FrancophonIA/ELRC3.0 huggingface dataset:
English: Collect the necessary items before you begin: - a vial of PegIntron powder for injection; - an ampoule of water for injections solvent to prepare PegIntron injection; - a 1 ml syringe; - a long needle (for example 0.8  40 mm [21 gauge 1.5 inch]) to be used to add water for injections to the PegIntron powder vial; - a short needle (for example 0.3  13 mm [30 gauge 0.5 inch]) for the subcutaneous injection; - a cleansing swab.
Danish: Saml det nødvendige udstyr, før du begynder: - et hætteglas med PegIntron pulver til injektionsvæske - en ampul med solvens, vand til injektionsvæsker til at fremstille PegIntron-opløsningen, - en 1 ml sprøjte, - en lang kanyle (for eksempel 0,8  40 mm [21 gauge 1,5 tomme]) til brug for at tilføre vand til injektionsvæsker til PegIntron pulver hætteglasset, - en kort kanyle (for eksempel 0,3  13 mm [30 gauge 0,5 tomme]) til den subkutane injektion, - en renseserviet.
English: In these studies, the effects of multiple-dose regimens of peginterferon alfa-2b (PegIntron) were investigated in Hepatitis C subjects (1.5 mcg/week) or healthy subjects (1 mcg/week or 3 mcg/week) (Table 4).
Danish: I disse studier blev virkningen af multidosisregimer med peginterferon alfa-2b (PegIntron) undersøgt hos forsøgspersoner med hepatitis C (1,5 mikrogram/uge) og raske forsøgspersoner (1 mikrogram/uge eller 3 mikrogram/uge) (Tabel 4).
English: Following multiple dosing of PegIntron (1.0 microgram/kg subcutaneously administered every week for four weeks) the clearance of PegIntron is reduced by a mean of 17 % in patients with moderate renal impairment (creatinine clearance 30-49 ml/minute) and by a mean of 44 % in patients with severe renal impairment (creatinine clearance 15-29 ml/minute) compared to subjects with normal renal function.
Danish: Efter gentagne doser af PegIntron (1,0 mikrogram/kg indgivet subkutant hver uge i fire uger) reduceres clearance af PegIntron med gennemsnitlig 17 % hos patienter med moderat nedsat nyrefunktion (kreatininclearance 30-49 ml/minut) og med gennemsnitlig 44 % hos patienter med stærkt nedsat nyrefunktion (kreatininclearance 15-29 ml/minut) sammenlignet med personer med normal nyrefunktion.
English: SVR after treatment of chronic HCV with PegIntron (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 PegIntron (med eller uden ribavirin), i langtidsclearence af virus og giver afhjælpning af den hepatiske infektion og klinisk ”helbredelse” af kronisk hcv.
English: - have epilepsy, a condition that causes convulsions (seizures, or “fits”).
Danish: • har epilepsi, der forårsager kramper (anfald eller trækninger).
English: If week 12 HCV-RNA is positive and decreased ≥ 2log10 from baseline, then retest HCV-RNA at week 24 and if positive, patients to stop therapy.
Danish: Hvis hcv-RNA findes positivt i uge 12, og der er et fald på ≥ 2log10 fra baseline, skal der re-testes for hcv-RNA i uge 24, og hvis dette findes positivt, skal patienten stoppe behandlingen.
English: PegIntron should be administered as a subcutaneous injection.
Danish: PegIntron skal gives som subkutan injektion.
English: In patients with chronic hepatitis C that were on stable methadone maintenance therapy and naïve to peginterferon alfa-2b, addition of 1.5 microgram/kg/week of PegIntron subcutaneously for 4 weeks increased R-methadone AUC by approximately 15 % (95 % Cl for AUC ratio estimate 103 - 128 %).
Danish: Hos patienter med kronisk hepatitis C, der fik stabil methadon-vedligeholdelsesbehandling, og som var behandlingsnaive for peginterferon alfa-2b, øgede et tillæg af 1,5 mikrogram/kg/uge PegIntron subkutant i 4 uger R-methadon-AUC med ca. 15 % (95 % Cl for AUC-ratio estimat 103-128 %).
English: Patients with severe renal dysfunction (creatinine clearance 15-29 ml/minute) should have the starting dose of PegIntron reduced by 50 %.
Danish: Patienter med stærkt nedsat nyrefunktion (kreatininclearance 15-29 ml/minut) bør have initialdosis af PegIntron reduceret med 50 %.
English: The plasma half-life of PegIntron is prolonged compared with nonpegylated interferon alfa-2b.
