FrancophonIA/ELRC3.0 huggingface dataset:
English: Stopping your treatment with Rydapt may cause your condition to become worse.
Danish: Hvis du stopper behandlingen med Rydapt, kan din tilstand forværres.
English: CGP62221 exhibited a similar pattern.
Danish: CGP62221 udviste et tilsvarende mønster.
English: - If you vomit after you swallow the capsules, do not take any more capsules until your next scheduled dose.
Danish: - Hvis du kaster op efter, at du har sunket kapslerne, må du ikke tage flere kapsler før din næste planlagte dosis.
English: In vitro data indicate that KIT wild type receptors are inhibited to a much lesser extent at these concentrations (average achieved exposure lower than IC50).
Danish: In vitro-data indikerer, at KIT-vildtype-receptorer i meget mindre grad er hæmmet ved disse koncentrationer (gennemsnitlig opnået eksponering lavere end IC50).
English: Mating index, fertility index and conception rates were reduced at 0, 5 and 15 mg/kg/day, but not at 2 mg/kg/day.
Danish: Parringstal, fertilitetsindeks og befrugtningshastigheder blev nedsat ved 0, 5 og 15 mg/kg/dag, men ikke ved 2 mg/kg/dag.
English: Rydapt has not been studied in patients with acute promyelocytic leukaemia and therefore its use is not recommended in this patient population.
Danish: Rydapt er ikke blevet undersøgt hos patienter med akut promyelocyt leukæmi, og derfor anbefales det ikke at anvende Rydapt hos denne patientpopulation.
English: 9/l) persists >2 weeks and is suspected to be related to Rydapt, discontinue Rydapt.
Danish: 9/l) varer ved i >2 uger og formodes at være relateret til Rydapt, skal behandlingen seponeres.
English: ADRs that led to treatment discontinuation occurred in 9.2% of patients.
Danish: Bivirkninger, der førte til seponering af behandlingen, forekom hos 9,2 % af patienterne.
English: Midostaurin binds to the catalytic domain of these kinases and inhibits the mitogenic signalling of the respective growth factors in cells, resulting in growth arrest.
Danish: Midostaurin binder sig til det katalytiske domæne af disse kinaser og hæmmer den mitogene signalering af de respektive vækstfaktorer i celler, hvilket resulterer i ophør af vækst.
English: CR induction (OR)
Danish: CR induktion (OR)
English: At baseline, 88.5% had >1 C finding and 69.2% had received at least one prior anti-neoplastic regimen.
Danish: Ved baseline havde 88,5 % >1 C-fund, og 69,2 % havde tidligere fået mindst ét antineoplastisk regime.
English: In the event of an overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic and supportive treatment initiated.
Danish: I tilfælde af overdosis skal patienter monitoreres nøje for tegn eller symptomer på bivirkninger, og passende symptomatisk og understøttende behandling påbegyndes.
English: Symptoms are caused when too many mast cells enter organs such as the liver, bone marrow or spleen, and release substances such as histamine into the blood.
Danish: Symptomerne opstår, når for mange mastceller havner i organer som leveren, knoglemarven eller milten og frigiver stoffer som fx histamin i blodet.
English: ANC: Absolute Neutrophil Count
Danish: ANC: absolut neutrofiltal.
English: The population pharmacokinetic analysis indicated that the absorption in patients was less than dose proportional at doses >50 mg twice daily.
Danish: Den populationsfarmakokinetiske analyse viste, at absorptionen hos patienter var mindre end dosisproportional i doser på >50 mg to gange dagligt.
English: Due to the limited pharmacokinetic data in paediatric patients, no comparison with midostaurin pharmacokinetics in adults can be made.
Danish: Grundet den begrænsede mængde farmakokinetiske data hos pædiatriske patienter kan der ikke foretages en sammenligning med midostaurins farmakokinetik hos voksne.
English: Interval assessments of QT by ECG should be considered if Rydapt is taken concurrently with medicinal products that can prolong QT interval.
Danish: Regelmæssige evalueringer af QT ved brug af EKG bør overvejes, hvis Rydapt tages samtidig med lægemidler, der kan forlænge QT-intervallet.
