (0.76, 1.07)
Croatian: ↔ buprenorfin AUC 0,98 (0,81; 1,19) Cmax 0,90 (0,76; 1,07)
English: GT 1 TE with HCV protease inhibitor regimen
Croatian: GT 1 PL režimom koji je uključivao inhibitor HCV proteaze s cirozom ili bez nje
English: (20-150 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: (20-150 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: For elbasvir, in HCV genotype 1a replicons, single NS5A substitutions Q30D/E/H/R, L31M/V and Y93C/H/N reduced elbasvir antiviral activity by 6- to 2,000-fold.
Croatian: Kada je riječ o elbasviru, kod replikona HCV-a genotipa 1a, pojedinačne supstitucije Q30D/E/H/R, L31M/V i Y93C/H/N u proteinu NS5A smanjile su antivirusnu aktivnost elbasvira od 6 do 2000 puta.
English: Placebo-controlled study in which subjects were randomised in a 2:1 ratio to EBR/GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Croatian: Placebom kontrolirano ispitivanje u kojem su ispitanici bili randomizirani u omjeru 2:1 za EBR/GZR tijekom 12 tjedana (skupina liječena odmah) ili placebo tijekom 12 tjedana, nakon čega je uslijedilo otvoreno 12-tjedno liječenje kombinacijom EBR/GZR (skupina s odgođenim liječenjem).
English: (300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
Croatian: (300 mg jedanput na dan)/ritonavir (100 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)
English: (intestinal BCRP inhibition)
Croatian: (inhibicija BCRP-a u crijevima)
English: ↔ Elbasvir AUC 1.98 (1.84, 2.13) Cmax 1.95 (1.84, 2.07) C24 2.21 (1.98, 2.47)
Croatian: AUC 1,98 (1,84; 2,13) Cmax 1,95 (1,84; 2,07) C24 2,21 (1,98; 2,47)
English: For grazoprevir, in HCV genotype 1a replicons, single NS3 substitutions D168A/E/G/S/V reduced grazoprevir antiviral activity by 2- to 81-fold.
Croatian: Kada je riječ o grazopreviru, kod replikona HCV-a genotipa 1a, pojedinačne supstitucije D168A/E/G/S/V u proteinu NS3 smanjile su antivirusnu aktivnost grazoprevira od 2 do 81 puta.
English: (600 mg PO single dose)/ elbasvir (50 mg single dose)
Croatian: (600 mg u jednokratnoj peroralnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)
English: Expected: ↑ Dabigatran
Croatian: Očekivano: ↑ dabigatran
English: Buprenorphine/naloxone (8 mg/2 mg single dose)/ elbasvir (50 mg single dose)
Croatian: OPIOIDNA NADOMJESNA TERAPIJA Buprenorfin/nalokson (8 mg/2 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)
English: ↔ Mycophenolic acid AUC 0.95 (0.87, 1.03) Cmax 0.85 (0.67, 1.07)
Croatian: ↔ mikofenolatna kiselina AUC 0,95 (0,87; 1,03) Cmax 0,85 (0,67; 1,07)
English: The dose of rosuvastatin should not exceed a daily dose of 10 mg when co-administered with ZEPATIER.
Croatian: Pri istodobnoj primjeni s lijekom ZEPATIER, doza rosuvastatina ne smije biti viša od dnevne doze od 10 mg.
