FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: may affect up to 1 in 10 people: - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver)* - being sensitive to sunlight (photosensitivity)
Danish: Almindelig: Kan ramme op til 1 ud af 10 personer: - for meget bilirubin i blodet (bilirubin er et farvestof, der dannes i leveren)* - øget følsomhed for sollys (fotosensibilitet)
English: Includes one prior null responder who experienced relapse after SVR12, who was considered to have an HCV re-infection (based on phylogenetic analyses).
Danish: Inkluderer en patient med tidligere nul respons, som fik recidiv efter SVR12, og som blev vurderet til at have en HCV-re-infektion (baseret på fylogenetiske analyser).
English: Elevations in amylase and lipase were transient and mostly of mild or moderate severity.
Danish: Stigningerne i amylase og lipase var forbigående og primært lette eller moderate i sværhedsgrad.
English: Monitoring of blood concentrations of sirolimus is recommended.
Danish: Monitorering af blodkoncentrationen af sirolimus anbefales.
English: - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
Danish: - sildenafil eller tadalafil til behandling af ‘pulmonal arteriel hypertension' - midazolam eller triazolam (når det tages gennem munden) behandling af søvnproblemer eller
English: Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
Danish: Den samlede varighed af behandling med peg-IFN-alfa og RBV var responsafhængig.
English: Double-blind, randomised, placebo-controlled, except for studies C212 and HPC3011 which were open-label, single arm.
Danish: Dobbeltblindt, randomiseret, placebokontrolleret, bortset fra studierne C212 og HPC3011, der var åbne med en enkelt
English: OATP1B1/3 and MRP2 are involved in the transport of bilirubin into and out of hepatocytes.
Danish: OATP1B1/3 og MRP2 er involveret i transporten af bilirubin ind og ud af hepatocytter.
English: - This medicine does not require any special temperature storage conditions.
Danish: - Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringstemperaturen.
English: Astemizole and terfenadine have the potential for cardiac arrhythmias.
Danish: Astemizol og terfenadin kan give hjertearytmier.
English: You and your partner must use an effective method of contraception during treatment and for several months afterwards.
Danish: - Du og din partner skal bruge en sikker præventionsmetode under behandlingen og i flere måneder efter, behandlingen er stoppet.
English: There were no grade 3 or 4 photosensitivity reactions reported and none of the patients discontinued treatment due to photosensitivity reactions.
Danish: Der blev ikke indberettet lysfølsomhedsreaktioner af grad 3 eller 4, og ingen af patienterne seponerede behandlingen på grund af lysfølsomhedsreaktioner .
English: OLYSIO helps to fight against hepatitis C infection by preventing HCV from multiplying.
Danish: OLYSIO er med til at bekæmpe hepatitis C-infektion ved at forhindre, at HCV formerer sig.
English: White gelatin capsule of approximately 22 mm in length, marked with “TMC435 150” in black ink.
Danish: Hvid gelatinekapsel, cirka 22 mm i længden og mærket “TMC435 150” med sort blæk.
English: Studies carried out in rats did not reveal significant findings on fertility, embryo-fetal development or pre- and post-natal development at any of the tested doses (corresponding to a systemic exposure in rats similar or lower than that observed in humans at the recommended dose of 150 mg once daily).
Danish: Studier på rotter viste ingen signifikante fund for så vidt angår fertilitet, embryoføtal udvikling eller præ- og postnatal udvikling ved nogen af de undersøgte doser (svarende til en systemisk eksponering hos rotter, der var lig med eller lavere end den, der ses hos mennesker ved den anbefalede dosis på 150 mg én gang dagligt).
English: If other medicinal products used in combination with OLYSIO for the treatment of CHC are permanently discontinued for any reason, OLYSIO must also be discontinued.
Danish: Hvis andre lægemidler, der bruges i kombination med OLYSIO til behandling af CHC, seponeres permanent, uanset årsagen, skal OLYSIO også seponeres.
English: In 32 out of 48 patients (67%) with emerging single D168V and in 34 out of 66 (52%) patients with emerging single R155K, the respective emerging variants were no longer detected at end of the studies.
Danish: Hos 32 ud af 48 patienter (67%) med opstået enkelt D168V og hos 34 ud af 66 (52%) patienter med opstået enkelt R155K kunne de respektive opståede varianter ikke længere påvises, da studierne var afsluttet.
