natgillin/translations-raw huggingface dataset:
Blandt genotype 1b/1 andet-inficerede forsøgspersoner var medianalderen 55 år (22 til 82); 61% var mænd; 60% var kaukasere; 20% var negroide eller afroamerikanere; 6% var latinamerikanere; 82% var behandlingsnaive; 18% var behandlingserfarne; gennemsnitligt BMI (body mass index) var 26 kg/m2; 64% havde HCV-RNA over 800.000 IE/ml ved baseline; 22% havde cirrose; 71% havde ikke-C/C IL28B-alleler (CT- eller TT-genotyper); 18% havde HCV/hiv 1-co-infektion. 
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.
• Placebo i 12 uger (N=113) 
• Placebo for 12 weeks (N=113)
C-SCAPE (ikke-blindet) 
C-SCAPE (open-label)
GT 1, 4, 6 TE med eller uden cirrose og med eller uden HCV/hiv 1-co-infektion 
GT 1, 4, 6 TE with or without cirrhosis, and with or without HCV/HIV-1 co-infection
I farmakokinetiske populationsanalyser estimeres AUC for elbasvir og grazoprevir at være hhv. 50% og 30% højere hos kvinder sammenlignet med mænd. 
In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 50 % and 30 % higher, respectively, in females compared to males.
Methadon (20-120 mg en gang dagligt)/elbasvir (50 mg en gang dagligt) 
Methadone (20-120 mg once daily)/ elbasvir (50 mg once daily)
(0,03 mg EE/0,15 mg LNG som enkeltdosis)/grazoprevir (200 mg en gang dagligt) 
(0.03 mg EE/ 0.15 mg LNG single-dose)/ grazoprevir (200 mg once daily)
• Placebo i 12 uger (N=105) 
• Placebo for 12 weeks (N=105)
GT 1, 3 TN med eller uden cirrose TE med nul respons med eller uden cirrose TN HCV/hiv 1-coinfektion uden cirrose 
GT 1, 3 TN with or without cirrhosis TE Null Responder with or without cirrhosis TN HCV/HIV1 co-infection without cirrhosis
Lactosemonohydrat Croscarmellosenatrium Natriumchlorid 
Lactose monohydrate Croscarmellose sodium Sodium chloride
Sådan skal du tage ZEPATIER 
How to take ZEPATIER
Blandt genotype 1a-inficerede forsøgspersoner var NS5A-resistens-associerede substitutioner persistente med detekterbare niveauer ved opfølgningsuge 12 hos 95% (35/37) af forsøgspersonerne og hos 100% (9/9) af forsøgspersonerne med data fra opfølgningsuge 24. 
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.
I genotype 1b-replikoner reducerede enkeltsubstitutionerne F43S, A156S/T/V og D168A/G/V i NS3 grazoprevirs antivirale aktivitet 3 til 375 gange. 
In genotype 1b replicons, single NS3 substitutions F43S, A156S/T/V, and D168A/G/V reduced grazoprevir antiviral activity by 3- to 375-fold.
Tabletterne er pakket i en æske, der indeholder to blisteromslag af karton. 
The tablets are packaged into a carton containing two cardboard cards, each cardboard card containing two 7-count aluminium blisters.
Tabel 10: SVR hos genotype 1a-inficerede forsøgspersoner Baseline-karakteristika 
Table 10: SVR in genotype 1a-infected subjects Baseline Characteristics
Referencesekvenser for NS5A ved aminosyreposition 58 er: H (genotype 1a) og P (genotype 1b og genotype 4a og 4d). 
‡Reference sequences for NS5A at amino acid 58 are H (genotype 1a) and P (genotype 1b and genotype 4a and 4d).
• Placebo i 12 uger (N=100) 
• Placebo for 12 weeks (N=100)
C-SALVAGE (ikke-blindet) 
C-SALVAGE (open-label)
Tabel 11: SVR hos genotype 4-inficerede forsøgspersoner Baseline-karakteristika 
Table 11: SVR in genotype 4-infected subjects Baseline Characteristics
Samtidig administration af ZEPATIER og potente CYP3A-hæmmere øger plasmakoncentrationen af elbasvir og grazoprevir, og samtidig administration anbefales ikke (se tabel 2 og pkt. 
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).
