FrancophonIA/ELRC3.0 huggingface dataset:
English: Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at week 4 and week 24 of therapy.
Danish: Enogfyrre procent af forsøgspersonerne (97/235) havde plasma hcv-RNA niveauer under detektionsgrænsen ved behandlingens uge 4 og uge 24.
English: Combination therapy with ribavirin
Danish: Kombinationsbehandling med ribavirin
English: Infrequently, adult patients treated for chronic hepatitis C with interferon alpha have developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
Danish: I sjældne tilfælde har voksne patienter behandlet for kronisk hepatitis C med interferon alfa udviklet thyroideaabnormiteter, enten hypothyreoidisme eller hyperthyreoidisme.
English: For patients on ViraferonPeg monotherapy: refer to monotherapy dose reduction guidelines section for dose reduction.
Danish: For patienter i ViraferonPeg monoterapi: Der henvises til afsnittet om retningslinjer for dosisreduktion ved monoterapi.
English: Any patient developing pyrexia, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken.
Danish: Enhver patient, der får feber, hoste, dyspnø eller andre luftvejssymptomer skal have taget thorax-røntgen.
English: The pre-filled pen, needle and all injection materials are intended for single use and must be discarded after the injection.
Danish: Den fyldte pen, kanylen og andet materiale fra indsprøjtningen er beregnet til engangsbrug og skal kasseres efter indsprøjtning.
English: Prior to initiation of ViraferonPeg therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Danish: Inden initiering af ViraferonPeg-behandling skal TSH-niveauet evalueres, og mulige thyroideaabnormaliteter detekteret på dette tidspunkt skal behandles med konventionel behandling.
English: The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
Danish: Det hvide pulver er indeholdt i et 2 ml hætteglas, og den klare, farveløse solvens er i en 2 ml glasampul.
English: SVR after treatment of chronic HCV with ViraferonPeg (with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical “cure” from chronic HCV.
Danish: SVR resulterer, efter behandling af kronisk hcv med ViraferonPeg (med eller uden ribavirin), i langtidsclearence af virus og giver afhjælpning af den hepatiske infektion og klinisk ”helbredelse” af kronisk hcv.
English: Fatigue, alopecia, pruritus, nausea, anorexia, weight decreased, irritability and insomnia occur at a notably lower rate in patients treated with ViraferonPeg monotherapy compared to those treated with combination therapy (see Table 6).
Danish: Træthed, alopeci, kløe, kvalme, anoreksi, vægttab, irritabilitet og søvnløshed forekommer i en bemærkelsesværdig lavere frekvens hos patienter behandlet med ViraferonPeg monoterapi sammenlignet med dem, der behandledes med kombinationsbehandling (se Tabel 6).
English: The intended dose of 1.5 g/kg of ViraferonPeg to be used in combination with ribavirin may be delivered in weight categories with the ViraferonPeg strengths according to Table 1.
Danish: Den foreskrevne dosis ViraferonPeg 1,5 g/kg til anvendelse i kombination med ribavirin kan indgives efter vægtkategorier og styrken af ViraferonPeg, som anført i Tabel 1.
English: Micturition frequency, polyuria, urine abnormality
Danish: Ændret vandladningsfrekvens, polyuri, abnorm urin
English: In the presence of thyroid dysfunction, ViraferonPeg treatment may be continued if TSH levels can be maintained in the normal range by medicine.
Danish: Ved tilstedeværelse af nedsat thyroideafunktion kan ViraferonPeg-behandling fortsættes, hvis TSH værdier kan bibeholdes i normalområdet med medicin.
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm
Danish: 5.1) blev der set et fald i absolut neutrofil-taltil under 500 celler/mm
English: Recombinant interferon alfa-2b is covalently conjugated with monomethoxy polyethylene glycol at an average degree of substitution of 1 mole of polymer/mole of protein.
Danish: Rekombinant interferon alfa-2b er kovalent konjugeret med monomethoxypolyethylenglycol med en gennemsnitlig substitutionsgrad på 1 mol polymer/mol protein.
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Danish: Vigtige behandlingsrelaterede bivirkninger, som opstod hos denne patientpopulation var nervøsitet (8 %), aggression (3 %), vrede (2%), depression / trykket stemning (4 %) og hypotyroidisme (3 %); 5 forsøgspersoner fik levothyroxin-behandling for hypotyroidisme / forhøjet TSH.
