FrancophonIA/ELRC3.0 huggingface dataset:
English: Because eltrombopag is not significantly renally excreted and is highly bound to plasma proteins, haemodialysis would not be expected to be an effective method to enhance the elimination of eltrombopag.
Danish: Da eltrombopag ikke udskilles i signifikant grad gennem nyrerne, og i høj grad er bundet til plasmaproteiner, forventes hæmodialyse ikke at være en effektiv metode til at forbedre udskillelsen af eltrombopag.
English: Dispose of the unused mixture in your household waste; don't pour it down the drain.
Danish: Smid den ubrugte blanding i skraldespanden; den må ikke hældes i afløbet.
English: Eltrombopag is a substrate for BCRP, but is not a substrate for P-glycoprotein or OATP1B1.
Danish: Eltrombopag er et substrat for BCRP, men er ikke et substrat for P-glykoprotein eller OATP1B1.
English: • Revolade may also be used to treat adult patients with low blood counts caused by severe aplastic anaemia (SAA).
Danish: • Revolade kan også bruges til at behandle voksne patienter med lave blodtal som følge af svær aplastisk anæmi (SAA).
English: The predominant route of eltrombopag excretion is via faeces (59%) with 31% of the dose found in the urine as metabolites.
Danish: Den vigtigste udskillelsesvej for eltrombopag er via fæces (59 %), og 31 % af dosis blev fundet i urinen som metabolitter.
English: Give the medicine to the child immediately after you have mixed the powder with water.
Danish: Giv barnet medicinen straks, efter at du har blandet pulveret med vand.
English: Following discontinuation of eltrombopag, platelet counts return to baseline levels within 2 weeks in the majority of patients, which increases the bleeding risk and in some cases may lead to bleeding.
Danish: Efter seponeringen vender trombocyttallet tilbage til udgangsniveauet i løbet af 2 uger hos de fleste patienter, hvilket øger blødningsrisikoen og i visse tilfælde kan føre til blødning.
English: Your doctor will check your platelet count for at least 4 weeks after you stop taking Revolade.
Danish: Lægen vil tjekke dit blodpladetal i mindst 4 uger efter du er stoppet behandlingen med Revolade.
English: In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.
Danish: I tilfælde af overdosis kan trombocyttallet stige voldsomt og resultere i trombotiske/tromboemboliske komplikationer.
English: Preliminary results from a supportive study (Study ELT116826), an ongoing non-randomised, phase II, single-arm, open-label study in refractory SAA patients, showed consistent results.
Danish: Præliminære resultater fra et understøttende studie (Study ELT116826), et igangværende ikkerandomiseret, åbent fase II-enkeltgruppestudie hos refraktære SAA-patienter, viste konsistente resultater.
English: After mixing, Revolade oral suspension should be administered immediately, but may be stored for no more than 30 minutes at room temperature.
Danish: Når blandingen er lavet, skal Revolade oral suspension skal anvendes straks, men kan opbevares i højst 30 minutter ved stuetemperatur.
English: If counts remain stable after 8 weeks at the reduced dose, then eltrombopag must be discontinued and blood counts monitored.
Danish: Hvis blodtallene forbliver stabile efter 8 uger ved den nedsatte dosis, skal eltrombopag seponeres, og blodtallene monitoreres.
English: If your doctor advises you to stop treatment, your platelet count will then be checked each week for four weeks.
Danish: Anbefaler lægen, at du skal stoppe behandlingen, vil dit blodpladetal blive tjekket ugentligt i fire uger.
English: 9/l and absolute reticulocyte count was 24.3 x 10
Danish: 9/l, og det absolutte retikulocyttal var 24,3 x 10
English: Your doctor will carry out tests to check that you do not have this blood condition before you start Revolade.
Danish: Din læge vil teste dit blod for at tjekke, at du ikke har denne blodsygdom, inden du starter behandling med Revolade.
English: Eltrombopag may increase the risk for development or progression of reticulin fibres within the bone marrow.
