FrancophonIA/ELRC3.0 huggingface dataset:
English: EE/Levonorgestrel 20 µg/100 µg once daily
Danish: EE/levonorgestrel 20 µg/100 µg én gang dagligt
English: Pibrentasvir was the only component observed in the milk of lactating rats without effect on nursing pups.
Danish: Pibrentasvir, der var den eneste komponent i mælken hos diegivende rotter, havde ingen indvirkning på de diende unger.
English: Pibrentasvir bioavailability when coadministered with glecaprevir is 3-fold of pibrentasvir alone.
Danish: Pibrentasvirs biotilgængelighed ved samtidig administration af glecaprevir er 3 gange så stor som ved administration af pibrentasvir alene.
English: The overall SVR12 rate was 100% (47/47).
Danish: Den samlede SVR12-rate var 100% (47/47).
English: Subjects were randomized (2:1) to either Maviret for 12 weeks or the combination of sofosbuvir and daclatasvir for 12 weeks; subsequently the study included a third arm (which was nonrandomized) with Maviret for 8 weeks.
Danish: Forsøgspersonerne blev randomiseret (2:1) til enten Maviret i 12 uger eller en kombination af sofosbuvir og daclatasvir i 12 uger; efterfølgende inkluderedes en tredje (ikkerandomiseret) gruppe, som fik Maviret i 8 uger.
English: − Tablet film-coating: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, iron oxide red (E172).
Danish: − Filmovertræk: hypromellose (E464), lactosemonohydrat, titandioxid, macrogol 3350, rød jernoxid (E172).
English: If more than 18 hours have passed since Maviret is usually taken, the missed dose should not be taken and the patient should take the next dose per the usual dosing schedule.
Danish: Hvis der er gået mere end 18 timer siden det tidspunkt, hvor patienten normalt tager sin dosis Maviret, må den manglende dosis ikke tages, idet patienten skal vente til den efterfølgende dosis i henhold til doseringsplanen.
English: Elvitegravir/cobicist at/emtricitabine/ tenofovir alafenamide
Danish: Elvitegravir/ cobicistat/ emtricitabin/ tenofoviralafenamid
English: Propylene glycol monocaprylate (Type II) Croscarmellose sodium
Danish: Propylenglycolmonocaprylat (type II) Croscarmellosenatrium
English: substitutions at these positions showed reductions in susceptibility to pibrentasvir.
Danish: Nogle kombinationer af NS5A-substitutioner ved disse positioner viste reduktion i følsomheden over for pibrentasvir.
English: A 16-week treatment duration should be considered in genotype 3-infected patients who are treatment experienced with peg-IFN + ribavirin +/sofosbuvir, or sofosbuvir + ribavirin.
Danish: Behandling i 16 uger bør overvejes hos patienter med genotype 3, der er behandlingserfarne med peginterferon + ribavirin +/- sofosbuvir eller sofosbuvir + ribavirin.
English: (CYP3A4 and P-gp inhibition)
Danish: (CYP3A4- og P-gphæmning)
English: 16 weeks
Danish: 16 uger
English: Glecaprevir and pibrentasvir are not significantly removed by haemodialysis.
Danish: Glecaprevir og pibrentasvir fjernes ikke i nævneværdig grad ved hæmodialyse.
English: Maviret contains lactose.
Danish: Maviret indeholder lactose.
English: • carbamazepine, phenobarbital, phenytoin, primidone (normally used for epilepsy)
Danish: • carbamazepin, phenobarbital, phenytoin, primidon (mod epilepsi)
English: Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir.
Danish: Lægemidler, der hæmmer OATP1B1/3 (f.eks. elvitegravir, ciclosporin, darunavir, lopinavir), øger den systemiske koncentration af glecaprevir.
English: Pibrentasvir AUC increased in a greater than dose-proportional manner at doses up to 120 mg, (over 10-fold exposure increase at 120 mg QD compared to 30 mg QD), but exhibited linear pharmacokinetics at doses ≥ 120 mg.
Danish: AUC for pibrentasvir steg mere end dosisproportionalt ved doser på op til 120 mg (over 10 gange større eksponering ved 120 mg én gang dagligt end ved 30 mg én gang dagligt), mens der sås lineær farmakokinetik ved doser ≥ 120 mg.
