FrancophonIA/ELRC3.0 huggingface dataset:
English: Rydapt may reduce fertility in men and women.
Danish: Rydapt kan nedsætte fertiliteten hos mænd og kvinder.
English: - if you have a heart disorder.
Danish: - hvis du har hjerteproblemer.
English: Induction, consolidation and maintenance
Danish: Induktion, konsolidering og vedligeholdelse
English: Secondary endpoints included duration of response, time to response, and overall survival.
Danish: De sekundære endepunkter omfattede varighed af respons, tiden til respons og samlet overlevelse.
English: The absolute bioavailability of midostaurin following oral administration is not known.
Danish: Den absolutte biotilgængelighed af midostaurin efter oral administration kendes ikke.
English: The primary endpoint was overall response rate (ORR).
Danish: Det primære endepunkt var samlet respons-rate (ORR).
English: One blister contains 4 soft capsules.
Danish: En blister indeholder 4 bløde kapsler.
English: Activity was observed regardless of number of prior therapies, and presence or absence of an AHN.
Danish: Der blev observeret aktivitet uagtet antal tidligere behandlinger og tilstedeværelse eller fravær af AHN.
English: Prophylactic antiemetics should be administered in accordance with local medical practice as per patient tolerance.
Danish: Profylaktiske antiemetika bør administreres i overensstemmelse med lokal medicinsk praksis i henhold til patientens tolerance.
English: The maximum concentration was reached between 2 and 3 hours after administration after single or repeated doses for all groups.
Danish: Maksimumskoncentrationen blev nået mellem 2 og 3 timer efter administration af enkeltdoser eller gentagne doser for alle grupper.
English: - Take Rydapt twice a day at about 12-hour intervals (for example, with breakfast and with your evening meal).
Danish: - Tag Rydapt to gange om dagen med omkring 12 timers mellemrum (for eksempel sammen med morgenmaden og aftensmaden).
English: AUCtau was decreased by 28% and 20% on day 7, respectively.
Danish: AUCtau var reduceret med henholdsvis 28% og 20% på dag 7.
English: Results for OS by SCT status are shown in Figure 2.
Danish: Resultater for OS ved SCT-status er vist i Figur 2.
English: The median duration of follow-up was 43 months.
Danish: Medianvarigheden af opfølgning var 43 måneder.
English: Lack of a major response (MR) or partial response (PR) by the end of the second cycle required discontinuation from the study treatment.
Danish: Manglende major respons (MR) eller partielt respons (PR) ved afslutningen af den anden serie nødvendiggjorde seponering af forsøgsbehandlingen.
English: Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
Danish: Behandlingen bør fortsættes, så længe der observeres en klinisk fordel, eller indtil der forekommer uacceptabel toksicitet.
English: There are no data on the effect of Rydapt on human fertility.
Danish: Der foreligger ingen data om Rydapts påvirkning af fertiliteten hos mennesker.
English: Of the 116 patients enrolled, 89 were considered eligible for response assessment and constituted the primary efficacy population.
Danish: Af de 116 inkluderede patienter blev 89 anset for egnede til responsvurdering og udgjorde primær effektpopulationen.
English: Rydapt may harm your unborn baby and is not recommended during pregnancy.
Danish: Rydapt kan skade dit ufødte barn og anbefales ikke under graviditet.
English: Single doses of up to 600 mg have been given with acceptable acute tolerability.
Danish: Der er givet enkeltdoser på op til 600 mg med acceptabel akut tolerabilitet.
English: The primary endpoint was ORR evaluated by the Valent criteria during the first two cycles of treatment.
Danish: Det primære endepunkt var ORR vurderet ved Valent-kriterierne under de to første behandlingsserier.
English: There were no effects on physical development, sensory function or behavioural function.
Danish: Der var ingen indvirkning på den fysiske udvikling, sansefunktionen eller adfærdsfunktionen.
English: Responses to midostaurin are shown in Table 7.
Danish: Responser på midostaurin er vist i tabel 7.
English: Median Survival (months)
Danish: Median Overlevelse (måneder)
English: The median duration of follow-up was 73 months, and the median duration of response has not been reached.
Danish: Medianvarigheden af opfølgning var 73 måneder, og medianvarigheden af respons er ikke nået.