English: For trial sites in North America, all grades were collected for 13 pre-specified adverse events.
Danish: For kliniske centre i Nordamerika blev alle grader af 13 på forhånd specificerede bivirkninger registreret.
English: There is limited experience with midostaurin in AML patients aged 60-70 years and no experience in AML patients above 70 years.
Danish: Erfaringen med midostaurin hos AML-patienter i alderen 60-70 år er begrænset, og der er ingen erfaring med AML-patienter over 70 år.
English: HR (95% CI) - SCT HR (95% CI) - no SCT
Danish: HR (95% CI) - SCT HR (95% CI) - ingen SCT
English: Table 6 Overview of OS, EFS, CR, DFS and CIR by gender in AML
Danish: Tabel 6 Oversigt over OS, EFS, CR, DFS og CIR i AML fordelt på køn
English: Ethanol anhydrous Maize oil mono-di-triglycerides All-rac-alpha-tocopherol
Danish: Majsolie-mono-di-triglycerider All-rac-alfa-tocopherol
English: If you stop taking Rydapt
Danish: Hvis du holder op med at tage Rydapt
English: Alternative medicinal products that do not strongly inhibit CYP3A4 activity should be considered.
Danish: Anvendelse af andre lægemidler, der ikke er stærke hæmmere af CYP3A4-aktivitet, bør overvejes.
English: QTc interval >470 msecs and ≤500 msecs
Danish: QTc interval >470 ms og ≤500 ms
English: These are disorders in which the body produces too many mast cells, a type of white blood cell.
Danish: Det er sygdomme, hvor kroppen danner for mange mastceller, en type hvide blodlegemer.
English: If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Danish: Hvis du bruger et hormonelt præventionsmiddel, skal du også bruge en barrieremetode, fx et kondom eller et pessar.
English: Midostaurin blocks the action of some enzymes (kinases) in the abnormal cells and stops their division and growth.
Danish: Midostaurin blokerer aktiviteten af nogle enzymer (kinaser) i de unormale celler og stopper cellernes deling og vækst.
English: - Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Danish: - Brug ikke lægemidlet, hvis pakningen er beskadiget, eller hvis der er tegn på, at den har været åbnet.
English: Available animal data have shown that midostaurin and its active metabolites pass into the milk of lactating rats.
Danish: Tilgængelige data fra dyr har vist, at midostaurin og dets aktive metabolitter går over i mælken hos diegivende rotter.
English: - if you have problems with your lungs or problems breathing.
Danish: - hvis du har lungeproblemer eller vejrtrækningsbesvær.
English: You should also tell your doctor if you are already taking Rydapt and you are prescribed a new medicine that you have not previously taken during treatment with Rydapt.
Danish: Du bør også fortælle det til lægen, hvis du allerede tager Rydapt og får ordineret et nyt lægemiddel, som du ikke tidligere har fået under behandling med Rydapt.
English: Dose modifications (interruption or adjustment) due to ADRs occurred in 31% of patients.
Danish: Dosisændringer (afbrydelse eller justering) som følge af bivirkninger forekom hos 31 % af patienterne.
English: Final CSR: September
Danish: Endelig CSR: september
English: Effect of Rydapt on other medicinal products
Danish: Rydapts indvirkning på andre lægemidler
English: The mean AUClast of CGP52421 decreased by 60%.
Danish: Den gennemsnitlige AUClast for CGP52421 blev reduceret med 60 %.
English: ASM SM-AHN MCL Subtype unknown
Danish: ASM SM-AHN MCL Ukendt undertype
English: Forty-six percent of patients had a decrease in bone marrow infiltration that exceeded 50% and 58% had a decrease in serum tryptase levels that exceeded 50%.
Danish: Seksogfyrre procent af patienterne havde et fald i knoglemarvsinfiltration, der oversteg 50 % og 58 % havde et fald i serumniveauet af tryptase, der oversteg 50 %.
English: If you forget to take Rydapt
Danish: Hvis du har glemt at tage Rydapt
English: The pharmacokinetics of the CGP62221 metabolite showed a similar trend.
