FrancophonIA/ELRC3.0 huggingface dataset:
English: ♦, vomiting, abdominal pain*, mouth haemorrhage, flatulence * Very common in paediatric ITP
Danish: ♦, opkast, abdominalsmerter*, blødning fra munden, flatulens * Meget almindelig hos pædiatrisk patienter med ITP
English: Hepatotoxixity
Danish: Hepatotoksicitet
English: In addition, the benefits of treatment in terms of the proportion achieving SVR compared with placebo were modest in these patients (especially for those with baseline albumin ≤35 g/l) compared with the group overall.
Danish: Fordelene ved behandling med hensyn til opnåelse af SVR sammenlignet med placebo var beskedne hos disse patienter (specielt for patienter med baseline albumin-niveau ≤ 35 g/l) sammenlignet med gruppen overordnet set.
English: Tapering for tri-lineage (white blood cells, red blood cells, and platelets) responders For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks: the dose of eltrombopag may be reduced by 50%.
Danish: Hos patienter, som opnår respons for tre celletyper, herunder transfusionsuafhængighed, som varer i mindst 8 uger, kan eltrombopagdosis nedsættes med 50 %.
English: Use lowest dose of eltrombopag to maintain platelet counts.
Danish: Brug den laveste eltrombopagdosis, der gør det muligt at fastholde trombocyttallet.
English: Diarrhoea, nausea, gingival bleeding, abdominal pain
Danish: Diarré, kvalme, gingivalblødning, abdominalsmerter
English: Table 1 Dose adjustments of eltrombopag in ITP patients
Danish: Tabel 1 Dosisjustering af eltrombopag hos patienter med ITP
English: The most common adverse reactions in paediatric ITP patients 1 year and older (≥3% and greater than placebo) were upper respiratory tract infection, nasopharyngitis, cough, pyrexia, abdominal pain, oropharyngeal pain, toothache and rhinorrhoea.
Danish: De mest almindelige bivirkninger I pædiatriske ITP patienter i alderen 1 år og ældre (≥ 3 % og større end placebo) var øvre luftvejsinfektion, nasofaryngitis, hoste, pyreksi, mavesmerter, orofaryngeale smerter, tandpine, og rinorré.
English: Common Cataract, retinal exudates, dry eye, ocular icterus, retinal haemorrhage
Danish: Almindelig Katarakt, retinale ekssudater, øjentørhed, okulær icterus, retinal hæmorrhagi
English: The suspension should be taken at least two hours before or four hours after any products such as antacids, dairy products (or other calcium containing food products), or mineral supplements containing polyvalent cations (e.g. iron, calcium, magnesium, aluminium, selenium and zinc) (see sections 4.5 and 5.2).
Danish: Suspensionen skal tages mindst to timer før eller fire timer efter antacida, mejeriprodukter (eller andre calciumholdige fødevarer) eller mineraltilskud med polyvalente kationer (f.eks. jern, calcium, magnesium, aluminium, selen og zink) (se pkt.
English: Hypersensitivity to eltrombopag or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for eltrombopag eller over for et eller flere af hjælpestofferne anført i pkt.
English: Human liver microsome studies identified UGT1A1 and UGT1A3 as the enzymes responsible for eltrombopag glucuronidation.
Danish: Fra undersøgelser af levermikrosomer fra mennesker blev det fundet, at UGT1A1 og UGT1A3 var de ansvarlige enzymer for eltrombopagglukuronideringen.
English: • generally feeling unwell, high temperature, feeling hot
Danish: • generel utilpashed, feber, varmefornemmelse
English: • 1 reusable mixing bottle with lid and cap (supplied in the kit)
Danish: • 1 genanvendelig blandeflaske med låg og hætte (findes i sættet)
English: Revolade 50 mg film-coated tablets also contain iron oxide red (E172) and iron oxide yellow (E172).
Danish: Revolade 50 mg filmovertrukne tabletter indeholder desuden rød jernoxid (E172) og gul jernoxid (E172).
