FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendation concerning co-administration with Harvoni
Danish: Anbefalinger vedrørende administration sammen med Harvoni
English: • swelling of the face, lips, tongue or throat (angioedema).
Danish: • hævelse af ansigt, læber, tunge eller svælg (angioødem).
English: Of the seven patients who did not achieve SVR12, none experienced virologic failure or relapsed.
Danish: Ud af de 7 patienter, som ikke opnåede SVR12, oplevede ingen virologisk svigt eller recidiv.
English: Table 1: Recommended treatment duration for Harvoni and the recommended use of co-administered ribavirin for certain subgroups
Danish: Tabel 1: Anbefalet behandlingsvarighed for Harvoni og den anbefalede anvendelse af samtidigt administreret ribavirin for visse undergrupper
English: Effect of baseline HCV resistance-associated variants on treatment outcome
Danish: Virkning af baseline HCV-resistensassocierede varianter på behandlingsresultatet
English: It is given to treat chronic (long-term) hepatitis C virus infection in adults and adolescents 12 to less than 18 years of age.
Danish: Det gives til behandling af kronisk (langvarig) infektion med hepatitis C-virus hos voksne og unge i alderen 12 til yngre end 18 år.
English: Atazanavir concentrations are also increased, with a risk for an increase in bilirubin levels/icterus.
Danish: Atazanavirkoncentrationerne er også forhøjede, med en risiko for en forhøjelse af bilirubinniveauerne/ikterus.
English: Previously treated adults with cirrhosis - SIRIUS - Genotype 1
Danish: Tidligere behandlede voksne med cirrose - SIRIUS - genotype 1
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 hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption bør ikke anvende dette lægemiddel.
English: Ledipasvir plasma exposure (AUCinf) was similar in patients with severe hepatic impairment and control patients with normal hepatic function.
Danish: Ledipasvirs plasmaeksponering (AUCinf) var sammenlignelig hos patienter med svært nedsat leverfunktion og kontrolpatienter med normal leverfunktion.
English: Serum HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Danish: Serum HCV-rna-værdier blev i de kliniske studier målt ved hjælp af COBAS TaqMan HCV-test (version 2.0) til brug med 'High Pure System'.
English: c Analysis (by deep sequencing) included NS5A resistance-associated polymorphisms that conferred > 2.5-fold change in
Danish: c. Analysen (ved dyb sekventering) omfattede NS5A-polymorfismer forbundet med resistens, der gav >2,5 gange ændring i
English: Interactions between Harvoni and other medicinal products
Danish: Lægemiddelinteraktioner mellem Harvoni og andre lægemidler
English: Harvoni [Outer packaging only]
Danish: Harvoni [Kun på den ydre emballage]
English: Race: Black/ African
Danish: Race: Sort/ amerikaner af afrikansk herkomst
English: Glucose levels of diabetic patients initiating direct-acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Danish: Blodsukkeret hos patienter med diabetes, der påbegynder behandling med direkte virkende antivirale lægemidler, bør overvåges nøje, navnlig inden for de første 3 måneder, og patienternes diabetesmedicinering bør om nødvendigt ændres.
English: Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome.
Danish: Der blev udført analyser for at udforske forbindelsen mellem eksisterende baseline-NS5A-RAVs og behandlingsresultatet.
English: Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Danish: Hver filmovertrukken tablet indeholder 90 mg ledipasvir og 400 mg sofosbuvir.
English: Carcinogenicity studies in mice and rats do not indicate any carcinogenicity potential of sofosbuvir administered at doses up to 600 mg/kg/day in mouse and 750 mg/kg/day in rat.
Danish: Studier af karcinogenicitet hos mus og rotter indikerer ikke karcinogenicitet af sofosbuvir administreret ved doser op til 600 mg/kg/dag hos mus og 750 mg/kg/dag hos rotter.
English: Additionally a Q30E substitution developed in genotype 1a replicons.
Danish: Desuden blev en Q30E-substitution udviklet i genotype 1a-replikoner.
