FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 level reduction (mcg)
Danish: 1. niveau reduktion (mikrogram)
English: No data is available on long-term follow-up posttreatment in these patients (see section 4.4).
Danish: Der findes ingen data på langsigtet opfølgning efter behandling hos disse patienter.
English: Depression, anxiety, hallucination, abnormal behaviour, aggression, anger, attention deficit / hyperactivity disorder
Danish: Depression, angst, hallucinationer, anormal adfærd, aggression, vrede, ADHD
English: Gastrointestinal disorder
Danish: Gastrointestinal blødning
English: 135 micrograms/0.5 ml
Danish: 135 mikrogram/0,5 ml
English: Patients infected with HCV genotype 2 or 3 who have detectable HCV RNA at week 4, regardless of pre-treatment viral load should receive 24 weeks of therapy.
Danish: Patienter, som er smittet med HCV-genotype 2 eller 3, og som har detekterbar HCV-RNA ved uge 4, uanset viral belastning ved baseline, skal have 24 ugers behandling.
English: You must use an effective contraceptive during the time you are taking the treatment and for 4 months after stopping treatment.
Danish: Du skal anvende en effektiv præventionsform i hele den periode, du er i behandling og i 4 måneder efter behandlingen er stoppet.
English: Genotype 2 or 3
Danish: Genotype 2 eller 3
English: Patients infected with HCV genotype 1 who have detectable HCV RNA at week 4 regardless of pre-treatment viral load should receive 48 weeks of therapy.
Danish: Patienter, som er smittet med HCV-genotype 1, som har påviselig HCV-RNA ved uge 4, uanset viral belastning ved baseline, skal have 48 ugers behandling.
English: Heart and blood vessel disorders: High blood pressure Breathing disorders: Wheezing
Danish: Hjerte og blodkar: Højt blodtryk
English: ● Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle while keeping the needle in the vial and without touching the tip of the syringe.
Danish: • Hold sprøjten med kanylen i hætteglasset pegende opad og fjern, uden at røre ved spidsen af sprøjten, sprøjten fra den lange kanyle, mens kanylen bliver i hætteglasset.
English: Table 7: Ribavirin dosing recommendations for paediatric patients with chronic hepatitis C aged 5 to 17 years
Danish: Tabel 7: Anbefalinger for dosering af ribavirin til pædiatriske patienter med kronisk hepatitis C fra 5 til 17 år
English: INFORMATION IN BRAILLE pegasys 135 mcg
Danish: INFORMATION I BRAILLESKRIFT pegasys 135 mcg
English: Dyspnoea, epistaxis
Danish: Dyspnø, epistaxis
English: Immune system disorders: Idiopathic (or thrombotic) thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) Eye disorders: Loss of vision
Danish: Immunsystemet: Idiopatisk (eller trombotisk) trombocytopenisk purpura (flere blå mærker, blødning, nedsat antal blodplader, blodmangel og ekstrem svaghed) Øjne: Synstab
English: Consideration should be given to continuing treatment with more frequent monitoring of liver function during ALT flares.
Danish: Hvis disse store stigninger i ALAT forekommer, skal det overvejes at fortsætte behandlingen med hyppigere kontrol af leverfunktionen.
English: Table 8: Ribavirin dose modification recommendations in paediatric patients with chronic hepatitis C Full dose (Approx. 15 mg/kg/day)
Danish: Tabel 8: Anbefalede dosisjusteringer for ribavirin hos pædiatriske patienter med kronisk hepatitis C Fuld dosis (Ca. 15 mg/kg/dag)
English: Table 22: Serological, virological and biochemical responses in paediatric patients with chronic hepatitis B
Danish: Tabel 22: Serologiske, virologiske og biokemiske reaktioner i pædiatriske patienter med kronisk hepatitis B
English: ● Remove the rubber cap from the syringe (3).
Danish: • Fjern gummihætten fra sprøjten (3).
