FrancophonIA/ELRC3.0 huggingface dataset:
English: Clean the mixing equipment.
Danish: Gør blandeudstyret rent.
English: • infection of the urinary system
Danish: • infektion i urinvejssystemet
English: In comparison, at Week 12, 55% of placebo patients reported any bleeding.
Danish: Til sammenligning var der ved uge 12 55 % af placebopatienterne, der rapporterede om nogen form for blødning.
English: The median time on study to a cytogenetic abnormality was 2.9 months.
Danish: I studiet var den gennemsnitlige tid til en cytogenetisk anomalitet 2,9 måneder.
English: Safety pharmacology and repeat-dose toxicity
Danish: Sikkerhedsfarmakologi og toksicitet efter gentagne doser
English: Hepatic decompensation (use with interferon)
Danish: Hepatisk dekompensation (anvendelse med interferon)
English: Cytogenetic abnormalities and progression to MDS/AML in patients with SAA
Danish: Cytogenetiske anomalier og progression til MDS/AML hos patienter med SAA
English: IMPORTANT - Use the medicine immediately after you have mixed the powder with water.
Danish: VIGTIGT - Medicinen skal anvendes straks efter, at du har blandet pulveret med vand.
English: Platelet counts >75,000/µl should be avoided.
Danish: Et trombocyttal > 75.000 pr. µl bør undgås.
English: • if you are at risk of blood clots in your veins or arteries, or you know that blood clots are common in your family.
Danish: • hvis du har risiko for blodpropper i dine vener eller arterier eller hvis du ved, at din familie er disponeret for blodpropper.
English: Stop eltrombopag; increase the frequency of platelet monitoring to twice weekly.
Danish: Seponer eltrombopag; forøg monitoreringen af trombocyttallet til to gange om ugen.
English: Approximately 21% of an eltrombopag dose could undergo oxidative metabolism.
Danish: Cirka 21 % af en eltrombopag-dosis undergå oxidativ metabolisme.
English: The corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Danish: Den tilsvarende frekvenskategori for hver bivirking er baseret på the følgende konvention (CIOMS III): 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 (kan ikke estimeres ud fra forhåndenværende data).
English: • Cut off the top of each sachet with scissors
Danish: • Klip toppen af hvert brev med en saks
English: EXP Use within 30 minutes of reconstitution.
Danish: EXP Skal anvendes inden for 30 minutter efter sammenblanding.
English: Patients who responded continued therapy in an extension phase of the study.
Danish: Responderende patienter fortsatte behandlingen i en forlængelsesfase af studiet.
English: • dairy foods such as cheese, butter, yoghurt or ice cream
Danish: • mejeriprodukter såsom ost, smør, yoghurt eller is
English: The majority of patients, 33 (77%), were considered to have ‘primary refractory disease', defined as having no prior adequate response to IST in any lineage.
Danish: Hovedparten af patienterne, 33 (77 %), blev betragtet som havende ”primær refraktær sygdom”, der defineres som ingen tidligere tilstrækkelige respons på immunsuppressiv behandling for nogen celletyper.
English: The treatment should not be initiated when the patients has existing cytogenetic abnormalities of chromosome 7.
Danish: Behandlingen bør ikke startes, hvis patienten har eksisterende cytogenetiske anomalier i kromosom 7.
English: Revolade is not recommended during pregnancy.
Danish: Revolade skal ikke anvendes under graviditet.
English: Interference with laboratory tests
Danish: Påvirkning af laboratorieundersøgelser
English: The most important serious adverse reactions were febrile neutropenia and sepsis/infection.
Danish: De vigtigste alvorlige bivirkninger var febril neutropeni og sepsis/infektion.
English: Plasma eltrombopag apparent clearance following oral administration (CL/F) increased with increasing body weight.
Danish: Eltrombopags tilsyneladende plasmaclearance efter oral administration (CL/F) steg i takt med stigende kropsvægt.
English: If you get a skin reaction, or if you have any questions, contact the doctor.
Danish: Hvis du får en hudreaktion, eller hvis du har spørgsmål, skal du kontakte lægen.
English: In the clinical studies of eltrombopag, overall no clinically significant differences in safety of eltrombopag were observed between patients aged at least 65 years and younger patients.
Danish: I de kliniske studier med eltrombopag sås generelt ingen klinisk signifikante forskelle i sikkerheden ved eltrombopag mellem patienter, der var 65 år eller ældre og yngre patienter.
English: p-value a
Danish: p-værdi a
English: Discard suspension if not administered within 30 minutes after preparation.
Danish: Kasser suspensionen, hvis den ikke er indgivet inden for 30 minutter efter klargøring.
