FrancophonIA/ELRC3.0 huggingface dataset:
English: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in the standard interferon multicentre trials.
Danish: Et fem-års langvarigt observatorisk opfølgningsstudie indrullerede 97 pædiatriske kronisk hepatitis C patienter, efter behandling i et standard-interferon multicenterforsøg.
English: Interferons may cause unusual tiredness; if you are injecting this medicine yourself, or giving it to a child, use it at bedtime.
Danish: Interferoner kan forårsage usædvanlig træthed; hvis du selv injicerer denne medicin, eller giver den til et barn, bør du gøre det før sengetid.
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Danish: Hvis du ser nogle bobler, træk stemplet lidt tilbage; bank let på sprøjten, med kanylen pegende opad, indtil boblerne forsvinder.
English: Your doctor will monitor you for signs and symptoms of these conditions (Please be sure to read the ribavirin Patient Leaflet also).
Danish: Din læge vil kontrollere dig for sygdomstegn og symptomer på disse tilstande (Læs endelig også ribavirin indlægssedlen).
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: 15 mg/kg per day once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Danish: 15 mg/kg per dag i 24 eller 48 uger, baseret på HCV-genotype og virusbelastning ved baseline.
English: Severity also increased with high dose therapy (WHO Grade 3 and 4, in 66 % and 14 % of patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
Danish: Sværhedgraden steg også med højdosis behandling (WHO Grad 3 og 4, i henholdsvis 66 % og 14 % af patienterne) sammenlignet med den lette til moderate sværhedsgrad, der sædvanligvis var forbundet med lavere doser.
English: When IntronA is used with hydroxyurea, the frequency and severity of cutaneous vasculitis may be increased.
Danish: Når IntronA anvendes med hydroxyurinstof, kan hyppigheden og sværhedsgraden af kutan vasculitis øges.
English: a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment, lower limit of detection=125 IU/mL.
Danish: a: Respons på behandling blev defineret som ikke-detekterbar HCV-RNA ved uge 24 efter behandling, nedre detektionsgrænse = 125 IE/ml.
English: Discontinuation of IntronA therapy has not reversed thyroid dysfunction occurring during treatment (also see Thyroid supplemental monitoring specific for children and adolescents).
Danish: Seponering af IntronA-behandling har ikke ændret thyroideadysfunktion opstået under behandlingen (se også supplerende thyroideamonitorering specifikt for børn og unge).
English: Therefore, check with your doctor or pharmacist about drinking alcoholic beverages, or taking sleeping pills, sedatives or strong pain medicines.
Danish: Spørg derfor din læge eller apoteket til råds om indtagelse af alkoholiske drikkevarer eller anvendelse af sovepiller, beroligende eller stærkt smertestillende medicin.
English: The mechanism by which IntronA may alter thyroid status is unknown.
Danish: Mekanismen med hvilken IntronA kan ændre thyroideafunktionen er ukendt.
English: Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with IntronA, and therefore it is recommended that they avoid driving or operating machinery.
Danish: Patienter bør informeres om, at de kan udvikle træthed, døsighed eller konfusion under behandling med IntronA, og derfor anbefales det, at de undgår at føre bil og betjene maskiner.
English: Patients with debilitating medical conditions
Danish: Patienter med invaliderende medicinske tilstande
English: If this is a multidose vial, you will only have to remove the cap when preparing the first dose.
Danish: Hvis dette er et flerdosis hætteglas, skal du kun fjerne låget ved forberedelse af den første dosis.
English: Your doctor has determined the exact dosage for administration of IntronA according to your individual needs.
Danish: Din læge har bestemt den nøjagtige dosering for indgift af IntronA efter dit individuelle behov.
