natgillin/translations-raw huggingface dataset:
Patienter med nydiagnosticeret FLT3-muteret AML bestemt med en klinisk studie-analyse blev randomiseret (1:1) til at tage 50 mg midostaurin to gange daglig (n=360) eller placebo (n=357) sekventielt i kombination med standard daunorubicin (60 mg/m daglig på dag 1-3)/cytarabin (200 mg/m daglig på dag 1-7)-induktion og højdosis-cytarabin (3 g/m hver 12. time på dag 1, 3, 5)-konsolidering efterfulgt af kontinuerlig behandling med midostaurin eller placebo i henhold til den indledende tildeling i op til yderligere 12 serier (28 dage/serie). 
Patients with newly diagnosed FLT3-mutated AML as determined by a clinical study assay were randomised (1:1) to receive midostaurin 50 mg twice daily (n=360) or placebo (n=357) sequentially in combination with standard daunorubicin (60 mg/m daily on days 1-3) / cytarabine (200 mg/m daily on days 1-7) induction and high-dose cytarabine (3 g/m every 12 hours on days 1, 3, 5) consolidation, followed by continuous midostaurin or placebo treatment according to initial assignment for up to 12 additional cycles (28 days/cycle).
OS-sandsynlighed, % 
Overall survival probability, %
I et dedikeret studie af nedsat leverfunktion blev der foretaget en vurdering af den systemiske eksponering for midostaurin efter oral administration af 50 mg to gange daglig i 6 dage hos forsøgspersoner med let eller moderat nedsat leverfunktion (henholdsvis Child-Pugh-klasse A eller B) ved baseline og kontrol-forsøgspersoner med normal leverfunktion. 
A dedicated hepatic impairment study assessed the systemic exposure of midostaurin after oral administration of 50 mg twice daily for 6 days in subjects with baseline mild or moderate hepatic impairment (Child-Pugh Class A or B, respectively) and control subjects with normal hepatic function.
Ved medianen af de højeste Cmin-koncentrationer opnået ved en dosis på 100 mg to gange daglig viste hverken midostaurin, CGP62221 eller CGP52421 potentiale til at forårsage klinisk signifikant QTcF-forlængelse, da de øvre grænser for forventet ændring ved disse koncentrationsniveauer var mindre end 10 ms (henholdsvis 5,8, 2,4 og 4,0 ms). 
At the median peak Cmin concentrations attained at a dose of 100 mg twice daily, neither midostaurin, CGP62221 nor CGP52421 showed a potential to cause clinically significant QTcF prolongation, since the upper bounds of predicted change at these concentration levels were less than 10 msecs (5.8, 2.4, and 4.0 msecs, respectively).
Hovedkomponenterne i plasma omfattede midostaurin og to aktive hovedmetabolitter, CGP62221 (via O-demethylering) og CGP52421 (via hydroxylering), der tegnede sig for henholdsvis 27,7 ± 2,7 % og 38,0±6,6 % af den samlede plasmaeksponering ved 96 timer efter en enkelt dosis på 50 mg midostaurin. 
The major plasma components included midostaurin and two major active metabolites, CGP62221 (via O-demethylation) and CGP52421 (via hydroxylation), accounting for 27.7±2.7% and 38.0±6.6%, respectively, of the total plasma exposure at 96 hours after a single 50 mg dose of midostaurin.
Rydapt indeholder: - Aktivt stof: midostaurin. 
What Rydapt contains - The active substance is midostaurin.
På grund af risikoen for alvorlige bivirkninger af Rydapt hos ammede spædbørn bør kvinder stoppe med at amme under behandling med Rydapt og i mindst 4 måneder efter behandlingsophør (se pkt. 
Because of the potential for serious adverse reactions in breast-feeding infants from Rydapt, women should discontinue breast-feeding during treatment with Rydapt and for at least 4 months after stopping treatment (see section 4.6).
Det understøttende studie var et ublindet fase II-multicenterstudie med en enkelt arm, der omfattede 26 patienter med ASM, SM-AHN og mastcelleleukæmi (CPKC412A2213). 
The supportive study was a single-arm, multicentre, open-label phase II study of 26 patients with ASM, SM-AHN and MCL (CPKC412A2213).
Hvis nogen af disse bivirkninger bliver alvorlige, skal du fortælle det til lægen eller apotekspersonalet. 
If any of these side effects become severe, tell your doctor or pharmacist.
