FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine if you notice discolouration of the powder, which should be white.
Danish: Anvend ikke lægemidlet, hvis du bemærker misfarvning af pulveret, som skal være hvidt.
English: If it cannot be used immediately, the solution may be refrigerated for up to 24 hours.
Danish: Hvis den ikke kan anvendes straks, kan opløsningen opbevares i køleskab i op til 24 timer.
English: This medicine is intended for subcutaneous use.
Danish: Dette lægemiddel er beregnet til subkutan anvendelse.
English: Therefore, you should not breast-feed an infant if you are taking this medicine.
Danish: Derfor må du ikke amme et barn, hvis du tager dette lægemiddel.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of ViraferonPeg therapy are:
Danish: Acceptable udgangsværdier, som kan anvendes som retningslinje før påbegyndelse af ViraferonPeg behandling, er:
English: The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 99 % (95 % CI: 98-100 %).
Danish: Kaplan-Meier-estimatet for fortsat vedvarende respons over 5 år for alle patienter er 99 % (95 % CI: 98-100 %).
English: During treatment, some patients may experience eye problems, or loss of vision in rare instances.
Danish: Under behandlingen kan nogle patienter opleve øjenproblemer, eller i sjældne tilfælde synstab.
English: o With zidovudine or stavudine, it is not certain if ribavirin will change the way these medicines work.
Danish: o Med zidovudin eller stavudin er det ikke sikkert, om ribavirin vil ændre den måde, disse lægemidler virker på.
English: It is important to brush your teeth thoroughly twice a day, rinse your mouth out if you vomit, and have regular dental check-ups.
Danish: Det er vigtigt at børste dine tænder grundigt to gange om dagen, skyl munden, hvis du kaster op, og gå til regelmæssig tandkontrol.
English: Effects on fertility have not been determined.
Danish: Effekt på fertiliteten er ikke undersøgt.
English: Positive predictive value
Danish: Positiv prædiktiv værdi
English: Treatment should be initiated and monitored only by a physician experienced in the management of patients with hepatitis C.
Danish: Behandling bør kun initieres og overvåges af en læge med erfaring i behandling af patienter med hepatitis C.
English: ViraferonPeg showed no genotoxic potential.
Danish: ViraferonPeg viste intet genotoksisk potentiale.
English: This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
Danish: Denne virkning hæmmer viral replikation, eller hvis replikation finder sted, så er de dannede virioner ude af stand til at forlade cellen.
English: ViraferonPeg is likely to also cause this effect.
Danish: ViraferonPeg kan sandsynligvis også have denne virkning.
English: The effects on growth were less in those subjects treated for 24 weeks than those treated for 48 weeks.
Danish: Virkningen på væksten var mindre hos de børn, der var blevet behandlet i 24 uger end hos dem, der var blevet behandlet i 48 uger.
English: Cleanse and disinfect the skin where the injection is to be made.
Danish: Rens og desinficer huden, hvor indsprøjtningen skal foretages.
English: Insert the needle into the pinched skin at an angle of approximately 45°.
Danish: Stik kanylen ind i den sammenklemte hud i en vinkel på cirka 45.
English: Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Danish: Når det er muligt, bør barnet først behandles efter pubertetens vækstspurt for at reducere risikoen for væksthæmning.
English: • Hold the pre-filled pen against the skin for 15 seconds.
Danish: • Hold den fyldte pen mod huden i 15 sekunder.
English: Children and adolescents are particularly prone to develop depression when being treated with this medicine and ribavirin.
Danish: Børn og unge er særligt udsatte for at udvikle depression, når de behandles med dette lægemiddel og ribavirin.
English: Interferons are made by your body's immune system to help fight infections and severe diseases.
Danish: Interferoner produceres af kroppens immunsystem for at bekæmpe infektioner og alvorlige sygdomme.
English: All Genotypes Genotype 1 Genotype 2 Genotype 3
Danish: Alle Genotyper Genotype 1 Genotype 2 Genotype 3 Genotype 4
English: - are taking telbivudine.
Danish: - tager telbivudin.
English: The clinical significance of this finding is unknown; however, patients should be monitored for signs and symptoms of increased sedative effect, as well as respiratory depression.
