FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation of ViraferonPeg should be considered in patients who develop new or worsening ophthalmological disorders.
Danish: Seponering af ViraferonPeg bør overvejes hos patienter, der udvikler nye eller forværrede oftalmologiske forstyrrelser.
English: Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Danish: Laboratorieundersøgelser skal udføres ved behandlingsuge 2 og 4 og herefter med mellemrum efter klinisk behov.
English: Women of childbearing potential/contraception in males and females ViraferonPeg is recommended for use in fertile women only when they are using effective contraception during the treatment.
Danish: Kvinder i den fertile alder/Kontraception til mænd og kvinder ViraferonPeg anbefales kun til brug hos fertile kvinder, når de anvender effektiv kontraception under behandlingen.
English: The biologic activity of the pegylated isomers is qualitatively similar, but weaker than free interferon alfa-2b.
Danish: Den biologiske aktivitet af de pegylerede isomerer er kvalitativt den samme, men svagere end frit interferon alfa-2b.
English: When used in combination with ribavirin, ViraferonPeg did not cause any effects not previously seen with either active substance alone.
Danish: Ved anvendelse i kombination med ribavirin forårsagede ViraferonPeg ikke nogen virkninger, som ikke tidligere var set med hvert aktivt stof alene.
English: Upon multiple dosing, there is an accumulation of immunoreactive interferons.
Danish: Efter flere doser akkumuleres immunreaktive interferoner.
English: A complete and illustrated set of instructions is provided in the Annex to the Package Leaflet.
Danish: Et fuldstændigt og illustreret sæt instruktioner findes i tillægget til indlægssedlen.
English: If you have kidney disease, your dose may be lower, depending upon your kidney function.
Danish: Hvis du har en nyresygdom, kan din dosis være lavere, afhængigt af din nyrefunktion.
English: Your doctor has determined the correct dose of this medicine based on how much you, or the child you are caring for weighs.
Danish: Lægen har bestemt den rette dosis af dette lægemiddel baseret på hvor meget du eller barnet, du har ansvar for, vejer.
English: Long-term efficacy data-Adults
Danish: Data vedrørende langtidsvirkning - Voksne
English: There were some cases of more severe neutropenia in patients treated with the recommended doses of ViraferonPeg 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 ViraferonPeg i kombination med ribavirin (WHO grad 3: 39 af 186 [21 %]; og WHO grad 4: 13 af 186 [7 %]).
English: 9/l (adults)
Danish: 9/l (voksne)
English: You might hear a soft sound when pushing on the needle.
Danish: Du kan høre en let lyd, når kanylen trykkes på plads.
English: Table 5 Precautions for co-administration (ViraferonPeg should be administered with care when co-administered with the following medicines)
Danish: Tabel 5 Forholdsregler ved samtidig administration (ViraferonPeg skal administreres med forsigtighed, når det administreres sammen med følgende lægemidler) Lægemiddel
English: Thyroid changes
Danish: Thyroidea-ændringer
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: 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: The active substance in this medicine is a protein called peginterferon alfa-2b, which belongs to the class of medicines called interferons.
Danish: Det aktive indholdsstof i dette lægemiddel er et protein som kaldes peginterferon alfa-2b, og som tilhører klassen af lægemidler kaldet interferoner.
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: However, renal elimination may account for a minority (approximately 30 %) of ViraferonPeg apparent clearance.
Danish: Renal elimination kan imidlertid forklare en mindre del (cirka 30 %) af den tilsyneladende clearance af ViraferonPeg.
English: Keep your work area, your hands, and the injection site clean to decrease the risk of infection.
Danish: hænderne og injektionsstedet rent for at mindske risikoen for infektion.
English: Periodic visual examinations are recommended during ViraferonPeg therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Danish: Regelmæssige synsundersøgelser anbefales under ViraferonPeg-behandling, især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
English: Metabolic disturbances
Danish: Metaboliske forstyrrelser
English: Description of selected adverse reactions in adults
Danish: Beskrivelse af udvalgte bivirkninger hos voksne
English: Paediatric population (bitherapy only) - Duration of treatment
Danish: Pædiatrisk population (kun 2-stofsbehandling) - Behandlingsvarighed
English: The clinical incidence of neutralising factors in patients who received ViraferonPeg 0.5 micrograms/kg is 1.1 %.
Danish: Den kliniske forekomst af neutraliserende faktorer hos patienter, der fik ViraferonPeg 0,5 mikrogram/kg, er 1,1 %.
English: Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease.