Danish: Eltrombopag kan muligvis øge risikoen for udvikling eller progression af retikulinfibre i knoglemarven.
English: Fifty-four percent of the eltrombopag-treated patients and 13% of placebo-treated patients achieved this level of response after 6 weeks of treatment.
Danish: 54 % af patienterne, der blev behandlet med eltrombopag, og 13 % af de placebobehandlede patienter nåede dette responsniveau efter 6 ugers behandling.
English: • skin problems including small red or purple spots caused by bleeding into the skin (petechiae)
Danish: • hudproblemer herunder små røde eller lilla prikker, der skyldes blødning i huden (petekkier)
English: • foamy, frothy or bubbly-looking urine (signs of protein in urine)
Danish: • skummende eller bobblende-lignende urin (tegn på protein i urinen)
English: Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the study and 53% (8/15) of patients were able to reduce (n=1) or discontinue (n=7) baseline ITP therapy, mainly corticosteroids, without needing rescue therapy.
Danish: Patienterne fik først lov til at reducere eller afbryde deres baseline ITP-behandling under studiets åbne fase, og 53 % (8/15) af patienterne kunne reducere (n = 1) eller afbryde (n = 7) baseline ITPbehandlingen, hovedsagelig kortikosteroider, uden behov for redningsmedicin.
English: p-value a a Logistic regression model adjusted for randomisation stratification variables
Danish: p-værdi a a Logistisk regressionsmodel justeret for stratificeringsvariable i randomiseringen
English: The risk-benefit balance should be considered in patients at risk of TEEs of any aetiology.
Danish: Balancen mellem fordele og ulemper skal overvejes hos patienter med risiko for TEEs af enhver ætiologi.
English: For more information, see ‘When to take it' in section 3.
Danish: For yderligere oplysninger se under punkt 3 ‘Hvornår skal du tage Revolade'.
English: Treatment with eltrombopag should be reinitiated in accordance with dosing and administration recommendations (see section 4.2).
Danish: Behandlingen med eltrombopag bør påbegyndes igen i overensstemmelse med doserings- og administrationsanbefalingerne (se pkt.
English: The efficacy and safety of eltrombopag for the treatment of thrombocytopenia in patients with HCV infection were evaluated in two randomised, double-blind, placebo-controlled studies.
Danish: Effekt og sikkerhed ved eltrombopag i behandling af trombocytopeni hos patienter med HCVinfektion blev vurderet i to randomiserede, dobbeltblindede og placebokontrollerede studier.
English: Check with your doctor if you think this applies to you.
Danish: Tal med lægen, hvis du mener, dette gælder for dig.
English: Dose adjustment is not required when eltrombopag is co-administered with either telaprevir or boceprevir.
Danish: Dosisjustering er ikke nødvendig, hverken når eltrombopag administreres sammen med telaprevir eller bonceprevir.
English: • changes in the enzymes that control blood clotting
Danish: • ændringer af de enzymer som styrer blodets størkningsevne
English: No specific risk factors were identified in those patients who experienced a TEE with the exception of platelet counts ≥200,000/µl (see section 4.4).
Danish: Der blev ikke identificeret nogen specifikke risikofaktorer hos patienter, der oplevede en TEE, med undtagelse af trombocyttal ≥ 200.000 pr. µl (se pkt.
English: Novartis Pharma GmbH, Roonstraße 25, D-90429 Nuremberg, Germany
Danish: Novartis Pharma GmbH, Roonstraße 25, D-90429 Nürnberg, Tyskland
English: Clinical studies comparing eltrombopag to other treatment options (e.g. splenectomy) have not been conducted.
Danish: Der er ikke udført kliniske studier, der sammenligner eltrombopag med andre behandlingsmuligheder (f.eks. splenektomi).
English: The primary endpoint was haematological response assessed after 12 weeks of eltrombopag treatment.
Danish: Det primære endepunkt var hæmatologisk respons vurderet efter 12 ugers behandling med eltrombopag.
