FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with severe renal dysfunction (creatinine clearance 15-29 ml/minute) should have the starting dose of ViraferonPeg reduced by 50 %.
Danish: Patienter med stærkt nedsat nyrefunktion (kreatininclearance 15-29 ml/minut) bør have initialdosis af ViraferonPeg reduceret med 50 %.
English: This medicine is a powder and solvent (liquid) for solution for injection in a pre-filled pen (CLEARCLICK).
Danish: Dette lægemiddel er et pulver og solvens (opløsningsmiddel) til injektionsvæske, opløsning i fyldt pen (CLEARCLICK).
English: Be sure the tip of needle is in the ViraferonPeg reconstituted solution.
Danish: Se efter, at spidsen af kanylen er i den færdigtilberedte ViraferonPeg-opløsning.
English: Dose reduction of ViraferonPeg in children and adolescents is accomplished by modifying the recommended dose in a two-step process from the original starting dose of 60 g/m 2/week, to 40 g/m 2/week, then to 20 g/m 2/week, if needed.
Danish: Dosisreduktion af ViraferonPeg hos børn og unge kan ske ved at modificere den anbefalede dosis i to trin fra den originale startdosis på 60 µg/m2/uge til 40
English: Patients who were HCV-RNA negative at treatment week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
Danish: Patienter, som var hcv-RNA negative ved afslutningen af en 12 ugers behandling, fortsatte behandlingen i alt 48 uger og blev overvåget i de næste 24 uger efter, at behandlingen var afsluttet.
English: After administering the dose, the ViraferonPeg pre-filled pen and any unused solution contained in it is to be disposed of in accordance with local requirements.
Danish: Efter indgift af dosen bortkastes ViraferonPeg fyldt pen med en eventuel rest af opløsning heri og bortskaffes i henhold til lokale retningslinjer.
English: a: 2 morning, 2 evening b: 2 morning, 3 evening c: 3 morning, 3 evening d: 3 morning, 4 evening * Refer to the SmPC of boceprevir for details about the dose of boceprevir to be administered in tritherapy.
Danish: a: 2 morgen, 2 aften b: 2 morgen, 3 aften c: 3 morgen, 3 aften d: 3 morgen, 4 aften
English: ViraferonPeg should be administered as a once weekly subcutaneous injection.
Danish: ViraferonPeg bør indgives som en ugentlig subkutan injektion.
English: Case by case benefit/risk assessment in children The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Danish: Den forventede fordel ved behandling skal nøje vægtes med de sikkerhedsresultater observeret hos børn og unge i de kliniske forsøg (se pkt.
English: Table 13 Sustained virological response based on genotype after ViraferonPeg in combination with Ribavirin in HCV/HIV Co-infected patients Study 1
Danish: Tabel 13 Vedvarende virologisk respons efter ViraferonPeg i kombination med Ribavirin hos patienter med samtidig infektion af hcv/hiv, baseret på genotype Undersøgelse 1
English: While pyrexia may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent pyrexia must be ruled out.
Danish: Da feber kan ses sammen med de influenzalignende reaktioner, der sædvanligvis rapporteres under interferonbehandling, bør andre årsager til vedvarende feber udelukkes.
English: Leukocytes
Danish: Leukocytter
English: - The use of ViraferonPeg in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Danish: - Brug af ViraferonPeg hos børn og unge som har eller har haft svære psykiske tilstande er kontraindiceret (se pkt.
English: ViraferonPeg monotherapy - Adults
Danish: ViraferonPeg monoterapi - Voksne
English: In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 micrograms/kg subcutaneously, once weekly, in combination with ribavirin 800 mg -1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 10).
Danish: I en separat undersøgelse fik 224 patienter med genotype 2 eller 3 ViraferonPeg, 1,5 mikrogram/kg subkutant en gang ugentlig, i kombination med ribavirin 800 mg -1.400 mg p.o. i 6 måneder (baseret på kropsvægt, kun tre patienter, der vejede > 105 kg, fik 1.400 mg dosen) (Tabel 10).
English: Reminder to adult patients prescribed combination therapy of this medicine, boceprevir and ribavirin: Please read the “Possible side effects” section of these Package Leaflets.
Danish: Bemærkning til voksne patienter, der får ordineret kombinationsbehandling med dette lægemiddel plus boceprevir og ribavirin: Læs afsnittet "Bivirkninger" i indlægssedlerne.
English: The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol.
Danish: Det aktive stof er en covalent konjugering af rekombinant interferon alfa-2b* med monomethoxypolyethylenglycol.
