FrancophonIA/ELRC3.0 huggingface dataset:
English: SVR12 rates for recommended treatment regimens by patient population
Danish: SVR12-rater for de anbefalede behandlingsregimer pr. patientpopulation
English: n/N % 95% CI
Danish: n/N % 95 %-KI
English: Some patients have reported feeling very tired when taking Exviera with other medicines for their hepatitis C infection.
Danish: Nogle patienter har indberettet, at de følte sig meget trætte, når de tog Exviera sammen med andre lægemidler mod hepatitis C-infektion.
English: While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Danish: Selvom der ikke forventes ændringer af warfarins farmakokinetik, anbefales tæt monitorering af INR sammen med alle vitamin K-antagonister.
English: Pitavastatin and fluvastatin
Danish: Pitavastatin og fluvastatin
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines.
Danish: HBV/HCV co-inficerede patienter har risiko for reaktivering af HBV og bør derfor monitoreres og behandles i henhold til gældende kliniske vejledninger.
English: 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
Danish: 60 patienter blev randomiseret og behandlet, og 60/60 (100 %) opnåede SVR 12.
English: In clinical studies
Danish: I kliniske studier
English: There are some medicines you must not take with Exviera - see the previous table “Medicines you must not take with Exviera”.
Danish: Der er visse lægemidler, som du ikke må tage sammen med Exviera - se ovenfor i tabellen "Lægemidler, du ikke må tage sammen med Exviera".
English: NA Decrease in amlodipine dose by 50% and monitor patients for clinical effects.
Danish: Ikke relevant Reducér amlodipin-dosen med 50 %, og overvåg patienten for kliniske virkninger.
English: Dasabuvir M1 metabolite was quantified in all the drug interaction studies.
Danish: Dasabuvirs M1-metabolit blev kvantificeret i alle lægemiddelinteraktionsstudierne.
English: Exviera tablets are packed into foil blisters containing 2 tablets.
Danish: Exviera-tabletterne er pakket i blisterpakninger, der indeholder 2 tabletter.
English: The recommended dose is one tablet, twice a day.
Danish: Den anbefalede dosis er 1 tablet 2 gange dagligt.
English: Hepatitis B virus reactivation
Danish: Reaktivering af hepatitis B-virus
English: Exviera tablets do not work on their own.
Danish: Exviera-tabletter virker ikke alene.
English: It is very important that you also read the package leaflets for the other antiviral medicines that you take with Exviera.
Danish: Det er meget vigtigt, at du også læser indlægssedlerne for de andre antivirale lægemidler, som du tager sammen med Exviera.
English: There was 1 relapse in the 12-week arm and 1 on-treatment virologic failure in the 24-week arm.
Danish: Der var 1 tilbagefald i 12 ugers armen og 1 virologisk svigt under behandling i 24 ugers armen.
English: Package leaflet: Information for the patient Exviera 250 mg film-coated tablets dasabuvir This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Exviera 250 mg filmovertrukne tabletter dasabuvir Dette lægemiddel er underlagt supplerende overvågning.
English: Overall, 61% had fibrosis stage F0-F1, 26% F2, 9% F3, and 4% F4.
Danish: Samlet set havde 61% fibrose stadium F0-F1, 26% F2, 9% F3 og 4% F4.
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AP09
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; direkte virkende antivirale midler; ATC-kode: J05AP09
English: Paediatric population Drug interaction studies have only been performed in adults.
Danish: Lægemiddelinteraktionsstudier er kun udført hos voksne.
English: Dasabuvir is highly bound to plasma proteins.
Danish: Dasabuvir har en høj bindingsgrad til plasmaproteiner.
English: Clinical monitoring and lower doses of imatinib are recommended.
Danish: Klinisk monitorering og lavere doser af imatinib anbefales.
English: Dasabuvir was absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Danish: Dasabuvir blev absorberet efter oral administration med en gennemsnitlig Tmax på ca. 4-5 timer.
English: Treatment-emergent variants and their prevalence in these virologic failure populations are shown in Table 5.
Danish: Behandlingsrelaterede varianter og deres prævalens i disse populationer med virologisk svigt er vist i tabel 5.
English: Ribavirin stays for a long time in the body after treatment is stopped, and effective contraception is therefore needed both during treatment and for some time afterwards.
