FrancophonIA/ELRC3.0 huggingface dataset:
English: • sleep disorders, abnormal drowsiness, depression, anxiety
Danish: • søvnproblemer, unormal døsighed, depression, angst
English: Table 8 Geometric mean (95% confidence intervals) of steady-state plasma eltrombopag pharmacokinetic parameters in adults with ITP
Danish: Tabel 8 Geometrisk middelværdi (95 % konfidensintervaller) for steady-state farmakokinetiske parametre i plasma for eltrombopag hos voksne med ITP
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Når et lægemiddel er godkendt, er indberetning af formodede bivirkninger vigtig.
English: It is recommended to wait for 2 weeks to assess the effects of this and any subsequent dose adjustments.
Danish: Det anbefales at vente i 2 uger efter dosisjusteringen med at vurdere effekten af denne og eventuelt efterfølgende dosisjusteringer.
English: Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).
Danish: Revolade er indiceret til voksne patienter med svær erhvervet aplastisk anæmi (SAA), som enten er refraktære over for tidligere immunsuppressiv behandling eller tidligere er stærkt behandlede, og som er uegnede til hæmopoietisk stamcelletransplantation (se pkt.
English: Increase daily dose by 25 mg to a maximum of 75 mg/day*.
Danish: Daglig dosis øges med 25 mg op til et maksimum på 75 mg/dag*.
English: If platelet counts drop to <30,000/µl, haemoglobin drops to <9 g/dl or absolute neutrophil count (ANC) to <0.5 x 10
Danish: Hvis trombocyttallet falder til < 30.000 pr. µl, hæmoglobin falder til < 9 g/dl eller absolut neutrofiltal (ANC) falder til < 0,5 x 10
English: Therefore, caution should be used when co-administration of eltrombopag with lopinavir/ritonavir takes place.
Danish: Derfor bør samtidig administration af eltrombopag og lopinavir/ritonavir ske med forsigtighed.
English: On initiation of antiviral therapy the platelet count may fall, so immediate eltrombopag dose reductions should be avoided.
Danish: Ved opstart af den antivirale behandling kan trombocyttallet falde, hvorfor samtidig dosisreduktion af eltrombopag skal undgås
English: Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking.
Danish: Eltrombopag skal anvendes med forsigtighed til patienter med kendte risikofaktorer for tromboemboli herunder, men ikke begrænset til, arvelige (f.eks. faktor V Leiden) eller erhvervede risikofaktorer (f.eks. ATIII-mangel, antifosfolipid-syndrom), fremskreden alder, patienter med langvarig immobilisering, malignitet, brug af kontraceptiva, hormonbehandling, operation/traume, overvægt eller rygning.
English: Immune thrombocytopenia in adult and paediatric patients
Danish: Immun trombocytopeni hos voksne og pædiatriske patienter
English: Thrombotic/thromboembolic events (TEEs)
Danish: Trombotiske/tromboemboliske hændelser (TEEs)
English: Posology
Danish: BREV
English: After initiating the dose of eltrombopag in patients with hepatic impairment an interval of 2 weeks should be observed before increasing the dose.
Danish: Efter opstart med denne eltrombopag-dosis hos patienter med nedsat leverfunktion bør der være et observationsinterval på 2 uger, før dosis øges.
English: • increased levels of liver enzymes (aspartate aminotransferase (AST))
Danish: • forhøjede niveauer af leverenzymer (aspartataminotransferase (ASAT))
English: For patients taking 25 mg once daily, increase the dose to 50 mg daily before increasing the dose amount by 50 mg.
Danish: Hos patienter, der tager 25 mg én gang daglig, øges dosis til 50 mg dagligt, inden dosis øges i trin på 50 mg.
English: Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1).
Danish: Revolade er indiceret til behandling af trombocytopeni hos voksne patienter med kronisk hepatitis Cvirusinfektion (HCV-infektion), hvor graden af trombocytopeni er den primære årsag til, at optimal interferonbaseret behandling ikke kan opstartes eller fortsættes (se pkt.