English: If intolerance persists after dose adjustment or if granulocytes decrease to < 250/mm
Danish: Hvis intolerance vedvarer efter dosisjustering, eller hvis granulocyttallet falder til < 250/mm
English: The relative benefit of combination therapy with IntronA + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Danish: Den relative gavn af kombinationsbehandling med IntronA + ribavirin er særlig signifikant i de undergrupper af patienter, der er vanskeligst at behandle (genotype 1 og høj virusmængde) (Tabel 3).
English: It is not known whether this medicine is present in human milk.
Danish: Det er uvist, om dette lægemiddel udskilles i mælken hos mennesker.
English: For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue IntronA therapy.
Danish: For alle patienter gælder, at hvis der ikke ses nogen forbedring i serum HBV-DNA efter 3 til 4 måneders behandling (ved den højeste tolererede dosis), skal IntronA-behandlingen afbrydes.
English: Very rarely, seizures have occurred with high doses of IntronA.
Danish: Meget sjældent er der set kramper ved høje doser af IntronA.
English: Caution must be exercised when administering IntronA in combination with other potentially myelosuppressive agents.
Danish: Der bør udøves forsigtighed, når IntronA indgives i kombination med andre potentielt myelosuppressive midler.
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Danish: Søg endelig akut hjælp, hvis du bemærker, at du bliver deprimeret eller har selvmordstanker eller ændrer din opførsel.
English: Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96 %).
Danish: Patienter, der ikke opnår virologisk respons efter 12 uger, har meget lille sandsynlighed for at blive vedvarende virologiske respondenter (negativ prædiktiv værdi 96 %).
English: Preparation of IntronA for intravenous infusion: The infusion is to be prepared immediately prior to use.
Danish: Tilberedning af IntronA til intravenøs infusion: Infusionsvæsken bør tilberedes umiddelbart før brug.
English: In particular, decrease in mean height percentile from baseline to the end of the longterm follow-up was most prominent in prepubertal age children (see section 4.4).
Danish: Reduktion i middelhøjdepercentil fra baseline til udgangen af langtidsopfølgningen var mest fremtrædende hos præpubertale børn (se pkt.
English: IntronA can be put back in the refrigerator at any time during this seven-day period.
Danish: IntronA kan sættes tilbage i køleskab på et hvilket som helst tidspunkt i denne syv dages periode.
English: Regardless of genotype, patients who received IntronA in combination with ribavirin and received  80 % of their treatment had a higher sustained response 6 months after 1 year of treatment than those who took < 80 % of their treatment (56 % vs. 32 % in trial C/I98-580).
Danish: Uafhængigt af genotype havde patienter, som fik IntronA i kombination med ribavirin og fik  80 % af deres behandling, et højere vedvarende respons 6 måneder efter 1 års behandling end dem, der anvendte < 80 % af deres behandling (56 % mod 32 % i undersøgelse C/I98-580).
English: The following instructions explain how to inject IntronA yourself.
Danish: Følgende vejledninger forklarer, hvordan du selv injicerer IntronA.
English: The undesirable effects seen with hepatitis C are representative of those reported when IntronA is administered in other indications, with some anticipated dose-related increases in incidence.
Danish: Bivirkningerne, der ses ved hepatitis C, er repræsentative for dem, der rapporteres, når IntronA gives ved andre indikationer, med nogle forventede dosisrelaterede stigninger i incidensen.
English: Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of IntronA in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Danish: På grund af rapporter med interferon alfa og akut forværring af tidligere psoriasislidelse og sarcoidosis, anbefales brug af IntronA hos patienter med psoriasis eller sarcoidosis kun, hvis den forventede gavnlige virkning opvejer den mulige risiko.
English: During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dose adjusted if necessary.
Danish: Ved samtidig behandling med xanthin-præparater bør serum-theophyllin-niveau monitoreres og dosis om nødvendigt justeres.
English: Moderate and usually reversible reduction in all three blood elements-white blood cells, red blood cells and platelets, has been reported.
Danish: Der er set moderat og sædvanligvis reversibel reduktion i alle 3 blodbestanddele - hvide blodlegemer, røde blodlegemer og blodplader.
