natgillin/translations-raw huggingface dataset:
Patienter med symptomatisk kronisk hjerteinsufficiens blev ekskluderet fra de kliniske studier. 
Patients with symptomatic congestive heart failure were excluded from clinical studies.
I et toksicitetsstudie hos unge rotter blev midostaurin administreret fra dag 7 til dag 70 postpartum. 
In a toxicity study in juvenile rats, midostaurin was administered from days 7 to 70 postpartum.
Hos patienter i alderen ≥60 år bør Rydapt kun anvendes til patienter, der er egnede til at modtage intensiv induktionskemoterapi med tilstrækkelig performance status og uden signifikante comorbiditeter. 
In patients aged ≥60 years, Rydapt should be used only in patients eligible to receive intensive induction chemotherapy with adequate performance status and without significant comorbidities.
In vitro hæmmede midostaurin ikke hERG-kanal-aktivitet op til opløselighedsgrænsen på 12 µM. 
In vitro, midostaurin did not inhibit hERG channel activity up to the limit of solubility of 12 µM.
Det anbefales at administrere Rydapt sammen med mad. 
Rydapt is recommended to be administered with food.
Rydapt (100 mg to gange daglig) N=142 
Rydapt (100 mg twice daily) N=142
CIR (CR induktion) (HR) *Odds ratio beregnet som (Ingen fuldstændig remission under behandling/Komplet remission under behandling) / (Ingen fuldstændig remission under placebo/fuldstændig remission under placebo) HR= Hazard ratio; OR=odds ratio 
CIR (CR induction) (HR) *Odds ratio calculated as (No complete remission in treatment/Complete remission in treatment) / (No complete remission in placebo/complete remission in placebo) HR= Hazard ratio; OR=odds ratio
Prævention hos kvinder 
Contraception in women
Så længe skal du tage Rydapt - Fortsæt med at tage Rydapt, så længe lægen siger, at du skal gøre det. 
How long to take Rydapt - Continue taking Rydapt for as long as your doctor tells you.
Behandling med Rydapt kan undlades i så mange cyklusser som nødvendigt, indtil QTc forbedres. 
Rydapt may be held for as many cycles as necessary until QTc improves.
Afhængigt af hvordan du reagerer på behandlingen med Rydapt, kan lægen sætte din dosis ned eller afbryde behandlingen midlertidigt. 
Depending on how you respond to Rydapt, your doctor may lower your dose or temporarily interrupt the treatment.
Rydapt påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner. 
Rydapt has minor influence on the ability to drive and use machines.
Respons fra Rydapt blev bestemt ved anvendelse af en computerberegningsalgoritme anvendt uden nogen bedømmelse. 
Response to Rydapt was determined using a computational algorithm applied without any adjudication.
Lægemidler eller stoffer, der påvirker aktiviteten af CYP3A4, kan påvirke plasmakoncentrationerne af midostaurin og dermed sikkerheden og/eller virkningen af Rydapt. 
Medicinal products or substances known to affect the activity of CYP3A4 may affect the plasma concentrations of midostaurin and therefore the safety and/or efficacy of Rydapt.
Akut myeloid leukæmi er en kræftform i en bestemt type hvide blodlegemer (kaldet myeloide celler), hvor kroppen overproducerer en unormal type af disse celler. 
Acute myeloid leukaemia is a form of cancer of certain white blood cells (called myeloid cells) in which the body over-produces an abnormal type of these cells.
De fleste af bivirkningerne er lette til moderate og vil normalt forsvinde efter nogle få ugers behandling. 
Most of the side effects are mild to moderate and will generally disappear after a few weeks of treatment.
Hos mennesker var absorptionen af midostaurin hurtig efter oral administration, med Tmax af samlet radioaktivitet observeret ved 1-3 timer efter dosering. 
In humans, the absorption of midostaurin was rapid after oral administration, with Tmax of total radioactivity observed at 1-3 hours post dose.
Det er ukendt, om midostaurin eller dets aktive metabolitter udskilles i human mælk. 
It is unknown whether midostaurin or its active metabolites are excreted in human milk.
