FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the interaction profile of the compounds must be considered as a combination.
Danish: Stoffernes interaktionsprofil skal derfor ses i sammenhæng.
English: Exviera should not be used during pregnancy or in women of childbearing potential not using effective contraception.
Danish: Exviera bør ikke anvendes under graviditet eller til kvinder i den fødedygtige alder, som ikke bruger sikker præventionsmetode.
English: Treatment of patients with HIV co-infection
Danish: Behandling af patienter med samtidig hiv-infektion
English: Talk to your doctor or pharmacist before taking Exviera if you: - have liver disease other than hepatitis C; - have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Exviera, hvis du: - har en anden leversygdom end hepatitis C; - har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere.
English: • More than 6 hours until your next dose - take the missed dose with food as soon as possible.
Danish: • over 6 timer til din næste dosis, så skal du hurtigst muligt tage den manglende dosis sammen med noget mad
English: Reduce pravastatin dose by 50%.
Danish: Ikke relevant Reducér pravastatindosen med 50 %.
English: No genotype 1b infected subjects had treatment-emergent variants in all 3 drug targets.
Danish: Ingen af de genotype 1b-smittede forsøgspersoner havde behandlingsrelaterede varianter i alle 3 lægemiddelmål.
English: In Phase 3 clinical trials, 1075 subjects (including 181 with compensated cirrhosis) received the recommended regimen (see section 4.2).
Danish: I kliniske fase 3-studier fik 1.075 patienter (herunder 181 med kompenseret cirrose) det anbefalede regime (se pkt.
English: Glucose levels of diabetic patients initiating direct acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medicinal products modified when necessary.
Danish: Blodsukkeret hos patienter med diabetes, der påbegynder behandling med direkte virkende antivirale lægemidler/DAA'er, bør overvåges nøje, navnlig inden for de første 3 måneder, og patienternes diabetes lægemidler bør om nødvendigt ændres.
English: Number of subjects treated
Danish: Antal behandlede forsøgspersoner
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2% (5/2,044) and 4.8% (99/2,044) of subjects had ribavirin dose reductions due to adverse reactions.
Danish: Andelen af forsøgspersoner, der stoppede behandlingen permanent på grund af bivirkninger var 0,2 % (5/2.044) og 4,8 % (99/2.044) af forsøgspersonerne fik nedsat ribavirin-dosis på grund af bivirkninger.
English: Dasabuvir is predominantly metabolised by CYP2C8 and to a lesser extent by CYP3A.
Danish: Dasabuvir metaboliseres hovedsagelig af CYP2C8 og i mindre omfang af CYP3A.
English: • efavirenz, nevirapine, etravirine
Danish: • efavirenz, nevirapin, etravirin
English: • Hepatic laboratory testing including direct bilirubin levels should be performed at baseline, during the first 4 weeks of starting treatment and as clinically indicated thereafter.
Danish: • Laboratorietest for leverfunktion, inklusive niveau af konjugeret bilirubin skal udføres ved baseline, i løbet af de første 4 ugers behandling og herefter, når det er klinsik indiceret.
English: Dasabuvir had no effects on embryo-foetal viability or on fertility in rodents and were not teratogenic in two species.
Danish: Dasabuvir havde ingen indvirkning på den embryo-føtale levedygtighed eller fertiliteten hos gnavere og var ikke teratogent hos to arter.
English: Given the low virologic failure rates observed with recommended treatment regimens for HCV genotype 1a- and 1b-infected subjects, the presence of baseline variants appears to have little impact on the likelihood of achieving SVR.
Danish: I lyset af den lave forekomst af virologisk svigt, der blev observeret med de anbefalede behandlingsregimer for HCV genotype 1a- og 1b-smittede patienter, synes tilstedeværelsen af baseline-varianter at have begrænset indvirkning på sandsynligheden for at opnå SVR.
English: Taking into account the protein binding and in vitro activity of M1 against HCV genotype 1, its contribution to efficacy is expected to be similar to that of dasabuvir.
Danish: Under hensyntagen til M1's proteinbinding og in vitro-aktivitet mod HCV genotype 1 forventes dens bidrag til virkningen at være af samme størrelsesorden som dasabuvirs.
English: Patients should be monitored frequently for any changes in renal function or tacrolimus or sirolimus associated adverse reactions.
Danish: Patienterne skal overvåges hyppigt for eventuelle ændringer i nyrefunktionen eller bivirkninger associeret med tacrolimus eller sirolimus.
English: In addition, M1 is a substrate of the hepatic uptake transporters OATP family and OCT1 and thus, the hepatocyte concentration and thereby contribution to efficacy, may be larger than dasabuvir.