English: 1 to 5 years (n=38)
Danish: 1 til 5 år (n = 38)
English: PETIT2 (TRA115450) was a 2-part, double-blind and open-label, randomised, placebo-controlled study.
Danish: PETIT2 (TRA115450) var et 2-delt, dobbeltblindet og åbent, randomiseret, placebokontrolleret studie.
English: Care should be taken when using Revolade if you are aged 65 years or above.
Danish: Du bør udvise forsigtighed, hvis du er 65 år eller derover.
English: The diagnosis of ITP or SAA in adults and elderly patients should be confirmed by the exclusion of other clinical entities presenting with thrombocytopenia, in particular the diagnosis of MDS must be excluded.
Danish: En ITP- eller SAA-diagnose hos voksne og ældre patienter bør bekræftes ved udelukkelse af andre kliniske diagnoser forbundet med trombocytopeni - især skal MDS-diagnosen udelukkes.
English: Six patients had cytogenetic abnormality at Month 3 of eltrombopag therapy and one patient had cytogenetic abnormality at Month 6.
Danish: Seks patienter havde cytogenetisk anomalitet ved måned 3 af behandling med eltrombopag, og en patient havde cytogenetisk anomalitet ved måned 6.
English: It is not known whether eltrombopag increases the risk of cytogenetic abnormalities in patients with SAA.
Danish: Det vides ikke, hvorvidt eltrombopag øger risikoen for cytogenetiske anomalier hos patienter med SAA.
English: Clinically significant drug interactions involving glucuronidation are not anticipated due to limited contribution of individual UGT enzymes in the glucuronidation of eltrombopag.
Danish: Klinisk signifikante lægemiddelinteraktioner, der involverer glukuronidisering, forventes ikke pga. et begrænset bidrag af de enkeltstående UGT-enzymer ved glukuronideringen af eltrombopag.
English: Other medicines and Revolade
Danish: Brug af anden medicin sammen med Revolade
English: • changes in the shape of red blood cells
Danish: • ændringer i formen af de røde blodlegemer
English: Risk of hepatotoxicity
Danish: Risiko for hepatotoksicitet
English: Do not re-use the oral dosing syringe.
Danish: Genbrug ikke den orale doseringssprøjte.
English: • medicines such as methotrexate and topotecan, to treat cancer Talk to your doctor if you take any of these.
Danish: • methotrexat og topotecan til behandling af kræft Fortæl lægen, hvis du tager nogen af ovenstående præparater.
English: Patients are analysed according to the treatment received (total safety double-blind population, Revolade n=955 and placebo n=484).
Danish: Patienterne er analyseret i henhold til den behandling de har fået (total dobbeltblindet sikkerhedspopulation, Revolade n = 955 og placebo n = 484).
English: HCV study population (in combination with anti-viral interferon and ribavirin therapy)
Danish: Population i HCV-studierne (i kombination med antiviral interferon og ribavirin behandling)
English: Medicinal products that inhibit or induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations, whereas medicinal products that inhibit or induce multiple enzymes have the potential to increase (e.g. fluvoxamine) or decrease (e.g. rifampicin) eltrombopag concentrations.
Danish: Lægemidler, der hæmmer eller inducerer et enkelt enzym, påvirker med lille sandsynlighed signifikant plasmakoncentrationen af eltrombopag, hvorimod lægemidler, der hæmmer eller inducerer flere enzymer, potentialt kan øge (f.eks. fluvoxamin) eller sænke (f.eks. rifampicin) koncentrationen af eltrombopag.
English: The product contact material is the polyethylene heat seal layer.
Danish: Kontaktmaterialet er polyethylen varmeforseglingslaget.
English: The other ingredients are: mannitol, sucralose and xanthan gum.
Danish: Øvrige indholdsstoffer: mannitol, sucralose og xanthangummi.
English: Eltrombopag is metabolised through multiple pathways including CYP1A2, CYP2C8, UGT1A1, and UGT1A3 (see section 5.2).
Danish: Eltrombopag metaboliseres via mange pathways, herunder CYP1A2, CYP2C8, UGT1A1 og UGT1A3 (se pkt.
