FrancophonIA/ELRC3.0 huggingface dataset:
English: 13/15 (86.7)c a. Calculated using the normal approximation to the binomial distribution b. 1 patient discontinued due to non-compliance c. Relapse in 2/15 patients (confirmed HCV RNA ≥ 15 IU/mL post-treatment before or during SVR12 window among subjects with HCV RNA < 15 IU/mL at last observation with at least 51 days of treatment).
Danish: 13/15 (86,7)c a. Beregnet ved hjælp af den normale approksimation til binomialfordelingen b. 1 patient udgik af studiet på grund af non-compliance c. Tilbagefald hos 2/15 patienter (bekræftet HCV-rna ≥ 15 IE/ml efter behandling før eller under SVR12-vinduet blandt forsøgspersoner med HCV-rna <15 IE/ml ved sidste observation efter mindst 51 dages behandling)
English: Similarly, dasabuvir was not carcinogenic in a 2-year rat study up to the highest dose tested (800 mg/kg/day), resulting in dasabuvir exposures approximately 19-fold higher than those in humans at 500 mg.
Danish: Dasabuvir var heller ikke karcinogent i et 2-årigt rotte-studie ved doser op til den højeste testede dosis (800 mg/kg/dag), der medførte en dasabuvir-eksponering, der var ca. 19 gange højere end ved 500 mg hos mennesker.
English: 10 subjects (29.4%) had at least one post baseline haemoglobin value of less than 10 g/dL.
Danish: 10 forsøgspersoner (29,4 %) havde mindst én hæmoglobin-værdi < 10 g/dl efter baseline.
English: Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Danish: Patienter, pårørende og sundhedshjælpere bør instrueres i at underrette lægen om eventuelle ændringer i adfærd eller humør og enhver form for selvmordstanker.
English: Co-administration of dasabuvir + ombitasvir/paritaprevir/ ritonavir with everolimus is not recommended because of a significant increase in everolimus exposures which cannot be properly dose adjusted with available dose strengths.
Danish: Samtidig administration af dasabuvir + ombitasvir/paritaprevir/ri tonavir med everolimus anbefales ikke, på grund af signifikant stigning i eksponering af everolimus, som ikke kan justeres tilstrækkeligt med de tilgængelige dosis-styrker.
English: CORAL-I: treatment-naïve or pegIFN + RBV-experienced, GT 1 or GT4 infected, at least 3 months post liver transplant or 12 months post renal transplant
Danish: CORAL-I: behandlingsnaive eller pegIFN + RBV-erfarne, GT1- eller GT4-inficerede, mindst 3 måneder efter levertransplantation eller 12 måneder efter nyretransplantation
English: Available pharmacokinetic data in animals have shown excretion of dasabuvir and metabolites in milk (see section 5.3).
Danish: De tilgængelige farmakokinetiske data fra dyreforsøg viser, at dasabuvir og dasabuvirs metabolitter udskilles i mælk (se pkt.
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 29% to 39% higher dasabuvir exposures than non-Asian subjects.
Danish: På basis af farmakokinetiske populationsanalyser af data fra kliniske fase 3-studier havde asiatiske patienter en eksponering for dasabuvir, der lå 29-39 % højere end ikke-asiatiske patienters eksponering.
English: In Part 2, SVR12 was achieved by 27/28 (96.4%) subjects with HCV GT4/HIV-1 coinfection (95% CI: 82.3%, 99.4%) with no virologic failures.
Danish: I del 2 blev SVR12 opnået af 27/28 (96,4%) forsøgspersoner samtidig inficeret med HCV GT4 og hiv-1 (95% KI: 82,3%, 99,4%) uden nogen virologiske svigt.
English: Cases of depression and more rarely of suicidal ideation and suicide attempt have been reported with dasabuvir with or without ombitasvir/paritaprevir/ritonavir treatment in combination with ribavirin in the majority of the cases.
