natgillin/translations-raw huggingface dataset:
ADRs reported during the maintenance phase led to discontinuation of 1.2% of patients in the Rydapt arm and none in the placebo arm. 
Nuspojave zabilježene tijekom faze održavanja dovele su do obustave terapije u 1,2% bolesnika u Rydapt skupini i kod nijednog u placebo skupini.
A 100 mg dose of Rydapt contains approximately 14 vol. % ethanol anhydrous, which corresponds to 333 mg alcohol. 
Doza Rydapta od 100 mg sadrži otprilike 14 vol. % bezvodnog etanola, što odgovara 333 mg alkohola.
Oral herpes 
Oralni herpes često
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%). 
Medijan dobi bolesnika bio je 47 godina (raspon: 18 do 60 godina), većina bolesnika imala je funkcionalni status po ECOG-u od 0 ili 1 (88,3%) i većina je bolesnika imala de novo AML (95%).
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. 
Stoga se promjena QTcF-a od početne vrijednosti s koncentracijama midostaurina i oba metabolita dalje istraživala u ispitivanju faze II u 116 bolesnika s ASM-om, SM-AHN-om ili MCL-om.
Rydapt should be discontinued in patients who develop recurrent or prolonged severe neutropenia that is suspected to be related to Rydapt (see section 4.2). 
Primjenu Rydapta treba obustaviti u bolesnika u kojih se razvije rekurentna ili produljena teška neutropenija za koju se sumnja da je povezana s Rydaptom (vidjeti dio 4.2).
No midostaurin dose adjustment is required based on gender. 
Nije potrebna prilagodba doze midostaurina na temelju spola.
Embryofoetal toxicity and breast-feeding 
Embriofetalna toksičnost i dojenje
Hypokalaemia* 
Hipokalijemija*
ANC <1.0 x 10 
ABN < 1,0 x 10
While the study included patients with various AML-related cytogenetic abnormalities, patients with acute promyelocytic leukaemia (M3) or therapy-related AML were excluded. 
Iako je ispitivanje uključivalo bolesnike s različitim citogenetskim abnormalnostima povezanima s AML-om, bolesnici s akutnom promijelocitnom leukemijom (M3) ili AML-om povezanim s terapijom bili su isključeni.
Midostaurin interferes with aberrant KIT D816V-mediated signalling and inhibits mast cell proliferation, survival and histamine release. 
Midostaurin interferira s aberantnim signaliziranjem posredovanim KIT D816V i inhibira proliferaciju mastocita, preživljenje i otpuštanje histamina.
Investigations Hyperglycaemia (non-fasting)* 
Pretrage Hiperglikemija (ne natašte)*
Two of its metabolites demonstrated pharmacological activities (CGP52421 and CGP62221). 
Dva od njegovih metabolita pokazali su farmakološke aktivnosti (CGP52421 i CGP62221).
(8.3, NE) 
(8,3; NP)
9/l attributed to 
9/l koji se pripisuje
If you have any questions about how long to take Rydapt, talk to your doctor or pharmacist. 
Ako imate bilo kakvih pitanja o tome koliko dugo uzimati Rydapt, obratite se svom liječniku ili ljekarniku.
Patients at risk 
Bolesnici izloženi riziku
Adverse reactions observed were diarrhoea, abdominal pain and vomiting. 
Opažene nuspojave bile su proljev, bol u abdomenu i povraćanje.
In adult patients with ASM, SM-AHN and MCL or AML, no midostaurin dose adjustment is required based on age. 
U odraslih bolesnika s ASM-om, SM-AHN-om i MCL-om ili AML-om nije potrebna prilagodba doze na temelju dobi.
Decrease Rydapt to 50 mg once daily for the remainder of the cycle. 
Smanjiti dozu Rydapta na 50 mg jedanput na dan do kraja ciklusa.
In the repeat-dose studies, target organs for toxicity were the gastrointestinal tract (emesis in dogs and monkeys, diarrhoea and mucosal alteration), testes (decreased spermatogenesis), bone marrow (hypocellularity) and lymphoid organs (depletion/atrophy). 
