FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of a single dose of eltrombopag 200 mg with boceprevir 800 mg every 8 hours did not alter plasma boceprevir AUC(0-), but increased Cmax by 20%, and decreased Cmin by 32%.
Danish: Samtidig administration af en enkelt dosis eltrombopag på 200 mg og boceprevir 800 mg hver 8. time ændrede ikke plasma-boceprevir-AUC(0-τ), men øgede Cmax med 20 % og nedsatte Cmin med 32 %.
English: In clinical studies, platelet counts generally began to increase within 1 week of starting eltrombopag.
Danish: I kliniske studier begyndte trombocyttallene generelt at stige inden for 1 uge efter indledning af behandling med eltrombopag.
English: In 3 controlled and 2 uncontrolled clinical studies among adult ITP patients receiving eltrombopag (n=446), 17 patients experienced a total of 19 TEEs, which included (in descending order of occurrence) deep vein thrombosis (n=6), pulmonary embolism (n=6), acute myocardial infarction (n=2), cerebral infarction (n=2), embolism (n=1) (see section 4.4).
Danish: I tre kontrollerede og to ikke-kontrollerede kliniske studier blandt voksne patienter med ITP, som fik eltrombopag (n = 446), fik 17 patienter i alt 19 tromboemboliske hændelser, som omfattede (med faldende hyppighed) dyb venetrombose (n = 6), lungeemboli (n = 6), akut myokardieinfarkt (n = 2), cerebral infarkt (n = 2) og emboli (n = 1) (se pkt.
English: Three patients had cytogenetic abnormalities at baseline.
Danish: Tre patienter havde cytogenetiske anomalier ved baseline.
English: If you are taking interferon-based treatments together with Revolade to treat low platelet count due to hepatitis C, some liver problems can get worse.
Danish: Hvis du tager Revolade sammen med antiviral interferonbehandling for at behandle lavt trombocyttal på grund af hepatitis C, kan nogle problemer med leveren blive værre.
English: Haematological response was defined as meeting one or more of the following criteria: 1) platelet count increases to 20,000/µl above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks; 2) haemoglobin increase by >1.5g/dl, or a reduction in ≥4 units of red blood cell (RBC) transfusions for 8 consecutive weeks; 3) absolute neutrophil count (ANC) increase of 100% or an ANC increase >0.5 x 10
Danish: Hæmatologisk respons blev defineret som opfyldelse af et eller flere af følgende kriterier: 1) stigning i trombocyttallet til 20.000 pr. µl over baseline eller stabile trombocyttal med transfusionsuafhængighed i mindst 8 uger; 2) stigning i hæmoglobin på > 1,5 g/dl eller reduktion på ≥ 4 enheder af erytrocyttransfusioner i 8 på hinanden følgende uger; 3) stigning i det absolutte neutrofiltal (ANC) på 100 % eller stigning i ANC på > 0,5 x 10
English: The plasma eltrombopag concentration-time data collected in 88 patients with ITP in studies TRA100773A and TRA100773B were combined with data from 111 healthy adult subjects in a population PK analysis.
Danish: Data for plasmakoncentrationen af eltrombopag over tid, indsamlet hos 88 patienter med ITP, i studierne TRA100773A og TRA100773B, blev kombineret med data fra 111 raske voksne personer i en farmakokinetisk populationsanalyse.
English: Very common side effects that may show up in blood tests: • increased of liver enzymes (alanine aminotransferase (ALT))
Danish: Meget almindelige bivirkninger, som kan ses i blodprøver • forhøjede leverenzymer (alaninaminotransferase (ALAT))
English: The other ingredients are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide (E171).
Danish: Øvrige indholdsstoffer: hypromellose, macrogol 400, magnesiumstearat, mannitol (E421), mikrokrystallinsk cellulose, povidon, natriumstivelsesglycolat, titandioxid (E171).
English: Make sure the plunger is pushed all the way into the syringe.
Danish: Sørg for, at stemplet er trykket helt ind i sprøjten.
English: Eltrombopag should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus (see section 4.6).
Danish: Eltrombopag bør kun anvendes under graviditet, hvis de forventede fordele opvejer den potentielle risiko for fosteret (se pkt.