English: Treatment difference -1.2%; 95% confidence interval (-5.6% to 3.1%) Treatment difference -0.4%; 97.5% confidence interval (-5.4% to 4.6%) Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb a. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Danish: Behandlingsforskel -1,2 %; 95 %-konfidensinterval (-5,6 % til 3,1 %) Behandlingsforskel -0,4 %; 97,5 %-konfidensinterval (-5,4 % til 4,6 %) Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidiva Andetb a Recidiv defineres som HCV-RNA ≥ LLOQ efter respons ved afsluttet behandling hos dem, der gennemførte behandlingen.
English: In a pooled analysis of treatment naïve patients without cirrhosis (including Phase 2 and 3 data) where SVR12 was assessed according to the presence of baseline A30K, a numerically lower SVR12 rate was achieved in patients with A30K treated for 8 weeks as compared to those treated for 12 weeks [78% (14/18) vs 93% (13/14)].
Danish: I en samlet analyse af behandlingsnaive patienter uden cirrose (herunder data fra fase 2 og 3), hvor SVR12 blev vurderet hos patienter med A30K ved baseline, blev der opnået en numerisk lavere SVR12-rate hos dem, der blev behandlet i 8 uger, end hos dem, der blev behandlet i 12 uger [78 % (14/18) vs. 93 % (13/14)].
English: Studies in treatment-naïve and peginterferon (pegIFN), ribavirin (RBV) and/or sofosbuvir treatmentexperienced subjects with or without cirrhosis
Danish: Studier med behandlingsnaive og peginterferon (pegIFN)-, ribavirin(RBV)- og/eller sofosbuvirerfarne forsøgspersoner med eller uden cirrose
English: Maviret is an antiviral medicine used to treat adults and adolescents (12 to less than 18 years old) with long-term (‘chronic') hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Danish: Maviret er et lægemiddel mod virus (et antiviralt lægemiddel), der anvendes til behandling af voksne og unge (fra 12 til under 18 år) med kronisk hepatitis C (en smitsom leversygdom, som forårsages af hepatitis C-virus).
English: Clinical Study in Subjects with Genotype 5 or 6 Infection ENDURANCE-5,6 was an open-label study in 84 HCV GT5 (N=23) or 6-infected (N=61) TN or TEPRS subjects.
Danish: Klinisk studie hos forsøgspersoner med genotype 5 eller 6-infektion ENDURANCE-5,6 var et åbent studie med 84 HCV GT5 (N = 23) eller 6-inficerede (N = 61) BNeller BE-PRS-personer.
English: Among the 2 genotype 2-infected subjects, no treatment-emergent substitutions were observed in NS3 or NS5A (the M31 polymorphism in NS5A was present at baseline and post-treatment in both subjects).
Danish: Hos de 2 forsøgspersoner med genotype 2-infektion sås ingen behandlingsrelaterede substitutioner i NS3 eller NS5A (M31-polymorfismen i NS5A var til stede ved baseline og efter behandlingen hos dem begge).
English: Maviret 8 weeks N=157
Danish: Maviret 8 uger N = 157
English: Maviret is available in a pack of 84 tablets as 4 cartons, each containing 21 film-coated tablets.
Danish: Maviret fås i en pakning med 84 tabletter pakket i 4 æsker, der hver indeholder 21 filmovertrukne tabletter.
English: Expected: ↓ glecaprevir and ↓ pibrentasvir
Danish: Forventet: ↓ glecaprevir og ↓ pibrentasvir
English: The SVR12 rate in TN or TE-PRS HCV/HIV-1 co-infected subjects treated for 8 or 12 weeks (without cirrhosis and with compensated cirrhosis, respectively) was 98.2% (165/168) from ENDURANCE-1 and EXPEDITION-2.
Danish: SVR12-raten i TN eller TE-PRS HCV/HIV-1-smittede forsøgspersoner behandlet i 8 eller 12 uger (henholdvis uden cirrose og med kompenseret cirrose) var 98,2% (165/168) fra ENDURANCE-1 og EXPEDITION-2.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of glecaprevir or pibrentasvir in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af glecaprevir og pibrentasvir til gravide kvinder (data fra færre end 300 graviditeter).
English: TN=treatment naïve, PRS-TE=treatment experienced (includes previous treatment that included pegIFN (or IFN), and/or RBV and/or sofosbuvir), PI=Protease Inhibitor, CKD=chronic kidney disease a. Included 33 subjects co-infected with HIV-1.