U ispitivanjima ponovljenih doza, ciljani organi za toksičnost bili su probavni sustav (emeza kod pasa i majmuna, proljev i promjena sluznica), testisi (smanjena spermatogeneza), koštana srž (hipocelularnost) i limfoidni organi (deplecija/atrofija).
EFS (CR induction) (HR) 
EFS (indukcija CR-a) (HR)
In vivo studies have not been conducted for the investigation of induction and inhibition of enzymes and transporters by midostaurin and the active metabolites. 
Nisu provođena in vivo ispitivanja da bi se istražilo kako midostaurin i aktivni metaboliti induciraju i inhibiraju enzime i transportere.
CR induction (OR) 
Indukcija CR-a (OR)
Neutropenia has occurred in patients receiving Rydapt as monotherapy and in combination with chemotherapy (see section 4.8). 
U bolesnika koji su primali Rydapt kao monoterapiju i u kombinaciji s kemoterapijom pojavila se neutropenija (vidjeti dio 4.8).
Based on the population pharmacokinetic analyses, midostaurin clearance was not significantly impacted by renal impairment and therefore no dosage adjustment is necessary for patients with mild or moderate renal impairment. 
Na temelju populacijskih farmakokinetičkih analiza, oštećenje bubrega nije značajno utjecalo na klirens midostaurina, pa stoga nije potrebna prilagodba doze za bolesnike s blagim ili umjerenim oštećenjem bubrega.
Otherwise continue Rydapt 50 mg once daily. 
U suprotnom, nastaviti primjenu Rydapta 50 mg jedanput na dan.
Patients who proceeded to haematopoietic stem cell transplant (SCT) stopped receiving study treatment prior to the start of the SCT conditioning regimen. 
Bolesnici koji su se podvrgnuli transplantaciji krvotvornih matičnih stanica (TMS) prestali su primati ispitivanu terapiju prije početka režima kondicioniranja za TMS.
Midostaurin is not an inhibitor of CYP3A4 in vivo. 
Midostaurin nije CYP3A4 inhibitor in vivo.
In addition, a time-dependent inhibition of CYP3A4 by midostaurin, CGP52421 and CGP62221 was also observed in vitro. 
Uz to, vremenski ovisna inhibicija CYP3A4 midostaurinom, CGP52421 i CGP62221 također je bila opažena in vitro.
In vitro experiments demonstrated that midostaurin, CGP52421 and CPG62221 can potentially inhibit P-gp, BCRP, OATP1B1 and BSEP. 
In vitro eksperimenti pokazali su da midostaurin, CGP52421 i CPG62221 potencijalno mogu inhibirati P-gp, BCRP, OATP1B1 i BSEP.
Platelet count less than 50 x 10 
Broj trombocita ispod 50 x 10
Caution is required when concomitantly prescribing with midostaurin medicinal products that are strong inhibitors of CYP3A4, such as, but not limited to, antifungals (e.g. ketoconazole), certain antivirals (e.g. ritonavir), macrolide antibiotics (e.g. clarithromycin) and nefazodone because they can increase the plasma concentrations of midostaurin especially when (re-)starting with midostaurin treatment (see section 4.5). 
Potreban je oprez kad se midostaurin propisuje istodobno s lijekovima koji su snažni CYP3A4 inhibitori, kao što su, između ostalih, antifungici (npr. ketokonazol), određeni antivirusni lijekovi (npr. ritonavir), makrolidni antibiotici (npr. klaritromicin) i nefazodon zato što oni mogu povećati koncentracije midostaurina u plazmi, osobito kad se (ponovno) počinje liječenje midostaurinom (vidjeti dio 4.5).
The effect on the bone marrow and lymphoid organs was accompanied by haematological changes of decreased white blood cells, lymphocytes and erythrocytic parameters. 
Učinak na koštanu srž i limfoidne organe bio je popraćen hematološkim promjenama, tj. sniženim bijelim krvnim stanicama, limfocitima i eritrocitnim parametrima.
