FrancophonIA/ELRC3.0 huggingface dataset:
English: Swallow the tablet whole with or without food.
Norwegian Bokmål: Svelg tabletten hel med eller uten mat. Ikke tygg, knus eller del tabletten.
English: ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Norwegian Bokmål: ZEPATIER er indisert til behandling av kronisk hepatitt C (CHC) hos voksne (se pkt.
English: (primarily due to intestinal BCRP inhibition)
Norwegian Bokmål: (primært pga. BCRP-hemming i tarm)
English: • Placebo for 12 weeks (N=100)
Norwegian Bokmål: • Placebo i 12 uker (N = 100)
English: †Reference sequences for NS5A at amino acid 31 are L (genotype 1a and genotype 1b) and M (genotype 4a and 4d).
Norwegian Bokmål: Referansesekvenser for NS5A ved aminosyre 31 er L (genotype 1a og genotype 1b) og M (genotype 4a og 4d).
English: GT 1, 4, 6 TE with or without cirrhosis, and with or without HCV/HIV-1 co-infection
Norwegian Bokmål: GT 1, 4, 6 TE med eller uten cirrhose, og med eller uten samtidig HCV/HIV-1infeksjon
English: Table 10: SVR in genotype 1a-infected subjects Baseline Characteristics
Norwegian Bokmål: Tabell 10: SVR hos genotype 1a-infiserte forsøkspersoner Karakteristika ved baseline
English: Table 11: SVR in genotype 4-infected subjects Baseline Characteristics
Norwegian Bokmål: Tabell 11: SVR hos genotype 4-infiserte forsøkspersoner Karakteristika ved baseline
English: If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Norwegian Bokmål: Rådfør deg med lege før du tar dette legemidlet dersom du er gravid, tror at du kan være gravid eller planlegger å bli gravid.
English: Efavirenz (600 mg once daily)/ elbasvir (50 mg once daily)
Norwegian Bokmål: Efavirenz (600 mg én gang daglig) / elbasvir (50 mg én gang daglig)
English: GT 1, 3 TN with or without cirrhosis TE Null Responder with or without cirrhosis TN HCV/HIV1 co-infection without cirrhosis
Norwegian Bokmål: GT 1, 3 TN med eller uten cirrhose TE nullrespondere med eller uten cirrhose TN med samtidig HCV/HIV-1infeksjon uten cirrhose
English: 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.
Norwegian Bokmål: Grazoprevir er aktiv in vitro mot følgende genotype 1a-NS3-substitusjoner som gir resistens mot andre NS3/4A-proteasehemmere: 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.
English: ↑ Tacrolimus AUC 1.43 (1.24, 1.64) Cmax 0.60 (0.52, 0.69) C12 1.70 (1.49, 1.94)
Norwegian Bokmål: ↑ Takrolimus AUC 1,43 (1,24; 1,64) Cmax 0,60 (0,52; 0,69) C12 1,70 (1,49; 1,94)
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.
Norwegian Bokmål: Grazoprevir er aktiv in vitro mot følgende genotype 1b-NS3-substitusjoner som gir resistens mot andre NS3/4A-proteasehemmere: 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.
English: (OATP1B inhibition)
Norwegian Bokmål: (OATP1B-hemming)
English: In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
Norwegian Bokmål: I genotype 1b-replikoner reduserte NS5A-enkeltsubstitusjonene L31F og Y93H den antivirale aktiviteten av elbasvir med 17 ganger.
English: For specific dosage instructions for ribavirin, including dose modification, refer to the ribavirin Summary of Product Characteristics.
Norwegian Bokmål: Se preparatomtalen (SmPC) for ribavirin for spesifikke doseringsinstruksjoner, inkludert dosemodifikasjoner.
