FrancophonIA/ELRC3.0 huggingface dataset:
English: Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
Danish: Øjeblikkelig seponering af interferon alfa og behandling med kortikosteroider synes at være forbundet med ophør af lungebivirkningerne.
English: The following treatment-related adverse reactions were reported in the study in children and adolescent patients treated with ViraferonPeg in combination with ribavirin.
Danish: Følgende behandlingsrelaterede bivirkninger blev rapporteret i undersøgelsen hos børn og unge behandlet med ViraferonPeg i kombination med ribavirin.
English: There are no data available regarding potential effects of ViraferonPeg treatment on male or female fertility.
Danish: Der foreligger ingen data vedrørende mulig påvirkning af fertiliteten ved behandling med ViraferonPeg.
English: Liver enzymes and hepatic function should be closely monitored in cirrhotic patients.
Danish: Leverenzymer og leverfunktion skal monitoreres tæt hos patienter med cirrose.
English: - have epilepsy, a condition that causes convulsions (seizures, or “fits”).
Danish: - har epilepsi, der forårsager kramper (anfald eller trækninger).
English: HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alpha interferon.
Danish: Patienter med misbrug hcv-inficerede patienter, der samtidig er misbrugere (af alkohol, cannabis osv.), har en øget risiko for udvikling af psykiske lidelser eller forværring af allerede eksisterende psykiske lidelser under behandling med interferon alfa.
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 ViraferonPeg (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 ViraferonPeg (se pkt.
English: decrease in rate of growth (height and weight for age), - decreases in red blood cells that may cause fatigue, shortness of breath, dizziness.
Danish: svaghed, nedsat væksthastighed (aldersvarende højde og vægt), - nedsat antal røde blodlegemer som kan skabe træthed, åndenød, svimmelhed.
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 opfølgning efter behandlingen var gennemsnitlig reduktion fra baseline i vægt og højde percentiler stadig henholdsvis 3 percentiler og 7 percentiler, og 20 % af børnene forsatte med at have hæmmet vækst (væksthastighed < 3. percentil).
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: 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 ViraferonPeg 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 ViraferonPeg og på legemsvægt for ribavirin.
English: Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Danish: Hepatisk dekompensering hos hcv/hiv co-inficerede patienter med fremskreden cirrose Co-inficerede patienter med fremskreden cirrose, der får HAART, kan have øget risiko for nedsat leverfunktion og død.
English: This medicine is used in combination with ribavirin in children 3 years of age and older and adolescents who have not been treated previously for chronic hepatitis C.
Danish: Dette lægemiddel anvendes i kombination med ribavirin hos børn i alderen 3 år og ældre samt unge, som ikke tidligere er blevet behandlet for kronisk hepatitis C.
English: Both the Metavir score and Ishak grade decreased among subjects treated with ViraferonPeg in combination with ribavirin.
Danish: Både Metavir-score og Ishak-graden faldt blandt forsøgspersoner, der blev behandlet med ViraferonPeg i kombination med ribavirin.
English: Midazolam (CYP3A4 substrate)
Danish: Midazolam (CYP3A4-substrat)
English: It is not known whether the components of this medicinal product are excreted in human milk.
Danish: Det vides ikke, om indholdsstofferne i dette lægemiddel udskilles i human mælk.
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Danish: Alvorlige bivirkninger blev rapporteret hos 7 % (8 / 107) af alle forsøgspersonerne og inkluderede smerter på injektionsstedet (1 %), smerter i ekstremitet (1 %), hovedpine (1 %), neutropeni (1 %), og feber (4 %).
English: Measuring the dose of ViraferonPeg from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Danish: Afmåling af ViraferonPeg dosis fra det færdigtilberedte pulver til indsprøjtning Vend hætteglasset og sprøjten med bunden i vejret i den ene hånd.
English: Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving ViraferonPeg and ribavirin combination therapy.
Danish: Dentale og parodontale lidelser, som kan føre til tab af tænder, er blevet rapporteret hos patienter, der fik ViraferonPeg og ribavirin kombinationsbehandling.
English: Haematological abnormalities were more frequently reported in patients receiving ViraferonPeg 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 ViraferonPeg i kombination med ribavirin end hos patienter, der modtog interferon alfa-2b i kombination med ribavirin.
