FrancophonIA/ELRC3.0 huggingface dataset:
English: Contusion class effect of interferon-alfa containing products - reported with standard interferon therapy in adult and paediatric patients; with PegIntron reported in adult patients.
Danish: Kontusion klasseeffekt for lægemidler som indeholder interferon-alfa - rapporteret ved standard interferon-behandling af voksne og pædiatriske patienter; med PegIntron er det rapporteret for voksne patienter.
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of PegIntron and ribavirin.
Danish: Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med kombinationen af PegIntron og ribavirin.
English: PegIntron vials are for single use only.
Danish: PegIntron hætteglas er kun til engangsbrug.
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of PegIntron with ribavirin needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Danish: Populationen, der var tilmeldt, bestod hovedsageligt af børn med mild til moderat hepatitis C. På grund af mangel på data for børn med svær progression af sygdommen, og potentialet for uønskede virkninger, skal fordel/risiko for kombinationen af PegIntron og ribavirin nøje overvejes i denne population (se pkt.
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Danish: Vigtige behandlingsrelaterede bivirkninger, som opstod hos denne patientpopulation, var nervøsitet (8 %), aggression (3 %), vrede (2%), depression / trykket stemning (4 %) og hypotyroidisme (3 %); 5 forsøgspersoner fik levothyroxin-behandling for hypotyroidisme / forhøjet TSH.
English: In general, patients infected with genotype 4 are considered harder to treat and limited study data (n=66) indicate they are compatible with a duration of treatment with bitherapy as for genotype 1.
Danish: Patienter inficeret med genotype 4 betragtes generelt som sværere at behandle, og begrænsede undersøgelsesresultater (n=66) tyder på, at de er forenelige med en behandlingsvarighed med 2stofsbehandling som for genotype 1.
English: As for all parenteral medicinal products, the reconstituted solution is to be inspected visually prior to administration.
Danish: Som ved alle parenterale lægemidler skal den tilberedte opløsning inspiceres visuelt før indgift.
English: The recommended dose of PegIntron is 60 g/m2/week subcutaneously in combination with ribavirin 15 mg/kg/day orally in two divided doses with food (morning and evening).
Danish: Den anbefalede dosis for PegIntron er 60 µg/m2/uge subkutant i kombination med 15 mg/kg/dag ribavirin oralt fordelt på to doser sammen med et måltid (morgen og aften).
English: No pharmacokinetic interactions were noted between PegIntron and ribavirin in a multiple-dose pharmacokinetic study.
Danish: Der sås ingen farmakokinetiske interaktioner mellem PegIntron og ribavirin i en flerdosis farmakokinetisk undersøgelse.
English: Approximately 21 % of children treated with PegIntron/ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Danish: Omtrent 21 % af børn behandlet med kombinationsbehandling med PegIntron/ribavirin fik øget thyroideastimulerende hormon (TSH).
English: In the PegIntron monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of PegIntron than by either 1.0 microgram/kg of PegIntron once weekly or 3 MIU of interferon alfa-2b three times a week.
Danish: I PegIntron monoterapiforsøget var livskvaliteten generelt mindre påvirket ved 0,5 mikrogram/kg PegIntron end ved enten 1,0 mikrogram/kg PegIntron en gang om ugen eller 3 MIE interferon alfa-2b tre gange om ugen.
English: Dose reduction of PegIntron in adults may be accomplished by reducing the prescribed volume or by utilizing a lower dose strength as shown in Table 2b.
Danish: Dosisreduktion af PegIntron hos voksne kan ske ved at reducere det ordinerede volumen eller ved at bruge en lavere styrke, som anført i Tabel 2b.
English: The reconstituted solution should be clear and colourless.
Danish: Den rekonstituerede opløsning bør være klar og farveløs.
English: Interferon neutralising factor assays were performed on serum samples of patients who received PegIntron in the clinical trial.
Danish: Analyser af interferonneutraliserende faktor blev udført på serum-prøver fra patienter, som fik PegIntron i det kliniske forsøg.