English: Body system
Danish: Systemorganklasse
English: Syncope, migraine, memory impairment, weakness, hypoaesthesia hyperaesthesi a, paraesthesia, tremor, taste disturbance, nightmares, somnolence
Danish: Besvimelse, migræne, hukommelsessvækkelse, svaghed, hypoæstesi, hyperæstesi, paræstesier, tremor, smagsforstyrrelser, mareridt, somnolens
English: Table 21: Sustained virological response based on genotype and pre-treatment viral load after Pegasys combination therapy with ribavirin in HIV-HCV co-infected patients Study NR15961 Interferon alfa-2a 3 MIU
Danish: Tabel 21: Vedvarende virologisk respons baseret på genotype og viral belastning ved baseline efter behandling med Pegasys i kombination med ribavirin hos hiv-HCV-co-inficerede patienter Studie NR15961 Interferon alfa-2a 3 MIE
English: *RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24; **RVR = rapid viral response (HCV RNA negative) by week 4
Danish: *RVR = hurtigt virologisk respons (ikke-detekterbar HCV-RNA) ved uge 4 og ikke-detekterbar HCV-RNA ved uge 24 **RVR = hurtigt virologisk respons (HCV-RNA-negativ) ved uge 4
English: Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAgnegative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).
Danish: Pegasys er indiceret til behandling af hepatitis B envelope antigen (HBeAg)-positiv og -negativ kronisk hepatitis B (CHB) hos voksne patienter med kompenseret leversygdom, evidens for viral replikation og forhøjet alanin aminotransferase (ALAT) eller histologisk verificeret leverinflammation (se pkt.
English: 3 level reduction (mcg)
Danish: 3. niveau reduktion (mikrogram)
English: ● Take the long needle and place it firmly on to the tip of the syringe (2).
Danish: • Tag den lange kanyle og sæt den fast på spidsen af sprøjten (2).
English: The decrease in ANC was reversible upon dose reduction or cessation of therapy (see section 4.2), reached normal values by 8 weeks in the majority of patients and returned to baseline in all patients after about 16 weeks.
Danish: 4.2), opnåede normale værdier efter 8 uger hos hovedparten af patienterne og vendte tilbage til baseline hos alle patienter efter 16 uger.
English: Use of peginterferon as long term maintenance monotherapy (unapproved use) In a randomised, controlled US study (HALT-C) of HCV non-responder patients with varied degrees of fibrosis where 3.5 years of treatment with 90 micrograms/week of Pegasys monotherapy was studied, no significant reductions were observed in the rate of fibrosis progression or related clinical events.
Danish: Brug af peginterferon som en langvarig vedligeholdelsesmonobehandling (ikke godkendt behandling) Et randomiseret, kontrolleret studie i USA (HALT-C) har undersøgt HCV-ikke-responderende patienter med varierende grad af fibrose, som blev behandlet med Pegasys monoterapi 90 mikrogram pr. uge i 3,5 år.
English: ● The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid and water for injections.
Danish: ● Øvrige indholdsstoffer: natriumchlorid, polysorbat 80, benzylalkohol, natriumacetat, eddikesyre og vand til injektionsvæsker.
English: The recommended dose for Pegasys is 180 micrograms once weekly given in combination with oral ribavirin or as monotherapy.
Danish: Den anbefalede dosis af Pegasys er 180 mikrogram én gang ugentlig i kombination med oral ribavirin eller som monoterapi.
English: The probabilities of achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was achieved at week 12 were 35% (20 of 57) and 57% (57 of 100), respectively.