English: ↔ S-Methadone AUC 1.23 (1.12, 1.35) Cmax 1.15 (1.07, 1.25)
Norwegian Bokmål: ↔ S-metadon AUC 1,23 (1,12; 1,35) Cmax 1,15 (1,07; 1,25)
English: ↔ Digoxin AUC 1.11 (1.02, 1.22) Cmax 1.47 (1.25, 1.73)
Norwegian Bokmål: ↔ Digoksin AUC 1,11 (1,02; 1,22) Cmax 1,47 (1,25; 1,73)
English: How to take ZEPATIER
Norwegian Bokmål: Hvordan du bruker ZEPATIER
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.
Norwegian Bokmål: Blant genotype 1binfiserte pasienter vedvarte NS5A-resistensassosierte substitusjoner med målbare nivåer hos 100 % (7/7) av pasientene ved oppfølging i uke 12 og hos 100 % (3/3) av pasientene ved oppfølging i uke 24.
English: Elderly No dose adjustment of ZEPATIER is required for elderly patients (see sections 4.4 and 5.2).
Norwegian Bokmål: Eldre Det er ikke nødvendig med dosejustering av ZEPATIER hos eldre pasienter (se pkt.
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.
Norwegian Bokmål: Blant genotype 1a-infiserte pasienter vedvarte NS5A-resistensassosierte substitusjoner med målbare nivåer hos 95 % (35/37) av pasientene i oppfølgingsuke 12 og hos 100 % (9/9) av pasientene i oppfølgingsuke 24.
English: ↔ Cobicistat AUC 1.49 (1.42, 1.57) Cmax 1.39 (1.29, 1.50)
Norwegian Bokmål: ↔ Kobicistat AUC 1,49 (1,42; 1,57) Cmax 1,39 (1,29; 1,50)
English: Buprenorphine/naloxone (8 mg/2 mg single dose)/ elbasvir (50 mg single dose)
Norwegian Bokmål: Buprenorfin/nalokson (8 mg/2 mg enkeltdose) / elbasvir (50 mg enkeltdose)
English: In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Norwegian Bokmål: I genotype 4-replikoner reduserte NS3-enkeltsubstitusjonen D168A/V den antivirale aktiviteten av grazoprevir med 110 til 320 ganger.
English: Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Norwegian Bokmål: Digoksin (0,25 mg enkeltdose) / elbasvir (50 mg én gang daglig)
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 50 % and 30 % higher, respectively, in females compared to males.
Norwegian Bokmål: I farmakokinetiske populasjonsanalyser er AUC for elbasvir og grazoprevir anslått å være hhv. 50 % og 30 % høyere hos kvinner enn hos menn.
English: • EBR/GZR for 12 weeks (N=218)
Norwegian Bokmål: • EBR/GZR i 12 uker (N = 218)
English: (8-24 mg/2-6 mg once daily)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: (8-24 mg / 2-6 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: 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).
Norwegian Bokmål: Samtidig administrering av ZEPATIER og CYP3A- eller P-gp-indusere er kontraindisert fordi dette kan redusere plasmakonsentrasjonene av elbasvir og grazoprevir betydelig og kan føre til redusert terapeutisk effekt av ZEPATIER (se pkt.
English: Based on pooled data from patients treated with ZEPATIER for 12 weeks without ribavirin
Norwegian Bokmål: Vanlige asteni, irritabilitet *Basert på samlede data fra pasienter behandlet med ZEPATIER i 12 uker uten ribavirin.
English: Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Norwegian Bokmål: Darunavir/ritonavir (600 mg to ganger daglig) / ritonavir (100 mg to ganger daglig) / elbasvir (50 mg én gang daglig)
English: • EBR/GZR for 12 weeks (N=201)
Norwegian Bokmål: • EBR/GZR i 12 uker (N = 201)
English: Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com
Norwegian Bokmål: Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
English: • EBR/GZR for 12 or 16 weeks (N=105 and respectively)
Norwegian Bokmål: • EBR/GZR i 12 eller 16 uker (N = 105 og 105, hhv.)