English: • some mineral and vitamin supplements including iron, calcium, magnesium, aluminium,
Danish: • nogle mineral- og vitamintilskud, herunder jern, calcium, magnesium, aluminium, selen og zink
English: Pooled data
Danish: Samlede data
English: Based on your response to Revolade your doctor may recommend that your daily dose is changed.
Danish: Lægen kan anbefale, at din daglige dosis Revolade ændres afhængig af, hvordan du reagerer på din behandling.
English: Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 25 mg. * For patients taking 25 mg eltrombopag once every other day, increase dose to 25 mg once daily.
Danish: Når trombocyttallet er ≤ 100.000 pr. µl, sættes behandlingen i gang igen med en daglig dosis, der er nedsat med 25 mg. * For patienter, der tager 25 mg eltrombopag en gang hver anden dag, øges dosis til 25 mg én gang daglig.
English: Administration of a single 50 mg dose of eltrombopag in tablet form with a standard high-calorie, high-fat breakfast that included dairy products reduced plasma eltrombopag mean AUC0-∞ by 59% and mean Cmax by 65%.
Danish: Administration af en enkelt 50 mg dosis eltrombopag i tabletform med et kalorierigt, fedtrigt standardmorgenmåltid, som inkluderede mælkeprodukter, reducerede det gennemsnitlige AUC0-∞ for eltrombopag i plasma med 59 % og den gennemsnitlige Cmax med 65 %.
English: The influence of hepatic impairment on the pharmacokinetics of eltrombopag following repeat administration was evaluated using a population pharmacokinetic analysis in 28 healthy adults and 714 patients with hepatic impairment (673 patients with HCV and 41 patients with chronic liver disease of other aetiology).
Danish: Påvirkningen af nedsat leverfunktion på eltrombopags farmakokinetik efter gentagen administration blev undersøgt ved en farmakokinetisk populationsanalyse med 28 raske voksne og 714 patienter med nedsat leverfunktion (673 patienter med HCV og 41 patienter med kronisk leversygdom af anden ætiologi).
English: Thrombocytopenia following discontinuation of treatment
Danish: Trombocytopeni efter seponering af behandling
English: Table 10 Geometric mean (95% CI) steady-state plasma eltrombopag pharmacokinetic parameters in paediatric patients with ITP (50 mg once daily dosing regimen)
Danish: Tabel 10 Farmakokinetiske gennemsnitsparametre (95 % CI) for eltrombopag i plasma i steady-state hos pædiatriske patienter med ITP (dosisregime: 50 mg én gang dagligt)
English: A new single-use oral dosing syringe should be used to prepare each dose of Revolade for oral suspension.
Danish: Der skal anvendes en ny oral doseringssprøjte til engangsbrug til at klargøre hver enkelt dosis Revolade til oral suspension.
English: • Turn the mixing bottle upside-down together with the syringe.
Danish: • Vend blandeflasken på hovedet sammen med sprøjten.
English: • kidney problems including inflammation of the kidney, excessive urination at night, kidney failure, white cells in urine
Danish: • nyreproblemer herunder nyrebetændelse, overdreven natlig vandladning, nyresvigt, hvide blodlegemer i urinen
English: The efficacy and safety of eltrombopag have not been established in patients with both moderate to severe renal impairment and hepatic impairment.
Danish: Eltrombopags effekt og sikkerhed er ikke undersøgt hos patienter med både nedsat nyrefunktion og nedsat leverfunktion.
English: If these side effects become severe, please tell your doctor, pharmacist or nurse.
Danish: Hvis disse bivirkninger bliver alvorlige, skal du fortælle det til din læge, sygeplejerske eller apoteket
English: Caution should be exercised in these patients (see section 4.4).
Danish: Der skal udvises forsigtighed ved behandling af disse patienter (se pkt.
English: Platelet counts should be closely monitored and consideration given to reducing the dose or discontinuing eltrombopag treatment if the platelet count exceeds the target levels (see section 4.2).
Danish: Trombocyttallet skal følges nøje, og reduktion af dosis eller seponering af eltrombopag skal overvejes, hvis trombocyttallet overstiger det forventede niveau (se pkt.
English: These tests will be repeated at intervals while you are taking it.
