FrancophonIA/ELRC3.0 huggingface dataset:
English: This enhancement in efficacy included loss of serum HCV (< 100 copies/mL by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when measured 6 months after the end of treatment.
Danish: Denne forøgelse af virkningen omfattede tab af serum HCV (< 100 kopier/ml ved PCR), forbedring i leverinflammation og normalisering af ALAT, og var opretholdt ved måling 6 måneder efter afsluttet behandling.
English: - if you are being treated for 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: - hvis du er i behandling for mental sygdom eller tidligere har fået behandling for anden nervøs eller mental lidelse herunder depression (såsom følelse af tristhed, modløshed) eller selvmords- eller drabstanker (se punkt 4 ”Bivirkninger”).
English: Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Danish: Defineret som HCV-RNA under detektionsgrænsen ved brug af en forskningsbaseret RT-PCR-analyse ved afslutningen af behandlingen og i opfølgningsperioden
English: Table 3 Sustained virologic response rates with IntronA + ribavirin (one year of treatment) by genotype and viral load
Danish: Tabel 3 Vedvarende virologiske responsrater med IntronA + ribavirin (et års behandling) efter genotype og virusmængde
English: The best way to use IntronA in this indication is in combination with ribavirin.
Danish: Den bedste måde at anvende IntronA ved denne indikation er i kombination med ribavirin.
English: During combination therapy for up to 48 weeks with IntronA and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Danish: Under kombinationsbehandling i op til 48 uger med IntronA og ribavirin blev der observeret væksthæmning, som medførte reduceret sluthøjde hos nogle patienter.
English: Cases of stroke (cerebrovascular events) have been reported.
Danish: (cerebrovaskulære tilfælde) er blevet rapporteret.
English: Sustained virologic response rates for treatment groups treated for one year with IntronA alone or in combination with ribavirin (from two studies) are shown in Table 3.
Danish: Vedvarende virologiske responsrater for behandlingsgrupper behandlet i et år med IntronA alene eller i kombination med ribavirin (fra to undersøgelser) er vist i Tabel 3.
English: The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % of children (n=20) despite being off treatment for more than 5 years.
Danish: Tilgængelige langtidsdata hos børn i kombinationsbehandling med standardinterferon/ribavirin indikerer også betragtelig højdereduktion (> 15 percentilreduktion i højdepercentilen i sammenligning med baseline) hos 21 % af børnene (n=20), til trods for at børnene ikke har været behandlet i mere end 5 år.
English: Chronic hepatitis C in adult patients
Danish: Kronisk hepatitis C hos voksne patienter
English: Palpitation, tachycardia
Danish: Palpitation, takykardi
English: Hairy cell leukaemia Treatment of patients with hairy cell leukaemia.
Danish: Hårcelleleukæmi Behandling af patienter med hårcelleleukæmi.
English: Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of treatment.
Danish: På grund af risikoen for bivirkninger hos de ammede børn, bør amning afbrydes, før behandling påbegyndes.
English: Decreased serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon.
Danish: Nedsat serumestradiol- og -progesteronkoncentration har været rapporteret hos kvinder behandlet med human leukocyt-interferon.
English: 3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to > 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates.
Danish: 3 eller alaninaminotransferase/aspartataminotransferase (ALAT/ASAT) stiger til > 5 gange den øvre normalgrænse, skal behandlingen midlertidigt afbrydes, indtil bivirkningen aftager.
English: Children and adolescents: - if you have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Danish: Børn og unge: - hvis du har haft alvorlig nervøs eller mental sygdom, såsom alvorlig depression eller selvmordstanker.
English: International Units are determined by comparison of the activity of the recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation.
Danish: 8 IE. Internationale enheder fastsættes ved at sammenligne aktiviteten af rekombinant interferon alfa-2b med aktiviteten af den internationale referencestandard af human leukocyt interferon fastsat af verdenssundhedsorganisationen WHO.
English: In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/m2/week in hairy cell leukaemia up to 100 MIU/m2/week in melanoma), the most commonly reported undesirable effects were pyrexia, fatigue, headache and myalgia.
Danish: I kliniske undersøgelser foretaget i en lang række indikationer og i et bredt dosisområde (fra 6 MIE/m2/uge ved hårcelleleukæmi op til 100 MIE/m2/uge ved melanom) var de mest almindeligt rapporterede bivirkninger feber, træthed, hovedpine og myalgi.
English: The most commonly reported potentially life-threatening or fatal adverse events include mucositis, diarrhoea, neutropaenia, renal impairment, and electrolyte disturbance.