9/l som tilskrives Rydapt hos patienter med en baseline ANC-værdi på 0,5-1,5 x 10 
9/l attributed to Rydapt in patients with baseline ANC value of 0.5-1.5 x 10
Lys orange, aflang kapsel påtrykt “PKC NVR” i rødt. 
Pale orange, oblong capsule with red imprint “PKC NVR”.
Der blev ikke observeret nogen forskel i CHF mellem armene med Rydapt + kemoterapi og placebo + kemoterapi i det randomiserede AML-studie. 
In the randomised AML study no difference in CHF was observed between the Rydapt + chemotherapy and placebo + chemotherapy arms.
De observerede bivirkninger var diarré, mavesmerter og opkastning. 
Adverse reactions observed were diarrhoea, abdominal pain and vomiting.
Bivirkninger som forekom oftere i midostaurin-armen kontra placebo i vedligeholdelsesfasen inkluderede: kvalme (46,4 % versus 17,9 %), hyperglykæmi (20,2 % versus 12,5 %), opkastning (19 % versus 5,4 %) og QT-forlængelse (11,9 % versus 5,4 %). 
ADRs occurring more often in the midostaurin arm versus placebo during maintenance included: nausea (46.4% versus 17.9%), hyperglycaemia (20.2% versus 12.5%), vomiting (19% versus 5.4%) and QT prolongation (11.9% versus 5.4%).
Nogle bivirkninger hos patienter med ASM, SM-AHN og mastcelleleukæmi kan være alvorlige. 
Some side effects in patients with ASM, SM-AHN and MCL could be serious.
Der kunne ikke identificeres nogen indvirkning af nedsat leverfunktion hos patienter med let eller moderat nedsat leverfunktion hos populationen med ASM, SM-AHN, mastcelleleukæmi og AML. 
No impact of hepatic impairment could be identified in patients with mild or moderate hepatic impairment in the ASM, SM-AHN, MCL and AML populations.
Den sædvanlige daglige dosis er 50 mg (2 kapsler) to gange daglig. 
The usual daily dose is 50 mg (2 capsules) twice daily.
Median EFS i måneder i betragtning af CR'er på et hvilket som helst tidspunkt under induktion (95 % CI) 
Median EFS in months, considering CRs any time during induction (95% CI)
Der blev påvist en statistisk signifikant forbedring i EFS for midostaurin plus standardkemoterapi sammenlignet med placebo plus standardkemoterapi (HR: 0,78 [95 % Cl, 0,66 til 0,93] p = 0,0024) og en median EFS på henholdsvis 8,2 måneder og 3,0 måneder; se tabel 5. 
The EFS showed a statistically significant improvement for midostaurin plus standard chemotherapy over placebo plus standard chemotherapy (HR: 0.78 [95% CI, 0.66 to 0.93] p = 0.0024), and a median EFS of 8.2 months and 3.0 months, respectively; see Table 5.
Så meget Rydapt skal du tage 
How much Rydapt to take
Effekt og sikkerhed hos patienter i alderen 60-70 år blev undersøgt i et fase-II-, enkeltarmet studie, initieret af investigator, af midostaurin kombineret med intensiv induktion, konsolidering inklusive allogen SCT og vedligeholdelse med enkeltstof, hos patienter med FLT3-ITD-muteret AML. 
Efficacy and safety in patients 60-70 years old were evaluated in a phase II, single- arm, investigator- initiated study of midostaurin in combination with intensive induction, consolidation including allogenic SCT and single-agent maintenance in patients with FLT3-ITD mutated AML.
Rydapt anvendes også hos voksne til behandling af aggressiv systemisk mastocytose (ASM), systemisk mastocytose i kombination med hæmatologisk neoplasma (SM-AHN), eller mastcelleleukæmi (MCL). 
Rydapt is also used in adults to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
I et studie af præ- og postnatal udvikling blev maternel dystoci og reduceret kuldstørrelse, lavere legemsvægt, accelereret komplet øjenåbning og forsinket startle-refleks på pludselige, skarpe lyde i ontogenesen bemærket. 
In a pre- and post-natal developmental study, maternal dystocia and reduced litter size, lower pup body weights, accelerated complete eye opening and delayed auricular startle ontogeny were noted.
Potente CYP3A4-induktorer nedsætter eksponeringen for midostaurin og dets aktive metabolitter (CGP52421 og CGP62221). 
Strong CYP3A4 inducers decrease exposure of midostaurin and its active metabolites (CGP52421 and CGP62221).