English: Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with IntronA.
Danish: Narkotika, hypnotika og sedativa skal indgives med forsigtighed samtidig med IntronA.
English: Hypotension may occur during IntronA therapy or up to two days post-therapy and may require supportive treatment.
Danish: Hypotension kan opstå under eller op til to dage efter IntronA-behandling og kan kræve understøttende behandling.
English: The study results are summarized in Table 6.
Danish: Undersøgelsens resultater er sammenfattet i Tabel 6.
English: Efficacy was defined as sustained virologic response, 6 months after the end of treatment.
Danish: Virkning blev defineret som vedvarende virologisk respons 6 måneder efter afsluttet behandling.
English: Improvement in all three haematological variables (granulocyte count, platelet count and haemoglobin level) may require six months or more.
Danish: Forbedring i alle tre hæmatologiske variable (granulocyttal, trombocyttal og hæmoglobinniveau) kan kræve seks måneder eller mere.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1,64 %  12 years of age.
Danish: I alt 118 patienter blev inkluderet: 57 % mænd, 80 % kaukasiske og 78 % genotype 1, 64 % i alderen  12 år.
English: - if you have hepatitis and have been treated recently with medicines that suppress the immune system (other than short-term treatment with cortisone-type medicine).
Danish: - hvis du har leverbetændelse og er blevet behandlet for nylig med medicin, der undertrykker immunsystemet (andet end korttidsbehandling med cortisonlignende medicin).
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 blevet vist.
English: If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to < 500/mm
Danish: Hvis der udvikles alvorlige bivirkninger under interferon alfa-2b behandlingen, især hvis granulocyttallet falder til < 500/mm
English: If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Danish: Hvis du selv injicerer IntronA, så vær sikker på, at den dosis, der er blevet foreskrevet til dig, angives tydeligt på den lægemiddelpakning, du modtager.
English: Remove the needle guard without touching the needle, and fill the syringe with air by pulling the plunger to the level that represents your dose as prescribed by your doctor.
Danish: Fjern kanylehætten uden at røre ved kanylen, og fyld sprøjten med luft ved at trække stemplet til det niveau, der svarer til din dosis som foreskrevet af din læge.
English: Interferon alfa-2b (6 MIU/m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B. Because of a methodological flaw, efficacy could not be demonstrated.
Danish: Interferon alfa-2b (6 MIE/m2 3 gange om ugen i 6 måneder) er blevet givet til børn med kronisk aktiv hepatitis B. På grund af en metodesvaghed, kunne virkning ikke påvises.
English: §, virilism
Danish: §, virilisering
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rarely (≥1/10,000 to <1/1,000); very rarely (<1/10,000); not known.
Danish: Indenfor systemorganklasserne, er bivirkningerne listet under overskrifter efter hyppighed under anvendelse af følgende kategorier: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt.
English: Ribavirin causes serious birth defects when administered during pregnancy.
Danish: Ribavirin forårsager alvorlige fosterskader ved anvendelse under graviditet.
English: If you are prescribed IntronA in combination with another medicine, please refer also to the Package Leaflet of the medicine to be used in combination.
Danish: Hvis du har fået ordineret IntronA i kombination med et andet lægemiddel, så læs venligst også indlægssedlen for det lægemiddel, der skal anvendes i kombinationen.
English: §, hyperthyroidism Diabetes, aggravated diabetes
Danish: §, hypertyroidisme Diabetes, forværret diabetes
English: Very rarely: Not known:
Danish: Meget sjælden: Ikke kendt:
English: The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline).
Danish: De bedste steder til injektion er væv med et fedtlag mellem hud og muskel: Lår, ydersiden af overarmen (du skal eventuelt have hjælp af en anden person for at bruge dette sted), underlivet (undtagen navlen og taljen).
English: Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with IntronA, must have a prompt and complete eye examination.