Danish: Disse blodprøver vil regelmæssigt blive gentaget, mens du er i behandling med Revolade.
English: • minerals such as iron, calcium, magnesium, aluminium, selenium and zinc which may be found in vitamin and mineral supplements (see also ‘When to take it' in section 3)
Danish: • nogle mineral- og vitamintilskud, herunder jern, calcium, magnesium, aluminium, selen og zink (se også ‘Hvornår skal du tage Revolade' under punkt 3)
English: • sudden shortness of breath especially together with sharp pain in the chest or rapid breathing
Danish: • Pludselig åndenød ledsaget af en skarp smerte i brystet eller hurtig vejrtrækning
English: Table 3 Dose adjustments of eltrombopag in patients with severe aplastic anaemia
Danish: Tabel 3 Justering af eltrombopagdosis hos patienter med svær aplastisk anæmi
English: Common Dizziness, disturbance in attention, dysgeusia, hepatic encephalopathy, lethargy, memory impairment, paraesthesia
Danish: Almindelig Svimmelhed, opmærksomhedsforstyrrelser, dysgeusi, hepatisk encefalopati, letargi, hukommelsesbesvær, paræstesi
English: To prepare the dose
Danish: Sådan fremstilles en dosis
English: Heart monitoring
Danish: Hjerteundersøgelser
English: The dose of eltrombopag was adjusted during the 6-month treatment period based on individual platelet counts.
Danish: Eltrombopag-dosis blev justeret i løbet af behandlingsperioden på 6 måneder ud fra den enkeltes trombocyttal.
English: Increase daily dose by 50 mg to a maximum of 150 mg/day.
Danish: Daglig dosis øges med 50 mg til et maksimum på 150 mg/dag.
English: • swelling, pain or tenderness in one leg
Danish: • Hævelse, smerte eller ømhed i det ene ben
English: In 2 controlled clinical studies in thrombocytopenic patients with HCV, hepatic decompensation (ascites, hepatic encephalopathy, variceal haemorrhage, spontaneous bacterial peritonitis) occurred more frequently in the eltrombopag arm (11%) than in the placebo arm (6%).
Danish: I to kontrollerede kliniske studier blandt trombocytopeniske patienter med HCV forekom dekompenseret leversygdom (ascites, hepatisk encefalopati, variceblødning, spontan bakteriel peritonitis) oftere i eltrombopag armen (11 %) end i placebo armen (6 %).
English: • localised swelling filled with blood from a break in a blood vessel (haematoma)
Danish: • lokal hævelse fyldt med blod fra en bristet blodåre (blåt mærke)
English: In 2 controlled clinical studies in thrombocytopenic patients with HCV, hepatic decompensation (ascites, hepatic encephalopathy, variceal haemorrhage, spontaneous bacterial peritonitis) was reported more frequently in the eltrombopag arm (11%) than in the placebo arm (6%).
Danish: I 2 kontrollerede kliniske studier blandt trombocytopeniske patienter med HCV blev der rapporteret hepatisk dekompensation (ascites, hapatisk encefalopati, variceblødning, spontan bakteriel peritonitis) oftere i eltrombopag armen (11 %) end i placebo armen (6 %).
English: Grouped term with preferred terms acute kidney injury and renal failure
Danish: Kombineret bivirkningsterm med de foretrukne termer akut nyreskade og nyresvigt
English: In 2 controlled clinical studies in patients with HCV, ALT or AST 3 x ULN was reported in 34% and 38% of the eltrombopag and placebo groups, respectively.
Danish: I 2 kontrollerede kliniske studier med patienter med HCV blev der rapporteret ALAT- eller ASAT  3 x ULN hos henholdsvis 34 % i eltrombopag-gruppen og 38 % i placebogruppen.
English: If you are breast-feeding or planning to breast-feed, tell your doctor.
Danish:  Hvis du ammer eller planlægger amning, skal du fortælle det til lægen.
English: The pharmacokinetics of eltrombopag have been studied after administration of eltrombopag to adult patients with renal impairment.