Danish: Desuden er M1 et substrat for de hepatiske uptake-transportere i OATP-familien og OCT1, og da hepatocyt-koncentrationen derved bliver større, kan bidraget til virkningen være større end dasabuvirs.
English: • apalutamide, enzalutamide
Danish: • apalutamid, enzalutamid
English: ANTIARRYTHMICS Digoxin
Danish: ANTIARYTMIKA Digoxin
English: Bilirubin elevations occurred after initiation of treatment, peaked by study Week 1, and generally resolved with ongoing therapy.
Danish: Forhøjet bilirubin sås efter påbegyndelse af behandlingen, peakede i studiets uge 1 og fortog sig generelt ved fortsat behandling.
English: It may not be excluded that the systemic exposure of dabigatran etexilate is increased by dasabuvir due to inhibition of P-gp in the intestine.
Danish: Det kan ikke udelukkes, at den systemiske eksponering for dabigatranetexilat øges af dasabuvir på grund af P-gp-hæmningen i tarmen.
English: Contents of the pack and other information What Exviera contains
Danish: Pakningsstørrelser og yderligere oplysninger Exviera indeholder:
English: If more than 6 hours have passed since dasabuvir 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 6 timer siden det tidspunkt, hvor patienten normalt tager sin dosis dasabuvir, må den manglende dosis IKKE tages, idet patienten skal vente til den efterfølgende dosis i henhold til doseringsplanen.
English: Not Studied.
Danish: Ikke undersøgt.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Danish: I tilfælde af overdosering anbefales det at overvåge patienten for tegn og symptomer på bivirkninger og straks iværksætte behandling af eventuelle symptomer.
English: Dasabuvirderived material was minimally transferred through the placenta in pregnant rats.
Danish: Dasabuvir-deriveret materiale passerede kun i minimalt omfang gennem placenta hos drægtige rotter.
English: Dasabuvir has also been found to inhibit UGT1A4, 1A6 and intestinal UGT2B7 in vitro at in vivo relevant concentrations.
Danish: Dasabuvir har også vist sig at hæmme UGT1A4, 1A6 og intestinal-UGT2B7 in vitro i in vivo relevante koncentrationer.
English: AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
Danish: AFP* < 20 ng/ml, trombocyttal ≥ 90 x 109/l OG albumin ≥ 35 g/l før behandling
English: Unchanged dasabuvir accounted for 26.2% and M1 for 31.5% of the total dose in faeces.
Danish: Uomdannet dasabuvir udgjorde 26,2 % og M1 31,5 % af den samlede dosis i fæces.
English: Examples of contraindicated CYP2C8 inhibitors are provided below.
Danish: Eksempler på kontraindicerede CYP2C8hæmmere er angivet nedenfor.
English: Take one tablet in the evening.
Danish: Tag én tablet om aftenen.
English: What you need to know before you take Exviera 3.
Danish: Det skal du vide, før du begynder at tage Exviera 3.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Exviera.
Danish: Hvis noget af ovenstående gælder for dig (eller du er i tvivl), skal du tale med lægen eller apotekspersonalet, før du tager Exviera.
English: This regimen can be used in the absence of extensive PI resistance (i.e. lack of darunavir associated RAMs), see also section 4.4.
Danish: Dette regime kan anvendes, hvis der ikke er udtalt PIresistens (dvs. hvis der ikke er nogen darunavirrelaterede RAM'er); se også pkt.
English: CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (Table 2).
Danish: De CYP2C19-substrater, der er undersøgt i lægemiddelinteraktionsstudier, omfatter omeprazol og escitalopram (se tabel 2).
English: • There is a risk for birth defects when ribavirin is given to a female patient that becomes pregnant.
Danish: • Der er risiko for fødselsdefekter, når ribavirin tages af kvindelige patienter, som bliver gravide.
English: No increase in incidence of ALT elevations was observed with other types of systemic oestrogens commonly used for hormone replacement therapy (e.g., oestradiol and conjugated oestrogens).
Danish: Der sås ingen stigning i incidensen af ALAT-forhøjelser med andre typer af systemisk østrogen, som normalt bruges i hormonbehandling (f.eks. østradiol og konjugerede østrogener).
English: Treatment duration was fixed in each trial and was not guided by subjects' HCV RNA levels (no response guided algorithm).
Danish: Behandlingsvarigheden var fast i hvert studie og var ikke afhængig af forsøgspersonernes HCV-rna-niveauer (ingen responstilpasset algoritme).
English: The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Danish: Kombinationen giver øget risiko for hyperbilirubinæmi (herunder okulær ikterus), især når ribavirin indgår i hepatitis C-regimet.
