FrancophonIA/ELRC3.0 huggingface dataset:
English: - have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Danish: - hvis du har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere.
English: - have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection.
Danish: - har fået en organtransplantation, enten af nyre eller lever, da interferonbehandling kan give øget risiko for afstødning.
English: For patients who exhibit virological response at week 12, treatment should be continued for at least another three-month period (i.e., a total of six months).
Danish: Hos patienter, som udviser virologisk respons ved uge 12, bør behandlingen fortsættes i en periode på mindst tre måneder mere (svarende til totalt seks måneder).
English: In case of any changes in vision, you must tell your doctor and have a prompt and complete eye examination.
Danish: I tilfælde af tegn på synsforstyrrelser skal du fortælle det til lægen og få en hurtig og fuldkommen øjenundersøgelse.
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): - ønske om at skade andre
English: Sustained response was assessed by the response rate six months after the cessation of treatment.
Danish: Vedvarende respons blev vurderet ved responsraten seks måneder efter behandlingsophør.
English: Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur: - 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: Derfor skal du og din partner bruge særlige forholdsregler i jeres seksuelle aktivitet, hvis der er nogen mulighed for, at en graviditet kan opstå: - 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: Your doctor should carry out an eye examination before starting your treatment.
Danish: Lægen bør foretage en øjenundersøgelse før behandlingsstart.
English: Patients with low CD4 counts
Danish: Patienter med lave CD4-tal
English: There are no adequate data from the use of interferon alfa-2b in pregnant women.
Danish: Der forligger ikke tilstrækkelige data om brugen af interferon alfa-2b hos gravide kvinder.
English: A large long-term follow-up study enrolled 567 patients after treatment in a prior study with ViraferonPeg (with or without ribavirin).
Danish: En stor undersøgelse med langtidsopfølgning inkluderede 567 patienter efter behandling i en tidligere undersøgelse med ViraferonPeg (med eller uden ribavirin).
English: Interferon neutralising factors
Danish: Interferonneutraliserende faktorer
English: No studies have been conducted in juvenile animals to examine the effects of treatment with ViraferonPeg on growth, development, sexual maturation, and behaviour.
Danish: Der er ikke udført studier hos unge dyr med henblik på at undersøge effekten af behandling med ViraferonPeg på vækst, udvikling, seksuel modning og adfærd.
English: d: ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Danish: d: ribavirin dosis var 800 mg for patienter < 60 kg, 1.000 mg for patienter 60-75 kg, og 1.200 mg for patienter > 75 kg.
English: - are diabetic or have high blood pressure, your doctor may ask you, or the child you are caring for to have an eye examination.
Danish: - har sukkersyge eller har højt blodtryk, kan lægen bede dig eller barnet du har ansvar for, om at få foretaget en øjenundersøgelse.
English: Patients may self-inject ViraferonPeg if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Patienterne kan selv injicere ViraferonPeg, hvis lægen beslutter, at det er hensigtsmæssigt og med opfølgning hos lægen efter behov.
English: No paediatric subjects with SVR had relapsed during the 5 years of follow-up.
Danish: Ingen af de pædiatriske forsøgspersoner med SVR fik tilbagefald i den 5-årige opfølgningsperiode.
English: It may be used in adults who have not been previously treated for HCV infection or who have previously used medicines called interferons and pegylated interferons.
Danish: Det kan bruges hos voksne, der ikke tidligere er behandlet for hcv-infektion, eller som tidligere har brugt lægemidler kaldet interferoner og pegylerede interferoner.
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 ViraferonPeg and subjects ≥ 75 kg received 150 µg/week ViraferonPeg.
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 ViraferonPeg og forsøgspersoner ≥ 75 kg fik 150 µg/uge ViraferonPeg.
English: After injection of the dose, discard the pen in an appropriate container.
Danish: Efter injektion af dosis skal pennen kasseres i en passende beholder.
English: A positive predictive value of 50 % (52/104; Study 1) was observed for HCV/HIV co-infected patients receiving bitherapy.
Danish: En positiv forudsigelig værdi på 50 % (52/104; Undersøgelse 1) blev observeret for hcv/hiv co-inficerede patienter, der fik 2stofsbehandling.
English: Mean (SD) ViraferonPeg elimination half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr/kg.
Danish: Gennemsnitlig (SD) ViraferonPeg eliminationshalveringstid er cirka 40 timer (13,3 timer) med tilsyneladende clearance på 22,0 ml/time∙kg.
English: Organ transplant recipients
Danish: Organtransplantatmodtagere
English: Minimum delivery for pen is 0.2 ml.
Danish: Mindste indgift med pen er 0,2 ml.
English: In addition, 303 patients received interferon alfa-2b (3 million International Units [MIU] three times a week) as a comparator.