Placebokontrolleret studie, hvor forsøgspersonerne blev randomiseret i forholdet 2:1 til EBR/GZR i 12 uger (ITG) eller placebo i 12 uger efterfulgt af ikke-blindet behandling med EBR/GZR i 12 uger (DTG). 
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).
Elbasvir: I HCV-genotype 1a-replikoner reducerede enkeltsubstitutionerne Q30D/E/H/R, L31M/V og Y93C/H/N i NS5A elbasvirs antivirale aktivitet 6 til 2.000 gange. 
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.
Samtidig administration af CYP3A- eller Pgp-induktorer og ZEPATIER er kontraindiceret, da det kan nedsætte plasmakoncentrationen af elbasvir og grazoprevir, hvilket kan medføre reduceret terapeutisk virkning af ZEPATIER (se pkt. 
Co-administration of inducers of CYP3A or P-gp with ZEPATIER is contraindicated because it may decrease elbasvir and grazoprevir plasma concentrations, which may lead to reduced therapeutic effect of ZEPATIER (see sections 4.3 and 4.4).
(OATP1B-hæmning) 
(OATP1B inhibition)
Referencesekvenser for NS5A ved aminosyreposition 31 er: L (genotype 1a og genotype 1b) og M (genotype 4a og 4d). 
†Reference sequences for NS5A at amino acid 31 are L (genotype 1a and genotype 1b) and M (genotype 4a and 4d).
I farmakokinetiske populationsanalyser estimeres AUC for elbasvir og grazoprevir at være hhv. 15% og 50% højere for asiater sammenlignet med kaukasere. 
In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 15 % and 50 % higher, respectively, for Asians compared to Whites.
↔ S-methadon AUC 1,23 (1,12; 1,35) Cmax 1,15 (1,07; 1,25) 
↔ S-Methadone AUC 1.23 (1.12, 1.35) Cmax 1.15 (1.07, 1.25)
Samlet SVR Resultat for forsøgspersoner, der ikke opnåede SVR Virologisk svigt under behandling Recidiv Andet SVR ud fra cirrosestatus Uden cirrose Med cirrose SVR ud fra HCV-RNA ved baseline ≤800.000 IE/ml >800.000 IE/ml 
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
Blandt genotype 1b-inficerede forsøgspersoner var NS3-resistens-associerede substitutioner persistente med detekterbare niveauer ved opfølgningsuge 24 hos 50% (1/2) af forsøgspersonerne. 
Among genotype 1b-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 50% (1/2) of subjects.
Fortæl det straks til lægen, hvis du får et eller flere af følgende tegn på leverproblemer: appetitløshed; kvalme eller opkastning; føler dig træt eller svag; får gulfarvning af huden eller øjnene; afføringens farve har ændret sig. 
• check how your liver is working - tell your doctor straight away if you have any of the following signs of liver problems: loss of appetite; feeling or being sick; feeling tired or weak;
Atorvastatin-dosis må ikke overstige 20 mg dagligt ved administration sammen med ZEPATIER. 
The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Blandt genotype 1a-inficerede forsøgspersoner var NS3-resistens-associerede substitutioner persistente med detekterbare niveauer ved opfølgningsuge 24 hos 31% (4/13) af forsøgspersonerne. 
Among genotype 1a-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 31% (4/13) of subjects.
• EBR/GZR + RBV† i 12 eller 16 uger (N= hhv. 104 og 106) 
• EBR/GZR + RBV† for 12 or 16 weeks (N=104 and respectively)
GT 1, 4, 6 TN med eller uden cirrose HCV/hiv 1-co-infektion 
GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
Grazoprevir er aktivt in vitro mod følgende genotype 1b NS3-substitutioner, der giver resistens over for andre NS3/4Aproteasehæmmere: 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 og V170A/I/T. 
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.
Grazoprevir er aktivt in vitro mod følgende genotype 1a NS3-substitutioner, der giver resistens over for andre NS3/4A-proteasehæmmere: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S og I170T/V. 
Grazoprevir is active in vitro against the following genotype 1a NS3 substitutions which confer resistance to other NS3/4A protease inhibitors: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S, I170T/V.