Danish: Plasmahalveringstiden for PegIntron er forlænget i sammenligning med ikke-pegyleret interferon alfa-2b.
English: The data suggest that no alteration in PegIntron dosage is necessary based on advancing age.
Danish: Resultater tyder på, at det ikke er nødvendigt med dosisændring af PegIntron med stigende alder.
English: As with interferon alfa-2b, adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, receiving PegIntron therapy require close monitoring.
Danish: Som med interferon alfa-2b kræves tæt monitorering af voksne patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/eller tidligere eller nuværende arytmilidelser, der får PegIntron-behandling.
English: Aspartate aminotransferase (AST)
Danish: Aspartataminotransferase (ASAT)
English: The negative predictive value for sustained response in HCV/HIV co-infected patients treated with PegIntron in combination with ribavirin was 99 % (67/68; Study 1) (see section 5.1).
Danish: Den negative forudsigelige værdi for vedvarende respons hos hcv/hiv co-inficerede patienter, der blev behandlet med PegIntron i kombination med ribavirin, var 99 % (67/68; Undersøgelse 1) (se pkt.
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: PegIntron monotherapy dose reduction guidelines in adults
Danish: PegIntron monoterapi vejledninger for dosisreduktion hos voksne
English: Table 13 Sustained virological response based on genotype after PegIntron in combination with Ribavirin in HCV/HIV Co-infected patients Study 1
Danish: Tabel 13 Vedvarende virologisk respons efter PegIntron i kombination med Ribavirin hos patienter med samtidig infektion af hcv/hiv, baseret på genotype Forsøg 1
English: Table 2b Two-step dose reduction of PegIntron in combination therapy in adults First dose reduction to PegIntron 1 µg/kg
Danish: Tabel 2b To-trins-dosisreduktion af PegIntron i kombinationsbehandling hos voksne Første dosisreduktion til PegIntron 1 µg/kg
English: - Stand the vial upright and let any bubbles present in the solution rise to the top of the solution.
Danish: • Stil hætteglasset fra dig og lad alle boblerne i opløsningen stige op til overfladen.
English: PegIntron 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: PegIntron 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: Virological response by week 4 is defined as at least 1-log viral load decrease or undetectable levels of HCV-RNA.
Danish: Det virologiske respons i uge 4, defineres som et fald på mindst 1-log virusbelastning eller et ikke-detekterbart niveau af hcv-RNA.
English: Table 9 Sustained response rates with PegIntron + ribavirin (by ribavirin dose, genotype and viral load) HCV Genotype
Danish: Tabel 9 Vedvarende responsrater med PegIntron + ribavirin (efter ribavirindosis, genotype og virusmængde) hcv Genotype
English: - Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Danish: • Fjern kanylehætten uden at røre kanylen og hold sprøjten med kanylen i din hånd.
English: In a separate trial, 224 patients with genotype 2 or 3 received PegIntron, 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 et separat forsøg fik 224 patienter med genotype 2 eller 3 PegIntron, 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: PegIntron (1.5 µg/kg/ week) + ribavirin (800 mg)
Danish: PegIntron (1,5 µg/kg/ uge) + ribavirin (800 mg)
English: Predictability of response and non-response in HCV/HIV co-infection - Early virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
Danish: Forudsigelighed af respons og non-respons ved hcv/hiv co-infektion Tidlig virologisk respons i Uge 12, defineret som et 2 log viralt fald i load eller ikke-detekterbare niveauer af hcv-RNA, har vist sig at være forudsigeligt for et vedvarende respons.
English: Monotherapy with PegIntron and bitherapy with PegIntron and ribavirin Naïve patients
Danish: Monoterapi med PegIntron og 2-stofsbehandling med PegIntron og ribavirin Behandlingsnaive patienter
English: Table 7 Adverse reactions very commonly, commonly and uncommonly reported in the clinical trial in children and adolescent patients treated with PegIntron in combination with ribavirin
Danish: Tabel 7 Bivirkninger, der er meget almindelige, almindelige og ikke almindelige rapporteret i kliniske forsøg hos børn og unge behandlet med PegIntron i kombination med ribavirin.
English: Hepatitis B reactivation in HCV/HBV co-infected patients
Danish: Reaktivering af hepatitis B hos HCV/HBV co-inficerede patienter
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 (hcv-RNA positiv ved afslutningen på en 12 ugers behandling).