English: Discontinue PegIntron if:
Danish: Seponer PegIntron, hvis:
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with PegIntron (1.5 µg/kg)/ribavirin combination therapy resulted in a higher sustained virologic response rate compared to PegIntron 1 µg/kg dose.
Danish: Hos patienter med afroamerikansk oprindelse (som er kendt for at være en dårlig prognostisk faktor for hcv-udryddelse), medførte en behandling med PegIntron (1,5 μg/kg)/ribavirin kombinationsbehandling højere vedvarende virologisk responsrate sammenlignet med PegIntron 1 μg/kg dosis.
English: For patients on PegIntron monotherapy: refer to monotherapy dose reduction guidelines section for dose reduction.
Danish: For patienter i PegIntron monoterapi: Der henvises til afsnittet om retningslinjer for dosisreduktion ved monoterapi.
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during PegIntron therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Danish: Psykiatriske sygdomme og sygdomme i centralnervesystemet (CNS) Alvorlig CNS-påvirkning, særlig depression, selvmordstanker og selvmordsforsøg, er set hos nogle patienter under PegIntron-behandling, og selv efter behandlingsophør især under 6-måneders opfølgningsperioden.
English: - Inject the solvent SLOWLY, aiming the stream of liquid at the glass wall of the vial.
Danish: • Tilsæt LANGSOMT solvens, ved at rette væskestrømmen mod glasvæggen i hætteglasset.
English: Neutrophil and white cell count reductions at the end of week 4 correlated with the dose of PegIntron.
Danish: Reduktionen i antallet af neutrofiler og leukocytter ved slutningen af uge 4 korrelerede til dosis af PegIntron.
English: Only 5 children and adolescents with Genotype 4 were treated in the PegIntron/ribavirin clinical trial.
Danish: Kun 5 børn og unge med Genotype 4 blev behandlet i kliniske forsøg med PegIntron/ribavirin.
English: In a single dose study (1.0 microgram/kg) in patients with impaired renal function, Cmax, AUC, and half-life increased in relation to the degree of renal impairment.
Danish: I en enkeltdosisforsøg (1,0 mikrogram/kg) hos patienter med nedsat nyrefunktion, steg Cmax, AUC og halveringstiden i forhold til graden af nyrefunktionsforringelsen.
English: At the end of 24 weeks post-treatment follow-up, mean decrease from baseline in weight and height percentiles were still of 3 percentiles and 7 percentiles respectively, and 20 % of the children continued to have inhibited growth (growth velocity < 3
Danish: Ved udgangen af 24 ugers opfølgningen efter behandling var den gennemsnitlige reduktion fra baseline i vægt og højde percentiler stadig henholdsvis 3 percentiler og 7 percentiler, og 20 % af børnene fortsatte med at have hæmmet vækst (væksthastighed < 3. percentil).
English: Therefore, the combination of PegIntron with telbivudine is contraindicated (see section 4.3).
Danish: Kombination af PegIntron og telbivudin er derfor kontraindiceret (se pkt.
English: However, renal elimination may account for a minority (approximately 30 %) of PegIntron apparent clearance.
Danish: Renal elimination kan imidlertid forklare en mindre del (cirka 30 %) af den tilsyneladende clearance af PegIntron.
English: Limited safety data (N= 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Danish: Begrænsede sikkerhedsdata er tilgængelige (N = 25) hos coinficerede patienter med CD4+-celletællinger < 200/μl (se pkt.
English: - are infected with both Human Immunodeficiency Virus (HIV-positive) and Hepatitis C Virus (HCV) and are being treated with an anti-HIV medicine(s) - [nucleoside reverse transcriptase inhibitor (NRTI), and/or highly active anti-retroviral therapy (HAART)].
Danish: • er smittet med både humant immundefekt-virus (hiv-positiv) og hepatitis C-virus (hcv), og bliver behandlet med et anti-hiv lægemiddel - [nukleosid revers transkriptasehæmmer (NRTI) og/eller høj-aktiv anti-retroviral terapi (HAART)].