English: Elevations in ALT were generally not associated with bilirubin elevations.
Danish: Forhøjet ALAT var generelt ikke forbundet med forhøjet bilirubin.
English: Exviera is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Danish: Exviera er et antiviralt lægemiddel, der bruges til behandling af voksne med kronisk (vedvarende) hepatitis C (en infektionssygdom i leveren, der skyldes hepatitis C-virus).
English: Overall SVR12
Danish: Samlet SVR12
English: The changes in dasabuvir exposures in subjects with mild, moderate and severe renal impairment are not considered to be clinically significant.
Danish: Ændringerne i eksponeringen for dasabuvir hos patienter med let, moderat og svært nedsat nyrefunktion anses ikke for at være klinisk signifikante.
English: Sustained virologic response (SVR) was the primary endpoint to determine the HCV cure rate in the Phase 3 studies and was defined as unquantifiable or undetectable HCV RNA 12 weeks after the end of treatment (SVR12).
Danish: Vedvarende virologisk respons (sustained virologic response (SVR)) var det primære endepunkt til bestemmelse af helbredelsesraten for HCV i fase 3-studier og blev defineret som ikke-kvantificerbar eller ikke-påviselig HCV-rna 12 uger efter behandlingsafslutning (SVR12).
English: What you need to know before you take Exviera Do not take Exviera:
Danish: Det skal du vide, før du begynder at tage Exviera Tag ikke Exviera:
English: The efficacy of dasabuvir in patients previously exposed to dasabuvir, or to medicinal products anticipated to be cross-resistant, has not been demonstrated.
Danish: Virkningen af dasabuvir hos patienter, der tidligere har været eksponeret for dasabuvir eller for lægemidler, der antages at indebære krydsresistens, er ikke undersøgt.
English: Immune system disorders Frequency unknown
Danish: Immunsystemet Ikke kendt
English: Inhibition of P-gp and BCRP is not expected to show clinically relevant increases in exposures of dasabuvir (Table 2).
Danish: Hæmning af P-gp og BCRP forventes ikke at medføre en klinisk relevant stigning i eksponeringen for dasabuvir (se tabel 2).
English: Sex or body weight
Danish: Køn og vægt
English: • Serious allergic reactions, signs may include: o Difficulty breathing or swallowing o Dizziness or light-headedness, which may be due to low blood pressure o Swelling of the face, lips, tongue or throat o Rash and itching of the skin
Danish: • Symptomer på alvorlige allergiske reaktioner kan inkludere: o Åndedrætsbesvær eller synkeproblemer o Svimmelhed eller omtågethed, som kan skyldes lavt blodtryk o Hævelse af ansigt, læber, tunge eller hals o Udslæt og kløe af huden
English: Following a 400 mg 14C-dasabuvir dose in humans, unchanged dasabuvir was the major component (approximately 60%) of drug related radioactivity in plasma.
Danish: Efter en dosis på 400 mg 14C-dasabuvir hos mennesker var uomdannet dasabuvir den væsentligste komponent (ca. 60 %) i den lægemiddelrelaterede radioaktivitet i plasma.
English: Microcrystalline cellulose (E 460(i)) Lactose monohydrate Copovidone
Danish: Mikrokrystallinsk cellulose (E 460(i)) Laktosemonohydrat Copovidon
English: Rilpivirine should be used cautiously, in the setting of repeated ECG monitoring.
Danish: Rilpivirin skal anvendes med forsigtighed og under løbende EKGmonitorering.
English: Norgestimate metabolites:
Danish: Norgestimat-metabolitter:
English: d. Observed in combination in genotype 1b-infected subjects.
Danish: d. Observeret i kombination hos genotype 1b-smittede forsøgspersoner.
English: Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome.
Danish: Dasabuvir er en non-nukleosidhæmmer af den HCV-rna-afhængige rna-polymerase, der kodes af NS5B-genet, som er afgørende for det virale genoms replikation.
English: It is not known whether dasabuvir and metabolites are excreted in human breast milk.
Danish: Det er ukendt, om dasabuvir og dets metabolitter udskilles i human mælk.
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in the paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑= increase more than 20%, ↓ = decrease more than 20%, ↔ = no change or change less than 20%).
Danish: Pilens retning angiver ændringen i eksponering (Cmax og AUC) for paritaprevir, ombitasvir, dasabuvir og det samtidigt administrerede lægemiddel (↑= stigning på over 20 %, ↓ = fald på over 20 %, ↔ = ingen ændring eller ændring på under 20 %).
