FrancophonIA/ELRC3.0 huggingface dataset:
English: However, at a maternally toxic dose of 60 mg/kg/day (6 times the human clinical exposure in ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) in rats, eltrombopag treatment was associated with embryo lethality (increased preand post-implantation loss), reduced foetal body weight and gravid uterine weight in the female fertility study and a low incidence of cervical ribs and reduced foetal body weight in the embryofoetal development study.
Danish: Derimod blev behandlingen af rotter med eltrombopag ved en maternel, toksisk dosis på 60 mg/kg/dag (6 gange den humane kliniske eksponering hos ITP-patienter ved doser på 75 mg/dag og 3 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC) forbundet med fosterletalitet (øget præog post-implantationstab) og reduceret foster- og uterusvægt under graviditet i fertilitetsstudiet med hunner samt en lav forekomst af cervikale ribben og nedsat fostervægt i fosterudviklingsstudiet.
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Meget almindelig
English: For patients with HCV initiate eltrombopag at a dose of 25 mg once daily (see section 4.2).
Danish: For patienter med HCV er startdosis af eltrombopag 25 mg én gang daglig (se pkt.
English: • increased levels of blood bilirubin (a substance produced by the liver)
Danish: • forhøjede niveauer af bilirubin i blodet (et stof som dannes i leveren)
English: • muscle pain, muscle spasm, muscle weakness
Danish: • muskelsmerter, muskelspasmer, muskelsvaghed
English: Based on model estimate, female HCV patient had approximately 41% higher plasma eltrombopag AUC(0-) as compared to male patients.
Danish: Ud fra modellerede estimater havde de kvindelige HCV-patienter ca. 41 % højere plasma-eltrombopag-AUC(0-)-værdier sammenlignet med mandlige patienter.
English: How much to take
Danish: Hvor meget Revolade skal du tage
English: Common Dry eye, cataract, ocular icterus, vision blurred, visual impairment, vitreous floaters
Danish: Almindelig Tørre øjne, katarakt, okulær icterus, sløret syn, nedsat syn, flydere i glaslegemet
English: The longest RBC transfusion-free period for responders was 266 days (median).
Danish: Den længste periode uden transfusion af erytrocytter for respondenter var 266 dage (median).
English: In controlled studies in thrombocytopenic patients with HCV (n=1,439), 38 out of 955 patients (4%) treated with eltrombopag experienced a TEE and 6 out of 484 patients (1%) in the placebo group experienced TEEs.
Danish: I kontrollerede studier blandt trombocytopeniske patienter med HCV (n = 1.439) oplevede 38 ud af 955 patienter (4 %), som blev behandlet med eltrombopag, en TEE, og 6 ud af 484 patienter (1 %) i placebogruppen oplevede TEE.
English: Two phase III, randomised, double-blind, placebo-controlled studies RAISE (TRA102537) and TRA100773B and two open-label studies REPEAT (TRA108057) and EXTEND (TRA105325) evaluated the safety and efficacy of eltrombopag in adult patients with previously treated ITP.
Danish: Sikkerheden af og effekten ved eltrombopag er vurderet i to randomiserede, dobbeltblindede og placebokontrollerede fase III-studier; RAISE (TRA102537) og TRA100773B samt i to ublindede studier; REPEAT (TRA108057) og EXTEND (TRA105325).
English: If new cytogenetic abnormalities are detected, it must be evaluated whether continuation of eltrombopag is appropriate (see sections 4.4 and 4.8).
Danish: Hvis der ses nye cytogenetiske anomalier, skal det vurderes, hvorvidt det er hensigtsmæssigt at fortsætte med eltrombopag (se pkt.