English: Patients were randomized to receive either PegIntron (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 PegIntron (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: Use the reconstituted solution (solution you prepared by adding water for injection to the PegIntron powder) immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Danish: Anvend den færdigt blandede opløsning (den opløsning, du forberedte ved tilsætning af vand til injektion til PegIntron pulver) straks eller inden for 24 timer ved opbevaring i køleskab (2 °C - 8 °C).
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: In children and adolescent patients receiving body surface area-adjusted dosing of PegIntron 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 PegIntron med 60 μg/m2/uge, forudses det logtransformerede 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: As monotherapy the PegIntron regimen is 0.5 or 1.0 g/kg/week.
Danish: Ved monoterapi er PegIntron-regimenet 0,5 eller 1,0 g/kg/uge.
English: In the PegIntron monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with PegIntron (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
Danish: I PegIntron monoterapiforsøget blev i alt 916 naive kroniske hepatitis C-patienter behandlet med PegIntron (0,5, 1,0 eller 1,5 mikrogram/kg/uge) i et år med en opfølgningsperiode på seks måneder.
English: After administering the dose, the PegIntron 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 PegIntron fyldt pen med en eventuel rest af opløsning heri og bortskaffes i henhold til lokale retningslinjer.
English: PegIntron - ampoule of solvent
Danish: PegIntron - ampul med solvens
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Danish: Forsøg 1 (RIBAVIC; P01017) var et randomiseret, multicenterforsøg, der omfattede 412 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med hiv.
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: - pulmonary fibrosis (scarring of the lungs).
Danish: • lungefibrose (dannelse af arvæv i lungerne).
English: Dose reduction of PegIntron 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 PegIntron 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: PegIntron/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 PegIntron, 1.5 micrograms/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Danish: PegIntron/ribavirin genbehandling af patienter, som ikke har responderet på tidligere behandling 2.293 patienter i et ikke sammenligningsforsøg, som havde moderat til svær fibrose, hvor tidligere behandling med kombinationen af alfa interferon/ribavirin var uden effekt, blev behandlet med PegIntron givet subkutant (1,5 mikrogram/kg/uge) i kombination med ribavirin baseret på kropsvægt.
English: Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Danish: Selvom hovedparten af dem kunne håndteres ved dosisreduktion, bør hæmatologiske parametre monitoreres tæt hos denne patientpopulation (se pkt.
English: PegIntron contains sucrose
Danish: PegIntron indeholder saccharose
English: A small volume is lost during preparation of PegIntron for injection when the dose is measured and injected.
Danish: Et lille volumen går tabt under tilberedningen af PegIntron til injektion, når dosen afmåles og injiceres.
English: Metabolism of theophylline is suppressed by inhibitory action of the product (PegIntron) on CYP1A2.
Danish: Theophyllins metabolisering hæmmes af PegIntrons hæmmende virkning på CYP1A2.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Danish: Forsøg 2 (P02080) var et randomiseret, enkelt centerforsøg, der omfattede 95 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med hiv.
English: Metabolism of thioridazine is suppressed by inhibitory action of the product (PegIntron) on CYP2D6.
Danish: Thioridazins metabolisering hæmmes af PegIntrons hæmmende virkning på CYP2D6.
English: Table 10 Virologic response at end of treatment, Sustained Virologic Response and relapse by HCV Genotype and viral load* PegIntron 1.5 g/kg once weekly plus Ribavirin 800-1,400 mg/day End of treatment response
Danish: Tabel 10 Virologisk respons ved afsluttet behandling, vedvarende virologisk respons og tilbagefald efter hcv-Genotype og virusmængde* PegIntron 1,5 g/kg en gang ugentlig plus ribavirin 800-1.400 mg/dag Respons ved afsluttet behandling
English: Response at treatment week
Danish: Respons ved behandlings -uge
English: Side effects of unknown frequency (frequency cannot be estimated from the available data): - pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells).
Danish: • pure red cell aplasia (en tilstand, hvor kroppen er ophørt med eller har nedsat produktionen af røde blodlegemer).
English: - This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (HCV genotype and viral load).
Danish: (især fibrose), co-morbiditet, der kan have en negativ effekt på sygdomsudviklingen (såsom hiv co infektion), såvel som prognostiske faktorer på respons (hcv-genotype og virusbelastning).
English: - Clean the rubber top of the vial with a cleansing swab.
Danish: • Rens gummimembranen med en renseserviet.
English: In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received PegIntron, 1.5 micrograms/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Danish: I et ikke-komparativt studie fik 235 patienter med genotype 1 og lav virusbelastning (< 600.000 IE/ml) PegIntron 1,5 mikrogram/kg subkutant en gang ugentlig i kombination med vægtjusteret ribavarin.