English: Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.
Danish: Interferon-monoterapi, inklusive ViraferonPeg, er hovedsageligt indiceret i tilfælde af intolerance eller kontraindikation over for ribavirin.
English: One ampoule of solvent contains 0.7 ml of water for injections.
Danish: En ampul med solvens indeholder 0,7 ml vand til injektionsvæsker.
English: When administered in combination with other interferon preparations, suppressive effect on bone marrow function may be strengthened and aggravation of blood cell reduction such as white blood cells decreased may occur.
Danish: Ved administration i kombination med andre interferonpræparater kan den hæmmende virkning på knoglemarvsfunktionen øges, og forværring af blodcellereduktionen såsom fald i hvide blodceller kan forekomme.
English: - have cirrhosis or other liver problems (other than hepatitis C).
Danish: - har skrumpelever eller anden leversygdom (ud over hepatitis C).
English: - Hypersensitivity to the active substance or to any interferon or to any of the excipients listed in section 6.1;
Danish: - Overfølsomhed over for det aktive stof eller over for et hvilket som helst interferon eller over for et eller flere af hjælpestofferne anført i pkt.
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with ViraferonPeg (1.5 µg/kg)/ribavirin combination therapy resulted in a higher sustained virologic response rate compared to ViraferonPeg 1 µg/kg dose.
Danish: Hos patienter med afroamerikansk oprindelse (som er kendt for at være en dårlig prognostisk faktor for hcv-udryddelse), medførte en behandling med ViraferonPeg (1,5 μg/kg)/ribavirin kombinationsbehandling højere vedvarende virologisk responsrate sammenlignet med ViraferonPeg 1 μg/kg dosis.
English: It has been demonstrated in a clinical study that peginterferon alfa-2b at low-dose (0.5 μg/kg/week) is not effective in long term maintenance monotherapy (for a mean duration of 2.5 years) for the prevention of disease progression in non responders with compensated cirrhosis.
Danish: I et klinisk studie blev det vist, at peginterferon alfa-2b ved lav dosis (0,5 μg/kg/uge) ikke var effektivt til langtidsvedligeholdelses-monoterapi (gennemsnitsvarighed 2,5 år) til forebyggelse af sygdomsprogression hos ikke-responderende med kompenseret cirrose.
English: You are ready to inject
Danish: Klar til indsprøjtning
English: The recommended dose of ViraferonPeg is 60 g/m2/week subcutaneously in combination with ribavirin 15 mg/kg/day orally in two divided doses with food (morning and evening).
Danish: Den anbefalede dosis for ViraferonPeg er 60 µg/m2/uge subkutant i kombination med 15 mg/kg/dag ribavirin oralt fordelt på to doser sammen med et måltid (morgen og aften).
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ViraferonPeg with ribavirin needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Danish: Populationen, der var tilmeldt, bestod hovedsageligt af børn med mild til moderat hepatitis C. På grund af mangel på data for børn med svær progression af sygdommen, og potentialet for uønskede virkninger, skal fordel/risiko for kombinationen af ViraferonPeg og ribavirin nøje overvejes i denne population (se pkt.
English: Approximately 21 % of children treated with ViraferonPeg/ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Danish: Omtrent 21 % af børn behandlet med kombinationsbehandling med ViraferonPeg/ribavirin fik øget thyroideastimulerende hormon (TSH).
English: Adults - Duration of treatment - HCV/HIV co-infection Bitherapy: The recommended duration of treatment for HCV/HIV co-infected patients is 48 weeks with bitherapy, regardless of genotype.
Danish: Voksne - Behandlingsvarighed - hcv/hiv co-infektion 2-stofsbehandling: Den anbefalede behandlingsvarighed af hcv/hiv co-inficerede patienter er 48 uger med 2-stofsbehandling uanset genotype.
English: Any subject with missing data in and after the follow-up week 12 window was considered to be a non-responder at week 24 of follow-up.
Danish: Enhver patient med manglende resultater i og efter perioden omkring opfølgningsuge 12 blev betragtet som non-responderende ved 24 ugers opfølgning.
English: * Must use vial.
Danish: * Hætteglas skal anvendes.
