FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products used in the treatment of ITP in combination with eltrombopag in clinical studies included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.
Danish: I kliniske studier er følgende lægemidler anvendt i kombination med eltrombopag til behandling af ITP: Kortikosteroider, danazol og/eller azathioprin, intravenøs immunglobulin (IVIG) og anti-D immunglobulin.
English: AUC (0-) and Cmax based on population PK post-hoc estimates at the highest dose in the data for each patient.
Danish: AUC (0-) og Cmax baseret på farmakokinetisk populations post-hoc-estimater ved den højeste dosis i data for hver patient.
English: Make sure the lid is not on the mixing bottle.
Danish: Sørg for, at låget ikke sidder på blandeflasken.
English: Use lowest dose of eltrombopag as necessary to avoid dose reductions of peginterferon.
Danish: Brug den lavest mulige dosis af eltrombopag for at undgå dosisreduktioner af peginterferon.
English: You may be at higher risk of blood clots: as you get older if you have had to stay in bed for a long time if you have cancer if you are taking the contraceptive birth control pill or hormone replacement therapy if you have recently had surgery or received a physical injury if you are very overweight (obese) if you are a smoker if you have advanced chronic liver disease If any of these apply to you, tell your doctor before starting treatment.
Danish: Du kan have større risiko for blodpropper: - når du bliver ældre - hvis du har været nødsaget til at være sengeliggende gennem længere tid - hvis du har kræft - hvis du tager p-piller eller får hormonterapi - hvis du for nylig er blevet opereret eller har fået en fysisk skade - hvis du er meget overvægtig (fed) - hvis du er ryger - hvis du har fremskreden kronisk leversygdom  Hvis noget af dette gælder for dig, så fortæl det til lægen, inden du begynder på behandlingen.
English: Median platelet counts at baseline were 16,000/l for both treatment groups and in the eltrombopag group were maintained above 50,000/µl at all on-therapy visits starting at Day 15; in contrast, median platelet counts in the placebo group remained <30,000/µl throughout the study.
Danish: Mediantrombocyttallet ved udgangsniveauet var 16.000 pr. µl i begge behandlingsgrupper, og i eltrombopag-gruppen blev mediantrombocyttallet fastholdt over 50.000 pr. µl ved alle besøg fra dag 15; i modsætning hertil forblev mediantrombocyttallet i placebogruppen < 30.000 pr. µl gennem hele studiet.
English: Platelet count response between 50,000-400,000/l in the absence of rescue treatment was achieved by significantly more patients in the eltrombopag treated group during the 6 month treatment period, p <0.001.
Danish: Et trombocyttalrespons mellem 50.000 - 400.000 pr. µl uden ”rescue”-behandling, blev opnået hos signifikant flere patienter i eltrombopag-behandlingsgruppen i den 6 måneder lange behandlingsperiode (p < 0,001).
English: Administration of eltrombopag 75 mg once daily for 7 days to 24 healthy male subjects did not inhibit or induce the metabolism of probe substrates for 1A2 (caffeine), 2C19 (omeprazole), 2C9 (flurbiprofen), or 3A4 (midazolam) in humans.
Danish: Administration af eltrombopag 75 mg én gang daglig i 7 dage til 24 raske mænd, hverken hæmmede eller inducerede metaboliseringen af substrater for 1A2 (caffein), 2C19 (omeprazol), 2C9 (fluriprofen) eller 3A4 (midazolam) hos mennesker.
English: • pain, swelling and tenderness in one of your legs (usually the calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
Danish: • smerte, hævelse og ømhed i et af dine ben (oftest i læggen) med varm hud i det berørte område
English: AUC(0-) and Cmax based on population PK post-hoc estimates
Danish: AUC(0-) og Cmax baseret på post-hoc estimater af populations-PK
English: A decision must be made whether to discontinue breast-feeding or to continue/abstain from Revolade therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Revolade skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In the pre-antiviral treatment phase, patients received open-label eltrombopag to increase the platelet count to ≥90,000/µl for ENABLE 1 and ≥100,000/µl for ENABLE 2.