English: Unbound eltrombopag (active) concentrations for this highly protein-bound medicinal product were not measured.
Danish: Ubundne koncentrationer af eltrombopag (aktiv), der er et stærkt proteinbundet lægemiddel, blev ikke målt.
English: Get medical help immediately if you develop signs and symptoms of a blood clot, such as:
Danish: Søg straks lægehjælp, hvis du oplever tegn eller symptomer på en blodprop, som f.eks.:
English: Unchanged eltrombopag excreted in faeces accounts for approximately 20% of the dose.
Danish: Uomdannet eltrombopag udskilt i fæces udgør ca. 20 % af dosis.
English: See also ‘Bleeding or bruising after you stop treatment' in section 4.
Danish: Se også ‘Blødninger og blå mærker, efter at du er stoppet behandlingen' under punkt 4.
English: • fast or irregular heartbeat (palpitations), shortness of breath
Danish: • hurtig eller uregelmæssig puls (palpitationer), åndenød
English: • Tap the top of each sachet to make sure the contents fall to the bottom
Danish: • Slå blødt på toppen af hvert brev for at sikre at indholdet falder ned i bunden af brevet.
English: Consideration should be given to performing a bone marrow aspirate and biopsy over the course of the disease and treatment, particularly in patients over 60 years of age, those with systemic symptoms, or abnormal signs such as increased peripheral blast cells.
Danish: Det bør overvejes at udføre knoglemarvsaspiration og -biopsi i løbet af sygdommen og behandlingen - især hos patienter over 60 år samt hos patienter med systemiske symptomer eller unormale tegn som f.eks. øget antal perifere blastceller.
English: Your doctor will recommend that you are checked for cataracts.
Danish: Lægen vil anbefale, at du bliver kontrolleret for grå stær.
English: Some everyday medicines interact with Revolade - including prescription and non-prescription medicines and minerals.
Danish: Andre lægemidler kan påvirke virkningen af Revolade - herunder både receptpligtige og ikkereceptpligtige lægemidler samt mineraler.
English: Eye examinations
Danish: Øjenundersøgelser
English: The risk of TEEs has been found to be increased in patients with chronic liver disease (CLD) treated with 75 mg eltrombopag once daily for 2 weeks in preparation for invasive procedures.
Danish: Det er fundet, at risikoen for TEEs øges hos patienter med kronisk leversygdom (CLD), der behandles med 75 mg eltrombopag én gang daglig i 2 uger forud for invasive indgreb.
English: • blisters in the mouth
Danish: • blister i munden
English: • increased levels of total protein
Danish: • forhøjede niveauer af total protein
English: Liver problems (increased enzymes showing up in blood tests) are common and may affect up to 1 in 10 people.
Danish: Leverproblemer (stigning i enzymer målt i blodprøver) er almindelige og kan forekomme hos op til 1 ud af 10 personer.
English: Blood tests for liver function
Danish: Blodprøver for at teste leverfunktionen
English: Powder for oral suspension
Danish: Pulver til oral suspension
English: Common Anxiety, depression
Danish: Almindelig Angst, depression
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Danish: Bivirkningerne er opstillet efter frekvens inden for hver systemorganklasse med den mest hyppige først.
English: Make sure the cap is firmly pushed onto the lid, so it is closed.
Danish: Sørg for, at hætten trykkes helt ned i låget, så det er lukket.
English: Interactions are also expected with other HMG-CoA reductase inhibitors, including atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin.
Danish: Interaktioner forventes også med andre HMG-CoA-reduktasehæmmere inklusive atorvastatin, fluvastatin, lovastatin, pravastatin og simvastatin.
English: Following identification of a stable dose of eltrombopag, full blood count (FBC) with white blood cell count (WBC) differential should be performed monthly.
Danish: Efter fastlæggelse af en stabil dosis eltrombopag skal komplet blodtælling (CBC) med differentialtælling for hvide blodlegemer foretages hver måned.