English: constipation, swollen stomach, taste disturbances, inflammation of the stomach, piles
Danish: forstoppelse, udspilet mave, smagsforstyrrelser, betændelse i maven, hæmorider, tarmirritation
English: • inflammation (swelling) and infection of the tonsils infection of the lungs, sinuses, tonsils, nose and throat
Danish: • inflammation (hævelse) og infektion i mandlerne, infektion i lungerne, bihulerne, mandlerne,
English: In vitro studies with eltrombopag suggest a potential phototoxicity risk; however, in rodents there was no evidence of cutaneous phototoxicity (10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 5 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) or ocular phototoxicity (4 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Danish: In vitro-studier med eltrombopag tyder på en potentiel fototoksisk risiko, men hos gnavere var der ingen tegn på kutan fototoksicitet (10 eller 7 gange den humane kliniske eksponering hos voksne eller pædiatriske ITP-patienter ved doser på 75 mg/dag og 5 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC) eller okulær fototoksicitet (≥ 4 gange den humane kliniske eksponering hos voksne eller pædiatriske ITP-patienter ved doser på 75 mg/dag og 3 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC).
English: • inflammation of the nasal passages, throat and mouth, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache
Danish: • inflammation (hævelse) i næsen, svælget eller munden, influenzalignende symptomer, tør mund, ømhed eller inflammation (hævelse) i munden, tandpine
English: Eltrombopag should be initiated at a dose of 25 mg once daily.
Danish: Eltrombopagbehandling bør indledes med en startdosis på 25 mg én gang daglig.
English: No dosage adjustment is necessary for HCV patients of Asian ancestry or patients with mild hepatic impairment (see section 5.2).
Danish: Det er ikke nødvendigt at justere doseringen hos patienter af asiatisk oprindelse med HCV eller hos patienter med let nedsat leverfunktion (se pkt.
English: >150,000/µl to 250,000/µl
Danish: > 150.000 pr. µl til  250.000 pr. µl
English: White, round, biconvex film-coated tablet (approximately 7.9 mm in diameter) debossed with ‘GS MZ1' and ‘12.5' on one side.
Danish: Hvid, rund, bikonveks, filmovertrukket tablet (ca, 7,9 mm i diameter), der er præget ”GS MZ1” og ”12,5” på den ene side.
English: Common side effects that may show up in blood tests:
Danish: Almindelige bivirkninger, som kan ses i blodprøver:
English: • sore throat and discomfort when swallowing
Danish: • ondt i halsen og ubehag med at synke
English: The exposure at the lowest dose was 1.2 or 0.8 times the human clinical exposure based on AUC in adult or paediatric ITP patients at 75 mg/day and 0.6 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Danish: Eksponeringen ved laveste dosis var 1,2 eller 0,8 gange den humane kliniske eksponering hos voksne eller pædiatriske ITP-patienter ved doser på 75 mg/dag og 0,6 gang den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC.
English: Bone marrow reticulin formation and risk of bone marrow fibrosis
Danish: Dannelse af knoglemarvsretikulin og risiko for knoglemarvsfibrose
English: Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Revolade a day.
Danish: Voksne - den sædvanlige startdosis for hepatitis C er én 25 mg tablet Revolade daglig.
English: Eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Danish: Eltrombopag bør ikke gives til patienter med nedsat leverfunktion (Child-Pugh score ≥ 5), medmindre fordelene ved behandlingen er større end den identificerede risiko for portal venetrombose.
English: Adults - the usual starting dose for SAA is one 50 mg tablet of Revolade a day.
Danish: Voksne - den sædvanlige startdosis for SAA er én 50 mg tablet Revolade daglig.
English: • cough bringing up phlegm, runny nose, flu, cold sore, sore throat and discomfort when swallowing
Danish: • hoste med slim, løbende næse, influenza, forkølelsessår, ondt i halsen og ubehag med at synke
English: Eltrombopag does not inhibit or induce CYP enzymes based on in vitro and in vivo data (see section 4.5).
Danish: Baseret på in vitro- og in vivo-data, hverken hæmmer eller inducerer eltrombopag CYP-enzymer (se pkt.
English: Revolade 25 mg film-coated tablets are round, biconvex, white, debossed with ‘GS NX3' and ‘25' on one side.
Danish: Revolade 25 mg filmovertrukne tabletter er runde, bikonvekse, hvide og præget ”GS NX3” og ”25” på den ene side.