Danish: Eltrombopags farmakokinetik er blevet undersøgt efter administration af eltrombopag til voksne patienter med nedsat leverfunktion.
English: On initiation of antiviral therapy the platelet count may fall, so immediate eltrombopag dose adjustments should be avoided (see Table 2).
Danish: Ved opstart af den antivirale behandling kan trombocyttallet falde, hvorfor samtidig dosisreduktion af eltrombopag bør undgås (se tabel 2).
English: • stomach pain and tenderness
Danish: • mavesmerte og ømhed
English: Table 2 Dose adjustments of eltrombopag in HCV patients during antiviral therapy
Danish: Tabel 2 Dosisjustering af eltrombopag hos patienter med HCV i antiviral behandling
English: In the controlled clinical studies in chronic ITP with eltrombopag, increases in serum ALT, AST and bilirubin were observed (see section 4.4).
Danish: I de kontrollerede kliniske studier med eltrombopag til kronisk ITP sås stigning i ALAT, ASAT og bilirubin i serum (se pkt.
English: During the randomised period of the study, patients were randomised by three age cohort strata (2:1) to eltrombopag (n=45) or placebo (n=22).
Danish: I studiets randomiserede del blev patienterne randomiseret efter tre alderskohortestrata (2:1) til eltrombopag (n = 45) eller placebo (n = 22).
English: People taking Revolade for either ITP or low blood platelet counts due to hepatitis C could develop signs of potentially serious side effects.
Danish: Symptomer, som du skal være opmærksom på: skal tilses af lægen Personer, der tager Revolade enten for ITP eller pga. for lavt trombocyttal ved hepatitis C, kan udvikle tegn på potentielt alvorlige bivirkninger.
English: ♦, upper respiratory tract infection
Danish: ♦, infektion i de øvre luftveje
English: Cataracts were observed in toxicology studies of eltrombopag in rodents (see section 5.3).
Danish: Der er konstateret katarakt hos gnavere i toksikologiske studier med eltrombopag (se pkt.
English: Revolade 75 mg film-coated tablets also contain iron oxide red (E172) and iron oxide black (E172).
Danish: Revolade 75 mg filmovertrukne tabletter indeholder desuden rød jernoxid (E172) og sort jernoxid (E172).
English: Phototoxicity
Danish: Fototoksicitet
English: • redness or swelling around, a woundbleeding around a catheter (if present) into the skinsensation of a foreign body
Danish: • blødning omkring et kateter (hvis der er et til stede) der går ind i huden
English: There are limited data on the use of eltrombopag in HCV and SAA patients aged over 75 years.
Danish: Der er begrænsede data for anvendelsen af eltrombopag hos HCV- og SAA-patienter over 75 år.
English: 50,000/µl to 150,000/µl
Danish:  50.000 pr. µl til  150.000 pr. µl
English: Eltrombopag should be terminated if antiviral therapy is discontinued for hepatic decompensation.
Danish: Behandlingen med eltrombopag bør afsluttes, hvis den antivirale behandling seponeres på grund af dekompenseret leversygdom.
English: Cytogenetic abnormalities are known to occur in SAA patients.
Danish: Det vides, at der forekommer cytogenetiske anomalier hos SAA-patienter.
English: Eltrombopag chelates with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc.
Danish: Eltrombopag chelerer med polyvalente kationer som f.eks. jern, calcium, magnesium, aluminium, selen og zink.
English: Do not change the dose or schedule for taking Revolade unless your doctor or pharmacist advises you to.
Danish: Du må ikke ændre dosis eller behandlingsplan for, hvornår du skal tage Revolade, medmindre lægen eller apotekspersonalet råder dig til det. Mens du tager Revolade, vil du blive fulgt af en læge, der har specialist erfaring i behandling af din sygdom.
English: In addition, in the RAISE study, 42% of patients with baseline platelet count ≤15,000/μl treated with eltrombopag responded at the end of the 6 month treatment period.
Danish: Herudover responderede 42 % af de eltrombopag-behandlede patienter i RAISE-studiet, med et trombocyttal ved udgangsniveau på ≤ 15.000 pr. µl, ved udgangen af den 6 måneders behandlingsperiode.