Danish: Sandsynligheden for at opnå et vedvarende virologisk respons med 48 eller 72 ugers behandling, hvis viral suppression var opnået ved uge 12, var henholdsvis 35 % (20/57) og 57 %
English: Abdominal pain upper, stomatitis, nausea, aphthous stomatitis, oral disorder
Danish: Øvre abdominalsmerte, stomatitis, kvalme, aftøs stomatitis, oral lidelse,
English: Psoriasis, urticaria, eczema, rash, sweating increased, skin disorder, photosensitivi ty reaction, night sweats
Danish: Psoriasis, urticaria, eksem, udslæt, øget svedtendens, hudsygdomme, lysoverfølsomhedsreaktioner, nattesved
English: 2 level reduction (mcg)
Danish: 2. niveau reduktion (mikrogram)
English: Table 1: Dosing recommendations for combination therapy for adult patients with chronic hepatitis C
Danish: Tabel 1: Anbefalet dosering for kombinationsbehandling til voksne patienter med kronisk hepatitis C
English: In study NV17317 in patients infected with viral genotype 2 or 3, all patients received Pegasys 180 mcg sc qw and a ribavirin dose of 800 mg and were randomised to treatment for either 16 or 24 weeks.
Danish: I studie NV17317 med patienter inficeret med virologisk genotype 2 eller 3, modtog alle patienter Pegasys 180 mikrogram subkutant én gang ugentlig og 800 mg ribavirin, og patienterne blev randomiseret til 16 eller 24 ugers behandling.
English: Substance overdose
Danish: Overdosering
English: (N=701) 48 weeks
Danish: (N=701) 48 uger
English: 25,000 to cells/mm cells/mm3
Danish: 25.000 til celler/mm celler/mm3
English: The device is for single use only and is then to be discarded.
Danish: Pennen er kun til engangsbrug og skal kasseres efter brug.
English: HIV-HCV co-infected adult patients
Danish: Hiv-HCV-co-infektion hos voksne patienter
English: Blindness transient, retinal exudates, visual impairment eye irritation, eye pain, eye pruritis
Danish: Forbigående blindhed, retinale ekssudater, synsforstyrrelse, øjenirritation, øjensmerte, øjenkløe
English: ● Take the short needle and place it firmly on to the tip of the syringe (5).
Danish: • Tag den korte kanyle og sæt den fast på spidsen af sprøjten (5).
English: 0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a fixed needle (stainless steel), plunger stopper (butyl rubber laminated with fluororesin) and a needle shield (polyisoprene) in a pre-filled pen.
Danish: 0,5 ml injektionsvæske, opløsning i en fyldt injektionssprøjte (type I silikoniseret glas) med en fastgjort kanyle (rustfrit stål), stempelprop (butylgummi lamineret med fluororesin) og kanylebeskyttelse (polyisopren) i en fyldt pen.
English: • Pegasys 180 mcg/week for 72 weeks
Danish: • Pegasys 180 mikrogram/uge i 72 uger
English: The duration of treatment with Pegasys in combination with ribavirin in paediatric patients with CHC depends on viral genotype.
Danish: Varigheden af behandling med Pegasys i kombination med ribavirin hos pædiatriske patienter med kronisk hepatitis C afhænger af viral genotype.
English: ● an injection needle Not included in the pack:
Danish: Ikke indlagt i pakningen:
English: Genotype 1 or 4 without RVR*
Danish: Genotype 1 eller 4 uden RVR*
English: For CHB patients, transient flares of ALT levels sometimes exceeding 10x ULN are not uncommon, and may reflect immune clearance.
Danish: Hos patienter med kronisk hepatitis B er forbigående store stigninger i ALAT, som nogle gange er mere end 10x over øvre referencegrænse, ikke ualmindelige.
English: For information on predictive values for ontreatment response, see section 5.1.
Danish: 5.1. for information om response for prædiktive værdier under behandling.
English: The mean changes from baseline in height and weight for age Z-scores at Week 48 of treatment in study YV25718 were -0.07 and -0.21 (n=108 and n= 106 respectively) for Pegasys-treated patients as compared to -0.01 and -0.08 (n=47 each) in untreated patients.
Danish: De gennemsnitlige ændringer fra baseline i højde og vægt for alder Z-score ved uge 48 af behandlingen i klinisk studie YV25718 var -0,07 og -0,21 (henholdsvis n=108 og n=106) for patienter behandlet med Pegasys sammenlignet med -0,01 og -0,08 ( begge n=47) for ubehandlede patienter.