Danish: Kardiomyopati, som kan være reversibel efter seponering af interferon alfa, er blevet rapporteret sjældent hos patienter uden tidligere observeret hjertesygdom.
English: Therefore, you must not take this medicine at the same time as telbivudine.
Danish: Du må derfor ikke tage dette lægemiddel sammen med telbivudin.
English: • Turn the dial to your prescribed dose (see Figure 8).
Danish: • Drej doseringsknappen til din foreskrevne dosis (se Figur 8).
English: Your doctor will determine the correct dose for you.
Danish: Lægen bestemmer, hvilken dosis der er korrekt for dig.
English: How to self-inject ViraferonPeg?
Danish: Hvordan du selv indsprøjter ViraferonPeg?
English: The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from ViraferonPeg 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 ViraferonPeg ved metabolisering in vivo, er blevet påvist i prækliniske akutte og subkroniske toksicitetsundersøgelser hos gnavere og aber, standard embryofoetale udviklingsundersøgelser og i in vitro mutagenicitetsforsøg.
English: Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Danish: Plasma-hcv-RNA blev målt ved en videnskabeligt baseret kvantitativ polymerasekædereaktionsanalyse på et centralt laboratorium *Intention-to-treat-populationen inkluderer 7 patienter, hvor mindst 12 ugers tidligere behandling ikke kunne bekræftes.
English: Among patients with undetectable HCV-RNA at the end of treatment, the relapse rate was 24 %.
Danish: Blandt patienter med ikke-detekterbart hcv-RNA efter endt behandling, var recidivraten 24 %.
English: Table 11 Virologic response at treatment week 12, end of treatment response, relapse rate *and Sustained Virologic Response (SVR) Treatment group
Danish: Tabel 11 Virologisk respons ved behandlingsuge 12, respons ved afslutning af behandlingen, tilbagefaldsrate *og vedvarende virologisk respons (SVR) Behandlingsgruppe
English: 3 was observed in 4 % (8/194) of patients receiving ViraferonPeg in combination with ribavirin.
Danish: 3 blev også observeret hos 4 % (8/194) af de patienter, der fik ViraferonPeg i kombination med ribavirin.
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Danish: Øget thyroideastimulerende hormon i blodet, øget thyroglobulin
English: The negative predictive value for sustained response in HCV/HIV co-infected patients treated with ViraferonPeg 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 ViraferonPeg i kombination med ribavirin, var 99 % (67/68; Undersøgelse 1) (se pkt.
English: The pharmacokinetics of ViraferonPeg following a single subcutaneous dose of 1.0 microgram/kg were not affected by age.
Danish: Farmakokinetikken for ViraferonPeg efter en enkelt subkutan dosis på 1,0 mikrogram/kg var ikke påvirket af alder.
English: It is recommended that all patients be treated with bitherapy for 24 weeks, except for HCV/HIV co-infected patients who should receive 48 weeks of treatment.
Danish: Det anbefales, at alle patienter behandles med 2-stofsbehandling i 24 uger, bortset fra hcv/hiv co-inficerede patienter, der bør behandles i 48 uger.
English: Adequate hydration must be maintained in patients undergoing ViraferonPeg 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 ViraferonPeg-behandling, da hypotension relateret til væskemangel er observeret hos nogle patienter behandlet med alfa interferoner.
English: Mean apparent volume of distribution is 0.99 l/kg.
Danish: Det gennemsnitlige tilsyneladende fordelingsvolumen er 0,99 l/kg.
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with ViraferonPeg.
Danish: Bivirkningerne kan indtræde på forskellige tidspunkter under behandlingen, typisk flere måneder efter påbegyndelse af behandlingen med ViraferonPeg.
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: The solvent is presented in a 2 ml ampoule (Type I flint glass).
Danish: Solvens findes i en 2 ml ampul (Type I flintglas).
English: Paediatric population ViraferonPeg can be used in combination with ribavirin in paediatric patients 3 years of age and older.
Danish: Pædiatrisk population ViraferonPeg kan anvendes i kombination med ribavirin hos pædiatriske patienter i alderen 3 år og ældre.
English: If you are exceptionally thin, use only the thigh or outer surface of the arm for injection.
Danish: Hvis du er usædvanligt tynd, så brug kun låret eller ydersiden af overarmen til indsprøjtning.
English: If your doctor prescribes this medicine with ribavirin or with ribavirin and boceprevir, please read the Package Leaflets of ribavirin and boceprevir before you begin combination treatment.