Danish: De mest almindeligt rapporterede potentielle livstruende eller fatale bivirkninger inkluderer mucositis, diarré, neutropeni, nyreinsufficiens og elektrolytforstyrrelse.
English: Combination therapy with ribavirin Ribavirin therapy is contraindicated in women who are pregnant.
Danish: Kombinationsbehandling med ribavirin Ribavirin-behandling er kontraindiceret, hos kvinder der er gravide.
English: Undesirable effects were usually managed by dose adjustment.
Danish: Bivirkninger blev almindeligvis kontrolleret ved dosisjustering.
English: If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with IntronA be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Danish: Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmords- eller drabstanker identificeres, anbefales det, at behandling med IntronA afbrydes, og patienten følges med passende psykiatrisk intervention
English: IntronA (3 MIU 3 times a week) I/R IntronA (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
Danish: IntronA (3 MIE 3 gange om ugen) I/R IntronA (3 MIE 3 gange om ugen) + ribavirin (1.000/1.200 mg/dag)
English: In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric- specific concern regarding growth inhibition as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Danish: Generelt svarede bivirkningsprofilen i den begrænsede undersøgte børn og unge population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring vedrørende væksthæmning, såvel som nedsat højdepercentil (gennemsnitlig percentilreduktion på 9 percentil) og vægtpercentil (gennemsnitlig percentilreduktion på 13 percentil) blev observeret under behandling.
English: High doses of other forms of interferons alpha and beta are known to produce doserelated anovulatory and abortifacient effects in rhesus monkeys.
Danish: Høje doser af andre former af interferon alfa og beta er kendt for at producere dosisrelateret anovulatorisk og abortfremkaldende virkning hos rhesus aber.
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with IntronA.
Danish: Bivirkningerne kan indtræde på forskellige tidspunkter under behandlingen, typisk flere måneder efter påbegyndelse af behandlingen med IntronA.
English: Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
Danish: Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon-alfa behandlede patienter, inklusive de, som er behandlet med IntronA.
English: (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) Rare
Danish: (påvirker 1 til 10 af 100 brugere) Ikke almindelig (påvirker 1 til 10 af 1.000 brugere) Sjælden
English: For short term travelling, the solution can be kept out of the refrigerator at or below 25°C for a period up to seven days before use.
Danish: For kortvarig transport kan opløsningen opbevares uden for køleskab ved temperaturer på 25°C eller derunder i en periode på op til syv dage inden anvendelse.
English: Relapse patients (adults)
Danish: Relaps patienter (voksne)
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 % var kaukasiske, 67 % havde HCV-genotype 1, og 63 % var < 12 år.
English: Patients should be closely monitored during therapy and even after treatment discontinuation.
Danish: Patienten bør overvåges nøje under behandlingen, og også efter behandlingen er ophørt.
English: If persistent or recurrent intolerance develops following adequate dose adjustment, or disease progresses, discontinue treatment with IntronA.
Danish: Hvis der opstår vedvarende eller tilbagevendende intolerance til trods for tilstrækkelig dosisjustering, eller hvis sygdommen progredierer, skal behandling med IntronA afbrydes.
English: - if you have thyroid disease that is not well controlled.
Danish: - hvis du har en sygdom i skjoldbruskkirtlen, der ikke er velkontrolleret.
English: If any of the following side effects happen, stop taking IntronA and tell your doctor immediately or go to the casualty department at your nearest hospital: - swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.
Danish: Hvis en af følgende bivirkninger forekommer, så ophør med at anvende IntronA og kontakt omgående din læge eller tag på skadestuen på det nærmeste hospital: - hævelse af hænder, fødder, ankler, ansigt, læber, mund eller hals, hvilket kan give besvær med at synke eller trække vejret; kløende udslæt; besvimelse.
English: If you are self-administering treatment, or if you are the caregiver of a child taking IntronA in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual.
Danish: Hvis du selv injicerer behandlingen, eller hvis du tager dig af et barn, der anvender IntronA i kombination med ribavirin, så injicer den anbefalede dosis, så snart du husker det og fortsæt behandlingen som sædvanligt.
English: Caution should be used when adding IntronA and ribavirin to HAART therapy (see ribavirin SPC).
Danish: Forsigtighed bør udvises, når IntronA og ribavirin adderes til HAART terapi (se produktresumeet for ribavirin).
English: It is not known whether the components of this medicinal product are excreted in human milk.
Danish: Det vides ikke, om indholdsstofferne i præparatet udskilles i human mælk.
English: Patients who also have HIV infection: Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART), an HIV treatment.
