FrancophonIA/ELRC3.0 huggingface dataset:
English: c. Data from various strains of full length NS5A replicons or chimeric NS5A replicons carrying full-length NS5A genes that contain L31 or M31 polymorphisms.
Danish: c. Data fra forskellige stammer af NS5A-replikoner af fuld længde eller kimære NS5A-replikoner, der bærer NS5A-gener af fuld længde, der indeholder L31 eller M31-polymorfismer.
English: Voxilaprevir is primarily a substrate of CYP3A4 with slow turnover.
Danish: Voxilaprevir er hovedsagligt et substrat for CYP3A4 med langsom omsætning.
English: Effect on fluvastatin, lovastatin, pitavastatin and simvastatin not studied.
Danish: Virkning på fluvastatin, lovastatin, pitavastatin og simvastatin ikke undersøgt.
English: It is recommended to separate antacid and Vosevi administration by 4 hours.
Danish: Det anbefales, at administration af antacida og Vosevi finder sted med 4 timers mellemrum.
English: No human data on the effect of Vosevi on fertility are available.
Danish: Der foreligger ingen data fra mennesker om Vosevis indvirkning på fertilitet.
English: • atazanavir, efavirenz or lopinavir, used to treat HIV infection;
Danish: • atazanavir, efavirenz eller lopinavir, som anvendes til at behandle hiv-infektion
English: The median terminal half-life of voxilaprevir following administration of Vosevi was approximately 33 hours.
Danish: Den mediane terminale halveringstid for voxilaprevir efter administration af Vosevi var ca. 33 timer.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with sofosbuvir/velpatasvir/voxilaprevir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med sofosbuvir/velpatasvir/voxilaprevir i en eller flere undergrupper af den pædiatriske population ved behandling af kronisk hepatitis C (se pkt.
English: The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Danish: Farmakokinetikken for lægemidler, der metaboliseres af leveren (f.eks. immunosuppressiva såsom calcineurinhæmmere) kan blive påvirket af ændringer i leverfunktionen under DAA-behandling, relateret til clearance af HCV.
English: • If it is 18 hours or more after the time you usually take Vosevi, wait and take the next dose at your usual time.
Danish: • Hvis det er 18 timer eller længere efter det tidspunkt, du normalt tager Vosevi, skal du vente og tage den næste dosis på det sædvanlige tidspunkt.
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin
Danish: HMG-CoA-REDUKTASEHÆMMERE Atorvastatin
English: d. Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184. e. Stable cell lines expressing Renilla luciferase-encoding replicons.
Danish: d. Data fra en kimær NS5A-replikon, der bærer NS5A-aminosyrer 9-184. e. Stabile cellelinjer, som udtrykker replikoner, der koder for Renilla luciferase.
English: The NS5B NI RAV S282T was not detected in any patient in POLARIS-2 and POLARIS-3 studies.
Danish: NS5B NI RAV'en S282T blev ikke detekteret hos nogen patienter i POLARIS-2 og POLARIS-3 studierne.
English: No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Danish: Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes race eller køn, for sofosbuvir, GS-331007, velpatasvir eller voxilaprevir.
English: Voriconazole (Inhibition of CYP3A)
Danish: Voriconazol (Hæmning af CYP3A)
English: Haemodialysis is unlikely to result in significant removal of velpatasvir or voxilaprevir since velpatasvir and voxilaprevir are highly bound to plasma proteins.
Danish: Det er ikke sandsynligt, at hæmodialyse medfører, at velpatasvir eller voxilaprevir fjernes i signifikant grad, da velpatasvir og voxilaprevir i høj grad er bundet til plasmaproteiner.
English: • If you notice within 18 hours of the time you usually take Vosevi, you must take the tablet as soon as possible.
Danish: • Hvis du opdager det inden for 18 timer efter det tidspunkt, du normalt tager Vosevi, skal du tage tabletten snarest muligt.
English: Colloidal anhydrous silica Copovidone
Danish: Vandfrit siliciumdioxid Copovidon
English: The median time between prior DAA failure and first dose of Vosevi for patients enrolled into POLARIS-1 was 39 weeks (range: 11 to 299 weeks).
Danish: Gennemsnitstiden mellem før-DAA-svigt og første dosis Vosevi til patienter inkluderet i POLARIS-1 var 39 uger (interval: 11 til 299 uger).
English: Relative to patients with normal hepatic function, the voxilaprevir AUCinf was 299% and 500% higher in patients with moderate and severe hepatic impairment, respectively.