English: Total number of patients entering antiviral treatment phase n=956 n=485 n=450 n=232 n=506 n=253
Danish: Samlet antal patienter, der indtrådte i fasen med antiviral behandling n = 956 n = 485 n = 450 n = 232 n = 506 n = 253
English: Revolade is not recommended for children aged under 1 year who have ITP.
Danish: Revolade må ikke anvendes til børn under 1 år, der har ITP.
English: Combination with direct-acting antiviral agents
Danish: Kombination med direkte aktive antivirale lægemidler
English: The primary efficacy endpoint for both studies was sustained virologic response (SVR), defined as the percentage of patients with no detectable HCV-RNA at 24 weeks after completion of the planned treatment period.
Danish: Det primære endepunkt i begge studier var opretholdt virologisk respons (SVR), der blev defineret som procentdel af patienter uden påviselig HVC-RNA 24 uger efter, at den planlagte behandlingsperiode var afsluttet.
English: Food interaction
Danish: Interaktion med fødevarer
English: Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C infection.
Danish: Sikkerhed og virkning er ikke undersøgt i kombination med direkte aktive antivirale lægemidler, som er godkendt til behandling af kronisk hepatitis C-infektion.
English: 9/l, eltrombopag may be reinitiated at the previous effective dose.
Danish: 9/l, kan eltrombopag genstartes ved den tidligere effektive dosis.
English: Revolade can cause blood test results that may be signs of liver damage - an increase of some liver enzymes, especially bilirubin and alanine / aspartate transaminases.
Danish: Revolade kan forårsage blodprøveresultater, der kan være tegn på leverskade - en stigning af visse leverenzymer i blodet, specielt bilirubin og alanin/ aspartat transaminaser.
English: Before you start taking Revolade, your doctor will carry out blood tests to check your blood cells, including platelets.
Danish: Inden du begynder på behandlingen med Revolade, vil lægen tage blodprøver for at kontrollere dine blodceller, herunder også blodpladerne.
English: For more details on preparation and administration of the suspension, see Instructions for Use in the package leaflet.
Danish: For yderligere information omkring klargøring og indgivelse af suspensionen, se Brugsanvisning i indlægssedlen.
English: In the clinical studies there was one report of overdose where the patient ingested 5000 mg of eltrombopag.
Danish: I de kliniske studier blev der rapporteret om én overdosis, hvor en patient indtog 5000 mg eltrombopag.
English: Eltrombopag has negligible influence on the ability to drive and use machines.
Danish: Eltrombopag påvirker kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: There are no or limited amount of data from the use of eltrombopag in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om anvendelse af eltrombopag til gravide kvinder.
English: If you have spilt any powder or mixed medicine, clean it up with a damp disposable cloth.
Danish: Hvis du har spildt pulver eller færdigblandet medicin, så tør det op med en fugtig engangsklud.
English: Marketing authorisation holder Novartis Europharm Limited Vista Building
Danish: Indehaver af markedsføringstilladelsen Novartis Europharm Limited Vista Building
English: It is used to help increase the number of platelets in your blood.
Danish: Revolade hjælper med at øge antallet af blodplader i dit blod.
English: Tubular toxicity was also observed in a 2-year oral carcinogenicity study in mice at doses of 25, 75 and 150 mg/kg/day.
Danish: Tubulær toksicitet blev også observeret i et 2-årigt oralt karcinogenicitetsstudie med mus ved doser på 25, 75 og 150 mg/kg/dag.
English: All 7 patients had normal cytogenetics at baseline.
Danish: Alle 7 patienter havde normal cytogenetik ved baseline.
English: Fertility was not affected in male or female rats at exposures that were comparable to those in humans.
Danish: Fertiliteten blev ikke påvirket hos hanrotter eller hunrotter ved eksponeringer, der kunne sammenlignes med eksponeringerne hos mennesker.
English: Carcinogenicity and mutagenicity
Danish: Karcinogenicitet og mutagenicitet
English: Furthermore, a clinical pharmacology study in 36 subjects showed no evidence that photosensitivity was increased following administration of eltrombopag 75 mg.
Danish: Endvidere viste et klinisk farmakologisk studie med 36 individer, at der ikke var evidens for, at fotosensibiliteten øges efter administration af 75 mg eltrombopag.
English: Total bilirubin >1.5 x ULN occurred in 14% of patients.
Danish: Totalbilirubin >1,5 x ULN forekom hos 14 % af patienterne.
English: In addition, patients could taper off concomitant ITP medicinal products and receive rescue treatments as dictated by local standard of care.