Danish: I fasen før antiviral behandling fik patienterne ublindet eltrombopag med henblik på at øge trombocyttallet til ≥ 90.000 pr. µl i ENABLE 1 og til ≥ 100.000 pr. µl i ENABLE 2.
English: Baseline disease characteristics were similar in both studies and were consistent with compensated cirrhotic HCV patient population.
Danish: Sygdomskarakteristika ved udgangsniveauet var tilsvarende i begge studier og var overensstemmende med en patientpopulation med HCV og kompenseret cirrose.
English: • scissors to cut sachet (not supplied)
Danish: • saks til at klippe brevet op (medfølger ikke)
English: In clinical studies with a TPO-R agonist in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to acute myeloid leukaemia (AML) were reported.
Danish: Hos patienter med MDS blev der i kliniske studier med en TPO-R-agonist set tilfælde af forbigående stigning i blastcelletal og rapporteret tilfælde af progression af MDS til akut myeloid leukæmi (AML).
English: The following additional side effects have been reported to be associated with treatment with Revolade in children (aged 1 to 17 years) with ITP:
Danish: Følgende bivirkninger er blevet indberettet til at være forbundet med behandling af Revolade hos børn (i alderen 1 til 17 år) med ITP:
English: • stomach flu (gastroenteritis)
Danish: • maveinfluenza (gastroenteritis)
English: Empty the water into the mixing bottle.
Danish: Tøm vandet ned i blandeflasken.
English: Higher risk of blood clots
Danish: Øget risiko for blodpropper
English: If you don't use the medicine within 30 minutes of mixing it, you will need to mix a new dose.
Danish: Hvis du ikke bruger medicinen inden for 30 minutter efter sammenblanding, skal du blande en ny dosis.
English: At non-tolerated doses in pre-weaning rats, ocular opacities were observed.
Danish: Ved ikke-tolererede doser i rotteunger før afvænning blev der observeret okulære forandringer.
English: TRA115450 (PETIT2): The primary endpoint was a sustained response, defined as the proportion of patients receiving eltrombopag, compared to placebo, achieving platelet counts ≥50,000/µl for at least 6 out of 8 weeks (in the absence of rescue therapy), between weeks 5 to 12 during the double-blind randomised period.
Danish: TRA115450 (PETIT2): Det primære endepunkt var vedvarende respons, defineret som den andel af patienterne, der fik eltrombopag, og som sammenlignet med placebo, opnåede trombocyttal ≥ 50.000 pr. µl i mindst 6 ud af 8 uger (uden brug af redningsmedicin), mellem uge 5 og 12 i løbet af den dobbeltblindede randomiserede periode.
English: Platelet counts should be monitored every week prior to starting antiviral therapy.
Danish: Trombocyttallet skal monitoreres hver uge, forud for indledning af den antivirale behandling.
English: • swollen blood vessels and bleeding in the gullet (oesophagus)
Danish: • hævede blodårer og blødning i spiserøret (oesophagus)
English: Revolade should not be used outside of clinical studies for the treatment of thrombocytopenia due to MDS.
Danish: Uden for kliniske studier bør Revolade ikke anvendes til at behandle trombocytopeni i forbindelse med MDS.
English: For TPO-R agonists there is a concern that they may stimulate the progression of existing haematopoietic malignancies such as MDS.
Danish: For TPO-R-agonister er der en bekymring for, at de kan stimulere udviklingen af eksisterende hæmatopoietiske maligne sygdomme som f.eks. MDS.
English: Very common side effects that may show up in blood tests: • decreased number of red blood cells (anaemia)
Danish: Meget almindelige bivirkninger, som kan ses i blodprøver: • nedsat antal røde blodlegemer (anæmi)
English: Key secondary endpoints Patients with a Day 43 bleeding assessment, n Bleeding (WHO Grades 1-4) n (%)
Danish: De væsentligste sekundære endepunkter Patienter med blødningsmåling på dag 43, n Blødning (WHO-niveau 1-4) n (%)
English: The lowest dose of eltrombopag to achieve and maintain a platelet count ≥50,000/µl should be used.
Danish: Den laveste dosis af eltrombopag, hvormed der kan opnås og fastholdes et trombocyttal på ≥ 50.000 pr. µl, skal anvendes.
