FrancophonIA/ELRC3.0 huggingface dataset:
English: The geometric mean apparent terminal half-life (% geometric mean coefficient of variation) is approximately 24 (24 %) hours at 50 mg elbasvir and approximately 31 (34 %) hours at 100 mg grazoprevir in HCV-infected subjects.
Danish: Den geometriske gennemsnitlige tilsyneladende terminale halveringstid (geometrisk gennemsnitlig variationskoefficient i %) hos HCV-inficerede forsøgspersoner er cirka 24 (24%) timer ved 50 mg elbasvir og cirka 31 (34%) timer ved 100 mg grazoprevir.
English: This change is not clinically relevant for grazoprevir.
Danish: Denne ændring for grazoprevir er ikke klinisk relevant.
English: Talk to your doctor about different contraception methods that are suitable for you.
Danish: Spørg din læge, hvilke præventionsmetoder der er bedst for dig.
English: ZEPATIER with ribavirin
Danish: ZEPATIER givet sammen med ribavirin
English: No human data on the effect of elbasvir and grazoprevir on fertility are available.
Danish: Der foreligger ingen data om elbasvirs og grazoprevirs indvirkning på human fertilitet.
English: When elbasvir/grazoprevir was studied with ribavirin, the most frequent adverse reactions to elbasvir/grazoprevir + ribavirin combination therapy were consistent with the known safety profile of ribavirin.
Danish: Når elbasvir/grazoprevir blev givet i kombination med ribavirin, var de hyppigst rapporterede bivirkninger i overensstemmelse med den kendte sikkerhedsprofil for ribavirin.
English: Elbasvir was excreted into the milk of lactating rats with concentrations 4-fold that of the maternal plasma concentrations.
Danish: Elbasvir blev udskilt i mælken hos diegivende rotter i koncentrationer, der var 4 gange højere end de maternelle plasmakoncentrationer.
English: GT 4, 6 TN without cirrhosis
Danish: GT 4, 6 TN uden cirrose
English: Outcome for subjects without SVR On-treatment virologic failure Relapse
Danish: Resultat for forsøgspersoner, der ikke opnåede SVR Virologisk svigt under behandling Recidiv
English: • oral ketoconazole for fungal infections
Danish: • ketoconazol gennem munden til behandling af en svampeinfektion
English: Frequent monitoring of tacrolimus whole blood concentrations, changes in renal function, and tacrolimus-associated adverse events upon the initiation of coadministration is recommended.
Danish: Efter initiering af samtidig administration anbefales hyppig monitorering af tacrolimuskoncentrationen i fuldblod, for ændringer i nyrefunktionen og for tacrolimus-associerede bivirkninger.
English: In addition, 11 subjects received open-label EBR + GZR for 12 weeks (intensive PK arm).
Danish: Derudover fik 11 forsøgspersoner ikkeblindet EBR + GZR i 12 uger (intensiv farmakokinetisk arm).
English: Following administration of elbasvir/grazoprevir to HCV-infected subjects, elbasvir peak plasma concentrations occur at a median Tmax of 3 hours (range of 3 to 6 hours); grazoprevir peak plasma concentrations occur at a median Tmax of 2 hours (range of 30 minutes to 3 hours).
Danish: Efter administration af elbasvir/grazoprevir til HCV-inficerede forsøgspersoner nås den maksimale plasmakoncentration for elbasvir med en median Tmax på 3 timer (3-6 timer); den maksimale plasmakoncentration for grazoprevir nås med en median Tmax på 2 timer (30 minutter til 3 timer).
English: What you need to know before you take ZEPATIER
Danish: Det skal du vide, før du begynder at tage ZEPATIER
English: Expected: ↑ Dabigatran
Danish: Forventet: ↑ Dabigatran
English: During clinical studies with ZEPATIER with or without ribavirin, < 1 % of subjects experienced elevations of ALT from normal levels to greater than 5 times the upper limit of normal (ULN), (see section 4.8).
Danish: I kliniske studier med ZEPATIER med eller uden ribavirin oplevede <1% af forsøgspersonerne forhøjelse af ALAT fra et normalt niveau til et niveau på mere end 5 gange den øvre normalgrænse (ULN) (se pkt.
English: Elbasvir has been shown to cross the placenta in rats and rabbits.
