FrancophonIA/ELRC3.0 huggingface dataset:
English: None of the subjects with hyperbilirubinemia had concomitant elevations of aminotransferases.
Danish: Ingen af forsøgspersonerne med hyperbilirubinæmi havde samtidig forhøjelse af aminotransferase.
English: Although causality is difficult to establish due to background advanced liver disease, a potential risk cannot be excluded.
Danish: Det er vanskeligt at afgøre kausalitet på grund af den bagvedliggende fremskredne leversygdom, men en risiko for sammenhæng med behandlingen kan ikke udelukkes.
English: • Swelling of the layers of skin which can affect any part of the body including the face, tongue or throat and may cause difficulty swallowing or breathing (angioedema)
Danish: • Hævelse i hudens lag, som kan påvirke alle dele af kroppen inklusive ansigtet, tungen eller halsen som kan give synke- eller vejrtrækningsbesvær (angioødem)
English: Adverse events of anaemia were not seen in the 18 GT1b-infected subjects who did not receive ribavirin.
Danish: Anæmi-bivirkninger sås ikke hos de 18 GT1binficerede patienter, som ikke fik ribavirin.
English: SAPPHIRE I and II PEARL II, III, and IV TURQUOISE II (subjects with cirrhosis)
Danish: PEARL II, III og IV TURQUOISE II (forsøgspersoner med cirrose)
English: b. Other includes early drug discontinuation not due to virologic failure and missing HCV RNA values in the
Danish: b. 'Andet' omfatter tidlig stop i behandlingen som ikke skyldes virologisk svigt og manglende HCV-rna-værdier i SVR12-vinduet.
English: In contrast, the rate of ALT elevations in subjects using other types of oestrogens as typically used in hormonal replacement therapy (i.e., oral and topical oestradiol and conjugated oestrogens) was similar to the rate observed in subjects who were not using oestrogen-containing products (approximately 1% in each group).
Danish: Til gengæld var forekomsten af forhøjet ALAT hos de forsøgspersoner, som anvendte andre typer østrogener, herunder dem, der typisk anvendes i hormonerstatningsbehandling (dvs. østradiol til oral og topikal anvendelse samt konjugerede østrogener), den samme som hos de forsøgspersoner, der ikke brugte østrogenholdige lægemidler (ca. 1 % i hver gruppe).
English: The blood to plasma concentration ratios in human ranged from 0.5 to 0.7 indicating that dasabuvir was preferentially distributed in the plasma compartment of whole blood.
Danish: Ratioen for blod/plasmakoncentrationen hos mennesker var 0,5-0,7, og det peger på, at dasabuvir fortrinsvis fordeles i plasmakompartmentet i helblod.
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, a 10 year increase or decrease in age from 54 years (median age in the Phase 3 studies) would results in <10% change in dasabuvir exposures.
Danish: På basis af farmakokinetiske populationsanalyser af data fra kliniske fase 3-studier vil en stigning eller et fald i alder fra 54 år (median alder i fase 3-studierne) medføre en ændring på < 10 % i eksponeringen for dasabuvir.
English: It is not known whether the active substance in Exviera (dasabuvir), passes into breast milk.
Danish: Det er ukendt, om det aktive stof i Exviera (dasabuvir) udskilles i human mælk.
English: If you do miss a dose and it is:
Danish: Hvis du alligevel skulle glemme en dosis, og hvis der er
English: Animal studies do not indicate harmful effects on fertility (see section 5.3).
Danish: Dyreforsøg indikerer ingen skadelige virkninger på fertiliteten (se pkt.
English: Food increased the exposure (AUC) of dasabuvir by up to 30% relative to the fasting state.
Danish: Mad øgede eksponeringen (AUC) for dasabuvir med op til 30 % i forhold til administration uden mad.
English: The overall safety profile in subjects with severe renal impairment was similar to that seen in prior Phase 3 studies in subjects without severe renal impairment, except that a greater proportion of subjects required intervention due to ribavirin-associated decreases in serum haemoglobin.
Danish: Den overordnede sikkerhedsprofil hos personer med alvorlig nedsat nyrefunktion var sammenlignelig med den, der blev set i tidligere fase 3-studier hos patienter uden alvorlig nedsat nyrefunktion bortset fra, at en større andel af patienterne krævede intervention på grund af ribavirin associerede fald i serumhæmoglobin.
English: The AUC values of dasabuvir M1 metabolite were unchanged, 57% lower, and 77% higher, respectively.
Danish: AUC-værdierne for dasabuvirs metabolit M1 var hhv. uændrede, 57 % lavere og 77 % højere.