Danish: Herudover fik 303 patienter interferon alfa-2b (3 millioner internationale enheder [MIE] tre gange om ugen [tre gange om ugen]) til sammenligning.
English: Patients who develop fatigue, somnolence or confusion during treatment with ViraferonPeg are cautioned to avoid driving or operating machines.
Danish: Patienter, der udvikler træthed, søvnighed eller forvirring under behandling med ViraferonPeg, advares mod at køre bil og betjene maskiner.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data): - pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells).
Danish: Bivirkninger med ukendt hyppighed (hyppigheden kan ikke vurderes ud fra forhåndenværende data): - pure red cell aplasia (en tilstand, hvor kroppen er ophørt med eller har nedsat produktionen af røde blodlegemer).
English: Do not inject ViraferonPeg into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
Danish: Indsprøjt ikke ViraferonPeg på et område, hvor huden er irriteret, rød, har blå mærker, er betændt, eller har ar, strækmærker eller knuder.
English: Ribavirin causes serious birth defects when administered during pregnancy, therefore ribavirin therapy is contraindicated in women who are pregnant.
Danish: Ribavirin forårsager alvorlige medfødte misdannelser ved indgivelse under graviditet, derfor er behandling med ribavirin kontraindiceret hos kvinder, der er gravide.
English: Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of ViraferonPeg 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 ViraferonPeg til patienter med psoriasis eller sarkoidose kun anbefales, hvis den potentielt gavnlige effekt retfærdiggør den mulige risiko.
English: Note: Once the pre-filled pen is removed from the skin, the needle shield will lock in place.
Danish: Bemærk: Når den fyldte pen fjernes fra huden, vil nålebeskytteren falde på plads.
English: Any unused material is to be discarded.
Danish: Ikke anvendt lægemiddel skal bortskaffes.
English: There are no data in children or adolescents with a history of cardiac disease.
Danish: Der foreligger ingen data for børn og unge med tidligere hjertesygdom.
English: The safety and efficacy of ViraferonPeg therapy has not been evaluated in patients with severe hepatic dysfunction, therefore ViraferonPeg must not be used for these patients.
Danish: Sikkerhed og effekt ved ViraferonPeg-behandling er ikke blevet vurderet hos patienter med alvorligt nedsat leverfunktion, derfor må ViraferonPeg ikke anvendes til disse patienter.
English: The purpose of the study was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
Danish: Formålet med undersøgelsen var at vurdere varigheden af det vedvarende virologiske respons (SVR) og bestemme betydningen af den fortsatte virale negativitet på det kliniske resultat.
English: ** For patients > 120 kg, the ViraferonPeg dose should be calculated based on the individual patient weight.
Danish: ** Ved vægt > 120 kg bør ViraferonPeg dosis beregnes på grundlag af den enkelte patients vægt.
English: Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code: L03AB10.
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende lægemidler, Interferoner, ATC-kode: L03A B10.
English: Prepare the dose just before you intend to inject it and use it immediately.
Danish: Tilbered dosis umiddelbart før du planlægger at indsprøjte den og brug den straks.
English: If this medicine is used in combination with ribavirin, your doctor should monitor you, or the child you are caring for more carefully for a decrease in red blood cell count.
Danish: Hvis dette lægemiddel bruges i kombination med ribavirin, bør lægen følge dig eller barnet, du har ansvar for, mere omhyggeligt for et fald i antallet af røde blodlegemer.
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear.
Danish: Hvis du ser nogle bobler, træk da stemplet lidt tilbage; bank let på sprøjten, med kanylen pegende opad, indtil boblerne forsvinder.
English: No statistically significant effect on the time to development of the first clinical event (liver decompensation, hepatocellular carcinoma, death and/or liver transplantation) was observed as compared to the absence of treatment.
Danish: Der blev ikke observeret statistisk signifikant effekt på tiden til udvikling af den første kliniske hændelse (leverdekompensation, hepatocellulært karcinom, død og/eller levertransplantation) sammenlignet med manglende behandling.
English: While changes in laboratory values were observed in some patients treated with ViraferonPeg 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 ViraferonPeg i kombination med ribavirin i kliniske forsøg, vendte værdierne tilbage til baselineniveau inden for et par uger efter afslutningen af behandlingen.
English: Medicines
Danish: Lægemiddel
English: Adverse events not observed in clinical trials were not seen in toxicity studies in monkeys.
Danish: Bivirkninger, der ikke sås i kliniske undersøgelser, blev ikke set i toksicitetsundersøgelser hos aber.
English: When the total amount of solvent is combined with the full amount of ViraferonPeg powder, the solution will be at the correct concentration to measure your dose (i.e., the labelled amount is contained in 0.5 ml).