English: • increased levels of creatinine
Danish: • forhøjede niveauer af kreatinin
English: • accumulation of iron in the body (iron overload)
Danish: • ophobning af jern i kroppen
English: Aluminum blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets.
Danish: Aluminiumsblisterpakninger (PA/Alu/PVC/Alu) i æske indeholdende 14 eller 28 filmovertrukne tabletter og multipakninger indeholdende 84 filmovertrukne tabletter (3 pakninger af 28).
English: Uridine diphosphoglucuronyl transferase UGT1A1 and UGT1A3 are responsible for glucuronidation, and bacteria in the lower gastrointestinal tract may be responsible for the cleavage pathway.
Danish: Uridin-diphosphoglukuronyl-transferase UGT1A1 og UGT1A3 er ansvarlige for glukuronideringen, og bakterier i den nederste del af mave-tarm-kanalen kan være ansvarlige for spaltnings-pathwayen.
English: No dose adjustment is required for thrombocytopenic patients with chronic HCV and mild hepatic impairment (Child-Pugh score ≤6).
Danish: Det er ikke nødvendigt at foretage dosisjustering hos trombocytopeniske patienter med kronisk HCV og let nedsat leverfunktion (Child-Pugh score ≤ 6).
English: There is an increased risk for adverse reactions, including potentially fatal hepatic decompensation and thromboembolic events, in thrombocytopenic HCV patients with advanced chronic liver disease, as defined by low albumin levels ≤35 g/l or model for end stage liver disease (MELD) score ≥10, when treated with eltrombopag in combination with interferon-based therapy.
Danish: Der er en øget risiko for bivirkninger, herunder potentielt dødelig dekompenseret leversygdom og tromboemboliske hændelser, hos trombocytopeniske HCV-patienter med fremskreden kronisk leversygdom, defineret som albumin-niveau ≤ 35 g/l eller en Model for End Stage Liver Disease (MELD)-score ≥ 10, hvis de behandles med eltrombopag i kombination med interferonbehandling.
English: Ocular changes
Danish: Okulære forandringer
English: Unchanged parent compound (eltrombopag) is not detected in urine.
Danish: Der sås intet uomdannet udgangsstof (eltrombopag) i urinen.
English: Patients with diagnosis of Fanconi anaemia, infection not responding to appropriate therapy, PNH clone size in neutrophils of ≥50%, where excluded from participation.
Danish: Patienter med diagnosen Fanconis anæmi, infektion, som ikke reagerede på passende behandling, eller neutrofil PNH-klonstørrelse på ≥ 50 % blev udelukket fra at deltage.
English: CYP1A2 and CYP2C8 inhibitors and inducers
Danish: CYP1A2- og CYP2C8-hæmmere og -induktorer
English: Cleaning of the mixing equipment:
Danish: Rengøring af blandeudstyret
English: • problems with balance, speech and nerve function, shaking
Danish: • balanceproblemer, taleproblemer, problemer med nervefunktion, rystelser
English: At baseline the median platelet count was 20,000/µl, haemoglobin was 8.4 g/dl, ANC was 0.58 x 10
Danish: Ved baseline var det mediane trombocyttal 20.000 pr. µl, hæmoglobin var 8,4 g/dl, ANC var 0,58 x 10
English: Compared to healthy volunteers, patients with mild hepatic impairment had approximately 111% (95% CI: 45% to 283%) higher plasma eltrombopag AUC(0-) values and patients with moderate hepatic impairment had approximately 183% (95% CI: 90% to 459%) higher plasma eltrombopag AUC(0-) values.
Danish: Sammenlignet med raske frivillige havde patienter med let nedsat leverfunktion omkring 111 % (95 % konfidensinterval: 45 % til 283 %) højere plasma-eltrombopag-AUC(0-)-værdier, og patienter med moderat nedsat leverfunktion havde omkring 183 % (95 % konfidensinterval: 90 % til 459 %) højere plasma-eltrombopag-AUC(0-)-værdier.
English: Retinal haemorrhages, mostly Grade 1 or 2, have been reported in HCV patients receiving interferon, ribavirin and eltrombopag (2% of the eltrombopag group and 2% of the placebo group.