English: For patients of Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), including those with hepatic impairment, eltrombopag should be initiated at a dose of 25 mg once daily (see section 5.2).
Danish: Hos patienter af asiatisk oprindelse (f.eks. kinesisk, japansk, taiwanesisk, koreansk eller thailandsk), herunder patienter med nedsat leverfunktion, bør eltrombopag startes med en dosis på 25 mg én gang daglig (se pkt.
English: Paediatric population aged 1 to 5 years The recommended starting dose of eltrombopag is 25 mg once daily.
Danish: Pædiatrisk population i alderen 1 til 5 år Den anbefalede startdosis af eltrombopag er 25 mg én gang daglig.
English: At non-tolerated doses in pre-weaning juvenile rats dosed from Days 4-32 (approximately equating to a 2-year-old human at the end of the dosing period), ocular opacities were observed (histology not performed) at 9 times the maximum human clinical exposure in paediatric ITP patients at 75 mg/day, based on AUC.
Danish: Ved ikke-tolererede doser hos rotteunger før afvænning, som blev doseret på dag 4-32 (omtrent svarende til et 2-årigt menneske ved doseringsperiodens udløb), blev der observeret okulære opaciteter (histologi ikke udført) ved 9 gange den maksimale humane kliniske eksponering hos pædiatriske ITP-patienter ved 75 mg/dag baseret på AUC.
English: Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo).
Danish: Portal venetrombose var den almindeligste TEE i begge behandlingsgrupper (2 % hos patienter, der fik eltrombopag i forhold til < 1 % i placebogruppen).
English: Common Blood bilirubin increased (hyperbilirubinemia), jaundice Not known Drug-induced liver injury* * Cases of drug-induced liver injury have been reported in patients with ITP and HCV
Danish: Ikke kendt Lægemiddelinduceret leverskade* * Der er blevet rapporteret tilfælde af lægemiddelinduceret leverskade hos patienter med ITP og HCV
English: Revolade 25 mg powder for oral suspension eltrombopag
Danish: Revolade 25 mg pulver til oral suspension eltrombopag
English: Increase daily dose by 25 mg to a maximum of 100 mg/day.
Danish: Daglig dosis øges med 25 mg op til et maksimum på 100 mg/dag.
English: Human liver microsome studies identified CYP1A2 and CYP2C8 as the enzymes responsible for eltrombopag oxidation.
Danish: Ved undersøgelser af levermikrosomer fra mennesker blev det identificeret, at CYP1A2 og CYP2C8 var de ansvarlige enzymer for eltrombopag-oxideringen.
English: • digestive system problems, including being sick (vomiting), stomach pain, indigestion,
Danish: • problemer med fordøjelsessystemet herunder opkastning, mavesmerter, fordøjelsesbesvær,
English: • mouth problems, including dry or sore mouth, sensitive tongue, bleeding gums
Danish: • mundproblemer herunder tør og øm mund, følsom tunge, blødende tandkød
English: Based on model estimate, elderly (≥65 years) patients had approximately 41% higher plasma eltrombopag AUC(0-) as compared to younger patients (see section 4.2).
Danish: Ud fra modellerede estimater havde ældre (≥ 65 år) patienter ca. 41 % højere plasma-eltrombopag-AUC(0-)-værdier sammenlignet med yngre patienter (se pkt.
English: Common Dyspnoea, oropharyngeal pain, dyspnoea exertional, productive cough
Danish: Almindelig Dyspnø, orofaryngeal smerte, funktionsdyspnø, produktiv hoste
English: Uncommon Thrombotic microangiopathy with acute renal failure
Danish: Trombotisk mikroangiopati med nyresvigt
English: Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets
Danish: Revolade 12,5 mg filmovertrukne tabletter Revolade 25 mg filmovertrukne tabletter Revolade 50 mg filmovertrukne tabletter Revolade 75 mg filmovertrukne tabletter
English: These may affect more than 1 in 10 children:
Danish: Disse kan forekomme hos flere end 1 ud af 10 børn:
English: In addition, the benefits of treatment in terms of the proportion achieving sustained virological response (SVR) compared with placebo were modest in these patients (especially for those with baseline albumin ≤35 g/l) compared with the group overall.