English: Common Arthralgia, muscle spasms, back pain, pain in extremity, musculoskeletal pain, bone pain
Danish: Almindelig Ledsmerter, muskelspasmer, rygsmerter, smerter i ekstremiteterne, muskuloskeletale smerter, knoglesmerter
English: Screw the lid onto the mixing bottle.
Danish: Skru låget på blandeflasken.
English: However blood clots can also form with normal or even low platelet counts.
Danish: Et meget højt blodpladetal kan give en øget risiko for blodpropper, men blodpropper kan også forekomme ved normale - og endda ved lave - blodpladetal.
English: Common Hypokalaemia, decreased appetite, blood uric acid increased Uncommon Anorexia, gout, hypocalcaemia
Danish: Metabolisme og ernæring Almindelig Hypokaliæmi, nedsat appetit, forhøjet urinsyre i blodet Ikke almindelig
English: g.h/ml a, g/ml Cmax
Danish: a µg .t/ml a, μg/ml Cmax
English: Chronic hepatitis C associated thrombocytopenia studies
Danish: Studier omhandlende trombocytopeni ved kronisk hepatitis C
English: Syringe tip
Danish: Sprøjtens spids
English: • mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
Danish: • mundproblemer herunder tør mund, øm mund, følsom tunge, blødende tandkød, sår i munden
English: • Slowly push the plunger all the way into the syringe.
Danish: • Tryk langsomt stemplet helt ind i sprøjten.
English: The reoccurrence of thrombocytopenia is possible upon discontinuation of treatment (see section 4.4).
Danish: Der kan forekomme trombocytopeni igen ved seponering af behandlingen (se pkt.
English: Adults and children (6 to 17 years) - the usual starting dose for ITP is one 50 mg tablet of Revolade a day.
Danish: Voksne og børn (6 til 17 år) - den sædvanlige startdosis af Revolade for ITP er én 50 mg tablet daglig.
English: Liver enzymes measured between Days 2 and 18 after ingestion peaked at a 1.6-fold ULN in AST, a 3.9-fold ULN in ALT, and a 2.4-fold ULN in total bilirubin, The platelet counts were 672,000/µl on Day 18 after ingestion and the maximum platelet count was 929,000/µl.
Danish: Leverenzymer, målt mellem dag 2 og 18 efter indtagelsen, nåede sit maksimum ved 1,6 gange den øvre normalgrænse i ASAT, 3,9 gange den øvre normalgrænse i ALAT og 2,4 gange den øvre normalgrænse i samlet bilirubin.
English: After initiating the dose of eltrombopag in patients with hepatic impairment an interval of 3 weeks should be observed before increasing the dose.
Danish: Efter opstart med denne eltrombopag-dosis bør der være et observationsinterval på 3 uger, før dosis øges.
English: Use lowest dose of eltrombopag and/or concomitant ITP treatment to maintain platelet counts that avoid or reduce bleeding.
Danish:  50.000 pr. µl til ≤ 150.000 pr. µl Anvend laveste eltrombopag-dosis og/eller anden ITP-medicin for at fastholde et trombocyttal, hvor blødning undgås eller reduceres.
English: Tablet coating Hypromellose (E464) Iron oxide red (E172) Iron oxide black (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
Danish: Tabletovertræk Hypromellose (E464) Jernoxid rød (E172) Jernoxid sort (E172) Macrogol 400 (E1521) Titandioxid (E171)
English: Cytogenetic abnormalities
Danish: Cytogenetiske anomalier
English: Eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis (see section 4.4).
Danish: Eltrombopag bør ikke gives til ITP-patienter med nedsat leverfunktion (Child-Pugh score ≥ 5), medmindre den forventede fordel ved behandlingen er større end den identificerede risiko for portal venetrombose (se pkt.
English: How to take Revolade
Danish: Sådan skal du tage Revolade
English: Patients with low albumin levels (≤ 35 g/l) or MELD ≥10 had a 2-fold greater risk of TEEs than those with higher albumin levels; those aged ≥60 years had a 2-fold greater risk of TEEs compared to younger patients.
