FrancophonIA/ELRC3.0 huggingface dataset:
English: H2-receptor antagonists may be administered simultaneously with or staggered from Epclusa at a dose that does not exceed doses comparable to famotidine 40 mg twice daily.
Danish: H2-receptorantagonister kan administreres samtidig med eller forskudt i forhold til Epclusa i en dosis, der ikke overstiger svarende til famotidin 40 mg to gange dagligt.
English: c Administered as Epclusa.
Danish: c. Administreret som Epclusa.
English: As Epclusa contains sofosbuvir and velpatasvir, any interactions that have been identified with these active substances individually may occur with Epclusa.
Danish: Da Epclusa indeholder sofosbuvir og velpatasvir, kan alle interaktioner, der er blevet identificeret med disse aktive stoffer individuelt, forekomme med Epclusa.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Epclusa.
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med lægemidler som Epclusa.
English: Overall SVR12 83% (75/90) Genotype 1
Danish: Samlet SVR12 83 % (75/90) Genotype 1
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir.
Danish: Samtidig anvendelse af amiodaron var begrænset under den kliniske udvikling af sofosbuvir.
English: Changes in the parameters found in the CPT score system in patients achieving SVR12 in ASTRAL-4 (all 3 regimens) are shown in Table 16.
Danish: Ændringer i de parametre, der findes i CPT-scoringssystemet, hos patienter, der opnåede SVR12 i ASTRAL-4 (alle 3 regimer) er vist i tabel 16.
English: Epclusa should not be administered concurrently with other medicinal products containing sofosbuvir.
Danish: Epclusa bør ikke administreres samtidig med andre lægemidler, der indeholder sofosbuvir.
English: See Table 3 for examples of interactions with sensitive substrates of P-gp (digoxin), BCRP (rosuvastatin), and OATP (pravastatin).
Danish: Se Tabel 3 for eksempler på interaktioner med sensitive substrater for P-gp (digoxin), BCRP (rosuvastatin) og OATP (pravastatin).
English: Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Danish: Behandling med Epclusa bør påbegyndes og monitoreres af en læge med erfaring i behandling af patienter med HCV-infektion.
English: The safety and efficacy of Epclusa in children and adolescents aged less than 18 years have not yet been established.
Danish: Epclusas sikkerhed og virkning hos børn og unge i alderen under 18 år er endnu ikke klarlagt.
English: 1.5-fold↑
Danish: 1,5 gange↑
English: The resistance associated variants (RAVs) selected in 2 or more genotypes were F28S, L31I/V and Y93H.
Danish: De resistensassocierede varianter (RAV'er), der blev selekteret i 2 eller flere genotyper, var F28S, L31I/V og Y93H.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Epclusa, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Danish: For at vurdere recidiv af hepatocellulært karcinom associeret med Epclusa skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne fra et prospektivt sikkerhedsstudie baseret på en vedtagen protokol med brug af data fra en kohorte af en veldefineret gruppe patienter.
English: If you are sick (vomit) after taking Epclusa it may affect the amount of Epclusa in your blood.
Danish: Hvis du kaster op, efter du har taget Epclusa, kan det påvirke mængden af Epclusa i blodet.
English: Sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment, was the primary endpoint to determine the HCV cure rate.
Danish: Vedvarende virologisk respons (SVR12), defineret som HCV-RNA under LLOQ 12 uger efter behandlingsophør, var det primære endepunkt til bestemmelse af HCV-helbredelsesraten.
English: The recommended dose of Epclusa is one tablet, taken orally, once daily with or without food (see section 5.2).
Danish: Den anbefalede dosis Epclusa er én tablet oralt én gang dagligt sammen med eller uden mad (se pkt.
English: Epclusa is sometimes used together with ribavirin.
Danish: Epclusa anvendes nogle gange sammen med ribavirin.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt 6.1.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Epclusa when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Danish: Da disse tilfælde er potentielt livstruende, bør amiodaron kun anvendes til patienter i behandling med Epclusa, når andre antiarytmika ikke tolereres eller er kontraindicerede.
English: Active
Danish: Aktiv
English: Co-administration of Epclusa with digoxin may increase the concentration of digoxin.
Danish: Samtidig administration af Epclusa og digoxin kan øge koncentrationen af digoxin.
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Epclusa.