Danish: Fordelene ved behandling med hensyn til opnåelse af opretholdt virologisk resons (SVR) sammenlignet med placebo var beskedne hos disse patienter (specielt for patienter med baseline albumin-niveau ≤ 35 g/l) sammenlignet med gruppen overordnet set.
English: The most common adverse reactions occurring in at least 10% of patients included headache, dizziness, cough, oropharyngeal pain, nausea, diarrhoea, abdominal pain, transaminases increased, arthralgia, pain in extremity, fatigue and pyrexia.
Danish: De mest almindelige bivirkninger, der forekom hos mindst 10 % af patienterne inkluderede hovedpine, svimmelhed, hoste, orofaryngeale smerter, kvalme, diarré, mavesmerter, forhøjede transaminaser, arthralgi, ekstremitetssmerter, træthed og pyreksi.
English: • swelling, pain, heat, redness, or tenderness in one leg
Danish: • hævelse, smerte, varme, rødme eller ømhed i et ben
English: The tablets should be taken at least two hours before or four hours after any products such as antacids, dairy products (or other calcium containing food products), or mineral supplements containing polyvalent cations (e.g. iron, calcium, magnesium, aluminium, selenium and zinc) (see sections 4.5 and 5.2).
Danish: Tabletterne skal tages mindst to timer før eller fire timer efter antacida, mejeriprodukter (eller andre calciumholdige fødevarer) eller mineraltilskud med polyvalente kationer (f.eks. jern, calcium, magnesium, aluminium, selen og zink) (se pkt.
English: >150,000/µl
Danish: > 150.000 pr. µl
English: The following side effects have been reported to be associated with treatment with Revolade in adult patients with ITP:
Danish: Følgende bivirkninger er blevet indberettet til at være forbundet med behandling af Revolade hos voksne patienter med ITP:
English: • skin changes, including rash, dry skin, eczema, redness of the skin, itching, excessive sweating,
Danish: • hudforandringer herunder udslæt, tør hud, eksem, rødme af huden, kløe, overdreven svedtendens, usædvanlige hudgevækster
English: Fatigue, pyrexia, chills
Danish: Træthed, pyreksi, kulderystelser
English: Uncommon Dry mouth, glossodynia, abdominal tenderness, faeces discoloured, food poisoning, frequent bowel movements, haematemesis, oral discomfort
Danish: Mundtørhed, glossodyni, abdominal ømhed, misfarvet fæces, madforgiftning, hyppig afføring, hæmatemese, oral ubehag
English: SAA study population
Danish: Population i SAA-studierne
English: * For patients taking 25 mg eltrombopag once daily, consideration should be given to reinitiating dosing at 25 mg every other day.
Danish: * Hos patienter, der tager 25 mg eltrombopag én gang dagligt, bør det overvejes at genopstarte behandling med 25 mg doseret hver anden dag.
English: Blood and lymphatic system disorders
Danish: Blod- og lymfesystem Meget almindelig
English: d p-value <0.05 for eltrombopag versus placebo e 64% patients participating in ENABLE 1 and ENABLE 2 were genotype 1 f Post-hoc analyses
Danish: e 64 % af patienterne, der deltog i ENABLE 1 og ENABLE 2, var genotype 1. f Post-hoc-analyser
English: Common Syncope
Danish: Almindelig Synkope
English: • joint pain (arthralgia)
Danish: • smerter i leddene (artralgi)
English: Eligible for efficacy analysis, n Patients with platelet count 50,000/l after up to 42 days of dosing (compared to a baseline count of <30,000/l), n (%)
Danish: Patienter med trombocyttal på  50.000 pr. µl efter op til 42 dages administration (sammenlignet med et udgangsniveau på < 30.000 pr. µl), n (%)
English: Common Asthenia, oedema peripheral, malaise
Danish: Almindelig Asteni, perifert ødem, utilpashed
English: • eye problems including increased production of tears, cloudy lens in the eye (cataract), bleeding of the retina
Danish: • øjenproblemer herunder øget tåreproduktion, uklar linse i øjet (grå stær), blødning på nethinden
English: Eltrombopag dosing requirements must be individualised based on the patient's platelet counts.