Danish: Tilfælde af depression og mere sjældent selvmordstanker og selvmordsforsøg er rapporteret ved dasabuvir-behandling med eller uden ombitasvir/paritaprevir/ritonavir, i de fleste tilfælde i kombination med ribavirin.
English: paritaprevir used together with dasabuvir + ombitasvir/paritaprevir/ ritonavir, administer sirolimus 0.2 mg twice a week (every 3 or 4 days on the same two days each week).
Danish: Hvis sirolimus anvendes sammen med dasabuvir + ombitasvir/paritaprevir/ri tonavir, administreres sirolimus 0,2 mg to gange om ugen (hver 3. eller 4. dag på de samme to dage hver uge).
English: Clinical monitoring and dose adjustment may be required for levothyroxine.
Danish: Klinisk overvågning og dosisjustering kan være nødvendig for levothyroxin
English: Exviera tablets are beige, ovaloid film-coated tablets, of dimensions of 14.0 mm x 8.0 mm, marked with “AV2”.
Danish: Exviera-tabletterne er beige, ovale filmovertrukne tabletter på 14,0 mm x 8,0 mm præget med "AV2".
English: Other CYP2C9 substrates (NSAIDs (e.g. ibuprofen), antidiabetics (e.g. glimepiride, glipizide) are not expected to require dose adjustments.
Danish: Andre CYP2C9-substrater (NSAID-præparater (f.eks. ibuprofen), antidiabetika (f.eks. glimepirid, glipizid)) forventes ikke at nødvendiggøre dosisjustering.
English: Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4).
Danish: Samtidig brug af fluvastatin og pitavastatin anbefales ikke (se pkt.
English: Primary SVR12 Assessment for Part 2, Subjects with HCV GT1/HIV-1 co-infection in TURQUOISE-I
Danish: Primær SVR12 vurdering for del 2, forsøgspersoner med samtidig HCV GT1/hiv-1-infektion i TURQUOISE-I
English: In Part 1a, SVR12 was achieved by 29/31 (93.5%) subjects on the 12-week arm (95% CI: 79.3%98.2%) and by 29/32 (90.6%) subjects on the 24-week arm (95% CI: 75.8% - 96.8%).
Danish: I del 1a blev SVR12 opnået af 29/31 (93,5%) forsøgspersoner i 12 ugers armen (95% KI: 79,3% - 98,2%) og af 29/32 (90,6%) forsøgspersoner i 24 ugers armen (95% KI: 75,8% - 96,8%).
English: Cross-resistance
Danish: Krydsresistens
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when dasabuvir is used with ribavirin.
Danish: Der skal træffes skærpede forholdsregler for at undgå graviditet hos kvindelige patienter og hos mandlige patienters kvindelige partnere, når dasabuvir administreres i kombination med ribavirin.
English: The frequency of indirect bilirubin elevations was lower among subjects who did not receive ribavirin.
Danish: Forekomsten af forhøjet ikke-konjugeret bilirubin var lavere hos forsøgspersoner, der ikke fik ribavirin.
English: 12 weeks N = 509 n (%)
Danish: 12 uger N = 509 n (%)
English: Clinical monitoring and dose adjustment maybe needed for smephenytoin.
Danish: Klinisk monitorering og dosisjustering kan være nødvendig for smephenytoin.
English: TURQUOISE II (open-label)
Danish: TURQUOISE II (åben)
English: Each film-coated tablet contains 45 mg lactose (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder 45 mg laktose (som monohydrat).
English: Women of childbearing potential /contraception in males and females
Danish: Fertile kvinder/prævention hos mænd og kvinder
English: TURQUOISE III (open-label)
Danish: TURQUOISE III (åben)
English: If rosuvastatin treatment is required during the treatment period, the maximum daily dose of rosuvastatin should be 5 mg (see section 4.5, Table 2).
Danish: Hvis det er nødvendigt at give patienten rosuvastatin i behandlingsperioden, må den daglige rosuvastatin-dosis højst være 5 mg (se pkt.
English: Resistance to dasabuvir conferred by variants in NS5B selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons.