English: The High Pure system assay had a lower limit of quantification (LLOQ) of 25 IU per mL and the AmpliPrep assay had a LLOQ of 15 IU per mL.
Danish: High Pure System-analysen havde en nedre kvantificeringsgrænse (LLOQ) på 25 IE/ml, og AmpliPrep-testen havde en LLOQ på 15 IE/ml.
English: Clinical monitoring and dose adjustment may be needed for other CYP1A2 substrates (e.g. ciprofloxacin, cyclobenzaprine, theophylline and caffeine).
Danish: Klinisk overvågning og dosisjustering kan være nødvendigt for andre CYP1A2-substrater (f.eks. ciprofloxacin, cyclobenzaprin, theophyllin og koffein).
English: • Diarrhoea
Danish: • diarré
English: GARNET (open-label)
Danish: GARNET (åben)
English: Table 16 shows SVR rates for these subjects.
Danish: Tabel 15 viser SVR-raterne for disse patienter.
English: The safety of dasabuvir in children and adolescents aged < 18 years has not yet been established.
Danish: Dasabuvirs sikkerhed og virkning hos børn og unge < 18 år er endnu ikke klarlagt.
English: Take one tablet in the morning and one tablet in the evening.
Danish: Tag 1 tablet om morgenen og 1 tablet om aftenen.
English: Teriflunomide may increase dasabuvir exposures and should be used with caution.
Danish: Teriflunomide kan øge dasabuvir s eksponering og skal anvendes med forsigtighed.
English: Therefore, dasabuvir is not expected to affect medicinal products which are primarily excreted by the renal route via these transporters (see section 5.2).
Danish: Dasabuvir forventes derfor ikke at påvirke lægemidler, der primært udskilles gennem nyrerne via disse transportere (se pkt.
English: Clinical Trial in patients receiving chronic opioid substitution therapy
Danish: Klinisk studie hos patienter i kronisk opioidsubstitutionsbehandling
English: The mean baseline haemoglobin level was 12.1 g/dL and the mean decline in haemoglobin at the end of treatment for subjects taking RBV was 1.2 g/dL.
Danish: Det gennemsnitlige hæmoglobin-niveau ved baseline var 12,1 g/dl, og det gennemsnitlige fald i hæmoglobin ved behandlingens afslutning for patienter, der tog ribavirin, var 1,2 g /dl.
English: The most abundant plasma metabolite was M1, which represented 21% of drug-related radioactivity (AUC) in circulation following single dose; it's formed via oxidative metabolism predominantly by CYP2C8.
Danish: Den mest udbredte plasmametabolit var M1, der repræsenterede 21 % af den lægemiddelrelaterede radioaktivitet (AUC) i kredsløbet (AUC) efter en enkelt dosis; metabolitten dannes ved oxidativ metabolisering, hovedsagelig via CYP2C8.
English: If the combination is used, repeated ECGmonitoring should be done, see section 4.4.
Danish: Hvis kombinationen anvendes, skal der foretages løbende EKGmonitorering (se pkt.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medicines after starting Exviera.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med Exviera.
English: Because of the potential for adverse reactions from the medicinal product in breastfed infants, a decision must be made whether to discontinue breastfeeding or discontinue treatment with dasabuvir, taking into account the importance of the therapy to the mother.
Danish: På grund af de potentielle bivirkninger for det diende barn skal det besluttes, om amning eller behandling med dasabuvir skal ophøre, idet der skal tages højde for behandlingens betydning for moderen.
English: No subjects experienced on-treatment virologic failure or relapse.
Danish: Ingen forsøgspersoner oplevede virologisk svigt under behandlingen eller recidiv.
English: Male patients and their female partners: Either male patients or their female partners of childbearing potential must use a form of effective contraception during treatment with ribavirin and for 7 months after treatment.
Danish: Mandlige patienter og deres kvindelige partnere: Enten mandlige patienter eller deres kvindelige partnere, som er i den fødedygtige alder, skal anvende effektiv prævention under behandlingen med ribavirin og i 7 måneder efter behandlingens afslutning.
English: See also Table 2 for specific advice on rosuvastatin which has been evaluated in a drug interaction study.
Danish: Se også tabel 2, der indeholder specifik vejledning vedrørende rosuvastatin, der er blevet undersøgt i et lægemiddelinteraktionsstudie.
English: Use in diabetic patients
Danish: Anvendelse hos patienter med diabetes
English: Female patients: Women of childbearing potential should not receive ribavirin unless they are using an effective form of contraception during treatment with ribavirin and for 4 months after treatment.
Danish: Kvindelige patienter: Fertile kvinder må ikke få ribavirin, medmindre de bruger en sikker præventionsmetode under behandlingen med ribavirin og i 4 måneder efter selve behandlingen.