Danish: Den kliniske signifikans af denne observation er ukendt; patienter bør imidlertid monitoreres for tegn og symptomer på øget sedativ effekt og respirationsdepression.
English: p value
Danish: p værdi
English: Contact your doctor immediately if you notice any of the following serious side effects occurring during treatment:
Danish: Kontakt omgående lægen, hvis en af følgende alvorlige bivirkninger forekommer:
English: You may develop gum disease, which could lead to loss of teeth.
Danish: Du kan få tandkødssygdomme, som kan føre til tab af tænder.
English: With one hand, pinch a fold of loose skin.
Danish: Med den ene hånd klemmes en fold af løs hud sammen.
English: Some people get depressed when taking this medicine alone or in combination treatment with ribavirin, and in some cases people have had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Danish: Nogle mennesker bliver deprimerede, når de anvender dette lægemiddel alene eller i kombination med ribavirin, og i nogle tilfælde har personer haft tanker om at true andre på livet, selvmordstanker eller aggressiv opførsel (sommetider rettet mod andre).
English: This may require combinations of various ViraferonPeg dose strengths and volumes.
Danish: Dette kan kræve kombination af flere ViraferonPeg styrker og volumener.
English: Although not all of these side effects may occur, they may need medical attention if they do.
Danish: Selv om ikke alle de anførte bivirkninger behøver at forekomme, kan de kræve lægehjælp, hvis de opstår.
English: Dyspepsia, gingivitis
Danish: Dyspepsi, gingivitis
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -betingelser under brug indtil indgift brugerens ansvar og skal normalt ikke være længere end 24 timer ved 2 °C - 8 °C.
English: Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e.g. TSH).
Danish: Børn og unge bør monitoreres hver 3. måned for tegn på thyroideadysfunktion (f.eks. TSH).
English: Renal clearance appears to account for 30 % of total clearance of ViraferonPeg.
Danish: Renal udskillelse synes at være ansvarlig for 30 % af total clearance af ViraferonPeg.
English: Metabolism of other medicines in the liver may be suppressed.
Danish: Metaboliseringen af disse lægemidler i leveren kan være hæmmet.
English: Negative predictive value
Danish: Negativ prædiktiv værdi
English: If you have a medical condition making use of ribavirin dangerous or if you already have had a problem taking it, your doctor will likely prescribe this medicine alone.
Danish: Hvis du har en sygdom, der gør brugen af ribavirin farlig, eller hvis du allerede har haft et problem med at bruge det, vil din læge sandsynligvis give dette lægemiddel alene.
English: < 12 g/dl after four weeks of dose reduction
Danish: < 12 g/dl efter 4 ugers dosisreduktion
English: This medicine contains sucrose.
Danish: Dette lægemiddel indeholder saccharose.
English: Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
Danish: Der er observeret hypertriglyceridæmi og forværring af hypertriglyceridæmi, undertiden alvorlig.
English: Interferon neutralising factors are antibodies which neutralise the antiviral activity of interferon.
Danish: Interferonneutraliserende faktorer er antistoffer, som neutraliserer interferons antivirale aktivitet.
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Danish: Dette udelukker imidlertid ikke forekomsten af hepatiske tilfælde hos patienter med cirrose (inklusive hepatokarcinom).
English: Growth and development (children and adolescents):
Danish: Vækst og udvikling (børn og unge):
English: • Take the pre-filled pen out of the refrigerator.
Danish: • Tag den fyldte pen ud af køleskabet.
English: Do not aim the stream directly at the white solid or powder, or inject the liquid quickly, as this causes a greater amount of bubbles.
Danish: Det er bedst ikke at rette strømmen direkte mod det hvide faste stof eller pulver, eller at tilsætte væsken hurtigt, da dette vil give en større mængde bobler.
English: - have autoimmune hepatitis or any other problem with your immune system.
Danish: - har autoimmun hepatitis eller en anden sygdom i dit immunsystem.
English: Mechanism of action is unknown, but it is considered that both medicines have bone marrow depressive effects.
Danish: Virkningsmekanismen er ukendt, men begge lægemidler anses for at have en hæmmende virkning på knoglemarven.