Danish: Endvidere kunne patienterne trappe deres anden ITP-medicin ned og modtog ”rescue”-medicin ud fra den lokale standardbehandling.
English: Taking Revolade may make it easier for you to complete a full course of antiviral medicine (peginterferon and ribavirin).
Danish: Hvis du tager Revolade, bliver det lettere for dig at gennemføre et fuldt behandlingsforløb med antivirale lægemidler (peginterferon og ribavirin).
English: An open-label, repeat-dose study (3 cycles of 6 weeks of treatment, followed by 4 weeks off treatment) showed that episodic use with multiple courses of eltrombopag has demonstrated no loss of response.
Danish: Et åbent studie med gentagne doser (3 cykler á 6 ugers behandling efterfulgt af 4 uger uden behandling) viste, at episodisk anvendelse med flere behandlinger med eltrombopag ikke har påvist mangel på respons.
English: After section 6 of this leaflet there are Instructions For Use on how to mix and administer the medicine.
Danish: Efter punkt 6 i denne indlægsseddel er der en brugsanvisning, der viser, medicinen skal blandes og gives.
English: The majority of patients were HCV genotype 1 (64%) and had bridging fibrosis/cirrhosis.
Danish: Størstedelen af patienterne var HCVgenotype 1 (64 %) og havde brodannende fibrose/cirrose.
English: It is also not recommended for people under 18 years with low platelet counts due to hepatitis C or severe aplastic anaemia.
Danish: Det må heller ikke anvendes til personer under 18 år med lavt blodpladetal som følge af hepatitis C eller alvorlig aplastisk anæmi.
English: If your doctor considers that the benefits of taking Revolade outweigh the risks, you will be closely monitored during treatment.
Danish: Hvis lægen vurderer, at fordelene ved at tage Revolade opvejer risikoen, vil du blive fulgt tæt under din behandling.
English: • Slowly push the plunger all the way down so the medicine goes into the child's mouth.
Danish: • Skub langsomt stemplet hele vejen ned, så medicinen flyder ind i barnets mund.
English: The clinical status of the patient and the adverse reaction profile of eltrombopag, including dizziness and lack of alertness, should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor and cognitive skills.
Danish: Patientens kliniske status og indflydelsen af bivirkninger fra eltrombopag, herunder svimmelhed og mangel på agtpågivenhed, skal tages i betragtning, når det overvejes om patienten er i stand til at udføre opgaver, som kræver dømmekraft samt motoriske og kognitive evner.
English: Reported thrombotic/thromboembolic complications included both venous and arterial events.
Danish: Rapporterede trombotiske/tromboemboliske komplikationer inkluderede både venøse og arterielle hændelser.
English: • If you spill any powder or liquid, clean it up with a damp cloth (see step 14 of the instructions).
Danish: • Hvis du spilder pulver eller væske, tørres det op med en fugtig klud (se trin 14 i brugsanvisningen).
English: The clinical relevance of the decrease in Cmin has not been established, increased clinical and laboratory monitoring for HCV suppression is recommended.
Danish: Den kliniske relevans af den lavere Cmin er ikke undersøgt, og øget klinisk monitorering og måling af laboratorieværdier for HCV-suppression anbefales.
English: • Make sure not to spill the powder outside the mixing bottle.
Danish: • Pas på ikke at spilde pulver uden for blandeflasken.
English: At Week 12, the proportion of eltrombopag patients reporting any bleeding was decreased to half of baseline (36%).
Danish: Ved uge 12 var andelen af eltrombopagpatienter, der rapporterede om nogen form for blødning, faldet til halvdelen af baselineværdien (36 %).
English: Effects of eltrombopag on other medicinal products
Danish: Effekt af eltrombopag på andre lægemidler
English: Youwill be monitored for any signs or symptoms of side effects and given appropriate treatment immediately.
Danish: Du vil blive overvåget for tegn og symptomer på bivirkninger og straks få passende behandling.
English: For ENABLE 1, 682 patients were randomised to the antiviral treatment phase; however 2 patients then withdrew consent prior to receiving antiviral therapy.
Danish: I ENABLE 1 blev 1.682 patienter randomiseret til den antivirale behandling, 2 patienter trak dog deres indvilligen tilbage inden opstart af den antivirale behandling.
English: Across the programme, no patients had evidence of clinically relevant bone marrow abnormalities or clinical findings that would indicate bone marrow dysfunction.
Danish: På tværs af programmet var der ingen patienter, der viste tegn på klinisk relevante knoglemarvsabnormiteter eller kliniske fund, der indikerede en dysfunktion af knoglemarven.
English: Revolade can cause changes that show up in blood tests, and may be signs of liver damage.