English: These medicines must be avoided during treatment with Rydapt.
Danish: Disse lægemidler skal undgås under behandling med Rydapt.
English: The two treatment groups were generally balanced with respect to the baseline demographics of disease characteristics.
Danish: De to behandlingsgrupper var generelt balancerede med hensyn til baseline-demografi af sygdomskarakteristika.
English: Analysis excludes ascites as a C-finding.
Danish: Analysen er eksklusive ascites som et C-resultat.
English: Taking this medicine - Taking Rydapt at the same time each day will help you to remember to take your medicine.
Danish: Sådan tager du Rydapt - Hvis du tager Rydapt på samme tidspunkt hver dag, vil det hjælpe dig med at huske at tage din medicin.
English: It belongs to a class of medicines called protein kinase inhibitors.
Danish: Det tilhører en klasse af lægemidler, der kaldes proteinkinasehæmmere.
English: The capsules should be swallowed whole with a glass of water.
Danish: Kapslerne bør synkes hele med et glas vand.
English: Midostaurin and its metabolites are distributed mainly in plasma rather than red blood cells.
Danish: Midostaurin og dets metabolitter fordeles overvejende i plasma, snarere end i røde blodceller.
English: Do not exceed the dose prescribed by your doctor.
Danish: Du må ikke overskride den dosis, som lægen har foreskrevet.
English: Do not stop taking your medicine unless your doctor tells you to do so.
Danish: Stop ikke med at tage din medicin, medmindre lægen har bedt dig om det.
English: - Patients with AML
Danish: - Patienter med AML
English: Finally, the long-term data from patients were analysed using a population pharmacokinetic approach.
Danish: Afslutningsvis blev langtidsdata fra patienter analyseret ved brug af populationsfarmakokinetik.
English: In clinical studies, the efficacy and safety of Rydapt were investigated following administration with a light meal.
Danish: I kliniske studier blev effekten og sikkerheden af Rydapt undersøgt efter administration med et let måltid.
English: Median overall survival was 40.0 months (patients were only followed up for one year after treatment discontinuation for survival).
Danish: Medianen af den samlede overlevelse var 40,0 måneder (patienterne blev kun fulgt for overlevelse i ét år efter behandlingsophør).
English: Midostaurin can cause foetal harm when administered to a pregnant woman.
Danish: Midostaurin kan forårsage fosterskade, når det administreres til en gravid kvinde.
English: The protocol includes a comprehensive collection of baseline data (including biomarkers), post-study treatments, and evaluation of minimal residual disease (MRD).
Danish: Protokollen inkluderer en omfattende indsamling af baseline data (herunder biomarkører), behandlinger efter studiet samt evaluering af minimal residual sygdom (MRD).
English: Rydapt should not be used in children and adolescents because it is not known whether it is safe and effective in this age group.
Danish: Rydapt bør ikke anvendes til børn og unge, da det ikke vides, om lægemidlet er sikkert og virker hos denne aldersgruppe.
English: This is equivalent to 8.4 ml beer or 3.5 ml wine.
Danish: Dette modsvarer 8,4 ml øl eller 3,5 ml vin.
English: Persistent Grade 1/2 toxicity Persistent Grade 1 or 2 toxicity that patients deem unacceptable may prompt an interruption for as many as 28 days.
Danish: Vedvarende grad 1/2 toksicitet Vedvarende grad 1 eller 2 toksicitet, som patienter anser som uacceptable, kan medføre en afbrydelse af behandlingen i op til 28 dage.
English: There are no differences in the pharmacokinetic profile between Caucasian and Black subjects.
Danish: Der er ingen forskelle i den farmakokinetiske profil mellem kaukasiske og sorte forsøgspersoner.
English: Major response, n
Danish: Major respons, n
English: Due to dose-limiting toxicity, clinical therapeutic exposure levels could not be reached in animals.
Danish: Som følge af dosisbegrænsende toksicitet kunne de kliniske terapeutiske eksponeringsniveauer ikke nås i dyr.
English: Not significant
Danish: Ikke signifikant.
English: For all other adverse events, only grades 3 and 4 were collected.
Danish: For alle andre bivirkninger blev kun grad 3 og 4 registreret.