Danish: Patienter, som også har hiv-infektion: Mælkesyreacidose og nedsat leverfunktion er bivirkninger, som er forbundet med højaktiv anti-retroviral terapi (HAART), en hiv-behandling.
English: During the one year of treatment with IntronA in combination with ribavirin, some children and adolescents did not grow or gain weight as much as expected.
Danish: I løbet af det ene år i kombinationsbehandling med IntronA og ribavirin voksede nogle børn og unge ikke eller havde ikke den vægtstigning, som var forventet.
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Danish: Et klinisk forsøg der undersøgte kombinationen af telbivudin 600 mg dagligt og pegyleret interferon alfa-2a 180 mikrogram én gang ugentlig s.c., indikerer, at denne kombination er associeret med en øget risiko for udvikling af perifer neuropati.
English: IntronA is available in nine different pack sizes: - Pack of 1 vial
Danish: IntronA er tilgængelig i ni forskellige pakningsstørrelser: - Pakning a 1 hætteglas
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Danish: Undersøgelse 2 (P02080) var en randomiseret enkeltcenterundersøgelse, der inkluderede 95 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med hiv.
English: Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon (see section 5.1).
Danish: Før behandling med IntronA påbegyndes, bør resultaterne fra de kliniske studier, som sammenligner IntronA med pegyleret interferon, tages i betragtning (se pkt.
English: Therefore, it is recommended that children and adolescent patients receiving IntronA/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment, or if they have detectable HCV-RNA at treatment week 24.
Danish: Det anbefales derfor, at behandlingen af børn og unge patienter, der får IntronA/ribavirin-kombination, afbrydes, hvis deres uge 12 HCV-RNA falder < 2 log10 i forhold til før behandlingen, eller hvis de har detekterbar HCV-RNA i behandlingsuge 24.
English: During ALT flare, the following liver function tests must be monitored at two-week intervals: ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin.
Danish: Under ALAT opblussen skal de følgende leverfunktionsprøver foretages med to-ugers mellemrum: ALAT, protrombintid, basisk fosfatase, albumin og bilirubin.
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Danish: Hvis du gør det, så husk at skylle munden omhyggeligt bagefter.
English: Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Danish: Sluthøjden var tilgængelig for 14 af disse børn og viste, at 12 fortsat udviste manglende højdevækst > 15 percentiler, 10-12 år efter afsluttet behandling.
English: §, pneumonitis Pulmonary fibrosis, pulmonary arterial hypertension
Danish: §, lungebetændelse Lungefibrose, pulmonal arteriel hypertension
English: Weight decrease *These events were only common with IntronA alone.
Danish: Vægttab *Disse hændelser var kun almindelige med IntronA alene Se pkt.
English: Any unused medicine must be discarded after withdrawal of the dose.
Danish: Ikke anvendt lægemiddel efter udtrækning af dosis skal kasseres.
English: More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
Danish: Mere signifikant omtågethed samt koma, inklusive tilfælde af encefalopati, er set hos nogle patienter, sædvanligvis hos ældre patienter behandlet med højere doser.
English: (See ribavirin capsules SPC for dose of ribavirin capsules and dose modification guidelines for combination therapy.
Danish: (Se produktresume for ribavirinkapsler med henblik på dosering af ribavirinkapsler og retningslinjerne for dosisjustering ved kombinationsbehandling.
English: From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2ºC - 8ºC.
Danish: Fra et mikrobiologisk synspunkt kan produktet når det er åbnet opbevares i maksimalt 28 dage ved 2C - 8C.
English: Pull back on the plunger slowly to draw the correct dose as prescribed by your doctor into the syringe (Diagram A).
Danish: Træk stemplet langsomt tilbage for at udtage den rigtige dosis, som foreskrevet af din læge, i sprøjten (Diagram A).
English: If treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Danish: Hvis behandling med interferon alfa-2b vurderes nødvendig hos voksne patienter med eksisterende eller tidligere alvorlige psykiatriske lidelser, bør denne kun initieres efter en passende individualiseret diagnosticering og terapeutisk håndtering af den psykiatriske lidelse er blevet sikret.
English: Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with IntronA.
Danish: Standard hæmatologiske prøver og klinisk-kemiske blodundersøgelser (komplet blodtælling og differentialtælling, trombocyttal, elektrolytter, leverenzymer, serum-protein, serum-bilirubin og serumkreatinin) bør udføres hos alle patienter før og med faste intervaller under systemisk IntronA-behandling.
English: In these patients, the addition of ribavirin to IntronA increased by as much as 10-fold the efficacy of IntronA used alone in the treatment of chronic hepatitis C (48.6 % vs. 4.7 %).