Danish: Hvis din læge ordinerer dette lægemiddel sammen med ribavirin eller sammen med ribavirin og boceprevir, skal du læse indlægssedlen for ribavirin og boceprevir, før du påbegynder kombinationsbehandlingen.
English: More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses for oncology indications.
Danish: Mere udtalt sløvhed og koma, inklusive tilfælde af encefalopati, er set hos nogle patienter, sædvanligvis ældre, behandlet med høje doser ved onkologiske indikationer.
English: As with all interferons, discontinue treatment with ViraferonPeg in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Danish: Som ved alle interferoner seponeres ViraferonPeg hos patienter, der udvikler forlængede koagulationsmarkører, hvilket kan være tegn på leversvigt.
English: The most frequently reported adverse reactions were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.
Danish: De hyppigst rapporterede bivirkninger var oftest af let til moderat sværhedsgrad og kunne klares uden behov for dosisjusteringer eller behandlingsophør.
English: ViraferonPeg 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: ViraferonPeg fyldt pen bør fjernes fra køleskabet før indgift for at lade solvens nå stuetemperatur (ikke over 25 C).
English: Dissolution of powder is completed by agitating it gently.
Danish: Opløsning af pulveret fuldendes ved at omryste forsigtigt.
English: Discontinue ribavirin if CrCL < 50ml/min
Danish: Seponer ribavirinbehandlingen hvis CrCL < 50 ml/min
English: Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.
Danish: Tidlig intervention over for tilbagevendende psykiske lidelser og misbrug eller udvikling heraf anbefales.
English: - are taking medicine that suppresses (weakens) your immune system.
Danish: - bruger medicin, der undertrykker dit immunsystem.
English: Overall, approximately 36 % (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Danish: Overordnet havde ca. 36 % (821/2.286) af patienterne ikke målbart plasma-hcv-RNA i den 12. behandlingsuge, målt ved hjælp af en videnskabelig baseret test (detektionsgrænse 125 IE/ml).
English: Discontinue combination therapy if:
Danish: Seponer kombinationsbehandling, hvis:
English: Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SmPC).
Danish: Mandlige patienter eller deres kvindelige partnere skal anvende effektiv kontraception under behandling og i 7 måneder efter, at behandlingen er afsluttet (se SPC for ribavirin).
English: Ribavirin dose (mg/kg)
Danish: Ribavirin dosis (mg/kg)
English: Water for injection and ViraferonPeg powder are provided in separate ampoules.
Danish: Vand til injektion og ViraferonPeg-pulver leveres i separate emballager.
English: Use in adults - ViraferonPeg 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 - ViraferonPeg 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: The appropriate dose can then be withdrawn with a sterilised injection syringe and injected.
Danish: Den foreskrevne dosis kan herefter udtrækkes med en steril injektionssprøjte og injiceres.
English: Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Danish: Skønt den nøjagtige antivirale virkningsmekanisme af rekombinant interferon alfa-2b er ukendt, synes det at ændre værtscellemetaboliseringen.
English: If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Danish: Hvis sådanne symptomer forekommer, skal den ordinerende læge være opmærksom på den potentielle alvor af disse bivirkninger, og behovet for passende terapeutisk håndtering bør overvejes.
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: 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 i kombinationsbehandling ikke.
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Danish: Andre CNS-virkninger inklusive aggressiv adfærd (sommetider rettet mod andre såsom drabstanker), bipolare lidelser, mani, forvirring og ændret mental tilstand er blevet set med alfainterferoner.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of ViraferonPeg therapy.
Danish: Hjertearytmier (primært supraventrikulære) responderer sædvanligvis på konventionel behandling, men kan kræve seponering af ViraferonPeg.
English: Hearing impaired/loss, tinnitus, vertigo
Danish: Nedsat hørelse/tab, tinnitus, svimmelhed
English: - have kidney disease, your doctor may prescribe a lower than usual dose and monitor your kidney blood values regularly during treatment.
Danish: - har en nyresygdom, så vil lægen eventuelt ordinere en mindre dosis end sædvanligt og undersøge blodtal for nyrefunktionen regelmæssigt under behandling.
English: This study showed that ViraferonPeg was superior to interferon alfa-2b (Table 8).
Danish: Dette studie viste, at ViraferonPeg var bedre end interferon alfa-2b (Tabel 8).
English: The combination of this medicine and ribavirin is recommended for adults 18 years of age and older who have not previously been treated with these medicines.
Danish: Kombination af dette lægemiddel med ribavirin anbefales til voksne i alderen 18 år og ældre, som ikke tidligere er behandlet med disse lægemidler.