Danish: Retinal blødning, for det meste Grad 1 eller 2, er rapporteret for HCV-patienter, som fik interferon, ribavirin og eltrombopag (hos 2 % i eltrombopaggruppen og hos 2 % i placebogruppen).
English: The adverse reactions in the adult ITP studies (N=763), paediatric ITP studies (N=171), the HCV studies (N=1,520), the SAA studies (N=43) and post-marketing reports are listed below by MedDRA system organ class and by frequency.
Danish: Bivirkningerne fra ITP-studierne i voksne (n = 763), de pædiatriske ITP-studier (n = 171), HCVstudierne (n = 1.520), SAA-studierne (n = 43) og rapporterne efter markedsføring er angivet herunder i henhold til MedDRA systemorganklasser og hyppighed.
English: • Throw away the used oral dosing syringe.
Danish: • Kassér den brugte orale sprøjte.
English: The effectiveness and safety of Revolade have not been established for the treatment of thrombocytopenia due to MDS.
Danish: Revolades virkning og sikkerhed til behandling af trombocytopeni i forbindelse med MDS, er ikke fastslået.
English: Tell your doctor if you have any bleeding or bruising after stopping Revolade.
Danish:  Fortæl det til lægen, hvis du får blå mærker eller blødninger efter, at du er stoppet med at tage
English: In studies utilising human liver microsomes, eltrombopag (up to 100 M) showed no in vitro inhibition of the CYP450 enzymes 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5, and 4A9/11 and was an inhibitor of CYP2C8 and CYP2C9 as measured using paclitaxel and diclofenac as the probe substrates.
Danish: I studier med humane levermikrosomer sås ingen in vitro-hæmning med eltrombopag (op til 100 µM) af følgende CYP-enzymer: 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5 og 4A9/11 med paclitaxel og diclofenac som substrater, mens eltrombopag hæmmede CYP2C8 og CYP2C9.
English: • digestive system problems including being sick (vomiting), change in appetite (increased or decreased), stomach pain/discomfort, swollen stomach, passing wind, change in stool colour
Danish: • problemer i fordøjelsessystemet, herunder opkastning, ændringer i appetitten, (øget eller nedsat), mavesmerter/-ubehag, oppustet mave, luftafgang, ændringer i afføringens farve
English: At baseline, more than 70% of ITP patients in each treatment group reported any bleeding (WHO Grades 1-4) and more than 20% reported clinically significant bleeding (WHO Grades 2-4), respectively.
Danish: Ved udgangsniveauet rapporterede mere end 70 % af ITP-patienterne i hver behandlingsgruppe om blødning (WHO-niveau 1-4) og mere end 20 % om klinisk signifikant blødning (WHO-niveau 2-4).
English: Symptoms patients with ITP may notice include petechiae (pinpointsized flat round red spots under the skin), bruising, nosebleeds, bleeding gums and not being able to control bleeding if they are cut or injured.
Danish: De symptomer, patienter med ITP kan opleve, omfatter petekkier (punktformede, flade,røde pletter under huden), blå mærker, næseblod, blødende gummer og ikke være i stand til at kontrollere en blødning, hvis de skærer sig eller kommer til skade.
English: Don't breast-feed while you are taking Revolade.
Danish: Du må ikke amme, mens du er i behandling med Revolade.
English: However, cataracts were not observed in juvenile rats given tolerated doses at 5 times the human clinical exposure in paediatric ITP patients, based on AUC.
Danish: Der blev dog ikke observeret kararakt hos rotteunger, der fik tolererede doser på 5 gange den humane kliniske eksponering hos pædiatriske ITP-patienter baseret på AUC.
English: Patients receiving ITP therapy at baseline (n) Patients who attempted to reduce or discontinue baseline therapy, n (%)
Danish: Patienter, der modtager ITP-behandling ved udgangsniveauet (n) Patienter, som forsøgte at reducere eller stoppe med udgangsniveau-behandlingen, n (%)
English: • 1 single-use oral dosing syringe (supplied in the kit)
Danish: • 1 oral doseringssprøjte til engangsbrug (findes i sættet)
English: Magnesium stearate Mannitol (E421)
Danish: Mannitol (E421)
English: In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for oxidative metabolism of eltrombopag.
Danish: In vitro-studier indikerer, at CYP1A2 og CYP2C8 er ansvarlige for den oxidative metabolisme af eltrombopag.