Af 116 patienter havde 113 et C-resultat som blev defineret i henhold til IWGresponskriterier (undtagen ascites som et C-resultat). 
Out of 116 patients, 113 had a C-finding as defined by IWG response criteria (excluding ascites as a C-finding).
Overvågning under behandling med Rydapt 
Monitoring during treatment with Rydapt
144 patienter havde normal nyrefunktion (CrCL >90 ml/min) ved baseline. 
144 patients showed normal renal function (CrCL >90 ml/min) at baseline.
Kapslen måler ca. 25,4 x 9,2 mm. 
The dimensions of the capsule are approximately 25.4 x 9.2 mm.
Studier af sikkerhedsfarmakologi indikerer, at det ikke er sandsynligt, at midostaurin påvirker vitale funktioner i centralnervesystemet. 
Safety pharmacology studies indicate that midostaurin is unlikely to interfere with vital functions of the central nervous system.
Alle de nedenfor beskrevne fund i dyr blev observeret ved en eksponering for midostaurin, der var signifikant lavere end de terapeutiske niveauer. 
All animal findings described below were observed at midostaurin exposure significantly lower than therapeutic levels.
QTc interval >500 ms 
QTc interval >500 msecs
Midostaurin har en fordeling i væv med en geometrisk middel på 95,2 l (Vz/F). 
Midostaurin has a tissue distribution of geometric mean of 95.2 l (Vz/F).
Vær ekstra forsigtig, når du kører og bruger maskiner, da du kan udvikle svimmelhed, mens du tager Rydapt. 
Take special care when driving and using machines as you may develop dizziness and vertigo while you are taking Rydapt.
Opbevares i den originale yderpakning for at beskytte mod fugt. 
Store in the original container in order to protect from moisture.
Hvis du bliver gravid eller tror, at du er gravid, skal du straks fortælle det til lægen. 
If you become pregnant or think you are pregnant, tell your doctor right away.
Spørg lægen eller apotekspersonalet, hvis du er i tvivl om, hvorvidt dit lægemiddel er et af de ovennævnte lægemidler. 
Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
KIT D816V-mutationen blev påvist hos 82 % af patienterne. 
The KIT D816V mutation was detected in 82% of patients.
Inden for hver systemorganklasse er bivirkningerne ordnet efter hyppighed med den hyppigste bivirkning først, baseret på følgende konvention (CIOMS III): meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first, using the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
På trods af at undersøgelsen var designet til at blive vurderet med de ændrede Valent- og Chesonkriterier, som en post-hoc-eksplorativ analyse, blev virkningen også undersøgt efter konsensuskriterier fra den internationale arbejdsgruppe fra 2013, Myeloproliferative Neoplasms Research and Treatment - European Competence Network on Mastocytosis (IWG-MRT-ECNM). 
Although the study was designed to be assessed with the modified Valent and Cheson criteria, as a post-hoc exploratory analysis, efficacy was also assessed per the 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment - European Competence Network on Mastocytosis (IWG-MRT-ECNM) consensus criteria.
- Hvis du bliver behandlet for ASM, SM-AHN eller mastcelleleukæmi, vil du få Rydapt som en langtidsbehandling, der kan vare i måneder eller år. 
- If you are being treated for ASM, SM-AHN or MCL, you will receive Rydapt as a long-term treatment, possibly lasting for months or years.
Det sekundære nøgleendepunkt var hændelsesfri overlevelse (EFS, en EFS-hændelse er defineret som manglende opnåelse af komplet remission [CR] inden for 60 dage efter initiering af protokolbehandling eller recidiv eller dødsfald uanset årsag). 
The key secondary endpoint was event-free survival (EFS; an EFS event is defined as a failure to obtain a complete remission (CR) within 60 days of initiation of protocol therapy, or relapse, or death from any cause).
Aktive alvorlige infektioner bør være under kontrol, før der startes behandling med Rydapt som monoterapi. 
Any active serious infection should be under control prior to starting treatment with Rydapt monotherapy.
Sandsynlighed for overlevelse (%) 
Probability of Survival (%)
Der er ingen kendt specifik antidot mod midostaurin. 