English: If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Danish: Hvis din kvindelige partner ikke er gravid, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandling og i 7 måneder efter, at behandlingen er stoppet.
English: Your doctor will test your blood before you begin therapy and throughout the treatment to make sure that the therapy you are getting is safe and effective.
Danish: Lægen vil teste dit blod, før du begynder behandlingen og under behandlingen for at sikre, at behandlingen er sikker og effektiv.
English: Change your injection site each time.
Danish: Varier indsprøjtningsstedet hver gang.
English: In general, the adverse events seen in overdose cases involving ViraferonPeg are consistent with the known safety profile for ViraferonPeg; however, the severity of the events may be increased.
Danish: Generelt er bivirkninger, der er set ved tilfælde af overdosering, hvor ViraferonPeg er involveret, i overensstemmelse med den kendte sikkerhedsprofil for ViraferonPeg; sværhedsgraden af tilfældene kan imidlertid øges.
English: The major treatment-related change was a reversible, mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Danish: Den største behandlingsrelaterede ændring var en reversibel, mild til moderat anæmi, hvis sværhedsgrad var større end den, der sås ved hvert aktivt stof alene.
English: Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
Danish: Interferoner udøver deres cellulære virkninger ved at binde sig til specifikke membranreceptorer på celleoverfladen.
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Danish: I alt 107 patienter fik behandling, hvoraf 52 % var kvinder, 89 % kaukasiske, 67 % med hcv Genotype 1 og 63 % < 12 år.
English: Patients predisposed to the development of autoimmune disorders may be at increased risk.
Danish: Patienter, der er prædisponerede for udviklingen af autoimmune sygdomme, kan have øget risiko.
English: Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Danish: Farmakologisk øger ribavirin fosforylerede metabolitter af purinnukleosider in vitro.
English: It is recommended that patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Danish: Det anbefales, at patienter, der har forud eksisterende hjerteanomalier, får taget elektrokardiogram før og under behandlingsforløbet.
English:  2 g/dl decrease in haemoglobin during any four week period during treatment (permanent dose reduction)
Danish:  2 g/dl fald i hæmoglobin under en hvilken som helst 4 ugers periode under behandling (permanent dosisreduktion)
English: Seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Danish: Søg akut hjælp, hvis du bemærker, at du bliver deprimeret eller har selvmordstanker eller ændringer i din opførsel.
English: Look at the date printed on the carton after EXP to make sure that the expiration date has not passed.
Danish: Kontrollér udløbsdatoen, der står på pakningen for at sikre dig, at udløbsdatoen ikke er overskredet.
English: You may hear a "click" sound.
Danish: Du hører et ”klik”.
English: The effect of this medicine on human pregnancy is not known.
Danish: Indvirkningen af dette lægemiddel på graviditet hos mennesker er ukendt.
English: The maximum daily dose reported is 1,200 µg for one day.
Danish: Den maksimale daglige dosis, der er set, er 1.200 mikrogram i én dag.
English: 2 x baseline and > 10 x ULN
Danish: 2 x baseline og > 10 x ULN
English: With up to one year of treatment with this medicine in combination with ribavirin, some children and adolescents did not grow or gain weight as much as expected.
Danish: Med op til et års behandling med dette lægemiddel i kombination med ribavirin, voksede nogle børn og unge ikke eller tog ikke på i vægt som forventet.
English: Alopecia, pruritus
Danish: Alopeci, pruritus
English: Side effects in children and adolescents The following effects have occurred in children and adolescents:
Danish: Bivirkninger hos børn og unge Følgende bivirkninger er blevet rapporteret hos børn og unge:
English: Pull back on the plunger slowly to draw just more than the dose prescribed by your doctor into the syringe.
Danish: Træk stemplet langsomt tilbage for at udtage lidt mere end den dosis, som er foreskrevet af din læge, i sprøjten.
English: While being treated with ViraferonPeg, your doctor may advise to drink extra fluids to help prevent low blood pressure.
Danish: Under behandlingen med ViraferonPeg vil lægen måske råde dig til at drikke ekstra væske for at hjælpe med at forebygge lavt blodtryk.