English: Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see section “How to self-inject PegIntron”).
Danish: Detaljerede vejledninger for subkutan anvendelse er angivet i slutningen af denne indlægsseddel (se pkt ”Hvordan du selv indsprøjter PegIntron”).
English: In a clinical trial, approximately 1.2 % of patients treated with PegIntron or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Danish: I et klinisk forsøg rapporterede cirka 1,2 % af patienter behandlet med PegIntron eller interferon alfa2b i kombination med ribavirin livstruende psykiatriske bivirkninger under behandling.
English: Studies with other interferons have demonstrated species specificity.
Danish: Forsøg med andre interferoner har vist artsspecificitet.
English: Tritherapy (PegIntron with ribavirin and boceprevir): applies to adult patients with genotype 1 CHC.
Danish: 3-stofsbehandling (PegIntron med ribavirin og boceprevir): Kan anvendes til voksne patienter med genotype 1-CHC.
English: The safety and efficacy of PegIntron alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Danish: Sikkerheden og effekten af PegIntron alene eller i kombination med ribavirin ved behandling af hepatitis C hos lever- eller andre organtransplanterede er ikke blevet undersøgt.
English: However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with PegIntron or interferon alfa-2b.
Danish: Responsraterne i dette forsøg blev imidlertid vist også at være afhængige af dosis af ribavirin indgivet i kombination med PegIntron eller interferon alfa-2b.
English: Haematological abnormalities were more frequently reported in patients receiving PegIntron in combination with ribavirin when compared to patients receiving interferon alfa-2b in combination with ribavirin.
Danish: Hæmatologiske anomalier blev rapporteret mere hyppigt hos patienter, der modtog PegIntron i kombination med ribavirin end hos patienter, der modtog interferon alfa-2b i kombination med ribavirin.
English: Important information about some of the ingredients of PegIntron 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 PegIntron Bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galaktose malabsorption eller sucrase-isomaltasemangel.
English: Reproduction studies of PegIntron have not been performed.
Danish: Der er ikke foretaget reproduktionsforsøg med PegIntron.
English: In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: - PegIntron (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511).
Danish: I PegIntron kombinationsforsøget blev 1.530 naive patienter behandlet i et år med et af følgende kombinationsregimer: - PegIntron (1,5 mikrogram/kg/uge) + ribavirin (800 mg/dag), (n = 511).
English: PegIntron has a potential to depegylate to free interferon alfa-2b.
Danish: PegIntron har et potentiale for at depegylere til frit interferon alfa-2b.
English: Because of marked inter-subject variability in interferon pharmacokinetics, it is recommended that patients with severe renal impairment be closely monitored during treatment with PegIntron (see section 4.2)
Danish: På grund af betydelig variabilitet i interferons farmakokinetik fra person til person anbefales det, at patienter med stærkt nedsat nyrefunktion monitoreres omhyggeligt under behandling med PegIntron (se pkt.
English: Second dose reduction to PegIntron 0.5 µg/kg
Danish: Anden dosisreduktion til PegIntron 0,5 µg/kg
English: Dose modification for all patients (monotherapy and combination therapy) If severe adverse reactions or laboratory abnormalities develop during treatment with PegIntron monotherapy or combination therapy, the dosages of PegIntron and/or ribavirin must be modified as appropriate, until the adverse reactions abate.
Danish: Dosisjustering for alle patienter (monoterapi og kombinationsbehandling) Hvis der udvikles alvorlige bivirkninger eller unormale laboratorieværdier under behandling med PegIntron monoterapi eller kombinationsbehandling, skal doserne af PegIntron og/eller ribavirin justeres efter behov, indtil bivirkningerne aftager.
English: Patients with creatinine clearance < 50 ml/minute must not be treated with PegIntron in combination with ribavirin (see ribavirin SmPC).
Danish: Patienter med kreatininclearance < 50 ml/minut må ikke behandles med PegIntron i kombination med ribavirin (se ribavirin SPC).