Danish: Ribavirin bliver i kroppen i længere tid efter, at behandlingen er stoppet, og sikker prævention er derfor nødvendig både under og i nogen tid efter behandlingen.
English: 14 film-coated tablets Component of a multipack, can't be sold separately.
Danish: 14 filmovertrukne tabletter Delpakning af multipakning - må ikke sælges separat.
English: Missed doses
Danish: Glemte doser
English: Mechanism:
Danish: Mekanisme:
English: • Take the tablets with food.
Danish: • Tag tabletterne sammen med noget mad.
English: A decrease in alprazolam dose can be considered based on clinical response.
Danish: Nedsættelse af alprazolam-dosen kan overvejes alt efter klinisk respons.
English: You should not breastfeed during treatment with Exviera.
Danish: Du må ikke amme under behandlingen med Exviera.
English: 24 weeks
Danish: 24 uger
English: • Read the “Contraception” section of the package leaflet for ribavirin very carefully.
Danish: • Læs punktet om “Prævention” i indlægssedlen for ribavirin meget grundigt.
English: No human data on the effect of dasabuvir on fertility are available.
Danish: Der foreligger ingen humane data om dasabuvirs indvirkning på fertiliteten.
English: Most patients with these severe outcomes had evidence of advanced or decompensated cirrhosis prior to initiating therapy.
Danish: De fleste patienter med disse alvorlige udfald havde tegn på fremskreden eller dekompenseret cirrose inden behandlingsstart.
English: Two subjects received a blood transfusion.
Danish: To patienter fik blodtransfusion.
English: Lower ribavirin dose at initiation may be appropriate.
Danish: En lavere dosis ribavirin kan være relevant ved opstart.
English: Without RBV
Danish: Uden RBV
English: G558R and D559G/N were observed as treatment-emergent substitutions but the activity of dasabuvir against these variants could not be evaluated due to poor replication capacity.
Danish: G558R og D559G/N sås som behandlingsrelaterede substitutioner, men aktiviteten af dasabuvir mod disse varianter kunne ikke vurderes på grund af ringe replikationsevne.
English: Do not stop taking Exviera unless your doctor tells you to.
Danish: Stop ikke behandlingen med Exviera, medmindre lægen siger, du skal.
English: Raltegravir exposure is substantially increased (2-fold).
Danish: Raltegravir-eksponeringen øges markant (med 2 gange).
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; therefore, ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant.
Danish: Signifikante teratogene og/eller embryocidale virkninger er påvist hos alle dyrearter, der er blevet eksponeret for ribavirin, og derfor er ribavirin kontraindiceret hos gravide kvinder og hos mænd, hvis partner er gravid.
English: Extra precautions are needed if Exviera is taken together with ribavirin.
Danish: Der er behov for ekstra forsigtighed, hvis Exviera tages sammen med ribavirin.
English: IMMUNOSUPPRESSANTS Ciclosporin
Danish: IMMUNOSUPPRESSIVA Ciclosporin
English: For immunosuppressive medication, most subjects were taking tacrolimus (81%), with the remainder taking cyclosporine.
Danish: Til immunsuppressiv medicinering tog de fleste forsøgspersoner tacrolimus (81%), mens resten tog cyclosporin.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjælden arvelig galaktoseintolerans, total laktase-mangel eller glukose-galaktose-malabsorption bør ikke behandles med dette lægemiddel.
English: A total of 129 subjects were treated, 84 with GT1a, 41 with GT1b, 1 with GT1 other, 3 with GT4 infection.
Danish: I alt 129 forsøgspersoner blev behandlet, 84 med GT1a, 41 med GT1b, 1 med anden GT1, 3 med GT4infektion.
English: *Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
Danish: *Bemærk: Følg dosisanbefalingerne for genotype 1a hos patienter med en ukendt genotype 1-undertype eller med en blandet genotype 1-infektion.
English: Patients treated with vitamin K antagonists
Danish: Patienter i behandling med vitamin K-antagonister
English: If you accidentally take more than the recommended dose, you should contact your doctor or go to the nearest hospital straight away.
Danish: Hvis du er kommet til at tage mere end den anbefalede dosis, skal du omgående kontakte lægen eller tage til den nærmeste skadestue.