English: ↔ R-Methadone AUC 1.09 (1.02, 1.17) Cmax 1.03 (0.96, 1.11)
Norwegian Bokmål: ↔ R-metadon AUC 1,09 (1,02; 1,17) Cmax 1,03 (0,96; 1,11)
English: Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
Norwegian Bokmål: Raltegravir (400 mg enkeltdose) / elbasvir (50 mg enkeltdose)
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.
Norwegian Bokmål: Blant genotype 1a-infiserte forsøkspersoner var median alder 54 år (spredning: 19-76); 71 % var menn; 71 % var hvite; 22 % var svarte eller afroamerikanske; 9 % var latinamerikanske eller av latinamerikansk opprinnelse; 74 % var behandlingsnaive; 26 % var tidligere behandlet; gjennomsnittlig kroppsmasseindeks var 27 kg/m2; 75 % hadde HCV-RNA-nivåer høyere enn
English: How to store ZEPATIER
Norwegian Bokmål: Hvordan du oppbevarer ZEPATIER
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.
Norwegian Bokmål: Blant genotype 1b/1andre-infiserte forsøkspersoner var median alder 55 år (spredning: 22 til 82); 61 % var menn; 60 % var hvite; 20 % var svarte eller afroamerikanske; 6 % var latinamerikanske eller av latinamerikansk opprinnelse; 82 % var behandlingsnaive; 18 % var tidligere behandlet; gjennomsnittlig kroppsmasseindeks var 26 kg/m2; 64 % hadde HCV-RNA-nivåer høyere enn
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.
Norwegian Bokmål: Blant genotype 1b-infiserte pasienter vedvarte NS3-resistensassosierte substitusjoner med målbare nivåer hos 50 % (1/2) av pasientene ved oppfølging i uke 24.
English: • being sick (vomiting)
Norwegian Bokmål: • være uvel (oppkast)
English: HBV AND HIV ANTIVIRAL AGENTS: NUCLEOS(T)IDE REVERSE TRANSCRIPTASE INHIBITORS
Norwegian Bokmål: ANTIVIRALE LEGEMIDLER MOT HBV OG HIV: NUKLEOSID- OG NUKLEOTIDREVERSTRANSKRIPTASEHEMMERE
English: Tenofovir disoproxil fumarate (300 mg once daily)/ elbasvir (50 mg once daily)
Norwegian Bokmål: Tenofovirdisoproksilfumarat (300 mg én gang daglig) / elbasvir (50 mg én gang daglig)
English: 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).
Norwegian Bokmål: Samtidig administrering av ZEPATIER med legemidler som hemmer OATP1B-transportører, er kontraindisert fordi dette kan resultere i en betydelig økning i plasmakonsentrasjonen av grazoprevir (se pkt.
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.
Norwegian Bokmål: Blant genotype 4-infiserte forsøkspersoner var median alder 51 år (spredning: 28-75); 66 % var menn; 88 % var hvite; 8 % var svarte eller afroamerikanske; 11 % var latinamerikanske eller av latinamerikansk opprinnelse; 77 % var behandlingsnaive; 23 % var tidligere behandlet; gjennomsnittlig kroppsmasseindeks var 25 kg/m2; 56 % hadde HCV-RNA-nivåer høyere enn
English: Grazoprevir is not a P-gp inhibitor based on in vitro data.
Norwegian Bokmål: På bakgrunn av in vitro-data er grazoprevir ikke en P-gp-hemmer.
English: • EBR/GZR* for 12 weeks (N=316)
Norwegian Bokmål: • EBR/GZR* i 12 uker (N = 316)
English: Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Norwegian Bokmål: Lopinavir/ritonavir (400 mg to ganger daglig) / ritonavir (100 mg to ganger daglig) / elbasvir (50 mg én gang daglig)
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.
