FrancophonIA/ELRC3.0 huggingface dataset:
English: Anhydrous lactose Microcrystalline cellulose Croscarmellose sodium Silicon dioxide (E551) Magnesium stearate
Danish: Vandfri lactose Mikrokrystallinsk cellulose Croscarmellosenatrium Siliconedioxid (E551) Magnesiumstearat
English: All N=126
Danish: Alle N=126
English: Following multiple-dose administration of daclatasvir in HCV-infected patients, the terminal elimination half-life of daclatasvir ranged from 12 to 15 hours.
Danish: Efter gentagen administration af daclatasvir til HCV-inficerede patienter strakte den terminale halveringstid sig fra 12 til 15 timer.
English: Frequency of baseline NS5A resistance-associated variants (RAVs) Baseline NS5A RAVs were frequently observed in clinical studies of daclatasvir.
Danish: Hyppighed af NS5A-resistensassocierede varianter (RAV'er) ved baseline NS5A-RAV'er ved baseline blev hyppigt observeret i kliniske studier med daclatasvir.
English: HCV/HIV co-infection (ALLY-2)
Danish: Samtidig infektion med HCV/hiv (ALLY-2)
English: All N=41
Danish: Alle N=41
English: >30 to ≤50 mL/min
Danish: >30 til ≤50 ml/min
English: Patients demographics and main disease characteristics are summarised in Table 8.
Danish: Patienternes demografiske data og vigtigste sygdomskarakteristika er vist i tabel 8.
English: Treatment-naïve N=101
Danish: Behandlingsnaiv N=101
English: Response was rapid (viral load at Week 4 showed that more than 97% of patients responded to therapy), and was not influenced by HCV subtype (1a/1b), IL28B genotype, or use of ribavirin.
Danish: Respons indtraf hurtigt (viral belastning ved uge 4 viste, at flere end 97% af patienterne responderede på behandlingen) og var ikke påvirket af HCV-undergruppe (1a/1b), IL28B-genotype eller anvendelse af ribavirin.
English: Paediatric population The pharmacokinetics of daclatasvir in paediatric patients have not been evaluated.
Danish: Pædiatrisk population Daclatasvirs farmakokinetik hos pædiatriske patienter er ikke blevet undersøgt.
English: Amiodarone
Danish: Amiodaron
English: Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Danish: ANTIEPILEPTIKA Carbamazepin Oxcarbazepin Phenobarbital Phenytoin
English: Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a cyclophilin inhibitor.
Danish: Recidiv * Hovedsageligt interferon-baseret behandling, men 7 patienter fik sofosbuvir + ribavirin, og 2 patienter fik en cyclophilin-hæmmer.
English: Cirrhosis status was not reported for four patients in the daclatasvir + pegIFN/RBV group.
Danish: ** Cirrose-status blev ikke rapporteret for fire patienter i daclatasvir + pegIFN/RBV guppen.
English: Treatment outcomes in study AI444010 for patients with HCV genotype 4 are presented in Table 13.
Danish: Behandlingsresultaterne fra studie AI444010 for patienter med HCV-genotype 4 er vist i tabel 13.
English: These medicines lower the effect of Daklinza so your treatment will not work.
Danish: Disse typer medicin mindsker Daklinzas virkning, så din behandling ikke virker.
English: Daklinza is not recommended for patients below 18 years of age.
Danish: Brugen af Daklinza frarådes til patienter under 18 år.
English: These medicines lower the effect of Daklinza and may result in your treatment not working.
Danish: Disse lægemidler mindsker virkningen af Daklinza og kan være skyld i at din behandling ikke virker.
English: The highest AUC value in unaffected females was 18-fold the clinical AUC exposure.
Danish: Den højeste AUC-værdi i ikke-påvirkede hunrotter var 18 gange højere end klinisk AUC-eksponering.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN MM/ÅÅÅÅ
English: and very rare (<1/10,000).
Danish: (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: Recommendations concerning coadministration
Danish: Anbefalinger ved samtidig administration
English: Patients with HCV genotype 1, 2, 3, 4, 5 or 6 infection were eligible to enroll.
Danish: Patienter med HCV-genotype 1-, 2-, 3-, 4-, 5eller 6-infektion var egnede til inklusion.