Contains macrogolglycerol hydroxystearate and ethanol anhydrous. 
Sadrži makrogolglicerolhidroksistearat i bezvodni etanol.
The most frequent Grade 3/4 adverse reaction leading to discontinuation in the Rydapt arm was exfoliative dermatitis (1.2%). 
Najučestalija nuspojava 3./4. stupnja koja je dovela do obustave terapije u Rydapt skupini bio je eksfolijativni dermatitis (1,2%).
CGP52421 concentrations do not appear to decline as significantly as for midostaurin and CGP62221. 
Čini se da koncentracije CGP52421 ne opadaju onoliko značajno kao kod midostaurina i CGP62221.
9/l) was generally reversible by withholding Rydapt until recovery and discontinuation in the ASM, SM-AHN and MCL studies. 
9/l) općenito je bila reverzibilna uslijed uskraćivanja Rydapta do oporavka te obustave primjene u ispitivanjima ASM-a, SM-AHN-a i MCL-a.
Rydapt is indicated: 
Rydapt je indiciran:
The safety evaluation of Rydapt (50 mg twice daily) in patients with newly diagnosed FLT3-mutated AML is based on a phase III, randomised, double-blind, placebo-controlled study with 717 patients. 
Ocjena sigurnosti primjene Rydapta (50 mg dvaput na dan) u bolesnika s novodijagnosticiranim AML-om s FLT3 mutacijom temelji se na randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III sa 717 bolesnika.
Interrupt Rydapt until platelet count greater than or equal to 50 x 10 
Prekinuti primjenu Rydapta dok broj trombocita ne bude veći od ili jednak 50 x 10
The pivotal study was a multicentre, single-arm phase II study in 116 patients with advanced SM (Study CPKC412D2201). 
Ključno ispitivanje bilo je multicentrično ispitivanje faze II s jednom skupinom u 116 bolesnika s uznapredovalim SM-om (ispitivanje CPKC412D2201).
The most frequent (incidence ≥1%) were febrile neutropenia, nausea, vomiting and pleural effusion. 
Najučestalije (incidencija ≥ 1%) bile su febrilna neutropenija, mučnina, povraćanje i pleuralni izljev.
- The other ingredients are: macrogolglycerol hydroxystearate, gelatin, macrogol, glycerol, ethanol anhydrous, maize oil mono-di-triglycerides, titanium dioxide (E171), all-rac-alpha-tocopherol, iron oxide yellow (E172), iron oxide red (E172), carmine (E120), hypromellose, propylene glycol, purified water. 
- Drugi sastojci su: makrogolglicerolhidroksistearat, želatina, makrogol, glicerol, bezvodni etanol, mono-, di- i trigliceridi kukuruznog ulja, titanijev dioksid (E171), sav-rac-alfa-tokoferol, željezov oksid žuti (E172), željezov oksid crveni (E172), boja karmin (E120), hipromeloza, propilenglikol, pročišćena voda.
Following multiple doses, the pharmacokinetics of midostaurin and CGP62221 were time-dependent, with an initial increase observed in the first week followed by a decline of concentrations until reaching steady state on day 28. 
Nakon višestrukih doza, farmakokinetika midostaurina i CGP62221 bila je ovisna o vremenu, s početnim povišenjem opaženim u prvom tjednu, nakon čega je uslijedilo smanjenje koncentracija do postizanja stanja dinamičke ravnoteže 28. dana.
Strong CYP3A4 inducers decrease exposure of midostaurin and its active metabolites (CGP52421 and CGP62221). 
Snažni CYP3A4 induktori smanjuju izloženost midostaurinu i njegovim aktivnim metabolitima (CGP52421 i CGP62221).
Table 7 Efficacy of midostaurin in ASM, SM-AHN and MCL: primary efficacy population 
Tablica 7 Djelotvornost midostaurina kod ASM-a, SM-AHN-a i MCL-a: populacija za utvrđivanje primarne djelotvornosti
A dedicated QT study in 192 healthy subjects with a dose of 75 mg twice daily did not reveal clinically significant prolongation of QT by midostaurin and CGP62221 but the study duration was not long enough to estimate the QTc prolongation effects of the long-acting metabolite CGP52421. 