Danish: Patienter med lave albumin-niveauer (≤ 35 g/l) eller med MELD ≥ 10 havde 2fold større risiko for at få TEEs end dem med højere albumin-niveauer; patienter ≥ 60 år havde 2-fold større risiko for at få TEEs sammenlignet med yngre patienter.
English: A decrease in eltrombopag exposure was observed with co-administration of 200 mg and 600 mg ciclosporin (a BCRP inhibitor).
Danish: Ved samtidig adminstration af 200 mg og 600 mg ciclosporin (en BCRP-hæmmer) blev der observeret et fald i eksponeringen af eltrombopag (se pkt.
English: Common Iron overload, decreased appetite, hypoglycaemia, increased appetite
Danish: Metabolisme og ernæring Almindelig Jernophobning, nedsat appetit, hypoglykæmi, øget appetit Psykiske forstyrrelser
English: Tablet coating Hypromellose (E464) Iron oxide red (E172) Iron oxide yellow (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
Danish: Tabletovertræk Hypromellose (E464) Jernoxid rød (E172) Jernoxid gul (E172) Macrogol 400 (E1521) Titandioxid (E171)
English: Revolade 50 mg film-coated tablets are round, biconvex, brown, debossed with ‘GS UFU' and ‘50' on one side.
Danish: Revolade 50 mg filmovertrukne tabletter er runde, bikonvekse, brune og præget ”GS UFU” og ”50” på den ene side.
English: Patients were diagnosed with ITP for at least 6 months and were refractory or relapsed to at least one prior ITP therapy with a platelet count <30,000/µl (n=67).
Danish: Patienterne var diagnosticeret med ITP mindst 6 måneder tidligere og havde refraktær sygdom eller recidiv efter mindst én tidligere ITP-behandling med trombocyttal <30.000 pr. µl.
English: In addition, a screw cap (ethylene vinyl acetate / LDPE) with syringeport capability is provided.
Danish: Yderligere indgår i sættet et skruelåg (etylenvinylacetat / LDPE) med mulighed for påfyldning af doseringssprøjte.
English: There is an increased risk for adverse events, including hepatic decompensation and thromboembolic events, in thrombocytopenic patients with advanced chronic liver disease treated with eltrombopag, either in preparation for invasive procedure or in HCV patients undergoing antiviral therapy (see sections 4.4 and 4.8).
Danish: For patienter behandlet med eltrombopag er der øget risiko for bivirkninger, herunder dekompenseret leversygdom og tromboemboliske hændelser, hos trombocytopeniske patienter med fremskreden kronisk leversygdom, som behandles med eltrombopag forud for et invasivt indgreb eller hos HCVpatienter, som får antiviral behandling (se pkt.
English: Based on estimates from the population pharmacokinetic analysis, Asian patients had approximately 55% higher plasma eltrombopag AUC(0-) values as compared to patients of other races who were predominantly Caucasian (see section 4.2).
Danish: Ud fra estimaterne fra den farmakokinetiske populationsanalyse havde asiatiske patienter i gennemsnit ca. 55 % højere plasma-eltrombopagAUC(0-)-værdier sammenlignet med patienter af andre racer, som overvejende var kaukasiske (se pkt.
English: Chronic HCV patients and severe aplastic anaemia patients with hepatic impairment should initiate eltrombopag at a dose of 25 mg once daily (see section 5.2).
Danish: Startdosis af eltrombopag hos patienter med kronisk HCV og svær aplastisk anæmi med nedsat leverfunktion bør være 25 mg én gang daglig (se pkt.
English: Based on estimates from the population pharmacokinetic analysis, Asian ITP patients had approximately 49% higher plasma eltrombopag AUC(0-) values as compared to non-Asian patients who were predominantly Caucasian (see section 4.2).
Danish: Ud fra estimaterne fra den farmakokinetiske populationsanalyse havde asiatiske ITP-patienter ca. 49 % højere plasma-eltrombopag-AUC(0-)værdier sammenlignet med ikke-asiatiske, som hovedsagelig var kaukasiere (se pkt.
English: In the phase II refractory SAA clinical study with eltrombopag at a dose of 150 mg/day (with ethnic or age related modifications as indicated) (ELT116826), the incidence of new cytogenetic abnormalities was observed in 22.6% of adult patients [7/31 (where 3 of them had changes in chromosome 7)].