English: The pharmacokinetic properties of daclatasvir were evaluated in healthy adult subjects and in patients with chronic HCV.
Danish: Daclatasvirs farmakokinetiske egenskaber er blevet undersøgt hos raske voksne forsøgspersoner og hos patienter med kronisk HCV.
English: 24 weeks treatment duration
Danish: 24 ugers behandlingsvarighed
English: Among the 167 patients with HCV genotype 1 infection, 126 were treatment-naïve and 41 had failed prior therapy with a PI regimen (boceprevir or telaprevir).
Danish: Blandt de 167 patienter med HCV-genotype 1infektion var 126 behandlingsnaive og hos 41 var tidligere behandling mislykket med PI-behandling (boceprevir eller telaprevir).
English: Daclatasvir administered as a tablet was readily absorbed following multiple oral doses with peak plasma concentrations occurring between 1 and 2 hours.
Danish: Daclatasvir administreret i tabletform blev hurtigt absorberet efter flere orale doser, hvor maksimal plasmakoncentration blev opnået efter 1 til 2 timer.
English: An oral contraceptive containing ethinylestradiol 35 μg and norgestimate
Danish: Et oralt svangerskabsforebyggende middel med ethinylestradiol 35 µg og norgestimat.
English: The efficacy and safety of daclatasvir 60 mg once daily in combination with sofosbuvir 400 mg once daily in the treatment of patients with chronic HCV infection were evaluated in four open-label studies (AI444040, ALLY-1, ALLY-2 and ALLY-3).
Danish: Sikkerheden og virkningen af daclatasvir 60 mg en gang dagligt i kombination med sofosbuvir 400 mg en gang dagligt til behandling af patienter med kronisk HCV-infektion blev undersøgt i fire åbne studier (AI444040, ALLY-1, ALLY-2 og ALLY-3).
English: No dose adjustment of either medicinal product is required when Daklinza is coadministered with cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil.
Danish: Dosisjustering er ikke nødvendig for nogen af lægemidlerne, når Daklinza administreres sammen med ciclosporin, tacrolimus, sirolimus eller mycophenolatmofetil.
English: Daclatasvir was excreted into the milk of lactating rats with concentrations 1.7- to 2-fold maternal plasma levels.
Danish: Daclatasvir blev udskilt i mælken hos diegivende rotter ved koncentrationer 1,7 til 2 gange højere end de maternelle plasmakoncentrationer.
English: Patients received daclatasvir 60 mg once daily, sofosbuvir 400 mg once daily, and ribavirin (600 mg starting dose) for 12 weeks and were monitored for 24 weeks post treatment.
Danish: Patienterne fik daclatasvir 60 mg en gang dagligt, sofosbuvir 400 mg en gang dagligt og ribavirin (600 mg som startdosis) i 12 uger og blev monitoreret i 24 uger efter behandlingsafslutning.
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Daklinza in combination with sofosbuvir.
Danish: På grund af amiodarons lange halveringstid skal der desuden foretages passende overvågning af patienter, som inden for de seneste måneder har fået seponeret amiodaron og skal sættes i behandling med Daklinza i kombination med sofosbuvir.
English: Table 8: Demographics and main disease characteristics in Study ALLY-1 Cirrhotic cohort N = 60
Danish: Tabel 8: Demografiske data og vigtigste sygdomskarakteristika i ALLY-1-studiet Cirrosekohorte N = 60
English: Patients with genotype 3 infection were treated with daclatasvir + sofosbuvir +/- ribavirin for 12 or 24 weeks, where the longer treatment duration was associated with a lower risk for relapse (around 5%) in a preliminary analysis.
Danish: Patienter med genotype 3-infektion blev behandlet med daclatasvir + sofosbuvir +/- ribavirin i 12 eller 24 uger, hvoraf den lange behandlingsperiode blev associeret med en lavere risiko for recidiv (ca. 5%) i en foreløbig analyse.
English: The clinical data to support the use of Daklinza and sofosbuvir in patients infected with HCV genotypes 4 and 6 are limited.
Danish: De kliniske data, der understøtter anvendelse af Daklinza og sofosbuvir hos patienter med HCV-genotype 4- og 6-infektion, er begrænsede.