(8-24 mg/2-6 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt 
(8-24 mg/2-6 mg once daily)/ grazoprevir (200 mg once daily)
• EBR/GZR i 12 eller 16 uger (N= hhv. 105 og 105) 
• EBR/GZR for 12 or 16 weeks (N=105 and respectively)
Efavirenz (600 mg en gang dagligt)/elbasvir (50 mg en gang dagligt) 
Efavirenz (600 mg once daily)/ elbasvir (50 mg once daily)
I genotype 1b-replikoner reducerede enkeltsubstitutionerne L31F og Y93H i NS5A elbasvirs antivirale aktivitet 17 gange. 
In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
69,85 mg) natrium pr. dosis. 
ZEPATIER contains 3.04 mmol (or 69.85 mg) sodium per dose.
I genotype 4-replikoner reducerede enkeltsubstitutionerne D168A/V i NS3 grazoprevirs antivirale aktivitet 110 til 320 gange. 
In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Grazoprevir: I HCV-genotype 1a-replikoner reducerede enkeltsubstitutionerne D168A/E/G/S/V i NS3 grazoprevirs antivirale aktivitet 2 til 81 gange. 
For grazoprevir, in HCV genotype 1a replicons, single NS3 substitutions D168A/E/G/S/V reduced grazoprevir antiviral activity by 2- to 81-fold.
Digoxin (0,25 mg enkeltdosis)/elbasvir (50 mg en gang dagligt) 
Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af race/etnisk oprindelse anbefales derfor ikke (se pkt. 
These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on race/ethnicity (see section 4.4).
• EBR/GZR i 12 uger (N=218) 
• EBR/GZR for 12 weeks (N=218)
Samtidig administration af ZEPATIER og lægemidler, som hæmmer OATP1B-transportører, er kontraindiceret, da det kan medføre en signifikant stigning i plasmakoncentrationen af grazoprevir (se pkt. 
Co-administration of ZEPATIER with medicinal products that inhibit OATP1B transporters is contraindicated because it may result in a significant increase in the plasma concentration of grazoprevir (see sections 4.3 and 4.4).
SYREREDUCERENDE MIDLER H2-receptorantagonister Famotidin (20 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis) 
ACID REDUCING AGENTS H2-receptor antagonists Famotidine (20 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Samtidig administration af ZEPATIER og CYP3A- eller P-gp-induktorer er kontraindiceret, da det kan nedsætte plasmakoncentrationen af elbasvir og grazoprevir betydeligt og kan medføre reduceret terapeutisk virkning af ZEPATIER (se pkt. 
Co-administration of ZEPATIER and CYP3A or P-gp inducers is contraindicated because it may significantly decrease elbasvir and grazoprevir plasma concentrations and may lead to a reduced therapeutic effect of ZEPATIER (see sections 4.3, 4.5 and 5.2).
Blandt genotype 1b-inficerede forsøgspersoner var NS5A-resistensassocierede substitutioner persistente med detekterbare niveauer hos 100% (7/7) af forsøgspersonerne ved opfølgningsuge 12 og hos 100% (3/3) af forsøgspersonerne med data fra opfølgningsuge 24. 
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.
• EBR/GZR i 12 uger (N=201) 
• EBR/GZR for 12 weeks (N=201)
Darunavir/ritonavir (600 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/elbasvir (50 mg en gang dagligt) 
Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Baseret på in vitro-data hæmmer grazoprevir ikke P-gp. 
Grazoprevir is not a P-gp inhibitor based on in vitro data.
Disse forskelle i eksponeringen for elbasvir og grazoprevir er ikke klinisk relevante. 
These differences in elbasvir and grazoprevir exposure are not clinically relevant; therefore, elbasvir/grazoprevir may be taken without regard to food.