Danish: Lægen kan være nødt til nøje at overvåge disse andre lægemidler, som du tager, og foretage dosisjusteringer efter påbegyndelse af Epclusa.
English: Evaluation of sofosbuvir in combination with velpatasvir showed no antagonistic effect in reducing HCV RNA levels in replicon cells.
Danish: Evaluering af sofosbuvir i kombination med velpatasvir viste ingen antagonistisk virkning i reduktion af HCV-RNA-niveauet i replikonceller.
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of velpatasvir by 13-fold against genotype 1a HCV replicons.
Danish: Tilstedeværelse af 40 % humant serum havde ingen virkning på sofosbuvirs anti-HCV-aktivitet, men reducerede anti-HCV-aktiviteten af velpatasvir 13 gange mod genotype 1a-HCV-replikoner.
English: Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet.
Danish: Epclusa er et lægemiddel, der indeholder de aktive stoffer sofosbuvir og velpatasvir i den samme tablet.
English: The response rates in Phase 3 studies were similar in HCV-infected patients who received Epclusa with food or without food.
Danish: Responsraterne i fase III-studier var sammenlignelige hos HCV-inficerede patienter, der fik Epclusa med eller uden mad.
English: • rosuvastatin or other statins used to treat high cholesterol.
Danish: • rosuvastatin eller andre statiner (anvendes til at behandle forhøjet kolesterol).
English: ↔ Ketoconazole
Danish: ↔ Ketoconazol
English: Patients should be instructed to swallow the tablet whole with or without food (see section 5.2).
Danish: Patienterne skal informeres om at sluge tabletten hel sammen med eller uden mad (se pkt.
English: SVR without Y93H 95% CI
Danish: SVR uden Y93H 95 % KI
English: Haemodialysis is unlikely to result in significant removal of velpatasvir, since velpatasvir is highly bound to plasma protein.
Danish: Det er ikke sandsynligt, at hæmodialyse medfører, at velpatasvir fjernes i signifikant grad, da velpatasvir i høj grad er bundet til plasmaprotein.
English: • Do not take any other medicine that contains sofosbuvir, one of the active substances in
Danish: • Tag ikke andre lægemidler, der indeholder sofosbuvir, et af de aktive stoffer i Epclusa.
English: No specific antidote is available for overdose with Epclusa.
Danish: Der findes ingen specifik antidot for en overdosis af Epclusa.
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Epclusa compared to subjects with normal renal function, as described in the text below, are provided in Table 18.
Danish: Et resumé af virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringen for indholdsstofferne i Epclusa sammenlignet med forsøgspersoner med normal nyrefunktion, som beskrevet nedenfor, vises i tabel 18.
English: All patients receiving Epclusa in combination with amiodarone with or without other medicinal products that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Danish: Alle patienter, som får Epclusa i kombination med amiodaron med eller uden andre lægemidler, der nedsætter hjertefrekvensen, skal advares om symptomerne på bradykardi og hjerteblok og informeres om øjeblikkeligt at søge lægehjælp, hvis symptomerne opstår.
English: These data indicate that biliary excretion of parent drug was a major route of elimination for velpatasvir.
Danish: Disse data indikerer, at galdeudskillelse af moderstoffet er en primær eliminationsvej for velpatasvir.
English: The moderate or high fat meal increased sofosbuvir AUC0-inf by 60% and 78%, respectively, but did not substantially affect the sofosbuvir Cmax.
Danish: Måltidet med moderat eller højt fedtindhold øgede AUC0-inf for sofosbuvir med hhv. 60 % og 78 %, men påvirkede ikke i væsentlig grad Cmax for sofosbuvir.
English: Table 16: Changes in CPT score parameters from baseline to week 12 and 24 post-treatment in patients achieving SVR12, ASTRAL-4
Danish: Tabel 16: Ændringer i CPT-scoreparametre fra baseline til uge 12 og 24 efter behandling hos patienter, der opnåede SVR12, ASTRAL-4
English: Site-directed mutagenesis of the S282T substitution in replicons of genotype 1 to 6 conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the replication viral capacity by 89% to 99% compared to the corresponding wild-type.
Danish: Site-directed mutagenese af S282T-substitutionen i replikoner fra genotype 1 til 6 gav 2 til 18 gange nedsat følsomhed for sofosbuvir, og reducerede den virale replikationskapacitet med 89 % til 99 %, sammenlignet med den tilsvarende vildtype.