English: White blood cell counts (WBCs) should be monitored regularly, especially at treatment initiation.
Danish: Leukocyttallet (WBC) bør monitoreres regelmæssigt, særligt ved behandlingsstart.
English: If you think you may be allergic, ask your doctor for advice.
Danish: Hvis du tror, at du kan være allergisk, så spørg lægen til råds.
English: Rydapt is indicated:
Danish: Rydapt er indiceret:
English: If you become pregnant while taking Rydapt, it may harm your baby.
Danish: Hvis du bliver gravid, mens du tager Rydapt, kan det skade dit barn.
English: Rydapt should be taken orally twice daily at approximately 12-hour intervals.
Danish: Rydapt skal tages oralt to gange daglig med ca. 12 timers mellemrum.
English: In a subgroup analysis, no apparent OS benefit was observed in females, however, a treatment benefit was observed in females in all secondary efficacy endpoints (see Table 6).
Danish: I en undergruppeanalyse blev der ikke observeret nogen tilsyneladende OS-fordel hos kvinder, men en behandlingsfordel blev observeret hos kvinder i alle sekundære effekt-endepunkter (se tabel 6).
English: The overall incidence of ADRs during the maintenance phase was generally lower than during the induction and consolidation phase.
Danish: Den samlede incidens af bivirkninger i vedligeholdelsesfasen var generelt lavere end under induktions- og konsolideringsfasen.
English: Therefore all grade AEs are summarised only for patients in non-North American trial sites, whereas Grades 3 and 4 are summarised for patients in all trial sites.
Danish: Derfor er samtlige grader af bivirkninger kun opsummeret for patienter i kliniske centre, der ikke er Nordamerikanske, mens grad 3 og 4 er opsummeret for patienter på alle kliniske centre.
English: Your doctor will ask you to take a pregnancy test before you start treatment with Rydapt to make sure you are not pregnant.
Danish: Lægen vil bede dig om at tage en graviditetstest, før du starter behandling med Rydapt for at være sikker på, at du ikke er gravid.
English: Your doctor will discuss with you the most suitable method of contraception for you to use.
Danish: Lægen vil tale med dig om, hvilken svangerskabsforebyggende metode der er mest passende for dig at bruge.
English: Pregnant women should be advised of the potential risk to the foetus.
Danish: Gravide kvinder bør informeres om den mulige risiko for fosteret.
English: Renal elimination is a minor route of elimination for midostaurin.
Danish: Renal elimination er en begrænset eliminationsvej for midostaurin.
English: What Rydapt is
Danish: Hvad Rydapt er
English: Safety pharmacology and single/repeat dose toxicity
Danish: Sikkerhedsfarmakologi og toksicitet efter enkeltdoser/gentagne doser
English: ADRs are listed according to MedDRA system organ class.
Danish: Bivirkningerne er angivet i henhold til MedDRA-systemorganklasse.
English: Your doctor may need to adjust, temporarily stop or completely discontinue your treatment with Rydapt.
Danish: Det kan måske være nødvendigt for lægen at justere, midlertidigt afbryde eller helt stoppe din behandling med Rydapt.
English: Midostaurin is a compound with good absorption and poor solubility.
Danish: Midostaurin er et stof med god absorption og lav opløselighed.
English: Partial response, n
Danish: Partielt respons, n
English: Response rates were assessed based on the modified Valent and Cheson criteria and responses were adjudicated by a study steering committee.
Danish: Responsraterne blev bestemt på basis af de modificerede Valent-kriterier og Cheson-kriterier, og responserne blev bedømt af en styregruppe i studiet.
English: You should discuss this with your doctor before starting treatment.
Danish: Du bør tale med lægen om dette, før du starter med behandlingen.
English: Neutropenia and infections
Danish: Neutropeni og infektioner
English: This is because Rydapt can affect the way some medicines work.
Danish: Grunden er, at Rydapt kan påvirke virkningen af nogle lægemidler.
English: - Swallow the capsules whole with a glass of water.
Danish: - Synk kapslerne hele med et glas vand.