English: The combination can also be used to treat adults who have already failed treatment with an interferon alpha or peginterferon alpha in combination with ribavirin or interferon alpha alone.
Danish: Denne kombination kan også anvendes til behandling af voksne, der ikke tidligere har reageret på interferon alfa eller peginterferon alfa i kombinationsbehandling med ribavirin eller interferon alfa alene.
English: Boceprevir must not be administered in the absence of ViraferonPeg and ribavirin.
Danish: Boceprevir må ikke gives uden samtidig behandling med ViraferonPeg og ribavirin.
English: In the ViraferonPeg monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with ViraferonPeg (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
Danish: I ViraferonPeg monoterapiundersøgelsen blev i alt 916 naive kroniske hepatitis C-patienter behandlet med ViraferonPeg (0,5, 1,0 eller 1,5 mikrogram/kg/uge) i et år med en opfølgningsperiode på seks måneder.
English: Discard the ViraferonPeg pre-filled pen (CLEARCLICK) with any solution that is left in it after you give yourself the injection.
Danish: ViraferonPeg pennen (CLEARCLICK) kasseres med en eventuel rest af opløsningen, der måtte være tilbage, efter du selv har givet indsprøjtningen.
English: Additionally, patients treated with this medicine and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Danish: Derudover kan patienter behandlet med dette lægemiddel og ribavirin kombinationsbehandling og zidovudin have en øget risiko for at få anæmi (lavt antal røde blodlegemer).
English: Clinical efficacy and safety - Adults Tritherapy with ViraferonPeg, ribavirin and boceprevir Refer to the SmPC for boceprevir.
Danish: Klinisk virkning og sikkerhed - Voksne 3-stofsbehandling med ViraferonPeg, ribavirin og boceprevir Se SPC for boceprevir.
English: Guidelines were developed in clinical trials for dose modification.
Danish: Vejledninger for dosisjustering blev udviklet i kliniske undersøgelser.
English: The data suggest that no alteration in ViraferonPeg dosage is necessary based on advancing age.
Danish: Resultater tyder på, at det ikke er nødvendigt med dosisændring af ViraferonPeg med stigende alder.
English: Telbivudine
Danish: Telbivudin
English: How to use the ViraferonPeg pre-filled pen
Danish: Sådan bruger du ViraferonPeg fyldt pen
English: • Genotype 2 or 3:
Danish: • Genotype 2 eller 3:
English: Anaemia, leucopenia, neutropenia
Danish: Anæmi, leukopeni, neutropeni
English: Collect the necessary items before you begin: - a vial of ViraferonPeg powder for injection; - an ampoule of water for injections solvent to prepare ViraferonPeg 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 ViraferonPeg 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 ViraferonPeg pulver til injektionsvæske - en ampul med solvens, vand til injektionsvæsker til at fremstille ViraferonPeg-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 ViraferonPeg pulver hætteglasset, - en kort kanyle (for eksempel 0,3  13 mm [30 gauge 0,5 tomme]) til den subkutane injektion, - en renseserviet.
English: Decreases in haemoglobin, white blood cells, platelets, neutrophils and increase in bilirubin may require dose reduction or permanent discontinuation from therapy (see section 4.2).
Danish: Fald i hæmoglobin, leukocytter, trombocytter, neutrofiler og stigning i bilirubin kan kræve dosisreduktion eller permanent seponering af behandlingen (se pkt.
English: Also see SmPCs for ribavirin and boceprevir if ViraferonPeg is to be administered in combination therapy in patients with chronic hepatitis C.
Danish: Se også SPC for ribavirin og boceprevir, hvis ViraferonPeg skal gives som kombinationsbehandling hos patienter med kronisk hepatitis C.
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 ViraferonPeg 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 ViraferonPeg 60 μg/m2 én gang ugentligt i 24 eller 48 uger, baseret på hcv-genotype og virusbelastning ved baseline.
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Thyroid changes and section 4.8).
Danish: Patienter med sygdomstegn eller symptomer, der er forenelige med autoimmune sygdomme, bør evalueres nøje, og fordele versus risici ved fortsat interferonbehandling bør revurderes (se også pkt.
English: ViraferonPeg should be used with caution in patients with moderate to severe renal impairment.
