FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).
Danish: Der forventes ingen klinisk signifikante interaktioner ved samtidig administration af eltrombopag og CYP450-substrater (se pkt.
English: Co-administration of eltrombopag with lopinavir/ritonavir may cause a decrease in the concentration of eltrombopag.
Danish: Samtidig administration af eltrombopag og lopinavir/ritonavir kan medføre et fald i koncentrationen af eltrombopag.
English: N AUC(0-)
Danish: AUC(0-)
English: In clinical studies with eltrombopag in SAA, 4% of patients (5/133) were diagnosed with MDS.
Danish: I kliniske SAA-studier med eltrombopag blev 4 % af patienterne (5/133) diagnosticeret med MDS.
English: ATC code: B02BX 05.
Danish: Farmakoterapeutisk klassifikation: Anti-hæmoragisk middel, ATC-kode: B02BX 05.
English: Patients achieving target platelet counts and initiating antiviral therapy c
Danish: Patienter, der opnåede det tilsigtede trombocyttal og indledte antiviral behandling c
English: There is a theoretical concern that TPO-R agonists may stimulate the progression of existing haematological malignancies such as MDS.
Danish: Der er en teoretisk bekymring for at TPO-R-agonister kan stimulere progression af eksisterende hæmatologiske maligniteter såsom MDS.
English: What you need to know before you take Revolade
Danish: Det skal du vide, før du begynder at tage Revolade
English: Of the 714 patients, 642 were with mild hepatic impairment, 67 with moderate hepatic impairment, and 2 with severe hepatic impairment.
Danish: Af de 714 patienter havde 642 let nedsat leverfunktion, 67 havde moderat nedsat leverfunktion, og 2 havde svært nedsat leverfunktion.
English: 12 to 17 years (n=62)
Danish: 12 til 17 år (n = 62)
English: Do not take Revolade with dairy foods or drinks as the calcium in dairy products affects the absorption of the medicine.
Danish: Brug af Revolade sammen med mad og drikke Tag ikke Revolade sammen med mad og drikke, da calciumindholdet i mejeriprodukter påvirker optagelsen af medicinen.
English: TPO-R agonists are growth factors that lead to thrombopoietic progenitor cell expansion, differentiation and platelet production.
Danish: TPO-R-agonister er vækstfaktorer, som fører til trombopoietisk progenitorcelle-ekspansion, differentiering og trombocytdannelse.
English: During treatment with eltrombopag 59% (23/39) became platelet transfusion independent (28 days without platelet transfusion) and 27% (10/37) became RBC transfusion independent (56 days without RBC transfusion).
Danish: Under behandlingen med eltrombopag blev 59 % (23/39) uafhængige af trombocyttransfusion (28 dage uden trombocyttransfusion), og 27 % (10/37) blev uafhængige af erytrocyttransfusion (56 dage uden erytrocyttransfusion).
English: Additional adverse reactions observed in paediatric studies (aged 1to 17 years).
Danish: Yderligere bivirkninger observeret i pædiatriske studier (i alderen 1 til 17 år).
English: 1 reusable mixing bottle with lid and cap (notethe mixing bottle may become stained)
Danish: 1 genanvendelig blandeflaske med låg og hætte (bemærk - blandeflasken kan blive misfarvet)
English: The most common adverse reactions occurring in at least 10% of patients included nausea, diarrhoea and increased alanine aminotransferase.
Danish: De mest almindelige bivirkninger, som forekom hos mindst 10 % af patienterne inkluderede kvalme, diarré og forhøjet alaninaminotransferase.
English: Prior to initiation of eltrombopag, the peripheral blood smear should be examined closely to establish a baseline level of cellular morphologic abnormalities.
Danish: Før behandling med eltrombopag indledes, skal den perifere blodudstrygning undersøges nøje med henblik på at fastlægge et udgangsniveau for cellemorfologiske abnormiteter.
English: Statistically fewer eltrombopag patients required rescue treatment during the randomised period compared to placebo patients (19% [12/63] vs. 24% [7/29], p=0.032).