Danish: Resistens over for dasabuvir fremkaldt af varianter i NS5B, der blev udvalgt i cellekultur eller identificeret i kliniske fase 2b- og fase 3-studier, blev fænotypisk karakteriseret i de relevante genotype 1a- eller 1b-replikoner.
English: 24 weeks (see section 5.1.)
Danish: 24 uger (se pkt.
English: Dasabuvir had reduced activity in biochemical assays against NS5B polymerases from HCV genotypes 2a, 2b, 3a and 4a (IC50 values ranging from 900 nM to >20 μM).
Danish: Dasabuvir havde nedsat aktivitet i biokemiske analyser mod NS5B-polymeraser fra HCV genotype 2a, 2b, 3a og 4a (med IC50-værdier inden for intervallet 900 nM til > 20 μM).
English: To maximise absorption, dasabuvir should be taken with food without regard to fat or calorie content.
Danish: For at maksimere absorptionen skal dasabuvir tages sammen med mad; fedt- og kalorieindholdet er ligegyldigt.
English: These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinyloestradiol -containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3).
Danish: Forhøjet ALAT sås signifikant hyppigere i den undergruppe, der brugte ethinyløstradiol-holdige lægemidler som f.eks. kombinerede p-piller eller p-ringe (6 ud af 25 forsøgspersoner) (se pkt.
English: Dasabuvir was 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 rat micronucleus assays.
Danish: Dasabuvir var ikke genotoksisk i et batteri 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 rotter.
English: The highest dasabuvir dose tested produced exposures equal to 16 to 24-fold (rat) or 6-fold (rabbit) the exposures in humans at the maximum recommended clinical dose.
Danish: Den højeste testede dosis dasabuvir gav en eksponering, der var 16 til24 gange højere (rotter) eller 6 gange højere (kaniner) end hos mennesker ved den maksimale anbefalede kliniske dosis.
English: Your doctor may also give you an antiviral medicine called ribavirin.
Danish: Lægen kan derudover give dig et antiviralt lægemiddel, der indeholder ribavirin.
English: Among these subjects, the positive predictive value of SVR12 on SVR24 was
Danish: Blandt disse patienter var den positive prognostiske værdi af SVR12 for SVR24 99,8 %.
English: NS3 variants V36A/M and R155K and NS5B variants M414T and S556G remained detectable at posttreatment Week 48, whereas NS3 variant D168V and all other NS5B variants were not observed at post-treatment Week 48.
Danish: NS3-varianterne V36A/M og R155K samt NS5B-varianterne M414T og S556G var stadig detekterbare 48 uger efter behandlingen, mens NS3-variant D168V og alle øvrige NS5B-varianter ikke blev observeret 48 uger efter behandlingen.
English: Anaphylactic reactions
Danish: Anafylaktisk reaktioner
English: Diazepam2 mg single dose
Danish: Diazepam2 mg enkelt dosis
English: F2 F3
Danish: F3
English: Medicinal products that are strong CYP2C8 inhibitors may increase dasabuvir plasma concentrations and must not be co-administered with dasabuvir (see section 4.5).
Danish: Lægemidler, der er stærke CYP2C8-hæmmere, kan øge plasmakoncentrationen af dasabuvir og må ikke administreres samtidig med dasabuvir (se pkt.
English: The safety and efficacy of dasabuvir in children less than 18 years of age have not been established.
Danish: Dasabuvirs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Patients who are taking ethinyloestradiol -containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating dasabuvir with ombitasvir/paritaprevir/ritonavir therapy (see sections 4.3 and 4.5).
Danish: Patienter, der tager ethinyløstradiol-holdige lægemidler (dvs. de fleste kombinerede p-piller og pringe), skal skifte til en alternativ præventionsmetode (f.eks. prævention med progestin alene eller ikke-hormonelle metoder), inden de starter behandling med dasabuvir med ombitasvir/paritaprevir/ritonavir (se pkt.