English: The SVR rate for patients treated for 8 weeks was lower with this treatment duration as summarized in Table 11.
Danish: SVR-raten for patienter, der blev behandlet i 8 uger, var lavere end for patienter, som fik 12 ugers behandling, hvilket er vist i tabel 11.
English: Patients with cirrhosis CP A or B
Danish: Patienter med cirrose CP A eller B
English: Daclatasvir had no effects on fertility in female rats at any dose tested.
Danish: Daclatasvir havde ingen effekt på hunrotters fertilitet ved nogen af de testede doser.
English: 0.180/0.215/0.250 mg once daily for 7/7/7 days (daclatasvir 60 mg once daily)
Danish: 0,180/0,215/0,250 mg en gang dagligt i 7/7/7 dage (daclatasvir 60 mg en gang dagligt)
English: Data from study ALLY-3 (AI444218) support a 12-week treatment duration of Daklinza + sofosbuvir for treatment-naïve and -experienced patients with genotype 3 infection without cirrhosis.
Danish: Data fra studiet ALLY-3 (AI444218) understøtter en 12 ugers behandlingsperiode med Daklinza + sofosbuvir til behandlingsnaive og -erfarne patienter med genotype 3-infektion uden cirrose.
English: Grade 3/4 increases in total bilirubin were observed in 5% of patients (all in patients with HIV coinfection who were receiving concomitant atazanavir, with Child-Pugh A, B, or C cirrhosis, or who were post-liver transplant).
Danish: Der blev observeret grad 3/4 stigning i total-bilirubin hos 5% af patienterne (alle tilfælde optrådte hos patienter, som samtidigt var inficeret med hiv-infektion og fik atazanavir, patienter med Child-Pugh A, B eller C cirrose eller patienter, som havde gennemgået en levertransplantation).
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Daklinza in combination with sofosbuvir.
Danish: Hvis samtidig brug af amiodaron findes nødvendig, anbefales tæt overvågning af patienterne ved initiering af behandlingen med Daklinza i kombination med sofosbuvir.
English: SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies.
Danish: SVR-rater var >94% på tværs af antiretroviral kombinationsbehandling (cART), inklusive boostet-PI-, NNRTI- og integrasehæmmer (INSTI)-baseret behandling.
English: Treatment week 4: >1000 IU/ml
Danish: Behandlingsuge 4: >1000 IE/ml
English: AI444042 enrolled patients with HCV genotype 4 infection and AI444010 enrolled patients with either genotype 1 or 4.
Danish: AI444042 inkluderede patienter med HCV-genotype 4-infektion og AI444010 inkluderede patienter med enten genotype 1 eller 4.
English: * Evaluated in opioid-dependent adults on stable buprenorphine/naloxone maintenance therapy.
Danish: * Undersøgt hos opioidafhængige voksne i stabil vedligeholdelsesbehandling med buprenorphin/naloxon.
English: Daclatasvir is embryotoxic and teratogenic in rats and rabbits at exposures at or above 4-fold (rat) and 16-fold (rabbit) the clinical AUC exposure.
Danish: Daclatasvir er embryotoksisk og teratogent i rotter og kaniner ved eksponering ved eller over 4 gange (rotte) og 16 gange (kanin) højere end klinisk AUC-eksponering.
English: Population pharmacokinetic analysis of data from clinical studies identified race (categories “other” [patients who are not white, black or Asian] and “black”) as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) and apparent volume of distribution (Vc/F) resulting in slightly higher exposures compared to white patients, but the magnitude of the effect on daclatasvir exposure is not clinically important.
Danish: Farmakokinetiske populationsanalyser af data fra kliniske studier identificerede race (kategorierne “andet” [patienter, som ikke er hvide, sorte eller asiater] og “sorte”) som en klinisk signifikant co-variat for daclatasvirs synlige orale clearance CL/F) og synlige fordelingsvolumen (Vc/F), hvilket medfører en anelse højere eksponering sammenlignet med hvide patienter, men betydningen af effekten på daclatasvir-eksponering er ikke klinisk vigtig.