English: Pneumonia, skin infection
Danish: Pneumoni, hudinfektioner
English: Differences in sustained virological response (SVR) based on treatment duration, demographics and best responses to previous treatment are displayed in Table
Danish: (SVR) baseret på behandlingsvarighed, demografiske karakteristika og bedste respons ved tidligere behandling er vist i tabel 19.
English: ● use if medicine is cloudy, hazy, discoloured or has particles in it.
Danish: ● bruge pennen, hvis medicinen er uklar, grumset, misfarvet, eller der er partikler tilstede.
English: ≥ 14 days apart during the 6 months before the first dose of study drug.
Danish: < 10 x øvre referencegrænse i to blodprøver målt ved ≥ 14 dagsinterval under de 6 måneder før første dosis af lægemiddel.
English: Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels.
Danish: Pegasys er indiceret til behandling af HBeAg-positiv kronisk hepatitis B hos ikke-cirrotiske børn og unge i alderen 3 år og ældre med evidens på viral replikation og vedvarende forhøjet serum-ALATniveauer.
English: The recommended dosage for Pegasys, alone or in combination with ribavirin, is 180 micrograms once weekly subcutaneously for 48 weeks.
Danish: Den anbefalede dosering af Pegasys, alene eller i kombination med ribavirin, er 180 mikrogram subkutant én gang ugentlig i 48 uger.
English: To remove air bubbles from the syringe, hold the syringe with the needle pointing up.
Danish: For at fjerne luftboblerne skal du holde sprøjten med kanylen pegende opad.
English: Table 16: Relapse of virological response at the end of treatment for rapid virological response population
Danish: Tabel 16: Recidiv for virologisk respons efter endt behandling hos patienter med hurtig virologisk respons
English: If you are receiving HAART, the addition of Pegasys + ribavirin may increase your risk of lactic acidosis or liver failure.
Danish: Hvis du bliver behandlet med HAART, og i tillæg dertil skal behandles med Pegasys og ribavirin kan det forøge risikoen for mælkesyreacidose eller leversvigt.
English: 250 to < 500 cells/mm3: interrupt dosing until ≥ 1000 cells/mm3, then resume dose with 2 level adjustments and monitor.
Danish: 500 til <750 celler/mm3:øjeblikkelig 1. niveau justering 250 til <500 celler/mm3: afbryd dosering indtil ≥1000 celler/mm3, derefter fortsæt dosering med 2. niveau justering og monitorer
English: In the NV17424 (PEDS-C) study, previously untreated paediatric patients 5 to 17 years of age (55% <12 years old) with compensated CHC and detectable HCV RNA were treated with Pegasys 180 mcg x BSA/1.73 m2 once weekly for 48 weeks with or without ribavirin 15 mg/kg/day.
Danish: I NV17424 (PEDS-C) studiet blev tidligere ubehandlede pædiatriske patienter fra 5 til 17 år (55 % <12 år) med kompenseret kronisk hepatitis C og detekterbar HCV-RNA behandlet med Pegasys 180 mikrogram x legemsoverfladeareal/1,73 m2 én gang om ugen i 48 uger med eller uden ribavirin
English: Each syringe should be used by one person only and is for single use.
Danish: Hvert hætteglas må kun anvendes til en person og er til engangsbrug.
English: Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Pegasys.
Danish: Der henvises til produktresuméerne for de lægemidler, som bruges i kombination med Pegasys.
English: Combination therapy with other medicines in chronic hepatitis C In the case of combination therapy with Pegasys, please follow the dosing regimen recommended by your doctor and refer also to the package leaflets of any other medicines that are used in combination with Pegasys.
Danish: Kombinationsbehandling med andre lægemidler ved kronisk hepatitis C Hvis Pegasys gives i kombination med andre lægemidler, skal du følge den dosering, som din læge har anbefalet, og læse indlægssedlerne for de andre lægemidler.
English: Please refer to the ribavirin SmPC.