Posebno ispitivanje QT intervala u 192 zdrava ispitanika s dozom od 75 mg dvaput na dan nije otkrilo klinički značajno produljenje QT intervala midostaurinom i CGP62221, ali ispitivanje nije trajalo dovoljno dugo da bi se procijenili učinci dugodjelujućeg metabolita CGP52421na produljenje QTc intervala.
Treatment with Rydapt should be initiated by a physician experienced in the use of anti-cancer therapies. 
Liječenje Rydaptom treba započeti liječnik s iskustvom primjene onkološke terapije.
The pharmacokinetics of midostaurin in paediatric patients were explored in a phase I dose escalation monotherapy study with 22 patients (12 aged 0-2 years and 10 aged 10-17 years) with AML or MLL-rearranged ALL using a population pharmacokinetic approach. 
Farmakokinetika midostaurina u pedijatrijskih bolesnika istraživala se u ispitivanju faze I u kojem se ispitivalo povišenje doze u monoterapiji kod 22 bolesnika (12 u dobi od 0 do 2 godine i 10 u dobi od 10 do 17 godina) s AML-om ili ALL-om s preustrojem MLL-a koristeći pristup populacijske farmakokinetike.
The usual daily dose is 100 mg (4 capsules) twice daily. 
Uobičajena dnevna doza je 100 mg (4 kapsule) dvaput na dan.
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). 
Pri medijanu vršnih Cmin koncentracija pri dozi od 100 mg dvaput na dan, ni midostaurin, CGP62221 ni CGP52421 nisu pokazali potencijal uzrokovanja klinički značajnog produljenja QTcF-a, budući da su gornje granice predviđene promjene pri tim razinama koncentracije bile manje od 10 msec (5,8; 2,4, odnosno 4,0 msec).
While the exact mechanism for the declining concentration of midostaurin is unclear, it is likely due to the auto-induction properties of midostaurin and its two active metabolite CGP52421 and CGP62221 on CYP3A4. 
Iako točan mehanizam opadanja koncentracije midostaurina nije jasan, vjerojatno je da je povezan s auto-indukcijskim svojstvima midostaurina i njegova dva aktivna metabolita CGP52421 i CGP62221 na CYP3A4.
What Rydapt contains - The active substance is midostaurin. 
Što Rydapt sadrži - Djelatna tvar je midostaurin.
Following multiple oral doses, midostaurin displayed time-dependent pharmacokinetics with an initial increase in plasma concentrations during the first week (peak Cmin) followed by a decline with time to a steady-state after approximately 28 days (2.5-fold decrease). 
Nakon višestrukih peroralnih doza midostaurin je pokazao o vremenu ovisnu farmakokinetiku s početnim povišenjem koncentracija u plazmi tijekom prvog tjedna (vršni Cmin), nakon čega je uslijedio pad s vremenom do stanja dinamičke ravnoteže nakon otprilike 28 dana (smanjenje od 2,5 puta).
It is unknown whether midostaurin or its active metabolites are excreted in human milk. 
Nije poznato izlučuju li se midostaurin ili njegovi aktivni metaboliti u majčino mlijeko.
The efficacy of midostaurin in patients with ASM, SM-AHN and MCL, collectively referred to as advanced systemic mastocytosis (SM), was evaluated in two open-label, single-arm, multicentre studies (142 patients in total). 
Djelotvornost midostaurina u bolesnika s ASM-om, SM-AHN-om i MCL-om, koji se skupno nazivaju uznapredovala sistemska mastocitoza (SM), ocijenjena je u dva otvorena multicentrična ispitivanja s po jednom skupinom (ukupno 142 bolesnika).
There was a trend favouring midostaurin for CR rate by day 60 for the midostaurin arm (58.9% versus 53.5%; p = 0.073) that continued when considering all CRs during induction (65.0% versus 58.0%; p = 0.027). 