Danish: Det er vist, at elbasvir passerer placenta hos rotter og kaniner.
English: Treatment-emergent substitutions were detected in both HCV drug targets in 23/37 (62 %) genotype 1a, 1/8 (13 %) genotype 1b and 2/5 (40 %) genotype 4 subjects.
Danish: Behandlingsrelaterede substitutioner blev detekteret i targets for begge HCV-lægemidler hos 23/37 (62%) forsøgspersoner med genotype 1a, 1/8 (13%) forsøgspersoner med genotype 1b og 2/5 (40%) forsøgspersoner med genotype 4.
English: The safety and efficacy of ZEPATIER in children and adolescents aged less than 18 years have not been established.
Danish: ZEPATIERs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Elbasvir and grazoprevir are not expected to be removed by peritoneal dialysis.
Danish: Det forventes ikke, at elbasvir og grazoprevir kan fjernes ved peritonealdialyse.
English: In a pooled analysis of subjects treated with regimens containing elbasvir/grazoprevir or elbasvir + grazoprevir with or without ribavirin in Phase 2 and 3 clinical studies, resistance analyses were conducted for 50 subjects who experienced virologic failure and had sequence data available (6 with on-treatment virologic failure, 44 with post-treatment relapse).
Danish: I en puljet analyse af forsøgspersoner, som blev behandlet med regimer indeholdende elbasvir/grazoprevir eller elbasvir + grazoprevir med eller uden ribavirin i kliniske fase II- og IIIstudier, blev der udført resistensanalyser hos 50 forsøgspersoner, som oplevede virologisk svigt, og som havde tilgængelige sekvensdata (6 med virologisk svigt under behandlingen, 44 med recidiv efter behandlingen).
English: In a biochemical assay, grazoprevir inhibited the proteolytic activity of the recombinant NS3/4A protease enzymes from HCV genotypes 1a, 1b, 3 and 4a with IC50 values ranging from 4 to 690 pM.
Danish: I en biokemisk analyse hæmmede grazoprevir den proteolytiske aktivitet af de rekombinante NS3/4A-proteaseenzymer fra HCV-genotype 1a, 1b, 3 og 4a med IC50værdier i intervallet 4 til 690 pM.
English: Recommended regimens and treatment durations are provided in Table 1 below (see sections 4.4 and 5.1):
Danish: Anbefalede doseringsregimer og behandlingsvarigheder er angivet i tabel 1 nedenfor (se pkt.
English: Co-administration of ZEPATIER with P-gp inhibitors is expected to have a minimal effect on the plasma concentrations of ZEPATIER.
Danish: Samtidig administration af ZEPATIER og P-gp-hæmmere forventes at have minimal indflydelse på plasmakoncentrationen af ZEPATIER.
English: Tell your doctor or pharmacist if you take any of the following medicines:
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler:
English: Subjects who had failed prior treatment with boceprevir, simeprevir, or telaprevir in combination with peg-IFN + RBV received EBR + GZR with RBV for 12 weeks.
Danish: Forsøgspersoner, som har haft svigt af tidligere behandling med boceprevir, simeprevir eller telaprevir i kombination med peg-IFN + RBV, fik EBR + GZR med RBV i 12 uger.
English: Renal impairment and end stage renal disease (ESRD) No dose adjustment of ZEPATIER is required in patients with mild, moderate, or severe renal impairment (including patients receiving haemodialysis or peritoneal dialysis) (see section 5.2).
Danish: Nedsat nyrefunktion og terminal nyresygdom (ESRD) Dosisjustering af ZEPATIER er ikke nødvendig hos patienter med let, moderat eller svært nedsat nyrefunktion (inklusive patienter, der får hæmodialyse eller peritonealdialyse) (se pkt.
English: Most late ALT elevations resolved with ongoing therapy with ZEPATIER or after completion of therapy (see section 4.4).
Danish: De fleste sent forhøjede ALAT-niveauer faldt igen med fortsat behandling med ZEPATIER eller efter behandlingsophør (se pkt.
English: Relative to fasting conditions, the administration of a single dose of elbasvir/grazoprevir with a highfat (900 kcal, 500 kcal from fat) meal to healthy subjects resulted in decreases in elbasvir AUC0-inf and Cmax of approximately 11 % and 15 %, respectively, and increases in grazoprevir AUC0-inf and Cmax of approximately 1.5-fold and 2.8-fold, respectively.