English: C24:= concentration at 24 hours following single dose of cyclosporine, tacrolimus or sirolimus.
Danish: C24: = koncentration ved 24 timer efter enkelt dosis af ciclosporin, tacrolimus eller sirolimus.
English: AbbVie (as logo)
Danish: AbbVie (som logo)
English: • Treatment should be discontinued in patients who develop evidence of hepatic decompensation.
Danish: • Behandlingen skal afbrydes hos patienter, som udvikler tegn på dekompenseret leversygdom.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Dasabuvir exposures increased in a dose proportional manner and accumulation is minimal.
Danish: Dasabuvir-eksponeringen steg proportionalt med dosis, og akkumulationen er minimal.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Exviera.
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med lægemidler som Exviera.
English: • If you are allergic to dasabuvir or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for dasabuvir eller et af de øvrige indholdsstoffer i Exviera (angivet i punkt 6).
English: The dosing recommendations in Table 1 should be followed.
Danish: Doseringsanbefalingerne i tabel 1 skal følges.
English: Contraceptive medicines that contains ethinyloestradiol cannot be used in combination with Exviera.
Danish: Prævention, der indeholder ethinyløstradiol, kan ikke anvendes i kombination med Exviera.
English: Tell your doctor if you have a history of depression or psychiatric illness.
Danish: Fortæl din læge, hvis du tidligere har haft depression eller psykisk sygdom.
English: Treatment with dasabuvir should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Danish: Behandling med dasabuvir skal påbegyndes og overvåges af en læge med erfaring i behandling af kronisk hepatitis C.
English: Patient population
Danish: Patientpopulation
English: Q80K, although a highly prevalent polymorphism in NS3 (41.2% of samples), confers minimal resistance to paritaprevir.
Danish: Selvom Q80K var en meget udbredt polymorfisme i NS3 (41,2 % af prøverne), fremkaldte den minimal resistens over for paritaprevir.
English: Pregnancy and contraception
Danish: Graviditet og prævention
English: Four subjects experienced a haemoglobin level < 8 g/dL.
Danish: Fire patienter oplevede et hæmoglobinniveau < 8 g /dl.
English: HIV-1 Co-infection
Danish: Samtidig hiv-1-infektion
English: Depression, including suicidal thoughts and behaviours, has been reported in some patients taking this medicine, particularly in patients with a prior history of depression or psychiatric illness or in patients taking ribavirin with this medicine.
Danish: Depression, herunder selvmordstanker og adfærd, er rapporteret hos nogle patienter, der tager denne medicin, især hos patienter som tidligere har haft depression eller psykisk sygdom, eller hos patienter der tager ribavirin med denne medicin.
English: Co-administration with other direct-acting antivirals against HCV
Danish: Samtidig administration af andre direkte virkende antivirale midler mod HCV
English: A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would result in <10% change in dasabuvir exposures.
Danish: En ændring på 10 kg i legemsvægt fra 76 kg (median vægt i fase 3-studierne) vil medføre en ændring på < 10 % i eksponeringen for dasabuvir.
English: Part 1 of the study was a Phase 2 pilot cohort consisting of 2 parts, Part 1a (63 subjects) and Part 1b (22 subjects).
Danish: Studiets 1. del var et fase 2 pilot kohorte studie bestående af 2 dele, del 1a (63 forsøgspersoner) og del 1b (22 forsøgspersoner).
English: Due to high SVR rates in genotype 1b, trends in persistence of treatment-emergent variants in this genotype could not be established.
Danish: På grund af høje SVR-rater i genotype 1b kunne persistenstendenserne for behandlingsrelaterede varianter i denne genotype ikke klarlægges.
English: Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Danish: Hyppigheden defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til
English: If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is, therefore, not recommended.
Danish: Hvis en hiv-proteasehæmmer tilføjes (atazanavir, darunavir), kan rilpivirin-eksponeringen øges endnu mere, derfor anbefales dette ikke.
English: The increase in exposure was similar regardless of meal type (e.g., high-fat versus moderate-fat) or calorie content (approximately 600 kcal versus approximately 1000 kcal).
