FrancophonIA/ELRC3.0 huggingface dataset:
English: Subjects were randomised in a 1:1 ratio to the study arms.
Slovenian: Preiskovanci so bili v skupine randomizirani v razmerju 1:1.
English: GT 1, 4, 6 TE with or without cirrhosis, and with or without HCV/HIV-1 co-infection
Slovenian: GT 1, 4, 6 TE s cirozo ali brez nje in s sočasno okužbo s HCV/HIV-1 ali brez nje
English: Efavirenz (600 mg once daily)/ elbasvir (50 mg once daily)
Slovenian: Efavirenz (600 mg enkrat na dan)/elbasvir (50 mg enkrat na dan)
English: Grazoprevir is active in vitro against the following genotype 1b NS3 substitutions conferring resistance to other NS3/4A protease inhibitors: V36A/I/L/M, Q41L/R, F43S, T54A/C/G/S, V55A/I, Y56F, Q80L/R, V107I, S122A/G/R, R155E/K/N/Q/S, A156G/S, D168E/N/S, V170A/I/T.
Slovenian: Grazoprevir je in vitro aktiven proti naslednjim substitucijam NS3 genotipa 1b, ki povzročijo odpornost na druge zaviralce proteaz NS3/4A: V36A/I/L/M, Q41L/R, F43S, T54A/C/G/S, V55A/I, Y56F, Q80L/R, V107I, S122A/G/R, R155E/K/N/Q/S, A156G/S, D168E/N/S, V170A/I/T.
English: The dose of rosuvastatin should not exceed a daily dose of 10 mg when co-administered with ZEPATIER.
Slovenian: Odmerek rosuvastatina med sočasno uporabo z zdravilom ZEPATIER ne sme preseči dnevnega odmerka 10 mg.
English: ↔ Cobicistat AUC 1.49 (1.42, 1.57) Cmax 1.39 (1.29, 1.50)
Slovenian: ↔ kobicistat AUC 1,49 (1,42; 1,57) Cmax 1,39 (1,29; 1,50)
English: Multiple-dose administration of elbasvir or grazoprevir is unlikely to induce the metabolism of medicinal products metabolised by CYP isoforms based on in vitro data.
Slovenian: Glede na podatke in vitro ni verjetno, da bi večkratni odmerki elbasvirja ali grazoprevirja inducirali presnovo zdravil, katerih presnova poteka z izooblikami CYP.
English: Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Slovenian: Digoksin (0,25 mg enkratni odmerek)/elbasvir (50 mg enkrat na dan)
English: ‡ with or without cirrhosis
Slovenian: ‡ s cirozo ali brez nje
English: ASTHMA AGENTS
Slovenian: ZDRAVILA PROTI ASTMI
English: In general, in HCV genotype 1a, 1b or 4 combinations of elbasvir resistance-associated substitutions further reduced elbasvir antiviral activity.
Slovenian: Na splošno so kombinacije substitucij, povezanih z odpornostjo na elbasvir, pri genotipih 1a, 1b ali 4 dodatno zmanjšale protivirusno aktivnost elbasvirja.
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.
Slovenian: Med preiskovanci, okuženimi z genotipom 1b/drugimi genotipi 1, je bila mediana starost 55 let (v razponu od 22 do 82), 61 % je bilo moških, 60 % je bilo belcev, 20 % je bilo črncev ali Afroameričanov, 6 % je bilo Latinoameričanov, 82 % je bilo predhodno nezdravljenih, 18 % je bilo predhodno že zdravljenih, povprečni indeks telesne mase je bil 26 kg/m2, 64 % je imelo izhodiščno koncentracijo HCV RNA večjo kot 800.000 i.e./ml, 22 % je imelo cirozo, 71 % je imelo varianto IL28B ne-CC (CT ali TT), 18 % je imelo sočasno okužbo s HCV/HIV-1.
English: †Reference sequences for NS5A at amino acid 31 are L (genotype 1a and genotype 1b) and M (genotype 4a and 4d).
Slovenian: †Referenčni zaporedji za NS5A na aminokislini 31 sta L (genotip 1a in genotip 1b) in M (genotipa 4a in 4d).
English: Elbasvir was given to rats and rabbits without eliciting adverse effects on embryofetal or post natal development at up to the highest doses tested (approximately 9- and 17-fold above human exposure in rats and rabbits, respectively).