Danish: I forhold til fastende tilstand medførte administration af en enkelt dosis elbasvir/grazoprevir sammen med et måltid med højt fedtindhold (900 kcal, 500 kcal fra fedt) til raske forsøgspersoner fald i AUC0inf og Cmax for elbasvir på hhv. cirka 11% og 15% og stigning i AUC0-inf og Cmax for grazoprevir på hhv. cirka 1,5 og 2,8 gange.
English: Subjects were randomised in a 1:1 ratio to the study arms.
Danish: Forsøgspersonerne blev randomiseret i forholdet 1:1 til studiearmene.
English: Sodium laurilsulfate, vitamin E polyethylene glycol succinate, copovidone, hypromellose, microcrystalline cellulose, mannitol, lactose monohydrate, croscarmellose sodium, sodium chloride, colloidal anhydrous silica, magnesium stearate Film-coating:
Danish: Natriumlaurilsulfat; E-vitamin, polyethylenglycolsuccinat; copovidon; hypromellose; mikrokrystallinsk cellulose; mannitol; lactosemonohydrat; croscarmellosenatrium; natriumchlorid; kolloid vandfri silica; magnesiumstearat Filmovertræk:
English: Film-coating Lactose monohydrate Hypromellose Titanium dioxide Triacetin
Danish: Filmovertræk Lactosemonohydrat Hypromellose Titandioxid Triacetin
English: C-EDGE COSTAR (double-blind)
Danish: C-EDGE COSTAR (dobbeltblindet)
English: HBV AND HIV ANTIVIRAL AGENTS: NUCLEOS(T)IDE REVERSE TRANSCRIPTASE INHIBITORS
Danish: HBV- OG HIV-ANTIVIRALE MIDLER: NUKLEOS(T)ID REVERS TRANSKRIPTASEHÆMMERE
English: A should be considered in patients with baseline HCV RNA level >800,000 IU/ml and/or the presence of specific NS5A polymorphisms causing at least a 5-fold reduction in activity of elbasvir to minimise the risk of treatment failure (see section 5.1).
Danish: HCV-RNA > 800.000 IE/ml ved baseline og/eller med forekomst af specifikke NS5A-polymorfismer, som medfører mindst 5 gange reduceret aktivitet af elbasvir, for at minimere risikoen for behandlingssvigt (se pkt.
English: HCV replicons with reduced susceptibility to elbasvir and grazoprevir have been selected in cell culture for genotypes 1a, 1b and 4.
Danish: I cellekultur er der blevet fundet HCV-replikoner med nedsat følsomhed for elbasvir og grazoprevir for genotype 1a, 1b og 4.
English: • feeling nervous (anxiety)
Danish: • nervøsitet eller ængstelse
English: General disorders and administration site conditions: Very common fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet: Meget almindelig
English: Serum Late ALT elevations
Danish: Sene ALAT-forhøjelser i serum
English: Potential for other medicinal products to affect ZEPATIER
Danish: Andre lægemidlers potentielle indvirkning på ZEPATIER
English: See list under “Do not take ZEPATIER if you are taking any of the following medicines.”
Danish: Se listen under 3. punkt ”hvis du tager et af følgende lægemidler” i punktet “Tag ikke ZEPATIER”.
English: ZEPATIER contains sodium.
Danish: ZEPATIER indeholder natrium.
English: In case a dose of ZEPATIER is missed and it is within 16 hours of the time ZEPATIER is usually taken, the patient should be instructed to take ZEPATIER as soon as possible and then take the next dose of ZEPATIER at the usual time.
Danish: Patienterne skal informeres om, at hvis en dosis af ZEPATIER er blevet glemt, og der er gået mindre end 16 timer, efter ZEPATIER normalt skulle tages, skal de tage ZEPATIER så hurtigt som muligt og herefter tage den næste dosis på det sædvanlige tidspunkt.
English: Based on pooled data from patients treated with ZEPATIER for 12 weeks without ribavirin
Danish: Baseret på puljede data fra patienter, der fik ZEPATIER i 12 uger uden ribavirin
English: No dose adjustment of ZEPATIER is required in patients with mild hepatic impairment (Child-Pugh A).