English: Grade 3/4 nausea and/or vomiting despite optimal anti-emetic therapy
Danish: Grad 3/4 kvalme og/eller opkastning på trods af optimal anti-emetisk behandling
English: Do not take Rydapt: - if you are allergic to midostaurin or to any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Rydapt: - hvis du er allergisk over for midostaurin eller et af de øvrige indholdsstoffer i Rydapt (angivet i punkt 6).
English: The primary endpoint of the study was overall survival (OS), measured from the date of randomisation until death by any cause.
Danish: Studiets primære endepunkt var samlet overlevelse (OS), målt fra randomiseringsdatoen frem til dødsfald uanset årsag.
English: The median time to response was 0.3 months (range: 0.1 to 3.7 months).
Danish: Mediantiden til respons var 0,3 måneder (interval: 0,1-3,7 måneder).
English: Treatment with Rydapt should be initiated by a physician experienced in the use of anti-cancer therapies.
Danish: Behandling med Rydapt bør initieres af en læge med erfaring inden for cancerbehandlinger.
English: Final CSR: June 2023
Danish: Endelig CSR: juni 2023
English: any time during induction (%)
Danish: på et hvilket som helst tidspunkt under induktion (%)
English: Time to peak concentration was also delayed in the presence of a high-fat meal.
Danish: Tiden til maksimumskoncentration blev også forlænget ved tilstedeværelsen af et fedtholdigt måltid.
English: If you take more capsules than you should, or if someone else takes your medicine, talk to a doctor or go to a hospital straight away, taking the pack with you, as medical treatment may be necessary.
Danish: Hvis du har taget flere kapsler, end du skulle, eller hvis en anden har taget din medicin, skal du omgående kontakte en læge eller tage på hospitalet og tage pakningen med, da lægebehandling kan være nødvendigt.
English: In situations where satisfactory therapeutic alternatives do not exist, patients should be closely monitored for midostaurin-related toxicity.
Danish: I situationer, hvor der ikke findes tilfredsstillende terapeutiske alternativer, bør patienterne overvåges nøje for toksicitet relateret til midostaurin.
English: Patients with symptomatic congestive heart failure were excluded from clinical studies.
Danish: Patienter med symptomatisk kronisk hjerteinsufficiens blev ekskluderet fra de kliniske studier.
English: In a toxicity study in juvenile rats, midostaurin was administered from days 7 to 70 postpartum.
Danish: I et toksicitetsstudie hos unge rotter blev midostaurin administreret fra dag 7 til dag 70 postpartum.
English: 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.
Danish: 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.
English: In vitro, midostaurin did not inhibit hERG channel activity up to the limit of solubility of 12 µM.
Danish: In vitro hæmmede midostaurin ikke hERG-kanal-aktivitet op til opløselighedsgrænsen på 12 µM.
English: Rydapt is recommended to be administered with food.
Danish: Det anbefales at administrere Rydapt sammen med mad.
English: Rydapt (100 mg twice daily) N=142
Danish: Rydapt (100 mg to gange daglig) N=142
English: 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
Danish: 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
English: Contraception in women
Danish: Prævention hos kvinder
English: How long to take Rydapt - Continue taking Rydapt for as long as your doctor tells you.
Danish: Så længe skal du tage Rydapt - Fortsæt med at tage Rydapt, så længe lægen siger, at du skal gøre det.
English: Rydapt may be held for as many cycles as necessary until QTc improves.
Danish: Behandling med Rydapt kan undlades i så mange cyklusser som nødvendigt, indtil QTc forbedres.
English: Depending on how you respond to Rydapt, your doctor may lower your dose or temporarily interrupt the treatment.
Danish: Afhængigt af hvordan du reagerer på behandlingen med Rydapt, kan lægen sætte din dosis ned eller afbryde behandlingen midlertidigt.
English: Rydapt has minor influence on the ability to drive and use machines.
Danish: Rydapt påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Response to Rydapt was determined using a computational algorithm applied without any adjudication.
Danish: Respons fra Rydapt blev bestemt ved anvendelse af en computerberegningsalgoritme anvendt uden nogen bedømmelse.
English: 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.
Danish: Lægemidler eller stoffer, der påvirker aktiviteten af CYP3A4, kan påvirke plasmakoncentrationerne af midostaurin og dermed sikkerheden og/eller virkningen af Rydapt.
English: 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.