English: • digestive system problems including frequent bowel movements, food poisoning, blood in stool
Danish: • problemer med fordøjelsessystemet herunder hyppig afføring, madforgiftning, blod i afførring
English: (haemolytic anaemia)
Danish: (hæmolytisk anæmi)
English: In the single-arm phase II monotherapy refractory SAA study, concurrent ALT or AST >3 x ULN with total (indirect) bilirubin >1.5 x ULN were reported in 5% of patients.
Danish: I fase II enkeltgruppestudiet med monoterapi til refraktær SAA, blev der samtidig rapporteret ALAT eller ASAT > 3 x ULN med totalbilirubin (indirekte) >1.5 x ULN hos 5 % af patienter.
English: ENABLE 1 (TPL103922 n=716) and ENABLE 2 (TPL108390 n=805) were randomised, double-blind, placebo-controlled, multicentre studies to assess the efficacy and safety of Revolade in thrombocytopenic patients with HCV infection who were otherwise eligible to initiate antiviral therapy.
Danish: ENABLE 1 (TPL103922 n = 716) og ENABLE 2 (TPL108390 n = 805) var randomiserede, dobbeltblindede, placebokontrollerede, multicenterstudier til vurdering af effekten og sikkerheden af Revolade hos trombocytopeniske patienter med HCV infektion, som var egnede til opstart af antiviral behandling.
English: EU/1/10/612/013 (30 sachets of powder for oral suspension)
Danish: EU/1/10/612/013 (30 breve med pulver til oral suspension)
English: • Put the tip of the syringe all the way into the water
Danish: • Sæt spidsen af sprøjten helt ned i vandet
English: Tell your doctor if any of these apply to you.
Danish:  Fortæl lægen, hvis ovenstående gælder for dig.
English: What Revolade looks like and contents of the pack Revolade 25 mg powder for oral suspension is available in kits containing 30 sachets; each sachet contains a reddish-brown to yellow powder.
Danish: Revolade 25 mg pulver til oral suspension fås i sæt, der indeholder 30 breve; hvert brev indeholder et rødbrunt til gult pulver.
English: Six of 143 (4%) adult patients with CLD receiving eltrombopag experienced TEEs (all of the portal venous system) and 2 of 145 (1%) patients in the placebo group experienced TEEs (one in the portal venous system and one myocardial infarction).
Danish: Seks ud af 143 (4 %) voksne patienter med CLD, der fik eltrombopag, oplevede TEEs (alle i det portale venesystem) og 2 ud af 145 (1 %) patienter i placebogruppen oplevede TEEs (én i det portale venesystem og ét myokardieinfarkt).
English: The co-administration of 600 mg ciclosporin decreased the Cmax and the AUCinf of eltrombopag by 39% and 24%, respectively.
Danish: Samtidig administration af 600 mg ciclosporin reducerede eltrombopags Cmax og AUCinf med henholdsvis 39 % og 24 %.
English: Caution is required when administering eltrombopag to patients with hepatic disease.
Danish: Der skal udvises forsigtighed, når eltrombopag administreres til patienter med leversygdom.
English: • liver injury due to medication
Danish: • leverskade pga. medicin
English: If the use of eltrombopag is deemed necessary for ITP patients with hepatic impairment the starting dose must be 25 mg once daily.
Danish: Hvis behandlingen med eltrombopag vurderes at være nødvendig for ITP-patienter med nedsat leverfunktion, skal startdosis være 25 mg én gang daglig.
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: For SAA patients refractory to or heavily pretreated with prior immunosuppressive therapy, bone marrow examination with aspirations for cytogenetics is recommended prior to initiation of eltrombopag, at 3 months of treatment and 6 months thereafter.
Danish: Hos SAA-patienter, som er refraktære over for eller tidligere er stærkt behandlede med immunsuppressiv behandling, anbefales det at udføre en cytogenetisk analyse af et knoglemarvsaspirat inden opstart af eltrombopag, efter 3 måneders behandling og efter yderligere 6 måneder.
English: The dose of eltrombopag should be adjusted in 50 mg increments every 2 weeks as necessary to achieve the target platelet count ≥50,000/µl.
