FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the use of zidovudine with this medicine and ribavirin combination therapy is not recommended.
Danish: Derfor anbefales anvendelse af zidovudin sammen med dette lægemiddel og ribavirin-kombinationsbehandling ikke.
English: Metabolism of other medicines in the liver may be suppressed.
Danish: Metabolisering af disse lægemidler i leveren kan være hæmmet.
English: Unknown frequency side effects (frequency cannot be estimated from the available data): - Wanting to harm others.
Danish: Bivirkninger med ukendt hyppighed (hyppigheden kan ikke vurderes ud fra forhåndenværende data):
English: The use of this medicine in children and adolescents with existence of or history of severe psychiatric conditions is not allowed (see section “Do not use PegIntron” above).
Danish: Brugen af dette lægemiddel er ikke tilladt hos børn og unge med eksisterende eller tidligere svære psykiske problemer (se afsnittet "Brug ikke PegIntron" ovenfor).
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Danish: Hcv-genotype og baseline-virusmængde er prognostiske faktorer, som er kendt for at påvirke responsrater.
English: Patients may self-inject PegIntron if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Patienterne kan selv injicere PegIntron, hvis lægen beslutter, at det er hensigtsmæssigt og med opfølgning hos lægen efter behov.
English: Table 5 Precautions for co-administration (PegIntron should be administered with care when co-administered with the following medicines)
Danish: Tabel 5 Forholdsregler ved samtidig administration (PegIntron skal administreres med forsigtighed, når det administreres sammen med følgende lægemidler) Lægemiddel
English: Ribavirin capsules are to be administered orally each day in two divided doses with food (morning and evening).
Danish: Ribavirin-kapsler skal indtages oralt hver dag fordelt på to doser samtidig med et måltid (morgen og aften).
English: While changes in laboratory values were observed in some patients treated with PegIntron used in combination with ribavirin in the clinical trial, values returned to baseline levels within a few weeks after the end of therapy.
Danish: Selv om der blev observeret ændringer i laboratorieværdier hos nogle patienter behandlet med PegIntron i kombination med ribavirin i kliniske forsøg, vendte værdierne tilbage til baselineniveau inden for et par uger efter afslutningen af behandlingen.
English: The safety and efficacy of PegIntron therapy has not been evaluated in patients with severe hepatic dysfunction, therefore PegIntron must not be used for these patients.
Danish: Sikkerhed og effekt ved PegIntron-behandling er ikke blevet vurderet hos patienter med alvorligt nedsat leverfunktion, derfor må PegIntron ikke anvendes til disse patienter.
English: - loss of consciousness has occurred very rarely with alpha interferons, mostly in elderly patients treated at high doses.
Danish: • Tab af bevidstheden er set i meget sjældne tilfælde ved alfa interferoner, oftest hos ældre patienter behandlet med høje doser.
English: PegIntron increases the risk of hepatic decompensation and death in patients with cirrhosis.
Danish: PegIntron øger risikoen for leverdekompensation og død hos patienter med cirrose.
English: Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking PegIntron in combination with ribavirin.
Danish: Den yderste forsigtighed skal udvises for at undgå graviditet hos kvindelige patienter eller hos partnere til mandlige patienter, der får PegIntron i kombination med ribavirin.
English: PegIntron Cmax and AUC measurements increase in a dose-related manner.
Danish: PegIntron Cmax og AUC målinger stiger på en dosis-relateret måde.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of PegIntron therapy.
Danish: Hjertearytmier (primært supraventrikulære) responderer sædvanligvis på konventionel behandling, men kan kræve seponering af PegIntron.
English: Adverse events not observed in clinical trials were not seen in toxicity studies in monkeys.
Danish: Bivirkninger, der ikke sås i kliniske forsøg, blev ikke set i toksicitetsforsøg hos aber.
English: - Combination of PegIntron with telbivudine.
Danish: - PegIntron i kombination med telbivudin.
English: There were some cases of more severe neutropenia in patients treated with the recommended doses of PegIntron in combination with ribavirin (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]).