English: Over 50% of responders who were transfusion-dependent at baseline, had >80% reduction in both platelet and RBC transfusion requirements compared to baseline.
Danish: Over 50 % af de responderende patienter, som var transfusionsafhængige ved baseline, havde en reduktion på > 80 % for transfusion af både trombocytter og erytrocytter sammenlignet med baseline.
English: If you do not use it within 30 minutes of mixing it, you will need to mix a new dose.
Danish: Hvis du ikke bruger den inden for 30 minutter efter blanding, skal du blande en ny dosis.
English: • increased number of myelocytes
Danish: • forhøjet antal myelocytter
English: Effects of other medicinal products on eltrombopag
Danish: Effekt af andre lægemidler på eltrombopag
English: • the loss of function of part of the lung caused by a blockage in the lung artery
Danish: • tab af funktion i dele af lungerne pga. en blokering i lungearterierne
English: Eltrombopag treatment delayed and reduced the number of peginterferon dose reductions.
Danish: Behandling med eltrombopag udsatte og reducerede antallet af dosisreduktioner af peginterferon.
English: Serum alanine aminotransferase (ALT), aspartate aminotrasferase (AST) and bilirubin should be measured prior to initiation of eltrombopag, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose.
Danish: Serum-alaninaminotransferase (ALAT), -aspartataminotranferase (ASAT) og -bilirubin skal måles, før behandling med eltrombopag indledes, og derefter hver anden uge i dosisjusteringsfasen samt hver måned, når en stabil dosis er nået.
English: At baseline, 71% of patients in the eltrombopag group and 69% in the placebo group reported any bleeding (WHO Grades 1-4).
Danish: Ved baseline rapporterede 71 % af patienterne i eltrombopag-gruppen og 69 % i placebogruppen om nogen form for blødning (WHO grad 1-4).
English: In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting eltrombopag and decreased within 1 to 2 weeks after discontinuation.
Danish: I kliniske studier steg trombocyttallene generelt inden for 1 til 2 uger efter opstart af eltrombopag og faldt 1 til 2 uger efter seponering.
English: During antiviral therapy, the aim of treatment should be to keep platelet counts at a level that prevents the risk of bleeding complications, normally around 50,000-75,000/µl.
Danish: Under den antivirale behandling bør formålet med behandlingen være at fastholde trombocyttallet på et niveau, som forebygger risikoen for blødningskomplikationer, normalt ca. 50.000-75.000 pr. µl.
English: The median time to achieve the target platelet count ≥90,000/µl (ENABLE 1) or ≥100,000/µl (ENABLE 2) was 2 weeks.
Danish: Mediantiden til opnåelse af det tilsigtede trombocyttal på ≥ 90.000 pr. µl (ENABLE 1) eller ≥ 100.000 pr. µl (ENABLE 2) var 2 uger.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom
Danish: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Storbritannien
English: The lowest dose of eltrombopag needed to achieve the targets should be used.
Danish: Den laveste dosis af eltrombopag, hvormed formålet opnås, skal anvendes.
English: †, dysuria
Danish: †, dysuri
English: Treatment-related cataracts were detected in rodents and were dose and time-dependent.
Danish: Behandlingsrelateret katarakt sås hos gnavere og var dosis- og tidsafhængig.
English: 30 sachets of powder
Danish: 30 breve med pulver
English: Empty water into open mixing bottle • Slowly pushing the plunger all the way into the syringe.
Danish: Tøm vandet ned i den åbne blandeflaske • Tryk langsomt stemplet helt ind i sprøjten.
English: • including yellowing of the eyes and skin (see ‘Liver problems' earlier in section 4)
Danish: • herunder gulfarvning af øjnene og huden ( se ‘Leverproblemer' tidligere i punkt 4)
English: The objective of treatment with eltrombopag should not be to normalise platelet counts.
Danish: Målet for behandlingen med eltrombopag bør ikke være at normalisere trombocyttallet.