Danish: Statistisk set havde færre eltrombopagpatienter behov for redningsmedicin under den randomiserede periode sammenlignet med placbopatienterne (19 % [12/63] vs. 24 % [7/29], p = 0,032).
English: Loss of response to eltrombopag
Danish: Manglende respons på eltrombopag
English: • Rinse the mixing bottle and lid under running water.
Danish: • Skyl blandeflasken og låget under rindende vand.
English: Following discontinuation of therapy, patients should be monitored for any signs or symptoms of gastrointestinal bleeding.
Danish: Efter seponering af behandling skal patienterne observeres for tegn og symptomer på gastrointestinal blødning.
English: • Add 10 ml of water to the mixing bottle and mix gently.
Danish: • Tilsæt 10 ml vand til blandeflasken og bland forsigtigt.
English: • increased levels of some proteins
Danish: • forhøjede niveauer af nogle proteiner
English: People who have low platelet counts as well as advanced chronic (long-term) liver disease are more at risk of side effects, including life-threatening liver damage and blood clots.
Danish: Personer med lavt trombocyttal og fremskreden kronisk (langvarig) leversygdom har større risiko for bivirkninger, herunder livstruende leverskader og blodpropper.
English: If new cytogenetic abnormalities are detected, it must be evaluated whether continuation of eltrombopag is appropriate.
Danish: Hvis der ses nye cytogenetiske anomalier, skal det vurderes, hvorvidt det er hensigtsmæssigt at fortsætte eltrombopag.
English: The median baseline platelet count was 19,000/l prior to eltrombopag administration.
Danish: Det mediane trombocyttal ved baseline var 19.000 pr. µl før administration af eltrombopag.
English: In HCV clinical studies, a higher incidence of gastrointestinal bleeding, including serious and fatal cases, was reported following discontinuation of peginterferon, ribavirin, and eltrombopag.
Danish: I kliniske studier med HCV-patienter blev gastrointestinal blødning, herunder alvorlige og dødelige tilfælde, rapporteret med en højere incidens efter seponering af peginterferon, ribavirin og eltrombopag.
English: The safety and efficacy of eltrombopag has not been established in children and adolescents (<18 years) with chronic HCV related thrombocytopenia or SAA.
Danish: Eltrombopags sikkerhed og virkning hos børn og unge (< 18 år) med kronisk HCV-relateret trombocytopeni eller SAA er ikke klarlagt.
English: • problems with the nose, throat and sinuses, breathing problems when sleeping
Danish: • problemer med næsen, halsen og bihulerne, vejrtrækningsproblemer under søvn
English: If possible show them the pack, or this leaflet.
Danish: Vis pakken eller denne indlægsseddel, hvis det er muligt.
English: Cohort 2 (6 to 11 years)
Danish: Kohorte 2 (6 til 11 år)
English: • irritation and inflammation (swelling) of the sinuses
Danish: • irritation og inflammation (hævelse) i bihulerne
English: • Use a reliable method of contraception while you're taking Revolade, to prevent pregnancy
Danish: • Brug sikker prævention for at undgå at blive gravid, mens du er i behandling med Revolade.
English: Based on urinary excretion and metabolites eliminated in faeces, the oral absorption of drug-related material following administration of a single 75 mg eltrombopag solution dose was estimated to be at least 52%.
Danish: Ud fra udskillelsen i urinen og metabolitter i fæces blev den orale absorption af lægemidlet anslået til at være mindst 52 % efter administration af en enkelt 75 mg eltrombopag-opløsning.
English: The median time to diagnosis was 3 months from the start of eltrombopag treatment.
Danish: Mediantiden, til diagnosen blev stillet, var 3 måneder fra behandlingsstart med eltrombopag.
English: The safety of Revolade in paediatric patients (aged 1 to 17 years) with previously treated ITP has been demonstrated in two studies.
Danish: Sikkerheden af Revolade hos pædiatriske patienter (i alderen 1 til 17 år) med tidligere behandlet ITP er blevet undersøgt i to studier.