English: ↔ Prednisolone AUC 1.08 (1.01, 1.16) Cmax 1.04 (0.99, 1.09)
Croatian: ↔ prednizolon AUC 1,08 (1,01; 1,16) Cmax 1,04 (0,99; 1,09)
English: ↔ R-Methadone AUC 1.03 (0.92, 1.15) Cmax 1.07 (0.95, 1.20) C24 1.10 (0.96, 1.26)
Croatian: ↔ R-metadon AUC 1,03 (0,92; 1,15) Cmax 1,07 (0,95; 1,20) C24 1,10 (0,96; 1,26)
English: ↔ S-Methadone AUC 1.09 (0.94, 1.26) Cmax 1.09 (0.95, 1.25) C24 1.20 (0.98, 1.47)
Croatian: ↔ S-metadon AUC 1,09 (0,94; 1,26) Cmax 1,09 (0,95; 1,25) C24 1,20 (0,98; 1,47)
English: (OATP1B inhibition)
Croatian: (inhibicija OATP1B)
English: GT 1, 3 TN with or without cirrhosis TE Null Responder with or without cirrhosis TN HCV/HIV1 co-infection without cirrhosis
Croatian: GT 1, 3 PN, s cirozom ili bez nje PL bez odgovora na prethodno liječenje, s cirozom ili bez nje PN s istodobnom HCV/HIV-1 infekcijom, bez ciroze
English: Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Croatian: ANTIARITMICI Digoksin (0,25 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)
English: ↔ Buprenorphine AUC 0.98 (0.89, 1.08) Cmax 0.94 (0.82, 1.08) C24 0.98 (0.88, 1.09)
Croatian: ↔ buprenorfin AUC 0,98 (0,89; 1,08) Cmax 0,94 (0,82; 1,08) C24 0,98 (0,88; 1,09)
English: ↔ Prednisone AUC 1.08 (1.00, 1.17) Cmax 1.05 (1.00, 1.10)
Croatian: ↔ prednizon AUC 1,08 (1,00; 1,17) Cmax 1,05 (1,00; 1,10)
English: In genotype 4 replicons, single NS5A substitutions L30S, M31V, and Y93H reduced elbasvir antiviral activity by 3to 23-fold.
Croatian: Kod replikona genotipa 4, pojedinačne supstitucije L30S, M31V i Y93H u proteinu NS5A smanjile su antivirusnu aktivnost elbasvira od 3 do 23 puta.
English: ↔ Emtricitabine AUC 1.07 (1.03, 1.10) Cmax 0.96 (0.90, 1.02) C24 1.19 (1.13, 1.25)
Croatian: ↔ emtricitabin AUC 1,07 (1,03; 1,10) Cmax 0,96 (0,90; 1,02) C24 1,19 (1,13; 1,25)
English: Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (0.03 mg EE/
Croatian: Etinilestradiol (EE) /levonorgestrel (LNG) (0,03 mg EE/0,15 mg LNG u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)
English: ↔ Rilpivirine AUC 1.13 (1.07, 1.20) Cmax 1.07 (0.97, 1.17) C24 1.16 (1.09, 1.23)
Croatian: ↔ rilpivirin AUC 1,13 (1,07; 1,20) Cmax 1,07 (0,97; 1,17) C24 1,16 (1,09; 1,23)
English: ↔ Elbasvir AUC 1.80 (1.41, 2.29) Cmax 1.29 (1.00, 1.66) C24 1.89 (1.37, 2.60)
Croatian: AUC 1,80 (1,41; 2,29) Cmax 1,29 (1,00; 1,66) C24 1,89 (1,37; 2,60)
English: Grazoprevir is not a P-gp inhibitor based on in vitro data.
Croatian: Prema podacima in vitro, grazoprevir nije inhibitor P-gp-a.
English: (CYP3A and OATP1B inhibition)
Croatian: (inhibicija CYP3A i OATP1B)
English: Both relapsers had baseline HCV RNA >800,000 IU/mL Both subjects who failed to achieve SVR for reasons other than virologic failure had baseline HCV RNA <=800,000 IU/mL.
Croatian: Oba ispitanika koja nisu uspjela postići SVR zbog nekog drugog razloga osim izostanka uspješnog virološkog odgovora imala su početnu vrijednost HCV RNK ≤ 800 000 IU/ml.
English: Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: Rilpivirin (25 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: Close monitoring of INR is recommended with all vitamin K antagonists.
Croatian: Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja lijekom ZEPATIER.