Danish: Dosisjustering af ZEPATIER er ikke nødvendig hos patienter med let nedsat leverfunktion (ChildPugh A).
English: Elbasvir and grazoprevir are not OATP1B inhibitors in humans.
Danish: Elbasvir og grazoprevir hæmmer ikke OATP1B hos mennesker.
English: Based on the population pharmacokinetic modeling in non-cirrhotic, HCV-infected subjects, the geometric mean steady-state elbasvir AUC0-24 and Cmax at 50 mg were 2,180 nM•hr and 137 nM, respectively, and the geometric mean steady-state grazoprevir AUC0-24 and Cmax at 100 mg were 1,860 nM•hr and 220 nM, respectively.
Danish: På basis af farmakokinetiske populationsanalyser hos HCV-inficerede forsøgspersoner uden cirrose var den geometrisk gennemsnitlige steady state AUC0-24 og Cmax for elbasvir ved 50 mg hhv. 2.180 nM•t og 137 nM, og den geometriske gennemsnitlige steady state AUC0-24 og Cmax for grazoprevir ved 100 mg var hhv. 1.860 nM•t og 220 nM.
English: Table 4: Selected treatment emergent laboratory abnormalities Laboratory Parameters
Danish: Tabel 4: Udvalgte unormale laboratorieværdier, der er opstået under behandlingen Laboratorieparametre
English: Co-administration with inhibitors of organic anion transporting polypeptide 1B (OATP1B), such as rifampicin, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cobicistat or ciclosporin (see sections 4.4 and 4.5).
Danish: Administration sammen med organisk anion-transport-polypeptid 1B- (OATP1B-) hæmmere såsom rifampicin, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cobicistat og ciclosporin (se pkt.
English: ZEPATIER 50 mg/100 mg film-coated tablets elbasvir/grazoprevir
Danish: ZEPATIER 50 mg/100 mg filmovertrukne tabletter elbasvir/grazoprevir
English: (intestinal BCRP inhibition)
Danish: (intestinal BCRP-hæmning)
English: PHOSPHATE BINDERS
Danish: PHOSPHATBINDERE
English: Based on in vitro data, a potential for GZR to inhibit BSEP cannot be excluded.
Danish: Baseret på in vitro-data kan det ikke udelukkes, at grazoprevir har potentiale til at hæmme BSEP.
English: Common asthenia, irritability
Danish: Asteni, irritabilitet
English: Diabetics may experience improved glucose control potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral (DAA) treatment.
Danish: Patienter med diabetes kan opleve forbedret blodsukkerkontrol efter påbegyndelse af HCV-behandling med direkte virkende antivirale lægemidler, hvilket potentielt kan resultere i symptomatisk hypoglykæmi.
English: NS5A substitutions conferring resistance to elbasvir may reduce the antiviral activity of other NS5A inhibitors.
Danish: NS5A-substitutioner, der giver resistens over for elbasvir, kan reducere den antivirale aktivitet af andre NS5A-hæmmere.
English: ZEPATIER contains lactose and sodium
Danish: ZEPATIER indeholder lactose og natrium
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Carnauba wax
Danish: Gul jernoxid (E172) Rød jernoxid (E172) Sort jernoxid (E172) Carnaubavoks
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).
Danish: Elbasvir blev givet til rotter og kaniner uden at fremkalde en negativ virkning på embryo-føtal eller postnatal udvikling ved de højeste testede doser (for rotter og kaniner hhv. cirka 9 og 17 gange over eksponeringen hos mennesker).
English: Haemodialysis does not remove elbasvir or grazoprevir.
Danish: Hæmodialyse fjerner ikke elbasvir eller grazoprevir.
English: In population pharmacokinetic analysis in HCV-infected patients, elbasvir and grazoprevir AUCs were 25 % and 10 % higher, respectively, in dialysis-dependent patients and 46 % and 40 % higher, respectively, in non-dialysis-dependent patients with severe renal impairment compared to elbasvir and grazoprevir AUC in patients without severe renal impairment.
Danish: I en farmakokinetisk populationsanalyse af patienter med HCV-infektion var AUC for elbasvir og grazoprevir hhv. 25% og 10% højere hos dialyseafhængige patienter og hhv. 46% og 40% højere hos ikke-dialyseafhængige patienter med svært nedsat nyrefunktion sammenlignet med AUC for elbasvir og grazoprevir hos patienter uden svært nedsat nyrefunktion.