English: Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
Danish: Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italien
English: OLYSIO combination treatment with sofosbuvir may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone, a medicine used to treat irregular heart beat.
Danish: Behandling med OLYSIO i kombination med sofosbuvir kan resultere i en langsommere hjertefrekvens (puls) og andre symptomer, når det tages sammen med amiodaron, der er et lægemiddel til behandling af en uregelmæssig hjerterytme.
English: 150 mg simeprevir 12 weeks % (n/N)
Danish: 150 mg simeprevir 12 uger % (n/N)
English: In these patients the SVR12 rates were 89%, 93%, 75% and 90%, respectively.
Danish: SVR12-raterne var henholdsvis 89%, 93%, 75% og 90% hos disse patienter.
English: Study HPC3021 N = 40 % (n/N)
Danish: Studie HPC3021 N = 40 % (n/N)
English: The clinical relevance of this difference in viral breakthrough rates is
Danish: Den kliniske relevans af denne forskel i viralt gennembrud er ukendt.
English: In the pooled phase 3 safety data, the majority of the adverse reactions reported during 12 weeks treatment with simeprevir were grade 1 to 2 in severity.
Danish: I de puljede sikkerhedsdata fra fase 3-studierne var størstedelen af de bivirkninger, der blev indberettet i løbet af de 12 ugers behandling med simeprevir, af sværhedsgrad 1 til 2.
English: The planned total duration of HCV treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12.
Danish: Den planlagte samlede varighed af HCV-behandling var 24 uger, hvis følgende protokoldefinerede kriterier for responsafhængig behandling var opfyldt under behandlingen: HCV-RNA < 25 IE/ml detekterbart eller ikke-detekterbart i uge 4 OG ikke-detekterbart HCVRNA i uge 12.
English: What you need to know before you take OLYSIO
Danish: Det skal du vide, før du begynder at tage OLYSIO
English: In these patients the SVR12 rates were 96%, 94%, 100% and 68%,
Danish: SVR12-raterne var henholdsvis 96%, 94%, 100% og 68% hos disse patienter.
English: One patient in the 12-week treatment group (0.3%) and none of the patients in the 24-week treatment group discontinued treatment due to adverse reactions.
Danish: En enkelt patient i gruppen med 12 ugers behandling (0,3%) og ingen af patienterne i gruppen med 24 ugers behandling seponerede behandlingen som følge af bivirkninger.
English: Therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients (see section 4.6).
Danish: Der skal derfor udvises særdeles stor forsigtighed for at undgå graviditet hos kvindelige patienter og kvindelige partnere til mandlige patienter (se pkt.
English: Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event.
Danish: Af de 3 patienter, der udviste manglende effekt under behandlingen, havde 2 patienter viralt gennembrud, og en patient afbrød behandlingen før det planlagte tidspunkt på grund af en bivirkning.
English: OLYSIO is supplied in push-through blister strips of 7 capsules.
Danish: OLYSIO leveres med trykblisterkort med 7 kapsler.
English: In a phase 3 study conducted in China and South-Korea, the mean plasma exposure of simeprevir in Asian HCV infected patients was 2.1-fold higher compared to non-Asian HCV infected patients in a pooled phase 3 population from global studies.
Danish: I et fase 3-studie, der blev gennemført i Kina og Sydkorea, var den gennemsnitlige plasmaeksponering af simeprevir hos asiatiske HCV-inficerede patienter 2,1 gange højere end hos ikke-asiatiske HCVinficerede patienter i en samlet fase 3-population fra globale studier.
English: The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 0.80 - 1.25 range.
Danish: Pilens retning (↑ = stigning, ↓ = fald, ↔ = ingen ændring) for hver farmakokinetisk parameter er baseret på, at 90% konfidensintervallet for ratioerne af middelværdierne er inden for (↔), under (↓) eller over (↑) intervallet 0,80-1,25.
English: Patients had compensated liver disease (including cirrhosis), HCV RNA of at least 10,000 IU/ml, and liver histopathology consistent with CHC (if available).
Danish: Patienterne havde kompenseret leversygdom (herunder cirrose), HCV-RNA på mindst 10.000 IE/ml og en lever-histopatologi svarende til kronisk HCV (hvis tilgængelig).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with simeprevir in one or more subsets of the paediatric population from 3 years to less than 18 years of age in the treatment of chronic viral 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 simeprevir i en eller flere undergrupper af den pædiatriske population i alderen 3 år til og med 17 år i behandlingen af kronisk viral hepatitis C (se pkt.