English: - Clean the rubber top of the vial with a cleansing swab.
Danish: - Rens gummimembranen med en renseserviet.
English: Important information about some of the ingredients of ViraferonPeg Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Danish: Vigtige oplysninger om visse af indholdsstofferne i ViraferonPeg Bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose-galactose malabsorption eller sucrasemangel.
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of ViraferonPeg and ribavirin, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Danish: I et klinisk forsøg med 107 børn og unge patienter (3 til 17 år) behandlet med ViraferonPeg og ribavirin som kombinationbehandling, var dosisændring nødvendig hos 25 % af patienterne, hyppigst på grund af anæmi, neutropeni eller vægttab.
English: Palpitations, tachycardia
Danish: Palpitation, takykardi
English: HCV/HIV Co-infection
Danish: Hcv/hiv co-infektion
English: You must use an effective birth control during the time you are taking ribavirin and for 4 months after stopping treatment.
Danish: Du skal anvende en effektiv præventionsmetode i den periode, du bruger ribavirin og i 4 måneder efter, at behandlingen er afsluttet.
English: ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis C virus RNA (HCV-RNA), including patients with compensated cirrhosis and/or co-infected with clinically stable HIV (see section 4.4).
Danish: ViraferonPeg er indiceret til behandling af voksne patienter (18 år og ældre) med CHC, som er positive med hensyn til hepatitis C-virus-RNA (hcv-RNA), inklusive patienter med kompenseret cirrose og/eller co-inficerede med klinisk stabil hiv (se pkt.
English: A small volume is lost during preparation of this medicine for injection and when the dose is measured and injected.
Danish: En lille smule går tabt under færdigtilberedning af dette lægemiddel til injektion, og når dosis afmåles og indsprøjtes.
English: Table 8 Sustained virological response (% patients HCV negative) ViraferonPeg monotherapy ViraferonPeg + ribavirin
Danish: Tabel 8 Vedvarende virologisk respons ( % patienter hcv-negative) ViraferonPeg monoterapi
English: Table 2a Dose modification guidelines for combination therapy based on laboratory parameters
Danish: Tabel 2a Retningslinjer for dosisjustering af kombinationsbehandling baseret på laboratorieparametre Laboratorieværdier
English: - Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
Danish: - Interferon alfa-2b (3 MIE tre gange om ugen) + ribavirin (1.000/1.200 mg/dag) (n = 505).
English: Combination therapy dose reduction guidelines
Danish: Kombinationsbehandling - vejledninger for dosisreduktion
English: This medicine is a powder and solvent (liquid) for solution for injection.
Danish: Dette lægemiddel er et pulver og solvens (opløsningsmiddel) til injektionsvæske, opløsning.
English: Discard any solution that is left in the vial after you give yourself the injection.
Danish: Kassér en eventuel rest af opløsningen, der måtte være tilbage i hætteglasset, efter at du selv har givet indsprøjtningen.
English: - Dissolve the entire contents by swirling the ViraferonPeg vial with a gentle rotary motion leaving the needle and attached syringe in the vial.
Danish: - Opløs indholdet fuldstændigt ved at svinge ViraferonPeg-hætteglasset med en rolig roterende bevægelse, mens kanylen og den påsatte sprøjte stadig sidder i hætteglasset.
English: Neuralgia, lethargy, paraesthesia, hypoaesthesia, psychomotor hyperactivity, tremor
Danish: Neuralgi, letargi, paræstesi, hypoæstesi, psykomotorisk hyperaktivitet, tremor
English: Myalgia, arthralgia, musculoskeletal pain
Danish: Myalgi, artralgi, muskulo-skeletale smerter
English: Table 2b Two-step dose reduction of ViraferonPeg in combination therapy in adults First dose reduction to ViraferonPeg 1 µg/kg
Danish: Tabel 2b To-trins-dosisreduktion af ViraferonPeg i kombinationsbehandling hos voksne Første dosisreduktion til ViraferonPeg 1 µg/kg Anden dosisreduktion til ViraferonPeg 0,5 µg/kg
English: Hypotension, hypertension, flushing
Danish: Hypotension, hypertension, rødmen
English: Bitherapy: Predictability of sustained virological response - Patients infected with virus genotype 1 who fail to achieve undetectable HCV-RNA or demonstrate adequate virological response at week 4 or 12 are highly unlikely to become sustained virological responders and should be evaluated for discontinuation (see also section 5.1).