English: The powder for oral suspension may lead to higher eltrombopag exposure than the tablet formulation (see section 5.2).
Danish: Pulveret til oral suspension kan medføre højere eksponering for eltrombopag end tabletformuleringerne (se pkt.
English: The standard eltrombopag dose adjustment, either decrease or increase, would be 25 mg once daily.
Danish: Den normale dosisjustering af eltrombopag - enten forøgelse eller reduktion - er 25 mg én gang daglig.
English: • decreased number of eosinophils
Danish: • nedsat antal eosinofiler
English: You may choose to wear disposable gloves so your skin doesn't get stained.
Danish: Du kan eventuelt bruge engangshandsker, så du ikke får noget på huden.
English: In a relative bioavailability study in adults, the eltrombopag powder for oral suspension delivered 22% higher plasma AUC(0-) than the film-coated tablet formulation.
Danish: I et studie af relativ biotilgængelighed hos voksne gav eltrombopagpulver til oral suspension 22 % højere plasma AUC(0-) end den filmovertrukne tabletformulering.
English: Eltrombopag can be administered in addition to other ITP medicinal products.
Danish: Eltrombopag kan gives sammen med andre ITP-lægemidler.
English: Food low in calcium (<50 mg calcium), including fruit, lean ham, beef and unfortified (no added calcium, magnesium or iron) fruit juice, unfortified soya milk and unfortified grain, did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content (see sections 4.2 and 4.5).
Danish: Calciumfattige fødevarer (< 50 mg calcium), herunder frugt, mager skinke, oksekød og ikke-beriget (ikke tilsat calcium, magnesium eller jern) frugtjuice, ikke-beriget sojamælk og ikke-beriget korn påvirkede ikke plasmaeksponeringen for eltrombopag i signifikant grad uanset kalorie- og fedtindhold (se pkt.
English: Eltrombopag was detected in the plasma of all F1 rat pups for the entire 22 hour sampling period following administration of medicinal product to the F0 dams, suggesting that rat pup exposure to eltrombopag was likely via lactation.
Danish: Eltrombopag blev fundet i plasma hos alle F1rotteunger i hele den 22 timers prøvetagningsperiode efter administration af lægemidlet til F0moderen, hvilket tyder på, at rotteynglen vil optage eltrombopag gennem diegivningen.
English: Based on a human study with radiolabelled eltrombopag, glucuronidation plays a minor role in the metabolism of eltrombopag.
Danish: Ud fra et humant studie med radioaktivt mærket eltrombopag er det fundet, at glukuronidering spiller en mindre rolle i eltrombopags metabolisme.
English: • Give the entire contents of the bottle to the patient using the same oral syringe.
Danish: • Hele flaskens indhold administreres til patienten ved hjælp af den samme orale sprøjte.
English: If immature or dysplastic cells are observed, peripheral blood smears should be examined for new or worsening morphological abnormalities (e.g. teardrop and nucleated red blood cells, immature white blood cells) or cytopenia(s).
Danish: Hvis der ses umodne eller dysplastiske celler, skal den perifere blodudstrygning undersøges igen for nye eller forværrede morfologiske abnormiteter (f.eks. dråbeformede, røde blodlegemer med kerne eller umodne hvide blodlegemer) eller cytopeni(er).
English: Pack size of 30 sachets.
Danish: Pakningsstørrelse på 30 breve.
English: • unusually dark-coloured urine tell your doctor immediately.
Danish: • din urin bliver usædvanlig mørk  skal du straks fortælle det til lægen
English: Eltrombopag should only be administered to such patients after careful consideration of the expected benefits in comparison with the risks.
Danish: Eltrombopag skal kun administreres til sådanne patienter efter grundig overvejelse af forventede fordele i forhold til risici.
English: Mannitol (E421) Sucralose Xanthan gum
Danish: Mannitol (E421) Sucralose Xanthangummi
English: Serum discolouration and interference with total bilirubin and creatinine testing have been reported in patients taking Revolade.