English: Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded as recommended in the Summary of Product Characteristics for ribavirin.
Danish: Kvinder i den fertile alder eller deres mandlige partnere skal anvende en sikker kontraceptionsmetode i løbet af behandlingen og i en tidsperiode efter behandlingen, som anbefalet i produktresuméet for ribavirin.
English: * - If a more normalized dose of ribavirin (by weight and renal function) cannot be reached for reasons of tolerability, 24 weeks of Harvoni + ribavirin should be considered in order to minimize the risk for relapse.
Danish: * - Hvis en mere normaliseret ribavirin-dosis (efter vægt og nyrefunktion) ikke kan opnås på grund af tolerabilitet, skal 24 ugers behandling med Harvoni + ribavirin overvejes for at minimere risikoen for recidiv.
English: • You or your partner must use an effective birth control method during treatment with Harvoni together with ribavirin and for some time afterwards.
Danish: • Du eller din partner skal anvende en sikker svangerskabsforebyggende metode i løbet af behandlingen med Harvoni sammen med ribavirin og i nogen tid derefter.
English: A total of 80 patients (80%) were treatment-naïve, while 20 patients (20%) were treatment-experienced.
Danish: I alt 80 patienter (80 %) var behandlingsnaive, mens 20 patienter (20 %) var behandlingserfarne.
English: In adolescent patients aged 12 to < 18 years the following ribavirin dosing is recommended where ribavirin is divided into two daily doses and given with food:
Danish: Hos unge patienter i alderen 12 til < 18 anbefales følgende ribavirin-dosis, hvor ribavirin fordeles på 2 daglige doser og gives sammen med mad:
English: Adolescents: for ribavirin dosing recommendations see table 3 below.
Danish: Unge: For anbefalinger vedrørende dosering af ribavirin, se tabel 3 nedenfor.
English: Afterwards, close monitoring and potential dose adjustment of ciclosporin may be required.
Danish: Efterfølgende kan nøje monitorering samt mulig dosisjustering af ciclosporin være nødvendig.
English: In genotype 3-infection, the use of Harvoni (always in combination with ribavirin) should only be considered for patients who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Danish: Hos patienter med genotype 3-infektion bør brugen af Harvoni (altid i kombination med ribavirin) kun overvejes til patienter, som skønnes at have en høj risiko for klinisk sygdomsprogression, og som ikke har alternative behandlingsmuligheder.
English: No dose adjustment of Harvoni is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Danish: Ingen dosisjustering af Harvoni er påkrævet for patienter med let, moderat eller svært nedsat leverfunktion (Child-Pugh-Turcotte [CPT] klasse A, B eller C) (se pkt.
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Harvoni compared to subjects with normal renal function, as described in the text below, are provided in Table 20.
Danish: Et resumé af virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringer for indholdsstofferne i Harvoni sammenlignet med forsøgspersoner med normal nyrefunktion, som beskrevet nedenfor, vises i tabel 20.
English: Package leaflet: Information for the user Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Harvoni 90 mg/400 mg filmovertrukne tabletter ledipasvir/sofosbuvir Dette lægemiddel er underlagt supplerende overvågning.
English: Animal studies do not indicate direct harmful effects with respect to reproductive toxicity.
Danish: Dyrestudier indikerer ingen direkte skadelige virkninger hvad angår reproduktionstoksicitet.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Harvoni, 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 Harvoni 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: All patients receiving Harvoni in combination with amiodarone with or without other drugs 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 Harvoni i kombination med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler, skal ligeledes advares om symptomerne på bradykardi og hjerteblok og tilrådes at søge øjeblikkelig lægehjælp, hvis de kommer ud for dem.
English: Site-directed mutagenesis of the S282T substitution in replicons of 8 genotypes conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the viral replication capacity by 89% to 99% compared to the corresponding wild-type.
Danish: Site-directed mutagenese af S282T-substitutionen i replikoner fra 8 genotyper tildelte 2 til 18 gange nedsat følsomhed over for sofosbuvir, og reducerede den virale replikationskapacitet med 89 % til 99 %, sammenlignet med den tilhørende vildtype.