Danish: Der henvises til produktresuméet for ribavirin.
English: ALT Normalisation
Danish: ALATnormalisering
English: Treatment for 24 weeks may be considered in patients infected with - genotype 1 with low viral load (LVL) (≤ 800,000 IU/ml) at baseline or
Danish: Behandling i 24 uger bør overvejes hos patienter inficeret med - genotype 1 med lav viral belastning (≤800.000 IE/ml) ved baseline eller - genotype 4
English: Table 2: Predictive value of week 12 virological response at the recommended dosing regimen while on Pegasys combination therapy in adult patients with chronic hepatitis C Genotype
Danish: Tabel 2: Prædiktiv værdi ved uge 12 for det virologiske respons under kombinationsbehandling med Pegasys efter den anbefalede dosis hos voksne patienter med kronisk hepatitis C Genotype
English: Study YV25718 was conducted in previously untreated paediatric patients aged 3 to 17 years (51% < 12 years old) with HBeAg positive CHB and ALT > ULN but < 10 x ULN in two blood samples taken ≥ 14 days apart during the 6 months before the first dose of study drug.
Danish: YV25718 studiet blev gennemført i tidligere ubehandlede pædiatriske patienter i alderen 3 til 17 år (51% <12 år) med HBeAg-positiv kronisk hepatitis B og ALAT-værdier > øvre referencegrænse, men < 10x øvre referencegrænse i to blodprøver målt ved ≥ 14 dagsinterval under de 6 måneder før første dosis af lægemiddel.
English: P=0.0006 P=0.11 P=0.002
Danish: Lav viral belastning Høj viral belastning p=0,0006 p=0,11 p=0,002
English: At Week 48 of Pegasys treatment, a height or weight percentile decrease of more than 15 percentiles on the normative growth curves was observed in 6% of patients for height and 11% of patient for weight, whereas in the untreated group it was 2% of patients for height and 9% for weight.
Danish: I 6% af patienterne blev et fald i højden observeret og i 11% af patienterne et fald i vægt, mens der i den ubehandlede gruppe var 2% af patienterne i højden og 9% i vægt.
English: ● Inject the solution by gently pushing the plunger all the way down.
Danish: • Injicer opløsningen ved blidt at skubbe stemplet helt i bund.
English: ● Place the needle firmly on the tip of the syringe (4).
Danish: • Sæt kanylen fast på sprøjtens spids (4).
English: Vertigo, earache
Danish: Vertigo, øresmerter
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 June 2002
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: ● Inject the solution by gently pushing the plunger all the way down to the appropriate graduation.
Danish: • Injicer opløsningen ved blidt at skubbe stemplet ned til den passende mængde (ses udfra gradueringen).
English: • Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 36 weeks
Danish: • Pegasys 360 mikrogram/uge i 12 uger efterfulgt af 180 mikrogram/uge i yderligere 36 uger
English: Pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.
Danish: Under behandling med Pegasys er der rapporteret om lungesymptomer, inklusive dyspnø, lungeinfiltrater, pneumoni og pneumonitis.
English: During therapy with Pegasys +/- ribavirin lasting up to 48 weeks in patients aged 3 to 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Danish: Under Pegasys- +/- ribavirin-behandling i op til 48 uger var vægttab og væksthæmning almindeligt hos patienter mellem 3 og 17 år (se pkt.
English: * For HBeAg-positive patients: HBV DNA < 105 copies/ml For HBeAg-negative/anti-HBe-positive patients: HBV DNA < 2 x 104 copies/ml
Danish: * For HBeAg-positive patienter: HBV-DNA <105 kopier/ml
English: In 13 patients with ESRD requiring chronic HD, administration of Pegasys 135 mcg once weekly resulted in 34% lower peginterferon alfa-2a exposure than in patients with normal renal function.
Danish: Hos 13 patienter med terminal nyresygdom som kræver kronisk hæmolyse, der fik 135 mikrogram Pegasys én gang ugenligt havde 34% lavere peginterferon alfa-2a eksponering sammenlignet med patienter med normal nyrefunktion.