Danish: Den øgede eksponering var den samme uanset madtype (f.eks. højt fedtindhold versus moderat fedtindhold) og kalorieindhold (ca. 600 kcal versus ca. 1.000 kcal).
English: Dose normalised parameters reported for methadone, buprenorphine and naloxone.
Danish: Dosisnormaliserede parametre rapporteret for metadon, buprenorphin og naloxon.
English: While no dose adjustment is necessary for digoxin, appropriate monitoring of serum digoxin levels is recommended.
Danish: Selvom dosisjustering af digoxin ikke er nødvendig, anbefales det at overvåge digoxinniveauet i serum.
English: c. Substitutions were observed in combination with other emergent substitutions at NS3 position R155 or D168.
Danish: c. Substitutioner blev observeret i kombination med andre opståede substitutioner ved NS3-position R155 eller D168.
English: Dasabuvir has no or negligible influence on the ability to drive and use machines.
Danish: Dasabuvir påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Co-administration of dasabuvir with other antivirals has not been studied and, therefore, cannot be recommended.
Danish: Samtidig administration af dasabuvir og andre antivirale midler er ikke undersøgt og anbefales derfor ikke.
English: Thirty-nine of the 50 subjects who received ribavirin required interruption of ribavirin, and 11 of these subjects were also treated with erythropoietin.
Danish: Ribavirin krævede afbrydelse hos 39 af de 50 patienter, som fik ribavirin, og 11 af disse patienter blev også behandlet med erythropoietin.
English: No subject received a blood transfusion.
Danish: Ingen forsøgspersoner fik blodtransfusion.
English: SEDATIVES / HYPNOTICS Zolpidem
Danish: SEDATIVA/HYPNOTIKA Zolpidem
English: In cell culture
Danish: I cellekultur
English: The recommended dose is 250 mg of dasabuvir (one tablet) twice daily (morning and evening).
Danish: Den anbefalede dosis er 250 mg dasabuvir (én tablet) to gange dagligt (morgen og aften).
English: The effects of Exviera during pregnancy are not known.
Danish: Exvieras virkning under graviditet er ukendt.
English: Elimination half-life in rat milk was slightly shorter than in plasma, AUC was about 2 fold of that in plasma.
Danish: Eliminationshalveringstiden i rotters modermælk var lidt kortere end i plasma, og AUC var ca. 2 gange større end i plasma.
English: NA Clinical monitoring of patients is recommended.
Danish: Ikke relevant Klinisk overvågning af patienten anbefales.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with dasabuvir, 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 dasabuvir 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: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System (except GARNET which used COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
Danish: I de kliniske studier blev HCV-rna-plasmaværdierne målt ved hjælp af COBAS TaqMan HCV-test (version 2.0) til brug med High Pure System (undtagen GARNET, som anvendte COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
English: Examples of contraindicated inducers are provided below.
Danish: Eksempler på kontraindicerede inducere er angivet nedenfor.
English: • Monitoring should be performed for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Danish: • Overvågning skal udføres for kliniske tegn og symptomer på dekompenseret leversygdom (såsom ascites, hepatisk encefalopati og varice-blødning).
English: Also contains lactose.
Danish: Indeholder også laktose.
English: Part 2 was a Phase 3 cohort consisting of 233 subjects.
Danish: Del 2 var et var et fase 3 kokorte studie bestående af 233 forsøgspersoner.
English: Potential for other medicinal products to affect the pharmacokinetics of dasabuvir
Danish: Andre lægemidlers mulighed for at påvirke dasabuvirs farmakokinetik
English: Dasabuvir is a substrate of P-gp and BCRP and its major metabolite M1 is a substrate of OCT1 in vitro.
Danish: Dasabuvir er et substrat af P-gp og BCRP, og dets største metabolit M1 er et substrat af OCT1 in vitro.
English: Medicinal products transported by BCRP
Danish: Lægemidler, der transporteres af BCRP
English: Ribavirin dose modification did not impact SVR rates.
Danish: Ændringen af ribavirin-dosen havde ingen indvirkning på SVR-raterne.
English: Routine monitoring of liver enzymes is not necessary in patients that do not have cirrhosis (for cirrhotics, see above).
Danish: Rutinemæssig monitorering af leverenzymer er ikke nødvendig hos patienter, der ikke har cirrose (vedrørende cirrose, se ovenfor).