Slovenian: Elbasvir pri podganah in kuncih vse do največjih testiranih odmerkov (približno 9-kratnik (pri podganah) in 17-kratnik (pri kuncih) izpostavljenosti pri človeku) ni imel neželenih učinkov na embrio-fetalni in postnatalni razvoj.
English: No circulating metabolites of either elbasvir or grazoprevir were detected in human plasma.
Slovenian: V humani plazmi niso odkrili presnovkov elbasvirja ali grazoprevirja.
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on age (see sections 4.2 and 4.4).
Slovenian: Te spremembe niso klinično pomembne, zato prilagoditev odmerka elbasvirja/grazoprevirja glede na starost ni potrebna (glejte poglavji 4.2 in 4.4).
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin had serious adverse reactions (abdominal pain, transient ischaemic attack and anaemia).
Slovenian: Resne neželene učinke (bolečino v trebuhu, tranzitorno ishemično atako in anemijo) je imelo manj kot 1 % preiskovancev, zdravljenih z zdravilom ZEPATIER z ribavirinom ali brez njega.
English: • You must not become pregnant if you are taking ZEPATIER with ribavirin.
Slovenian: • Medtem ko jemljete zdravilo ZEPATIER z ribavirinom, ne smete zanositi.
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.
Slovenian: Med preiskovanci, okuženimi z genotipom 1b, so bile z odpornostjo povezane substitucije NS5A prisotne v zaznavnih vrednostih pri 100 % (7/7) preiskovancev v 12. tednu spremljanja in pri 100 % (3/3) v 24. tednu spremljanja.
English: (OATP1B inhibition)
Slovenian: (zaviranje OATP1B)
English: Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Slovenian: Darunavir/ritonavir (600 mg dvakrat na dan)/ritonavir (100 mg dvakrat na dan)/elbasvir (50 mg enkrat na dan)
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.
Slovenian: Med preiskovanci, okuženimi z genotipom 1a, je bila mediana starost 54 let (v razponu od 19 do 76), 71 % je bilo moških, 71 % je bilo belcev, 22 % je bilo črncev ali Afroameričanov, 9 % je bilo Latinoameričanov, 74 % je bilo predhodno nezdravljenih, 26 % je bilo predhodno že zdravljenih, povprečni indeks telesne mase je bil 27 kg/m2, 75 % je imelo izhodiščno koncentracijo HCV RNA večjo kot 800.000 i.e./ml, 23 % je imelo cirozo, 72 % je imelo varianto IL28B ne-CC (CT ali TT), 30 % je imelo sočasno okužbo s HCV/HIV-1.
English: Grazoprevir was given to rats and rabbits without eliciting adverse effects on embryofetal or post natal development at up to highest doses tested (approximately 79- and 39-fold above human exposure in rats and rabbits, respectively).
Slovenian: Grazoprevir pri podganah in kuncih vse do največjih testiranih odmerkov (približno 79-kratnik (pri podganah) in 39-kratnik (pri kuncih) izpostavljenosti pri človeku) ni imel neželenih učinkov na embrio-fetalni in postnatalni razvoj.
English: • EBR/GZR for 12 weeks (N=218)
Slovenian: • EBR/GZR 12 tednov (n = 218)
English: ↔ R-Methadone AUC 1.09 (1.02, 1.17) Cmax 1.03 (0.96, 1.11)
Slovenian: ↔ R-metadon AUC 1,09 (1,02; 1,17) Cmax 1,03 (0,96; 1,11)
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.
Slovenian: Med preiskovanci, okuženimi z genotipom 4, je bila mediana starost 51 let (v razponu od 28 do 75), 66 % je bilo moških, 88 % je bilo belcev, 8 % je bilo črncev ali Afroameričanov, 11 % je bilo Latinoameričanov, 77 % je bilo predhodno nezdravljenih, 23 % je bilo predhodno že zdravljenih, povprečni indeks telesne mase je bil 25 kg/m2, 56 % je imelo izhodiščno koncentracijo HCV RNA večjo kot 800.000 i.e./ml, 22 % je imelo cirozo, 73 % je imelo varianto IL28B ne-CC (CT ali TT), 40 % je imelo sočasno okužbo s HCV/HIV-1.
English: Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
Slovenian: Raltegravir (400 mg enkratni odmerek)/elbasvir (50 mg enkratni odmerek)
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.