Danish: Farmakokinetikken af CGP62221-metabolitten viste en lignende tendens.
English: Grades 3/4
Danish: Alle grader Grader 3/4
English: In vivo studies have not been conducted for the investigation of induction and inhibition of enzymes and transporters by midostaurin and the active metabolites.
Danish: Der er ikke foretaget in vivo-studier for at undersøge induktion og hæmning af enzymer og transportører af midostaurin og de aktive metabolitter.
English: Table 5 Efficacy of midostaurin in AML
Danish: Tabel 5 Effekt af midostaurin ved AML
English: Dizziness and vertigo have been reported in patients taking Rydapt and should be considered when assessing a patient's ability to drive or use machines.
Danish: Der er rapporteret svimmelhed og vertigo hos patienter, som er i behandling med Rydapt, og dette bør der tages højde for i vurderingen af en patients evne til at føre motorkøretøj eller betjene maskiner.
English: Incidences of ADRs were, however, higher in the Rydapt arm than in the placebo arm during the maintenance phase.
Danish: Incidensen af bivirkninger var imidlertid højere i Rydapt-armen end i placebo-armen i vedligeholdelsesfasen.
English: The mean apparent plasma clearance (CL/F) was 2.4-3.1 l/h in healthy subjects.
Danish: Den gennemsnitlige tilsyneladende plasmaclearance (CL/F) var 2,4-3,1 l/t hos raske forsøgspersoner.
English: Injury, poisoning and procedural complications Contusion
Danish: Traumer, forgiftninger og behandlingskomplikationer Kontusion
English: Figure 1 Kaplan-Meier curve for overall survival, non-censored for SCT
Danish: Figur 1 Kaplan-Meier-kurve for samlet overlevelse, ikke censureret for SCT
English: All patients evaluated
Danish: Alle undersøgte patienter
English: Other Grade 3/4 non-haematological toxicities
Danish: Anden ikke-hæmatologisk grad 3/4-toksicitet
English: Overall survival n/N (%)
Danish: Samlet overlevelse n/N (%)
English: In vitro and in vivo genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of mutagenic or clastogenic activity.
Danish: I studier af genotoksicitet in vitro og in vivo, der dækkede relevante genotoksicitets-endepunkter, blev der ikke set tegn på mutagen eller klastogen aktivitet.
English: In vitro data showed midostaurin is more than 98% bound to plasma proteins, such as albumin, α1-acid glycoprotein (AGP) and lipoprotein.
Danish: In vitro-data viste, at midostaurin er mere end 98 % bundet til plasmaproteiner, fx albumin, α-1-syre-glycoprotein (AGP) og lipoprotein.
English: In vitro evaluation of drug-drug interaction potential
Danish: Vurdering af potentiale for lægemiddelinteraktion in vitro
English: In patients who develop unexplained severe neutropenia, treatment with Rydapt should be interrupted until ANC is ≥1.0 x 10
Danish: Hos patienter, der udvikler uventet svær neutropeni, bør behandling med Rydapt afbrydes, indtil ANC er ≥1,0 x 10
English: The median age in the primary efficacy population was 64 years with approximately half of the patients ≥65 years.
Danish: Medianalderen i primær effekt-populationen var 64 år med ca. halvdelen af patienterne ≥65 år.
English: Investigations Hyperglycaemia (non-fasting)*
Danish: Undersøgelser Hyperglykæmi (ikke efter faste)*
English: Your doctor will perform regular blood tests during treatment with Rydapt in order to monitor the amount of blood cells (white blood cells, red blood cells and platelets) and electrolytes (e.g. calcium, potassium, magnesium) in your body.
Danish: Lægen vil regelmæssigt tage blodprøver under behandlingen med Rydapt for at holde øje med mængden af blodceller (hvide blodlegemer, røde blodlegemer og blodplader) og elektrolytter (fx calcium, kalium, magnesium) i din krop.
English: AUC0-12 was decreased by 39% and 36% in subjects with mild and moderate hepatic impairment, respectively.
Danish: AUC0-12 var reduceret med 39 % og 36 % hos forsøgspersoner med henholdsvis let og moderat nedsat leverfunktion.