Danish: Der var nogle tilfælde af mere alvorlig neutropeni hos patienter behandlet med de anbefalede doser af PegIntron i kombination med ribavirin (WHO grad 3: 39 af 186 [21 %]; og WHO grad 4: 13 af 186 [7 %]).
English: The potential interaction of peginterferon alfa-2b (PegIntron) on substrates of metabolic enzymes was evaluated in 3 multiple-dose clinical pharmacology studies.
Danish: Den potentielle interaktion mellem peginterferon alfa-2b (PegIntron) og substrater for metaboliske enzymer blev vurderet i 3 klinisk farmakologiske multidosis-studier.
English: The clinical incidence of neutralising factors in patients who received PegIntron 0.5 micrograms/kg is 1.1 %.
Danish: Den kliniske forekomst af neutraliserende faktorer hos patienter, der fik PegIntron 0,5 mikrogram/kg, er 1,1 %.
English: Periodic visual examinations are recommended during PegIntron therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Danish: Regelmæssige synsundersøgelser anbefales under PegIntron-behandling, især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
English: The use of PegIntron in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Danish: Anvendelsen af PegIntron i kombination med ribavirin havde ingen observerbar negativ indvirkning på kontrollen af hiv-viræmi under behandling eller opfølgning.
English: Water for injection and PegIntron powder are provided in separate ampoules.
Danish: Vand til injektion og PegIntron-pulver leveres i separate emballager.
English: 3 was observed in 4 % (8/194) of patients receiving PegIntron in combination with ribavirin.
Danish: 3 blev også observeret hos 4 % (8/194) af de patienter, der fik PegIntron i kombination med ribavirin.
English: The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from PegIntron by metabolism in vivo has been demonstrated in preclinical acute and subchronic toxicity studies in rodents and monkeys, standard embryo-foetal development studies and in in vitro mutagenicity assays.
Danish: Den relative non-toksicitet af monomethoxy-polyethylenglycol (mPEG), som frigøres fra PegIntron ved metabolisering in vivo, er blevet påvist i prækliniske akutte og subkroniske toksicitetsforsøg hos gnavere og aber, standard embryofoetale udviklingsforsøg og i in vitro mutagenicitetsforsøg.
English: Body weight(kg)
Danish: Legemsvægt (kg)
English: Reduce PegIntron to one-half dose if:
Danish: Reducer PegIntron til halv dosis, hvis:
English: - Do not shake, but gently turn the vial upside down until any powder at the top of the vial is dissolved.
Danish: • Omryst ikke, men vend hætteglasset roligt op og ned, indtil alt pulver i toppen af hætteglasset er opløst.
English: Discontinuation of PegIntron should be considered in patients who develop new or worsening ophthalmological disorders.
Danish: Seponering af PegIntron bør overvejes hos patienter, der udvikler nye eller forværrede oftalmologiske forstyrrelser.
English: PegIntron pre-filled pen is to be removed from the refrigerator before administration to allow the solvent to reach room temperature (not more than 25°C).
Danish: PegIntron fyldt pen bør fjernes fra køleskabet før indgift for at lade solvens nå stuetemperatur (ikke over 25 C).
English: In the presence of thyroid dysfunction, PegIntron treatment may be continued if TSH levels can be maintained in the normal range by medicine.
Danish: Ved tilstedeværelse af nedsat thyroideafunktion kan PegIntron-behandling fortsættes, hvis TSH værdier kan bibeholdes i normalområdet med medicin.
English: The pharmacokinetics of PegIntron following a single subcutaneous dose of 1.0 microgram/kg were not affected by age.
Danish: Farmakokinetikken for PegIntron efter en enkelt subkutan dosis på 1,0 mikrogram/kg var ikke påvirket af alder.
English: Concomitant administration of peginterferon alfa-2b (PegIntron) with caffeine or desipramine modestly increased the exposure of caffeine and desipramine.
Danish: Samtidig administration af peginterferon alfa-2b (PegIntron) og caffein eller desipramin øger i beskeden grad eksponeringen for caffein og desipramin.
English: Prepare the dose by adding water for injection to PegIntron powder just before you intend to inject it and use it immediately.