Slovenian: Za grazoprevir je v replikonih genotipa HCV 1a posamezna substitucija NS3 D168A/E/G/S/V zmanjšala protivirusno aktivnost grazoprevirja za 2- do 81-krat.
English: Less than 1% of subjects treated with ZEPATIER with or without ribavirin experienced ALT elevations >2.5 - 5 times the ULN during treatment; there were no treatment discontinuations due to these ALT elevations.
Slovenian: Trajanje zdravljenja ni vplivalo na pojavnost zakasnelih zvišanj ALT. Ciroza ni bila dejavnik tveganja za zakasnelo zvišanje ALT. Zvišanja ALT na > 2,5 - 5-krat nad ZNM med zdravljenjem so zabeležili pri manj kot 1 % preiskovancev, zdravljenih z zdravilom ZEPATIER z ribavirinom ali brez njega.
English: Grazoprevir is not a P-gp inhibitor based on in vitro data.
Slovenian: Glede na podatke in vitro grazoprevir ni zaviralec P-gp.
English: Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Slovenian: Kalcijev acetat (2.668 mg enkratni odmerek)/elbasvir (50 mg enkratni odmerek)/grazoprevir (100 mg enkratni odmerek)
English: • EBR/GZR for 12 weeks (N=201)
Slovenian: • EBR/GZR 12 tednov (n = 201)
English: N=519
Slovenian: 16 tednov n = 519
English: Buprenorphine/naloxone (8 mg/2 mg single dose)/ elbasvir (50 mg single dose)
Slovenian: Buprenorfin/nalokson (8 mg/2 mg enkratni odmerek)/elbasvir (50 mg enkratni odmerek)
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
Slovenian: Celokupni SVR Izid pri preiskovancih brez SVR Virološki neuspeh med zdravljenjem Recidiv Drugo SVR glede na prisotnost ciroze Brez ciroze S cirozo SVR glede na izhodiščno koncentracijo HCV RNA < = 800.000 i.e./ml > 800.000 i.e./ml
English: • EBR/GZR* for 12 weeks (N=316)
Slovenian: • EBR/GZR* 12 tednov (n = 316)
English: If you are unsure of any information in the package leaflet, please contact your doctor or pharmacist.
Slovenian: Če ste glede katere koli informacije v navodilu za uporabo negotovi, se posvetujte z zdravnikom ali farmacevtom.
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).
Slovenian: Sočasna uporaba zdravila ZEPATIER z močnimi zaviralci CYP3A zviša koncentracijo elbasvirja in grazoprevirja v plazmi in zato sočasna uporaba ni priporočljiva (glejte preglednico 2 in poglavje 4.4).
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.
Slovenian: Med preiskovanci, okuženimi z genotipom 1a, so bile z odpornostjo povezane substitucije NS3 prisotne v zaznavnih vrednostih pri 31 % (4/13) preiskovancev v 24. tednu spremljanja.
English: Tenofovir disoproxil fumarate (300 mg once daily)/ elbasvir (50 mg once daily)
Slovenian: Dizoproksiltenofovirijev fumarat (300 mg enkrat na dan)/elbasvir (50 mg enkrat na dan)
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 50 % and 30 % higher, respectively, in females compared to males.
Slovenian: V populacijskih farmakokinetičnih analizah so ocenili, da je pri ženskah AUC elbasvirja za 50 % večja in AUC grazoprevirja za 30 % večja kot pri moških.
English: (20-150 mg once daily)/ grazoprevir (200 mg once daily)
Slovenian: (20-150 mg enkrat na dan)/grazoprevir (200 mg enkrat na dan)
English: The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Slovenian: Odmerek atorvastatina med sočasno uporabo z zdravilom ZEPATIER ne sme preseči dnevnega odmerka 20 mg.
English: GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
Slovenian: GT 1, 4, 6 TN s cirozo ali brez nje, sočasna okužba s HCV/HIV-1
English: In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
Slovenian: V replikonih genotipa HCV 1b sta posamezni substituciji NS5A L31F in Y93H zmanjšali protivirusno aktivnost elbasvirja za 17-krat.
English: In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Slovenian: V replikonih genotipa HCV 4 je posamezna substitucija NS3 D168A/V zmanjšala protivirusno aktivnost grazoprevirja za 110- do 320-krat.
English: No clinically relevant change in exposure is represented by a horizontal arrow “↔”.
Slovenian: Vodoravna puščica "↔" predstavlja, da ne gre za klinično pomembno spremembo izpostavljenosti.