Danish: Doseringen af eltrombopag skal tilpasses den enkelte patient på baggrund af patientens trombocyttal.
English: Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets eltrombopag
Danish: Revolade 12,5 mg filmovertrukne tabletter Revolade 25 mg filmovertrukne tabletter Revolade 50 mg filmovertrukne tabletter Revolade 75 mg filmovertrukne tabletter eltrombopag
English: Haematologic malignancies
Danish: Hæmatologisk malignitet
English: • decreased levels of blood albumin
Danish: • nedsatte niveauer af albumin i blodet
English: • eye problems including abnormal eye test, dry eye, eye pain and blurred vision
Danish: • øjenproblemer herunder unormal øjentest, tørre øjne, øjensmerter, og sløret syn
English: The most common adverse reactions occurring in at least 10% of patients included headache, anaemia, decreased appetite, cough, nausea, diarrhoea, hyperbilirubinaemia, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, asthenia, chills and oedema.
Danish: De mest almindelige bivirkninger, som forekom hos mindst 10 % af patienterne inkluderede hovedpine, anæmi, nedsat appetit, hoste, kvalme, diarré, hyperbilirubinæmi, alopeci, pruritus, myalgi, pyreksi, træthed, influenzalignende symptomer, asteni, kulderystelser og ødemer.
English: Pharmacokinetics
Danish: Farmakokinetik
English: Common Blood bilirubin increased, weight decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, international normalised ratio increased, activated partial thromboplastin time prolonged, blood glucose increased, blood albumin decreased Uncommon Electrocardiogram QT prolonged Grouped term with preferred terms oliguria, renal failure and renal impairment
Danish: Almindelig Forhøjet bilirubin i blodet, vægttab, reduceret antal hvide blodlegemer, nedsat hæmoglobin, nedsat neutrofiltal, forhøjet INR (international normaliseret ratio), forlænget aktiveret partiel tromboplastintid, forhøjet blodglukose, nedsat albumin i blodet
English: • weakness (asthenia)
Danish: • svaghed (asteni)
English: Eltrombopag chelates with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc (see sections 4.2 and 4.5).
Danish: Eltrombopag chelerer med polyvalente kationer som f.eks. jern, calcium, magnesium, aluminium, selen og zink (se pkt.
English: • increased levels of bilirubin (a substance produced by the liver)
Danish: • forhøjede niveauer af bilirubin (et stof som dannes i leveren)
English: • blood in your stools
Danish: • blod i afføringen
English: • black tarry stools (discoloured bowel movements are a uncommon side effect that may affect up to 1 in 100 people)
Danish: • sort tjæreagtig afføring (det kan være tegn på blødning i tarmen, misfarvet afføring er en ”ikke almindelig” bivirkning og kan forekomme hos op til 1 ud af 100 personer)
English: Asian paediatric ITP patients had approximately 43% higher plasma eltrombopag AUC(0-) values as compared to non-Asian patients.
Danish: Asiatiske pædiatriske ITP-patienter havde ca. 43 % højere AUC(0-)værdier for eltrombopag i plasma sammenlignet med ikke-østasiatiske patienter.
English: These may affect up to 1 in 10 children:
Danish: Disse kan forekomme hos op til 1 ud af 10 børn:
English: In controlled studies in thrombocytopenic patients with HCV receiving interferon therapy (n=1,439), progression of pre-existing baseline cataract(s) or incident cataracts was reported in 8% of the eltrombopag group and 5% of the placebo group.
Danish: I kontrollerede kliniske studier hos trombocytopeniske patienter med HCV, som fik interferon behandling (n = 1439) blev der rapporteret progression af forud-eksisterende baseline katarakt eller opstået katarakt hos 8 % af patienterne i eltrombopaggruppen og hos 5 % i placebogruppen.