Norwegian Bokmål: Blant genotype 1a-infiserte pasienter vedvarte NS3-resistensassosierte substitusjoner med målbare nivåer hos 31 % (4/13) av pasientene ved oppfølging i uke 24.
English: Lactose monohydrate Croscarmellose sodium Sodium chloride
Norwegian Bokmål: Laktosemonohydrat Krysskarmellosenatrium Natriumklorid
English: GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
Norwegian Bokmål: GT 1, 4, 6 TN med eller uten cirrhose Samtidig HCV/HIV-1infeksjon
English: (20-150 mg once daily)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: (20-150 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: (600 mg PO single dose)/ elbasvir (50 mg single dose)
Norwegian Bokmål: (600 mg oral enkeltdose) / elbasvir (50 mg enkeltdose)
English: ↔ Buprenorphine AUC 0.98 (0.81, 1.19) Cmax 0.90 (0.76, 1.07)
Norwegian Bokmål: ↔ Buprenorfin AUC 0,98 (0,81; 1,19) Cmax 0,90 (0,76; 1,07)
English: (combination of OATP1B and CYP3A inhibition)
Norwegian Bokmål: (kombinasjon av OATP1B- og CYP3A-hemming)
English: Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
Norwegian Bokmål: Montelukast (10 mg enkeltdose) / grazoprevir (200 mg enkeltdose)
English: ↔ Prednisone AUC 1.08 (1.00, 1.17) Cmax 1.05 (1.00, 1.10)
Norwegian Bokmål: ↔ Prednison 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.
Norwegian Bokmål: I genotype 4-replikoner reduserte NS5A-enkeltsubstitusjonene L30S, M31V og Y93H den antivirale aktiviteten av elbasvir med 3 til 23 ganger.
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.
Norwegian Bokmål: For elbasvir reduserte NS5A-enkeltsubstitusjonene Q30D/E/H/R, L31M/V og Y93C/H/N den antivirale aktiviteten av elbasvir med 6 til 2000 ganger i replikoner fra HCV-genotype 1a.
English: Common dizziness
Norwegian Bokmål: Vanlige svimmelhet
English: ↔ Mycophenolic acid AUC 0.95 (0.87, 1.03) Cmax 0.85 (0.67, 1.07)
Norwegian Bokmål: ↔ Mykofenolsyre AUC 0,95 (0,87; 1,03) Cmax 0,85 (0,67; 1,07)
English: ANTICOAGULANTS
Norwegian Bokmål: ANTIKOAGULANTIA
English: • EBR* + GZR* for 12 weeks (N=122)
Norwegian Bokmål: • EBR* + GZR* i 12 uker (N = 122)
English: Ketoconazole (400 mg PO once daily)/ elbasvir (50 mg single dose)
Norwegian Bokmål: Ketokonazol (400 mg oralt én gang daglig) / elbasvir (50 mg enkeltdose)
English: • EBR* + GZR* for 12 weeks (N=14)
Norwegian Bokmål: • EBR* + GZR* i 12 uker (N = 14)
English: Proton pump inhibitors Pantoprazole (40 mg once daily)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Norwegian Bokmål: Protonpumpehemmere Pantoprazol (40 mg én gang daglig) / elbasvir (50 mg enkeltdose) / grazoprevir (100 mg enkeltdose)
English: ↔ R-Methadone AUC 1.03 (0.92, 1.15) Cmax 1.07 (0.95, 1.20) C24 1.10 (0.96, 1.26)
Norwegian Bokmål: ↔ R-metadon AUC 1,03 (0,92; 1,15) Cmax 1,07 (0,95; 1,20) C24 1,10 (0,96; 1,26)
English: • feeling very tired (fatigue)
Norwegian Bokmål: • betydelig tretthet (fatigue)
English: ↔ S-Methadone AUC 1.09 (0.94, 1.26) Cmax 1.09 (0.95, 1.25) C24 1.20 (0.98, 1.47)
Norwegian Bokmål: ↔ S-metadon AUC 1,09 (0,94; 1,26) Cmax 1,09 (0,95; 1,25) C24 1,20 (0,98; 1,47)
English: (300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
Norwegian Bokmål: (300 mg én gang daglig) / ritonavir (100 mg én gang daglig) / elbasvir (50 mg én gang daglig)
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