Danish: Tilbered dosis ved at tilsætte vand til injektion til PegIntron-pulver umiddelbart før du planlægger at indsprøjte den og brug den straks.
English: Description of selected adverse reactions in children and adolescents Most of the changes in laboratory values in the PegIntron/ribavirin clinical trial were mild or moderate.
Danish: Beskrivelse af udvalgte bivirkninger hos børn og unge De fleste af ændringerne i laboratorieværdierne for de kliniske forsøg med PegIntron/ribavirin var milde eller moderate.
English: - Remove the protective cap from the PegIntron vial.
Danish: • Fjern beskyttelseslåget fra PegIntron-hætteglasset.
English: PegIntron is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
Danish: PegIntron er et velkarakteriseret polyethylenglycol-modificeret (“pegyleret”) derivat af interferon alfa2b og består hovedsageligt af monopegylerede arter.
English: Paediatric population PegIntron can be used in combination with ribavirin in paediatric patients 3 years of age and older.
Danish: Pædiatrisk population PegIntron kan anvendes i kombination med ribavirin hos pædiatriske patienter i alderen 3 år og ældre.
English: Subjects treated with PegIntron showed mild dose-related elevations in body temperature.
Danish: Personer behandlet med PegIntron viste lette dosisrelaterede stigninger i legemstemperatur.
English: Determine TSH levels if, during the course of therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Danish: TSH-værdier bør bestemmes, hvis en patient under behandlingsforløbet udvikler symptomer, der stemmer overens med mulig nedsat thyroideafunktion.
English: • Remove the yellow paper from the needle cap before attaching the needle ("Push-On Needle") to the pre-filled pen (see Figure 5),
Danish: • Fjern den gule papirflig fra kanylehætten, før kanylen ("Push-On Needle") sættes på den fyldte pen (se Figur 5)
English: This study showed that PegIntron was superior to interferon alfa-2b (Table 8).
Danish: Dette studie viste, at PegIntron var bedre end interferon alfa-2b (Tabel 8).
English: Adequate hydration must be maintained in patients undergoing PegIntron therapy since hypotension related to fluid depletion has been seen in some patients treated with alpha interferons.
Danish: Tilstrækkelig hydrering skal opretholdes hos patienter, der får PegIntron-behandling, da hypotension relateret til væskemangel er observeret hos nogle patienter behandlet med alfa interferoner.
English: - Break off the top of the ampoule of solvent.
Danish: • Bræk toppen af ampullen med solvens.
English: The dose of PegIntron is determined by a calculation accounting for both height and weight.
Danish: PegIntron-dosis beregnes ud fra både højde og vægt.
English: These criteria were used in the protocol: If week 12 HCV-RNA is positive and < 2log10 decrease from baseline, patients to stop therapy.
Danish: Disse kriterier blev anvendt i protokollen: Hvis hcv-RNA findes positivt i uge 12, og der er et fald på < 2log10 fra baseline, skal patienterne stoppe behandlingen.
English: As with all interferons, discontinue treatment with PegIntron in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Danish: Som ved alle interferoner seponeres PegIntron hos patienter, der udvikler forlængede koagulationsmarkører, hvilket kan være tegn på leversvigt.
English: - have thyroid disease that is not well controlled with medicines.
Danish: • har en skjoldbruskkirtelsygdom, der ikke er velkontrolleret med medicin.
English: Use in adults - PegIntron in combination treatment This medicine, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram per kilogram of body weight once a week.
Danish: Brug hos voksne - PegIntron i kombinationsbehandling Når dette lægemiddel anvendes sammen med ribavirin-kapsler, gives det sædvanligvis i en dosis på 1,5 mikrogram per kilo legemsvægt en gang om ugen.
English: If such a reaction develops during treatment with PegIntron, discontinue treatment and institute appropriate medical therapy immediately.
Danish: Hvis en sådan reaktion udvikles under behandling med PegIntron, skal behandlingen seponeres og passende behandling omgående iværksættes.
English: dizziness), decrease in certain white blood cells (that makes you more susceptible to different infections), - pain in joints and muscles, muscle and bone pain.