English: ↔ Elbasvir AUC 1.66 (1.35, 2.05) Cmax 1.67 (1.36, 2.05) C24 1.82 (1.39, 2.39)
Slovenian: AUC 1,66 (1,35; 2,05) Cmax 1,67 (1,36; 2,05) C24 1,82 (1,39; 2,39)
English: Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (0.03 mg EE/
Slovenian: Etinilestradiol (EE)/levonorgestrel (LNG) (0,03 mg EE/0,15 mg LNG enkratni odmerek)/elbasvir (50 mg enkrat na dan)
English: Table 10: SVR in genotype 1a-infected subjects Baseline Characteristics
Slovenian: Preglednica 10: SVR pri preiskovancih ¶, okuženih z genotipom 1a
English: Table 11: SVR in genotype 4-infected subjects Baseline Characteristics
Slovenian: Preglednica 11: SVR pri preiskovancih ¶, okuženih z genotipom 4
English: ↔ Buprenorphine AUC 0.98 (0.81, 1.19) Cmax 0.90 (0.76, 1.07)
Slovenian: ↔ buprenorfin AUC 0,98 (0,81; 1,19) Cmax 0,90 (0,76; 1,07)
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.
Slovenian: Oba preiskovanca, ki nista dosegla SVR zaradi katerega koli drugega vzroka kot virološkega neuspeha, sta imela izhodiščno koncentracijo HCV RNA < = 800.000 i.e./ml.
English: Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Slovenian: Lopinavir/ritonavir (400 mg dvakrat na dan)/ritonavir (100 mg dvakrat na dan)/elbasvir (50 mg enkrat na dan)
English: The incidence of late ALT elevations was not affected by treatment duration.
Slovenian: Zdravljenja zaradi teh zvišanj ALT v nobenem primeru ni bilo treba ukiniti.
English: (300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
Slovenian: (300 mg enkrat na dan)/ritonavir (100 mg enkrat na dan)/elbasvir (50 mg enkrat na dan)
English: Table 9: SVR in genotype 1b †-infected subjects Baseline Characteristics
Slovenian: Preglednica 9: SVR pri preiskovancih ¶, okuženih z genotipom 1b
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.
Slovenian: Med preiskovanci, okuženimi z genotipom 1b, so bile z odpornostjo povezane substitucije NS3 prisotne v zaznavnih vrednostih pri 50 % (1/2) preiskovancev v 24. tednu spremljanja.
English: • EBR* + GZR* for 12 weeks (N=122)
Slovenian: • EBR* + GZR* 12 tednov (n = 122)
English: Tablet core
Slovenian: Tarčna molekula
English: ↔ Mycophenolic acid AUC 0.95 (0.87, 1.03) Cmax 0.85 (0.67, 1.07)
Slovenian: ↔ mikofenolna kislina AUC 0,95 (0,87; 1,03) Cmax 0,85 (0,67; 1,07)
English: Ketoconazole (400 mg PO once daily)/ elbasvir (50 mg single dose)
Slovenian: Ketokonazol (400 mg peroralno enkrat na dan)/elbasvir (50 mg enkratni odmerek)
English: ↔ Elbasvir AUC 1.98 (1.84, 2.13) Cmax 1.95 (1.84, 2.07) C24 2.21 (1.98, 2.47)
Slovenian: AUC 1,98 (1,84; 2,13) Cmax 1,95 (1,84; 2,07) C24 2,21 (1,98; 2,47)
English: In genotype 4 replicons, single NS5A substitutions L30S, M31V, and Y93H reduced elbasvir antiviral activity by 3to 23-fold.
Slovenian: V replikonih genotipa HCV 4 so posamezne substitucije NS5A L30S, M31V in Y93H zmanjšale protivirusno aktivnost elbasvirja za 3- do 23-krat.
English: ZEPATIER is not for use in children and adolescents under 18 years of age.
Slovenian: Zdravilo ZEPATIER ni namenjeno za uporabo pri otrocih in mladostnikih, starih manj kot 18 let, ker v tej starostni skupini ni bilo raziskano.
English: Elbasvir has been shown to cross the placenta in rats and rabbits.
Slovenian: Elbasvir pri podganah in kuncih prehaja skozi placento.