English: A new oral dosing syringe should be used to prepare each dose of Revolade for oral suspension.
Danish: En ny doseringssprøjte skal bruges til at klargøre hver dosis Revolade til oral suspension.
English: • interruption in blood supply to spleen (splenic infarction)
Danish: • afbrydelse af blodforsyningen til milten (miltinfarkt)
English: If after 2 weeks of eltrombopag therapy at 100 mg the required platelet level to initiate antiviral therapy is not achieved, eltrombopag should be discontinued.
Danish: Hvis trombocyttallet, som er nødvendigt for at opstarte den antivirale behandling, ikke er opnået efter 2 ugers behandling med 100 mg eltrombopag daglig, skal eltrombopag seponeres.
English: Patients were diagnosed with chronic ITP for at least 1 year and were refractory or relapsed to at least one prior ITP therapy or unable to continue other ITP treatments for a medical reason and had platelet count <30,000/µl.
Danish: Patienterne var diagnosticeret med kronisk ITP i mindst 1 år og havde refraktær sygdom eller recidiv efter mindst én tidligere ITP-behandling eller var ikke i stand til at fortsætte med andre ITP-behandlinger af en medicinsk årsag og havde trombocyttal <30.000 pr. µl.
English: Studies in animals have shown that eltrombopag is likely secreted into milk (see section 5.3); therefore a risk to the suckling child cannot be excluded.
Danish: Dyrestudier har vist, at eltrombopag sandsynligvis udskilles i mælk (se pkt.
English: Tablet coating Hypromellose (E464) Macrogol 400 (E1521) Polysorbate 80 (E433) Titanium dioxide (E171)
Danish: Tabletovertræk Hypromellose (E464) Macrogol 400 (E1521) Polysorbat 80 (E433) Titandioxid (E171)
English: • rash, bruising at the injection site
Danish: • udslæt, blå mærker ved injektionsstedet
English: A total of 114 patients with previously treated ITP were randomised 2:1 eltrombopag (n=76) to placebo (n=38).
Danish: I alt 114 patienter med tidligere behandlet ITP blev randomiseret i forholdet 2:1, eltrombopag (n = 76) mod placebo (n = 38).
English: Very common side effects These may affect more than 1 in 10 people:
Danish: Meget almindelige bivirkninger Kan forekomme hos flere end 1 ud af 10 personer:
English: Table 9 Geometric mean (95% CI) steady-state plasma eltrombopag pharmacokinetic parameters in patients with chronic HCV
Danish: Tabel 9 Geometrisk middelværdi (95 % konfidensinterval) for steady-state farmakokinetiske parametre i plasma for eltrombopag hos patienter med kronisk HCV
English: Administration of a single 25 mg dose of eltrombopag as powder for oral suspension with a highcalcium, moderate-fat and moderate-calorie meal reduced plasma eltrombopag mean AUC0-∞ by 75% and mean Cmax by 79%.
Danish: Administration af en enkelt 25 mg dosis eltrombopag som pulver til oral suspension med et calciumrigt måltid med moderat fedt- og kalorieindhold reducerede det gennemsnitlige AUC0-∞ for eltrombopag i plasma med 75 % og den gennemsnitlige Cmax med 79 %.
English: • eye problems, including cloudy lens in the eye (cataract), dry eye, small yellow deposits in the retina, yellowing of the whites of the eye
Danish: • øjenproblemer herunder uklar linse i øjnene (grå stær), tørre øjne, små gule aflejringer på nethinden, gulfarvning af det hvide i øjnene
English: The active substance in Revolade is eltrombopag.
Danish: Revolade indeholder: Aktivt stof: eltrombopag.
English: Common Irritability, pain, malaise, injection site reaction, non-cardiac chest pain, oedema, oedema peripheral
Danish: Almindelig Irritabilitet, smerter, utilpashed, reaktion på injektionsstedet, ikkekardielle smerter i brystkassen, ødem, perifert ødem
English: Revolade is indicated for the treatment of patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Danish: Revolade er indiceret til behandling af patienter i alderen 1 år og derover med primær immun thrombocytopeni (ITP) med en varighed på 6 måneder eller længere fra diagnose og som er refraktære over for anden behandling (f.eks. kortikosteroider og immunglobuliner) (se pkt.