Norwegian Bokmål: M/L28A/G/T/S* Q30H/K/R/Y, L/M31F/M/I/V, H/P58D, Y93H/N/S
English: If you take more ZEPATIER than you should
Norwegian Bokmål: Dersom du tar for mye av ZEPATIER
English: ↔ Buprenorphine AUC 0.98 (0.89, 1.08) Cmax 0.94 (0.82, 1.08) C24 0.98 (0.88, 1.09)
Norwegian Bokmål: ↔ Buprenorfin AUC 0,98 (0,89; 1,08) Cmax 0,94 (0,82; 1,08) C24 0,98 (0,88; 1,09)
English: ↔ Emtricitabine AUC 1.07 (1.03, 1.10) Cmax 0.96 (0.90, 1.02) C24 1.19 (1.13, 1.25)
Norwegian Bokmål: ↔ Emtricitabin AUC 1,07 (1,03; 1,10) Cmax 0,96 (0,90; 1,02) C24 1,19 (1,13; 1,25)
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.
Norwegian Bokmål: For grazoprevir reduserte NS3-enkeltsubstitusjonen D168A/E/G/S/V den antivirale aktiviteten av grazoprevir med 2 til 81 ganger i replikoner fra HCV-genotype 1a.
English: ↔ Rilpivirine AUC 1.13 (1.07, 1.20) Cmax 1.07 (0.97, 1.17) C24 1.16 (1.09, 1.23)
Norwegian Bokmål: ↔ Rilpivirin AUC 1,13 (1,07; 1,20) Cmax 1,07 (0,97; 1,17) C24 1,16 (1,09; 1,23)
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.
Norwegian Bokmål: Begge forsøkspersonene som ikke oppnådde SVR av andre grunner enn virologisk svikt, hadde HCV-RNA ≤ 800 000 IE/ml ved baseline.
English: (400 mg PO once daily)/ grazoprevir (100 mg single dose)
Norwegian Bokmål: (400 mg oralt én gang daglig) / grazoprevir (100 mg enkeltdose)
English: Subjects without baseline NS3 polymorphisms, % (n/N)
Norwegian Bokmål: Forsøkspersoner uten NS3polymorfismer ved baseline, % (n/N)
English: GT 1, 4, 6 TN with or without cirrhosis Opiate agonist therapy
Norwegian Bokmål: GT 1, 4 og 6, TN med eller uten cirrhose, opiatagonistbehandling
English: MSD Pharma Hungary Kft. Tel.: +361 888 53 00 hungary_msd@merck.com
Norwegian Bokmål: Tel.: +361 888 53 00 hungary_msd@merck.com
English: Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Norwegian Bokmål: Sofosbuvir (400 mg enkeltdose sofosbuvir) / elbasvir (50 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: STIMULANTS
Norwegian Bokmål: STIMULERENDE LEGEMIDLER
English: (300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Norwegian Bokmål: (300 mg én gang daglig) / elbasvir (50 mg én gang daglig) / grazoprevir (100 mg én gang daglig)
English: Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: Atorvastatin (20 mg enkeltdose) / grazoprevir (200 mg én gang daglig)
English: Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: Rosuvastatin (10 mg enkeltdose) / grazoprevir (200 mg én gang daglig)
English: Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: Midazolam (2 mg enkeltdose) / grazoprevir (200 mg én gang daglig)
English: ↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
Norwegian Bokmål: ↔ Nalokson AUC 0,88 (0,76; 1,02) Cmax 0,85 (0,66; 1,09)
English: Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: Pitavastatin (1 mg enkeltdose) / grazoprevir (200 mg én gang daglig)
English: (intestinal BCRP inhibition)
Norwegian Bokmål: (muligens pga. BCRP-hemming i tarm)
English: Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: Rilpivirin (25 mg én gang daglig) / elbasvir (50 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: 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
Norwegian Bokmål: 4.2) Tidligere behandlingssvikt med boceprevir, telaprevir eller simeprevir i kombinasjon med peg-IFN + RBV