English: Dasabuvir was greater than 99.5%, and M1 major metabolite of dasabuvir was 94.5% bound to human plasma proteins over a concentration range of 0.05 to 5 µg/mL.
Danish: Dasabuvir var mere end 99,5 %, og dets største metabolit M1 94,5 %, bundet til humane plasmaproteiner i et koncentrationsområde på 0,05-5 µg/ml.
English: No clinically relevant changes in dasabuvir, paritaprevir, and ombitasvir exposures (based on comparison with historical data) were observed during the coadministration.
Danish: Der sås ingen klinisk relevante ændringer i dasabuvir-, paritaprevir- og ombitasvir-eksponeringen (baseret på en sammenligning med historiske data) ved samtidig administration.
English: Bilirubin elevations were not associated with aminotransferase elevations.
Danish: Forhøjet bilirubin var ikke forbundet med forhøjede aminotransferaser.
English: Dasabuvir is an inhibitor of BCRP in vivo.
Danish: Dasabuvir er en BCRP-hæmmer in vivo.
English: The highest documented single dose of dasabuvir administered to healthy volunteers was 2 g. No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed.
Danish: Den højeste dokumenterede enkeltdosis dasabuvir administreret til raske forsøgspersoner er 2 g. Der sås ingen lægemiddelrelaterede bivirkninger eller klinisk signifikante laboratorieanomalier.
English: Risk of hepatic decompensation and hepatic failure in patients with cirrhosis
Danish: Risiko for dekompenseret leversygdom og leversvigt hos patienter med cirrose
English: CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments.
Danish: CYP2D6substrater (f.eks. desipramin, metoprolol og dextromethorphan) forventes ikke at nødvendiggøre dosisjustering.
English: AUC (ng*hr/ml) (CV%)
Danish: AUC (ng*t/ml) (CV %)
English: Transient elevations in total bilirubin >3 x ULN (mostly indirect) occurred in 17 (27.0%) subjects; 15 of these subjects were receiving atazanavir.
Danish: Forbigående forhøjelse af total bilirubin > 3 x den øvre normalgrænse (for det meste ikke-konjugeret) sås hos 17 (27,0 %) af forsøgspersonerne; 15 af disse forsøgspersoner var i behandling med atazanavir.
English: (administere d in the evening)
Danish: (administreret på samme tid)
English: 8 weeks may be considered in previously untreated genotype 1binfected patients with minimal to moderate fibrosis** (see section 5.1, GARNET study)
Danish: 8 uger kan overvejes hos tidligere ubehandlede genotype 1b-patienter med minimal til moderat fibrose (se pkt.
English: Other medicines and Exviera
Danish: Brug af anden medicin sammen med Exviera
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERFOLIE
English: In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
Danish: Blandt de patienter, der fik det anbefalede regime, var der samlet set 97 %, som opnåede SVR (heraf var der 181 patienter med kompenseret cirrose, der opnåede SVR på 97 %); 0,5 % oplevede virologisk gennembrud, og 1,2 % fik recidiv efter behandlingen.
English: *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
Danish: Træthed *Datasættet omfatter alle genotype 1-smittede patienter i fase 2- og fase 3-studier, herunder patienter med cirrose.
English: M1 is mainly cleared through direct biliary excretion with the contribution of UGT-mediated glucuronidation and, to a small extent, oxidative metabolism.
Danish: M1 udskilles primært ved direkte biliær udskillelse og delvist ved UGT-medieret glukoronidering og i mindre grad ved oxidativ metabolisering.
English: Following a 400 mg 14C-dasabuvir dose, approximately 94% of the radioactivity was recovered in faeces with limited radioactivity (approximately 2%) in urine.
Danish: Efter en dosis på 400 mg 14C-dasabuvir blev ca. 94 % af radioaktiviteten udskilt i fæces og en begrænset andel (ca. 2 %) i urinen.
English: Clinical Comments
Danish: Klinisk kommentar
English: Do not use the medicine after the expiry date which is stated on the carton after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In Part 1b, SVR12 was achieved by 22/22 (100%) subjects (95% CI: 85.1%, 100%).
Danish: I del 1b blev SVR12 opnået af 22/22 (100%) forsøgspersoner (95% KI: 85,1%, 100%).
English: 12 or 24 weeks N = 380 n (%)
Danish: 12 eller 24 uger N = 380 n (%)
English: Multipack: 56 (4 packs of 14) film-coated tablets
Danish: Multipakning: 56 (4 æsker a 14) filmovertrukne tabletter
English: See also Table 2 for specific advice on raltegravir and buprenorphine which have been evaluated in drug interaction studies.