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity and exposure to the major metabolite GS-331007 was instead used to estimate exposure margins.
Danish: I studier med gnavere kunne der ikke registreres nogen eksponering for sofosbuvir sandsynligvis på grund af høj esteraseaktivitet, og eksponering for den vigtigste metabolit GS-331007 blev i stedet anvendt til estimering af eksponeringsgrænser.
English: NA = Not available a Mean value from multiple experiments of same laboratory replicon.
Danish: a. Middelværdi fra adskillige eksperimenter med samme laboratoriereplikon.
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Tenofovir disoproxil fumarate
Danish: ANTIVIRALE MIDLER MOD HIV: REVERS TRANSKRIPTASE-HÆMMERE Tenofovirdisoproxilfumarat
English: The increase in tenofovir exposure (AUC and Cmax) was around 40-80% during cotreatment with Epclusa and tenofovir disoproxil fumarate/emtricitabine as part of various HIV regimens.
Danish: Tenofovireksponeringen (AUC og Cmax) blev øget ca. 40-80 % under samtidig behandling med Epclusa og tenofovirdisoproxilfumarat/emtricitabin som en del af forskellige hiv-regimer.
English: Table 2: Guidance for ribavirin dosing when administered with Epclusa to patients with decompensated cirrhosis
Danish: Tabel 2: Retningslinjer for dosering af ribavirin administreret sammen med Epclusa til patienter med dekompenseret cirrose
English: This is due to liver function changes during treatment with Epclusa.
Danish: Dette skyldes, at leverfunktionen kan ændre sig under behandling med Epclusa.
English: No human data on the effect of Epclusa on fertility are available.
Danish: Der foreligger ingen data fra mennesker om Epclusas indvirkning på fertilitet.
English: The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir or velpatasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with sofosbuvir/velpatasvir.
Danish: De beskrevne lægemiddelinteraktioner er baseret på studier udført med enten sofosbuvir/velpatasvir eller velpatasvir og sofosbuvir som enkeltstoffer, eller er forventede lægemiddelinteraktioner, der kan opstå med sofosbuvir/velpatasvir.
English: (Inhibition of OATP1B)
Danish: (Hæmning af OATP1B)
English: Afterwards, close monitoring and potential dose adjustment of ciclosporin may be required.
Danish: Nøje monitorering og mulig dosisjustering af ciclosporin kan efterfølgende være nødvendig.
English: The use of Epclusa in children and adolescents has not yet been studied.
Danish: Epclusa er endnu ikke undersøgt hos børn og unge.
English: These should be taken at least 4 hours before or 4 hours after Epclusa;
Danish: Disse lægemidler skal tages mindst 4 timer før eller 4 timer efter Epclusa.
English: In the ASTRAL-3 study, the Y93H RAV was detected at baseline in 9% of patients treated with Epclusa.
Danish: I ASTRAL-3-studiet blev Y93H-RAV detekteret ved baseline hos 9 % af de patienter, der blev behandlet med Epclusa.
English: Overall 95% CI
Danish: Samlet 95 % KI
English: Note: Baseline frequency of ascites was: 20% none, 77% mild/moderate, 3% severe Baseline frequency of encephalopathy was: 38% none, 62% grade 1-2.
Danish: Bemærk: Hyppighed af ascites ved baseline var: 20 % ingen, 77 % let/moderat, 3 % svær Hyppighed af encefalopati ved baseline var: 38 % ingen, 62 % grad 1-2.
English: Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered dose.
Danish: Efter en enkelt dosis på 400 mg sofosbuvir fjernede en 4-timers hæmodialysesession 18 % af den administrerede sofosbuvir-dosis.
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Danish: Defosforylering resulterer i dannelse af nukleosidmetabolitten GS-331007, der ikke kan refosforyleres effektivt, og som mangler anti-HCV-aktivitet in vitro.
English: Some medicines should not be taken with Epclusa.
Danish: Nogle lægemidler må ikke tages sammen med Epclusa.
English: Epclusa has no or negligible influence on the ability to drive and use machines.
Danish: Epclusa påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: These and other adverse events were reported at a similar frequency in placebo treated patients compared with Epclusa treated patients.