Postojao je trend u korist midostaurina za stopu CR-a do 60. dana za skupinu koja je primala midostaurin (58,9% u usporedbi s 53,5%; p = 0,073) koji se nastavio kada se uzmu u obzir svi CR-i tijekom indukcije (65,0% u odnosu na 58,0%; p = 0,027).
ASM, SM-AHN and MCL 
ASM, SM-AHN i MCL
For EFS, considering complete remissions within 60 days of study treatment start, the HR was 0.602 (95% CI: 0.372, 0.974) for patients with SCT and 0.827 (95% CI: 0.689, 0.993) for patients without SCT, favouring midostaurin. 
Za EFS, kada se u obzir uzmu potpune remisije unutar 60 dana od početka ispitivane terapije, HR je bio 0,602 (95% CI: 0,372; 0,974) za bolesnike s TMS-om i 0,827 (95% CI: 0,689; 0,993) za bolesnike bez TMS-a, što ide u prilog midostaurinu.
NR (3.6, NE) 
NO (3,6; NP)
The European Medicines Agency has waived the obligation to submit the results of studies with Rydapt in all subsets of the paediatric population in the treatment of malignant mastocytosis and mast cell leukaemia (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Rydapt u svim podskupinama pedijatrijske populacije u liječenju maligne mastocitoze i mastocitne leukemije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
AML The recommended dose of Rydapt is 50 mg orally twice daily. 
AML Preporučena doza Rydapta je 50 mg peroralno dvaput na dan.
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. 
Glavne komponente u plazmi uključivale su midostaurin i dva glavna aktivna metabolita, CGP62221 (putem O-demetilacije) odnosno CGP52421 (putem hidroksilacije), koji su odgovorni za 27,7±2,7% odnosno 38,0±6,6% ukupne izloženosti u plazmi 96 sati nakon jednokratne doze midostaurina od 50 mg.
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). 
Lijekovi s uskom terapijskom širinom koji su supstrati CYP1A2 (npr. tizanidin), CYP2D6 (npr. kodein), CYP2C8 (npr. paklitaksel), CYP2C9 (npr. varfarin), CYP2C19 (npr. omeprazol), CYP2E1 (npr. klorzoksazon), CYP3A4/5 (npr. takrolimus), CYP2B6 (npr. efavirenz), P-gp (npr. paklitaksel), BCRP (npr. atorvastatin) ili OATP1B1 (npr. digoksin) trebaju se koristiti oprezno kad se primjenjuju istodobno s midostaurinom, a možda će biti potrebna prilagodba doze da bi se održala optimalna izloženost (vidjeti dio 5.2).
Dose modifications in AML Recommendations for dose modifications of Rydapt in patients with AML are provided in Table 1. 
Prilagodbe doze kod AML-a Preporuke za prilagodbe doze Rydapta u bolesnika s AML-om navedene su u Tablici 1.
On day 7, AUCCtrough (exposure under the curve of Ctrough from day 1 to day 7) was 5410 ng*h/ml in healthy subjects and was decreased by 35% and 20% in subjects with mild and moderate hepatic impairment, respectively. 
Sedmog dana je AUCCnajniži (izloženost ispod krivulje Cnajniži od 1. do 7. dana) bio 5410 ng*h/ml u zdravih ispitanika te se smanjio za 35%, odnosno 20% u ispitanika s blagim, odnosno umjerenim oštećenjem jetre.
Overall survival probability, % 
Vjerojatnost OS-a, %
Midostaurin in combination with chemotherapeutic agents (cytarabine, doxorubicin, idarubicin and daunorubicin) resulted in synergistic growth inhibition in FLT3-ITD expressing AML cell lines. 
Midostaurin je u kombinaciji s kemoterapijskim lijekovima (citarabin, doksorubicin, idarubicin i daunorubicin) imao za posljedicu sinergističku inhibiciju rasta u AML staničnim linijama koje eksprimiraju FLT3-ITD.