English: The dose of ribavirin was individualized at the discretion of the investigator, with most subjects receiving 600 to 800 mg as a starting dose, and most subjects also receiving 600 to 800 mg per day at the end of treatment.
Danish: Ribavirin-dosis blev fastsat individuelt efter investigators skøn, hvor de fleste forsøgspersoner modtog 600 til 800 mg som begyndelsesdosis, og de fleste forsøgspersoner fik også 600 til 800 mg dagligt i slutningen af behandlingen.
English: Exposures of cyclobenzaprine, a CYP1A2 substrate, were decreased.
Danish: Eksponering for cyclobenzaprin, et CYP1A2-substrat blev reduceret.
English: All 3 (100%) subjects with GT 4 infection who were post liver transplant achieved SVR12
Danish: Alle 3 (100%) forsøgspersoner med GT4-infektion, som var levertransplanterede, opnåede SVR12.
English: ↑ norgestrel ↑ nor elgestromin e
Danish: ↑ norgestrel ↑ nor elgestromin
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Danish: Plasmaproteinbindingen ændres ikke nævneværdigt hos patienter med nedsat nyre- eller leverfunktion.
English: On-treatment VF
Danish: VF under behandling
English: For a general comment on treatment of HIV co-infected patients, including a discussion on different antiretroviral regimens that may be used, please see section 4.4 (Treatment of HIV co-infected patients) and the Summary of Product Characteristics of ombitasvir/ paritaprevir /ritonavir.
Danish: For generelle kommentarer til behandling af patienter med samtidig hiv-infektion, inklusive diskussion af forskellige antiretrovirale regimer, som kan anvendes, se pkt.4.4 (behandling af patienter med samtidig hiv-infektion) og produktresuméerne for ombitasvir/ paritaprevir /ritonavir.
English: In the 8.5% of subjects who had ribavirin dose adjustments during therapy, the SVR rate (98.5%) was comparable to subjects who maintained their starting ribavirin dose throughout treatment.
Danish: Blandt de 8,5 % af patienterne, der fik justeret deres ribavirin-dosis under behandlingen, sås stort set den samme SVR-rate (98,5 %) som hos patienter, der bibeholdt deres initiale ribavirin-dosis gennem hele behandlingen.
English: The physician in charge of the diabetic care of the patient should be informed when direct acting antiviral therapy is initiated.
Danish: Den læge, der er ansvarlig for patientens diabetesbehandling, bør informeres, når behandling med direkte virkende antivirale lægemidler/DAA'er påbegyndes.
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Danish: Der er rapporteret om tilfælde af reaktivering af hepatitis B-virus (HBV), herunder dødelige tilfælde, under eller efter behandling med direkte virkende antivirale lægemidler.
English: One subject experienced relapse at Post-Treatment Week 4, 2 subjects prematurely discontinued study drug and 1 subject had missing SVR12 data.
Danish: En patient oplevede tilbagefald 4 uger efter behandling, 2 patienter afbrød behandlingen for tidligt og 1 patient manglede SVR12 data.
English: Tell your doctor or pharmacist before taking Exviera, if you are taking any of the medicines in the table below.
Danish: Tal med lægen eller apotekspersonalet, før du tager Exviera, hvis du tager et eller flere af de lægemidler, der er angivet i tabellen nedenfor.
English: All treatment-emergent variants in NS5A remained detectable at posttreatment Week 48.
Danish: Alle behandlingsrelaterede varianter i NS5A var stadig detekterbare 48 uger efter behandlingen.
English: Metabolism and nutrition disorders Uncommon Dehydration Psychiatric disorders Very common Insomnia Gastrointestinal disorders Very common Nausea, Diarrhoea Common
Danish: Metabolisme og ernæring Ikke almindelig Dehydrering Psykiske forstyrrelser Meget almindelig Søvnløshed Mave-tarm-kanalen Meget almindelig Kvalme, Diarré Almindelig
English: ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 857 days) and most resolved with ongoing therapy.
Danish: ALAT-forhøjelserne var typisk asymptomatiske, forekom generelt i løbet af de første 4 uger af behandlingen (middelvarighed 20 dage, interval 8-57 dage) og forsvandt for de flestes vedkommende ved fortsat behandling.
English: Since dasabuvir is a BCRP substrate, distribution to the milk may change if this transporter is inhibited or induced by co-administration of other medicinal products.
Danish: Da dasabuvir er et BCRP-substrat, kan udskillelsen i modermælk ændres, hvis denne transporter hæmmes eller induceres ved samtidig administration af andre lægemidler.