English: Glaxo Wellcome S.A. Avenida de Extremadura 3 09400 Aranda de Duero Burgos
Danish: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spanien
English: The respective interferon summary of product characteristics should be referenced for discontinuation criteria.
Danish: Der henvises til det respektive produktresumé for interferon i forbindelse med seponeringskriterier.
English: There are no PK data on the use of eltrombopag in patients ≥75 years.
Danish: Der foreligger ingen farmakokinetiske data om anvendelse af eltrombopag til patienter ≥ 75 år.
English: In RAISE and TRA100773B studies, in the subgroup of ITP patients with baseline platelet count ≤15,000/μl the median platelet counts did not reach the target level (>50,000/l), although in both studies 43% of these patients treated with eltrombopag responded after 6 weeks of treatment.
Danish: I RAISE- og TRA100773B-studierne, i subgruppen af ITP-patienter med et trombocyttal ved udgangsniveau på ≤ 15.000 pr. µl, nåede mediantrombocyttallet ikke det tilsigtede niveau (> 50.000 pr. µl), selvom 43 % af disse eltrombopag-behandlede patienter responderede efter 6 uger behandling i begge studier.
English: There are no findings in juvenile rats to suggest a greater risk of toxicity with eltrombopag treatment in paediatric vs. adult ITP patients.
Danish: Der var ingen fund hos rotteunger, der tydede på en større risiko for toksicitet med eltrombopagbehandling hos pædiatriske vs. voksne ITP-patienter.
English: Across the 3 placebo-controlled studies in adults with chronic ITP, 1 patient in the placebo group and 1 patient in the eltrombopag group experienced a Grade 4 liver test abnormality.
Danish: På tværs af de 3 placebo-kontrollerede studier med voksne patienter med kronisk ITP havde 1 patient i placebogruppen og 1 patient i eltrombopag-gruppen et unormalt levertal af grad 4.
English: Chronic HCV patients with cirrhosis may be at risk of hepatic decompensation when receiving alfa interferon therapy.
Danish: Patienter med kronisk HCV og cirrose kan have en risiko for hepatisk dekompensation, når de behandles med interferon alfa.
English: PETIT (TRA108062) was a 3-part, staggered-cohort, open-label and double-blind, randomised, placebo-controlled study.
Danish: PETIT (TRA108062) var et 3-delt, forskudt kohorte, kombineret ublindet og dobbeltblindet, randomiseret, placebokontrolleret studie.
English: There was substantial variability and significant overlap in exposures between patients with renal impairment and healthy volunteers.
Danish: Der var tydelig variation og signifikant overlap i eksponeringen mellem patienter med nedsat leverfunktion og raske frivillige.
English: What you need Each Revolade powder for oral suspension kit contains:
Danish: Det skal du bruge Hvert sæt med Revolade pulver til oral suspension indeholder:
English: • Remove the syringe from the bottle.
Danish: • Tag sprøjten ud af flasken.
English: If bilirubin is elevated fractionation should be performed.
Danish: Hvis bilirubinniveauet er forhøjet, bør fraktioneret bilirubin bestemmes.
English: Eltrombopag dose, once daily
Danish: Eltrombopag-dosis, én gang daglig n
English: Five of the 6 patients treated with eltrombopag experienced the thrombotic complication at a platelet count >200,000/µl and within 30 days of the last dose of eltrombopag.
Danish: Fem ud af de seks patienter, der blev behandlet med eltrombopag, oplevede de trombotiske komplikationer ved et trombocyttal > 200.000 pr. µl og inden for 30 dage efter sidste eltrombopag-dosis.
English: HMG CoA reductase inhibitors
Danish: HMG-CoA reduktasehæmmere
English: Thrombocytopenia with HCV infection in adult patients
Danish: Trombocytopeni med HCV infektion hos voksne patienter
English: Platelet counts should be monitored weekly during antiviral therapy until a stable platelet count is achieved, normally around 50,000-75,000/µl.
Danish: Trombocyttallet monitoreres ugentligt under den antivirale behandling, indtil der er opnået et stabilt trombocyttal normalt omkring 50.000-75.000 pr. µl.