English: Elderly (above 65 years of age)
Danish: Alder (år) median (interval) % over 65 år Mand
English: The majority of the adverse reactions reported were grade 1 in severity.
Danish: Størstedelen af de indberettede bivirkninger var af sværhedsgrad 1.
English: Simeprevir does not affect CYP2C9, CYP2C19 or CYP2D6 in vivo.
Danish: Simeprevir påvirker ikke CYP2C9, CYP2C19 eller CYP2D6 in vivo.
English: Antiretroviral - nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTIs) No dose adjustment is required.
Danish: Antiretrovirale midler - nukleosid eller nukleotid revers transkriptasehæmmere (N(t)RTI'er) Dosisjustering ikke nødvendig.
English: The recommended co-administered medicinal product(s) and treatment duration for OLYSIO combination therapy are provided in tables 1 and 2.
Danish: Anbefalet samtidigt lægemiddel (samtidige lægemidler) og varighed af kombinationsbehandling med OLYSIO vises i tabel 1 og 2.
English: None of the patients discontinued treatment due to ‘blood bilirubin increased'.
Danish: Ingen af patienterne seponerede behandlingen på grund af forhøjet bilirubin i blodet.
English: Due to the long elimination 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 OLYSIO combination treatment with sofosbuvir.
Danish: På grund af amiodarons lange halveringstid bør der desuden iværksættes passende monitorering af patienter, der har seponeret amiodaron inden for de seneste få måneder og skal initieres på kombinationsbehandling med OLYSIO og sofosbuvir.
English: Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating OLYSIO combination treatment with sofosbuvir.
Danish: Hvis samtidig anvendelse af amiodaron anses for at være nødvendig, anbefales det, at patienterne monitoreres nøje, når kombinationsbehandlingen med OLYSIO og sofosbuvir initieres.
English: In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic
Danish: En in vitro-kombination af simeprevir med interferon, ribavirin, NS5A- eller NS5B-hæmmere medførte additive eller synergistiske effekter.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on OLYSIO combination treatment with sofosbuvir when other alternative antiarrhythmic treatments are
Danish: Tilfælde er potentielt livstruende, og amiodaron bør derfor kun anvendes til patienter, der er i kombinationsbehandling med OLYSIO og sofosbuvir, når andre alternative behandlinger med antiarytmika ikke tolereres eller er kontraindicerede.
English: - OLYSIO must not be used by itself.
Danish: - OLYSIO må ikke anvendes som eneste behandling.
English: Race No dose adjustment is necessary based on race (see section 5.2).
Danish: Race Dosisjustering er ikke nødvendig på baggrund af race (se pkt.
English: - you have ever taken any medicines to treat hepatitis C; - you have any other liver problems in addition to hepatitis C; - you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely; - you have had or are going to have an organ transplant.
Danish: - du nogensinde har taget medicin til behandling af hepatitis C - du har andre problemer med leveren end hepatitis C - du har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere - du har eller skal gennemgå en organtransplantation Tal med din læge eller apotekspersonalet, inden du tager OLYSIO, hvis noget af ovenstående gør sig gældende for dig, eller hvis du er i tvivl.
English: Consider starting with the lowest dose of the PDE-5 inhibitor and increase as needed, with clinical monitoring as appropriate.
Danish: Det bør overvejes at starte med den laveste dosis af PDE-5hæmmeren og øge dosis efter behov samtidig med klinisk monitorering efter behov.
English: Especially avoid intense or prolonged exposure to sunlight (including tanning devices).
Danish: Du skal især undgå kraftig eller længerevarende eksponering i sollyset
English: A trend for a higher incidence of increased bilirubin levels with increasing simeprevir plasma exposure was observed.
Danish: Der blev observeret en tendens til øget forekomst af forhøjet bilirubin i takt med en øget eksponering for simeprevir i plasma.
English: - The recommended dose of OLYSIO is one capsule (150 milligrams) once a day.
Danish: - Den anbefalede dosis af OLYSIO er én kapsel (150 mg) én gang om dagen.
English: There are no data to support the co-administration of OLYSIO and telaprevir or boceprevir.
Danish: Der findes ingen data, der understøtter samtidig indgivelse af OLYSIO og telaprevir eller boceprevir.