Danish: 2-stofsbehandling: Forudsigelighed for vedvarende virologisk respons - Patienter inficeret med virus genotype 1, som ikke opnår ikke-detekterbar hcv-RNA eller demonstrerer tilstrækkeligt virologisk respons ved uge 4 eller 12, har en meget lille sandsynlighed for at blive vedvarende virologisk responderende og bør evalueres for seponering (se også pkt.
English: Acute hypersensitivity reactions including angioedema, anaphylaxis and anaphylactic reactions including anaphylactic shock, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, systemic lupus erythematosus
Danish: Akutte allergiske reaktioner inklusive angioødem, anafylaksi og anafylaktiske reaktioner inklusive anafylaktisk shock, idiopatisk trombocytopenisk purpura, trombotisk trombocytopenisk purpura, systemisk lupus erythematosus
English: • Genotype 1: - Patients who have undetectable HCV-RNA at treatment week 12, treatment should be continued for another nine month period (i.e., a total of 48 weeks).
Danish: • Genotype 1: - Patienter, som ikke har detekterbar hcv-RNA ved behandlingsuge 12, bør fortsætte behandlingen i yderligere ni måneder (dvs. i alt 48 uger).
English: A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies and Vogt-Koyanagi-Harada syndrome (see also section 4.4).
Danish: Mange forskellige autoimmune og immunmedierede lidelser er blevet rapporteret med alfa interferoner inklusive thyroidea lidelser, systemisk lupus erythematosus, reumatoid athritis (ny eller forværret), idiopatiske og trombotiske trombocytopenisk purpura, vaskulitis, neuropatier inklusive mononeuropatier og Vogt-Koyanagi-Harada syndrom (se også pkt.
English: Hydration
Danish: Hydrering
English: Congestive heart failure, cardiomyopathy, arrhythmia, pericarditis
Danish: Kongestivt hjertesvigt, kardiomyopati, arytmi, perikarditis
English: Geometric Mean Ratio (Ratio with/without peginterferon alfa-2b)
Danish: Geometrisk middelværdi (med/uden peginterferon alfa-2b)
English: Inject the solution by pushing the plunger all the way down gently.
Danish: Indsprøjt opløsningen ved blidt at trykke stemplet helt i bund.
English: The powder and solvent are both contained in a two-chamber cartridge (Type I flint glass) separated by a bromobutyl rubber plunger.
Danish: Pulver og solvens er begge anbragt i en tokammer cylinderampul (type I flintglas) adskilt af et brombutylgummimembranstempel.
English: 9/l, and < 1.5 x 10
Danish: 9/l, og < 1,5 x 10
English: For patients with prior failure on therapy with nonpegylated interferon or pegylated interferon and negative at week 12, the sustained response rates were 59 % and 50 %, respectively.
Danish: For patienter, som tidligere ikke har responderet på behandling med ikke-pegyleret interferon eller pegyleret interferon, og som var negative i 12. behandlings uge, var den vedvarende responsrate henholdsvis 59 % og 50 %.
English: The following treatment-related adverse reactions were reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg/ribavirin.
Danish: Følgende behandlingsrelaterede bivirkninger blev rapporteret hos voksne i kliniske undersøgelser eller via post-marketing overvågning hos patienter behandlet med peginterferon alfa-2b, herunder ViraferonPeg monoterapi eller ViraferonPeg/ribavirin.
English: Response at treatment week
Danish: Respons ved behandling s uge
English: Diabetes mellitus, hypertriglyceridaemia
Danish: Diabetes mellitus, hypertriglyceridæmi
English: - hepatitis B reactivation in HCV/HBV co-infected patients (recurrence of hepatitis B disease).
Danish: - reaktivering af hepatitis B hos patienter med samtidig infektion med HCV og HBV (tilbagevenden af hepatitis B-sygdom).
English: Laboratory values for HCV/HIV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Danish: Laboratorieværdier for samtidig infektion med hcv/hiv Selvom hæmatologisk toksicitet af neutropeni, trombocytopeni og anæmi forekom mere hyppigt hos patienter med samtidig infektion af hcv/hiv, kunne hovedparten afhjælpes med en modificering af dosis og krævede sjældent for tidlig afbrydelse af behandling (se pkt.
English: For adult patients who use 0.5 g/kg ViraferonPeg monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half as shown in Table 3b.
Danish: Hos voksne patienter, som anvender ViraferonPeg 0,5 g/kg som monoterapi, kan dosisreduktion ske ved at reducere det ordinerede volumen med halvdelen som vist i Tabel 3b.