English: Some other medicines can also affect how Rydapt works.
Danish: Andre lægemidler kan også påvirke virkningen af Rydapt.
English: An increase in liver enzymes (ALT and AST) was seen consistently in rats, and in dogs and monkeys in long-term studies of ≥3 months duration, without histopathological correlates.
Danish: En stigning i niveauet af leverenzymer (ALAT og ASAT) blev konsekvent set hos rotter, og hos hunde og aber i længerevarende studier af ≥3 måneders varighed uden histopatologiske korrelater.
English: Midostaurin was administered orally at 100 mg twice daily until disease progression or intolerable toxicity.
Danish: Midostaurin blev administreret oralt i doser på 100 mg to gange daglig, indtil der blev observeret sygdomsprogression eller ikke-tolerabel toksicitet.
English: Withhold or interrupt Rydapt for the remainder of the cycle.
Danish: Tilbagehold eller afbryd behandlingen med Rydapt i resten af cyklussen.
English: However, the median survival for KIT D816V positive patients was longer, i.e.
Danish: Medianoverlevelsen for KIT D816V-positive patienter var dog længere;
English: Interrupt Rydapt until toxicities considered at least possibly related to Rydapt have resolved to Grade ≤2, then resume Rydapt.
Danish: Afbryd doseringen af Rydapt indtil toksicitet, der betragtes som i hvert fald muligvis relateret til Rydapt, er opløst til grad ≤2, og genoptag herefter doseringen med Rydapt.
English: Final CSR: December
Danish: Endelig CSR: december
English: Spleen volume decreased by ≥10% in 68.9% of patients with at least 1 post-baseline assessment (26.7% of patients had a reduction of ≥35%, which correlates with a 50% decrease by palpation).
Danish: Miltvolumenet blev reduceret med ≥10 % hos 68,9 % af patienterne med mindst 1 post-baseline-vurdering (26,7 % af patienterne havde en reduktion på ≥35 %, hvilket korrelerer med en reduktion på 50 % ved palpering).
English: The safety and efficacy of Rydapt in children and adolescents below 18 years have not been established (see section 5.1).
Danish: Rydapts sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt (se pkt.
English: 1: MIDOSTAURIN - SCT 2: PLACEBO - SCT 3: MIDOSTAURIN - no SCT 4: PLACEBO - no SCT Censored
Danish: 1: MIDOSTAURIN - SCT 2: PLACEBO - SCT 3: MIDOSTAURIN - ingen SCT 4: PLACEBO - ingen SCT Censureret
English: If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Rydapt.
Danish: Hvis du tager nogen af disse lægemidler, kan lægen ordinere et andet lægemiddel til dig i stedet, mens du er i behandling med Rydapt.
English: CTCAE severity: Grade 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.
Danish: CTCAE-sværhedsgrad: grad 1 = lette symptomer, grad 2 = moderate symptomer; grad 3 = svære symptomer, grad 4 = livstruende symptomer.
English: Based on population pharmacokinetic model analyses of the effect of gender on clearance of midostaurin and its active metabolites, there was no statistically significant finding and the anticipated changes in exposure (<20%) were not deemed to be clinically relevant.
Danish: På basis af populationsfarmakokinetikmodel-baserede analyser af virkningen af køn på clearance af midostaurin og dets aktive metabolitter var der ingen statistisk signifikante fund, og de forudsete ændringer i eksponering (<20%) blev ikke anset for at være klinisk relevante.
English: Talk to your doctor, pharmacist or nurse before taking Rydapt: - if you have any infections.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Rydapt: - hvis du har en infektion.
English: Patients should be monitored for signs and symptoms of infection, including any device-related infections, and if a diagnosis of infection is made appropriate treatment must be instituted promptly, including, as needed, the discontinuation of Rydapt.
Danish: Patienter bør monitoreres for tegn og symptomer på infektion, inklusive infektioner relateret til administrationssystem, og hvis infektionen konstateres, skal der omgående iværksættes passende behandling, herunder seponering af Rydapt ved behov.
English: Resume Rydapt at the same dose when infiltrate resolves to Grade ≤1.