There is no known specific antidote for midostaurin.
Dosisjustering er ikke påkrævet hos patienter over 65 år (se pkt. 
No dose adjustment is required in patients aged over 65 years (see section 5.2).
Måneder Midostaurin Placebo 
Months Midostaurin Placebo
Hvis du stopper behandlingen med Rydapt, kan din tilstand forværres. 
Stopping your treatment with Rydapt may cause your condition to become worse.
CGP62221 udviste et tilsvarende mønster. 
CGP62221 exhibited a similar pattern.
- Hvis du kaster op efter, at du har sunket kapslerne, må du ikke tage flere kapsler før din næste planlagte dosis. 
- If you vomit after you swallow the capsules, do not take any more capsules until your next scheduled dose.
In vitro-data indikerer, at KIT-vildtype-receptorer i meget mindre grad er hæmmet ved disse koncentrationer (gennemsnitlig opnået eksponering lavere end IC50). 
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).
Parringstal, fertilitetsindeks og befrugtningshastigheder blev nedsat ved 0, 5 og 15 mg/kg/dag, men ikke ved 2 mg/kg/dag. 
Mating index, fertility index and conception rates were reduced at 0, 5 and 15 mg/kg/day, but not at 2 mg/kg/day.
Rydapt er ikke blevet undersøgt hos patienter med akut promyelocyt leukæmi, og derfor anbefales det ikke at anvende Rydapt hos denne patientpopulation. 
Rydapt has not been studied in patients with acute promyelocytic leukaemia and therefore its use is not recommended in this patient population.
9/l) varer ved i >2 uger og formodes at være relateret til Rydapt, skal behandlingen seponeres. 
9/l) persists >2 weeks and is suspected to be related to Rydapt, discontinue Rydapt.
Bivirkninger, der førte til seponering af behandlingen, forekom hos 9,2 % af patienterne. 
ADRs that led to treatment discontinuation occurred in 9.2% of patients.
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. 
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.
CR induktion (OR) 
CR induction (OR)
Ved baseline havde 88,5 % >1 C-fund, og 69,2 % havde tidligere fået mindst ét antineoplastisk regime. 
At baseline, 88.5% had >1 C finding and 69.2% had received at least one prior anti-neoplastic regimen.
I tilfælde af overdosis skal patienter monitoreres nøje for tegn eller symptomer på bivirkninger, og passende symptomatisk og understøttende behandling påbegyndes. 
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.
Symptomerne opstår, når for mange mastceller havner i organer som leveren, knoglemarven eller milten og frigiver stoffer som fx histamin i blodet. 
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.
ANC: absolut neutrofiltal. 
ANC: Absolute Neutrophil Count
Den populationsfarmakokinetiske analyse viste, at absorptionen hos patienter var mindre end dosisproportional i doser på >50 mg to gange dagligt. 
The population pharmacokinetic analysis indicated that the absorption in patients was less than dose proportional at doses >50 mg twice daily.
Grundet den begrænsede mængde farmakokinetiske data hos pædiatriske patienter kan der ikke foretages en sammenligning med midostaurins farmakokinetik hos voksne. 
Due to the limited pharmacokinetic data in paediatric patients, no comparison with midostaurin pharmacokinetics in adults can be made.
Regelmæssige evalueringer af QT ved brug af EKG bør overvejes, hvis Rydapt tages samtidig med lægemidler, der kan forlænge QT-intervallet. 
Interval assessments of QT by ECG should be considered if Rydapt is taken concurrently with medicinal products that can prolong QT interval.
For kliniske centre i Nordamerika blev alle grader af 13 på forhånd specificerede bivirkninger registreret. 
For trial sites in North America, all grades were collected for 13 pre-specified adverse events.
Erfaringen med midostaurin hos AML-patienter i alderen 60-70 år er begrænset, og der er ingen erfaring med AML-patienter over 70 år. 
There is limited experience with midostaurin in AML patients aged 60-70 years and no experience in AML patients above 70 years.