English: Summary of the safety profile
Danish: Sammendrag af bivirkningsprofilen
English: Do not use this medicine after the expiry date which is stated on the carton and the sachet.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og brevene efter EXP.
English: This decrease of exposure was attenuated when a single 25 mg dose of eltrombopag powder for oral suspension was administered 2 hours before a high-calcium meal (mean AUC0-∞ was decreased by 20% and mean Cmax by 14%).
Danish: Dette fald i eksponering blev formindsket, når en enkelt 25 mg dosis eltrombopag pulver til oral suspension blev administreret 2 timer før et calciumrigt måltid (gennemsnitlig AUC0-∞ faldt med 20 % og gennemsnitlig Cmax med
English: Patients with impaired renal function should use eltrombopag with caution and close monitoring, for example by testing serum creatinine and/or performing urine analysis (see section 5.2).
Danish: Patienter med nedsat nyrefunktion skal anvende eltrombopag med forsigtighed og overvåges nøje ved f.eks. at måle serum-kreatinin og/eller foretage urinanalyse (se pkt.
English: The median baseline platelet count was 59,500/µl in both treatment groups: 0.8%, 28% and 72% of the patients recruited had platelet counts <20,000/µl, <50.000/µl and ≥50,000/µl respectively.
Danish: Det mediane trombocyttal ved baseline var 59.500 pr. µl i begge behandlingsgrupper: 0,8 %, 28 % og 72 % af de rekrutterede patienter havde trombocyttal på hhv. < 20.000 pr. µl, < 50.000 pr. µl og ≥ 50.000 pr. µl.
English: • heart beating faster, irregular heartbeat, bluish discolouration of the skin
Danish: • hjertet slår hurtigere, uregelmæssige hjerteslag, blåfarvet hud
English: After initiating eltrombopag, the dose must be adjusted to achieve and maintain a platelet count ≥50,000/µl as necessary to reduce the risk for bleeding.
Danish: Når behandlingen med eltrombopag er sat i gang, skal dosis justeres efter behov, så der opnås og fastholdes et trombocyttal på ≥ 50.000 pr. µl, for at nedsætte risikoen for blødning.
English: Immune (primary) thrombocytopenia (ITP) studies
Danish: Studier med immun (primær) trombocytopeni (ITP)
English: 75 mg a AUC(0-) and Cmax based on population PK post-hoc estimates.
Danish: 75 mg a AUC(0-) og Cmax baseret på farmakokinetisk populations post-hoc-estimater.
English: Thrombotic/thromboembolic complications
Danish: Trombotiske/tromboemboliske komplikationer
English: Dose reductions on the daily dose by 25 mg should be considered if platelet counts exceed the required target.
Danish: Dosisreduktioner på 25 mg af den daglige dosis skal overvejes, hvis trombocyttallet overstiger det tilsigtede.
English: As the highest authorised dose is indicated for patients with SAA (150 mg/day) and due to the nature of the reaction, TEEs might be expected in this patient population.
Danish: På grund af reaktionens natur og fordi den højest anbefalede dosis er indiceret til patienter med SAA (150 mg/dag), kan TEE ikke udelukkes i denne patientpopulation.
English: ITP is caused by a low blood platelet count (thrombocytopenia).
Danish: ITP forårsages af et lavt blodpladetal (trombocytopeni).
English: The safety of Revolade was assessed using the pooled double-blind, placebo-controlled studies TRA100773A and B, TRA102537 (RAISE) and TRA113765, in which 403 patients were exposed to Revolade and 179 to placebo, in addition to data from the completed open-label studies TRA108057, TRA105325 (EXTEND) and TRA112940.
Danish: Sikkerheden af Revolade blev vurderet på baggrund af de samlede data fra de dobbeltblindede, placebokontrollerede studier TRA100773A og B, TRA102537 (RAISE) og TRA113765, hvor 403 patienter blev eksponeret til Revolade og 179 til placebo, foruden data fra de afsluttede åbne studier TRA108057, TRA105325 (EXTEND) og TRA112940.