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 transkriptase-hæmmer (NRTI), og/eller høj-aktiv anti-retroviral terapi (HAART)].
English: Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
Danish: Tilfælde af Vogt-Koyanagi-Harada (VKH) syndrom er rapporteret hos patienter med kronisk hepatitis C, der blev behandlet med interferon.
English: The potential interaction of peginterferon alfa-2b (ViraferonPeg) on substrates of metabolic enzymes was evaluated in 3 multiple-dose clinical pharmacology studies.
Danish: Den potentielle interaktion mellem peginterferon alfa-2b (ViraferonPeg) og substrater for metaboliske enzymer blev vurderet i 3 klinisk farmakologiske multidosis-studier.
English: Description of selected adverse reactions in children and adolescents Most of the changes in laboratory values in the ViraferonPeg/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 ViraferonPeg/ribavirin var milde eller moderate.
English: This medicine, when given alone, is usually given at a dose of 0.5 or 1.0 microgram per kilogram of body weight once a week, for 6 months to 1 year.
Danish: Når dette lægemiddel anvendes alene, gives det sædvanligvis i en dosis på 0,5 eller 1,0 mikrogram per kilo legemsvægt en gang om ugen i 6 måneder til 1 år.
English: Based on single dose data, clearance was similar in patients with severe renal impairment not on dialysis and in patients who were receiving hemodialysis.
Danish: Baseret på resultater med enkeltdosis var clearance den samme hos patienter med stærkt nedsat nyrefunktion uden dialyse som hos patienter, der fik hæmodialyse.
English: Use in adults - ViraferonPeg alone
Danish: Brug hos voksne - ViraferonPeg alene
English: - Break off the top of the ampoule of solvent.
Danish: - Bræk toppen af ampullen med solvens.
English: Prepare the dose by adding water for injection to ViraferonPeg powder just before you intend to inject it and use it immediately.
Danish: Tilbered dosis ved at tilsætte vand til injektion til ViraferonPeg-pulver umiddelbart før du planlægger at indsprøjte den og brug den straks.
English: This would be particularly important in patients with a known history of zidovudine-induced anaemia.
Danish: Dette vil være særligt vigtigt for patienter, der har zidovudininduceret anæmi i anamnesen.
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: If blood comes into the syringe, the needle has entered a blood vessel.
Danish: Hvis der kommer blod ind i sprøjten, har kanylen ramt en blodåre.
English: Data from elderly patients treated with a single dose of ViraferonPeg suggest no alteration in ViraferonPeg dose is necessary based on age (see section 5.2).
Danish: Resultater fra ældre patienter behandlet med en enkelt dosis ViraferonPeg tyder på, at ingen ændring i ViraferonPeg dosis er nødvendig på basis af alder (se pkt.
English: Ninety-four of 107 subjects enrolled in the 5 year long-term follow-up trial.
Danish: 94 af 107 børn blev inkluderet i det opfølgende 5-årige langtidsstudie.
English: Once all bubbles have risen to the top of the solution, you should have a clear solution with a small ring of tiny bubbles around the top.
Danish: Når opløsningen har sat sig, og alle bobler er steget op til overfladen af opløsningen, skulle du have en klar opløsning med en lille ring af bittesmå bobler i kanten af overfladen.
English: General information about taking this medicine
Danish: Generel information om brugen af dette lægemiddel
English: The safety and efficacy of ViraferonPeg 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 ViraferonPeg alene eller i kombination med ribavirin ved behandling af hepatitis C hos lever- eller andre organtransplanterede patienter er ikke blevet undersøgt.
English: Do not use this medicine after the expiry date which is stated on the carton, after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Select the injection site.
Danish: Vælg indsprøjtningsstedet.
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 positiv i uge 12 og der er et fald på < 2log10 fra baseline, skal patienterne stoppe behandlingen.
English: Dose reduction of ViraferonPeg 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 ViraferonPeg hos voksne kan ske ved at reducere det ordinerede volumen eller ved at bruge en lavere styrke, som anført i Tabel 2b.
English: Following single doses of ViraferonPeg between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Danish: Efter enkeltdoser af ViraferonPeg mellem 0,25 og 2,0 mikrogram/kg/uge, blev serum neopterin-koncentrationen øget på en dosisafhængig måde.
English: Subjects treated with ViraferonPeg showed mild dose-related elevations in body temperature.
Danish: Personer behandlet med ViraferonPeg viste lette dosisrelaterede stigninger i legemstemperatur.