Danish: Der er blevet rapporteret misfarvning af serum og påvirkning af total bilirubin- og kreatininundersøgelser hos patienter, der tager Revolade.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet efter EXP.
English: Hepatic decompensation in patients with chronic hepatitis C: Monitoring is required in patients with low albumin levels (≤35 g/l) or with MELD score ≥10 at baseline.
Danish: Dekompenseret leversygdom hos patienter med kronisk hepatitis C: Det er nødvendigt at monitorere patienter med lave albumin-niveauer (≤ 35 g/l) eller med MELD-score ≥ 10 ved baseline.
English: If you are also taking medicines to prevent blood clots, there is a greater risk of bleeding.
Danish: Hvis du tager medicin, som forebygger blodpropper, har du øget risiko for blødninger.
English: Do not take Revolade
Danish: Tag ikke Revolade
English: The aim of treatment with eltrombopag should be to achieve the minimum level of platelet counts needed to initiate antiviral therapy, in adherence to clinical practice recommendations.
Danish: Formålet med eltrombopagbehandling bør være at opnå det laveste trombocytniveau, som er nødvendig for at kunne opstarte antiviral behandling i overensstemmelse med de kliniske retningslinjer.
English: Eltrombopag dose (once daily)
Danish: Eltrombopag-dosis (én gang daglig)
English: If the patient develops new or worsening morphological abnormalities or cytopenia(s), treatment with eltrombopag should be discontinued and a bone marrow biopsy considered, including staining for fibrosis.
Danish: Hvis patienten udvikler nye eller forværrede morfologiske abnormiteter eller cytopeni(er), skal behandlingen med eltrombopag standses, og knoglemarvsbiopsi inklusive farvning for fibrose skal overvejes.
English: Revolade 12.5 mg and 25 mg film-coated tablets also contain polysorbate 80 (E433).
Danish: Revolade 12,5 mg og 25 mg filmovertrukne tabletter indeholder desuden polysorbat 80 (E433).
English: • problems sleeping, depression
Danish: • søvnproblemer, depression
English: Thirty-one percent of patients had been treated with prior HCV therapies, primarily pegylated interferon plus ribavirin.
Danish: 31 % af patienterne var tidligere blevet behandlet for HCV, primært med pegyleret interferon plus ribavirin.
English: If no haematological response has occurred after 16 weeks of therapy with eltrombopag, therapy should be discontinued.
Danish: Hvis der ikke er opnået et hæmatologisk respons efter 16 ugers behandling med eltrombopag, bør behandlingen seponeres.
English: Carton of 25 mg powder for oral suspension - without blue box - 30 sachets
Danish: Æske med 25 mg pulver til oral suspension - uden blue box - 30 breve
English: • decreased levels of calcium
Danish: • nedsatte niveauer af calcium
English: Bleeding following discontinuation of eltrombopag
Danish: Blødning efter seponering af eltrombopag
English: 6 to 11 years (n=68)
Danish: 6 til 11 år (n = 68)
English: Concomitant administration of eltrombopag and OATP1B1 (e.g. methotrexate) and BCRP (e.g. topotecan and methotrexate) substrates should be undertaken with caution (see section 5.2).
Danish: Samtidig administration af eltrombopag og OATP1B1-substrater (f.eks. methotrexat) og BCRPsubstrater (f.eks. topotecan og methotrexat) skal foregå med forsigtighed (se pkt.
English: Eltrombopag is primarily metabolised through cleavage, oxidation and conjugation with glucuronic acid, glutathione, or cysteine.
Danish: Eltrombopag metaboliseres primært gennem spaltning, oxidering og konjugering med glukuronsyre, glutathion eller cystein.
English: During therapy with eltrombopag full blood counts (FBCs), including platelet count and peripheral blood smears, should be assessed weekly until a stable platelet count (≥50,000/µl for at least 4 weeks) has been achieved.
Danish: Under behandling med eltrombopag skal det fuldstændige blodbillede (komplet blodtælling (CBC)) inklusive trombocyttal og perifer blodudstrygning vurderes ugentligt, indtil der opnås et stabilt trombocyttal (≥ 50.000 pr. µl i mindst 4 uger).