English: Although ALT elevations associated with dasabuvir and ombitasvir/paritaprevir/ritonavir have been asymptomatic, patients should be instructed to watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice and discoloured faeces, and to consult a doctor without delay if such symptoms occur.
Danish: Selvom de forhøjede ALAT-niveauer i forbindelse med dasabuvir og ombitasvir/paritaprevir/ritonavir har været asymptomatiske, skal patienterne have at vide, at de skal være opmærksomme på tidlige tegn på leverbetændelse, f.eks. træthed, kraftesløshed, nedsat appetit, kvalme og opkastning, samt senere tegn som f.eks. gulsot og misfarvet afføring.
English: In case a dose of dasabuvir is missed, the prescribed dose can be taken within 6 hours.
Danish: Hvis en patient glemmer at tage en dosis dasabuvir, kan den ordinerede dosis tages op til 6 timer senere.
English: All clinical trials with dasabuvir have been conducted following administration with food.
Danish: I alle de kliniske studier med dasabuvir blev forsøgslægemidlet administreret sammen med mad.
English: • Less than 6 hours until your next dose - do not take the missed dose, take your next dose as usual with food.
Danish: • under 6 timer til din næste dosis, så skal du ikke tage den manglende dosis, men vente til den efterfølgende dosis og tage denne sammen med noget mad.
English: Coadministration with enzyme inducers may lead to an increased risk of adverse reactions and ALT elevations (see Table 2).
Danish: Samtidig administration af enzym-inducere kan medføre øget risiko for bivirkninger og forhøjet ALAT (se tabel 2).
English: Efavirenz/ emtricitabine / tenofovir disoproxil fumarate mg once daily
Danish: Efavirenz/ emtricitabin/ tenofovirdisoproxilfumarat mg én gang dagligt
English: Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Observed in at least 2 subjects of the same subtype.
Danish: Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Observeret hos mindst 2 forsøgspersoner med samme undertype.
English: Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, dolutegravir (Part 2 only), or darunavir (Part 1b and Part 2 GT4 only)-, co-administered with a backbone of tenofovir plus emtricitabine or lamivudine.
Danish: Forsøgspersonerne var på en stabil hiv-1-antiretroviral behandling (antiretroviral therapy (ART)), der omfattede ritonavir-boostet atazanavir eller raltegravir, dolutegravir (kun del 2) eller darunavir (kun del 1b og del 2 GT4)-der blev administreret samtidig med en baggrundsbehandling bestående af tenofovir + emtricitabin eller lamivudin.
English: See also Section 4.8 for discussion of safety information for RUBY-I.
Danish: 4.8 vedrørende bivirkninger for RUBY-I.
English: 200 mg once daily followed by 200 mg twice daily
Danish: 200 mg én gang dagligt efterfulgt af 200 mg to gange dagligt
English: Beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm and debossed on one side with ‘AV2'.
Danish: Beige, ovale filmovertrukne tabletter på 14,0 mm x 8,0 mm præget med "AV2" på den ene side.
English: ** When assessing severity of liver disease using non-invasive methods, a combination of blood biomarkers or the combination of liver stiffness measurement and a blood test improves accuracy and should be undertaken prior to 8 week treatment in all patients with moderate fibrosis.
Danish: ** Nøjagtigheden i vurdering af graden af leversygdom med non-invasive metoder kan forbedres ved en kombination af biomarkører i blodet eller ved at kombinere leverstivhedsmåling med en blodprøve.
English: If ribavirin is co-administered with dasabuvir and ombitasvir/paritaprevir/ritonavir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics of ribavirin).
Danish: Hvis ribavirin administreres samtidig med dasabuvir og ombitasvir/paritaprevir/ritonavir, gælder kontraindikationerne for brug af ribavirin under graviditet (se også produktresuméet for ribavirin).