Danish: ViraferonPeg bør anvendes med forsigtighed hos patienter med moderat til kraftig nedsættelse af nyrefunktionen.
English: Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see ANNEX TO THE PACKAGE LEAFLET “How to use the ViraferonPeg pre-filled pen”).
Danish: Detaljerede vejledninger for subkutan anvendelse er angivet i slutningen af denne indlægsseddel (se TILLÆG TIL INDLÆGSSEDLEN ”Sådan bruger du ViraferonPeg fyldt pen”).
English: Caffeine (CYP1A2 substrate)
Danish: Caffein (CYP1A2-substrat)
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: • Choose an injection site on your stomach area (abdomen) or thigh.
Danish: • Vælg et indsprøjtningssted på maven eller låret.
English: The pharmacokinetics of ViraferonPeg have not been evaluated in patients with severe hepatic dysfunction.
Danish: Farmakokinetikken for ViraferonPeg er ikke blevet undersøgt hos patienter med svær leverfunktionspåvirkning.
English: Fungal infection, influenza, oral herpes, otitis media, pharyngitis streptococcal, nasopharyngitis, sinusitis
Danish: Svampeinfektion, influenza, oral herpes, otitis media, streptokokfaryngitis, nasofaryngitis, sinusitis
English: Chronic Hepatitis C Subjects (N=22)
Danish: Forsøgspersoner med kronisk hepatitis C (N=22)
English: Following multiple dosing of ViraferonPeg (1.0 microgram/kg subcutaneously administered every week for four weeks) the clearance of ViraferonPeg 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 ViraferonPeg (1,0 mikrogram/kg indgivet subkutant hver uge i fire uger) reduceres clearance af ViraferonPeg 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: In patients with moderate renal dysfunction (creatinine clearance 30-50 ml/minute), the starting dose of ViraferonPeg should be reduced by 25 %.
Danish: Hos patienter med moderat nedsat nyrefunktion (kreatininclearance 30-50 ml/minut) bør initialdosis af ViraferonPeg reduceres med 25 %.
English: For special handling information see section 6.6.
Danish: For specielle håndteringsoplysninger se pkt.
English: Data are not available for the use of ViraferonPeg in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Danish: Der er ingen resultater til rådighed for anvendelse af ViraferonPeg hos patienter med kreatininclearance < 15 ml/minut (se pkt.
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 antihepatitis-behandlingen seponeres øjeblikkeligt, og ARV-behandlingen skal revurderes.
English: Weight loss and growth inhibition were very common during the treatment (at the end of treatment, mean decrease from baseline in weight and height percentile were of 15 percentiles and 8 percentiles, respectively) and growth velocity was inhibited (< 3
Danish: Vægttab og væksthæmning var meget almindeligt under behandlingen (ved slutningen af behandlingen var gennemsnitlig nedgang fra baseline i vægt- og højdepercentil henholdsvis 15 percentiler og 8 percentiler) og væksthastighed var inhiberet (< 3. percentil i 70 % af patienterne).
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: - The active substance is peginterferon alfa-2b.
Danish: - Aktivt stof: Peginterferon alfa-2b.
English: Uncommon side effects (may affect up to 1 in 100 people): - suicide, attempted suicide, thoughts about threatening the life of yourself, panic attack,
Danish: Ikke almindelige bivirkninger (kan berøre op til 1 ud af 100 personer): - selvmord, selvmordsforsøg, tanker om at skade sig selv, panikanfald, vrangforestillinger,
English: Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Danish: Kardiovaskulære (CV) bivirkninger, specielt arytmi, syntes for det meste at være indbyrdes forbundet med tidligere CV sygdom og tidligere behandling med kardiotoksiske stoffer (se pkt.
English: Do not use ViraferonPeg
Danish: Tag ikke ViraferonPeg
English: No sustained response
Danish: Intet vedvarend e respons
English: As monotherapy the ViraferonPeg regimen is 0.5 or 1.0 g/kg/week.
Danish: Ved monoterapi er ViraferonPeg-regimenet 0,5 eller 1,0 g/kg/uge.
English: ≥ 8.5 g/dl, and < 10 g/dl
Danish: ≥ 8,5 g/dl, og < 10 g/dl
English: nd dose reduction of ribavirin is by an additional 200 mg/day.