English: Total daily ribavirin dose (mg)
Danish: Total daglig ribavirin dosis (mg)
English: Patients with severe renal impairment, including those on hemodialysis, should be closely monitored.
Danish: Patienter med stærkt nedsat nyrefunktion, inklusive patienter i hæmodialyse, bør nøje monitoreres.
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during ViraferonPeg therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Danish: Psykiatriske sygdomme og sygdomme i centralnervesystemet (CNS) Alvorlig CNS-påvirkning, særlig depression, selvmordstanker og selvmordsforsøg, er set hos nogle patienter under ViraferonPeg-behandling, og selv efter behandlingsophør især under 6-måneders opfølgningsperioden.
English: These reactions are listed in Table 7 by system organ class and frequency (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), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Danish: Reaktionerne er anført i tabel 7 efter systemorganklasse og hyppighed (meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see section “How to self-inject ViraferonPeg”).
Danish: Detaljerede vejledninger for subkutan anvendelse er angivet i slutningen af denne indlægsseddel (se pkt ”Hvordan du selv indsprøjter ViraferonPeg”).
English: Suicide, suicide attempt, suicidal ideation, psychosis, hallucination, panic attack
Danish: Selvmord, selvmordsforsøg, selvmordstanker, psykose, hallucinationer, panikanfald
English: These reactions are listed in table 6 by system organ class and frequency (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), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Danish: Reaktionerne er anført i tabel 6 efter systemorganklasse og hyppighed (meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: Aspartate aminotransferase (AST)
Danish: Aspartat aminotransferase (ASAT)
English: In a single dose study (1.0 microgram/kg) in patients with impaired renal function, Cmax, AUC, and half-life increased in relation to the degree of renal impairment.
Danish: I en enkeltdosisundersøgelse (1,0 mikrogram/kg) hos patienter med nedsat nyrefunktion, steg Cmax, AUC og halveringstiden i forhold til graden af nyrefunktionsforringelsen.
English: Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients.
Danish: Lungeinfiltrater, pneumonitis og pneumoni, i visse tilfælde dødeligt forløbende, er i sjældne tilfælde blevet set hos interferon alfa-behandlede patienter.
English: If you forget to take ViraferonPeg
Danish: Hvis du har glemt at tage ViraferonPeg
English: A five-year long-term, observational, follow-up study enrolled 94 paediatric chronic hepatitis C patients after treatment in a multicentre trial.
Danish: Data vedrørende langtidsvirkning - pædiatrisk population Et fem-årigt langtidsopfølgende observationsstudie indrullerede 94 pædiatriske patienter med kronisk hepatitis C efter behandling i et multicenterstudie.
English: Interferon neutralising factor assays were performed on serum samples of patients who received ViraferonPeg in the clinical trial.
Danish: Analyser af interferonneutraliserende faktor blev udført på serum-prøver fra patienter, som fik ViraferonPeg i den kliniske undersøgelse.
English: Gently turn the pre-filled pen up-side-down two times to mix (see Figure 2).
Danish: Vend forsigtigt den fyldte pen på hovedet to gange (se figur 2).
English: Cases of hepatitis B re-activation (some with severe consequences) have been reported in patients coinfected with hepatitis B and C viruses treated with interferon.
Danish: Der er rapporteret om tilfælde af reaktivering af hepatitis B (nogle med alvorlige konsekvenser) hos patienter, der er co-inficerede med hepatitis B- og hepatitis C-virus, som blev behandlet med interferon.
English: Dose modification for all patients (monotherapy and combination therapy) If severe adverse reactions or laboratory abnormalities develop during treatment with ViraferonPeg monotherapy or combination therapy, the dosages of ViraferonPeg and/or ribavirin must be modified as appropriate, until the adverse reactions abate.
Danish: Dosisjustering for alle patienter (monoterapi og kombinationsbehandling) Hvis der udvikles alvorlige bivirkninger eller unormale laboratorieværdier under behandling med ViraferonPeg monoterapi eller kombinationsbehandling, skal doserne af ViraferonPeg og/eller ribavirin justeres efter behov, indtil bivirkningerne aftager.
English: Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely during interferon alfa-2b therapy.
Danish: Akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) er observeret i sjældne tilfælde under interferon alfa-2b-behandling.