English: randomised, global multicentre, double-blind, placebo-controlled
Danish: randomiseret, globalt multicenter studie, dobbeltblindet, placebokontrolleret
English: Tell your doctor or pharmacist if you notice any of the following side effects: Side effects when taking Exviera with ombitasvir/paritaprevir/ritonavir:
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du får en eller flere af følgende bivirkninger: Bivirkninger ved indtagelse af Exviera sammen med ombitasvir/paritaprevir/ritonavir:
English: • Check for side effects of Exviera or other antiviral medicines your doctor has prescribed for you to use with Exviera (such as “ombitasvir/paritaprevir/ritonavir” and “ribavirin”).
Danish: • se, om der er bivirkninger ved Exviera eller de andre antivirale lægemidler, som din læge har ordineret sammen med Exviera (f.eks. ombitasvir/paritaprevir/ritonavir og ribavirin).
English: Croscarmellose sodium Colloidal anhydrous silica (E 551) Magnesium stearate (E 470b)
Danish: Croscarmellosenatrium Kolloid vandfri silica (E 551) Magnesiumstearat (E 470b)
English: The long-term clinical impact of the emergence or persistence of virus containing dasabuvir and ombitasvir/paritaprevir/ritonavirresistance-associated substitutions on future treatment is unknown.
Danish: Den kliniske langtidseffekt på fremtidig behandling ved forekomst af virus eller persistens hos virus, som indeholder dasabuvir og ombitasvir/paritaprevir/ritonavir-resistensrelaterede substitutioner, kendes ikke.
English: 300 mg once daily (given at the same time)
Danish: 300 mg én gang dagligt (administreret på samme tid)
English: Overall, 37 (97.4%) of 38 subjects achieved SVR12.
Danish: I alt opnåede 37 ud af 38 forsøgspersoner (97,4 %) SVR12.
English: With compensated cirrhosis
Danish: Med kompenseret cirrose
English: Tacrolimus 2 mg single dose7
Danish: Tacrolimus 2 mg enkeltdosis7
English: SVR12, n/N (%) [95% CI] Outcome for subjects not achieving SVR12 On-treatment virologic failure Post-treatment relapse Otherb a. Includes all HCV GT1 subjects in Part 2 excluding Arm G subjects that did not receive recommended regimen.
Danish: SVR12, n/N (%) [95% KI] Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidiv efter behandling Andetb a. Omfatter alle HCV GT1 forsøgspersoner i del 2 eksklusive forsøgspersoner i arm G, som ikke fik den anbefalede dosering.
English: In the greater than 500 genotype 1a baseline samples in this analysis, the most frequently observed resistance-associated variants were M28V (7.4%) in NS5A and S556G (2.9%) in NS5B.
Danish: I analysens mere end 500 genotype 1a-baseline-prøver var de hyppigst observerede resistensrelaterede varianter M28V (7,4 %) i NS5A og S556G (2,9 %) i NS5B.
English: CYP2C8 inhibitor:
Danish: CYP2C8-hæmmer:
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 14 to 30% higher dasabuvir exposures than male subjects.
Danish: På basis af farmakokinetiske populationsanalyser af data fra kliniske fase 3-studier har kvindelige patienter en eksponering for dasabuvir, der ligger ca. 14-30 % højere end mandlige patienters eksponering.
English: Serum bilirubin elevations
Danish: Forhøjet bilirubin i serum
English: Co-administration of dasabuvir with medicinal products that inhibit CYP2C8 (e.g. teriflunomide, deferasirox) may increase dasabuvir plasma concentrations.
Danish: Samtidig administration af dasabuvir og lægemidler, der hæmmer CYP2C8 (f.eks. teriflunomid, deferasirox), kan øge plasmakoncentrationen af dasabuvir.
English: Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing dasabuvir, ombitasvir and paritaprevir with or without ribavirin (for 8, 12 or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Danish: Ud af de 2.510 HCV genotype 1-smittede forsøgspersoner, der blev behandlet med regimer indeholdende dasabuvir, ombitasvir og paritaprevir med eller uden ribavirin (i 8, 12 eller 24 uger) i de kliniske fase 2b- og fase 3-studier, var der i alt 74 (3 %), som oplevede virologisk svigt (primært recidiv efter behandlingen).