English: The most common treatment-related adverse reactions reported during clinical trials with PegIntron in combination with ribavirin in adults, seen in more than half of the study subjects, were fatigue, headache, and injection site reaction.
Danish: De hyppigste behandlingsrelaterede bivirkninger, der er rapporteret under kliniske undersøgelser med PegIntron i kombination med ribavirin hos voksne, og som er set hos mere end halvdelen af forsøgspersonerne, var træthed, hovedpine og reaktion på injektionsstedet.
English: - In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
Danish: - I undergruppen af patienter med genotype 1 og lav virusmængde (< 600.000 IE/ml), som bliver hcv-RNA-negative ved behandlingsuge 4, og som stadig er hcv-RNA-negative ved uge 24, kan behandlingen enten stoppes efter denne 24 ugers behandlingsperiode eller fortsættes i yderligere 24 uger (dvs. en samlet 48 ugers behandlingsperiode).
English: Discard the PegIntron pre-filled pen (CLEARCLICK) with any solution that is left in it after you give yourself the injection.
Danish: PegIntron pennen (CLEARCLICK) kasseres med en eventuel rest af opløsningen, der måtte være tilbage, efter du selv har givet indsprøjtningen.
English: - The use of PegIntron in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Danish: - Brug af PegIntron hos børn og unge som har eller har haft svære psykiske tilstande er kontraindiceret (se pkt.
English: Boceprevir must not be administered in the absence of PegIntron and ribavirin.
Danish: Boceprevir må ikke gives uden samtidig behandling med PegIntron og ribavirin.
English: Alanine aminotransferase (ALT)
Danish: Alanin aminotransferase (ALAT)
English: Paediatric population (bitherapy only) - Dose to be administered Dosing for children 3 years of age and older and adolescent patients is determined by body surface area for PegIntron and by body weight for ribavirin.
Danish: Pædiatrisk population (kun 2-stofsbehandling) - Dosering Dosering til børn i alderen 3 år og derover og unge patienter er baseret på patientens legemsoverfladeareal for PegIntron og på legemsvægt for ribavirin.
English: What you need to know before you use PegIntron
Danish: Det skal du vide, før du begynder at tage PegIntron
English: Solvent for PegIntron Water for injections
Danish: Solvens til PegIntron Vand til injektionsvæsker
English: The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SmPC).
Danish: 4.3, 4.4 og 4.5 i SPC for telbivudin).
English: Also see SmPCs for ribavirin and boceprevir if PegIntron is to be administered in combination therapy in patients with chronic hepatitis C.
Danish: Se også SPC for ribavirin og boceprevir, hvis PegIntron skal gives som kombinationsbehandling hos patienter med kronisk hepatitis C.
English: Detailed information on this medicinal product is available on the web-site of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving PegIntron and ribavirin combination therapy.
Danish: Dentale og parodontale lidelser, som kan føre til tab af tænder, er blevet rapporteret hos patienter, der fik PegIntron og ribavirin kombinationsbehandling.
English: No response at treatment week
Danish: Ingen respons ved behandlings -uge
English: If renal function decreases during treatment, PegIntron therapy should be discontinued.
Danish: Hvis nyrefunktionen nedsættes under behandling, bør PegIntronbehandlingen seponeres.
English: The pharmacokinetics of PegIntron have not been evaluated in patients with severe hepatic dysfunction.
Danish: Farmakokinetikken for PegIntron er ikke blevet undersøgt hos patienter med svær leverfunktionspåvirkning.
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Danish: Hos patienter, som udvikler hepatisk dekompensation, skal antihepatis-behandlingen seponeres øjeblikkeligt, og ARV-behandlingen skal revurderes.
English: Both the Metavir score and Ishak grade decreased among subjects treated with PegIntron in combination with ribavirin.
Danish: Både Metavir-score og Ishak-graden faldt blandt forsøgspersoner, der blev behandlet med PegIntron i kombination med ribavirin.