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Danish: Angående anbefalede regimer med forskellige HCV-genotyper, se pkt.
English: Vitamin K antagonists
Danish: Vitamin K-antagonister
English: The medicinal product interactions described are based on studies conducted with either ledipasvir/sofosbuvir or ledipasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with ledipasvir/sofosbuvir.
Danish: De beskrevne lægemiddelinteraktioner er baseret på studier udført med enten ledipasvir/sofosbuvir eller ledipasvir og sofosbuvir som enkeltstoffer, eller de forventede lægemiddelinteraktioner, der kan opstå med ledipasvir/sofosbuvir.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Tørremidlet med silicagel findes i en separat lille pose eller en beholder, og må ikke sluges.
English: Patients with decompensated cirrhosis irrespective of transplant status
Danish: Patienter med dekompenseret cirrose uanset transplantationsstatus
English: Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Danish: Efter en enkelt 400 mg dosis af sofosbuvir fjernede en 4-timers hæmodialysesession 18 % af den administrerede sofosbuvir-dosis.
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 påbegyndes.
English: b Two patients who did not have decompensated cirrhosis and had also not received a liver transplant were excluded due to failure to meet the inclusion criteria for any of the treatment groups.
Danish: b. To patienter, som ikke havde dekompenseret cirrose, og som heller ikke havde fået foretaget en levertransplantation, blev ekskluderet, da de ikke opfyldte inklusionskriterierne for nogen af behandlingsgrupperne.
English: Tell your doctor or pharmacist if you have problems swallowing tablets.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du har problemer med at sluge tabletter.
English: Table 5: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas
Danish: Tabel 5: Interaktioner mellem Harvoni og andre lægemidler Lægemiddel i henhold til terapeutiske områder
English: Afterwards, close monitoring and potential dose adjustment of tacrolimus may be required.
Danish: Efterfølgende kan nøje monitorering samt mulig dosisjustering af tacrolimus være nødvendig.
English: Use with strong P-gp inducers
Danish: Brug sammen med stærke P-gp-inducere
English: Such co-administration is not recommended.
Danish: En sådan samtidig administration bør ikke anvendes.
English: NARCOTIC ANALGESICS Methadone
Danish: NARKOTISKE ANALGETIKA Methadon
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Harvoni.
Danish: Din læge kan være nødt til nøje at overvåge de andre lægemidler, du tager samt foretage justeringer, efter du begynder at tage Harvoni.
English: The safety of Harvoni has been evaluated in a 12-week non-controlled study including 95 patients with ESRD requiring dialysis (Study 4063).
Danish: Harvonis sikkerhed blev vurderet i et 12-ugers, ikke-kontrolleret studie hos 95 patienter med ESRD, som krævede dialyse (Studie 4063).
English: BOTTLE AND CARTON LABELLING
Danish: ETIKETTERING PÅ FLASKE OG KARTON
English: If vomiting occurs more than 5 hours after dosing, no further dose is needed (see section 5.1).
Danish: Hvis de kaster op mere end 5 timer efter dosering, er der ikke behov for en yderligere dosis (se pkt.
English: Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively.
Danish: NS5A og NS5B dybe sekvensdata efter baseline (analyse Cut-off på 1 %) var tilgængelige for hhv. 37/37 og 36/37 patienter.
English: Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected.
Danish: Der forventes ikke klinisk signifikante lægemiddelinteraktioner med ledipasvir/sofosbuvir medieret af CYP 450- eller UGT1A1-enzymer.
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Danish: Størstedelen af den sofosbuvirdosis, der blev genfundet i urinen, var GS-331007 (78 %), men 3,5 % blev genfundet som sofosbuvir.
English: Unchanged ledipasvir excreted in faeces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose.
Danish: Uændret ledipasvir, som blev udskilt i fæces, udgjorte i gennemsnit 70 % af den administrerede dosis, og den oxidative metabolit, M19, udgjorde 2,2 % af dosis.