Danish: Eltrombopagdosen bør justeres i trin af 50 mg hver 2. uge som nødvendigt for at opnå det tilsigtede trombocyttal ≥ 50.000 pr. µl.
English: Data presented as geometric mean (95%CI).
Danish: Data præsenteret som geometrisk middelværdi (95 % CI).
English: Results of a drug-drug pharmacokinetic (PK) interaction study show that co-administration of repeat doses of boceprevir 800 mg every 8 hours or telaprevir 750 mg every 8 hours with a single dose of eltrombopag 200 mg did not alter plasma eltrombopag exposure to a clinically significant extent.
Danish: Resultater af interaktion mellem lægemidler i et farmakokinetisk studie viste at co-administration med gentagne doser af boceprevir 800 mg hver 8. time eller telaprevir 750 mg hver 8. time med en enkelt dosis af eltrombopag 200 mg ikke ændrede plasmaeksponeringen af eltrombopag til en grad, der var klinisk signifikant.
English: In two placebo-controlled studies in paediatric patients (aged 1 to 17 years) with chronic ITP, ALT 3 x ULN was reported in 4.7% and 0% of the eltrombopag and placebo groups, respectively.
Danish: I to placebokontrollerede studier med pædiatriske patienter (i alderen 1 til 17 år) med kronisk ITP blev der rapporteret ALAT  3 x ULN hos 4,7 % og 0 % af henholdsvis eltrombopag- og placebogruppen.
English: Frequency Adverse reaction
Danish: Frekvens Bivirkning
English: Common Blood creatine phosphokinase increased
Danish: Almindelig Forhøjet kreatin-fosfokinase i blodet
English: • Pull back on the plunger to the 20 ml mark on the syringe.
Danish: • Træk stemplet tilbage til 20 ml-mærket på sprøjten.
English: • heavy menstrual period
Danish: • kraftig menstruationsblødning
English: Patients with bleeding (WHO Grades 2-4) at any time during 6 months, n (%)
Danish: Patienter med blødning (WHO niveau 2-4) på et tidspunkt i løbet af de 6 måneder, n (%)
English: Eltrombopag should be discontinued if ALT levels increase (3 times the upper limit of normal [x ULN] in patients with normal liver function, or ≥3 x baseline or >5 x ULN, whichever is the lower, in patients with pre-treatment elevations in transaminases) and are:
Danish: Eltrombopag skal seponeres, hvis ALAT-tallene stiger (for patienter med normal leverfunktion: ≥ 3 gange den øvre normalgrænse [x ULN], for patienter med forhøjede transminaser forud for behandlingen: den laveste værdi af ≥ 3 gange baseline eller > 5 gange den øvre normalgrænse) og er:
English: When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).
Danish: Når statiner gives sammen med eltrombopag, bør en dosisnedsættelse af statinerne overvejes, og der skal foretages en omhyggelig monitorering for bivirkninger pga. statinerne (se pkt.
English: All 10 had received at least 2 prior IST regimens and 50% had received at least 3 prior IST regimens.
Danish: Alle 10 patienter havde tidligere fået mindst to immunsuppressive behandlingsregimer, og 50 % havde tidligere fået mindst tre immunsuppressive behandlingsregimer.
English: The improvement in the proportion of patients who achieved SVR was consistent across all subgroups in the randomisation strata (baseline platelet counts (<50,000 vs. >50,000), viral load (<800,000 IU/ml vs. ≥800,000 IU/ml) and genotype (2/3 vs. 1/4/6)).
Danish: Stigningen i andelen af patienter, der opnåede SVR, var overensstemmende på tværs af alle undergrupper i de randomiserede strata (baseline trombocyttal (< 50.000 vs. > 50.000), virusbelastning (< 800.000 IE/ml vs. ≥ 800.000 IE/ml) og genotype (2/3 vs. 1/4/6).
English: In both RAISE and TRA100773B the response to eltrombopag relative to placebo was similar irrespective of ITP medicinal product use, splenectomy status and baseline platelet count (≤15,000/µl, >15,000/µl) at randomisation.
Danish: Både i RAISE- og TRA100773B-studierne var responset på eltrombopag ved randomisering, i forhold til placebo, det samme, uanset anvendelsen af ITP-lægemidler, splenektomi-status og trombocyttal ved udgangsniveau (≤ 15.000 pr. µl, > 15.000 pr. µl).