HR (95% CI) - SCT HR (95% CI) - ingen SCT 
HR (95% CI) - SCT HR (95% CI) - no SCT
Tabel 6 Oversigt over OS, EFS, CR, DFS og CIR i AML fordelt på køn 
Table 6 Overview of OS, EFS, CR, DFS and CIR by gender in AML
Majsolie-mono-di-triglycerider All-rac-alfa-tocopherol 
Ethanol anhydrous Maize oil mono-di-triglycerides All-rac-alpha-tocopherol
Hvis du holder op med at tage Rydapt 
If you stop taking Rydapt
Anvendelse af andre lægemidler, der ikke er stærke hæmmere af CYP3A4-aktivitet, bør overvejes. 
Alternative medicinal products that do not strongly inhibit CYP3A4 activity should be considered.
QTc interval >470 ms og ≤500 ms 
QTc interval >470 msecs and ≤500 msecs
Det er sygdomme, hvor kroppen danner for mange mastceller, en type hvide blodlegemer. 
These are disorders in which the body produces too many mast cells, a type of white blood cell.
Hvis du bruger et hormonelt præventionsmiddel, skal du også bruge en barrieremetode, fx et kondom eller et pessar. 
If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Midostaurin blokerer aktiviteten af nogle enzymer (kinaser) i de unormale celler og stopper cellernes deling og vækst. 
Midostaurin blocks the action of some enzymes (kinases) in the abnormal cells and stops their division and growth.
- Brug ikke lægemidlet, hvis pakningen er beskadiget, eller hvis der er tegn på, at den har været åbnet. 
- Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Tilgængelige data fra dyr har vist, at midostaurin og dets aktive metabolitter går over i mælken hos diegivende rotter. 
Available animal data have shown that midostaurin and its active metabolites pass into the milk of lactating rats.
- hvis du har lungeproblemer eller vejrtrækningsbesvær. 
- if you have problems with your lungs or problems breathing.
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. 
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.
Dosisændringer (afbrydelse eller justering) som følge af bivirkninger forekom hos 31 % af patienterne. 
Dose modifications (interruption or adjustment) due to ADRs occurred in 31% of patients.
Endelig CSR: september 
Final CSR: September
Rydapts indvirkning på andre lægemidler 
Effect of Rydapt on other medicinal products
Den gennemsnitlige AUClast for CGP52421 blev reduceret med 60 %. 
The mean AUClast of CGP52421 decreased by 60%.
ASM SM-AHN MCL Ukendt undertype 
ASM SM-AHN MCL Subtype unknown
Seksogfyrre procent af patienterne havde et fald i knoglemarvsinfiltration, der oversteg 50 % og 58 % havde et fald i serumniveauet af tryptase, der oversteg 50 %. 
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%.
Hvis du har glemt at tage Rydapt 
If you forget to take Rydapt
Farmakokinetikken af CGP62221-metabolitten viste en lignende tendens. 
The pharmacokinetics of the CGP62221 metabolite showed a similar trend.
Alle grader Grader 3/4 
Grades 3/4
Der er ikke foretaget in vivo-studier for at undersøge induktion og hæmning af enzymer og transportører af midostaurin og de aktive metabolitter. 
In vivo studies have not been conducted for the investigation of induction and inhibition of enzymes and transporters by midostaurin and the active metabolites.
Tabel 5 Effekt af midostaurin ved AML 
Table 5 Efficacy of midostaurin in AML
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. 
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.
Incidensen af bivirkninger var imidlertid højere i Rydapt-armen end i placebo-armen i vedligeholdelsesfasen. 
Incidences of ADRs were, however, higher in the Rydapt arm than in the placebo arm during the maintenance phase.
Den gennemsnitlige tilsyneladende plasmaclearance (CL/F) var 2,4-3,1 l/t hos raske forsøgspersoner. 
The mean apparent plasma clearance (CL/F) was 2.4-3.1 l/h in healthy subjects.