English: LVL (≤600,000 IU/ml)
Danish: LVL (≤600.000 IE/ml)
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: Additional adverse reactions reported in more than 25 % of subjects included nausea, chills, insomnia, anaemia, pyrexia, myalgia, asthenia, pain, alopecia, anorexia, weight decreased, depression, rash and irritability.
Danish: Yderligere bivirkninger, der er rapporteret hos mere end 25 % af personerne, omfattede kvalme, kuldegysninger, søvnløshed, anæmi, feber, myalgi, asteni, smerte, alopeci, anoreksi, vægttab, depression, udslæt og irritabilitet.
English: - Dissolve the entire contents by swirling the PegIntron vial with a gentle rotary motion leaving the needle and attached syringe in the vial.
Danish: • Opløs indholdet fuldstændigt ved at svinge PegIntron-hætteglasset med en rolig, roterende bevægelse, mens kanylen og den påsatte sprøjte stadig sidder i hætteglasset.
English: Be sure the tip of needle is in the PegIntron reconstituted solution.
Danish: Se efter, at spidsen af kanylen er i den færdigtilberedte PegIntron-opløsning.
English: The following treatment-related adverse reactions were reported in the study in children and adolescent patients treated with PegIntron in combination with ribavirin.
Danish: Følgende behandlingsrelaterede bivirkninger blev rapporteret i forsøgene hos børn og unge behandlet med PegIntron i kombination med ribavirin.
English: - are being treated with telbivudine (see section “Other medicines and PegIntron”).
Danish: • er i behandling med telbivudin (se punktet "Brug af anden medicin sammen med PegIntron").
English: - Remove the syringe from the wrapping and do not touch the tip of the syringe.
Danish: • Tag sprøjten ud af emballagen og rør ikke ved spidsen af sprøjten.
English: PegIntron combination therapy (bitherapy or tritherapy) Bitherapy (PegIntron with ribavirin): applies to all adult and paediatric patients 3 years of age and older.
Danish: PegIntron kombinationsbehandling (2-stofs- eller 3-stofsbehandling) 2-stofsbehandling (PegIntron med ribavirin): Kan anvendes til alle voksne og pædiatriske patienter i alderen tre år og ældre.
English: Patients were randomized to receive either PegIntron (100 or 150 µg/week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Danish: Patienterne blev randomiseret til enten at modtage PegIntron (100 eller 150 μg/uge baseret på vægt) plus ribavirin (800-1.200 mg/dag baseret på vægt) eller interferon alfa-2b (3 MIE TIW) plus ribavirin (800-1.200 mg/dag baseret på vægt).
English: Table 3a Dose modification guidelines for PegIntron monotherapy in adults based on laboratory parameters
Danish: Tabel 3a Retningslinjer for dosisjustering for PegIntron-monoterapi hos voksne, baseret på laboratorieparametre Laboratorieværdier
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µl.
Danish: Blandt patienter, der er co-inficeret med hcv/hiv, er der begrænsede tilgængelige effekt- og sikkerhedsdata for patienter med CD4-tal under 200 celler/μl (N = 25).
English: Please refer to the respective SmPCs of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with PegIntron in combination with ribavirin.
Danish: For de antiretrovirale lægemidler, der skal tages samtidig med hcv-behandling, henvises der til disses respektive SPCer for kendskab og håndtering af toksicitet, der er specifik for det enkelte produkt samt potentialet for overlappende toksiciteter med PegIntron i kombination med ribavirin.
English: Using a sterilised injection syringe and injection needle, 0.7 ml of water for injections is injected into the vial of PegIntron.
Danish: Ved hjælp af en steril injektionssprøjte og kanyle injiceres 0,7 ml vand til injektionsvæsker, i hætteglasset med PegIntron.
English: Table 3c Reduced PegIntron dose (0.5 g/kg) for the 1.0 g/kg monotherapy regimen in adults Body weight (kg)
Danish: Tabel 3c - Reduceret PegIntron-dosis (0,5 µg/kg) for 1,0 g/kg monoterapiregimenet hos voksne Legemsvægt (kg)
English: Co-administration of theophylline with the product (PegIntron) may increase the blood concentrations of theophylline.
Danish: Samtidig administration af theophyllin og PegIntron kan øge koncentrationen af theophyllin i blodet.
English: Co-administration of thioridazine with the product (PegIntron) may increase the blood concentrations of thioridazine.
Danish: Samtidig administration af thioridazin og PegIntron kan øge koncentrationen af thioridazin i blodet.