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: Measuring the dose of PegIntron from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Danish: Afmåling af PegIntron dosis fra det færdigtilberedte pulver til indsprøjtning Vend hætteglasset og sprøjten med bunden i vejret i den ene hånd.
English: if you are a girl or a woman of childbearing age who is taking ribavirin: you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Danish: hvis du er en pige eller kvinde i den fødedygtige alder og bruger ribavirin: skal du have en negativ graviditetstest før behandling, hver måned under behandling, og i 4 måneder efter, at behandlingen er stoppet.
English: PegIntron is injected subcutaneously after reconstituting the powder as instructed, attaching a needle and setting the prescribed dose.
Danish: PegIntron injiceres subkutant efter tilberedning af pulveret som foreskrevet, påsættelse af en kanyle og indstilling af den foreskrevne dosis.
English: PegIntron pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2'5'oligoadenylate synthetase (2'5'-OAS), as well as white cell and neutrophil counts.
Danish: Farmakodynamikken af PegIntron blev undersøgt i et forsøg med stigende enkeltdoser hos raske forsøgspersoner ved at undersøge ændringer i mundtemperatur, koncentrationer af effektorproteiner såsom serum neopterin og 2'5'-oligoadenylatsyntetase (2'5'-OAS), og ligeledes antal leukocytter og neutrofiler.
English: How to use the PegIntron pre-filled pen
Danish: Sådan bruger du PegIntron fyldt pen
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction (PCR) assay (> 30 IU/ml), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Danish: Hos patienter, der var egnede til disse forsøg, var kronisk hepatitis C bekræftet ved en positiv hcv-RNA polymerasekædereaktionstest (PCR) (> 30 IE/ml), en leverbiopsi i overensstemmelse med en histologisk diagnose på kronisk hepatitis uden anden årsag til den kroniske hepatitis, samt en abnorm serum-ALAT.
English: PegIntron (100 or c µg/week) + ribavirin
Danish: PegIntron (100 or c µg/uge) + ribavirin
English: Clinical efficacy and safety - Adults Tritherapy with PegIntron, ribavirin and boceprevir Refer to the SmPC for boceprevir.
Danish: Klinisk virkning og sikkerhed - Voksne 3-stofsbehandling med PegIntron, ribavirin og boceprevir Se SPC for boceprevir.
English: Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see ANNEX TO THE PACKAGE LEAFLET “How to use the PegIntron pre-filled pen”).
Danish: Detaljerede vejledninger for subkutan anvendelse er angivet i slutningen af denne indlægsseddel (se TILLÆG TIL INDLÆGSSEDLEN ”Sådan bruger du PegIntron fyldt pen”).
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated ribavirin for co-HCV infection (see section 4.4).
Danish: Mitokondriel toksicitet og mælkesyreacidose har været rapporteret hos hiv-positive patienter, der modtog NRTI-regimen og associeret ribavirin for samtidig hcv-infektion (se pkt.
English: In patients with moderate renal dysfunction (creatinine clearance 30-50 ml/minute), the starting dose of PegIntron should be reduced by 25 %.
Danish: Hos patienter med moderat nedsat nyrefunktion (kreatininclearance 30-50 ml/minut) bør initialdosis af PegIntron reduceres med 25 %.
English: Clinical efficacy and safety - paediatric population Children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCV-RNA were enrolled in a multicentre trial and treated with ribavirin 15 mg/kg per day plus PegIntron 60 g/m2 once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Danish: Klinisk virkning og sikkerhed - pædiatrisk population Børn og unge i alderen 3 til 17 år med kompenseret kronisk hepatitis C og påviselig hcv-RNA deltog i et multicenter-forsøg og blev behandlet med ribavirin 15 mg/kg per dag plus PegIntron 60 μg/m2 én gang ugentligt i 24 eller 48 uger, baseret på hcv-genotype og virusbelastning ved baseline.
English: Data are not available for the use of PegIntron in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Danish: Der er ingen resultater til rådighed for anvendelse af PegIntron hos patienter med kreatininclearance < 15 ml/minut (se pkt.