English: SAA is a disease in which the bone marrow is damaged, causing a deficiency of the red blood cells (anaemia), white blood cells (leukopenia) and platelets (thrombocytopenia).
Danish: SAA er en sygdom hvor knoglemarven er beskadiget, som forårsager mangel på de røde blodlegemer (anæmi), hvide blodlegemer (leukopeni) og blodplader (trombocytopeni).
English: • Give the entire contents of the bottle to the patient using one of the accompanying oral syringes.
Danish: • Hele flaskens indhold administreres til patienten ved hjælp af en af de medfølgende orale sprøjter.
English: Plasma eltrombopag Cmax and AUC(0-) estimates for patients with HCV enrolled in the phase III studies are presented for each dose studied in Table 9.
Danish: Plasma-eltrombopag-Cmax- og AUC(0-)estimater for patienter med HCV, der var inkluderet i fase III-studierne, er for hver undersøgt dosis vist i tabel 9.
English: Very common side effects that may show up in the blood tests • abnormal changes to the cells in your bone marrow
Danish: Meget almindelige bivirkninger, der kan ses i blodprøver • unormale ændringer af cellerne i din knoglemarv
English: Additional medical management may include cessation of anticoagulant and/or anti-platelet therapy, reversal of anticoagulation, or platelet support.
Danish: Yderligere medicinsk behandling kan omfatte seponering af antikoagulantia og/eller trombocythæmmere, ændret antikoagulation eller støttende behandling med trombocytter.
English: - This medicine has been prescribed for you only.
Danish: • Lægen har ordineret dette lægemiddel til dig personligt.
English: Your doctor may consider it necessary to monitor your heart during treatment with Revolade and carry out an electrocardiogram (ECG) test.
Danish: Lægen vurderer, om det er nødvendigt at undersøge hjertet med et elektrokardiogram (EKG) under behandling med Revolade.
English: • increase in enzymes due to muscle breakdown (creatine phosphokinase)
Danish: • forhøjede antal enzymer som følge af nedbrydning af muskler (kreatinkinase)
English: Don't use Revolade if you are pregnant unless your doctor specifically recommends it.
Danish: Du må ikke tage Revolade, hvis du er gravid, medmindre lægen specifikt anbefaler det. Revolades virkning under graviditet kendes ikke.
English: Platelet counts must be monitored weekly for 4 weeks following discontinuation of eltrombopag.
Danish: Trombocyttallet skal monitoreres hver uge i 4 uger efter seponering af eltrombopag.
English: There are limited data on the use of eltrombopag in ITP patients aged 65 years and older and no clinical experience in ITP patients aged over 85 years.
Danish: Der er begrænsede data om anvendelsen af eltrombopag til ITP-patienter, der er 65 år eller ældre og der findes ingen data vedrørende klinisk erfaring med patienter over 85 år med ITP.
English: Haematological response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting eltrombopag (see section 5.1).
Danish: Hæmatologisk respons kræver dosistitrering, normalt op til 150 mg, og kan tage op til 16 uger efter opstarten af eltrombopag (se punkt 5.1).
English: Eltrombopag is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease in preparation for invasive procedures.
Danish: Eltrombopag er ikke indiceret til behandling af trombocytopeni hos patienter med kronisk leversygdom som forberedelse til invasive indgreb.
English: Revolade is not recommended in women of childbearing potential not using contraception.
Danish: Revolade bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: • infection in the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection)
Danish: • infektion i næsen, bihulerne, halsen og de øvre luftveje, almindelig forkølelse (infektion i de øvre luftveje)
English: Platelet counts should be closely monitored.
Danish: Trombocyttallet skal følges nøje.
English: In the HCV studies the safety population consisted of all randomised patients who received double-blind study medicinal product during Part 2 of ENABLE 1 (Revolade treatment n=450, placebo treatment n=232) and ENABLE 2 (Revolade treatment n=506, placebo treatment n=253).