English: ANTIMYCOBACTERIALS
Slovenian: ZDRAVILA PROTI MIKOBAKTERIJAM
English: (400 mg PO once daily)/ grazoprevir (100 mg single dose)
Slovenian: (400 mg peroralno enkrat na dan)/grazoprevir (100 mg enkratni odmerek)
English: ↔ Prednisolone AUC 1.08 (1.01, 1.16) Cmax 1.04 (0.99, 1.09)
Slovenian: ↔ 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)
Slovenian: ↔ R-metadon AUC 1,03 (0,92; 1,15) Cmax 1,07 (0,95; 1,20) C24 1,10 (0,96; 1,26)
English: NS5A Any of the following NS5A substitutions: M/L28A/G/T/S* Q30H/K/R/Y, L/M31F/M/I/V, H/P58D, Y93H/N/S
Slovenian: M/L28A/G/T/S* Q30H/K/R/Y, L/M31F/M/I/V, H/P58D, Y93H/N/S
English: • EBR* + GZR* for 12 weeks (N=14)
Slovenian: • EBR* + GZR* 12 tednov (n = 14)
English: ↔ S-Methadone AUC 1.09 (0.94, 1.26) Cmax 1.09 (0.95, 1.25) C24 1.20 (0.98, 1.47)
Slovenian: ↔ S-metadon AUC 1,09 (0,94; 1,26) Cmax 1,09 (0,95; 1,25) C24 1,20 (0,98; 1,47)
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on race/ethnicity (see section 4.4).
Slovenian: Te spremembe niso klinično pomembne, zato prilagoditev odmerka elbasvirja/grazoprevirja glede na raso/etnično pripadnost ni potrebna (glejte poglavje 4.4).
English: ↔ Buprenorphine AUC 0.98 (0.89, 1.08) Cmax 0.94 (0.82, 1.08) C24 0.98 (0.88, 1.09)
Slovenian: ↔ 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)
Slovenian: ↔ prednizon AUC 1,08 (1,00; 1,17) Cmax 1,05 (1,00; 1,10)
English: ZEPATIER combines two direct-acting antiviral agents with distinct mechanisms of action and nonoverlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Slovenian: Njuni profili odpornosti se ne prekrivajo in zdravilo tako deluje usmerjeno proti HCV na več stopnjah življenjskega ciklusa virusa.
English: ↔ Emtricitabine AUC 1.07 (1.03, 1.10) Cmax 0.96 (0.90, 1.02) C24 1.19 (1.13, 1.25)
Slovenian: ↔ emtricitabin AUC 1,07 (1,03; 1,10) Cmax 0,96 (0,90; 1,02) C24 1,19 (1,13; 1,25)
English: ↔ Rilpivirine AUC 1.13 (1.07, 1.20) Cmax 1.07 (0.97, 1.17) C24 1.16 (1.09, 1.23)
Slovenian: ↔ 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)
Slovenian: AUC 1,80 (1,41; 2,29) Cmax 1,29 (1,00; 1,66) C24 1,89 (1,37; 2,60)
English: HIV ANTIVIRAL AGENTS: OTHER
Slovenian: PROTIVIRUSNA ZDRAVILA ZA ZDRAVLJENJE HIV: DRUGA ZDRAVILA
English: • EBR/GZR for 12 or 16 weeks (N=105 and respectively)
Slovenian: • EBR/GZR 12 tednov (n = 105) ali 16 tednov (n = 105)
English: (combination of OATP1B and CYP3A inhibition)
Slovenian: (kombinacija zaviranja OATP1B in CYP3A)
English: HIV ANTIVIRAL AGENTS: INTEGRASE STRAND TRANSFER INHIBITORS
Slovenian: PROTIVIRUSNA ZDRAVILA ZA ZDRAVLJENJE HIV: ZAVIRALCI INTEGRAZE
English: Talk to your doctor before taking ZEPATIER if you are breast-feeding.
Slovenian: Če dojite, se posvetujte z zdravnikom, preden začnete jemati zdravilo ZEPATIER.
English: (600 mg PO single dose)/ elbasvir (50 mg single dose)
Slovenian: (600 mg peroralno enkrat na dan)/elbasvir (50 mg enkratni odmerek)
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on sex (see section 4.4).
Slovenian: Te spremembe niso klinično pomembne, zato prilagoditev odmerka elbasvirja/grazoprevirja glede na spol ni potrebna (glejte poglavje 4.4).