- hvis du har eller oplever smerter eller ubehag i brystkassen, ørhed, besvimelse, svimmelhed, blåfarvning af læber, hænder eller fødder, åndenød eller hævelse af ben (ødem) eller hud, da disse kan være tegn på hjerteproblemer. 
- if you have or experience chest pain or discomfort, light-headedness, fainting, dizziness, blue discolouration of your lips, hands or feet, shortness of breath, or swelling of your lower limbs (oedema) or skin, because these may be signs of heart problems.
Induktion af cytochrom P450 
Cytochrome P450 induction
Fortæl din læge eller apotekspersonalet, hvis du tager nogle af følgende lægemidler: - visse lægemidler til behandling af infektioner, fx ketoconazol eller clarithromycin; - visse lægemidler til behandling af HIV, fx ritonavir eller efavirenz; - nefazadon, et lægemiddel til behandling af depression; - visse lægemidler, der anvendes til at forebygge, at kroppen afstøder transplanterede organer, fx tacrolimus; - visse lægemidler til behandling af kræft, fx paclitaxel eller cyclophosphamid; - visse lægemidler, der anvendes til at kontrollere fedtindholdet i dit blod, fx atorvastatin; - digoxin, et lægemiddel til behandling af hjertesvigt; - warfarin, et lægemiddel, der anvendes til at behandle og forebygge blodpropper; - tizanidine, et lægemiddel, der anvendes til at få musklerne til at slappe af; - kodein, et lægemiddel, der anvendes til behandling af smerter; - omeprazol, et lægemiddel, der anvendes til behandling af for meget mavesyre, mavesår og halsbrand; - chlorzoxazon, et lægemiddel, der anvendes til behandling af ubehag forårsaget af muskelkramper. 
Tell your doctor or pharmacist if you are taking any of the following medicines: - some medicines used to treat infections, such as ketoconazole or clarithromycin; - some medicines used to treat HIV, such as ritonavir or efavirenz; - nefazadone, a medicine used to treat depression; - some medicines used to stop the body from rejecting organ transplants, such as tacrolimus; - some medicines used to treat cancer, such as paclitaxel or cyclophosphamide; - some medicines used to control levels of fat in your blood, such as atorvastatin; - digoxin, a medicine used to treat heart failure; - warfarin, a medicine used to treat and prevent thrombosis; - tizanidine, a medicine used to relax muscles; - codeine, a medicine used to treat pain; - omeprazole, a medicine to treat excessive stomach acid, ulcers and heartburn; - chlorzoxazone, a medicine used for treating discomfort caused by muscle spasms.
Der forekom alvorlige bivirkninger i tilsvarende hyppigheder hos patienterne i Rydapt-armen versus placebo-armen. 
Serious ADRs occurred at similar rates in patients in the Rydapt versus the placebo arm.
• som monoterapi til behandling af voksne patienter med aggressiv systemisk mastocytose (ASM), systemisk mastocytose associeret med hæmatologisk neoplasi (SM-AHN) eller mastcelleleukæmi (MCL). 
• as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
Ved baseline havde 65 % af patienterne i primær effektpopulationen >1 målbare C-fund (trombocytopeni, hypoalbuminæmi, anæmi, højt totalbilirubinniveau, transfusionsafhængig anæmi, vægttab, neutropeni, højt ALAT-niveau eller højt ASATniveau). 
Approximately one third (36%) received prior anti-neoplastic therapy for ASM, SM-AHN or MCL.At baseline in the primary efficacy population, 65% of the patients had >1 measurable C finding (thrombocytopenia, hypoalbuminaemia, anaemia, high total bilirubin, transfusion-dependent anaemia, weight loss, neutropenia, high ALT or high AST).
De hyppigste hæmatologiske anomalier af grad 3/4 rapporteret hos patienter i vedligeholdelsesfasen med Rydapt var fald i ANC (20,8 % versus 18,8 %) og leukopeni (7,5 % versus 5,9 %). 
The most frequent Grade 3/4 haematological abnormalities reported in patients during the maintenance phase with Rydapt were ANC decrease (20.8% versus 18.8%) and leukopenia (7.5% versus 5.9%).
9/l, og genoptag herefter med 50 mg to gange daglig. 
9/l, then resume at 50 mg twice daily.