Danish: Se også tabel 2, der indeholder specifik vejledning vedrørende raltegravir og buprenorphin, der er blevet undersøgt i lægemiddelinteraktionsstudier.
English: 5 subjects required erythropoietin, all of whom initiated ribavirin at the starting dose of 1000 to 1200 mg daily.
Danish: 5 forsøgspersoner havde behov for erytropoietin, og de havde alle fået en startdosis ribavirin på 1.000-1.200 mg pr. dag.
English: Deferasirox may increase dasabuvir exposures and should be used with caution.
Danish: Deferasirox kan øge dasabuvirs eksponering og skal anvendes med forsigtighed.
English: Sixty four of 68 (94.1%) subjects achieved SVR12.
Danish: 64 ud af 68 (94,1%) patienter opnåede SVR12.
English: Table 17 shows the primary efficacy analysis of SVR12 performed on subjects with HCV GT1/HIV-1 co-infection that received recommended regimen in Part 2 of the TURQUOISE-I study.
Danish: Tabel 17 viser den primære effektanalyse af SVR12 udført på forsøgspersoner med samtidig HCV GT1 og hiv-1-infektion, der modtog det anbefalede regime i del 2 af TURQUOISE-I-studiet.
English: Dasabuvir should be used in combination with other medicinal products for the treatment of HCV (see section 5.1).
Danish: Dasabuvir skal anvendes i kombination med andre lægemidler til behandling af HCV (se pkt.
English: ALT elevations were asymptomatic and generally occurred during the first 4 weeks of treatment, without concomitant elevations of bilirubin, and declined within approximately two weeks of onset with continued dosing of dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin.
Danish: De forhøjede ALAT-niveauer var asymptomatiske og optrådte som regel i løbet af de første 4 uger af behandlingen uden samtidig forhøjelse af bilirubin-niveauet, og de faldt igen inden for ca. 2 uger ved fortsat dosering af dasabuvir og ombitasvir/paritaprevir/ritonavir med eller uden ribavirin.
English: The efficacy of dasabuvir has not been established in patients with HCV genotypes other than genotype 1; dasabuvir should not be used for the treatment of patients infected with other genotypes than 1.
Danish: Dasabuvirs virkning hos patienter med andre HCV-genotyper end genotype 1 er ikke klarlagt, og dasabuvir må derfor ikke bruges til behandling af patienter med andre genotyper end genotype 1.
English: Sirolimus dose and/or dosing frequency should be adjusted as needed.
Danish: Sirolimus dosis og/eller doseringshyppighed bør justeres efter behov.
English: Pharmacodynamic interactions
Danish: Farmakodynamiske interaktioner
English: Interactions between dasabuvir with ombitasvir/paritaprevir/ritonavir and other medicinal products
Danish: Interaktioner mellem dasabuvir med ombitasvir/paritaprevir/ritonavir og andre lægemidler
English: As a precautionary measure, it is preferable to avoid the use of dasabuvir during pregnancy.
Danish: For en sikkerheds skyld bør dasabuvir undgås under graviditet.
English: Outcome for subjects without SVR12
Danish: Resultat for patienter uden SVR12
English: Although some cases had previous history of depression, psychiatric illness and/or substance abuse, a causal relation with dasabuvir with or without ombitasvir/paritaprevir/ritonavir treatment cannot be excluded.
Danish: Selvom nogle tilfælde havde anamnese med depression, psykisk sygdom og/eller stofmisbrug, kan en årsagssammenhæng med dasabuvir-behandling med eller uden ombitasvir/paritaprevir/ritonavir ikke udelukkes.
English: Medicinal products metabolised by CYP2D6 or CYP1A2
Danish: Lægemidler, der metaboliseres af CYP2D6 eller CYP1A2
English: Changes in exposures of the metabolite were generally consistent with that observed with dasabuvir except for studies with CYP2C8 inhibitor, gemfibrozil, where the metabolite exposures decreased by up to 95% and CYP3A inducer, carbamazepine, where the metabolite exposures decreased by only up to 39%.
Danish: Ændringen i metaboliteksponeringen svarede generelt til ændringen i dasabuvir-eksponeringen, bortset fra i studier med CYP2C8-hæmmeren gemfibrozil, hvor metaboliteksponeringen faldt med op til 95 %, og CYP3A-induceren carbamazepin, hvor metaboliteksponeringen kun faldt med op til 39 %.
English: Stop taking Exviera and talk to your doctor or get medical help immediately if any of the following occur:
Danish: Stop med at tage Exviera og kontakt omgående din læge eller hospitalet, hvis du oplever følgende:
English: • Feeling weak or lack of energy (asthenia).