English: Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Croatian: Pitavastatin (1 mg u jednokratnoj dozi)/grazoprevir (200 mg jedanput na dan)
English: Overall SVR Outcome for subjects without SVR On-treatment virologic failure Relapse Other SVR by cirrhosis status Non-cirrhotic Cirrhotic SVR by baseline HCV RNA <=800,000 IU/mL >800,000 IU/mL
Croatian: SVR prema početnoj vrijednosti HCV RNK ≤ 800 000 IU/ml > 800 000 IU/ml
English: (400 mg PO once daily)/ grazoprevir (100 mg single dose)
Croatian: (400 mg peroralno jedanput na dan)/grazoprevir (100 mg u jednokratnoj dozi)
English: EBR with GZR + RBV
Croatian: SVR EBR s GZR-om EBR s GZR-om + RBV 12 tjedana
English: Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Croatian: Rosuvastatin (10 mg u jednokratnoj dozi)/grazoprevir (200 mg jedanput na dan)
English: ↔ Elbasvir AUC 1.22 (1.06, 1.40) Cmax 1.41 (1.18, 1.68) C24 1.31 (1.12, 1.53)
Croatian: AUC 1,22 (1,06; 1,40) Cmax 1,41 (1,18; 1,68) C24 1,31 (1,12; 1,53)
English: ↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
Croatian: ↔ nalokson AUC 0,88 (0,76; 1,02) Cmax 0,85 (0,66; 1,09)
English: Among genotype 1a-infected subjects, NS5A resistance-associated substitutions persisted at detectable levels at follow-up week 12 in 95% (35/37) of subjects and in 100% (9/9) of subjects with follow-up week 24 data.
Croatian: Virusne populacije sa supstitucijama povezanima s rezistencijom u NS5A koje su nastale tijekom liječenja u pravilu su bile postojanije nego supstitucije povezane s rezistencijom u NS3. Među ispitanicima s infekcijom genotipom 1a, supstitucije povezane s rezistencijom u NS5A bile su i dalje prisutne u mjerljivim količinama u 95% (35/37) ispitanika u 12. tjednu praćenja te u 100% (9/9) ispitanika u 24. tjednu praćenja.
English: ↔ Ciclosporin AUC 0.96 (0.90, 1.02) Cmax 0.90 (0.85, 0.97) C12 1.00 (0.92, 1.08)
Croatian: ↔ ciklosporin AUC 0,96 (0,90; 1,02) Cmax 0,90 (0,85; 0,97) C12 1,00 (0,92; 1,08)
English: Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Croatian: Midazolam (2 mg u jednokratnoj dozi)/grazoprevir (200 mg jedanput na dan)
English: ↔ Elbasvir AUC 1.17 (1.11, 1.24) Cmax 1.25 (1.16, 1.35) C24 1.04 (0.97, 1.12)
Croatian: AUC 1,17 (1,11; 1,24) Cmax 1,25 (1,16; 1,35) C24 1,04 (0,97; 1,12)
English: Talk to your doctor before taking ZEPATIER if you are breast-feeding.
Croatian: Ako dojite, obratite se svom liječniku prije nego uzmete ZEPATIER.
English: ↔ Elbasvir AUC 1.22 (0.98, 1.52) Cmax 1.13 (0.87, 1.46) C24 1.22 (0.99, 1.51)
Croatian: AUC 1,22 (0,98; 1,52) Cmax 1,13 (0,87; 1,46) C24 1,22 (0,99; 1,51)
English: (600 mg IV single dose)/ grazoprevir (200 mg single dose)
Croatian: (600 mg u jednokratnoj i.v. dozi)/grazoprevir (200 mg u jednokratnoj dozi)
English: ↔ Elbasvir AUC 1.09 (0.98, 1.21) Cmax 1.11 (0.99, 1.26) C24 0.96 (0.86, 1.08)
Croatian: AUC 1,09 (0,98; 1,21) Cmax 1,11 (0,99; 1,26) C24 0,96 (0,86; 1,08)
English: Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
Croatian: ANTIASTMATICI Montelukast (10 mg u jednokratnoj dozi)/grazoprevir (200 mg u jednokratnoj dozi)
English: Rifampicin (600 mg IV single dose)/ elbasvir (50 mg single dose)
Croatian: LIJEKOVI Rifampicin (600 mg u jednokratnoj i.v. dozi)/elbasvir (50 mg u jednokratnoj dozi)