English: 12 weeks OLYSIO + sofosbuvir (without ribavirin) may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see sections 4.4 and 5.1)
Danish: 12 ugers OLYSIO + sofosbuvir (uden ribavirin) kan overvejes til patienter, der skønnes at have ringe risiko for klinisk sygdomsprogression, og som har mulighed for genbehandling efterfølgende (se pkt.
English: Table 21: SVR12 rates for selected subgroups (study HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
Danish: Tabel 21: SVR12-raterne for udvalgte undergrupper (studie HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
English: In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis
Danish: I studie HPC3017 deltog patienter uden cirrose; i studie HPC3018 deltog patienter med cirrose (tabel 12).
English: Cisapride has the potential to cause cardiac arrhythmias.
Danish: Cisaprid kan forårsage hjertearytmier.
English: Use of a sensitive quantitative HCV RNA assay for monitoring HCV RNA levels during treatment is recommended.
Danish: Det anbefales at bruge en følsom, kvantitativ HCV-RNA-analyse til kontrol af HCV-RNA-niveauerne under behandlingen.
English: Re-evaluation of HCV RNA is recommended in case of HCV RNA ≥ 25 IU/ml after previous undetectable HCV RNA to confirm HCV RNA levels prior to discontinuing HCV treatment.
Danish: Reevaluering af HCV-RNA anbefales, hvis HCV-RNA ≥ 25 IE/ml efter tidligere udetekterbart HCV-RNA for at bekræfte HCV-RNA-niveauet inden seponering af HCV-behandlingen.
English: Established and theoretical interactions between simeprevir and selected medicinal products are listed in table 4 (least square mean ratios with 90% confidence intervals (90% CI) are presented, increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Tabel 4 viser de fastlagte og teoretiske interaktioner mellem simeprevir og udvalgte lægemidler (ratioerne er fundet ved mindste kvadraters metode med 90% konfidensintervaller [90% CI]; stigning vises som “↑”, fald som “↓” og ingen ændring som “↔”).
English: In study C208, all patients received peginterferon alfa-2a; in study C216, 69% of the patients received peginterferon alfa-2a and 31% received peginterferon alfa-2b.
Danish: I studie C208 fik alle patienter peginterferon alfa-2a; i studie C216 fik 69% af patienterne peginterferon alfa-2a, og 31% fik peginterferon alfa-2b.
English: If treatment with OLYSIO is discontinued because of adverse reactions or inadequate on-treatment virologic response, OLYSIO treatment must not be reinitiated.
Danish: Hvis behandling med OLYSIO seponeres på grund af bivirkninger eller utilstrækkeligt virologisk respons under behandlingen, må behandlingen ikke iværksættes igen.
English: Simeprevir is not a clinically relevant inhibitor of cathepsin A enzyme activity.
Danish: Simeprevir er ikke en klinisk relevant hæmmer af aktiviteten af cathepsin Aenzymet.
English: Dosing of animals resulted in similar (dogs) or lower (rats) exposures than those observed in humans at the recommended dose of 150 mg once daily.
Danish: Dosering af dyr resulterede i lignende (hunde) eller lavere (rotter) eksponering som observeret hos mennesker ved den anbefalede dosis på 150 mg én gang daglig.
English: When ribavirin is added to the combination of OLYSIO and sofosbuvir, and ribavirin needs to be discontinued, treatment of OLYSIO with sofosbuvir without ribavirin can be continued (see section 5.1).
Danish: Når ribavirin anvendes som tillægsbehandling til OLYSIO og sofosbuvir, og ribavirinbehandlingen skal afbrydes, kan behandling med OLYSIO og sofosbuvir uden ribavirin fortsætte (se pkt.
English: Interaction studies have been performed in healthy adults with the recommended dose of 150 mg simeprevir once daily unless otherwise noted.
Danish: Der er udført interaktionsstudier hos raske voksne med den anbefalede dosis på 150 mg simeprevir én gang dagligt, medmindre andet er angivet.
English: Age (18-73 years) had no clinically meaningful effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis (n = 21, age above 65 years) of HCV infected patients treated with simeprevir.
Danish: Alder (18-73 år) havde ingen klinisk relevant virkning på simeprevirs farmakokinetik baseret på en farmakokinetisk populationsanalyse (n = 21, alder over 65 år) af HCV-inficerede patienter, der blev behandlet med simeprevir.