English: • being sick (vomiting)
Slovenian: • slabost v želodcu (siljenje na bruhanje)
English: Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Slovenian: Atorvastatin (20 mg enkratni odmerek)/grazoprevir (200 mg enkrat na dan)
English: Inner wallet
Slovenian: Pretisna zgibanka
English: (300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Slovenian: (300 mg enkrat na dan)/elbasvir (50 mg enkrat na dan)/grazoprevir (100 mg enkrat na dan)
English: Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Slovenian: Rilpivirin (25 mg enkrat na dan)/elbasvir (50 mg enkrat na dan)/grazoprevir (200 mg enkrat na dan)
English: Grazoprevir has been shown to cross the placenta in rats and rabbits.
Slovenian: Grazoprevir pri podganah in kuncih prehaja skozi placento.
English: ↔ Elbasvir AUC 1.22 (1.06, 1.40) Cmax 1.41 (1.18, 1.68) C24 1.31 (1.12, 1.53)
Slovenian: AUC 1,22 (1,06; 1,40) Cmax 1,41 (1,18; 1,68) C24 1,31 (1,12; 1,53)
English: Proton pump inhibitors Pantoprazole (40 mg once daily)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Slovenian: Zaviralci protonske črpalke Pantoprazol (40 mg enkrat na dan)/elbasvir (50 mg enkratni odmerek)/ grazoprevir (100 mg enkratni odmerek)
English: ↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
Slovenian: ↔ nalokson AUC 0,88 (0,76; 1,02) Cmax 0,85 (0,66; 1,09)
English: Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Slovenian: Sofosbuvir (400 mg enkratni odmerek sofosbuvirja)/elbasvir (50 mg enkrat na dan)/grazoprevir (200 mg enkrat na dan)
English: ↔ Ciclosporin AUC 0.96 (0.90, 1.02) Cmax 0.90 (0.85, 0.97) C12 1.00 (0.92, 1.08)
Slovenian: ↔ ciklosporin AUC 0,96 (0,90; 1,02) Cmax 0,90 (0,85; 0,97) C12 1,00 (0,92; 1,08)
English: ↔ Elbasvir AUC 1.17 (1.11, 1.24) Cmax 1.25 (1.16, 1.35) C24 1.04 (0.97, 1.12)
Slovenian: AUC 1,17 (1,11; 1,24) Cmax 1,25 (1,16; 1,35) C24 1,04 (0,97; 1,12)
English: ↔ Elbasvir AUC 1.22 (0.98, 1.52) Cmax 1.13 (0.87, 1.46) C24 1.22 (0.99, 1.51)
Slovenian: AUC 1,22 (0,98; 1,52) Cmax 1,13 (0,87; 1,46) C24 1,22 (0,99; 1,51)
English: (due in part to OATP1B and CYP3A inhibition)
Slovenian: (deloma zaradi zaviranja OATP1B in CYP3A)
English: BLISTER GLUED WITHIN THE INNER WALLET
Slovenian: PRETISNI OMOT, PRILEPLJEN V PRETISNO ZGIBANKO
English: Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Slovenian: Pitavastatin (1 mg enkratni odmerek)/grazoprevir (200 mg enkrat na dan)
English: Subjects without baseline NS5A polymorphisms, % (n/N)
Slovenian: preiskovanci brez izhodiščnih polimorfizmov NS5A % (n/N)
English: How to store ZEPATIER
Slovenian: Shranjevanje zdravila ZEPATIER
English: ↔ Elbasvir AUC 1.09 (0.98, 1.21) Cmax 1.11 (0.99, 1.26) C24 0.96 (0.86, 1.08)
Slovenian: AUC 1,09 (0,98; 1,21) Cmax 1,11 (0,99; 1,26) C24 0,96 (0,86; 1,08)
English: SVR by cirrhosis status Non-cirrhotic
Slovenian: SVR glede na prisotnost ciroze Brez ciroze
English: Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Slovenian: Rosuvastatin (10 mg enkratni odmerek)/grazoprevir (200 mg enkrat na dan)
English: Your doctor may want to test your blood to check how your liver is working if you develop any of these symptoms.
Slovenian: • da preveri, kako vam delujejo jetra.
English: (300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Slovenian: (300 mg enkrat na dan)/ritonavir (100 mg enkrat na dan)/grazoprevir (200 mg enkrat na dan)
English: Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Slovenian: Sevelamerijev karbonat (2.400 mg enkratni odmerek)/elbasvir (50 mg enkratni odmerek)/grazoprevir (100 mg enkratni odmerek)