English: ↔ Ciclosporin AUC 0.96 (0.90, 1.02) Cmax 0.90 (0.85, 0.97) C12 1.00 (0.92, 1.08)
Norwegian Bokmål: ↔ Ciklosporin AUC 0,96 (0,90; 1,02) Cmax 0,90 (0,85; 0,97) C12 1,00 (0,92; 1,08)
English: ANTIFUNGALS
Norwegian Bokmål: ANTIARYTMIKA
English: Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (0.03 mg EE/
Norwegian Bokmål: Etinyløstradiol (EE) / Levonorgestrel (LNG) (0,03 mg EE / 0,15 mg LNG enkeltdose) / elbasvir (50 mg én gang daglig)
English: (10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
Norwegian Bokmål: (10 mg enkeltdose) / elbasvir (50 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: GT 1 TE with HCV protease inhibitor regimen
Norwegian Bokmål: GT 1 TE med HCVproteasehemmerregime med eller uten cirrhose
English: Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Norwegian Bokmål: Kalsiumacetat (2668 mg enkeltdose) / elbasvir (50 mg enkeltdose) / grazoprevir (100 mg enkeltdose)
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on race/ethnicity (see section 4.4).
Norwegian Bokmål: Det anbefales derfor ingen dosejustering av elbasvir/grazoprevir basert på rase/etnisitet (se pkt.
English: Subjects with baseline NS3 polymorphisms, % (n/N)
Norwegian Bokmål: Forsøkspersoner med NS3polymorfismer ved baseline, % (n/N)
English: Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Norwegian Bokmål: Sevelamerkarbonat (2400 mg enkeltdose) / elbasvir (50 mg enkeltdose) / grazoprevir (100 mg enkeltdose)
English: (OATP1B inhibition and CYP3A induction)
Norwegian Bokmål: (OATP1B-hemming og CYP3Ainduksjon)
English: (300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Norwegian Bokmål: (300 mg én gang daglig) / ritonavir (100 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on sex (see section 4.4).
Norwegian Bokmål: Det anbefales derfor er ingen dosejustering av elbasvir/grazoprevir basert på kjønn (se pkt.
English: (300 mg once daily)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: (300 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: Mykofenolatmofetil (1000 mg enkeltdose) / elbasvir (50 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: (400 mg twice daily)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: (400 mg to ganger daglig) / grazoprevir (200 mg én gang daglig)
English: Dolutegravir (50 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Norwegian Bokmål: Dolutegravir (50 mg enkeltdose) / elbasvir (50 mg én gang daglig) / grazoprevir (200 mg én gang daglig)
English: Placebo-controlled study in subjects with CKD Stage 4 (eGFR 15-29 mL/min/1.73 m2) or Stage 5 (eGFR < 15 mL/min/1.73 m2), including subjects on hemodialysis, Subjects were randomised in a 1:1 ratio to one of the following treatment groups: EBR + GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Norwegian Bokmål: Placebokontrollert studie hos forsøkspersoner med CKD-stadium 4 (eGFR 15-29 ml/min/ 1,73 m2) eller stadium 5 (eGFR < 15 ml/min/1,73 m inkludert forsøkspersoner på hemodialyse.
English: (600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Norwegian Bokmål: (600 mg to ganger daglig) / ritonavir (100 mg to ganger daglig) / grazoprevir (200 mg én gang daglig)
English: • loss of appetite
Norwegian Bokmål: • tap av matlyst