Danish: Genoptag doseringen af Rydapt med samme dosis, når infiltrationerne er opløst til grad ≤1.
English: Strong CYP3A4 inhibitors may increase midostaurin blood concentrations.
Danish: Potente CYP3A4-hæmmere kan øge blodkoncentrationerne af midostaurin.
English: In ASM, SM-AHN and MCL patients these events led to dose adjustment or interruption in 26% and to discontinuation in 4.2% of the patients.
Danish: For ASM-, SM-AHN- og mastcelleleukæmipatienter førte disse hændelser til dosisjustering eller afbrydelse hos 26 % og til seponering hos 4,2 % af patienterne.
English: Grade 3/4 pulmonary infiltrates
Danish: Grad 3/4 lungeinfiltrationer
English: Most of the haematological abnormalities reported occurred during the induction and consolidation phase when the patients received Rydapt or placebo in combination with chemotherapy.
Danish: Størstedelen af de rapporterede hæmatologiske anomalier forekom i induktions- og konsolideringsfasen, når patienterne fik Rydapt eller placebo i kombination med kemoterapi.
English: In patients at risk, Rydapt should be used with caution and the patient closely monitored by assessing LVEF when clinically indicated (at baseline and during treatment).
Danish: Hos risikopatienter bør Rydapt anvendes med forsigtighed og patienten monitoreres tæt ved at vurdere LVEF, når det er klinisk indiceret (ved baseline og under behandling).
English: - Do not use this medicine after the expiry date which is stated on the carton and the blister foil after EXP.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterfolien efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Midostaurin was administered orally at 100 mg twice daily in cycles of 28 days.
Danish: Midostaurin blev administreret oralt i doser på 100 mg to gange daglig i cyklusser på 28 dage.
English: The pharmacokinetics of midostaurin were less than dose proportional with the doses of 30 mg/m and 60 mg/m after single and multiple doses.
Danish: Midostaurins farmakokinetik var mindre end dosisproportional ved doser på 30 mg/m og 60 mg/m efter enkeltdoser og flere doser.
English: Confirmed responses were observed in both KIT D816V mutation positive patients (ORR=63%) and KIT D816V wild type or unknown patients (ORR=43.8%).
Danish: Bekræftede responser blev observeret hos både KIT D816V-mutationspositive patienter (ORR=63%) og KIT D816V vildtype eller ukendte patienter (ORR=43,8%).
English: The combination of data on in vivo midostaurin auto-induction upon repeated dosing and increase in plasma 4β-OH cholesterol levels suggest that midostaurin may be at least a moderate CYP3A4 inducer in vivo.
Danish: Kombinationen af data på in vivo-midostaurin autoinduktion ved gentagen dosering og stigning i niveauer af plasma 4β-OH-kolesterol tyder på, at midostaurin i hvert fald kan være en moderat CYP3A4 inducer in vivo.
English: The median age of the patients was 47 years (range: 18 to 60 years), a majority of the patients had ECOG performance status of 0 or 1 (88.3%), and most patients had de novo AML (95%).
Danish: Patienternes medianalder var 47 år (område: 18 til 60 år), et flertal af patienterne havde ECOG-præstationsstatus på 0 eller 1 (88,3 %), og de fleste patienter havde de novo AML (95 %).
English: Nineteen patients (73.1%; 95% CI = [52.2, 88.4]) achieved a response during the first two cycles of treatment (13 MR; 6 PR).
Danish: Nitten patienter (73,1 %; 95 % CI = [52,2, 88,4]) opnåede et respons i løbet af de to første behandlingsserier (13 MR, 6 PR).
English: In vitro data indicate that midostaurin inhibits D816V mutant KIT receptors at exposure levels achieved in patients (average achieved exposure higher than IC50).
Danish: In vitro-data indikerer, at midostaurin hæmmer D816V mutant KIT receptorer ved eksponeringsniveauer opnået hos patienter (gennemsnitlig opnået eksponering højere end IC50).