English: Dose modification of ribavirin in adults taking 1,000-1,200 mg daily If Harvoni is used in combination with ribavirin and a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Danish: Dosismodifikation af ribavirin hos voksne, der tager 1.000-1.200 mg dagligt Hvis Harvoni anvendes i kombination med ribavirin og en patient har en alvorlig bivirkning, som muligvis er relateret til ribavirin, skal dosis af ribavirin modificeres eller seponeres, hvis det er hensigtsmæssigt, indtil bivirkningen svinder eller reduceres i sværhedsgrad.
English: Age (years): median (range) Male gender
Danish: Alder (år): median (interval) Køn: Mand
English: Table 6: Adverse drug reactions identified with Harvoni Frequency
Danish: Tabel 6: Bivirkninger identificeret med Harvoni Hyppighed
English: All patients in the study were treated with ledipasvir/sofosbuvir for 12 weeks.
Danish: Alle patienterne i studiet blev behandlet med ledipasvir/sofosburvir i 12 uger.
English: Co-administration of Harvoni with digoxin may increase the concentration of digoxin.
Danish: Administration af Harvoni sammen med digoxin kan øge koncentrationen af digoxin.
English: Within ledipasvir/sofosbuvir, GS-331007 accounts for approximately 85% of total systemic exposure.
Danish: I ledipasvir/sofosbuvir udgør GS-331007 ca. 85 % af total systemisk eksponering.
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite was approximately 5 times higher than the clinical exposure at 400 mg sofosbuvir.
Danish: I rottestudierne kunne eksponeringen for sofosbuvir ikke bestemmes, men eksponeringsmarginer baseret på den primære humane metabolit var ca. 5 gange højere end den kliniske eksponering ved 400 mg sofosbuvir.
English: Some medicines should not be taken with Harvoni.
Danish: Nogle lægemidler må ikke tages sammen med Harvoni.
English: • Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110” before taking this medicine.
Danish: • Fortæl det til lægen, hvis du er overfølsom over for sunset yellow FCF aluminiumpigment, også kaldet ”E110”, før du tager denne medicin.
English: In rabbit studies exposure to sofosbuvir was 6 times the expected clinical exposure.
Danish: I studier med kaniner var eksponeringen for sofosbuvir 6 gange den forventede kliniske eksponering.
English: • If it's 18 hours or more after the time you usually take Harvoni, wait and take the next dose at your usual time.
Danish: • Hvis det er 18 timer eller længere efter det tidspunkt, du normalt tager Harvoni, skal du vente og tage den næste dosis på det sædvanlige tidspunkt.
English: NS5A substitutions conferring resistance to ledipasvir may reduce the antiviral activity of other NS5A inhibitors.
Danish: NS5Asubstitutioner, der giver resistens over for ledipasvir, kan reducere den antivirale aktivitet af andre NS5A-hæmmere.
English: e 0/4 of these patients had cirrhosis.
Danish: e. 0/4 af disse patienter havde cirrose.
English: • The active substances are ledipasvir and sofosbuvir.
Danish: • Aktive stoffer: ledipasvir og sofosbuvir.
English: NS5A RAVs: No genotype 2 infected patients experienced relapse in the clinical study and therefore there are no data regarding NS5A RAVs at the time of failure.
Danish: NS5A-RAVs: Ingen genotype 2-inficerede patienter oplevede recidiv i det kliniske studie, og derfor foreligger der ingen data vedrørende NS5A-RAVs på tidspunktet for svigt.
English: The proportion of such baseline NS5A RAVs seen with deep sequencing varied from very low (cut off for assay = 1%) to high (main part of the plasma population).
Danish: Andelen af sådanne NS5A-RAVs ved baseline, der blev observeret ved dyb sekventering, varierede fra meget lav (analyse Cut-off = 1 %) til høj (hovedparten af plasmapopulationen).