Danish: I forhold til patienter med normal leverfunktion, var voxilaprevirs AUCinf 299 % og 500 % højere hos patienter med hhv. moderat og svært nedsat leverfunktion.
English: Renal impairment No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment.
Danish: Nedsat nyrefunktion Dosisjustering af Vosevi er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: sofosbuvir/velpatasvir/voxilaprevir 12 weeks POLARIS-1 (n = 260)
Danish: sofosbuvir/velpatasvir/voxilaprevir i 12 uger POLARIS-1 (n = 260)
English: h. Administered as sofosbuvir, velpatasvir fixed-dose combination.
Danish: h. Administreret som sofosbuvir, velpatasvir fastdosis kombination.
English: No dose adjustment of Vosevi or tacrolimus is required at initiation of co-administration.
Danish: Dosisjustering af Vosevi eller tacrolimus er ikke nødvendig ved initiering af samtidig administration.
English: No individual RAV tested in genotypes 2a, 4a or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Danish: Ingen individuelle RAV testet i genotype 2a, 4a eller 5a gav en > 100 gange nedsat følsomhed for velpatasvir.
English: The effects of Vosevi during pregnancy are not known.
Danish: Virkningerne af Vosevi på graviditet kendes ikke.
English: Pharmacokinetic interactions
Danish: Farmakokinetisk interaktioner
English: For voxilaprevir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were Q41H, A156V/T/L and D168E/H/Y.
Danish: For voxilaprevir i replikoner fra genotype 1-6 var resistensforbundne substitutioner, der blev selekteret i 2 eller flere genotyper, Q41H, A156V/T/L og D168E/H/Y.
English: • If you are sick (vomit) more than 4 hours after taking Vosevi, you do not need to take another tablet until your next scheduled tablet.
Danish: • Hvis du kaster op mere end 4 timer efter, du har taget Vosevi, skal du ikke tage en anden tablet før din næste skemalagte tablet.
English: HCV/HBV co-infection
Danish: Samtidig infektion med HCV/HBV
English: Patients receiving tenofovir disoproxil fumarate and Vosevi concomitantly should be monitored for adverse reactions associated with tenofovir disoproxil fumarate.
Danish: Patienter, der får tenofovirdisoproxilfumarat og Vosevi samtidig, skal overvåges for bivirkninger forbundet med tenofovirdisoproxilfumarat.
English: Effect on atazanavir and ritonavir exposure not studied.
Danish: Effekt på eksponering for atazanavir og ritonavir ikke undersøgt.
English: In patients with genotype 1a without cirrhosis treated with Vosevi for 8 weeks, outcome was influenced by the following baseline factors: BMI ≥ 30 kg/m2, Q80K/L/R RAVs, IL28B non-CC, HCV RNA ≥ 800,000 IU/mL.
Danish: Hos patienter med genotype 1a uden cirrosebehandling med Vosevi i 8 uger, blev resultatet påvirket af følgende baselinefaktorer: BMI ≥ 30 kg/m2, Q80K/L/R RAV'er, IL28B non-CC, HCV
English: Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Danish: Sofosbuvir og GS-331007 AUC0-24 og Cmax var tilsvarende hos raske voksne personer og patienter med HCV-infektion.
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in patients with moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Danish: I forhold til patienter med normal leverfunktion var sofosbuvirs AUC0-24 126 % og 143 % højere hos patienter med moderat og svært nedsat leverfunktion, mens AUC0-24 af GS-331007 var hhv. 18 % og 9 % højere.
English: SVR12 was achieved in 18 of 19 (95%) patients who had baseline NS5B NI RAVs in POLARIS-1, including 2 patients who had virus with the S282T NS5B NI RAV in addition to NS5A RAVs at baseline.
Danish: SVR12 blev opnået hos 18 ud af 19 (95 %) patienter, som havde NS5B NI RAV'er ved baseline i POLARIS-1, herunder 2 patienter, som havde virus med S282T NS5B NI RAV'en foruden NS5A RAV'er ved baseline.
English: Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Danish: Hver filmovertrukket tablet indeholder 400 mg sofosbuvir, 100 mg velpatasvir og 100 mg voxilaprevir.
English: In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a, and 4a.
Danish: I en biokemisk analyse hæmmede GS-461203 polymerase-aktiviteten af rekombinant NS5B fra HCV-genotype 1b, 2a, 3a og 4a.
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);
Danish: • carbamazepin, phenobarbital og phenytoin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald)
English: • digoxin, used to treat heart conditions;
Danish: • digoxin, som anvendes til at behandle hjertesygdomme
English: It is unknown whether sofosbuvir, metabolites of sofosbuvir, velpatasvir or voxilaprevir are excreted in human milk.