English: • increased number of white blood cells (leukocytosis)
Danish: • forhøjet antal hvide blodlegemer (leukocytose)
English: If the abnormalities are confirmed, serum liver tests should be monitored until the abnormalities resolve, stabilise, or return to baseline levels.
Danish: Hvis de unormale levertal bekræftes, skal serum-levertallene monitoreres, indtil de ikke længere er unormale, de stabiliserer sig, eller de vender tilbage til udgangsniveauet.
English: Signs of bone marrow changes may show up as abnormal results in your blood tests.
Danish: Tegn på knoglemarvsforandringer kan vise sig som anormale resultater i dine blodprøver.
English: Uncommon Rectosigmoid cancer
Danish: Rektosigmoid cancer
English: • accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
Danish: • ledsages af kliniske symptomer på leverskader eller tegn på hepatisk dekompensation.
English: • pain in the nose and throat
Danish: • ondt i næsen og halsen
English: • sudden shortness of breath, especially when accompanied with sharp pain in the chest and /or rapid breathing, which could be signs of a blood clot in the lungs (see ‘Higher risk of blood clots' earlier in section 4)
Danish: • pludselig åndenød, især når den er ledsaget af en skarp smerte i brystet og/eller hurtig vejrtrækning, det kan være tegn på en blodprop i lungerne (se ‘Øget risiko for blodpropper'
English: Platelet count should be monitored at least weekly for 2 to 3 weeks when eltrombopag is co-administered with ciclosporin.
Danish: Trombocyttallet bør monitoreres mindst en gang om ugen i 2-3 uger, når eltrombopag administreres samtidigt med ciclosporin.
English: Paediatric population (aged 1 to 17 years)
Danish: Pædiatrisk population (i alderen 1 til 17 år)
English: Add the powder from the prescribed number of sachets to the bottle.
Danish: Hæld pulveret fra det ordinerede antal breve ned i flasken.
English: A total of 14 patients entered the extension phase of the trial.
Danish: I alt indgik 14 patienter i studiets forlængelsesfase.
English: In the in vitro mouse lymphoma assay, eltrombopag was marginally positive (<3-fold increase in mutation frequency).
Danish: I in vitro-analysen med muselymfomer var eltrombopag marginalt positivt (< 3 gange forøget mutationshyppighed).
English: • Revolade can also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infections, if they have had problems with side effects while on interferon treatment.
Danish: • Revolade kan også bruges til at behandle et lavt trombocyttal (trombocytopeni) hos patienter med hepatitis C-virus (HCV)-infektion, hvis de har haft problemer med bivirkninger under interferonbehandling.
English: Treatment with eltrombopag should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of eltrombopag therapy at 75 mg once daily.
Danish: Eltrombopag skal seponeres, hvis trombocyttallet ikke stiger til et niveau, der er tilstrækkeligt til at undgå klinisk vigtig blødning efter 4 ugers behandling med 75 mg eltrombopag daglig.
English: Nausea, diarrhoea
Danish: Kvalme, diarré
English: Plasma eltrombopag AUC(0-) and Cmax estimates for ITP patients are presented (Table 8).
Danish: Plasma-eltrombopag-AUC(0-)- og Cmax-estimater for ITPpatienter er vist (tabel 8).
English: Cohort 3 (1 to 5 years)
Danish: Kohorte 3 (1 til 5 år)
English: Minor metabolites due to glucuronidation and oxidation were also detected.
Danish: Der blev også observeret en ubetydelig mængde metabolitter pga. glukuronidering og oxidering.
English: In people who have problems with their bone marrow, medicines like Revolade could make the problems worse.
Danish: Hos personer som har problemer med deres knoglemarv, kan lægemidler som Revolade gøre disse problemer værre.
English: Platelet count should be closely monitored in order to ensure appropriate medical management of the dose of eltrombopag when lopinavir/ritonavir therapy is initiated or discontinued.
Danish: Trombocyttallet skal monitoreres tæt for at sikre den mest hensigtsmæssige dosis af eltrombopag, når lopinavir/ritonavir-behandling påbegyndes eller stoppes.