English: Preliminary data indicate that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Danish: Præliminære resultater tyder på, at behandling med interferon alfa kan være forbundet med en øget frekvens af nyretransplantatafstødning.
English: Retreatment duration greater than 48 weeks in non-responder patients with genotype 1 has not been studied with pegylated interferon alfa-2b and ribavirin combination therapy.
Danish: Genbehandling af mere end 48 ugers varighed for ikke-responderende patienter med genotype 1 er ikke blevet undersøgt med kombinationsbehandling med pegyleret interferon alfa-2b og ribavirin.
English: Dextromethorphan hydrobromide (CYP2D6 and CYP3A substrate)
Danish: Dextromethorphan hydrobromid (CYP2D6 og CYP3Asubstrat)
English: As for all parenteral medicinal products, the reconstituted solution is to be inspected visually prior to administration.
Danish: Som ved alle parenterale lægemidler, skal den tilberedte opløsning inspiceres visuelt før indgift.
English: c: Patients with genotype 3 low viral load (< 600,000 IU/ml) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/ml) were to receive 48 weeks of treatment.
Danish: c: Patienter med genotype 3 lav virusbelastning (< 600.000 IE/ml) fik 24 ugers behandling, mens de med genotype 3 og høj virusbelastning (≥ 600.000 IE/ml) fik 48 ugers behandling.
English: In those patients that received > 10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received  10.6 mg/kg ribavirin (Table 9), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Danish: Hos disse patienter, som fik > 10,6 mg/kg ribavirin (800 mg dosis for en typisk patient på 75 kg), uafhængigt af genotype eller virusbelastning, var responsraten signifikant højere end hos de patienter, der fik  10,6 mg/kg ribavirin (Tabel 9), mens responsraten hos patienter, der fik > 13,2 mg/kg ribavirin var endnu højere.
English: In a clinical trial, approximately 1.2 % of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Danish: I en klinisk undersøgelse rapporterede cirka 1,2 % af patienter behandlet med ViraferonPeg eller interferon alfa-2b i kombination med ribavirin livstruende psykiatriske bivirkninger under behandling.
English: If discolouration or particulate matter is present, the reconstituted solution should not be used.
Danish: Hvis der er misfarvning eller bundfald i den rekonstituerede opløsning, må den ikke anvendes.
English: Pulmonary changes
Danish: Lungeforandringer
English: Psychiatric and central nervous system:
Danish: Psykiske sygdomme og sygdomme i centralnervesystemet:
English: Tritherapy (ViraferonPeg with ribavirin and boceprevir): applies to adult patients with genotype 1 CHC.
Danish: 3-stofsbehandling (ViraferonPeg med ribavirin og boceprevir): Kan anvendes til voksne patienter med genotype 1-CHC.
English: Neutrophil and white cell count reductions at the end of week 4 correlated with the dose of ViraferonPeg.
Danish: Reduktionen i antallet af neutrofiler og leukocytter ved slutningen af uge 4 korrelerede til dosis af ViraferonPeg.
English: The recommended duration of treatment with bitherapy is 24 weeks.
Danish: Den anbefalede behandlingsvarighed ved 2-stofsbehandling er 24 uger.
English: Facial palsy, mononeuropathies
Danish: Ansigtslammelse, mononeuropatier
English: Patients with creatinine clearance < 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SmPC).
Danish: Patienter med kreatininclearance < 50 ml/minut må ikke behandles med ViraferonPeg i kombination med ribavirin (se ribavirin SPC).
English: There are no apparent age-related effects on the pharmacokinetics of ViraferonPeg.
Danish: Der er ingen påviselige aldersrelaterede virkninger på farmakokinetikken for ViraferonPeg.
English: It is not known whether this medicine is present in human milk.
Danish: Det vides ikke, om dette lægemiddel udskilles i mælken hos mennesker.
English: Only 1 subject discontinued therapy as the result of an adverse reaction (thrombocytopenia).
Danish: Kun 1 forsøgsperson ophørte med behandlingen som følge af en bivirkning (trombocytopeni).
English: Theophylline, Antipyrine, Warfarin
Danish: Theophyllin, Phenazon, Warfarin
English: A complete set of instructions is provided in the Annex to the Package Leaflet.
Danish: En komplet instruktion er givet i bilaget til indlægssedlen.