9/l som tilskrives Rydapt hos patienter med trombocyttal ved baseline på 25-75 x 10 
9/l attributed to Rydapt in patients with baseline platelet count of 25-75 x 10
Psykiske forstyrrelser Insomni 
Psychiatric disorders Insomnia
Hver blød kapsel indeholder 25 mg midostaurin. 
Each soft capsule contains 25 mg midostaurin.
Giv ikke Rydapt i løbet af den næste cyklus, hvis QTc-intervallet ikke er forbedret i tide til at starte behandling i denne cyklus. 
If QTc interval is not improved in time to start the next cycle do not administer Rydapt during that cycle.
Samtidig administration af potente CYP3A4-induktorer, fx rifampicin, prikbladet perikon (Hypericum perforatum), carbamazepin, enzalutamid, phenytoin (se pkt. 
Concomitant administration of potent CYP3A4 inducers, e.g. rifampicin, St. John's Wort (Hypericum perforatum), carbamazepine, enzalutamide, phenytoin (see section 4.5).
Samlet overlevelse (OS) Median OS i måneder (95 % CI) 
Overall Survival (OS) Median OS in months (95% CI)
Tabel 4 viser hyppighedskategorien af bivirkninger baseret på sammenlagte data fra to studier hos patienter med ASM, SM-AHN og mastcelleleukæmi. 
Table 4 presents the frequency category of ADRs based on pooled data from two studies in patients with ASM, SM-AHN and MCL.
Rydapt + kemo n=345 
Rydapt + chemo n=345
Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion. 
No dose adjustment is required for patients with mild or moderate renal impairment.
Hvis neutropeni (ANC <1,0 x 10 
If neutropenia (ANC <1.0 x 10
Kvalme, opkastning og diarré blev observeret hos patienter med AML, ASM, SM-AHN og mastcelleleukæmi. 
Nausea, vomiting and diarrhoea were observed in AML, ASM, SM-AHN and MCL patients.
Andre bivirkninger omfatter dem, der er anført nedenfor. 
Other possible side effects in patients with AML Other side effects include those listed below.
Kapslerne bør tages sammen med mad (se pkt. 
The capsules should be taken with food (see sections 4.5 and 5.2).
Afbryd doseringen af Rydapt indtil ANC ≥1,0 x 10 
Interrupt Rydapt until ANC ≥1.0 x 10
Dyrestudier med midostaurin har vist nedsat fertilitet (se pkt. 
Animal studies with midostaurin have shown impaired fertility (see section 5.3).
Den hyppigste alvorlige bivirkning i begge behandlingsarme var febril neutropeni 
The most frequent serious ADR in both arms was febrile neutropenia (16%).
Fald i absolut lymfocyttal* 
Absolute lymphocyte decreased*
Hæmning af cytochrom P450 
Cytochrome P450 inhibition
Lægemidler med smalt terapeutisk interval, der er substrater af CYP1A2 (fx tizanidin), CYP2D6 (fx kodein), CYP2C8 (fx paclitaxel), CYP2C9 (fx warfarin), CYP2C19 (fx omeprazol), CYP2E1 (fx chlorzoxazon), CYP3A4/5 (fx tacrolimus), CYP2B6 (fx efavirenz), P-Gp (fx paclitaxel), BCRP (fx atorvastatin) eller OATP1B1 (fx digoxin) skal anvendes med forsigtighed, når de administreres samtidigt med midostaurin. 
Medicinal products with a narrow therapeutic range that are substrates of CYP1A2 (e.g. tizanidine), CYP2D6 (e.g. codeine), CYP2C8 (e.g. paclitaxel), CYP2C9 (e.g. warfarin), CYP2C19 (e.g. omeprazole), CYP2E1 (e.g. chlorzoxazone), CYP3A4/5 (e.g. tacrolimus), CYP2B6 (e.g. efavirenz), P-gp (e.g. paclitaxel), BCRP (e.g. atorvastatin) or OATP1B1 (e.g. digoxin) should be used with caution when administered concomitantly with midostaurin and may need dose adjustment to maintain optimal exposure (see section 5.2).
Hypercalcæmi* 
Hypercalcaemia*
Rydapt 25 mg bløde kapsler er lys orange, aflange kapsler påtrykt “PKC NVR” med rødt. 
What Rydapt looks like and contents of the pack Rydapt 25 mg soft capsules are pale orange, oblong capsules with red imprint “PKC NVR”.