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).
Danish: Grazoprevir blev givet til rotter og kaniner uden at fremkalde en negativ virkning på embryo-føtal eller postnatal udvikling ved de højeste testede doser (for rotter og kaniner hhv. cirka 79 og 39 gange over eksponeringen hos mennesker).
English: (combination of mechanisms including CYP3A inhibition)
Danish: (kombination af mekanismer, inklusive CYP3A-hæmning)
English: Population PK analyses of HCV-infected patients in Phase 2 and 3 studies demonstrated that grazoprevir steady-state AUC0-24 increased by approximately 65 % in HCV-infected patients with compensated cirrhosis (all with CP-A) compared to HCV-infected non-cirrhotic patients, while elbasvir steady-state AUC was similar (see section 4.2).
Danish: Farmakokinetiske populationsanalyser af patienter med HCV-infektion i fase II- og III-studier viste, at steady state AUC0-24 for grazoprevir var cirka 65% højere hos patienter med HCV-infektion med kompenseret cirrose (alle med CP-A) sammenlignet med patienter med HCV-infektion uden cirrose, mens steady state AUC for elbasvir var sammenlignelige (se pkt.
English: Emtricitabine (200 mg once daily)
Danish: Emtricitabin (200 mg en gang dagligt)
English: The observed treatment response differences by treatment regimen in specific patient populations in the presence or absence of baseline NS5A or NS3 polymorphisms are summarised in Table 7.
Danish: Tabel 7 opsummerer de observerede forskelle i behandlingsrespons hos specifikke patientpopulationer med eller uden NS5A- eller NS3-polymorfismer ved baseline ud fra behandlingsregime.
English: C-EDGE TN (double-blind)
Danish: C-EDGE TN (dobbeltblindet)
English: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (fixed-dose combination) elvitegravir (150 mg once daily)/cobicistat (150 mg once daily)/ emtricitabine (200 mg once daily)/ tenofovir disoproxil fumarate (300 mg once daily)/elbasvir (50 mg once daily)/ grazoprevir (100 mg once daily)
Danish: Elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat (fastdosiskombination) elvitegravir (150 mg en gang dagligt)/cobicistat (150 mg en gang dagligt)/emtricitabin (200 mg en gang dagligt)/tenofovir disoproxilfumarat (300 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)/grazoprevir (100 mg en gang dagligt)
English: Some NS3 substitutions at A156 and at D168 confer reduced antiviral activity to grazoprevir as well as to other NS3/4A protease inhibitors.
Danish: Nogle NS3-substitutioner ved position A156 og position D168 giver reduceret antiviral aktivitet over for grazoprevir og over for andre NS3/4A-proteasehæmmere.
English: Patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2 and 5.2).
Danish: Patienter med moderat eller svært nedsat leverfunktion (Child-Pugh B eller C) (se pkt.
English: TE = Treatment-Experienced (failed prior treatment with interferon [IFN] or peginterferon alfa [peg-IFN] with or without ribavirin (RBV) or were intolerant to prior therapy) *EBR = elbasvir 50 mg; GZR = grazoprevir 100 mg; EBR/GZR = co-administered as a fixed-dose combination; EBR + GZR = co-administered as separate single agents
Danish: TE = Behandlingserfarne (svigt af tidligere behandling med interferon [IFN] eller peginterferon alfa [pegIFN] med eller uden ribavirin (RBV), eller som var intolerante over for tidligere behandling) *EBR = elbasvir 50 mg, GZR = grazoprevir 100 mg; EBR/GZR = administreret samtidigt som en fastdosiskombination; EBR + GZR = administreret samtidigt som separate enkeltstoffer RBV blev administreret med en samlet daglig dosis på 800-1.400 mg på basis af vægt (se pkt.
English: TN subjects with GT 1 infection with or without cirrhosis (with or without HCV/HIV1 co-infection) or who were peg-IFN + RBV null responders, were randomised to EBR + GZR with or without RBV for 8, 12 or 18 weeks.
Danish: TN forsøgspersoner med GT 1-infektion med eller uden cirrose (med eller uden HCV/hiv 1-co-infektion), eller som havde nul respons på peg-IFN + RBV, blev randomiseret til EBR + GZR med eller uden RBV i 8, 12 eller 18 uger.