Danish: • kraftesløshed, manglende energi (asteni)
English: Symptoms include: o Feel sick (nauseous), are sick (vomit) or lose your appetite o Notice yellowing of your skin or eyes o Your urine is darker than normal o Confusion o Notice swelling of your stomach area
Danish: Symptomerne omfatter: o Hvis du får kvalme, kaster op eller mister appetitten o hvis du bemærker gulfarvning af huden eller øjnene o hvis din urin er mørkere end normalt o hvis du lettere bliver forvirret o hvis du bemærker, at din mave svulmer op
English: Duration
Danish: Varighed
English: These medicines can affect the way Exviera and ombitasvir/paritaprevir/ritonavir work and Exviera and ombitasvir/paritaprevir/ritonavir can affect the way these other medicines work.
Danish: De kan påvirke den måde, Exviera og ombitasvir/paritaprevir/ritonavir virker på, ligesom Exviera og ombitasvir/paritaprevir/ritonavir kan påvirke den måde, de andre lægemidler virker på.
English: Enzyme inducers:
Danish: Enzym-inducere:
English: Peginteferon+ribavirin-experienced, without cirrhosis SAPPHIRE II
Danish: Peginteferon + ribavirin-erfarne, uden cirrose SAPPHIRE II
English: Dasabuvir retained full activity against replicons containing substitutions S282T in the nucleoside binding site, M423T in the lower thumb site, and P495A/S, P496S or V499A in the upper thumb site.
Danish: Dasabuvir bibeholdt fuld aktivitet mod replikoner indeholdende substitutionen S282T i nukleosid-bindingsstedet, substitutionen M423T i lower thumbsitet og substitutionerne P495A/S, P496S eller V499A i upper thumb-sitet.
English: ANTICOAGULANTS Warfarin
Danish: ANTIKOAGULANTIA Warfarin
English: Among the GT1 subjects who were post renal transplant, 9/12 (75%) achieved SVR12; however, there were no virologic failures.
Danish: Blandt de GT1-forsøgspersoner, der var nyretransplanterede, opnåede 9/12 (75%) SVR12; der var dog ingen virologiske svigt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dasabuvir and ombitasvir/paritaprevir/ritonavir in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med dasabuvir og ombitasvir/paritaprevir/ritonavir i en eller flere undergrupper af den pædiatriske population ved behandling af kronisk hepatitis C (se pkt.
English: Impact of ribavirin dose adjustment on probability of SVR In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Danish: Effekt af justering af ribavirin-dosis på sandsynligheden for SVR I kliniske fase 3-studier var det ikke nødvendigt at justere ribavirin-dosen under behandlingen hos 91,5 % af forsøgspersonerne.
English: Purpose of the medicine alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, everolimus, sirolimus, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms dabigatran to thin the blood deferasirox to help reduce iron levels in the blood digoxin, amlodipine for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain imatinib for the treatment of some cancers of the blood levothyroxine for thyroid problems darunavir/ritonavir, atazanavir/ritonavir, rilpivirine for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems rosuvastatin, pravastatin, fluvastatin, pitavastatin to lower blood cholesterol s-mephenytoin for epilepsy teriflunomide for multiple sclerosis sulfasalazine to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis warfarin and other similar medicines called vitamin K antagonists*
Danish: Alprazolam, diazepam mod angst, panikanfald og søvnbesvær ciclosporin, everolimus, sirolimus, tacrolimus for at undertrykke immunsystemet cyclobenzaprine, carisoprodol mod muskelkramper dabigatran til fortynding af blodet deferasirox for at nedsætte indholdet af jern i blodet digoxin, amlodipin mod hjerteproblemer eller forhøjet blodtryk furosemid mod væskeophobning i kroppen hydrokodon mod smerter imatinib til behandling af visse former for kræft i blodet levothyroxin mod problemer med skjoldbruskkirtlen darunavir/ritonavir, atazanavir/ritonavir, rilpivirin mod hiv-infektion omeprazol, lansoprazol, esomeprazol mod mavesår og andre maveproblemer rosuvastatin, pravastatin, fluvastatin, pitavastatin mod forhøjet kolesterol s-mephenytoin mod epilepsi teriflunomid mod multipel sklerose sulfasalazin til behandling og styring af inflammatorisk tarmsygdom eller til behandling af gigt
English: increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
Danish: HCV-rna fra nadir eller HCV-rna vedvarende ≥ 25 IE/ml efter mindst 6 ugers behandling.