MIDOSTAURIN - SCT PLACEBO - SCT MIDOSTAURIN - no SCT PLACEBO - no SCT 
MIDOSTAURIN - TMS PLACEBO - TMS MIDOSTAURIN - bez TMS-a PLACEBO - bez TMS-a
- 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. 
- ako imate ili osjetite bol ili nelagodu u grudima, ošamućenost, nesvjesticu, omaglicu, plavilo usana, šaka ili stopala, nedostatak zraka ili oticanje donjih ekstremiteta (edem) ili kože, zato što bi to mogli biti znakovi srčanih problema.
Rydapt contains macrogolglycerol hydroxystearate (castor oil) Rydapt contains macrogolglycerol hydroxystearate, which may cause stomach discomfort and diarrhoea. 
Rydapt sadrži makrogolglicerolhidroksistearat (ricinusovo ulje) Rydapt sadrži makrogolglicerolhidroksistearat, koji može uzrokovati nelagodu u želucu i proljev.
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. 
Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova: - neke lijekove koji se koriste za liječenje infekcija, kao što je ketokonazol ili klaritromicin; - neke lijekove koji se koriste za liječenje HIV-a, kao što je ritonavir ili efavirenz; - nefazodon, lijek koji se koristi za liječenje depresije; - neke lijekove koji se koriste da bi se spriječilo tijelo da odbaci presađene organe, kao što je takrolimus; - neke lijekove koji se koriste za liječenje raka, kao što je paklitaksel ili ciklofosfamid; - neke lijekove koji se koriste za kontroliranje razina masnoća u Vašoj krvi, kao što je atorvastatin; - digoksin, lijek koji se koristi za liječenje zatajenja srca; - varfarin, lijek koji se koristi za liječenje i sprječavanje tromboze; - tizanidin, lijek koji se koristi za opuštanje mišića; - kodein, lijek koji se koristi za liječenje boli; - omeprazol, lijek koji se koristi za liječenje prekomjerne kiseline u želucu, čira i žgaravice; - klorzoksazon, lijek koji se koristi za liječenje nelagode koju uzrokuju grčevi mišića.
Some side effects in patients with ASM, SM-AHN and MCL could be serious. 
Neke nuspojave u oboljelih od ASM-a, SM-AHN-a i MCL-a mogu biti ozbiljne.
• in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2); 
• u kombinaciji sa standardnom indukcijskom kemoterapijom daunorubicinom i citarabinom i konsolidacijskom kemoterapijom visokom dozom citarabina te za bolesnike s potpunim terapijskim odgovorom na te kombinacije nakon kojih se Rydapt koristi kao monoterapija održavanja, za odrasle bolesnike s novodijagnosticiranom akutnom mijeloičnom leukemijom (AML) koji su pozitivni na FLT3 mutaciju (vidjeti dio 4.2);
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). 
U zdravih ispitanika, nakon primjene jednokratne doze midostaurina od 50 mg s hranom, AUC midostaurina povećao se na 20 800 ng*h/ml, a Cmax se smanjio na 963 ng/ml (vidjeti dio 4.5).
The efficacy and safety of midostaurin in combination with standard chemotherapy versus placebo plus standard chemotherapy and as single agent maintenance therapy was investigated in 717 patients (18 to 60 years of age) in a randomised, double-blind, phase III study. 
Djelotvornost i sigurnost midostaurina u kombinaciji sa standardnom kemoterapijom u usporedbi s placebom plus standardna kemoterapija te kao monoterapija održavanja istraživane su na 717 bolesnika (u dobi od 18 do 60 godina) u randomiziranom, dvostruko slijepom ispitivanju faze III.
No study has been completed in patients with severe (Child-Pugh C) hepatic impairment (see section 4.4). 
Nije dovršeno nijedno ispitivanje u bolesnika s teškim (Child-Pugh C) oštećenjem jetre (vidjeti dio 4.4).
• 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). 
• kao monoterapija za liječenje odraslih bolesnika s agresivnom sistemskom mastocitozom (ASM), sistemskom mastocitozom s povezanom hematološkom neoplazmom (SM-AHN) ili mastocitnom leukemijom (MCL).