English: Daclatasvir showed additive to synergistic interactions with interferon alfa, HCV nonstructural protein 3 (NS3) PIs, HCV nonstructural protein 5B (NS5B) non-nucleoside inhibitors, and HCV NS5B nucleoside analogues in combination studies using the cell-based HCV replicon system.
Danish: Daclatasvir viste additiv og synergistisk interaktion med interferon alfa, HCV ustrukturelt protein 3 (NS3)-PI'ere, HCV ustrukturelt protein 5B (NS5B) non-nukleoside hæmmere og HCV-NS5B nukleosidanaloger i kombinationsstudier, der anvendte det cellebaserede HCV-replikonsystem.
English: Ribavirin may be added based on clinical assessment of an individual patient.
Danish: Baseret på klinisk vurdering af den enkelte patient kan ribavirin tilføjes.
English: Daclatasvir Cmax, AUC, and Cmin increased in a near dose-proportional manner.
Danish: Cmax, AUC og Cmin for daclatasvir øgedes næsten proportionelt med dosis.
English: At the 60 mg dose, exposure to daclatasvir was similar between healthy subjects and HCV-infected patients.
Danish: Ved 60 mg dosis var daclatasvir-eksponering den samme for raske forsøgspersoner og HCV-inficerede patienter.
English: SVR was the primary endpoint to determine the HCV cure rate, which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12) for studies AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study AI444010.
Danish: HCV-RNA mindre end LLOQ ved uge 12 efter afsluttet behandling (SVR12) for studierne AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), AI444042 og AI444043 og som HCV-RNA ikke-detekterbart ved uge 24 efter afsluttet behandling (SVR24) for studie AI444010.
English: In clinical studies of daclatasvir in combination with sofosbuvir or with peginterferon alfa and ribavirin, plasma HCV RNA values were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, with a lower limit of quantification (LLOQ) of 25 IU/ ml.
Danish: I kliniske studier med daclatasvir i kombination med sofosbuvir eller med peginterferon alfa og ribavirin blev plasmaværdierne for HCV-RNA målt ved hjælp af COBAS TaqMan HCV-testen (version 2.0), med High Pure-systemet, med en nedre kvantificeringsgrænse (LLOQ) på 25 IE/ml.
English: One treatment-naïve patient was missing both post-treatment Weeks 12 and 24 data.
Danish: En behandlingsnaiv patient manglede data for både uge 12 og 24 efter behandlingen.
English: Subjects with end-stage renal disease requiring haemodialysis had a 27% increase in daclatasvir AUC and a 20% increase in unbound AUC compared to subjects with normal renal function (see section 4.2).
Danish: Forsøgspersoner med nyresygdom i slutstadiet med behov for hæmodialyse havde en 27% stigning i AUC for daclatasvir og en 20% stigning i ubunden AUC sammenlignet med forsøgspersoner med normal nyrefunktion (se pkt.
English: Pregnancy and contraception requirements
Danish: Graviditet og påkrævet kontraception
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs).
Danish: Samtidig anvendelse af amiodaron blev begrænset ved den kliniske udvikling af sofosbuvir plus direkte virkende antivirale midler.
English: If the starting dose is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (breakpoint 75 kg).
Danish: Hvis stardosis tolereres godt, kan dosis titreres op til maksimalt 1.000 mg (patienter <75 kg) til 1.200 mg (patienter ≥75 kg) dagligt.
English: - If undetectable HCV RNA is achieved, but not at both treatment weeks 4 and 12, Daklinza should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.
Danish: - Hvis der opnås ikke-detekterbart HCV-RNA, men ikke både ved behandlingsuge 4 og 12, bør Daklinza seponeres ved uge 24, og peginterferon alfa og ribavirin bør fortsætte i i alt 48 uger.
English: Daclatasvir was not carcinogenic in mice or in rats at exposures 8-fold or 4-fold, respectively, the clinical AUC exposure.
Danish: Daclatasvir var ikke karcinogent i mus eller rotter ved eksponeringer, der var henholdsvis 8 gange højere eller 4 gange højere end AUC-eksponering.
English: No human data on the effect of daclatasvir on fertility are available.
Danish: Der foreligger ingen data om daclatasvirs virkning på fertilitet hos mennesker.
English: This medicine has been prescribed for you only.