9/l som tilskrives Rydapt hos patienter uden mastcelleleukæmi, eller ANC på under 0,5 x 10 
9/l attributed to Rydapt in patients without MCL, or ANC less than 0.5 x 10
De hyppigste bivirkninger af grad 3/4 var træthed (8,5 %), sepsis (7,7 %), pneumoni (7 %), febril neutropeni (7 %) og diarré (6,3 %). 
The most frequent Grade 3/4 ADRs were fatigue (8.5%), sepsis (7.7%), pneumonia (7%), febrile neutropenia (7%), and diarrhoea (6.3%).
Der skal udvises forsigtighed, når det overvejes, om midostaurin skal administreres til patienter med alvorlig nedsat leverfunktion, og patienterne bør overvåges nøje for tegn på toksicitet (se pkt. 
Caution is warranted when considering the administration of midostaurin in patients with severe hepatic impairment and patients should be carefully monitored for toxicity (see section 5.2).
De hyppigste ikke-hæmatologiske laboratorieanomalier var hyperglykæmi (93,7 %), forhøjet totalbilirubin-niveau (40,1 %), forhøjet lipase-niveau (39,4 %), forhøjet aspartataminotransferase (ASAT)-niveau (33,8 %) og forhøjet alaninaminotransferase (ALAT)-niveau (33,1 %), mens den hyppigste hæmatologiske laboratorieanomali var fald i absolut lymfocyttal (73,2 %) og fald i ANC (58,5 %). 
The most frequent non-haematological laboratory abnormalities were hyperglycaemia (93.7%), total bilirubin increased (40.1%), lipase increased (39.4%), aspartate aminotransferase (AST) increased (33.8%), and alanine aminotransferase (ALT) increased (33.1%), while the most frequent haematological laboratory abnormalities were absolute lymphocyte count decreased (73.2%) and ANC decreased (58.5%).
Amning bør stoppe under behandling med Rydapt og i mindst 4 måneder efter behandlingsophør. 
Breast-feeding should be discontinued during treatment with Rydapt and for at least 4 months after stopping treatment.
Det skal være bekræftet ved brug af en valideret test, at AML-patienter har en FLT3-mutation (intern tandemduplikation [ITD] eller tyrosinkinasedomæne [TKD]), inden patienten begynder at tage midostaurin. 
Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.
Generelt viste midostaurin og dets metabolitter ingen større afvigelse fra dosisproportionalitet efter en enkelt dosis i intervallet 25 mg til 100 mg. Der var imidlertid en mindre end dosisproportional øgning i eksponering efter flere doser inden for dosisintervallet 50 mg til 225 mg daglig. 
In general, midostaurin and its metabolites showed no major deviation from dose-proportionality after a single dose in the range of 25 mg to 100 mg.
48 % af patienterne i midostaurinarmen og 41 % i placeboarmen var mænd. 
Forty-eight per cent were male in the midostaurin arm and 41% in the placebo arm.
26,8 (17,6, 34,7) 51,1 (28,7, NE) 20,7 (16,3, 33,9) 9,4 (7,5, NE) 
26.8 (17.6, 34.7) 51.1 (28.7, NE) 20.7 (16.3, 33.9)
Antal patienter fortsat i risiko 
Patients at risk
CGP62221 Cmin,ss i populationen af AML- og ASM-, SM-AHN-, mastcelleleukæmi var henholdsvis 1610 ng/ml og 2020 ng/ml. 
The CGP62221 Cmin, ss in the AML and the ASM, SM-AHN, MCL population were 1610 ng/ml and 2020 ng/ml, respectively.
I et studie med 36 raske forsøgspersoner førte samtidig administration af den potente CYP3A4-hæmmer ketoconazol indtil steady state samt en enkelt dosis midostaurin på 50 mg til en signifikant øgning i eksponeringen for midostaurin (stigning til 1,8 gange Cmax og 10 gange AUCinf) og 3,5 gange stigning i AUCinf for CGP62221, mens Cmax af de aktive metabolitter (CGP62221 og CGP52421) blev halveret (se pkt. 
In a study with 36 healthy subjects, co-administration of the strong CYP3A4 inhibitor ketoconazole to steady state with a single dose of 50 mg midostaurin led to a significant increase in midostaurin exposure (1.8-fold Cmax increase and 10-fold AUCinf increase) and 3.5-fold increase in AUCinf of CGP62221, while the Cmax of the active metabolites (CGP62221 and CGP52421) decreased by half (see section 5.2).