English: SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatment-naïve or previously treated with pegIFN/RBV
Danish: SVR12 for genotype 1-smittede patienter med kompenseret cirrose, der var behandlingsnaive eller tidligere behandlet med pegIFN/RBV
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of multipack of 14 film-coated tablets - without blue box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Indre æske i multipakning a 14 filmovertrukne tabletter - uden blue box
English: Co-administration of dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine).
Danish: Samtidig administration af dasabuvir og andre lægemidler, der primært metaboliseres af UGT1A1, medfører forhøjede plasmakoncentrationer af disse lægemidler; rutinemæssig klinisk monitorering anbefales for lægemidler med snævert terapeutisk indeks (f.eks. levothyroxin).
English: Among all GT1 subjects who were post liver transplant, 111/114 (97.4%) achieved SVR12; with 2 relapsing post treatment and 1 breakthrough on treatment.
Danish: Blandt alle GT1-levertransplanterede forsøgspersoner, opnåede 111/114 (97,4%) SVR12; 2 med recediv efter behandling og 1 med gennembrud under behandling.
English: If statin treatment is required during the treatment period, a switch to dose reduced pravastatin or rosuvastatin is possible.
Danish: Hvis det er nødvendigt at give patienten statiner i behandlingsperioden, er det muligt at skifte til en reduceret dosis af pravastatin eller rosuvastatin.
English: A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment.
Danish: Det anbefales at afbryde behandlingen med fluvastatin og pitavastatin midlertidigt, så længe behandlingen pågår.
English: Medicines you must tell your doctor about before taking Exviera Medicine or active substance
Danish: Lægemidler, som lægen skal vide, om du tager, før du tager Exviera Lægemiddel eller aktivt stof
English: Medicinal products metabolised by glucuronidation Dasabuvir is an inhibitor of UGT1A1 in vivo.
Danish: Lægemidler, der metaboliseres ved glukoronidering Dasabuvir er en UGT1A1-hæmmer in vivo.
English: For subjects who received ribavirin, the ribavirin dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg.
Danish: Patienter, der fik ribavirin, fik en ribavirin-dosis på 1.000 mg om dagen, hvis de vejede under 75 kg, eller på 1.200 mg om dagen, hvis de vejede 75 kg eller derover.
English: Refer to the tacrolimus or sirolimus Summary of Product Characteristics for additional dosing and monitoring instructions.
Danish: Se produktresuméerne for tacrolimus eller sirolimus for yderligere instruktioner vedrørende dosering og overvågning.
English: Potential for dasabuvir to affect the pharmacokinetics of other medicinal products In vivo drug interaction studies evaluated the net effect of the combination treatment, including ritonavir.
Danish: Dasabuvirs potentielle indvirkning på andre lægemidlers farmakokinetik Nettovirkningen af kombinationsbehandlingen, inklusive ritonavir, er undersøgt i lægemiddelinteraktionsstudier in vivo.
English: The following section describes the specific transporters and metabolizing enzymes that are affected by dasabuvir when combined with ombitasvir/paritaprevir/ritonavir.
Danish: I det følgende afsnit beskrives de specifikke transportere og metaboliserende enzymer, der påvirkes af dasabuvir ved kombination med ombitasvir/paritaprevir/ritonavir.
English: Dasabuvir was the predominant component observed in the milk of lactating rats, without effect on nursing pups.
Danish: Dasabuvir, der var den primære komponent i mælken hos diegivende rotter, havde ingen indvirkning på de diende unger.
English: ↔ ethinyl oestradiol
Danish: ↔ ethinyl østradiol
English: Medicinal products renally excreted via transport proteins Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate).
Danish: Lægemidler, der udskilles renalt via transportproteiner Dasabuvir hæmmer ikke den organiske aniontransporter (OAT1) in vivo, idet der ikke ses nogen interaktion med tenofovir (OAT1-substrat).
English: Treated subjects had a median age of 51 years (range: 26 to 64); 65.8% were male and 5.3% were Black.
Danish: De behandlede forsøgspersoner havde en median alder på 51 år (interval: 26-64), 65,8 % var mænd og 5,3 % var sorte.
English: PEARL II (open-label)
Danish: PEARL II (åben)
English: 10 of 34 subjects (29.4%) dose modified ribavirin due to decrease in haemoglobin and 2.9% (1/34) had an interruption of ribavirin.
Danish: 10 ud af 34 forsøgspersoner (29,4 %) fik nedsat ribavirin-dosen på grund af fald i hæmoglobin-niveauet, og 2,9 % (1 ud af 34) fik afbrudt behandlingen med ribavirin.