English: (combination of OATP1B and CYP3A inhibition)
Croatian: (kombinacija inhibicije OATP1B i CYP3A)
English: ↔ Elbasvir AUC 1.05 (0.92, 1.18) Cmax 1.11 (0.98, 1.26) C24 1.03 (0.91, 1.17)
Croatian: AUC 1,05 (0,92; 1,18) Cmax 1,11 (0,98; 1,26) C24 1,03 (0,91; 1,17)
English: (300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Croatian: (300 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)/grazoprevir (100 mg jedanput na dan)
English: Subjects without baseline NS5A polymorphisms, % (n/N)
Croatian: Ispitanici bez polimorfizama NS5A na početku ispitivanja, % (n/N)
English: Subjects without baseline NS3 polymorphisms, % (n/N)
Croatian: Ispitanici bez polimorfizama NS3 na početku ispitivanja, % (n/N)
English: (OATP1B inhibition and CYP3A induction)
Croatian: (inhibicija OATP1B i indukcija CYP3A)
English: ↔ Elbasvir AUC 1.13 (0.94, 1.37) Cmax 1.07 (0.88, 1.29) C24 1.22 (1.02, 1.45)
Croatian: AUC 1,13 (0,94; 1,37) Cmax 1,07 (0,88; 1,29) C24 1,22 (1,02; 1,45)
English: ↔ Elbasvir AUC 0.93 (0.82, 1.05) Cmax 0.88 (0.77, 1.00) C24 0.92 (0.18, 1.05)
Croatian: AUC 0,93 (0,82; 1,05) Cmax 0,88 (0,77; 1,00) C24 0,92 (0,18; 1,05)
English: ↔ Elbasvir AUC 1.05 (0.93, 1.18) Cmax 1.02 (0.92, 1.14) C24 1.03 (0.92, 1.17)
Croatian: AUC 1,05 (0,93; 1,18) Cmax 1,02 (0,92; 1,14) C24 1,03 (0,92; 1,17)
English: (10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
Croatian: (10 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Croatian: Pri istodobnoj primjeni s lijekom ZEPATIER, doza atorvastatina ne smije biti viša od dnevne doze od 20 mg.
English: Subjects were not excluded or discontinued from the trial based on a positive urine drug screen.
Croatian: Pozitivan nalaz pretrage mokraće na drogu nije bio razlog za neuključivanje ispitanika u ispitivanje ili isključivanje iz njega.
English: ↔ Elbasvir AUC 0.97 (0.90, 1.06) Cmax 0.99 (0.88, 1.10) C24 0.92 (0.83, 1.02)
Croatian: AUC 0,97 (0,90; 1,06) Cmax 0,99 (0,88; 1,10) C24 0,92 (0,83; 1,02)
English: Subjects with baseline NS5A polymorphisms, % (n/N)
Croatian: Ispitanici s polimorfizmima NS5A na početku ispitivanja, % (n/N)
English: (600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Croatian: (600 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)
English: ↔ Elbasvir AUC 1.17 (0.98, 1.39) Cmax 1.29 (1.06, 1.58) C24 1.21 (1.03, 1.43)
Croatian: AUC 1,17 (0,98; 1,39) Cmax 1,29 (1,06; 1,58) C24 1,21 (1,03; 1,43)
English: (300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Croatian: (300 mg jedanput na dan)/ritonavir (100 mg jedanput na dan)/grazoprevir (200mg jedanput na dan)
English: ↔ Elbasvir AUC 1.07 (1.00, 1.15) Cmax 1.07 (0.99, 1.16) C24 1.04 (0.98, 1.11)
Croatian: AUC 1,07 (1,00; 1,15) Cmax 1,07 (0,99; 1,16) C24 1,04 (0,98; 1,11)
English: ↔ Elbasvir AUC 0.92 (0.75, 1.14) Cmax 0.86 (0.71, 1.04) C24 0.87 (0.70, 1.09)
Croatian: AUC 0,92 (0,75; 1,14) Cmax 0,86 (0,71; 1,04) C24 0,87 (0,70; 1,09)
English: (300 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: (300 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: (400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Croatian: (400 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)
English: (400 mg twice daily)/ grazoprevir (200 mg once daily)
Croatian: (400 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)