English: In both HCV studies, a significantly greater proportion of patients treated with eltrombopag (n=201, 21%) achieved SVR compared to those treated with placebo (n=65, 13%) (see Table 7).
Danish: I begge HCV-studier opnåede en signifikant større andel af de patienter, der blev behandlet med eltrombopag (n = 201, 21 %), SVR sammenlignet med de patienter, der fik placebo (n = 65, 13 %) (se tabel 7).
English: In contrast, the administration of eltrombopag 2 hours before or 4 hours after a high-calcium meal or with low-calcium food [<50 mg calcium] did not alter plasma eltrombopag exposure to a clinically significant extent (see section 4.2).
Danish: Modsat ændrede administration af eltrombopag 2 timer før eller 4 timer efter et calciumrigt måltid eller sammen med fødevarer med lavt calciumindhold [< 50 mg calcium] ikke plasma-eltrombopageksponeringen i klinisk betydende omfang (se pkt.
English: • depression, anxiety, sleep problems, nervousness
Danish: • depression, angst, søvnproblemer, nervøsitet
English: Eltrombopag treatment should be initiated by and remain under the supervision of a physician who is experienced in the treatment of haematological diseases or the management of chronic hepatitis C and its complications.
Danish: Behandling med eltrombopag må kun indledes og vedligeholdes af en læge med erfaring i behandling af trombocytopeni eller behandling af kronisk hepatitis C og komplikationer til denne sygdom.
English: The haematological response rate was 40% (17/43 patients; 95% CI 25, 56), the majority were unilineage responses (13/17, 76%) whilst there were 3 bilineage and 1 trilineage responses at week 12.
Danish: Den hæmatologiske responsrate var 40 % (17/43 patienter; 95 % CI 25-56), størstedelen var unilineære respons (13/17; 76 %), mens der var 3 bilineære og 1 trilineært respons i uge 12.
English: Other secondary findings of the studies included the following: significantly fewer patients treated with eltrombopag prematurely discontinued antiviral therapy compared to placebo (45% vs. 60%, p=<0.0001).
Danish: Andre sekundære fund i studierne inkluderede følgende: Signifikant færre patienter behandlet med eltrombopag fik seponeret den antivirale behandling før tid sammenlignet med placebo (45 % i forhold til 60 %, p = < 0,0001).
English: Patients were randomised 2:1 and received Revolade (n=63) or placebo (n=29) for up to 13 weeks in the randomised period of the study.
Danish: Patienter blev randomiseret i forholdet 2:1 og fik Revolade (n = 63) eller placebo (n = 29) i op til 13 uger i den randomiserede periode af studiet.
English: • decrease in blood sugar levels (hypoglycaemia)
Danish: • nedsat niveau af blodsukker (hypoglykæmi)
English: The sachets are co-packaged in a kit with a 40 ml HDPE mixing bottle, and 30 single-use 20 ml oral dosing syringes (polypropylene/silicon rubber) with 1 ml graduations.
Danish: Brevene er sammenpakket i et sæt med en 40 ml HDPE blandeflaske og 30 x 20 ml orale doseringssprøjter til engangsbrug (polypropylen/silikone) med 1 ml afmærkninger.
English: It is necessary to wait for at least 2 weeks to see the effect of any dose adjustment on the patient's platelet response prior to considering another dose adjustment.
Danish: Det er nødvendigt at observere effekten af alle dosisjusteringer på patientens trombocyttal i mindst 2 uger, før endnu en dosisjustering overvejes.
English: Eltrombopag must not be used to normalise platelet counts.
Danish: Eltrombopag må ikke anvendes til at normalisere trombocyttallet.
English: • spinning sensation (vertigo)
Danish: • snurrende fornemmelse (vertigo)
English: Eltrombopag was studied in a single-arm, single-centre open-label study in 43 patients with severe aplastic anaemia with refractory thrombocytopenia following at least one prior immunosuppressive therapy (IST) and who had a platelet count ≤30,000/µl.
Danish: Eltrombopag er undersøgt i et åbent enkeltgruppe, enkeltcenterstudie med 43 patienter med svær aplastisk anæmi med refraktær trombocytopeni efter mindst en tidligere immunsuppressiv behandling (IST), som havde et trombocyttal ≤ 30.000 pr. µl.