Danish: Revolade kan give forandringer, som kan ses i blodprøver, og som kan være tegn på leverskade.
English: Dose adjustment or response
Danish: Dosisjustering eller respons
English: Microcrystalline cellulose Povidone
Danish: Mikrokrystallinsk cellulose Povidon
English: More than half of all patients in each treatment group had ≥3 prior ITP therapies and 36% had a prior splenectomy.
Danish: Mere end halvdelen af alle patienter i hver behandlingsgruppe havde tidligere fået ≥ 3 ITP-behandlinger, og 36 % af patienterne var tidligere splenektomererede.
English: Revolade contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists.
Danish: Revolade indeholder eltrombopag, der tilhører en gruppe af lægemidler, som kaldes trombopoietinreceptor-agonister.
English: If you stop taking Revolade
Danish: Hvis du holder op med at tage Revolade
English: No specific temporal relationship between start of treatment and event of TEE were observed.
Danish: Der var ingen specifik sammenhæng mellem, hvornår behandlingen blev opstartet og tidspunktet for hvornår TEE indtraf.
English: • increased pH of urine
Danish: • forhøjet pH i urinen
English: Eighty-six percent of patients were RBC transfusion dependent, and 91% were platelet transfusion dependent.
Danish: 86 % af patienterne var afhængige af erytrocyttransfusion, og 91 % var afhængige af trombocyttransfusion.
English: When eltrombopag is given in combination with antivirals reference should be made to the full summary of product characteristics of the respective coadministered medicinal products for comprehensive details of relevant safety information or contraindications.
Danish: Når eltrombopag gives i kombination med antivirale lægemidler, skal de fulde produktresuméer for de respektive samtidigt administrerede lægemidler konsulteres for at få de fuldstændige detaljer om relevante sikkerhedsoplysninger eller kontraindikationer.
English: When switching between the tablet and powder for oral suspension formulations, platelet counts should be monitored weekly for 2 weeks.
Danish: Ved skift mellem tabletter og pulver til oral susppension skal trombocyttællinger monitoreres ugentligt i 2 uger.
English: • milk or milk shakes, drinks containing milk, yoghurt or cream
Danish: • mælk, milkshakes og andre drikkevarer indeholdende mælk, yoghurt eller fløde
English: Most patients receiving eltrombopag in combination with peginterferon / ribavirin therapy will experience indirect hyperbilirubinaemia.
Danish: De fleste patienter, der får eltrombopag i kombination med peginterferon/ribavirin, vil opleve indirekte hyperbilirubinæmi.
English: The laminate material is comprised of polyester (PET) / orientated polyamide (OPA) / 9 µm aluminium foil (AL) / low density polyethylene heat seal layer (LDPE).
Danish: Laminatmaterialet består af polyester (PET) / orienteret polyamid (OPA) / 9 µm aluminiumsfolie (AL) / lav densitet polyethylen varmeforseglingslag (LDPE).
English: NO dairy products, antacids or mineral supplements
Danish: INGEN mejeriprodukter, syreneutraliserende midler eller mineraltilskud
English: Your doctor will adjust your dose of Revolade to ensure that your platelet count does not become too high.
Danish: Lægen vil justere din dosis af Revolade for at sikre, at dit blodpladetal ikke bliver for højt.
English: Sustained response was seen in 50% of the initial responders during 20 out of 24 weeks in the PETIT 2 study and 15 out of 24 weeks in the PETIT study.
Danish: Der blev observeret vedvarende respons hos 50 % af de initiale respondenter i løbet af 20 ud af 24 uger i PETIT 2 studiet og 15 ud af 24 uger i PETIT studiet.
English: Hepatocyte degeneration and/or necrosis, often accompanied by increased serum liver enzymes, was observed in mice, rats and dogs at doses that were associated with morbidity and mortality or were poorly tolerated.
Danish: Hepatocyt-degenerering og/eller -nekroser, der ofte er ledsaget af et øget niveau af serumleverenzymer, blev observeret hos mus, rotter og hunde i doser, der forbindes med morbiditet og mortalitet eller som tåles dårligt.
English: • Pull back the plunger until all the medicine is in the syringe.
Danish: • Træk stemplet tilbage, indtil al medicinen er i sprøjten.
English: Renal tubular toxicity was observed in studies of up to 14 days duration in mice and rats at exposures that were generally associated with morbidity and mortality.
Danish: Renal tubulær toksicitet blev observeret hos mus og rotter i studier på op til 14 dages varighed ved en eksponering, som generelt forbindes med morbiditet og mortalitet.