Danish: Lægen har ordineret dette lægemiddel til dig personligt.
English: Lamivudine Zidovudine Emtricitabine Abacavir Didanosine Stavudine
Danish: Lamivudin Zidovudin Emtricitabin Abacavir Didanosin Stavudin
English: Use of highly effective contraception should be continued for 5 weeks after completion of Daklinza therapy (see section 4.5).
Danish: Anvendelse af yderst sikker kontraception bør fortsætte i 5 uger efter ophør med behandling med Daklinza (se pkt.
English: Patients with CP A or B cirrhosis GT 1 or 4
Danish: Patienter med CP A eller B cirrose GT 1 eller 4
English: When Daklinza is used together with sofosbuvir (without ribavirin), the following side effects have been reported.
Danish: Når Daklinza anvendes sammen med sofosbuvir (uden ribavirin), er følgende bivirkninger blevet rapporteret.
English: Patients with CP C cirrhosis
Danish: Patienter med CP C cirrose
English: Sirolimus Mycophenolate mofetil
Danish: Sirolimus Mycophenolatmofetil
English: Non-responders (non-SVR12) with baseline and postbaseline sequence with emergent NS5A RAVs M28: T Q30: H, K, R L31: I, M, V P32-deletion H58: D, P S62: L Y93: C, H, N Patient(s) lost to follow-up One patient considered a protocol failure (non-SVR) achieved SVR *** NS5A RAVs monitored at amino acid positions are 28, 29, 30, 31, 32, 58, 62, 92, and 93
Danish: Ikke-responderende (nonSVR12) med baseline og efter baseline forløb med opstået NS5A-RAV'er M28: T Q30: H, K, R L31: I, M, V P32-sletning H58: D, P S62: L Y93: C, H, N Followup ikke mulig for patient(er) En patient blev anset som at have opnået SVR på grund af en protokolfejl (non-SVR) *** NS5A-RAV'er monitoreret ved aminosyrepositioner er 28, 29, 30, 31, 32, 58, 62, 92 og 93
English: Maternal toxicity including mortality, abortions, adverse clinical signs, decreases in body weight and food consumption was noted in both species at exposures 25-fold (rat) and 72-fold (rabbit) the clinical AUC exposure.
Danish: Maternel toksicitet, herunder mortalitet, aborter, kliniske bivirkninger, nedsat kropsvægt og fødeindtagelse blev set hos begge arter ved eksponering 25 gange (rotte) og 72 gange (kanin) højere end ved klinisk AUCeksponering.
English: Coadministration of Daklinza can alter the concentration of other medicinal products and other medicinal products may alter the concentration of daclatasvir.
Danish: Samtidig administration af Daklinza kan ændre koncentrationen af andre lægemidler, og andre lægemidler kan ændre koncentrationen af daclatasvir.
English: The safety and efficacy of Daklinza in children and adolescents aged below 18 years have not yet been established.
Danish: Daklinzas sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: In repeat-dose toxicology studies in animals, hepatic effects (Kupffer-cell hypertrophy/ hyperplasia, mononuclear cell infiltrates and bile duct hyperplasia) and adrenal gland effects (changes in cytoplasmic vacuolation and adrenal cortical hypertrophy/hyperplasia) were observed at exposures similar or slightly higher than the clinical AUC exposure.
Danish: I toksikologiske studier med gentagne doser blev leverpåvirkninger (Kupffercellehypertrofi/hyperplasi, mononucleære celle-infiltrater og galdevejshyperplasi) og binyrepåvirkninger (ændring i cytoplasmatisk vakuolisering og adrenokortical hypertrofi/hyperplasi) observeret ved eksponering svarende til eller en anelse højere end klinisk AUC-eksponering.
English: If you have any of these side effects, do not drive or use any tools or machines.
Danish: Du må ikke køre bil eller betjene værktøj eller maskiner, hvis du får en eller flere af disse bivirkninger.
English: In study AI444040, 211 adults with HCV genotype 1, 2, or 3 infection and without cirrhosis received daclatasvir and sofosbuvir, with or without ribavirin.
Danish: I AI444040 studiet fik 211 voksne med HCV-genotype 1-, 2- eller 3-infektion og uden cirrose daclatasvir og sofosbuvir med eller uden ribavirin.