Danish: Det er ukendt, om sofosbuvir, sofosbuvirs metabolitter, velpatasvir eller voxilaprevir udskilles i human mælk.
English: Mean ratio (90% confidence interval)a,b Recommendation concerning co-administration with Vosevi
Danish: Middelratio (90 % konfidensinterval)a, b
English: • being sick (vomiting)
Danish: • føle sig dårlig (kvalme)
English: b. Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing.
Danish: b. Der blev anvendt stabile kimære 1b-replikoner, der bærer NS5B-gener fra genotype 2b, 5a eller 6a, til testningen.
English: Vosevi has been shown to increase tenofovir exposure (P-gp inhibition).
Danish: Det er vist, at Vosevi øger tenofovireksponering (P-gp-hæmning).
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil and a silica gel desiccant.
Danish: Beholder af højdensitetspolyethylen (HDPE) med et børnesikret lukke af polypropylen, som indeholder 28 filmovertrukne tabletter med en polyesterspiral og et silicagel-tørremiddel.
English: The efficacy of Vosevi (sofosbuvir [SOF]/velpatasvir [VEL]/voxilaprevir [VOX]) was evaluated in four Phase 3 studies, two studies in DAA-experienced patients and two studies in DAA-naïve patients with, genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis, as summarised in Table 8.
Danish: Virkningen af Vosevi (sofosbuvir [SOF]/velpatasvir [VEL]/voxilaprevir [VOX]) blev evalueret i fire fase III-studier, to studier hos DAA-behandlingserfarne patienter og to studier hos DAAbehandlingsnaive patienter med genotype 1- til 6-HCV-infektion uden cirrose eller med kompenseret cirrose, som opsummeret i tabel 8.
English: The safety of tenofovir disoproxil fumarate in the setting of Vosevi and a pharmacokinetic enhancer has not been established.
Danish: Tenofovirdisoproxilfumarats sikkerhed ved anvendelse sammen med Vosevi og en farmakokinetisk forstærker er ikke klarlagt.
English: Body weight did not have a clinically significant effect on sofosbuvir, velpatasvir or voxilaprevir exposure according to a population pharmacokinetic analysis.
Danish: Legemsvægt havde ikke nogen klinisk signifikant indvirkning på eksponeringen for sofosbuvir, velpatasvir eller voxilaprevir i henhold til en populationsfarmakokinetisk analyse.
English: • dabigatran (a medicine used to prevent blood clots);
Danish: • dabigatran (medicin, der anvendes til at forebygge blodpropper)
English: However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.5 fold the human exposure at recommended clinical dose.
Danish: Der sås dog en mulig teratogen virkning hos kaniner, hvor der sås en stigning i samlede viscerale misdannelser hos dyr, der blev udsat for AUC-eksponeringer på op til 0,5 gange den humane eksponering ved den anbefalede kliniske dosis.
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 Vosevi.
Danish: På grund af amiodarons lange halveringstid skal patienter, som inden for de seneste par måneder har stoppet behandling med amiodaron, og som skal sættes i behandling med Vosevi, monitoreres på passende vis.
English: ANTIMYCOBACTERIALS Rifampicin (single dose)
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifampicin (enkeltdosis)
English: R-methadon e
Danish: Observeret: R-methadon
English: Velpatasvir was not carcinogenic in the 26-week transgenic mouse and 2-year rat carcinogenicity studies at exposures up to 67- and 5-times higher than human exposure, respectively.
Danish: Velpatasvir var ikke karcinogen i det transgene musestudie på 26 uger og i de 2-årige karcinogenicitetsstudier med rotter ved eksponeringer på op til hhv. 67 og 5 gange højere end den humane eksponering.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Danish: Der er set tilfælde af svær bradykardi og hjerteblok ved anvendelse af regimer, der indeholder sofosbuvir, i kombination med amiodaron med eller uden andre lægemidler, der nedsætter hjertefrekvensen.
English: (Increase in gastric pH decreases velpatasvir solubility)
Danish: (Øget gastrisk pH reducerer opløseligheden af velpatasvir)
English: Adults previously treated with sofosbuvir/velpatasvir-containing regimens Vosevi for 12 weeks was evaluated in patients who were previously treated with a sofosbuvir/velpatasvir-containing regimen.
Danish: Voksne, der tidligere er blevet behandlet med regimer, der indeholder sofosbuvir/velpatasvir Vosevi blev evalueret i 12 uger hos patienter, som tidligere var blevet behandlet med et regime, der indeholder sofosbuvir/velpatasvir.