Danish: Når hele mængden af solvens kombineres med hele mængden af ViraferonPeg-pulveret, vil opløsningen være i den rigtige koncentration til at afmåle din dosis (det vil sige at den anførte mængde er indeholdt i 0,5 ml).
English: - have had any serious illness affecting breathing or blood.
Danish: - har haft en alvorlig sygdom med påvirkning af din vejrtrækning eller dit blod.
English: The response to treatment in both of these trials is presented in Table 13.
Danish: Respons på behandlingen i disse to undersøgelser er vist i Tabel 13.
English: - If you are also being treated for HIV (see section “Other medicines and ViraferonPeg”).
Danish: - Hvis du også behandles for hiv (se afsnittet ”Brug af anden medicin sammen med ViraferonPeg”).
English: Ribavirin capsules
Danish: Ribavirin-kapsler
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 denne undersøgelse blev tolereret bedre end et års behandling i den grundlæggende kombinationsundersøgelse; seponering hos 5 % versus 14 %, dosisjustering hos 18 % versus 49 %.
English: These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with ViraferonPeg monotherapy.
Danish: Disse bivirkninger var almindelige (≥ 1/100 til < 1/10) i kliniske undersøgelser hos patienter behandlet med ViraferonPeg monoterapi.
English: Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Danish: Når først interferon er bundet til cellemembranen, udløser det en kompleks række af intracellulære virkninger, som inkluderer induktion af visse enzymer.
English: After withdrawal of the dose, any remaining solution must be discarded.
Danish: Efter udtagning af dosis skal eventuel restopløsning kasseres.
English: Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking ViraferonPeg 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 ViraferonPeg i kombination med ribavirin.
English: All patients in the selected chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Danish: Alle patienter i de udvalgte kliniske undersøgelser af kronisk hepatitis C fik foretaget leverbiopsi før inklusion, men i visse tilfælde (for eksempel patienter med genotype 2 og 3), kan behandling være mulig uden histologisk verifikation.
English: The potency of this product should not be compared to that of another pegylated or non-pegylated protein of the same therapeutic class (see section 5.1).
Danish: Potensen af dette lægemiddel bør ikke sammenlignes med et andet pegyleret eller ikke-pegyleret protein i samme terapeutiske gruppe (se pkt.
English: This medicine contains less than 1 mmol sodium (23 mg) per 0.7 ml, i.e., essentially "sodium-free".
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per 0,7 ml, det vil sige, at det praktisk taget er "natriumfrit".
English: Patients should be closely monitored during therapy and even after treatment discontinuation.
Danish: Patienten bør overvåges nøje under behandlingen, og også efter at behandlingen er ophørt.
English: However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1).
Danish: Imidlertid kan en samlet 24 ugers behandlingsperiode være forbundet med større risiko for relaps frem for en 48 ugers behandlingsperiode (se pkt.
English: The use of ViraferonPeg in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Danish: Anvendelsen af ViraferonPeg i kombination med ribavirin havde ingen observerbar negativ indvirkning på kontrollen af hiv-viræmi under behandling eller opfølgning.
English: Reduce only ViraferonPeg dose (see note 2) if:
Danish: Reducer kun ViraferonPeg dosis (se note 2), hvis:
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Danish: Faldet i CD4+-celletællinger var reversible efter dosisreduktion eller behandlingsophør.
English: This may occur in particular in patients with risk factors such as HIV infection or severe liver problems (cirrhosis).
Danish: Dette kan navnlig forekomme hos patienter med risikofaktorer såsom hivinfektion eller svære leverproblemer (cirrose).
English: *produced by rDNA technology in E. coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Danish: *produceret ved hjælp af rDNA teknologi i E. coli-celler indeholdende et genetisk fremstillet plasmahybrid med et interferon alfa-2b-gen fra humane leukocytter.
English: When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients.
Danish: Ved beslutning om ikke at udsætte behandlingen til barnet er voksent, er det vigtigt at betænke, at kombinationsbehandlingen forårsagede væksthæmning, som kan være irreversibel hos nogle patienter.
English: Any patient complaining of ocular symptoms, including loss of visual acuity or visual field must have a prompt and complete eye examination.
Danish: Enhver patient, som klager over øjensymptomer, inklusive nedsat synsskarphed eller forringet synsfelt skal straks have foretaget en fuldstændig øjenundersøgelse.
English: You may dial up or down to any dose prior to injection.
Danish: Du kan dreje op eller ned til den ønskede dosis før indsprøjtning.
English: - develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing.
Danish: - får symptomer forbundet med en forkølelse eller anden luftvejsinfektion, såsom feber, hoste eller anden form for vejrtrækningsbesvær.