English: Therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on weight/BMI (see section 4.4).
Danish: Dosisjustering af elbasvir/grazoprevir på basis af vægt/BMI anbefales derfor ikke (se pkt.
English: In non-HCV-infected subjects with dialysis-dependent, severe renal impairment, elbasvir and grazoprevir AUC values were unchanged compared to subjects with normal renal function.
Danish: Hos forsøgspersoner uden HCV-infektion med dialyseafhængig svært nedsat nyrefunktion var AUC-værdierne for elbasvir og grazoprevir uændrede i forhold til forsøgspersoner med normal nyrefunktion.
English: In non-HCV-infected subjects with severe renal impairment (eGFR < 30 mL/min/1.73 m2) who were not on dialysis, elbasvir and grazoprevir AUC values were increased by 86 % and 65 %, respectively, compared to non-HCV-infected subjects with normal renal function (eGFR > 80 mL/min/1.73 m2).
Danish: Hos forsøgspersoner uden HCV-infektion med svært nedsat nyrefunktion (eGFR <30 ml/min/1,73 m2), som ikke var i dialyse, steg AUC-værdierne for elbasvir og grazoprevir med hhv. 86% og 65% i forhold til forsøgspersoner uden HCV-infektion med normal nyrefunktion (eGFR >80 ml/min/1,73 m2).
English: Co-administration with inducers of cytochrome P450 3A (CYP3A) or P-glycoprotein (P-gp), such as efavirenz, phenytoin, carbamazepine, bosentan, etravirine, modafinil or St. John's wort (Hypericum perforatum) (see sections 4.4 and 4.5).
Danish: Administration sammen med CYP3A-induktorer eller P-glykoprotein- (P-gp-) induktorer såsom efavirenz, phenytoin, carbamazepin, bosentan, etravirin, modafinil eller perikon (Hypericum perforatum) (se pkt.
English: The persistence of elbasvir and grazoprevir treatment-emergent amino acid substitutions in NS5A, and NS3, respectively, was assessed in genotype 1-infected subjects in Phase 2 and 3 studies whose virus had treatment-emergent resistance-associated substitution in the drug target, and with available data through at least 24 weeks post-treatment using population (or Sanger) sequencing.
Danish: Persistensen af behandlingsrelaterede elbasvir- og grazoprevir-aminosyresubstitutioner i henholdsvis NS5A og NS3 blev vurderet ved hjælp af populationssekventering (eller Sanger-sekventering) i fase II- og III-studier hos genotype 1-inficerede forsøgspersoner, hvis virus havde behandlingsrelateret resistens-associeret substitution i target for henholdsvis elbasvir og grazoprevir, og som havde tilgængelige data til og med mindst 24 uger efter behandlingen.
English: Potential for ZEPATIER to affect other medicinal products
Danish: ZEPATIERs potentielle indvirkning på andre lægemidler
English: HIV ANTIVIRAL AGENTS: OTHER
Danish: HIV-ANTIVIRALE MIDLER: ANDRE
English: ↑ Lovastatin (CYP3A inhibition)
Danish: ↑ Lovastatin (CYP3A-hæmning)
English: C-EDGE COINFECTION (open-label)
Danish: C-EDGE COINFECTION (ikke-blindet)
English: Psychiatric disorders: Common insomnia, anxiety, depression
Danish: Insomni, angst, depression
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin permanently discontinued treatment due to adverse reactions.
Danish: Under 1% af forsøgspersonerne, der fik ZEPATIER med eller uden ribavirin, seponerede behandlingen permanent som følge af bivirkninger.
English: Lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), carnauba wax
Danish: Lactosemonohydrat; hypromellose; titandioxid; triacetin; gul jerndioxid (E172); rød jernoxid (E172); sort jernoxid (E172); carnaubavoks
English: In general, other NS5A substitutions conferring resistance to NS5A inhibitors may also confer resistance to elbasvir.
Danish: Andre NS5A-substitutioner, der giver resistens over for NS5A-hæmmere, kan generelt også give resistens over for elbasvir.
English: ↑ Simvastatin (primarily due to intestinal BCRP inhibition and CYP3A inhibition)
Danish: ↑ Simvastatin (primært på grund af intestinal BCRPhæmning og CYP3A-hæmning)