Danish: Sikkerhedspopulationen i HCV-studierne bestod alle af randomiserede patienter som fik dobbeltblindet forsøgsmedicin i 2. del af ENABLE 1 (Revolade-behandling n = 450, placebobehandling n = 232) og ENABLE 2 (Revolade-behandling n = 506, placebo-behandling n = 253).
English: Eltrombopag inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinaemia.
Danish: Eltrombopag hæmmer UGT1A1 og OAT1B1, hvilket kan føre til indirekte hyperbilirubinæmi.
English: The effects of race and sex on plasma eltrombopag CL/F estimates were consistent between paediatric and adult patients.
Danish: Der var overensstemmelse mellem estimater af racens og kønnets virkning på eltrombopags plasma-CL/F hos pædiatriske og voksne patienter.
English: Some people have bleeding in the digestive system after they stop taking peginterferon, ribavirin, and Revolade.
Danish: Nogle patienter får blødning i fordøjelsessystemet efter, at de holdt op med at tage peginterferon, ribavirin og Revolade.
English: QTc interval prolongation has been reported in clinical studies of patients with ITP and thrombocytopenic patients with HCV.
Danish: Forlængelse af QTc-intervallet er rapporteret i kliniske studier hos patienter med ITP og hos trombocytopeniske patienter med HCV.
English: Severe aplastic anaemia in adult patients
Danish: Svær aplastisk anæmi hos voksne patienter
English: The proportion of eltrombopag-treated patients with any bleeding (Grades 1-4) and clinically significant bleeding (Grades 2-4) was reduced from baseline by approximately 50% from Day 15 to the end of treatment throughout the 6-month treatment period.
Danish: Andelen af eltrombopag-behandlede patienter med blødning (niveau 1-4) og klinisk signifikant blødning (niveau 2-4) faldt fra udgangsniveauet med ca. 50 % fra dag 15 til afslutningen af behandlingen, i hele behandlingsperioden på 6 måneder.
English: • if you have cataracts (the lens of the eye getting cloudy)
Danish: • hvis du har grå stær (linsen i øjet bliver uklar)
English: TRA108062 (PETIT): The primary endpoint was the proportion of patients achieving platelet counts ≥50,000/µl at least once between weeks 1 and 6 of the randomised period.
Danish: TRA108062 (PETIT): Det primære endepunkt var andelen af patienter, der opnåede trombocyttal ≥50.000 pr. µl mindst én gang mellem uge 1 og 6 i den randomiserede periode.
English: • yellowing of the skin and eyes, tenderness around the liver
Danish: • gulfarvning af huden og øjnene, ømhed omkring leveren
English: A greater proportion of patients on eltrombopag did not require any antiviral dose reduction as compared to placebo (45% vs. 27%).
Danish: En større andel af patienterne behandlet med eltrombopag krævede ikke dosisreduktion af den antivirale behandling sammenlignet med placebo (45 % i forhold til 27 %).
English: The sudden blocking of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.
Danish: Pludselig blokering af et blodkar pga. en blodprop er en ikke almindelig bivirkning og kan forekomme hos op til 1 ud af 100 personer.
English: The pharmacokinetic parameters of eltrombopag in paediatric patients with ITP are shown in Table 10.
Danish: Eltrombopags farmakokinetiske parametre hos pædiatriske patienter med ITP er vist i tabel 10.
English: • increased levels of alkaline phosphatase
Danish: • forhøjede niveauer af alkalisk fosfatase
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold efter sammenblanding af lægemidlet, se pkt.
English: Get medical help immediately if you have any of these signs of a blood clot:
Danish: Søg straks lægehjælp, hvis du oplever følgende tegn på en blodprop:
English: Patients should be closely monitored for signs and symptoms of TEE.
Danish: Patienterne skal monitoreres tæt for tegn og symptomer på TEE.
English: • disturbances of heart rhythm (QT prolongation)
Danish: • forstyrrelser i hjerterytmen (QT-forlængelse)