Danish: Disse og andre bivirkninger blev rapporteret med sammenlignelige hyppigheder hos patienter i placebo-armen og hos Epclusa-behandlede patienter.
English: Velpatasvir had no adverse effects on mating and fertility.
Danish: Velpatasvir havde ingen negative virkninger på parring og fertilitet.
English: The median terminal half-life of velpatasvir following administration of Epclusa was approximately 15 hours.
Danish: Den mediane terminale halveringstid for velpatasvir efter administration af Epclusa er ca. 15 timer.
English: • If you are allergic to sofosbuvir, velpatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • Hvis du er allergisk over for sofosbuvir, velpatasvir eller et af de øvrige indholdsstoffer i Epclusa (angivet i punkt 6).
English: Demographics and baseline characteristics were balanced between the Epclusa and placebo group.
Danish: De demografiske karakteristika og baseline-karakteristika var afbalancerede mellem Epclusa- og placebogruppen.
English: Velpatasvir is > 99.5% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 µg/mL to 1.8 µg/mL.
Danish: Velpatasvir er > 99,5 % bundet til humane plasmaproteiner, og bindingen er uafhængig af lægemiddelkoncentrationen i intervallet fra 0,09 μg/ml til 1,8 μg/ml.
English: The film-coated tablets are pink, diamond-shaped tablets debossed with “GSI” on one side and “7916” on the other side.
Danish: De filmovertrukne tabletter er lyserøde, rombeformede tabletter, præget med ”GSI” på den ene side og med ”7916” på den anden side.
English: Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Epclusa.
Danish: Hvis samtidig brug af amiodaron findes nødvendig, anbefales nøje monitorering af patienterne ved initiering af behandlingen med Epclusa.
English: Velpatasvir is an inhibitor of drug transporter P-gp, BCRP, OATP1B1 and OATP1B3 and its involvement in drug interactions with these transporters is primarily limited to the process of absorption.
Danish: Velpatasvir hæmmer lægemiddeltransportørerne P-gp, BCRP, OATP1B1 og OATP1B3, og dets involvering i lægemiddelinteraktioner med disse transportører er primært begrænset til absorptionsprocessen.
English: Afterwards, close monitoring and potential dose adjustment of tacrolimus may be required.
Danish: Nøje monitorering og mulig dosisjustering af tacrolimus kan efterfølgende være nødvendig.
English: Sofosbuvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study.
Danish: Sofosbuvir havde ingen negative virkninger på adfærd, reproduktion eller afkommets udvikling hos rotter i et udviklingsstudie før og efter fødslen.
English: d Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184.
Danish: d. Data fra en kimær NS5A-replikon, der bærer NS5A-aminosyrer 9-184.
English: Interaction only studied with sofosbuvir Expected:
Danish: Interaktion kun undersøgt med sofosbuvir Forventet:
English: GS-331007 is efficiently removed by haemodialysis with an extraction coefficient of approximately 53%.
Danish: GS-331007 fjernes effektivt ved hæmodialyse med en ekstraktionskoefficient på ca. 53 %.
English: • The active substances are sofosbuvir and velpatasvir.
Danish: • Aktive stoffer: sofosbuvir og velpatasvir.
English: (Increase in gastric pH)
Danish: (Øget gastrisk pH)
English: Post-treatment Week 24 (N = 236), % (n/N) Decreased score (Improvement)
Danish: Uge 24 efter behandling (N=236), % (n/N) Reduceret score (forbedring)
English: It is recommended to separate antacid and Epclusa administration by 4 hours.
Danish: Det anbefales, at administration af antacida og Epclusa finder sted med 4 timers mellemrum.
English: Velpatasvir Animal studies have shown a possible link to reproductive toxicity (see section 5.3).
Danish: Dyrestudier har vist en mulig forbindelse til reproduktionstoksicitet (se pkt.
English: Animal studies do not indicate harmful effects of sofosbuvir or velpatasvir on fertility.
Danish: Dyrestudier indikerer ingen skadelige virkninger af sofosbuvir eller velpatasvir på fertilitet.
English: The adverse events observed were consistent with expected clinical sequelae of decompensated liver disease, or the known toxicity profile of ribavirin for patients receiving Epclusa in combination with ribavirin.
Danish: De observerede bivirkninger var konsistente med de forventede kliniske følgevirkninger af dekompenseret leversygdom eller ribavirins kendte bivirkningsprofil for patienter, der fik Epclusa i kombination med ribavirin.