English: In conclusion, taking into account the exposure margins based on AUC, a risk of eltrombopag-related cataracts in paediatric patients cannot be excluded.
Danish: Ved at tage eksponeringsmarginer baseret på AUC i betragtning, kan det konkluderes, at en risiko for eltrombopag-relateret katarakt ikke kan udelukkes hos pædiatriske patienter.
English: Eltrombopag does not stimulate platelet production in mice, rats or dogs because of unique TPO receptor specificity.
Danish: Eltrombopag stimulerer ikke trombocytproduktionen hos mus, rotter eller hunde pga. en særlig TPOR-specificitet.
English: Patient platelet count should continue to be monitored and the standard criteria for further dose modification followed.
Danish: Trombocyttallet skal stadig monitoreres, og standardkriterierne for yderligere dosisændringer skal følges.
English: Women of childbearing potential / Contraception in males and females
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder
English: Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician.
Danish: Patienterne skal vurderes klinisk regelmæssigt, og den behandlende læge skal i hvert enkelt tilfælde afgøre, om behandlingen skal fortsætte.
English: If you are taking corticosteroids, danazol, and/or azathioprine you may need to take a lower dose or to stop taking them while you are taking Revolade.
Danish: Hvis du tager kortikosteroider, danazol og/eller azathioprin, skal behandlingen med disse måske reduceres eller stoppes, mens du tager Revolade.
English: A similar platelet response was maintained throughout the study, with 52% and 16% of patients responding at the end of the 6-month treatment period.
Danish: Et lignende trombocytrespons blev bibeholdt i hele studieperioden, svarende til at 52 % og 16 % af patienterne responderede ved afslutningen af den 6 måneders lange behandlingsperiode.
English: There are limited data on the use of Revolade in patients aged 65 years and older.
Danish: Der er begrænset data ved brugen af Revolade hos patienter i alderen 65 år og derover.
English: Your doctor may also carry out tests to directly check your bone marrow during treatment with Revolade.
Danish: Lægen kan også lave tests specifikt med henblik på at tjekke din knoglemarv under behandlingen med Revolade.
English: If you do not have routine eye-tests your doctor should arrange regular testing.
Danish: Hvis du ikke allerede får tjekket dine øjne regelmæssigt, bør din læge arrangere regelmæssige undersøgelser.
English: How to give a dose of medicine
Danish: Sådan gives en dosis medicin
English: • unusual hair loss
Danish: • unormalt hårtab
English: The pharmacokinetics of eltrombopag have been evaluated in 168 paediatric ITP patients dosed once daily in two studies, TRA108062/PETIT and TRA115450/PETIT-2.
Danish: Eltrombopags farmakokinetik er blevet evalueret hos 168 pædiatriske ITP-patienter ved dosering en gang dagligt i to studier, TRA108062/PETIT og TRA115450/PETIT-2.
English: At tolerated doses, no ocular opacities were observed (see above subsection ‘Safety pharmacology and repeat-dose toxicity').
Danish: Der sås ingen okulærer forandringer ved tolererede doser (se afsnit ovenfor ‘Sikkerhedsfarmakologi og toksicitet efter gentagne doser').
English: • Dispose of the cloth and gloves used to clean up the spillage in your household waste.
Danish: • Smid kluden og handskerne, som du har brugt til at tørre spild op, ud i skraldespanden.
English: Common Epistaxis
Danish: Almindelig Epistaxis
English: • confusion, agitation
Danish: Konfusion, agitation
English: In case of an overdose, consideration should be given to oral administration of a metal cation-containing preparation, such as calcium, aluminium, or magnesium preparations to chelate eltrombopag and thus limit absorption.
Danish: I tilfælde af en overdosis bør oral administration af et metallisk kation-holdigt præparat overvejes, f.eks. calcium, aluminium eller magnesium, for at chelere eltrombopag og således begrænse absorptionen.
English: • increased blood sugar (glucose)
Danish: • forhøjet blodsukker (glucose)
English: A QTc study in healthy volunteers dosed 150 mg eltrombopag per day did not show a clinically significant effect on cardiac repolarisation.
Danish: Et QT-studie med raske frivillige, som fik 150 mg eltrombopag om dagen, viste ikke klinisk signifikant påvirkning af hjertets repolarisering.
English: The remaining 5 patients discontinued treatment, three due to relapse at the month 3 extension visit.
Danish: De resterende 5 patienter afbrød behandlingen, tre på grund af tilbagefald ved 3. månedersbesøget i forlængelsesfasen.
English: How to take the tablets Swallow the tablet whole, with some water.
Danish: Sådan skal du tage tabletterne Synk tabletten hel sammen med vand.