English: No dosage adjustment is necessary for HCV patients of East Asian ancestry or patients with mild hepatic impairment (see section 5.2).
Danish: Det er ikke nødvendigt at justere doseringen hos patienter af østasiatisk oprindelse med HCV eller hos patienter med let nedsat leverfunktion (se pkt 5.2).
English: • increased levels of blood albumin
Danish: • forhøjede niveauer af albumin i blodet
English: These may affect up to 1 in 10 people.
Danish: Kan forekomme hos op til 1 ud af 10 personer.
English: Adults and paediatric population aged 6 to 17 years The recommended starting dose of eltrombopag is 50 mg once daily.
Danish: Voksne og pædiatrisk population i alderen 6 til 17 år Den anbefalede startdosis af eltrombopag er 50 mg én gang daglig.
English: Common Paraesthesia, hypoaesthesia, somnolence, migraine Uncommon Tremor, balance disorder, dysaesthesia, hemiparesis, migraine with aura, neuropathy peripheral, peripheral sensory neuropathy, speech disorder, toxic neuropathy, vascular headache
Danish: Tremor, balanceforstyrrelser, dysæstesi, hemiparese, migræne med aura, perifer neuropati, perifer sensorisk neuropati, taleforstyrrelser, toksisk neuropati, vaskulær hovedpine
English: Immune (primary) thrombocytopenia
Danish: Immun (primær) trombocytopeni
English: The influence of Asian ethnicity (such as Japanese, Chinese, Taiwanese and Korean) on the pharmacokinetics of eltrombopag was evaluated using a population pharmacokinetic analysis in 111 healthy adults (31 Asians) and 88 patients with ITP (18 Asians).
Danish: Indflydelsen af asiatisk etnicitet (så som japansk, kinesisk, taiwanesisk, koreansk) på eltrombopags farmakokinetik blev vurderet vha. en farmakokinetisk populationsanalyse med 111 raske voksne (31 asiater) og 88 patienter med ITP (18 asiater).
English: • decreased number of platelets (thrombocytopenia)
Danish: • nedsat antal blodpalder (trombocytopeni)
English: >250,000/µl
Danish: > 250.000 pr. µl
English: A dose of 100 mg eltrombopag once daily must not be exceeded.
Danish: Dosis af eltrombopag må ikke overstige 100 mg én gang daglig.
English: All patients initiated treatment with eltrombopag 50 mg. From Day 29 to the end of treatment, 15 to 28% of eltrombopag treated patients were maintained on ≤25 mg and 29 to 53% received 75 mg.
Danish: Fra dag 29 og til afslutningen af behandlingen blev 15-28 % af de patienter, der blev behandlet med eltrombopag fastholdt på ≤ 25 mg og 29-53 % på 75 mg.
English: • joint pain, back pain, bone pain, pain in the hands or feet, muscle spasms
Danish: • ledsmerter, rygsmerter, knoglesmerter, smerter i hænder eller fødder, muskelspasmer
English: • infection of the skin
Danish: • misfarvning af huden
English: • increased levels of uric acid
Danish: • forhøjede niveauer af urinsyre
English: In clinical studies with eltrombopag, a dose reduction of statins by 50% was recommended.
Danish: En 50 % dosisreduktion af statiner blev anbefalet i kliniske studier med eltrombopag.
English: Do not open the foil sachets until ready for use.
Danish: Foliebrevene må først åbnes lige inden de skal anvendes.
English: Preparation and administration of the powder for oral suspension:
Danish: Klargøring og indgivelse af pulver til oral suspension.
English: Within two weeks of stopping Revolade, your blood platelet count will usually drop back down to what it was before starting Revolade.
Danish: Blødninger og blå mærker efter, at du er stoppet behandlingen Inden for to uger efter, at du er stoppet med behandlingen med Revolade, vil dit blodpladetal normalt falde tilbage til samme niveau, som inden behandlingen med Revolade startede.