Tabel 4 Bivirkninger observeret i de kliniske studier af ASM, SM-AHN og mastcelleleukæmi 
Table 4 Adverse drug reactions observed in the ASM, SM-AHN and MCL clinical studies
Undersøgelser Fald i hæmoglobin-niveau* 
Investigations Haemoglobin decreased*
Tabel 2 Anbefalinger til doseringsafbrydelse, reduktion og seponering af Rydapt hos patienter med ASM, SM-AHN eller mastcelleleukæmi 
Table 2 Rydapt dose interruption, reduction and discontinuation recommendations in patients with ASM, SM-AHN or MCL
Titandioxid (E 171) Jernoxid, gul (E 172) Jernoxid, rød (E 172) Vand, renset 
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Purified water
Embryoføtal toksicitet og amning 
Embryofoetal toxicity and breast-feeding
Transportør-lægemiddel-lægemiddel-interaktioner In vitro-eksperimenter viste, at midostaurin, CGP52421 og CPG62221 potentielt kan hæmme P-gp, BCRP, OATP1B1 og BSEP. 
In vitro experiments demonstrated that midostaurin, CGP52421 and CPG62221 can potentially inhibit P-gp, BCRP, OATP1B1 and BSEP.
- Hvis du bliver behandlet for AML, vil du få Rydapt alene i op til 12 måneder efter det tidspunkt, 
you will receive Rydapt alone for up to 12 months.
Tilsvarende steg AUC for CGP52421 og CGP62221 til 19000 og 29200 ng*t/ml, og Cmax faldt til henholdsvis 172 og 455 ng/ml. 
Similarly, for CGP52421 and CGP62221 AUC increased to 19000 and 29200 ng*h/ml and Cmax decreased to 172 and 455 ng/ml, respectively.
Efter administration af en enkelt dosis på 50 mg midostaurin sammen med mad hos raske forsøgspersoner, blev AUC af midostaurin øget til 20800 ng*t/ml og Cmax blev nedsat til 963 ng/ml (se pkt. 
In healthy subjects, after administration of a single dose of 50 mg midostaurin with food, AUC of midostaurin was increased to 20800 ng*h/ml and Cmax was decreased to 963 ng/ml (see section 4.5).
Svær neutropeni (ANC <0,5 x 10 
Severe neutropenia (ANC <0.5 x 10
Infektioner og parasitære sygdomme Urinvejsinfektion 
Infections and infestations Urinary tract infection
Median-samlet overlevelse, måneder (95 % CI) 
Median overall survival, months (95% CI)
Rydapt indeholder ricinusolie, polyoxyleret, hydrogeneret, hvilket kan give mavebesvær og diarré. 
Rydapt contains macrogolglycerol hydroxystearate, which may cause stomach discomfort and diarrhoea.
AUC0-12t og Cmax for CGP62221 var henholdsvis 8700 ng*t/ml og 931 ng/ml. 
AUC0-12h and Cmax for CGP62221 were 8700 ng*h/ml and 931 ng/ml, respectively.
Ricinusolie, polyoxyleret, hydrogeneret Macrogol 
Macrogolglycerol hydroxystearate Macrogol
PAES: For at undersøge effekten hos ældre patienter, skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne af et randomiseret, dobbeltblindet studie, E2301, af midostaurin versus placebo i kombination med kemoterapi under induktion og konsolidering, efterfulgt af 12 måneders midostaurin monoterapi hos voksne patienter (≥18 år) med nydiagnosticeret AML uden FL3-mutation. 
PAES: In order to investigate the efficacy in elderly patients, the MAH should conduct and submit the results of a randomised, double-blind E2301 study of midostaurin versus placebo in combination with chemotherapy during induction and consolidation, followed by 12 months of midostaurin monotherapy in adult patients (aged ≥18 years) with newly diagnosed AML, without FLT3 mutation.
Hazard ratio (HR) estimeret ved brug af Cox' regressionsmodel stratificeret i henhold til FLT3-mutationrandomiseringsfaktoren. 
2key secondary endpoint; NE: Not Estimated Hazard ratio (HR) estimated using Cox regression model stratified according to the randomisation FLT3 mutation factor.
CGP52421, Cmin,ss i populationen af AML- og ASM-, SM-AHN-, mastcelleleukæmi var henholdsvis 8630 ng/ml og 2860 ng/ml. 
The CGP52421, Cmin,ss in the AML and the ASM, SM-AHN, MCL population were 8630 ng/ml and 2860 ng/ml, respectively.