Danish: Akut myeloid leukæmi er en kræftform i en bestemt type hvide blodlegemer (kaldet myeloide celler), hvor kroppen overproducerer en unormal type af disse celler.
English: Most of the side effects are mild to moderate and will generally disappear after a few weeks of treatment.
Danish: De fleste af bivirkningerne er lette til moderate og vil normalt forsvinde efter nogle få ugers behandling.
English: In humans, the absorption of midostaurin was rapid after oral administration, with Tmax of total radioactivity observed at 1-3 hours post dose.
Danish: Hos mennesker var absorptionen af midostaurin hurtig efter oral administration, med Tmax af samlet radioaktivitet observeret ved 1-3 timer efter dosering.
English: It is unknown whether midostaurin or its active metabolites are excreted in human milk.
Danish: Det er ukendt, om midostaurin eller dets aktive metabolitter udskilles i human mælk.
English: Out of 116 patients, 113 had a C-finding as defined by IWG response criteria (excluding ascites as a C-finding).
Danish: Af 116 patienter havde 113 et C-resultat som blev defineret i henhold til IWGresponskriterier (undtagen ascites som et C-resultat).
English: Monitoring during treatment with Rydapt
Danish: Overvågning under behandling med Rydapt
English: 144 patients showed normal renal function (CrCL >90 ml/min) at baseline.
Danish: 144 patienter havde normal nyrefunktion (CrCL >90 ml/min) ved baseline.
English: The dimensions of the capsule are approximately 25.4 x 9.2 mm.
Danish: Kapslen måler ca. 25,4 x 9,2 mm.
English: Safety pharmacology studies indicate that midostaurin is unlikely to interfere with vital functions of the central nervous system.
Danish: Studier af sikkerhedsfarmakologi indikerer, at det ikke er sandsynligt, at midostaurin påvirker vitale funktioner i centralnervesystemet.
English: All animal findings described below were observed at midostaurin exposure significantly lower than therapeutic levels.
Danish: Alle de nedenfor beskrevne fund i dyr blev observeret ved en eksponering for midostaurin, der var signifikant lavere end de terapeutiske niveauer.
English: QTc interval >500 msecs
Danish: QTc interval >500 ms
English: Midostaurin has a tissue distribution of geometric mean of 95.2 l (Vz/F).
Danish: Midostaurin har en fordeling i væv med en geometrisk middel på 95,2 l (Vz/F).
English: Take special care when driving and using machines as you may develop dizziness and vertigo while you are taking Rydapt.
Danish: Vær ekstra forsigtig, når du kører og bruger maskiner, da du kan udvikle svimmelhed, mens du tager Rydapt.
English: Store in the original container in order to protect from moisture.
Danish: Opbevares i den originale yderpakning for at beskytte mod fugt.
English: If you become pregnant or think you are pregnant, tell your doctor right away.
Danish: Hvis du bliver gravid eller tror, at du er gravid, skal du straks fortælle det til lægen.
English: Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
Danish: Spørg lægen eller apotekspersonalet, hvis du er i tvivl om, hvorvidt dit lægemiddel er et af de ovennævnte lægemidler.
English: The KIT D816V mutation was detected in 82% of patients.
Danish: KIT D816V-mutationen blev påvist hos 82 % af patienterne.
English: 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).
Danish: 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).
English: 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.
Danish: 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).
English: - 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.
Danish: - Hvis du bliver behandlet for ASM, SM-AHN eller mastcelleleukæmi, vil du få Rydapt som en langtidsbehandling, der kan vare i måneder eller år.
English: 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).
Danish: 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).
English: Any active serious infection should be under control prior to starting treatment with Rydapt monotherapy.
Danish: Aktive alvorlige infektioner bør være under kontrol, før der startes behandling med Rydapt som monoterapi.
English: Probability of Survival (%)
Danish: Sandsynlighed for overlevelse (%)
English: There is no known specific antidote for midostaurin.
Danish: Der er ingen kendt specifik antidot mod midostaurin.
English: No dose adjustment is required in patients aged over 65 years (see section 5.2).
Danish: Dosisjustering er ikke påkrævet hos patienter over 65 år (se pkt.
English: Months Midostaurin Placebo
Danish: Måneder Midostaurin Placebo