English: There were no adverse effects of simeprevir on vital functions (cardiac, respiratory and central
Danish: Der var ingen negative virkninger af simeprevir på vitale funktioner (hjerte, luftveje og centralnervesystem) i dyrestudier.
English: If a dose of OLYSIO is missed, and the patient notices within 12 hours of the usual dosing time, the patient should take the missed dose of OLYSIO with food as soon as possible and then take the next dose of OLYSIO at the regularly scheduled time.
Danish: Hvis en dosis af OLYSIO glemmes, og patienten kommer i tanke om det inden for 12 timer efter det sædvanlige doseringstidspunkt, skal patienten snarest muligt tage den manglende dosis sammen med mad og derefter tage den næste OLYSIO-dosis på det sædvanlige, planlagte tidspunkt.
English: In dogs, simeprevir was associated with a reversible multifocal hepatocellular necrosis with associated increases in ALT, AST, alkaline phosphatase and/or bilirubin.
Danish: Hos hunde var simeprevir forbundet med reversibel, multifokal, hepatocellulær nekrose med tilhørende stigninger i ALAT, ASAT, alkalisk fosfatase og/eller bilirubin.
English: In study HPC3021 (PLUTO), patients received simeprevir + sofosbuvir for 12 weeks (see table 11).
Danish: I studie HPC3021 (PLUTO) fik patienterne simeprevir + sofosbuvir i 12 uger (se tabel 11).
English: It is not recommended to co-administer OLYSIO with systemic itraconazole, ketoconazole or posaconazole.
Danish: Det anbefales ikke at administrere OLYSIO sammen med systemisk itraconazol, ketoconazol eller posaconazol.
English: Treatment-emergent laboratory abnormalities in amylase and lipase have been observed in patients treated with simeprevir in combination with sofosbuvir (table 6).
Danish: Der er observeret behandlingsrelaterede laboratorieanomalier i amylase og lipase hos patienter, der blev behandlet med simeprevir i kombination med sofosbuvir (tabel 6).
English: Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
Danish: Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
English: Combination treatment of OLYSIO with other medicinal products for the treatment of CHC may affect a patient's ability to drive and use machines.
Danish: Kombinationsbehandling med OLYSIO og andre lægemidler til behandling af CHC kan påvirke patientens evne til at føre motorkøretøj og betjene maskiner.
English: Prior non-responder patients (including partial and null responders)
Danish: Patienter med tidligere manglende respons (herunder delvist og nul respons) 48 uger
English: Mild increases in concentrations of these antiarrhythmics may be expected when these medicinal products are administered orally.
Danish: koncentrationerne af disse antiarytmika kan forventes, hvis disse lægemidler indgives oralt.
English: No clinically relevant drug-drug interaction is expected.
Danish: Ingen klinisk relevant lægemiddelinteraktion forventes.
English: There are no virologic treatment stopping rules that apply to the combination of OLYSIO with sofosbuvir.
Danish: Der er ingen regler for stop af den virologiske behandling for kombinationen af OLYSIO og sofosbuvir.
English: The overall SVR12 rate was similar in patients receiving simeprevir + sofosbuvir with or without ribavirin.
Danish: Den samlede SVR12-rate var ens hos patienter, der fik simeprevir + sofosbuvir med eller uden ribavirin.
English: peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin); SMV = simeprevir.
Danish: peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (dosis af ribavirin baseret på legemsvægt og fordelt på to daglige doser i henhold til produktresumeet for ribavirin); SMV = simeprevir.
English: Effect of baseline HCV polymorphisms on treatment response Analyses were conducted to explore the association between naturally-occurring baseline NS3/4A amino acid substitutions (polymorphisms) and treatment outcome.
Danish: Effekt af HCV-polymorfismer ved baseline på behandlingsresponset Der blev udført analyser med henblik på at udforske sammenhængen mellem naturligt forekommende NS3/4A-aminosyresubstitutioner ved baseline (polymorfismer) og udfaldet af behandlingen.
English: The safety and efficacy of simeprevir have not been established in HCV infected patients with moderate or severe hepatic impairment (Child-Pugh B or C).
Danish: Simeprevirs sikkerhed og virkning er ikke blevet fastlagt hos HCV-inficerede patienter med moderat eller svær leverinsufficiens (Child-Pugh B eller C).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from OLYSIO therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Danish: Det skal besluttes, om amning eller behandling med OLYSIO skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til den terapeutiske