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A or carboxylesterase 1 and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Danish: Den metaboliske aktiveringsvej omfatter sekventiel hydrolyse af carboxylesterdelen, hvilket katalyseres af humant cathepsin A eller carboxylesterase 1 og phosphoramidat-kløvning af histidin-triad nukleotid-bindende protein 1, efterfulgt af phosphorylering af pyrimidin-nukleotid-biosyntesevejen.
English: Table 7: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Danish: Tabel 7: Aktiviteten af ledipasvir og sofosbuvir mod kimere replikoner Replikonergenotype
English: If it is after 18 hours then patients should be instructed to wait and take the next dose at the usual time.
Danish: Hvis der er gået over 18 timer, skal patienterne instrueres i at vente, og tage den næste dosis til sædvanlig tid.
English: The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side.
Danish: De filmovertrukne tabletter er orange, diamantformede tabletter, præget med ”GSI” på den ene side og med ”7985” på den anden side.
English: In the SOLAR-2 study, one patient with genotype 4d developed NS5B substitution E237G at the time of relapse.
Danish: I SOLAR-2studiet udviklede en patient med genotype 4d NS5B-substitutionen E237G på tidspunktet for recidiv.
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Harvoni.
Danish: På grund af amiodarons lange halveringstid skal der desuden foretages passende overvågning af patienter, som inden for de seneste måneder har fået seponeret amiodaron og skal sættes i behandling med Harvoni.
English: 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
Danish: 1.000 mg pr. dag for patienter < 75 kg og 1.200 mg for patienter, som vejer ≥ 75 kg
English: Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
Danish: I forhold til raske personer (n = 191) var ledipasvir AUC0-24 og Cmax hhv. 24 % lavere og 32 % lavere hos HCV-inficerede patienter.
English: • if you are awaiting a liver transplant; • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Danish: • hvis du har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere;
English: No specific antidote is available for overdose with Harvoni.
Danish: Der findes ingen specifik antidot for en overdosis af Harvoni.
English: 264b a. Transient replicons carrying NS5A or NS5B from patient isolates.
Danish: 264b a. Transitoriske replikoner, der bærer NS5A eller NS5B fra patientisolater.
English: Other statins
Danish: Andre statiner
English: Following oral administration of ledipasvir/sofosbuvir to HCV-infected patients, ledipasvir median peak plasma concentration was observed at 4.0 hours post-dose.
Danish: Efter oral administration af ledipasvir/sofosbuvir til HCV-inficerede patienter blev den mediane maksimale plasmakoncentration af ledipasvir observeret 4,0 timer efter dosering.
English: Do not take it before Harvoni.
Danish: Du må ikke tage den før Harvoni.
English: Biochemical confirmation of NS5A inhibition by ledipasvir is not currently possible as NS5A has no enzymatic function.
Danish: Biokemisk bekræftelse af, at ledipasvir hæmmer NS5A er aktuelt ikke muligt, da NS5A ikke har en enzymatisk funktion.
English: SVR was the primary endpoint to determine the HCV cure rate which was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment.
Danish: SVR var det primære endepunkt til bestemmelse af helbredelsesraten for HCV, og det blev defineret som HCV-rna under LLOQ 12 uger efter behandlingsophør.
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: (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til
English: The relative efficacy of a 12-week regimen consisting of ledipasvir/sofosbuvir + ribavirin, compared to a 24-week regimen of sofosbuvir + ribavirin has not been investigated.
Danish: Den relative virkning af et 12-ugers regimen bestående af ledipasvir/sofosbuvir + ribavirin, sammenlignet med et 24-ugers regimen med sofosbuvir + ribavirin er ikke blevet undersøgt.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Harvoni when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Danish: Da disse tilfælde er potentielt livstruende, bør amiodaron kun anvendes hos patienter i behandling med Harvoni, når andre antiarytmika ikke tolereres eller er kontraindicerede.
English: The adverse reactions observed were consistent with those observed in clinical studies of ledipasvir/sofosbuvir in adults (see Table 6).
Danish: De observerede bivirkninger var i overensstemmelse med de observerede i kliniske studier med ledipasvir/sofosbuvir hos voksne (se Tabel 6).