English: Limited data in patients with end-stage renal disease indicate no clinically significant changes in exposure also in this patient group.
Danish: Begrænset dokumentation hos patienter med nyresygdom i slutstadiet indikerer ikke væsentlige kliniske ændringer i eksponeringen hos denne patientgruppe.
English: Exviera contains the active substance dasabuvir.
Danish: Exviera indeholder det aktive stof dasabuvir.
English: NA Monitor patients for clinical effects; a decrease in furosemide dose of up to 50% may be required.
Danish: Ikke relevant Overvåg patienten for kliniske virkninger; det kan være nødvendigt at reducere furosemiddosen med op til 50 %.
English: No (for any parameter listed above) *AFP= serum alpha fetoprotein
Danish: Nej (til et eller flere af parametrene ovenfor) *AFP = serum-alfaføtoprotein
English: • There may also be a risk for birth defects if ribavirin is taken by a male patient, whose female partner becomes pregnant.
Danish: • Der kan også være risiko for fødselsdefekter, hvis ribavirin tages af en mandlig patient, hvis kvindelige partner bliver gravid.
English: Medicines you must not take with Exviera Medicine or active substance
Danish: Lægemidler, du ikke må tage sammen med Exviera Lægemiddel eller aktivt stof
English: The interactions with pitavastatin and fluvastatin have not been investigated.
Danish: Der er ikke foretaget undersøgelser af interaktionen med pitavastatin og fluvastatin.
English: Ask your doctor about the best contraception for you.
Danish: Spørg din læge, hvilke præventionsmetoder der er bedst for dig.
English: Caution should be used in patients with a pre-existing history of depression or psychiatric illness.
Danish: Der bør udvises forsigtighed ved anvendelse til patienter med en allerede eksisterende anamnese med depression eller psykisk sygdom.
English: Such medicinal products include sulfasalazine, imatinib and some of the statins (see Table 2).
Danish: Det gælder f.eks. sulfasalazin, imatinib og visse statiner (se tabel 2).
English: At steady-state the exposures ratio of M1 to dasabuvir is approximately 0.6.
Danish: Ved steady-state er eksponeringsratioen for M1 i forhold til dasabuvir ca. 0,6.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerstoffer, skal du kontakte lægen, før du tager dette lægemiddel.
English: 25 mg once daily administered in the morning, with food
Danish: 25 mg én gang dagligt taget om morgenen med mad
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu..
English: MUSCLE RELAXANTS Carisoprodol
Danish: MUSKEL RELAKSANTIA Carisoprodol
English: If you forget to take Exviera
Danish: Hvis du har glemt at tage Exviera
English: • Dehydration
Danish: • dehydrering
English: You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Danish: Du eller din pårørende eller sundhedshjælper skal også straks informere din læge om eventuelle ændringer i adfærd eller humør og eventuelle selvmordstanker du måtte have.
English: Severe renal impairment or ESRD includes CKD Stage 4 defined as eGFR <30-15 mL/min/1.73 m2 or CKD Stage 5 defined as <15 mL/min/1.73 m2 or requiring haemodialysis.
Danish: Alvorlig nedsat nyrefunktion eller ESRD omfatter CKD-stadium 4 defineret som eGFR <30-15 ml / min / 1,73 m2 eller CKD-stadium 5 defineret som <15 ml / min / 1,73 m2 eller hæmodialyse krævende.
English: 12 weeks
Danish: 12 uger
English: • carbamazepine, phenytoin, phenobarbital
Danish: • carbamazepin, phenytoin, phenobarbital
English: Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with dasabuvir.
Danish: Se produktresuméerne for de lægemidler, der anvendes i kombination med dasabuvir.
English: Clinical trials in treatment-naïve adults
Danish: Kliniske studier med behandlingsnaive voksne
English: Dasabuvir should be administered with food.
Danish: Dasabuvir skal administreres sammen med mad.
English: Pregnancy and concomitant use with ribavirin
Danish: Graviditet og samtidig brug af ribavirin
English: Changes for dasabuvir and ombitasvir, paritaprevir are the same as shown for paracetamol above
Danish: Ændringerne for dasabuvir og ombitasvir, paritaprevir er de same som vist ovenfor for paracetamol