Traumer, forgiftninger og behandlingskomplikationer Kontusion 
Injury, poisoning and procedural complications Contusion
Figur 1 Kaplan-Meier-kurve for samlet overlevelse, ikke censureret for SCT 
Figure 1 Kaplan-Meier curve for overall survival, non-censored for SCT
Alle undersøgte patienter 
All patients evaluated
Anden ikke-hæmatologisk grad 3/4-toksicitet 
Other Grade 3/4 non-haematological toxicities
Samlet overlevelse n/N (%) 
Overall survival n/N (%)
I studier af genotoksicitet in vitro og in vivo, der dækkede relevante genotoksicitets-endepunkter, blev der ikke set tegn på mutagen eller klastogen aktivitet. 
In vitro and in vivo genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of mutagenic or clastogenic activity.
In vitro-data viste, at midostaurin er mere end 98 % bundet til plasmaproteiner, fx albumin, α-1-syre-glycoprotein (AGP) og lipoprotein. 
In vitro data showed midostaurin is more than 98% bound to plasma proteins, such as albumin, α1-acid glycoprotein (AGP) and lipoprotein.
Vurdering af potentiale for lægemiddelinteraktion in vitro 
In vitro evaluation of drug-drug interaction potential
Hos patienter, der udvikler uventet svær neutropeni, bør behandling med Rydapt afbrydes, indtil ANC er ≥1,0 x 10 
In patients who develop unexplained severe neutropenia, treatment with Rydapt should be interrupted until ANC is ≥1.0 x 10
Medianalderen i primær effekt-populationen var 64 år med ca. halvdelen af patienterne ≥65 år. 
The median age in the primary efficacy population was 64 years with approximately half of the patients ≥65 years.
Undersøgelser Hyperglykæmi (ikke efter faste)* 
Investigations Hyperglycaemia (non-fasting)*
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. 
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.
AUC0-12 var reduceret med 39 % og 36 % hos forsøgspersoner med henholdsvis let og moderat nedsat leverfunktion. 
AUC0-12 was decreased by 39% and 36% in subjects with mild and moderate hepatic impairment, respectively.
Andre lægemidler kan også påvirke virkningen af Rydapt. 
Some other medicines can also affect how Rydapt works.
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. 
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.
Midostaurin blev administreret oralt i doser på 100 mg to gange daglig, indtil der blev observeret sygdomsprogression eller ikke-tolerabel toksicitet. 
Midostaurin was administered orally at 100 mg twice daily until disease progression or intolerable toxicity.
Tilbagehold eller afbryd behandlingen med Rydapt i resten af cyklussen. 
Withhold or interrupt Rydapt for the remainder of the cycle.
Medianoverlevelsen for KIT D816V-positive patienter var dog længere; 
However, the median survival for KIT D816V positive patients was longer, i.e.
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. 
Interrupt Rydapt until toxicities considered at least possibly related to Rydapt have resolved to Grade ≤2, then resume Rydapt.
Endelig CSR: december 
Final CSR: December
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). 
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).
Rydapts sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt (se pkt. 
The safety and efficacy of Rydapt in children and adolescents below 18 years have not been established (see section 5.1).
1: MIDOSTAURIN - SCT 2: PLACEBO - SCT 3: MIDOSTAURIN - ingen SCT 4: PLACEBO - ingen SCT Censureret 
1: MIDOSTAURIN - SCT 2: PLACEBO - SCT 3: MIDOSTAURIN - no SCT 4: PLACEBO - no SCT Censored
Hvis du tager nogen af disse lægemidler, kan lægen ordinere et andet lægemiddel til dig i stedet, mens du er i behandling med Rydapt. 
If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Rydapt.
CTCAE-sværhedsgrad: grad 1 = lette symptomer, grad 2 = moderate symptomer; grad 3 = svære symptomer, grad 4 = livstruende symptomer. 
CTCAE severity: Grade 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.
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. 
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.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Rydapt: - hvis du har en infektion. 
Talk to your doctor, pharmacist or nurse before taking Rydapt: - if you have any infections.
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. 
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.
Genoptag doseringen af Rydapt med samme dosis, når infiltrationerne er opløst til grad ≤1. 
Resume Rydapt at the same dose when infiltrate resolves to Grade ≤1.
Potente CYP3A4-hæmmere kan øge blodkoncentrationerne af midostaurin. 
Strong CYP3A4 inhibitors may increase midostaurin blood concentrations.