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Danish: Sofosbuvir metaboliseres i udstrakt grad i leveren under dannelse af den farmakologisk aktive nukleosid-analog triphosphat GS-461203.
English: Post-treatment Week 12 (N = 236), % (n/N) Decreased score (Improvement)
Danish: Uge 12 efter behandling (N=236), % (n/N) Reduceret score (forbedring)
English: The overall SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed Epclusa treatment and relapsed and two did not meet virologic failure criteria.
Danish: Den samlede SVR-rate var 95 % (56/59); ud af de tre patienter, som ikke opnåede SVR12, havde én afsluttet behandling med Epclusa og recidiveret, og to opfyldte ikke kriterierne for virologisk svigt.
English: Oxcarbazepine (Induction of P-gp and CYPs)
Danish: Oxcarbazepin (Induktion af P-gp og CYP'er)
English: When co-administered with Epclusa, careful monitoring for statin adverse reactions should be undertaken and a reduced dose of statins should be considered if required.
Danish: Ved administration sammen med Epclusa skal der monitoreres nøje for statinbivirkninger, og en reduceret statindosis skal om nødvendigt overvejes.
English: Table 18: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Velpatasvir Compared to Subjects with Normal Renal Function
Danish: Tabel 18: Virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringer (AUC) for sofosbuvir, GS-331007 og velpatasvir sammenlignet med forsøgspersoner med normal nyrefunktion
English: After a single 400 mg oral dose of [14C]-sofosbuvir, GS-331007 accounted for approximately > 90% of total systemic exposure.
Danish: Efter en enkelt oral 400 mg-dosis af [14C]-sofosbuvir udgjorde GS-331007 ca. > 90 % af den samlede systemiske eksponering.
English: Interaction only studied with velpatasvir.
Danish: Interaktion kun undersøgt med velpatasvir.
English: In vitro data suggests that the majority of NS5A RAVs that confer resistance to ledipasvir and daclatasvir remained susceptible to velpatasvir.
Danish: In vitro-data indikerer, at størstedelen af NS5A-RAV'er med resistens over for ledipasvir og daclatasvir, forblev følsomme for velpatasvir.
English: Body weight did not have a clinically significant effect on sofosbuvir or velpatasvir exposure according to a population pharmacokinetic analysis.
Danish: Legemsvægt havde ikke nogen klinisk signifikant indvirkning på eksponeringen for sofosbuvir eller velpatasvir i henhold til en populationsfarmakokinetisk analyse.
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↑ Velpatasvir
Danish: GS-331007 1,6 gange↑ 1,9 gange↑ 5,5 gange↑ ≥ 10 gange↑ ≥ 20 gange↑
English: Co-administration of Epclusa with rosuvastatin increases the concentration of rosuvastatin, which is associated with increased risk of myopathy, including rhabdomyolysis.
Danish: Administration af Epclusa sammen med rosuvastatin øger koncentrationen af rosuvastatin, hvilket er forbundet med en øget risiko for myopati, herunder rabdomyolyse.
English: In the pooled analysis of the Phase 3 studies, 380/1,023 (37%) patients' virus had baseline NS5A RAVs.
Danish: I den samlede analyse af fase III-studierne havde 380/1.023 (37 %) af patienterne virus med NS5A-RAV'er ved baseline.
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: Reduced susceptibility to sofosbuvir was associated with the primary NS5B substitution S282T in all replicon genotypes examined.
Danish: Nedsat følsomhed for sofosbuvir var forbundet med den primære NS5B-substitution S282T i alle de undersøgte replikon-genotyper.
English: GS-331007 is not an inhibitor of OAT1, OCT2, and MATE1.
Danish: GS-331007 hæmmer ikke OAT1, OCT2 og MATE1.
English: Velpatasvir AUC increases in a nearly dose proportional manner over the dose range of 25 mg to 150 mg. Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1,200 mg.
Danish: Velpatasvir-AUC øges næsten proportionalt med dosis over doseringsintervallet fra 25 mg til 150 mg. AUC for sofosbuvir og GS-331007 er næsten proportional med dosis over doseringsintervallet fra 200 mg til 1.200 mg.
English: Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
Danish: Hver filmovertrukket tablet indeholder 400 mg sofosbuvir og 100 mg velpatasvir.