Danish: BN = behandlingsnaive, PRS-BE = behandlingserfarne (omfatter tidligere behandling med pegIFN (eller IFN) og/eller RBV og/eller sofosbuvir), PI = proteasehæmmer, CKD = kronisk nyresygdom a. Omfattede 33 forsøgspersoner med samtidig HIV-1
English: ANTICONVULSANTS Carbamazepine 200 mg twice daily
Danish: ANTIKONVULSIVA Carbamazepin 200 mg to gange dagligt
English: Studies VOYAGE-1 and VOYAGE-2 were conducted in China, Singapore, and South Korea in HCV genotype 1-6 subjects without cirrhosis (VOYAGE-1) or with compensated cirrhosis (VOYAGE-2) that were treatmentnaïve (TN) or treatment-experienced to combinations of interferon, peg-interferon, ribavirin and/or sofosbuvir (TE-PRS).
Danish: VOYAGE-1 og VOYAGE2 studierne blev udført i Kina, Singapore og Sydkorea i HCV genotype 1-6 forsøgspersoner uden cirrose (VOYAGE-1) eller med kompenseret cirrose (VOYAGE-2), der var behandlingsnaive (BN) eller behandlingserfarne med kombinationer af interferon, peg-interferon, ribavirin og/eller sofosbuvir (BE-PRS).
English: Tacrolimus 1 mg single dose
Danish: Tacrolimus 1 mg enkeltdosis
English: Table 1: Recommended Maviret treatment duration for patients without prior HCV therapy Genotype
Danish: Tabel 1: Anbefalet behandlingsvarighed af Maviret hos patienter, der ikke tidligere er blevet behandlet for HCV
English: The ability to assess the impact of baseline polymorphisms in NS5A was limited among treatment-naïve subjects with cirrhosis and treatment-experienced subjects due to low prevalence of A30K (1.6%, 2/128) or Y93H (3.9%,
Danish: Muligheden for at vurdere indvirkningen af baseline-polymorfismer i NS5A var begrænset blandt de behandlingsnaive forsøgspersoner med cirrose og de behandlingserfarne forsøgspersoner på grund af en lav forekomst af A30K (1,6 %, 2/128) og Y93H (3,9 %, 5/128).
English: Three GT3b TN subjects experienced relapse and two GT3b TEPRS subjects experienced on-treatment virologic failure.
Danish: Tre GT3b BNforsøgspersoner oplevede tilbagefald, og to GT3b BE-PRS-forsøgspersoner oplevede virologisk svigt mens de var i behandling.
English: Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘NXT'.
Danish: Lyserøde, aflange, bikonvekse, filmovertrukne tabletter på 18,8 mm x 10,0 mm, præget på den ene side med "NXT".
English: film-coated tablets 84 (4 x 21) film-coated tablets
Danish: filmovertrukne tabletter 84 (4 x 21) filmovertrukne tabletter
English: All subjects without cirrhosis or with compensated cirrhosis received 8 or 12 weeks of Maviret, respectively, except GT3 TE-PRS subjects who received 16 weeks of Maviret.
Danish: Alle forsøgspersoner uden cirrose eller med kompenseret cirrose fik henholdsvis 8 eller 12 ugers behandling med Maviret, undtagen GT3 BE-PRS forsøgspersoner, som fik Maviret i 16 uger.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral 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: Effect of baseline HCV amino acid polymorphisms on treatment response A pooled analysis of treatment-naïve and pegylated interferon, ribavirin and/or sofosbuvir treatmentexperienced subjects receiving Maviret in the Phase 2 and Phase 3 clinical studies was conducted to explore the association between baseline polymorphisms and treatment outcome and to describe substitutions seen upon virologic failure.
Danish: Indvirkning af HCV-aminosyrepolymorfismer ved baseline på behandlingsrespons Der blev gennemført en puljet analyse af behandlingsnaive og peginterferon-, ribavirin- og/eller sofosbuvir-erfarne forsøgspersoner, der fik Maviret i de kliniske fase 2- og fase 3-studier, for at undersøge sammenhængen mellem polymorfismer ved baseline og behandlingsresultatet og for at beskrive de substitutioner, der ses efter virologisk svigt.
English: Maviret 12 weeks N=233
Danish: Maviret 12 uger N = 233
English: Both glecaprevir and pibrentasvir inhibit the bile salt export pump (BSEP) in vitro.