• EBR/GZR* i 12 uger (N=316) 
• EBR/GZR* for 12 weeks (N=316)
(600 mg oral enkeltdosis)/elbasvir (50 mg enkeltdosis) 
(600 mg PO single dose)/ elbasvir (50 mg single dose)
↔ Buprenorphin AUC 0,98 (0,81; 1,19) Cmax 0,90 (0,76; 1,07) 
↔ Buprenorphine AUC 0.98 (0.81, 1.19) Cmax 0.90 (0.76, 1.07)
Tenofovirdisoproxilfumarat (300 mg en gang dagligt)/elbasvir (50 mg en gang dagligt) 
Tenofovir disoproxil fumarate (300 mg once daily)/ elbasvir (50 mg once daily)
↔ Mycophenolsyre AUC 0,95 (0,87; 1,03) Cmax 0,85 (0,67; 1,07) 
↔ Mycophenolic acid AUC 0.95 (0.87, 1.03) Cmax 0.85 (0.67, 1.07)
C-EDGE TE (ikke-blindet) 
C-EDGE TE (open-label)
Raltegravir (400 mg enkeltdosis)/elbasvir (50 mg enkeltdosis) 
Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
↔ Naloxon AUC 0,88 (0,76; 1,02) Cmax 0,85 (0,66; 1,09) 
↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
• EBR* + GZR* + RBV† i 12 uger (N=14) 
• EBR* + GZR* + RBV† for 12 weeks (N=14)
ZEPATIER indeholder: 
What ZEPATIER contains
(20-150 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt) 
(20-150 mg once daily)/ grazoprevir (200 mg once daily)
I genotype 4replikoner reducerede enkeltsubstitutionerne L30S, M31V og Y93H i NS5A elbasvirs antivirale aktivitet 3 til 23 gange. 
In genotype 4 replicons, single NS5A substitutions L30S, M31V, and Y93H reduced elbasvir antiviral activity by 3to 23-fold.
Hvis du har taget for meget ZEPATIER 
If you take more ZEPATIER than you should
Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af køn anbefales derfor ikke (se pkt. 
These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on sex (see section 4.4).
Blandt genotype 1a-inficerede forsøgspersoner var medianalderen 54 år (19 til 76); 71% var mænd; 71% var kaukasere; 22% var negroide eller afroamerikanere; 9% var latinamerikanere; 74% var behandlingsnaive; 26% var behandlingserfarne; gennemsnitligt BMI var 27 kg/m2; 75% havde HCV 
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.
Montelukast (10 mg enkeltdosis)/grazoprevir (200 mg enkeltdosis) 
Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
Rifampicin (600 mg intravenøs enkeltdosis)/elbasvir (50 mg enkeltdosis) 
Rifampicin (600 mg IV single dose)/ elbasvir (50 mg single dose)
• EBR* + GZR* i 12 uger (N=122) 
• EBR* + GZR* for 12 weeks (N=122)
Ketoconazol (400 mg oralt en gang dagligt)/ elbasvir (50 mg enkeltdosis) 
Ketoconazole (400 mg PO once daily)/ elbasvir (50 mg single dose)
↔ Buprenorphin AUC 0,98 (0,89; 1,08) Cmax 0,94 (0,82; 1,08) C24 0,98 (0,88; 1,09) 
↔ Buprenorphine AUC 0.98 (0.89, 1.08) Cmax 0.94 (0.82, 1.08) C24 0.98 (0.88, 1.09)
Ethinylestradiol (EE)/Levonorgestrel (LNG) (0,03 mg EE/0,15 mg LNG som enkeltdosis)/elbasvir (50 mg en gang dagligt) 
Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (0.03 mg EE/
Knogler, led, muskler og bindevæv: Almindelig 
Musculoskeletal and connective tissue disorders: Common arthralgia, myalgia
AUC 1,11 (1,02; 1,22) Cmax 1,47 (1,25; 1,73) 
↔ Digoxin AUC 1.11 (1.02, 1.22) Cmax 1.47 (1.25, 1.73)
Lopinavir/ritonavir (400 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/elbasvir (50 mg en gang dagligt) 
Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Calciumacetat (2.668 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/ grazoprevir (100 mg enkeltdosis) 
Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
GT 1, 4, 6 TN med eller uden cirrose Behandling med opiatagonist 
GT 1, 4, 6 TN with or without cirrhosis Opiate agonist therapy
(400 mg oralt en gang dagligt)/ grazoprevir (100 mg enkeltdosis) 
(400 mg PO once daily)/ grazoprevir (100 mg single dose)
Protonpumpehæmmere Pantoprazol (40 mg en gang dagligt)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis) 
Proton pump inhibitors Pantoprazole (40 mg once daily)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
(300 mg en gang dagligt)/ritonavir (100 mg en gang dagligt/elbasvir (50 mg en gang dagligt) 
(300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
Blandt genotype 4-inficerede forsøgspersoner var medianalderen 51 år (28 til 75); 66% var mænd; 88% var kaukasere; 8% var negroide eller afroamerikanere; 11% var latinamerikanere; 77% var behandlingsnaive; 23% var behandlingserfarne; gennemsnitligt BMI var 25 kg/m2; 56% havde HCV 
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.