English: Paediatric population The pharmacokinetics of Vosevi in paediatric patients have not been established (see section 4.2).
Danish: Pædiatrisk population Farmakokinetikken af Vosevi hos pædiatriske patienter er ikke klarlagt (se pkt.
English: Voxilaprevir had no adverse effects on mating and fertility.
Danish: Voxilaprevir havde ingen negative virkninger på parring og fertilitet.
English: DAA-naïve patients, GT 1, 2, 4, 5, or 6, with or without cirrhosis GT 3 without cirrhosis
Danish: DAAbehandlingsnaive patienter, GT 1, 2, 4, 5, eller 6, med eller uden cirrose GT 3 uden cirrose
English: Clinically significant medicinal product interactions with Vosevi mediated by P-gp, BCRP and CYP inhibitors are not expected.
Danish: Klinisk signifikante lægemiddelinteraktioner med Vosevi medieret af P-gp, BCRP, og CYP-hæmmere forventes ikke.
English: DAA: direct-acting antiviral agent * In clinical trials the DAA experienced patients had been exposed to combination regimens containing any of the following: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir, voxilaprevir (administered with sofosbuvir and velpatasvir for less than 12 weeks)
Danish: DAA: direkte virkende antiviralt middel *I kliniske forsøg blev DAA-behandlingserfarne patienter eksponeret for blandingsregimer, der indeholdt noget af følgende: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, partaprevir, sofosbuvir, velpatasvir, voxilaprvir (administreret med sofosbuvir og velpatasvir i mindre end 12 uger)
English: DAA-experienced patients (who have not received an NS5A inhibitor), GT1-6, with or without cirrhosis
Danish: DAAbehandlingserfarne patienter (som ikke har fået en NS5Ahæmmer), GT1-6, med eller uden cirrose
English: Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1200 mg. Velpatasvir AUC increases in a greater than proportional manner from 5 to 50 mg and in a less than proportional manner from 50 to 450 mg, indicating velpatasvir absorption is solubility limited.
Danish: AUC for sofosbuvir og GS-331007 er næsten proportional med dosis over doseringsintervallet fra 200 mg til 1200 mg. AUC for velpatasvir steg mere end proportionalt fra 5 til 50 mg og mindre end proportionalt fra 50 til 450 mg.
English: velpatasvir (400/100 mg once daily)f, h
Danish: velpatasvir (400/100 mg én gang dagligt)f, h
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑
Danish: GS-331007 1,6 gange↑ 1,9 gange↑ 5,5 gange↑ ≥ 10 gange↑
English: If vomiting occurs more than 4 hours after dosing, no further dose of Vosevi is needed (see section 5.1).
Danish: Hvis de kaster op mere end 4 timer efter dosering, er det ikke nødvendigt at tage en ekstra dosis af Vosevi (se pkt.
English: The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir/voxilaprevir, its components (sofosbuvir, velpatasvir, and/or voxilaprevir), or are predicted medicinal product interactions that may occur with Vosevi.
Danish: De beskrevne lægemiddelinteraktioner er baseret på studier udført med enten sofosbuvir/velpatasvir/voxilaprevir, deres indholdsstoffer (sofusbuvir, velpatasvir og/eller voxilaprevir), eller er forventede lægemiddelinteraktioner, der kan opstå med Vosevi.
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 85 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter viste, at inden for det analyserede aldersinterval (18 til 85 år) havde alder ingen klinisk relevant indvirkning på eksponeringen for sofosbuvir, GS-331007, velpatasvir eller voxilaprevir.
English: Sofosbuvir was not carcinogenic in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 17 and 10-times higher, respectively than human exposure.
Danish: Sofosbuvir var ikke karcinogen i de 2-årige karcinogenicitetsstudier hos mus og rotter ved GS331007-eksponeringer op til hhv. 17 og 10 gange højere end den humane eksponering.
English: a. One patient with undetermined genotype achieved SVR12.
Danish: a. En patient med ubestemt genotype opnåede SVR12.
English: Observed: Efavirenz Sofosbuvir
Danish: Observeret: Efavirenz Sofosbuvir
English: The pharmacokinetic properties of sofosbuvir, GS-331007, velpatasvir and voxilaprevir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C.
Danish: De farmakokinetiske egenskaber for sofosbuvir, GS-331007, velpatasvir og voxilaprevir er blevet evalueret hos raske voksne personer og hos patienter med kronisk hepatitis C.
English: The safety assessment of Vosevi was based on data from Phase 2 and 3 clinical trials in which 1383 patients received sofosbuvir/velpatasvir/voxilaprevir or sofosbuvir/velpatasvir + voxilaprevir for 8 or 12 weeks.