Danish: Hos disse patienter øgede tillæg af ribavirin til IntronA helt op til 10 gange virkningen af IntronA anvendt alene i behandlingen af kronisk hepatitis C (48,6 % mod 4,7 %).
English: Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during IntronA therapy.
Danish: Akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) over for interferon alfa-2b har sjældent været observeret under IntronA-behandling.
English: In a large study, 1,071 patients were enrolled after treatment in a prior non-pegylated interferon alfa2b or non-pegylated interferon alfa-2b/ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes.
Danish: I en stor undersøgelse, blev 1.071 patienter inkluderet efter behandling i en tidligere ikke pegyleret interferon alfa-2b eller ikke pegyleret interferon alfa-2b/ribavirin undersøgelse for at evaluere varigheden af vedvarende virologisk respons og bestemme virkningen af fortsat viral negativitet på kliniske resultater.
English: Periodic visual examinations during IntronA therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Danish: Regelmæssige synsundersøgelser under IntronA-behandling anbefales især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
English: IntronA is also used in adult patients for the treatment of chronic hepatitis B or C, which are viral infections of the liver.
Danish: IntronA anvendes også hos voksne patienter til behandling af kronisk hepatitis B og C, der er virusinfektioner i leveren.
English: The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.
Danish: Kombinationen af interferon alfa-2b og cytarabin (Ara-C) givet under de første 12 måneders behandling har vist signifikant at øge hyppigheden af større cytogenetisk respons og signifikant at forlænge den samlede overlevelse efter 3 år sammenlignet med interferon alfa-2b givet alene.
English: Pulmonary conditions
Danish: Pulmonale forhold
English: Tell your doctor if you have ever had a heart attack or a heart problem; if you have a history of breathing irregularities or pneumonia, problems with blood clotting, liver condition, thyroid problems, diabetes, or high or low blood pressure.
Danish: Fortæl din læge, hvis du nogensinde har haft et hjerteanfald eller en hjertelidelse; hvis du tidligere har haft vejrtrækningsbesvær eller lungebetændelse, problemer med blodstørkningen, leverfunktionen, thyroidealidelser, diabetes, eller højt eller lavt blodtryk.
English: if you are also being treated for HIV (see section “Other medicines and IntronA”).
Danish: - hvis du også behandles for hiv (se punktet ”Brug af anden medicin sammen med IntronA”).
English: Pre-existing thyroid disease unless it can be controlled with conventional treatment.
Danish: - Tidligere thyroideasygdom, medmindre den er velkontrolleret med konventionel behandling.
English: Interferon alfa-2b has been shown to have abortifacient effects in Macaca mulatta (rhesus monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m2.
Danish: Interferon alfa-2b er vist til at have abortfremkaldende virkninger hos Macaca mulatta (rhesus aber) ved 90 og 180 gange den anbefalede intramuskulære eller subkutane dosis på 2 millioner IE/m2.
English: Malignant melanoma, induction therapy: 20 million IU/m 2, intravenously, given daily for 5 days a week for a 4 week period.
Danish: Malignt melanom: Induktionsbehandling: 20 millioner IE/m 2 intravenøst givet daglig i 5 dage om ugen i en 4 ugers periode.
English: In clinical trials using IntronA therapy, 2.8 % patients overall developed thyroid abnormalities.
Danish: I kliniske undersøgelser med IntronA-behandling udviklede 2,8 % af patienterne unormal thyroideafunktion.
English: Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with "carcinoid syndrome".
Danish: Karcinoid tumor Behandling af carcinoide tumorer med lymfesvulst eller levermetastaser og med "carcinoid syndrom".
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Danish: Behandlingsvarigheden var 48 uger med en opfølgningsperiode på 6 måneder med undtagelse af de patienter, der var inficeret med genotype 2 og 3 og en virusbelastning < 800.000 IE/ml (Amplicor), som blev behandlet i 24 uger med en opfølgningsperiode på 6 måneder.
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Danish: Undersøgelse 1 (RIBAVIC; P01017) var en randomiseret multicenterundersøgelse, der inkluderede 412 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med hiv.
English: - Severe renal or hepatic dysfunction; including that caused by metastases.
Danish: - Alvorlig nyre- eller leverlidelse, inklusive lidelser forårsaget af metastaser.
English: As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g., patients with primary or recurrent (clinical or pathological) lymph node involvement.
Danish: Supplerende behandling hos patienter, som er sygdomsfri efter operation, men har høj risiko for tilbagefald, for eksempel patienter med primær eller recidiverende (klinisk eller patologisk) lymfeknudepåvirkning.
English: Naïve patients (children and adolescents)
Danish: Naive patienter (børn og unge)