English: If you are not sure, talk to your doctor or pharmacist before taking Exviera.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet, før du tager Exviera.
English: Concerning genotype-specific virological and clinical activity, see section 5.1.
Danish: 5.1 for genotypespecifik virologisk og klinisk aktivitet.
English: GIVE N WITH
Danish: GIVET SAMMEN MED
English: Cross-resistance is expected among NS5A inhibitors, NS3/4A protease inhibitors, and non-nucleoside NS5B inhibitors by class.
Danish: Krydsresistens forventes blandt NS5A-hæmmere, NS3/4A-proteasehæmmere og non-nukleoside NS5B-hæmmere (efter klasse).
English: ↑ sulfasalazine
Danish: ↑ sulfasalazin
English: 20-120 mg once daily8
Danish: 20-120 mg én gang dagligt8
English: Cirrhosis was not a risk factor for elevated ALT (see section 4.4).
Danish: Cirrose udgjorde ikke en risikofaktor for forhøjet ALAT (se pkt.
English: In the greater than 200 genotype 1b baseline samples in this analysis, the most frequently observed resistance-associated variants observed were Y93H (7.5%) in NS5A, and C316N (17.0%) and S556G (15%) in NS5B.
Danish: I analysens mere end 200 genotype 1b-baseline-prøver var de hyppigst observerede resistensrelaterede varianter Y93H (7,5 %) i NS5A og C316N (17,0 %) og S556G (15 %) i NS5B.
English: HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine2
Danish: HIV-ANTIVIRALE MIDLER: NON-NUKLEOSID REVERS TRANSKRIPTASE-HÆMMERE Rilpivirin2
English: GT1-infected subjects with or without cirrhosis with severe renal impairment or end-stage renal disease (ESRD)
Danish: GT1-inficerede patienter med eller uden cirrose med alvorlig nedsat nyrefunktion eller nyrefunktion i slutstadiet (ESRD)
English: Target Emergent amino acid substitutionsa
Danish: Opståede aminosyresubstitutionera
English: Resistance-associated variants at amino acid positions R155 and D168 in NS3 were rarely observed (less than 1%) at baseline.
Danish: Resistensrelaterede varianter ved aminosyrepositionerne R155 og D168 i NS3 sås sjældent (under
English: Main characteristics are shown below.
Danish: De vigtigste karateristika er vist nedenfor:
English: Exviera 250 mg film-coated tablets
Danish: Exviera 250 mg filmovertrukne tabletter
English: Exviera 250 mg tablets dasabuvir
Danish: Exviera 250 mg tabletter dasabuvir
English: • mitotane
Danish: • mitotan
English: As the incidence of such elevations was 26% among women taking a concomitant ethinyloestradiol-containing medicine, such medicinal products are contraindicated with dasabuvir and ombitasvir/paritaprevir/ritonavir.
Danish: Da incidensen af sådanne forhøjelser var 26 % blandt de kvinder, der samtidig tog et ethinyløstradiol-holdigt lægemiddel, er ethinyløstradiol-holdige lægemidler kontraindiceret ved behandling med dasabuvir og ombitasvir/paritaprevir/ritonavir.
English: In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1).
Danish: I post-levertransplantationsstudiet blev ribavirin-dosen justeret individuelt, og de fleste forsøgspersoner fik 600-800 mg pr. dag (se pkt.
English: Avoid concomitant use of tacrolimus or sirolimus with dasabuvir and ombitasvir/paritaprevir/ritonavir unless the benefits outweigh the risks.
Danish: Undgå samtidig brug af tacrolimus eller sirolimus med dasabuvir og ombitasvir/paritaprevir/ritonavir medmindre fordelene opvejer risiciene.
English: When coadministered they exert mutual effects on each other (see section 5.2).
Danish: Når disse stoffer administreres samtidig, har de en gensidig indvirkning på hinanden (se pkt.
English: Dasabuvir must not be administered as monotherapy.
Danish: Dasabuvir må ikke gives som enkeltstofbehandling.