English: • antacids, a type of medicine for indigestion and heartburn
Danish: • syreneutraliserende lægemidler, som er medicin mod fordøjelsesproblemer og halsbrand
English: The dose of eltrombopag could be adjusted based on individual platelet counts.
Danish: Eltrombopag-dosen kunne justeres ud fra individuelle trombocyttal.
English: For patients of Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2).
Danish: Patienter fra Asien (såsom kinesere, japanere, taiwanesere, koreanere eller thaier) skal begynde med en nedsat dosis på 25 mg eltrombopag én gang daglig (se pkt.
English: TRA100773B: The primary efficacy endpoint was the proportion of responders, defined as ITP patients who had an increase in platelet counts to 50,000/l at Day 43 from a baseline of <30,000/l; patients who withdrew prematurely due to a platelet count 200,000/l were considered responders, those that discontinued for any other reason were considered non-responders irrespective of platelet count.
Danish: TRA100773B: Det primære endepunkt var andelen af respondenter, der blev defineret som ITPpatienter, der oplevede en stigning i trombocyttal til ≥ 50.000 pr. µl på dag 43 fra et udgangsniveau på < 30.000 pr. µl.
English: • Start with the plunger pushed all the way into the syringe.
Danish: • Start med stemplet trykket helt ind i sprøjten.
English: Each sachet contains a powder for reconstitution that delivers 32 mg eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid.
Danish: Hvert brev indeholder et pulver som skal blandes med vand, med 32 mg eltrombopagolamin svarende til 25 mg eltrombopag som fri syre.
English: FBCs including platelet counts and peripheral blood smears should be obtained monthly thereafter.
Danish: Herefter analyseres CBC inklusive trombocyttal og perifer blodudstrygning hver måned.
English: Common Depression, anxiety, sleep disorder Uncommon Confusional state, agitation
Danish: Almindelig Depression, angst, søvnforstyrrelser Ikke almindelig
English: Revolade 75 mg film-coated tablets are round, biconvex, pink, debossed with ‘GS FFS' and ‘75' on one side.
Danish: Revolade 75 mg filmovertrukne tabletter er runde, bikonvekse, pink og præget ”GS FFS” og ”75” på den ene side.
English: Common Pharyngitis, influenza, oral herpes, pneumonia, sinusitis, tonsillitis,
Danish: Almindelig Pharyngitis, influenza, herpes labialis, pneumoni, sinusitis, tonsillitis, infektion i luftvejene, gingivitis
English: The longest platelet transfusion-free period for responders was 287 days (median).
Danish: Den længste periode uden transfusion af trombocytter for respondenter var 287 dage (median).
English: In the 3 controlled clinical ITP studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 8% and 8% of the eltrombopag and placebo groups, respectively (see section 4.4).
Danish: I de 3 kontrollerede, kliniske ITP-studier sås et forbigående fald i trombocyttallet, efter seponering af behandlingen, til et niveau under udgangsniveauet hos hhv. 8 % i eltrombopag-gruppen og 8 % i placebogruppen (se pkt.
English: For patients of Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2).
Danish: Patienter af asiatisk oprindelse skal starte med en nedsat dosis på 25 mg eltrombopag én gang daglig (se punkt 5.2).
English: ≤ 35g/l > 35g/l MELD score f a Eltrombopag given in combination with peginterferon alfa-2a (180 μg once weekly for 48 weeks for genotypes 1/4/6; 24 weeks for genotype 2/3) plus ribavirin (800 to 1200 mg daily in 2 divided doses orally) b Eltrombopag given in combination with peginterferon alfa-2b (1.5 μg/kg once weekly for 48 weeks for genotype 1/4/6; 24 weeks for genotype 2/3) plus ribavirin (800 to 1400 mg orally in 2 divided doses) c Target platelet count was 90,000/µl for ENABLE 1 and 100,000/µl for ENABLE 2.