Danish: Både glecaprevir og pibrentasvir hæmmer galdesalteksportpumpen (BSEP) in vitro.
English: Animal studies do not indicate harmful effects of glecaprevir or pibrentasvir on fertility at exposures higher than the exposures in humans at the recommended dose (see Section 5.3).
Danish: Dyreforsøg med glecaprevir og pibrentasvir indikerer ingen skadelige virkninger på fertiliteten ved eksponeringer, der ligger over eksponeringen hos mennesker ved den anbefalede dosis (se pkt.
English: Purpose of the medicine ciclosporin, tacrolimus to suppress the immune system darunavir, efavirenz, lopinavir, ritonavir for HIV infection digoxin for heart problems fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol warfarin and other similar medicines*
Danish: Lægemidlet tages/gives ciclosporin, tacrolimus for at undertrykke immunsystemet darunavir, efavirenz, lopinavir, ritonavir mod hiv digoxin mod hjerteproblemer fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin mod forhøjet kolesterol warfarin og lignende lægemidler*
English: Potential for other medicinal products to affect Maviret
Danish: Andre lægemidler, der kan påvirke Maviret
English: No dose adjustment of Maviret is required in patients with mild hepatic impairment (Child-Pugh A).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let nedsat leverfunktion (Child-Pugh A).
English: SURVEYOR-2 Part 3 was an open-label study randomizing non-cirrhotic treatment-experienced subjects to 12- or 16-weeks of treatment; in addition, the study evaluated the efficacy of Maviret in subjects with compensated cirrhosis and genotype 3 infection in two dedicated treatment arms using 12-week (treatment-naïve only) and 16-week (treatmentexperienced only) durations.
Danish: SURVEYOR-2 del 3 er et åbent studie, hvor ikkecirrotiske, behandlingserfarne forsøgspersoner blev randomiseret til 12 eller 16 ugers behandling; derudover vurderedes Mavirets virkning hos forsøgspersoner med kompenseret cirrose og HCV genotype 3 i to dedikerede behandlingsgrupper, der fik henholdsvis 12 ugers behandling (kun behandlingsnaive) og 16 ugers behandling (kun behandlingserfarne).
English: The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg tablets), taken orally, once daily with food (see section 5.2).
Danish: Den anbefalede orale dosis Maviret er 300 mg/120 mg (tre 100 mg/40 mg)-tabletter én gang dagligt sammen med mad (se pkt.
English: − Tablet core: copovidone (Type K 28), vitamin E polyethylene glycol succinate, silica, anhydrous colloidal, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate.
Danish: − Tabletkerne: copovidon (type K 28), vitamin E polyethylenglycolsuccinat, vandfri kolloid silica, propylenglycolmonocaprylat (type II), croscarmellosenatrium, natriumstearylfumarat.
English: Substitutions important for the HCV protease inhibitor class at positions 36, 43, 54, 55, 56, 155, 166, or 170 in NS3 had no impact on glecaprevir activity.
Danish: Substitutioner, der har betydning for klassen af HCV-proteasehæmmere ved NS3-position 36, 43, 54, 55, 56, 155, 166 eller 170, havde ingen indvirkning på aktiviteten af glecaprevir.
English: ↑ losartan carboxylic acid
Danish: ↑ losartan carboxylsyre
English: Treatment-naïve with cirrhosis
Danish: Behandlingsnaive med cirrose
English: Relative to healthy subjects (N=230), population estimates of AUC24, ss were similar (10% difference) for glecaprevir and 34% lower for pibrentasvir in HCV-infected patients without cirrhosis.
Danish: Sammenholdt med raske forsøgspersoner (N = 230) var populationsestimater for AUC24, ss for glecaprevir næsten de samme (10 % forskel) og 34 % lavere for pibrentasavir hos HCV-smittede patienter uden cirrose; AUC24,ss..
English: ANTICOAGULANTS Dabigatran etexilate 150 mg single dose
Danish: ANTIKOAGULANTIA Dabigatranetexilat 150 mg enkeltdosis
English: Vitamin E (tocopherol) polyethylene glycol succinate Silica, colloidal anhydrous
Danish: Vitamin E (tocoferol) polyethylenglycolsuccinat Vandfri kolloid silica
English: Co-administration with atazanavir is contraindicated due to the risk of ALT elevations (see section 4.3).