English: Administer once weekly (ml)
Danish: Indgives en gang om ugen (ml)
English: Neuropathy, neuropathy peripheral
Danish: Neuropati, perifer neuropati
English: If you have a medical condition that may lead to future eye problems (e.g. diabetes or high blood pressure), you should receive regular eye exams during therapy.
Danish: Hvis du har en sygdom, som kan føre til fremtidige øjenproblemer (f.eks. sukkersyge eller forhøjet blodtryk), bør du få foretaget regelmæssige øjenundersøgelser under behandlingen.
English: If you are injecting this medicine yourself, please be sure that the dose that has been prescribed is clearly provided on the package of medicine you receive.
Danish: Hvis du selv indsprøjter dette lægemiddel, skal du se efter, at den dosis, som er blevet ordineret, er tydeligt angivet på pakningen af lægemidlet, du får.
English: These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 12).
Danish: Disse tidspunkter (4- og 12 behandlingsuge) har vist sig at være prædiktive med hensyn til vedvarende respons (Tabel 12).
English: Caution is therefore warranted in the treatment of patients with low CD4 counts.
Danish: Forsigtighed anbefales derfor i behandlingen af patienter med lave CD4-tal.
English: If your eye disorder becomes more severe or if you develop new eye disorders, your treatment will be discontinued.
Danish: Hvis din øjensygdom bliver forværret, eller hvis du får nye øjensygdomme, vil din behandling blive afbrudt.
English: In addition, children and adolescents must not use this medicine if they have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Danish: Desuden må børn og unge ikke tage dette lægemiddel, hvis de har haft alvorlige nervøse eller psykiske problemer, såsom svær depression eller selvmordstanker.
English: As adherence might be of importance for outcome of therapy, the dose of ViraferonPeg and ribavirin should be kept as close as possible to the recommended standard dose.
Danish: Da efterlevelse kan være vigtig for udfaldet af behandlingen, skal dosis for ViraferonPeg og ribavirin være så tæt på den anbefalede standard dosis som muligt.
English: Steatosis was significantly improved in patients infected with HCV Genotype 3.
Danish: Steatose var signifikant forbedret hos de patienter, der var inficeret med hcv-genotype 3.
English: - pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Danish: - pulmonal arteriel hypertension - en sygdom, der medfører svær forsnævring af blodkarrene i lungerne med deraf følgende højt blodtryk i de blodkar, der fører blodet fra hjertet til lungerne.
English: Elevation of blood concentrations of these medicines has been reported when administered in combination with other interferon preparations and therefore care should be taken.
Danish: Der er rapporteret om stigning i koncentrationen af disse lægemidler i blodet, når de blev administreret i kombination med andre interferonpræparater, og forsigtighed skal derfor udvises.
English: Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART) regimen if this is already established.
Danish: Det bør overvejes, hvorvidt zidovudin kan erstattes i en kombinationsbehandling med anti-retrovirale (ART) lægemidler, hvis en sådan allerede er etableret.
English: Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of selfinjection.
Danish: Prøv ikke selv at indsprøjte, medmindre du er sikker på, at du forstår proceduren og forudsætningen for selv-injektion.
English: These are thigh, outer surface of the upper arm (you may need the assistance of another person to use this site) and abdomen (except the navel or waistline).
Danish: Disse er lår, ydersiden af overarmen (du skal eventuelt have hjælp af en anden person for at bruge dette sted) og underlivet (undtagen navlen og taljen).
English: However, certain monkey species, e.g., Rhesus monkeys are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Danish: Dog er visse abearter, som for eksempel Rhesusaber, følsomme overfor farmakodynamisk stimulering ved udsættelse for humane type 1 interferoner.
English: The decision to extend therapy to one year of treatment should be based on prognostic factors (e.g., genotype, age > 40 years, male gender, bridging fibrosis).
Danish: Beslutningen om at forlænge behandlingen til et års behandling bør træffes på grundlag af andre prognostiske faktorer (såsom alder > 40 år, hankøn, bridging fibrose).
English: Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Danish: Patienter bør følges nøje for eventuelle tegn eller symptomer på psykiske lidelser.