Danish: Enhver patient, som klager over forandringer i den visuelle skarphed eller synsfeltet, eller rapporterer om andre oftalmologiske symptomer under behandling med IntronA, skal straks have foretaget en fuldstændig øjenundersøgelse.
English: If the medicine is not used during the seven-day period, it should be discarded.
Danish: Hvis præparatet ikke anvendes i denne syv dages periode, skal det kasseres.
English: - if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives) while on this medicine seek medical help immediately.
Danish: - hvis du udvikler symptomer på en alvorlig allergisk reaktion (såsom vejrtrækningsbesvær, hiven efter vejret eller udslæt) under behandling med denne medicin, så søg straks lægehjælp.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials sustained virological response rates in children and adolescents were similar to those in adults.
Danish: Den inkluderede population bestod hovedsageligt af børn med mild til moderat hepatitis C. I de to multicenterforsøg var vedvarende virologiske responsrater hos børn og unge svarede til dem, der sås hos voksne.
English: Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61 % achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/kg, p < 0.01).
Danish: Bedre virkning er blevet demonstreret med kombinationen af pegyleret interferon med ribavirin (vedvarende responsrate 61 % opnået i en undersøgelse udført hos naive patienter med en ribavirin dosis > 10,6 mg/kg, p < 0,01).
English: Discontinuation of IntronA should be considered in patients who develop new or worsening ophthalmological disorders.
Danish: Seponering af IntronA bør overvejes hos patienter, som udvikler nye eller forværrede oftalmologiske lidelser.
English: Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals.
Danish: Rekombinant interferon alfa-2b har vist antiproliferative virkninger i undersøgelser under anvendelse af både animale og humane cellekultursystemer, såvel som humane tumor xentotransplantater på dyr.
English: Your doctor will determine the exact dosage schedule and regimen according to your needs.
Danish: Din læge vil bestemme den nøjagtige dosering og kur afhængig af dit behov.
English: Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/mL.
Danish: Enhver størrelse hætteglas kan anvendes til at måle den nødvendige dosis, men slutkoncentrationen af interferon i natriumchloridopløsning må ikke være mindre end 0,3 millioner IE/ml.
English: The infusion must be prepared immediately prior to use.
Danish: Infusionsvæsken skal tilberedes umiddelbart før brug.
English: IntronA (interferon alfa-2b) modifies the response of the body's immune system to help fight infections and severe diseases.
Danish: IntronA (interferon alfa-2b) supplerer reaktionen fra kroppens immunsystem med henblik på at bekæmpe infektioner og alvorlige sygdomme.
English: - Chronic hepatitis with decompensated cirrhosis of the liver.
Danish: - Kronisk hepatitis med dekompenseret levercirrose.
English: After intravenous administration, serum interferon levels peaked (135 to 273 IU/mL) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration of medicinal product, becoming undetectable four hours after the infusion.
Danish: Efter intravenøs indgift sås det maksimale interferonniveau (135-273 IE/ml) ved slutningen af infusionen, og herefter faldt det med en lidt hurtigere hastighed end efter subkutan eller intramuskulær indgift, idet det ikke kunne påvises fire timer efter infusion.
English: Auto-antibodies and autoimmune disorders
Danish: Auto-antistoffer og autoimmune lidelser
English: Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/kg), and was statistically significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m2).
Danish: Abort blev observeret i alle dosisgrupper (7,5 millioner, 15 millioner og 30 millioner IE/kg), og var statistisk signifikant mod kontrolgruppen for medium- og højdosisgrupperne (svarende til 90 og 180 gange den anbefalede intramuskulære eller subkutane dosis på 2 millioner IE/m2).
English: - IntronA alone
Danish: - IntronA alene
English: Women of childbearing potential/contraception in males and females Women of childbearing potential have to use effective contraception during treatment.