English: Daclatasvir is an inhibitor of P-gp, organic anion transporting polypeptide (OATP) 1B1, OCT1 and breast cancer resistance protein (BCRP).
Danish: Daclatasvir hæmmer P-gp, organisk anion-transporterende polypetid (OATP) 1B1, OCT1 og brystcancer-resistent protein (BCRP).
English: When Daklinza is used together with peginterferon alfa and ribavirin the reported side effects are the same as those listed in the package leaflets for these medicines.
Danish: Når Daklinza anvendes sammen med peginterferon alfa og ribavirin, er de rapporterede bivirkninger de samme som de bivirkninger, der er beskrevet i indlægssedlerne for disse lægemidler.
English: Caution should be used when Daklinza is coadministered with rosuvastatin or other substrates of OATP 1B1 or BCRP.
Danish: Der bør udvises forsigtighed ved samtidig administration af Daklinza og rosuvastatin eller andre substrater for OATP1B1 eller BCRP.
English: EU/1/14/939/001 EU/1/14/939/002 EU/1/14/939/003 EU/1/14/939/004 EU/1/14/939/005 EU/1/14/939/006
Danish: EU/1/14/939/004 EU/1/14/939/005 EU/1/14/939/006
English: Refer to the Summary of Product Characteristics of ribavirin.
Danish: Se produktresumeet for ribavirin.
English: In case of non-response to therapy with daclatasvir + peginterferon alfa + ribavirin, NS5A RAVs generally emerged at failure (139/153 genotype 1a and 49/57 genotype 1b).
Danish: I tilfælde af manglende respons på behandlingen med daclatasvir + peginterferon alfa + ribavirin opstod NS5A-RAV'er generelt ved behandlingssvigt (139/153 genotype 1a og 49/57 genotype 1b).
English: A third treatment group in study ALLY-2 included 50 HCV treatment-naïve HIV co-infected patients who received daclatasvir and sofosbuvir for 8 weeks.
Danish: En tredje behandlingsgruppe i ALLY-2-studiet omfattede 50 HCV-behandlingsnaive patienter med samtidig hiv-infektion, som fik daclatasvir og sofosbuvir i 8 uger.
English: Peginterferon alfa 180 µg once weekly and ribavirin 1000 mg or 1200 mg/day in two divided doses (daclatasvir 60 mg once daily)
Danish: Peginterferon alfa 180 µg en gang ugentligt og ribavirin 1000 mg eller 1200 mg/dag i to delte doser (daclatasvir 60 mg en gang dagligt)
English: Close monitoring is recommended if this medicinal product is administered with Daklinza in combination with sofosbuvir (see sections 4.4 and
Danish: Tæt overvågning anbefales, hvis dette lægemiddel administreres med Daklinza i kombination med sofosbuvir (se pkt.
English: HCV replicons expressing daclatasvir-associated resistance substitutions remained fully sensitive to interferon alfa and other anti-HCV agents with different mechanisms of action, such as NS3 protease and NS5B polymerase (nucleoside and non-nucleoside) inhibitors.
Danish: HCV-replikoner, der viste daclatasvir-associeret resistenssubstitutioner, bevarede deres følsomhed over for interferon alfa og andre anti-HCV stoffer med forskellige virkningsmekanismer som f.eks. NS3 protease- og NS5B polymerase (nukleosid og non-nukleosid)-hæmmere.
English: Following multiple oral doses of daclatasvir 60 mg once daily in combination with peginterferon alfa and ribavirin in treatment-naïve patients with genotype 1 chronic HCV, the geometric mean (CV%) daclatasvir Cmax was 1534 (58) ng/ml, AUC0-24h was 14122 (70) ng•h/ml, and Cmin was 232 (83) ng/ml.
Danish: Efter flere orale doser af daclatasvir 60 mg en gang dagligt i kombination med peginterferon alfa og ribavirin hos behandlingsnaive patienter med kronisk genotype 1-HCV var gennemsnitlig (CV%) Cmax for daclatasvir 1534 (58) ng/ml, AUC0-24h var 14122 (70) ng•h/ml, og Cmin var 232 (83) ng/ml.