English: ViraferonPeg (100 or c µg/week) + ribavirin
Danish: ViraferonPeg (100 or c µg/uge) + ribavirin
English: Therefore, it is recommended that children and adolescent patients receiving ViraferonPeg/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment or if they have detectable HCV-RNA at treatment week 24.
Danish: Det anbefales derfor, at behandlingen af børn og unge patienter, der får ViraferonPeg/ribavirin kombination, afbrydes, hvis deres uge 12 hcv-RNA falder < 2 log10 i forhold til før behandlingen, eller hvis de har detekterbar hcv-RNA i behandlingsuge 24.
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two ViraferonPeg/ribavirin regimens [ViraferonPeg 1.5 µg/kg and 1 µg/kg subcutaneously once weekly both in combination with ribavirin 800 to 1,400 mg p.o. daily (in two divided doses)] and peginterferon alfa-2a 180 µg subcutaneously once weekly with ribavirin 1,000 to 1,200 mg p.o. daily (in two divided doses) in 3,070 treatment-naïve adults with chronic hepatitis C genotype 1.
Danish: Et stort randomiseret studie sammenlignede sikkerhed og effekt af behandling i 48 uger med to ViraferonPeg/ribavirin regimer [ViraferonPeg 1,5 μg/kg og 1 μg/kg subkutant en gang ugentligt begge i kombination med ribavirin 800 til 1.400 mg p.o. dagligt (fordelt på to doser)] og peginterferon alfa2a 180 μg subkutant en gang ugentligt med ribavirin 1.000 til 1.200 mg per os dagligt (fordelt på to doser) hos 3.070 behandlingsnaive voksne med kronisk hepatitis C genotype 1.
English: Mitochondrial toxicity and lactic acidosis
Danish: Mitokondriel toksicitet og mælkesyreacidose
English: Bitherapy: Predictability of sustained virological response - All patients, irrespective of genotype, who have demonstrated serum HCV-RNA below the limits of detection at week 12 should receive 48 weeks of bitherapy.
Danish: 2-stofsbehandling: Forudsigelighed af vedvarende virologisk respons - Alle patienter, uanset genotype, der har vist serum hcv-RNA under de målbare grænser i Uge 12, bør modtage 48 ugers 2stofsbehandling.
English: Table 9 Sustained response rates with ViraferonPeg + ribavirin (by ribavirin dose, genotype and viral load) HCV Genotype
Danish: Tabel 9 Vedvarende responsrater med ViraferonPeg + ribavirin (efter ribavirindosis, genotype og virusmængde) hcv Genotype
English: It is not known whether the components of this medicinal product are excreted into experimental animal or human milk (see section 4.6 for relevant human data on pregnancy and lactation).
Danish: Det er uvist, om dele af dette lægemiddel udskilles i mælken hos forsøgsdyr eller mennesker (se pkt.
English: Refer to the SmPC for boceprevir.
Danish: 3-stofsbehandling Se SPC for boceprevir.
English: Chronic Hepatitis C Subjects (N=24)
Danish: Forsøgspersoner med kronisk hepatitis C (N=24)
English: Patients were randomized to receive either ViraferonPeg (1.5 µg/kg/week) plus ribavirin (800 mg/day) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Danish: Patienterne blev randomiseret til enten at modtage ViraferonPeg (1,5 μg/kg/uge) plus ribavirin (800 mg/dag) eller interferon alfa-2b (3 MIE TIW) plus ribavirin (800 mg/dag) i 48 uger med en opfølgningsperiode på 6 måneder.
English: For adult patients who use 1.0 g/kg ViraferonPeg monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3c.
Danish: Hos voksne patienter, som anvender ViraferonPeg 1,0 g/kg som monoterapi, kan dosisreduktion ske ved at reducere det ordinerede volumen med halvdelen eller ved at anvende en lavere styrke, som vist i Tabel 3c.
English: - facial palsy (weakness and slumping on one side to the face), severe allergic reactions such as angioedema (an allergic skin disease characterized by patches of swelling involving the skin and its subcutaneous layers, the mucous membranes, and sometimes the internal organs), mania (excessive or unreasonable enthusiasm), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), change in colour of the tongue.