Danish: Sikkerhedsvurderingen af Vosevi blev baseret på data fra kliniske fase II- og III- studier, hvori 1383 patienter fik sofosbuvir/velpatasvir/voxilaprevir eller sofosbuvir/velpatasvir + voxilaprevir i 8 eller 12 uger.
English: The pharmacokinetics of voxilaprevir have not been studied in subjects with ESRD requiring dialysis (see section 4.2).
Danish: Farmakokinetikken af voxilaprevir er ikke blevet undersøgt hos forsøgspersoner med ESRD, som kræver dialyse (se pkt.
English: Famotidine dosed simultaneously with Vosevi
Danish: Famotidin doseret samtidig med Vosevi
English: Animal studies do not indicate harmful effects of sofosbuvir, velpatasvir or voxilaprevir on fertility.
Danish: Dyrestudier indikerer ingen skadelige virkninger af sofosbuvir, velpatasvir eller voxilaprevir på fertilitet.
English: • The active substances are sofosbuvir, velpatasvir and voxilaprevir.
Danish: • Aktive stoffer: sofosbuvir, velpatasvir og voxilaprevir.
English: Package leaflet: Information for the user Vosevi 400 mg/100 mg/100 mg film-coated tablets sofosbuvir/velpatasvir/voxilaprevir This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Vosevi 400 mg/100 mg/100 mg filmovertrukne tabletter sofosbuvir/velpatasvir/voxilaprevir Dette lægemiddel er underlagt supplerende overvågning.
English: The median terminal half-life of velpatasvir following administration of Vosevi was approximately 17 hours.
Danish: Den mediane terminale halveringstid for velpatasvir efter administration af Vosevi var ca. 17 timer.
English: When Vosevi or its components taken together were administered with food, sofosbuvir AUC0-inf and Cmax were 64% to 144% and 9% to 76% higher, respectively; velpatasvir AUC0-inf and Cmax were 40% to 166% and 37% to 187% higher, respectively; and voxilaprevir AUC0-inf and Cmax were 112% to 435% and 147% to 680% higher, respectively.
Danish: 64 % til 144 %, og 9 % til 76 % højere; AUC0-inf og Cmax for velpatasvir var hhv. 40 % til 166 %, og 37 % til 187 % højere; og AUC0-inf og Cmax for voxilaprevir var hhv. 112 % til 435 % og 147 % til 680 % højere.
English: Vosevi is not recommended in patients with moderate or severe hepatic impairment (CPT Class B or C) (see section 5.2).
Danish: Vosevi frarådes hos patienter med moderat eller svært nedsat leverfunktion (CPT klasse B eller C) (se pkt.
English: Voxilaprevir is active in vitro against most of the NS3 RAVs that confer resistance to first generation NS3/4A protease inhibitors.
Danish: Voxilaprevir er aktiv in vitro mod de fleste NS3 RAV'er, der er forbundet med resistens over for første-generations NS3/4A-proteasehæmmere.
English: • rifapentine (an antibiotic used to treat infections, including tuberculosis);
Danish: • rifapentin (et antibiotikum, der anvendes til behandling af infektioner, herunder tuberkulose)
English: Velpatasvir plasma exposure (AUCinf) was similar in patients with moderate hepatic impairment, severe hepatic impairment, and control subjects with normal hepatic function.
Danish: Velpatasvirs samlede plasmaeksponering (AUCinf) var sammenlignelig hos patienter med moderat nedsat leverfunktion, svært nedsat leverfunktion, og kontrolpersoner med normal leverfunktion.
English: Famotidine dosed 12 hours prior to Vosevi
Danish: Famotidin doseret 12 timer før Vosevi
English: Impact of DAA therapy on drugs metabolized by the liver
Danish: Indvirkning af DAA-behandling på lægemidler, der metaboliseres af leveren
English: The potential risks and benefits associated with co-administration of Vosevi with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Danish: De mulige risici og fordele forbundet med administration af Vosevi sammen med fastdosis-kombinationstabletter, der indeholder elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller tenofovirdisoproxilfumarat, givet sammen med en boostet hiv-proteasehæmmer (f.eks. darunavir) bør overvejes, især hos patienter med øget risiko for renal dysfunktion.
English: No individual RAV tested in genotypes 2b, 5a or 6a conferred a > 100-fold reduction in voxilaprevir susceptibility.
Danish: Ingen individuelle RAV testet i genotype 2b, 5a eller 6a gav en > 100 gange nedsat følsomhed for voxilaprevir.