English: ● if you develop symptoms associated with depression (e.g. feelings of sadness, dejection, etc.) (see section 4).
Danish: ● hvis du får symptomer forbundet med depression (f.eks. er ked af det, føler dig nedtrykt osv.)
English: Hepatic failure, cholangitis, fatty liver
Danish: Leverinsufficiens, cholangitis, fedtlever
English: Decrease in ANC levels below 500 cells/mm3 was observed in 13% and 11% of patients receiving Pegasys monotherapy and combination therapy, respectively.
Danish: Der blev observeret fald i det absolutte neutrofilocyttal til under 500 celler/mm3 hos henholdsvis 13 % og 11 % af patienterne, som fik Pegasys-monoterapi eller kombinationsbehandling.
English: Optic neuropathy, papilloedema, retinal vascular disorder, retinopathy, corneal ulcer
Danish: Optisk neuropati, papilødem, retinal vaskulær lidelse, retinopati, sår på cornea
English: It is available in packs containing 1, 4 or 12 pre-filled pens.
Danish: Det findes i pakninger, der indeholder 1, 4 eller 12 fyldte penne.
English: Pegasys is presented as a solution for injection in a vial (1 ml).
Danish: Pegasys findes som injektionsvæske, opløsning i et hætteglas (1 ml).
English: HCV genotype 2 and 3
Danish: HCV-genotype 2 og 3
English: Serum concentrations of theophylline should be monitored and appropriate dose adjustments of theophylline made for patients taking theophylline and Pegasys concomitantly.
Danish: Hos patienter, som samtidigt tager theophyllin og Pegasys, skal serumkoncentrationerne af theophyllin kontrolleres, og theophyllindosis skal justeres.
English: Available in packs containing 1, 4 or 12 pre-filled pens.
Danish: Findes i pakninger, som indeholder 1, 4 eller 12 fyldte penne.
English: Duration of treatment - dual therapy with Pegasys and ribavirin The duration of combination therapy with ribavirin for CHC depends on viral genotype.
Danish: Behandlingsvarighed - to-stofsbehandling med Pegasys og ribavirin Behandlingsvarigheden af kombinationsbehandlingen med ribavirin ved kronisk hepatitis C afhænger af viral genotype.
English: Female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Danish: Kvindelige patienter i den fertile alder skal anvende sikker prævention under behandlingen og i 4 måneder efter, behandlingen er ophørt.
English: • Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 60 weeks
Danish: • Pegasys 360 mikrogram/uge i 12 uger efterfulgt af 180 mikrogram/uge i yderligere 60 uger
English: 135 or 180 micrograms peginterferon alfa-2a.
Danish: 180 mikrogram peginterferon alfa-2a.
English: Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Danish: Sygdomme i tænder og gummer, som kan medføre tab af tænder, er blevet rapporteret hos patienter, der får behandling med Pegasys, samtidigt med ribavirin.
English: INFORMATION IN BRAILLE pegasys 90 mcg
Danish: INFORMATION I BRAILLESKRIFT pegasys 90 mcg
English: Available in packs of 1 or 4 vials.
Danish: Foreligger i pakninger med 1 eller 4 hætteglas.
English: It is available in packs containing 1 or 4 single dose vials.
Danish: Det findes i pakninger, der indeholder 1 eller 4 enkeltdosis hætteglas.
English: Ribavirin, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine.
Danish: Dette kan muligvis føre til en akkumulering af 6-methylthio inosin-monofosfat (6-MTIMP), som har været forbundet med myelotoksicitet hos patienter behandletmed azathioprin.
English: Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that Pegasys has no effect on in vivo metabolic activity of cytochrome P450 3A4, 2C9, 2C19 and 2D6 isozymes.
Danish: Administration af 180 mikrogram Pegasys én gang ugentlig i 4 uger til raske mænd havde ingen effekt på farmakokinetikken af mephenytoin, dapson, debrisoquin og tolbutamid.