Danish: - ansigtslammelse (svækkelse og lammelse i den ene side af ansigtet) og alvorlige allergiske reaktioner såsom angioødem (en allergisk hudsygdom karakteriseret ved afgrænsede hævede pletter, der omfatter huden og dens subkutane lag, slimhinderne og indimellem de indre organer), mani (unormalt stor eller unødvendig entusiasme), perikardial effusion (en væskeansamling, der udvikles mellem perikardium (hjertesækken) og selve hjertet), VogtKoyanagi-Harada syndrom (en autoimmun inflammatorisk lidelse, der påvirker øjnene, huden og membraner i ører, hjerne og rygmarv), ændring i tungens farve.
English: Tolbutamide (CYP2C9 substrate)
Danish: Tolbutamid (CYP2C9-substrat)
English: Healthy Subjects (N=13)
Danish: Raske forsøgspersoner (N=13)
English: For BMI, pre-treatment to end of long-term follow-up, BMI-for-age percentiles decreased 1.8 and 7.5 percentiles among subjects treated for 24 weeks or 48 weeks, respectively.
Danish: Med hensyn til BMI var der en reduktion i BMI for alderen fra før behandling til afslutning af langtidsopfølgningen på henholdsvis 1,8 og 7,5 percentiler hos de børn, der var blevet behandlet i 24 eller 48 uger.
English: Disodium phosphate, anhydrous Sodium dihydrogen phosphate dihydrate Sucrose
Danish: Dinatriumphosphat, vandfri Natriumdihydrogenphosphatdihydrat Saccharose
English: ViraferonPeg/ribavirin retreatment of prior treatment failures In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with ViraferonPeg, 1.5 micrograms/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Danish: ViraferonPeg/ribavirin genbehandling af patienter som ikke har responderet på tidligere behandling 2.293 patienter i en ikke sammenligningsundersøgelse, som havde moderat til svær fibrose, hvor tidligere behandling med kombinationen af alfa interferon/ribavirin var uden effekt, blev behandlet med ViraferonPeg givet subkutant (1,5 mikrogram/kg/uge) i kombination med ribavirin baseret på kropsvægt.
English: In the treatment phase of this study, the most prevalent adverse reactions in all subjects were pyrexia (80 %), headache (62 %), neutropenia (33 %), fatigue (30 %), anorexia (29 %) and injection-site erythema (29 %).
Danish: I behandlingsfasen af dette studie var de hyppigste bivirkninger hos alle forsøgspersoner feber (80 %), hovedpine (62 %), neutropeni (33 %), træthed (30 %), anoreksi (29 %) og erytem på injektionsstedet (29 %).
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Danish: Manglende effekt af tidligere behandling blev defineret som recidiv eller non-respons (hcvRNA-positiv ved afslutningen på en 12 ugers behandling).
English: You must not use ViraferonPeg if any of the conditions above should apply to you, or the child you are caring for.
Danish: Du må ikke tage ViraferonPeg, hvis du, eller det barn du har ansvar for, har en eller flere af ovenstående sygdomme.
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: Metabolism of theophylline is suppressed by inhibitory action of the product (ViraferonPeg) on CYP1A2.
Danish: Theophyllins metabolisering hæmmes af ViraferonPegs hæmmende virkning på CYP1A2.
English: Response to the treatment was measured by Sustained Virologic Response (SVR) which is defined as undetectable HCV-RNA at 24 weeks post-treatment (see Table 11).
Danish: Respons på behandlingen blev målt ved vedvarende virologisk respons (SVR), der er defineret som ikke målbart hcv-RNA 24 uger efter behandlingen (se tabel 11).
English: You should use a different place each time you give yourself an injection.
Danish: Du bør bruge forskellige steder, hver gang du
English: A small volume is lost during preparation of ViraferonPeg for injection when the dose is measured and injected.
Danish: Et lille volumen går tabt under færdigtilberedningen af ViraferonPeg til injektion, når dosen udmåles og injiceres.
English: Figure 10: Thigh injection
Danish: Figur 10: Indsprøjtning i låret
English: Metabolism of thioridazine is suppressed by inhibitory action of the product (ViraferonPeg) on CYP2D6.
Danish: Thioridazins metabolisering hæmmes af ViraferonPegs hæmmende virkning på CYP2D6.
English: Long term maintenance monotherapy
Danish: Langtidsvedligeholdelses-monoterapi
English: ViraferonPeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy (see section 5.1).
Danish: ViraferonPeg i kombination med ribavirin og boceprevir (3-stofsbehandling) er indiceret til behandling af kronisk hepatitis C (CHC) genotype 1-infektion hos voksne patienter (18 år og ældre) med kompenseret leversygdom, der ikke tidligere har været i behandling, eller hvor tidligere behandling er mislykkedes (se pkt.