English: Eltrombopag administration can cause abnormal liver function and severe hepatotoxicity, which might be life-threatening (see section 4.8).
Danish: Administration af eltrombopag kan forårsage unormal leverfunktion og svær hepatotoksicitet, hvilket kan være livstruende (se pkt.
English: The influence of gender on eltrombopag pharmacokinetics was evaluated using population pharmacokinetics analysis in 635 patients with HCV (260 females).
Danish: Indflydelsen af køn på eltrombopags farmakokinetik blev vurderet vha. en farmakokinetisk populationsanalyse blandt 635 patienter med HCV (260 kvinder).
English: (vitreous floaters), dry eye, itchy eye, yellowing of the whites of the eyes or skin
Danish: (flydere i glaslegemet), tørre øjne, kløende øjne, gulfarvning af det hvide i øjnene eller af huden
English: • Place the tip of the syringe into the inside of the child's cheek.
Danish: • Anbring sprøjtens spids mod indersiden af barnets kind.
English: • Pull back on the plunger to the 10 ml mark on the syringe.
Danish: • Træk stemplet tilbage til 10 ml mærket på sprøjten.
English: Tests to check your bone marrow
Danish: Undersøgelser for at tjekke knoglemarven
English: Sodium starch glycolate
Danish: Natriumstivelsesglycolat
English: • Empty all contents of each sachet into the mixing bottle
Danish: • Tøm hele indholdet af hvert brev ned i blandeflasken
English: Overall, a significantly greater proportion of eltrombopag patients (62%) compared with placebo patients (32%) met the primary endpoint (Odds Ratio: 4.3 [95% CI: 1.4, 13.3] p=0.011).
Danish: Samlet set opnåede en signifikant højere andel af eltrombopagpatienterne (62 %) sammenlignet med placebopatienterne (32 %) det primære endepunkt (Odds Ratio: 4,3 [95 % CI: 1,4; 13,3] p = 0,011).
English: • liver problems, including blood clot, tumour in the liver (see ‘Liver problems' earlier in section 4)
Danish: • leverproblemer, herunder blodprop, tumor i leveren, (se 'Leverproblemer' tidligere i punkt 4)
English: Platelet counts should be monitored when combining eltrombopag with other medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range (see section 4.2).
Danish: Trombocyttallet skal monitoreres, når eltrombopag kombineres med andre lægemidler til behandling af ITP, for at undgå, at trombocyttallet falder uden for det anbefalede interval (se pkt.
English: In both studies, patients with a platelet count of <75,000/µl were enrolled and stratified by platelet count (<50,000/µl and ≥50,000/µl to <75,000/µl), screening HCV RNA (<800,000 IU/ml and ≥800,000 IU/ml), and HCV genotype (genotype 2/3, and genotype 1/4/6).
Danish: I begge studier blev patienter med et trombocyttal på < 75.000 pr. µl inkluderet og stratificeret efter trombocyttal (< 50.000 pr. µl og ≥ 50.000 pr. µl til < 75.000 pr. µl), HCV-RNA ved screeningen (< 800.000 IE/ml og ≥ 800.000 IE/ml) og HCV-genotype (genotype 2/3 og genotype 1/4/6).
English: Eltrombopag was administered to 302 ITP patients in the open-label extension study EXTEND (TRA105325), 218 patients completed 1 year, 180 completed 2 years, 107 completed 3 years, 75 completed 4 years, 34 completed 5 years and 18 completed 6 years.
Danish: I det forlængede, åbne studie EXTEND (TRA105325) blev eltrombopag givet til 302 ITP-patienter; 218 patienter gennemførte 1 år, 180 gennemførte 2 år, 107 gennemførte 3 år, 75 gennemførte 4 år, 34 gennemførte 5 år og 18 gennemførte 6 år.
English: The dose regimen of concomitant ITP medicinal products should be modified, as medically appropriate, to avoid excessive increases in platelet counts during therapy with eltrombopag.
Danish: Dosis af andre ITP-lægemidler bør ændres efter behov, for at undgå for store stigninger i trombocyttallet under behandlingen med eltrombopag.
English: Common Menorrhagia
Danish: Almindelig Menoragi