Danish: Kvinder i den fertile alder/Kontraception til mænd og kvinder Kvinder i den fertile alder skal anvende effektiv kontraception under behandlingen.
English: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, who require IntronA therapy, must be closely monitored.
Danish: Voksne patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/eller tidligere eller eksisterende arytmisygdomme, som kræver IntronA-behandling, skal følges tæt.
English: IntronA is used in adult patients to treat certain disorders that affect the blood, bone marrow, lymph glands, or skin and may extend into the body.
Danish: IntronA anvendes hos voksne patienter til at behandle visse lidelser, der påvirker blodet, knoglemarven, lymfekirtler eller huden og kan spredes i kroppen.
English: In patients treated for malignant melanoma, liver function and white blood cell (WBC) count and differential must be monitored weekly during the induction phase of therapy and monthly during the maintenance phase of therapy.
Danish: Hos patienter behandlet for malignt melanom bør leverfunktion og hvide blodlegemer (WBC) samt differentialtælling undersøges ugentligt under behandlingens induktionsfase og månedligt under vedligeholdelsesbehandlingen.
English: If you use more IntronA than you should Contact your doctor or healthcare professional as soon as possible.
Danish: Hvis du har taget for meget IntronA Kontakt snarest muligt din læge eller sundhedspersonale.
English: During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCVRNA below lower limit of detection six months after withdrawal of treatment).
Danish: I kliniske undersøgelser blev patienter, som ikke udviste virologisk respons efter 6 måneders behandling (HCV-RNA under nedre detektionsgrænse), ikke vedvarende virologiske respondere (HCVRNA under nedre detektionsgrænse 6 måneder efter ophørt behandling).
English: Rarely reported side effects: pneumonia.
Danish: Sjældne bivirkninger: lungebetændelse.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: IntronA 3 MIU/m 2 3 times a week (n = 54)
Danish: 3 MIE/m 2 3 gange om ugen (n = 54)
English: Because of the risk of increased toxicity, careful adjustments of doses are required for IntronA and for the concomitant chemotherapeutic agents (see section 4.5).
Danish: På grund af risikoen for forøget toksicitet, er omhyggelige dosisjusteringer påkrævet med hensyn til IntronA og de samtidige kemoterapeutika (se pkt.
English: Table 5 Sustained virological response in previously untreated children and adolescents IntronA 3 MIU/m2 3 times a week ribavirin 15 mg/kg/day
Danish: Tabel 5 Vedvarende virologisk respons hos tidligere ubehandlede børn og unge IntronA 3 MIE/m2 3 gange om ugen ribavirin 15 mg/kg/dag
English: Activate Safety Mechanism of the syringe after removal from the injection site by moving the pushrod completely forward until the pushrod is fully extended and the needle tip is covered (Diagram D).
Danish: Aktiver sprøjtens sikkerhedsmekanisme, efter du har fjernet den fra injektionsstedet ved at bevæge trykstangen helt frem, indtil trykstangen er er helt udstrakt, og kanylespidsen er dækket (Diagram D).
English: Adverse experiences including prolongation of coagulation markers and liver abnormalities Moderate to severe adverse experiences may require modification of the patient's dose regimen, or in some cases, termination of IntronA therapy.
Danish: Bivirkninger, herunder forlængelse af koagulationsmarkører og leverabnormaliteter Moderate til alvorlige bivirkninger kan nødvendiggøre justering af patientens dosering eller i nogle tilfælde afbrydelse af IntronA-behandling.
English: The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment of the 48-week interferon alfa-2b and ribavirin treatment.
Danish: Formålet med undersøgelsen var årligt at vurdere varigheden af vedvarende virologisk respons (SVR) og vurdere virkningen af fortsat viral negativitet på de kliniske resultater hos patienter, der var vedholdende respondenter 24 uger efter behandling med interferon alfa-2b og ribavirin i 48uger.
English: For storage conditions of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold for lægemidlet, se pkt.