Danish: Samtidig administration af atazanavir er kontraindiceret pga. risikoen for forhøjet ALAT (se pkt.
English: Unchanged glecaprevir was the main component observed in the milk of lactating rats without effect on nursing pups.
Danish: Uomdannet glecaprevir, der var den primære komponent i mælken hos diegivende rotter, havde ingen indvirkning på de diende unger.
English: Glecaprevir and pibrentasvir were not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rodent micronucleus assays.
Danish: Glecaprevir og pibrentasvir var ikke genotoksiske i en række af in vitro- og in vivo-analyser, der bl.a. omfattede bakteriel mutagenicitet, kromosomafvigelse i lymfocytter fra humant perifert blod og in vivo-analyser af mikronukleus hos gnavere.
English: In case a dose of Maviret is missed, the prescribed dose can be taken within 18 hours after the time it was supposed to be taken.
Danish: Hvis en patient glemmer at tage en dosis Maviret, kan den ordinerede dosis tages op til 18 timer efter det planlagte tidspunkt.
English: Table 9: SVR12 in treatment-naïve, genotype 3-infected subjects without cirrhosis (ENDURANCE-3)
Danish: Tabel 9: SVR12 hos behandlingsnaive forsøgspersoner med HCV genotype 3 uden cirrose (ENDURANCE-3)
English: Overall SVR12 Rate from the Clinical Studies in Treatment-Naïve or Treatment-Experienced Subjects with or without Cirrhosis
Danish: Samlet SVR12 rate fra kliniske studier i behandlingsnaive eller behandlingserfarne forsøgspersoner med eller uden cirrose
English: Genotype 1
Danish: Genotype 1a
English: Maviret tablets are pink, oblong, curved on both sides (biconvex), film-coated tablets with dimensions of 18.8 mm x 10.0 mm and debossed on one side with ‘NXT'.
Danish: Maviret-tabletter er lyserøde, aflange, udadbuede (bikonvekse), filmovertrukne tabletter på 18,8 mm x 10,0 mm og præget på den ene side med "NXT".
English: The safety assessment of Maviret in subjects treated for 8, 12 or 16 weeks with compensated liver disease (with or without cirrhosis) was based on registrational Phase 2 and 3 studies which evaluated approximately 2,300 subjects.
Danish: Vurderingen af Mavirets sikkerhed hos forsøgspersoner med kompenseret leversygdom (med eller uden cirrose), der blev behandlet i 8, 12 eller 16 uger, var baseret på fase 2 og 3-registreringsstudier med i alt ca. 2.300 forsøgspersoner.
English: Baseline polymorphisms relative to a subtype-specific reference sequence at amino acid positions 155, 156, and 168 in NS3, and 24, 28, 30, 31, 58, 92, and 93 in NS5A were evaluated at a 15% detection threshold by next-generation sequencing.
Danish: Polymorfismer ved baseline, der var relateret til en undertypespecifik referencesekvens ved aminosyreposition 155, 156 og 168 i NS3 samt 24, 28, 30, 31, 58, 92 og 93 i NS5A, blev vurderet med en detektionstærskel på 15 % ved hjælp af næstegenerationssekventering.
English: In population pharmacokinetic analysis of HCV-infected subjects, 86% higher glecaprevir and 54% higher pibrentasvir AUC were observed for subjects with end stage renal disease, with or without dialysis, compared to subjects with normal renal function.
Danish: Ved farmakokinetisk populationsanalyse hos HCV-smittede forsøgspersoner var AUC for glecaprevir 86 % højere og AUC for pibrentasvir 54 % højere hos forsøgspersoner med terminal nyresygdom, med eller uden dialyse, end hos forsøgspersoner med normal nyrefunktion.
English: • The active substances are glecaprevir and pibrentasvir.
Danish: • Aktive stoffer: glecaprevir og pibrentasvir.
English: PVC/PE/PCTFE aluminium foil blister packs.
Danish: Blisterpakninger fremstillet af PVC/PE/PCTFE-aluminiumsfolie.
English: Maviret is not recommended for the re-treatment of patients with prior exposure to NS3/4A- and/or NS5A-inhibitors.
Danish: Maviret anbefales ikke til fornyet behandling hos patienter, der tidligere er blevet eksponeret for både NS3/4A- og/eller NS5A-hæmmere.