English: Treatment with eltrombopag in these patients should be initiated only by physicians experienced in the management of advanced HCV, and only when the risks of thrombocytopenia or withholding antiviral therapy necessitate intervention.
Danish: Behandling med eltrombopag hos disse patienter skal opstartes af en læge med erfaring i behandling af fremskreden HCV, og kun hvis det kræves på grund af risiko for trombocytopeni eller er nødvendigt for at kunne vedligeholde antiviral behandling.
English: Absorbed eltrombopag is extensively metabolised.
Danish: Absorberet eltrombopag metaboliseres i høj grad.
English: Cohort 1 (12 to 17 years)
Danish: Kohorte 1 (12 til 17 år)
English: In vitro studies demonstrated that eltrombopag is not a substrate for the organic anion transporter polypeptide, OATP1B1, but is an inhibitor of this transporter (IC50 value of 2.7 μM (1.2 μg/ml).
Danish: In vitro-studier har vist, at eltrombopag ikke er et substrat for polypeptidet OATP1B1, der er en organisk anion-transportør, men derimod er en hæmmer af denne transportør (IC50-værdi på 2,7 μM (1,2 μg/ml)).
English: In vitro studies also demonstrated that eltrombopag is a breast cancer resistance protein (BCRP) substrate and inhibitor (IC50 value of 2.7 μM (1.2 μg/ml).
Danish: In vitro-studier har endvidere vist, at eltrombopag er et substrat for, og en hæmmer af, det brystcancer-resistente protein (BCRP) (IC50-værdi på 2,7 μM (1,2 μg/ml)).
English: Common Palpitations
Danish: Almindelig Palpitationer
English: In a human radiolabel study, eltrombopag accounted for approximately 64% of plasma radiocarbon AUC0-.
Danish: I et humant studie med radioaktivt mærket eltrombopag udgjorde eltrombopag ca. 64 % af plasma
English: Forty-two to 60% of the eltrombopag-treated patients in the RAISE study were receiving 75 mg from Day 29 to the end of treatment.
Danish: 42 til 60 % af de eltrombopag-behandlede patienter i RAISE-studiet fik 75 mg fra dag 29 og til afslutningen af behandlingen.
English: In eltrombopag clinical studies in ITP thromboembolic events were observed at low and normal platelet counts.
Danish: I kliniske ITP-studier med eltrombopag blev tromboemboliske hændelser observeret ved lave og normale trombocyttal.
English: During antiviral therapy, the dose of eltrombopag should be adjusted as necessary to avoid dose reductions of peginterferon due to decreasing platelet counts that may put patients at risk of bleeding (see Table 2).
Danish: Under den antivirale behandling justeres dosis af eltrombopag som påkrævet for at undgå dosisreduktioner af peginterferon som følge af et fald i trombocyttallet, der kan resultere i blødningsrisiko (se tabel 2).
English: • irritability, generally feeling unwell, chest pain and discomfort
Danish: • irritabel, generel følelse af utilpashed, smerter i brystet og ubehag
English: Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation (see section 4.4).
Danish: Patienter med disse karakteristika skal monitoreres tæt for tegn og symptomer på hepatisk dekompensation (se pkt.
English: Excessive platelet count responses (as outlined in Table 3) or important liver test abnormalities also necessitate discontinuation of eltrombopag (see section 4.8).
Danish: Udtalt trombocyttalrespons (som vist i tabel 3) eller afgørende unormale levertal nødvendiggør også seponering af eltrombopag (se pkt 4.8).
English: Median platelet counts at 1, 2, 3, 4, 5, 6 and 7 years on study were 85,000/l, 85,000/l, 105,000/l, 64,000/l, 75,000/l, 119,000/l and 76,000/l, respectively.
Danish: Det mediane trombocyttal ved 1, 2, 3, 4, 5, 6, og 7 år i studiet var hhv. 85.000 pr. µl, 85.000 pr. µl, 105.000 pr. µl, 64.000 pr. µl, 75.000 pr. µl, 119.000 pr. µl og 76.000 pr. µl.