Danish: 2. dosisreduktion af ribavirin er med yderligere 200 mg/dag, hvis det er nødvendigt.
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: > 4 mg/dl (for > 4 weeks)
Danish: > 4 mg/dl (i > 4 uger)
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: Table 7 Adverse reactions very commonly, commonly and uncommonly reported in the clinical trial in children and adolescent patients treated with ViraferonPeg in combination with ribavirin
Danish: Tabel 7 Bivirkninger, der er meget almindelige, almindelige og ikke almindelige rapporteret i kliniske undersøgelser hos børn og unge behandlet med ViraferonPeg i kombination med ribavirin.
English: Bacterial infection (including sepsis), fungal infection, influenza, upper respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis
Danish: Bakterieinfektion (inklusive sepsis), svampeinfektion, influenza, øvre luftvejsinfektion, bronkitis, herpes simplex, sinuitis, otitis media, rinitis
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 ViraferonPeg 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 ViraferonPeg subkutant i 4 uger R-methadon-AUC med ca. 15 % (95 % Cl for AUC-ratio estimat 103-128 %).
English: In these studies, the effects of multiple-dose regimens of peginterferon alfa-2b (ViraferonPeg) 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 (ViraferonPeg) undersøgt hos forsøgspersoner med hepatitis C (1,5 mikrogram/uge) og raske forsøgspersoner (1 mikrogram/uge eller 3 mikrogram/uge) (Tabel 4).
English: The cartridge is sealed at one end with a polypropylene cap containing a bromobutyl rubber liner and at the other end by a bromobutyl rubber plunger.
Danish: Cylinderampullen er forseglet i den ene ende med en polypropylenhætte indeholdende en brombutylgummiindsats og i den anden ende med et brombutylgummistempel.
English: What you need to know before you use ViraferonPeg
Danish: Det skal du vide, før du begynder at tage ViraferonPeg
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 ViraferonPeg 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 ViraferonPeg behandling.
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: 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: The powder is contained in a 2 ml vial (Type I flint glass) with a butyl rubber stopper in an aluminium flip-off seal with a polypropylene bonnet.
Danish: Pulveret er påfyldt i et 2 ml hætteglas (Type I flintglas) med en butylgummiprop i flip-off-forsegling af aluminium med en polypropylenhætte.
English: ViraferonPeg is injected subcutaneously after reconstituting the powder as instructed, attaching a needle and setting the prescribed dose.
Danish: ViraferonPeg injiceres subkutant efter tilberedning af pulveret som foreskrevet, påsættelse af en kanyle og indstilling af den foreskrevne dosis.
English: Females of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Danish: Fertile kvinder skal anvende effektiv kontraception under behandlingen og i 4 måneder efter, at behandlingen er afsluttet.
English: The plasma half-life of ViraferonPeg is prolonged compared with nonpegylated interferon alfa-2b.
Danish: Plasmahalveringstiden for ViraferonPeg er forlænget i sammenligning med ikke-pegyleret interferon alfa-2b.
English: Interferon alfa-2b 3 MIU
Danish: Interferon alfa-2b 3 MIE
English: Musculoskeletal pain, pain in extremity, back pain
Danish: Muskulo-skeletale smerter, smerter i ekstremiteterne, rygsmerter
English: You or your partner must use an effective birth control during the time you are taking ribavirin and for 7 months after stopping treatment.
Danish: Du eller din partner skal bruge en effektiv præventionsmetode i den periode, du bruger ribavirin og i 7 måneder efter, at behandlingen er stoppet.
English: Reproductive system and breast disorders Uncommon:
Danish: Det reproduktive system og mammae Ikke almindelig:
English: Twenty-four percent of subjects (11/46) treated for 24 weeks and 40 % of subjects (19/48) treated for 48 weeks had a > 15 percentile height-for-age decrease from pre-treatment to the end of the 5 year long-term follow-up compared to pre-treatment baseline percentile.
Danish: Hos 24 % (11/46) af de børn, der blev behandlet i 24 uger, og hos 40 % (19/48) af de børn, der blev behandlet i 48 uger, var der en reduktion på > 15 percentil for alderen i perioden fra før behandling til afslutningen af den 5-årige langtidsopfølgning i forhold til baseline-percentilerne før behandlingen.