English: Figure 2 Kaplan Meier curve for overall survival by SCT status in AML
Danish: Figur 2 Kaplan-Meier-kurve for samlet overlevelse for SCT-status ved AML
English: The most frequent Grade 3/4 adverse reaction leading to discontinuation in the Rydapt arm was exfoliative dermatitis (1.2%).
Danish: Den hyppigste bivirkning af grad 3/4, der førte til seponering i Rydapt-armen, var exfoliativ dermatitis (1,2 %).
English: Talk to your doctor if you are told that you have to start taking one of them during Rydapt treatment.
Danish: Tal med din læge, hvis du får at vide, at du skal begynde at tage et af disse lægemidler, imens du er i behandling med Rydapt.
English: The Human Mass Balance study results indicated that faecal excretion is the major route of excretion (78% of the dose), and mostly as metabolites (73% of the dose), while unchanged midostaurin accounts for 3% of the dose.
Danish: Human Mass Balance-studieresultater indikerede, at udskillelse via fæces er den primære udskillelsesvej (78 % af dosis), og mest som metabolitter (73 % af dosis), mens uomdannet midostaurin tegner sig for 3 % af dosis.
English: Women using hormonal contraceptives should add a barrier method of contraception.
Danish: Kvinder, der bruger hormonel prævention, bør tilføje prævention af barrieremetoden.
English: Missed doses If a dose is missed, the patient should take the next dose at the scheduled time.
Danish: Glemte doser Hvis en dosis glemmes, skal patienten tage den efterfølgende dosis på det planlagte tidspunkt.
English: If you forget to take Rydapt, skip the missed dose and take your next dose at the usual time.
Danish: Hvis du har glemt at tage Rydapt, skal du springe den glemte dosis over og tage din næste dosis på det sædvanlige tidspunkt.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE39
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE39
English: ANC decreased*
Danish: Fald i ANC*
English: Population pharmacokinetic analyses were conducted using data from clinical studies in patients with AML (n=180) and ASM, SM-AHN and MCL (n=141).
Danish: Der blev udført populationsfarmakokinetiske analyser med data fra kliniske studier hos patienter med AML (n=180) og ASM, SM-AHN og mastcelleleukæmi (n=141).
English: Caution is warranted in patients at risk of QTc prolongation (e.g. due to concomitant medicinal products and/or electrolyte disturbances).
Danish: Der skal udvises forsigtighed hos patienter med risiko for QTc-forlængelse (fx på grund af samtidig behandling med anden medicin og/eller elektrolytforstyrrelser).
English: Patients were stratified by FLT3 mutation status: TKD, ITD with allelic ratio <0.7, and ITD with allelic ratio ≥0.7.
Danish: Patienterne blev stratificeret efter FLT3-mutationsstatus: TKD, ITD med et allelratio på <0,7 og ITD med et allelratio på ≥0,7.
English: Alcohol may be harmful in patients with alcohol-related problems, epilepsy or liver problems or during pregnancy or breast-feeding.
Danish: Alkohol kan være skadeligt for patienter med alkoholrelaterede problemer, epilepsi eller leverproblemer, eller under graviditet eller amning.
English: In addition, midostaurin inhibits several other receptor tyrosine kinases such as PDGFR (platelet-derived growth factor receptor) or VEGFR2 (vascular endothelial growth factor receptor 2), as well as members of the serine/threonine kinase family PKC (protein kinase C).
Danish: Derudover hæmmer midostaurin flere andre receptortyrosinkinaser som fx PDGFR (trombocytderiveret vækstfaktor-receptor) eller VEGFR2 (vaskulær endotelvækstfaktor-receptor 2) såvel som medlemmer af serin-threonin-kinase-familien PKC (proteinkinase C).
English: Acute promyelocytic leukaemia
Danish: Akut promyelocyt leukæmi
English: Therefore, the change from baseline in QTcF with the concentration of midostaurin and both metabolites was further explored in a phase II study in 116 patients with ASM, SM-AHN or MCL.
Danish: Derfor blev ændringen i forhold til baseline i QTcF som funktion af koncentrationen af midostaurin og begge metabolitter yderligere undersøgt i et fase II-studie hos 116 patienter med ASM, SM-AHN eller mastcelleleukæmi.