English: Population pharmacokinetic analysis demonstrated that following administration of Maviret in HCVinfected subjects with compensated cirrhosis, exposure of glecaprevir was approximately 2-fold and pibrentasvir exposure was similar to non-cirrhotic HCV-infected subjects.
Danish: En farmakokinetisk populationsanalyse har vist, at eksponeringen for glecaprevir efter administration af Maviret hos HCV-smittede forsøgspersoner med kompenseret cirrose var dobbelt så stor som hos ikke-cirrotiske HCV-smittede forsøgspersoner, og at eksponeringen for pibrentasvir var den samme.
English: One TN GT5-infected subject without cirrhosis experienced relapse, and one TN GT6-infected subject with compensated cirrhosis experienced ontreatment virologic failure.
Danish: Én BN GT5-inficeret forsøgsperson uden cirrose oplevede recidiv, og én BN GT6-inficeret forsøgsperson med kompenseret cirrose oplevede virologisk svigt under behandling.
English: (Inhibition of P-gp)
Danish: (Hæmning af P-gp)
English: Subjects were either treatment-naïve or treatment-experienced to combinations of (peg) interferon, ribavirin, and/or sofosbuvir and received Maviret for 8, 12, or 16 weeks per approved treatment durations.
Danish: Forsøgspersonerne var enten behandlingsnaive eller behandlingserfarne med kombinationer af (peg-) interferon, ribavirin og / eller sofosbuvir og fik Maviret i 8, 12 eller 16 uger alt efter anbefalet behandlingsvarighed.
English: • If you vomit less than 3 hours after taking Maviret, take another dose.
Danish: • Hvis du kaster op mindre end 3 timer efter at have taget Maviret, skal du tage en ny dosis.
English: Expected: ↑ fluvastatin and ↑ pitavastatin
Danish: Forventet: ↑ fluvastatin og ↑ pitavastatin
English: Activity of glecaprevir and pibrentasvir against HCV genotypes 1-6 replicon cell lines
Danish: Glecaprevirs og pibrentasvirs aktivitet mod replikon-cellelinjer ved HCV genotype 1-6 HCV-undertype
English: Activity of glecaprevir and pibrentasvir against transient replicons containing NS3 or
Danish: Glecaprevirs og pibrentasvirs aktivitet mod transitoriske replikoner indeholdende NS3
English: EXPEDITION-4 Maviret for 12 weeks (n=104)
Danish: EXPEDITION-4 Maviret i 12 uger (n = 104)
English: The SVR12 rate was 95.7% (22/23) for GT5-infected subjects and 98.4% (60/61) for GT6-infected subjects.
Danish: SVR12-raten var 95,7% (22/23) for GT5-inficerede forsøgspersoner og 98,4% (60/61) for GT6-inficerede forsøgspersoner.
English: Glecaprevir AUC increased in a greater than dose-proportional manner (1200 mg QD had 516-fold higher exposure than 200 mg QD) which may be related to saturation of uptake and efflux transporters.
Danish: AUC for glecaprevir steg mere end dosisproportionalt (1.200 mg én gang dagligt medførte en 516 gange større eksponering end 200 mg én gang dagligt), hvilket kan skyldes mætning af optag og efflukstransportere.
English: Based on population pharmacokinetic models for Maviret in chronic hepatitis C patients, steady-state AUC24 values for glecaprevir and pibrentasvir were 4800 and 1430 ng∙h/mL in subjects without cirrhosis (N=1804), and 10500 and 1530 ng∙h/mL in subjects with cirrhosis (N=280), respectively.
Danish: Baseret på farmakokinetiske populationsmodeller for Maviret hos kroniske patienter med hepatitis C var steady state AUC24-værdierne for glecaprevir og pibrentasvir hhv. 4.800 og 1.430 ng∙time/ml hos forsøgspersoner uden cirrose (N = 1.804) og 10.500 og 1.530 ng∙time/ml hos forsøgspersoner med cirrose (N = 280).
English: AbbVie Kft. Tel.: +36 1 455 8600
Danish: AbbVie Kft. Tlf.: +36 1 455 8600
English: • you should take Maviret and for how long
Danish: • beslutte, om og i givet fald hvor længe du skal tage Maviret
English: • dabigatran etexilate (to prevent blood clots)
Danish: • dabigatranetexilat (til fortynding af blodet)