English: * Any subject with an undetectable HCV-RNA level at the follow-up week 12 visit and missing data at the follow-up week 24 visit was considered a sustained responder.
Danish: * Enhver patient med et ikke målbart hcv-RNA niveau ved besøget i opfølgningsuge 12 og manglende resultater ved besøget i opfølgningsuge 24 blev betragtet som vedvarende responderende.
English: *, dry skin *, rash
Danish: *, tør hud *, udslæt
English: In children and adolescent patients receiving body surface area-adjusted dosing of ViraferonPeg at 60 g/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 g/kg/week.
Danish: Hos børn og unge patienter, der fik legemsoverflade-justeret dosering af ViraferonPeg med 60 μg/m2/uge, forudses det log-transformerede ratioestimat af eksponering i doseringsintervallet at være 58 % (90 % CI: 141-177 %) højere end observeret hos voksne, der fik 1,5 μg/kg/uge.
English: Tongue pigmentation
Danish: Pigmentering af tungen
English: Myalgia, arthralgia
Danish: Myalgi, artralgi
English: Talk to your doctor before taking this medicine if you, or the child you are caring for: - have had a severe nervous or mental disorder or have a history of substance abuse (e.g. alcohol or drugs).
Danish: Kontakt lægen, før du tager denne medicin, hvis du eller barnet, du har ansvar for: - har haft alvorlige nervøse eller psykiske problemer eller tidligere har haft et misbrug (f.eks. af alkohol eller stoffer).
English: st dose reduction of ribavirin is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
Danish: Note 1: Hos voksne patienter er 1. dosisreduktion af ribavirin med 200 mg/dag (undtagen hos patienter, der fik 1.400 mg, her bør dosis nedsættes med 400 mg/dag).
English: The combination of this medicine, ribavirin and boceprevir is recommended for use for some types of chronic hepatitis C virus infection (also called HCV infection) in adults 18 years of age and older.
Danish: Kombination af dette lægemiddel med ribavirin og boceprevir anbefales til brug ved nogle typer af kronisk hepatitis C virus-infektion (kaldes også hcv-infektion) hos voksne i alderen 18 år og ældre.
English: The white powder and the clear and colourless solvent are both contained in a two-chamber glass cartridge assembled into a single use pre-filled pen.
Danish: Det hvide pulver og det klare og farveløse solvens er begge indeholdt i en to-kammer glascylinder samlet i en enkeltdosis fyldt pen.
English: Non-responders to prior therapy with pegylated interferon alpha/ribavirin were less likely to achieve a week 12 response to retreatment than non-responders to nonpegylated interferon alpha/ribavirin (12.4 % vs. 28.6 %).
Danish: Ikke-responderende, som tidligere havde fået behandling med pegyleret interferon alfa/ribavirin, var mindre tilbøjelige til at respondere i 12. uge på genbehandling end ikke-responderende på ikke pegyleret interferon alfa/ribavirin (12,4 % versus 28,6 %).
English: For the 1.0 g/kg dose, similar volume adjustments can be made or alternate strengths can be used as shown in Table 2.
Danish: For dosen 1,0 g/kg kan der foretages en tilsvarende justering af volumen, eller der kan anvendes andre styrker, som vist i Tabel 2.
English: In the ViraferonPeg combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: - ViraferonPeg (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511).
Danish: I ViraferonPeg kombinationsundersøgelsen blev 1.530 naive patienter behandlet i et år med et af følgende kombinationsregimer: - ViraferonPeg (1,5 mikrogram/kg/uge) + ribavirin (800 mg/dag), (n = 511).
English: No response at treatment week
Danish: Intet respons ved behandlings -uge
English: Your doctor will determine the correct dose for you, or the child you are caring for.
Danish: Lægen bestemmer, hvilken dosis der er korrekt for dig eller det barn, du har ansvar for.
English: However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with ViraferonPeg or interferon alfa-2b.
Danish: Responsraterne i denne undersøgelse blev imidlertid vist også at være afhængige af dosis af ribavirin indgivet i kombination med ViraferonPeg eller interferon alfa-2b.
English: ViraferonPeg has a potential to depegylate to free interferon alfa-2b.
Danish: ViraferonPeg har et potentiale for at depegylere til frit interferon alfa-2b.