Danish: nedsat antal af bestemte hvide blodlegemer (som gør dig mere modtagelig over for forskellige infektioner), - smerter i led og muskler, muskel- og knoglesmerter.
English: During combination therapy for up to 48 weeks with PegIntron and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Danish: Ved kombinationsbehandling i op til 48 uger med PegIntron og ribavirin blev der observeret væksthæmning, som medførte reduceret højde hos nogle patienter (se pkt.
English: Do not use PegIntron
Danish: Tag ikke PegIntron
English: • Lay the pre-filled pen on a flat clean surface and wait until it reaches room temperature (but not more than 25
Danish: • Læg den fyldte pen på en plan, ren overflade og vent, til den får stuetemperatur (men ikke over
English: NR: Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Danish: NR: Ikke-responderende defineres som serum/plasma-hcv-RNA-positive ved afslutning af mindst 12 ugers behandling.
English: Multiple-dose pharmacokinetic properties for PegIntron and ribavirin (capsules and oral solution) in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Danish: Flerdosis farmakokinetiske egenskaber for PegIntron og ribavirin (kapsler og oral opløsning) hos børn og unge patienter med kronisk hepatitis C er blevet evalueret i et klinisk forsøg.
English: PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Danish: PegIntron 1,5 mikrogram/kg/uge i kombination med ribavirin kapsler.
English: Table 8 Sustained virological response (% patients HCV negative) PegIntron monotherapy
Danish: Tabel 8 Vedvarende virologisk respons (% patienter hcv-negative) PegIntron monoterapi
English: The negative predictive value for sustained response in patients treated with PegIntron in monotherapy was 98 %.
Danish: Den negative prædiktive værdi for vedvarende respons hos patienter behandlet med PegIntron i monoterapi var 98 %.
English: Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of PegIntron in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Danish: På grund af meddelelser om at interferon alfa kan forværre tilstedeværende psoriasissygdom og sarkoidose, kan brug af PegIntron til patienter med psoriasis eller sarkoidose kun anbefales, hvis den potentielle gavnlige effekt retfærdiggør den mulige risiko.
English: PegIntron monotherapy was not studied in HCV/HIV co-infected patients.
Danish: PegIntron monoterapi blev ikke undersøgt i hcv/hiv co-inficerede patienter.
English: Data from elderly patients treated with a single dose of PegIntron suggest no alteration in PegIntron dose is necessary based on age (see section 5.2).
Danish: Resultater fra ældre patienter behandlet med en enkelt dosis PegIntron tyder på, at ingen ændring i PegIntron dosis er nødvendig på basis af alder (se pkt.
English: When patients are administered PegIntron with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin (Table 5).
Danish: Når patienterne får PegIntron sammen med medicin, der metaboliseres af CYP1A2 eller CYP2D6, er det ikke sandsynligt, at faldet i CYP-aktivitet har klinisk indvirkning, undtagen med medicin, der har en snæver terapeutisk margin (Tabel 5).
English: Dose modification guidelines for adult patients who use PegIntron monotherapy are shown in Table 3a.
Danish: Retningslinjer for dosisjustering hos voksne patienter, som anvender PegIntron monoterapi, fremgår af Tabel 3a.
English: - Insert the needle in the ampoule of solvent and withdraw the total amount of solvent.
Danish: • Indfør kanylen i ampullen med solvens og træk hele mængden af solvens op.
English: - Tap the top of the ampoule of solvent gently to make sure that all the liquid is at the bottom of the ampoule.
Danish: • Bank let på toppen af ampullen med solvens for at sikre, at al væsken er i bunden af ampullen.
English: Following single doses of PegIntron between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Danish: Efter enkeltdoser af PegIntron mellem 0,25 og 2,0 mikrogram/kg/uge, blev serum neopterin-koncentrationen øget på en dosisafhængig måde.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week PegIntron and subjects ≥ 75 kg received 150 µg/week PegIntron.
Danish: a: p værdi baseret på Cochran-Mantel Haenszel Chi square test. b: P-værdi baseret på chi-square test. c: forsøgspersoner < 75 kg fik 100 µg/uge PegIntron og forsøgspersoner ≥ 75 kg fik 150 µg/uge PegIntron.