Sofosbuvir (400 mg enkeltdosis sofosbuvir)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt) 
Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Er du i tvivl, så spørg lægen eller apotekspersonalet. 
If you have any questions about your medicines, please ask your doctor or pharmacist.
(600 mg intravenøs enkeltdosis)/grazoprevir (200 mg enkeltdosis) 
(600 mg IV single dose)/ grazoprevir (200 mg single dose)
Begge forsøgspersoner, som ikke opnåede SVR af andre årsager end virologisk svigt, havde HCV-RNA ≤800.000 IE/ml ved baseline. 
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.
• EBR* + GZR* i 12 uger (N=14) 
• EBR* + GZR* for 12 weeks (N=14)
(kombination af OATP1B- og CYP3Ahæmning) 
(combination of OATP1B and CYP3A inhibition)
Atorvastatin (20 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt) 
Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Rilpivirin (25 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt) 
Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Sevelamercarbonat (2.400 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis) 
Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
(300 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)/grazoprevir (100 mg en gang dagligt) 
(300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Der er 2 x 7 stk. aluminiumblisterkort i hvert blisteromslag, hvilket giver i alt 28 tabletter. 
The tablets are packaged into a carton containing two (2) cardboard cards, each cardboard card containing (2) 7-count aluminium blisters sealed in a cardboard card for a total of 28 tablets.
Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af alder anbefales derfor ikke (se pkt. 
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).
GT 1 TE med HCVproteasehæmmerregime med eller uden cirrose 
GT 1 TE with HCV protease inhibitor regimen
Mycophenolatmofetil (1.000 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt) 
Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Midazolam (2 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt) 
Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Rosuvastatin (10 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt) 
Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Pitavastatin (1 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt) 
Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Tal med lægen, før du tager dette lægemiddel, hvis du er på en diæt med lavt natriumindhold. 
Talk to your doctor before taking ZEPATIER if you are breast-feeding.
4.2) Tidligere behandlingssvigt med boceprevir, telaprevir eller simeprevir i kombination med peg-IFN + RBV 
RBV was administered at a total daily dose of 800 mg to 1,400 mg based on weight (see section 4.2) Failed prior treatment with boceprevir, telaprevir, or simeprevir in combination with peg-IFN + RBV
(300 mg en gang dagligt)/ritonavir (100 mg en gang dagligt/grazoprevir (200 mg en gang dagligt) 
(300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Forsøgspersoner uden NS3polymorfismer ved baseline % (n/N) 
Subjects without baseline NS3 polymorphisms, % (n/N)
Med cirrose 
Cirrhotic
• EBR* + GZR* + RBV† i 8, 12 eller 18 uger (N= hhv. 
• EBR* + GZR* + RBV† for 8, 12, or 18 weeks (N=60, 152, and 65, respectively)
(dels på grund af OATP1B- og CYP3A-hæmning) 
(due in part to OATP1B and CYP3A inhibition)
Tacrolimus (2 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/ grazoprevir (200 mg en gang dagligt) 
Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
(10 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt) 
(10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
(300 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt) 
(300 mg once daily)/ grazoprevir (200 mg once daily)
Brug af anden medicin sammen med ZEPATIER Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
HIV-ANTIVIRALE MIDLER: INTEGRASEHÆMMERE (AF GENOMOVERFØRSEL) 
HIV ANTIVIRAL AGENTS: INTEGRASE STRAND TRANSFER INHIBITORS
Uden cirrose 
‡ with or without cirrhosis
Det skal du vide, før du begynder at tage ZEPATIER Sådan skal du tage ZEPATIER Bivirkninger 
What ZEPATIER is and what it is used for What you need to know before you take ZEPATIER How to take ZEPATIER
Forsøgspersoner med NS3polymorfismer ved baseline % (n/N) 
Subjects with baseline NS3 polymorphisms, % (n/N)
(600 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/grazoprevir (200 mg en gang dagligt) 
(600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
ANTIMYKOTIKA 
ANTIARRHYTHMICS
Ciclosporin (400 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt) 
Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
(400 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/grazoprevir (200 mg en gang dagligt) 
(400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Forsøgspersoner uden NS5Apolymorfismer ved baseline, % (n/N) 
Subjects without baseline NS5A polymorphisms, % (n/N)