Danish: I det kliniske fase II-studie til refraktær SAA med eltrombopag ved en dosis på 150 mg/dag (med etnisk eller aldersrelaterede modifikationer som indiceret) (ELT116826), blev nye cytogenetiske anormalier set hos 22,6 % af voksne patienter [7/31 (hvoraf 3 havde ændringer i kromosom 7)].
English: Common Mouth ulceration, toothache
Danish: Almindelig Mundsår, tandpine
English: Based on estimates from the population pharmacokinetic analysis, female ITP patients had approximately 23% higher plasma eltrombopag AUC(0-) as compared to male patients, without adjustment for body weight differences.
Danish: Ud fra estimaterne fra den farmakokinetiske populationsanalyse havde de kvindelige ITP-patienter ca. 23 % højere plasma-eltrombopag-AUC(0-) sammenlignet med mandlige patienter.
English: Number of cumulative weeks with platelet counts 50,000-400,000/µl, Mean (SD) Patients with ≥75% of assessments in the target range (50,000 to 400,000/l), n (%)
Danish: Patienter med ≥ 75 % af målingerne i det tilsigtede interval (50.000 - 400.000 pr. µl), n (%)
English: Common Vomiting, ascites, abdominal pain, abdominal pain upper, dyspepsia, dry mouth, constipation, abdominal distension, toothache, stomatitis, gastrooesophagal reflux disease, haemorrhoids, abdominal discomfort, varices oesophageal Uncomon Oesophageal varices haemorrhage, gastritis, aphthous stomatitis
Danish: Almindelig Opkast, ascites, abdominalsmerter, øvre abdominalsmerter, dyspepsi, mundtørhed, obstipation, udspilet abdomen, tandpine, stomatitis, gastroøsofageal refluks, hæmorider, abdominalt ubehag, øsofagusvaricer
English: You will have blood tests to check your liver function before you start taking Revolade and at intervals while you are taking it. You may need to stop taking Revolade if the amount of these substances increases too much, or if you get other signs of liver damage.
Danish: Du kan blive nødt til at stoppe behandlingen med Revolade, hvis indholdet af disse stoffer i blodet stiger for meget, eller hvis du får andre tegn på leverskade.
English: Common Petechiae, rash, pruritus, urticaria, skin lesion, rash macular Not known Skin discolouration, skin hyperpigmentation
Danish: Almindelig Petekkier, udslæt, kløe, urticaria, hudlæsioner, makulært udslæt Ikke kendt Misfarvning af huden, hyperpigmentering af huden
English: Revolade 12.5 mg film-coated tablets EU/1/10/612/010
Danish: Revolade 12,5 mg filmovertrukne tabletter EU/1/10/612/010
English: • abdominal (stomach) pain, enlarged abdomen, blood in your stools
Danish: • Mavesmerter, forstørret mave, blod i afføringen
English: Therefore, eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis (see sections 4.2 and 4.4).
Danish: Derfor bør eltrombopag ikke gives til ITP-patienter med nedsat leverfunktion (Child-Pugh score ≥ 5), medmindre de forventede fordele ved behandlingen opvejer den identificerede risiko for portal venetrombose (se pkt.
English: Arthralgia, pain in extremity, muscle spasms
Danish: Artralgi, ekstremitetssmerter, muskelspasmer
English: When treatment is considered appropriate, caution is required when administering eltrombopag to patients with hepatic impairment (see sections 4.2 and 4.8).
Danish: Hvis behandling vurderes at være nødvendig, skal der udvises forsigtighed ved administration af eltrombopag til ITP-patienter med nedsat leverfunktion (se pkt.
English: • skin changes including change in colour, peeling, redness, itching and sweating
Danish: • hudforandringer herunder ændring i farve, afkalning, rødme, kløe og øget svedtendens
English: In the phase II refractory SAA clinical study with eltrombopag with a starting dose of 50 mg/day (escalated every 2 weeks to a maximum of 150 mg/day) (ELT112523), the incidence of new cytogenetic abnormalities was observed in 17.1% of adult patients [7/41 (where 4 of them had changes in chromosome 7)].