English: A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (PegIntron) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Danish: Der sås ingen klinisk signifikant farmakokinetisk interaktion mellem peginterferon alfa-2b (PegIntron) og tolbutamid, midazolam eller dapson; dosisjustering er derfor ikke nødvendig, når peginterferon alfa-2b (PegIntron) administreres sammen med lægemidler, der metaboliseres af CYP2C9, CYP3A4 og N-acetyltransferase.
English: There are no apparent age-related effects on the pharmacokinetics of PegIntron.
Danish: Der er ingen påviselige aldersrelaterede virkninger på farmakokinetikken for PegIntron.
English: Caution should be used when adding PegIntron and ribavirin to HAART therapy (see ribavirin SmPC).
Danish: Forsigtighed bør udvises, når PegIntron og ribavirin adderes til HAART terapi (se ribavirin SPC).
English: PegIntron should be used with caution in patients with moderate to severe renal impairment.
Danish: PegIntron bør anvendes med forsigtighed hos patienter med moderat til kraftig nedsættelse af nyrefunktionen.
English: If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Danish: Hvis psykiatriske symptomer vedvarer eller forværres, eller hvis selvmords- eller drabstanker identificeres, anbefales det, at PegIntron seponeres, og at patienten følges med passende psykiatrisk intervention.
English: At the PegIntron 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml, and in patients > 40 years old.
Danish: Ved PegIntron 1,5 μg/kg plus ribavirin-dosen, var den vedvarende virologiske responsrate lavere hos patienter med cirrose, end patienter med normal ALAT-værdi, hos patienter med en baseline virusbelastning > 600.000 IE/ml, og hos patienter > 40 år.
English: Fatigue, alopecia, pruritus, nausea, anorexia, weight decreased, irritability and insomnia occur at a notably lower rate in patients treated with PegIntron 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 PegIntron monoterapi sammenlignet med dem, der behandledes med kombinationsbehandling (se Tabel 6).
English: PegIntron should be administered as a once weekly subcutaneous injection.
Danish: PegIntron bør indgives som en ugentlig subkutan injektion.
English: Two trials have been conducted in patients co-infected with HIV and HCV.
Danish: Der er udført to forsøg hos patienter med samtidig infektion af hcv og hiv.
English: PegIntron monotherapy - Adults
Danish: PegIntron-monoterapi - Voksne
English: Prior to initiation of PegIntron therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Danish: Inden initiering af PegIntron-behandling skal TSH-niveauet evalueres, og mulige thyroideaabnormaliteter detekteret på dette tidspunkt skal behandles med konventionel behandling.
English: The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
Danish: Den 6 måneders behandlingsvarighed i dette forsøg blev tolereret bedre end et års behandling i det grundlæggende kombinationsforsøg; seponering hos 5 % versus 14 %, dosisjustering hos 18 % versus
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm 3 was observed in 4 %
Danish: 5.1) blev der set et fald i absolut neutrofil-tal til under 500 celler/mm
English: In this trial, the combination of PegIntron (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 8), particularly in patients infected with Genotype 1 (Table 9).
Danish: I dette forsøg var kombinationen af PegIntron (1,5 mikrogram/kg/uge) og ribavirin signifikant mere effektivt end kombinationen af interferon alfa-2b og ribavirin (Tabel 8), især hos patienter inficeret med genotype 1 (Tabel 9).
English: In vitro and in vivo studies suggest that the biological activity of PegIntron is derived from its interferon alfa-2b moiety.
Danish: In vitro og in vivo forsøg tyder på, at den biologiske aktivitet af PegIntron stammer fra dets interferon alfa2b-del.
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of PegIntron 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 PegIntron og ribavirin som kombinationbehandling, var dosisændring nødvendig hos 25 % af patienterne, hyppigst på grund af anæmi, neutropeni og vægttab.
English: - If you are also being treated for HIV (see section “Other medicines and PegIntron”).
Danish: - Hvis du også behandles for hiv (se afsnittet ”Brug af anden medicin sammen med PegIntron”).
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.