English: It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virusinfected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Danish: Det formodes, at denne proces, i det mindste delvist er ansvarlig for de forskellige cellulære reaktioner på interferon, inklusive hæmning af virusreplikation i virusinficerede celler, suppression af celledeling og sådanne immunmodulerende aktiviteter som øgning af makrofagers fagocytiske aktivitet og øgning af lymfocytters specifikke cytotoksicitet for målcellerne.
English: - are being treated for a mental illness or had treatment in the past for any other nervous or mental disorder, including depression (such as feelings of sadness, dejection) or suicidal or homicidal behaviour (see section 4 “Possible side effects”).
Danish: - er i behandling for mental sygdom eller tidligere har fået behandling for anden nervøs eller psykisk lidelse herunder depression (såsom følelse af tristhed, modløshed) eller selvmords- eller drabstanker (se punkt 4 ”Bivirkninger”).
English: ViraferonPeg should therefore not be used as long term maintenance monotherapy.
Danish: ViraferonPeg bør derfor ikke anvendes som langtidsvedligeholdelses-monoterapi.
English: - have thyroid disease that is not well controlled with medicines.
Danish: - har en skjoldbruskkirtelsygdom, der ikke er velkontrolleret med medicin.
English: • Find a well-lit, clean flat work surface such as a table.
Danish: • Find en ren, godt belyst, plan overflade, fx et bord.
English: The negative predictive value for sustained response in patients treated with ViraferonPeg in monotherapy was 98 %.
Danish: Den negative prædiktive værdi for vedvarende respons hos patienter behandlet med ViraferonPeg i monoterapi var 98 %.
English: - Remove the protective cap from the ViraferonPeg vial.
Danish: - Fjern beskyttelseslåget fra ViraferonPeg-hætteglasset.
English: Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Danish: Patienter, hvis ribavirindosis er reduceret til 600 mg dagligt, skal have en 200 mg kapsel om morgenen og to 200 mg kapsler om aftenen.
English: Other baseline factors in co-infected patients that may be associated with a higher risk of hepatic decompensation include treatment with didanosine and elevated bilirubin serum concentration.
Danish: Andre baseline-faktorer hos coinficerede patienter, som kan associeres med en højere risiko for hepatisk dekompensering, inkluderer behandling med didanosin og forhøjet bilirubin serumkoncentration.
English: Colitis ulcerative
Danish: Colitis ulcerosa
English: Very rarely, seizures have occurred with high doses of interferon alpha.
Danish: Meget sjældent er der set kramper ved høje doser af interferon alfa.
English: This means that it is injected through a short needle into the fatty tissue just under the skin.
Danish: Dette betyder, at det indsprøjtes med en kort kanyle i fedtvævet lige under huden.
English: Moreover, the safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
Danish: Derudover er telbivudins sikkerhed og virkning i kombination med interferoner ved behandling af kronisk hepatitis B ikke klarlagt.
English: Class label for interferon products, see below Pulmonary arterial hypertension.
Danish: Vedrørende klassebetegnelse for interferonlægemidler: se pulmonal arteriel hypertension nedenfor.
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 ViraferonPeg” above).
Danish: Brugen af dette lægemiddel er ikke tilladt hos børn og unge med eksisterende eller tidligere svære psykiske problemer (se afsnittet "Brug ikke ViraferonPeg" ovenfor).
English: Two pivotal trials have been conducted, one (C/I97-010) with ViraferonPeg monotherapy; the other (C/I98-580) with ViraferonPeg in combination with ribavirin.
Danish: To pivotale undersøgelser er blevet udført, en (C/I97-010) med ViraferonPeg monoterapi; den anden (C/I98-580) med ViraferonPeg i kombination med ribavirin.
English: If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection.
Danish: Hvis du selv skal indsprøjte denne medicin, vil du blive instrueret i, hvordan injektionen forberedes og indsprøjtes.
English: In this subgroup, there was a 56 % (463/823) sustained virological response rate.
Danish: I denne undergruppe opretholdt 56 % (463/823) den virologiske responsrate.
English: This medicinal product should only be reconstituted with the solvent provided (see section 6.6).
Danish: Dette lægemiddel bør kun tilberedes med det leverede solvens (se pkt.
English: Do not attempt to administer an injection until you are sure you understand how to use the pre-filled pen.
Danish: Forsøg ikke at give dig selv en indsprøjtning, før du er sikker på, at du forstår, hvordan du bruger pennen.
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: All patients should be screened for hepatitis B before starting treatment with interferon for hepatitis C; patients co-infected with hepatitis B and C must then be monitored and managed according to current clinical guidelines.
Danish: Alle patienter skal screenes for hepatitis B før initiering af behandling med interferon for hepatitis C. Patienter, der er co-inficerede med hepatitis B og C, skal herefter monitoreres og behandles i henhold til gældende kliniske vejledninger.