Danish: I det kliniske fase II-studie til refraktær SAA med eltrombopag ved en startdosis på 50 mg/dag (øget hver 2 uge til maksimalt 150 mg/dag) (ELT112523), blev nye cytogenetiske anomalier set hos 17,1 % af voksne patienter [7/41 (hvoraf 4 havde ændringer i kromosom 7)].
English: Pyrexia, fatigue, influenza-like illness, asthenia, chills
Danish: Pyreksi, træthed, influenzalignende symptomer, asteni, kulderystelser
English: Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg tablet of Revolade a day.
Danish: Børn (1 til 5 år) - den sædvanlige startdosis for ITP er én 25 mg tablet Revolade daglig.
English: The longest platelet transfusion-free period for non-responders was 27 days (median).
Danish: Den længste periode uden transfusion af trombocytter for ikkerespondenter var 27 dage (median).
English: These may affect more than 1 in 10 people:
Danish: Kan forekomme hos flere end 1 ud af 10 personer:
English: Endosteal hyperostosis was observed in a 28-week toxicity study in rats at a non-tolerated dose of 60 mg/kg/day (6 times or 4 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Danish: Endosteal hyperostose blev observeret i et 28 uger langt toksicitetsstudie med rotter med ikke-tålbare doser på 60 mg/kg/dag (6 eller 4 gange den humane kliniske eksponering voksne eller pædiatriske hos ITP-patienter ved doser på 75 mg/dag og 3 gange den humane kliniske eksponering hos HCVpatienter ved doser på 100 mg/dag, baseret på AUC).
English: Patients with low albumin levels (≤35 g/l) or MELD ≥10 had a 2-fold greater risk of TEEs than those with higher albumin levels; those aged ≥60 years had a 2-fold greater risk of TEEs compared to younger patients.
Danish: Patienter med lave albumin-niveauer (≤ 35 g/l) eller med MELD ≥ 10 havde 2 gange øget risiko for at få TEEs i forhold til patienter med højere albumin-niveauer; patienter ≥ 60 år havde 2 gange øget risiko for at få TEEs sammenlignet med yngre patienter.
English: Pink, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS' and ‘75' on one side.
Danish: Lyserød, rund, bikonveks, filmovertrukket tablet (ca, 10,3 mm i diameter), der er præget ”GS FFS” og ”75” på den ene side.
English: Multipack containing 84 (3 packs of 28) film-coated tablets
Danish: Multipakning, der indeholder 84 filmovertrukne tabletter (3 pakninger med 28)
English: • Insert the syringe tip into the hole in the bottle lid. 9.
Danish: • Sæt spidsen af sprøjten i hullet i låget på blandeflasken.
English: • swelling of the lower limbs due to the accumulation of fluids
Danish: • hævelser i underarme og underben, som følge af væskeophobning
English: • increased haemaglobin level
Danish: • forhøjet hæmoglobinniveau
English: • tingling or numbness of the hands or feet
Danish: • prikken, snurren eller sovende fornemmelse i hænder eller fødder
English: Adults - the usual starting dose for SAA is two 25 mg sachets of Revolade a day.
Danish: Voksne - den sædvanlige startdosis for SAA er to 25 mg breve Revolade daglig.
English: In controlled studies in thrombocytopenic patients with HCV receiving interferon-based therapy (n=1,439), 38 out of 955 patients (4%) treated with eltrombopag and 6 out of 484 patients (1%) in the placebo group experienced thromboembolic events (TEEs).
Danish: I kontrollerede studier med trombocytopeniske patienter med HCV, som modtog interferon behandling (n = 1439), oplevede 38 ud af 955 patienter (4 %) som fik eltrombopag, og 6 ud af 484 patienter (1 %) i placebogruppen tromboemboliske hændelser (TEEs).
English: Revolade 25 mg powder for oral suspension
Danish: Revolade 25 mg pulver til oral suspension
English: • increased number of platelets
Danish: • forhøjet antal båndneutrofiler