Danish: ≤ 35 g/l > 35 g/l MELD score f a Eltrombopag givet i kombination med peginterferon alfa-2a (180 µg én gang ugentligt i 48 uger for genotyperne 1/4/6; i 24 uger genotype 2/3) plus ribavirin (800 til 1.200 mg daglig fordelt på 2 orale doser).
English: Common side effects that may show up in the blood tests
Danish: Almindelige bivirkninger, der kan ses i blodprøver
English: Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo) (see section 4.4).
Danish: Portal venetrombose var den mest almindelige TEE i begge behandlingsgrupper (2 % af patienterne, som blev behandlet med eltrombopag, i forhold til 1 % for placebo)(se pkt.
English: • increase in bilirubin (a substance produced by the liver)
Danish: • forhøjet bilirubin (et stof som dannes i leveren)
English: In the single-arm, open-label study in SAA, three (7%) patients were diagnosed with MDS following treatment with eltrombopag, in the two ongoing studies (ELT116826 and ELT116643), 1/28 (4%) and 1/62 (2%) patient has been diagnosed with MDS or AML in each study.
Danish: I de to igangværende studier (ELT116826 og ELT116643) er henholdsvis 1/28 (4 %) og 1/62 (2 %) patienter blevet diagnosticeret med MDS eller AML.
English: • decreased levels of white blood cells
Danish: • nedsatte niveauer af hvide blodlegemer
English: Give the medicine to the child. Do this straight away when you have mixed the dose.
Danish: Det skal gøres straks efter, at du har blandet dosen.
English: • rectal bleeding, blood in your stool, abdominal bloating, constipation
Danish: • blødning i endetarmen, blod i din afførring, oppustet mave, forstoppelse
English: At 4 times the human clinical exposure in ITP patients at 75 mg/day and 2 times the human exposure in HCV patients at 100 mg/day, based on AUC, cataracts were observed in mice after 13 weeks and in rats after 39 weeks of dosing.
Danish: Ved ≥ 4 gange den humane kliniske eksponering hos ITP-patienter ved doser på 75 mg/dag og 2 gange den humane kliniske eksponering hos HCV-patienter med 100 mg/dag, baseret på AUC, sås katarakt hos mus efter 13 ugers administration og hos rotter efter 39 ugers administration.
English: Also there was no effect on embryofoetal development in rabbits at doses up to 150 mg/kg/day, the highest dose tested (0.3 to 0.5 times the human clinical exposure in ITP patients at 75 mg/day and HCV patients at 100 mg/day, based on AUC).
Danish: Der sås heller ingen virkning på fosterudviklingen hos kaniner ved doser på op til 150 mg/kg/dag - den højeste testede dosis (0,3-0,5 gange den humane kliniske eksponering hos ITP-patienter ved doser på 75 mg/dag og hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC).
English: Ninety-two patients were randomised by three age cohort strata (2:1) to eltrombopag (n=63) or placebo (n=29).
Danish: Tooghalvfems patienter blev randomiseret efter tre alderskohortestrata (2:1) til eltrombopag (n = 63) eller placebo (n = 29).
English: • flu (influenza)
Danish: • influenza
English: At ≥6 times the human clinical exposure in adult ITP patients at 75 mg/day and 3 times the human clinical exposure in adult HCV patients at 100 mg/day, based on AUC, cataracts were observed in mice after 6 weeks and rats after 28 weeks of dosing.
Danish: Ved ≥ 6 gange den humane kliniske eksponering hos voksne ITP-patienter ved doser på 75 mg/dag og 3 gange den humane kliniske eksponering hos voksne HCV-patienter ved doser på 100 mg/dag, baseret på AUC, sås katarakt hos mus efter 6 ugers administration og hos rotter efter 28 ugers administration.
English: • itchy eyes
Danish: • kløende øjne
English: Thrombocytopenia is likely to reoccur in ITP patients upon discontinuation of treatment with eltrombopag.
Danish: Trombocytopeni kan med en vis sandsynlighed forekomme igen ved seponering af eltrombopag.
English: • abdominal (stomach) pain, enlarged abdomen, blood in your stools.
Danish: • mavesmerter, forstørret mave, blod i afføringen.