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Danish: Begrænsede historiske data indikerer, at behandling i 48 uger kan være forbundet med en højere vedvarende responsrate (11/11) og en lavere risiko for recidiv (0/11 i sammenligning med 7/96 efter 24 ugers behandling).
English: You may develop a dry mouth or vomiting, both of which can damage your teeth.
Danish: Du kan få mundtørhed eller opkastninger, begge dele kan skade tænderne.
English: - have severe medical conditions that leave you very weak.
Danish: - har en eller flere alvorlige sygdomme, der gør dig meget svag.
English: - have ever had a heart attack or a heart problem.
Danish: - har haft et hjerteanfald eller en hjertelidelse.
English: • Pinch a fold of loose skin in the area you have cleaned for injection.
Danish: • Klem en fold af løs hud sammen i det område, du har renset til indsprøjtningen.
English: If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient.
Danish: Om nødvendigt bør en interdisciplinær tilgang, der involverer en psykiatrisk behandler eller misbrugsspecialist, overvejes, for at evaluere, behandle og følge patienten.
English: Histological response: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Danish: Histologisk respons: Leverbiopsier blev taget før og efter behandling i Undersøgelse 1 og var tilgængelige for 210 af de 412 forsøgspersoner (51%).
English: Seek medical help immediately in case of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives).
Danish: Søg øjeblikkelig lægehjælp i tilfælde af en alvorlig allergisk reaktion (såsom vejrtrækningsbesvær, hiven efter vejret eller udslæt).
English: Treatment with ViraferonPeg in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Danish: Behandling med ViraferonPeg i kombination med ribavirin, blev associeret med et fald i absolut CD4+- celletælling inden for de 4 første uger uden en reduktion i CD4+-celleprocenten.
English: # Calculated from urine data collected over an interval of 48-hours ## Calculated from urine data collected over an interval of 24-hours
Danish: # Beregnet på baggrund af urindata samlet over et 48 timers interval ## Beregnet på baggrund af urindata samlet over et 24 timers interval
English: No specific antidote for ViraferonPeg is available; therefore, symptomatic treatment and close observation of the patient are recommended in cases of overdose.
Danish: Der findes ingen specifik antidot til ViraferonPeg; i tilfælde af overdosering anbefales derfor symptomatisk behandling og tæt observation af patienten.
English: The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Danish: Udvikling af auto-antistoffer og autoimmune sygdomme er blevet rapporteret under behandling med alfa interferoner.
English: Do not massage the injection site.
Danish: Massere ikke indsprøjtningsstedet.
English: Following subcutaneous administration, maximal serum concentrations occur between 15-44 hours post-dose, and are sustained for up to 48-72 hours post-dose.
Danish: Efter subkutan indgift forekommer maksimale serumkoncentrationer mellem 15-44 timer efter dosis, og vedvarer i op til 48-72 timer efter dosis.
English: The duration of treatment is up to 1 year based on the doctor's judgement for you, or the child you are caring for.
Danish: Behandlingsvarigheden er op til 1 år baseret på lægens vurdering for dig/barnet.
English: This medicine is used for the treatment of chronic hepatitis C, a viral infection of the liver.
Danish: Dette lægemiddel anvendes til behandling af kronisk hepatitis C, en virusinfektion i leveren.
English: - have advanced, uncontrolled liver disease (other than hepatitis C).
Danish: - har en fremskreden, ikke-kontrolleret leversygdom (ud over hepatitis C).
English: Most cases of neutropenia and thrombocytopenia were mild (WHO grades 1 or 2).
Danish: De fleste tilfælde af neutropeni og trombocytopeni var milde (WHO grad 1 eller 2).
English: Study Population
Danish: Studiepopulation
English: Table 15 Sustained virological response rates (n a,b
Danish: Tabel 15 Vedvarende virologisk responsrate (n a,b
English: Ask your healthcare provider or pharmacist for an appropriate container.
Danish: Bed sundhedspersonalet eller apotekspersonalet om en egnet beholder.
English: Viral infection *, pharyngitis
Danish: Virusinfektion *, faryngitis
English: ViraferonPeg is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: ViraferonPeg skal kun anvendes under graviditet, hvis den mulige fordel opvejer den mulige risiko for fosteret.