natgillin/translations-raw huggingface dataset:
Midostaurin blocks the action of some enzymes (kinases) in the abnormal cells and stops their division and growth. 
Midostaurin blokira djelovanje nekih enzima (kinaza) u poremećenim stanicama i zaustavlja njihovu diobu i rast.
Overall survival n/N (%) 
Ukupno preživljenje n/N (%)
Stable disease, n (%) Progressive disease, n 
Djelomični odgovor, n (%) Stabilna bolest, n (%) Progresivna bolest, n
Months Midostaurin Placebo 
Mjeseci Midostaurin Placebo
If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Rydapt. 
Ako uzimate bilo koji od ovih lijekova, liječnik će Vam možda propisati drugi lijek tijekom liječenja Rydaptom.
Talk to your doctor, pharmacist or nurse before taking Rydapt: - if you have any infections. 
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Rydapt: - ako imate bilo kakve infekcije. - ako imate srčani poremećaj.
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. 
Perzistentna toksičnost stupnja 1. ili 2. koju bolesnici smatraju neprihvatljivom može biti povod za prekid primjene sve do 28 dana.
9/l) persists >2 weeks and is suspected to be related to Rydapt, discontinue Rydapt. 
9/l) ustraje > 2 tjedna i sumnja se da je povezana s Rydaptom, obustaviti primjenu Rydapta.
Overall survival (months) 
Ukupno preživljenje (mjeseci)
In vitro data showed midostaurin is more than 98% bound to plasma proteins, such as albumin, α1-acid glycoprotein (AGP) and lipoprotein. 
In vitro podaci pokazali su da je midostaurin više od 98% vezan za proteine u plazmi, kao što je albumin, α1-kiseli glikoprotein (AGP) i lipoprotein.
- If you vomit after you swallow the capsules, do not take any more capsules until your next scheduled dose. 
- Ako povratite nakon što ste progutali kapsule, nemojte uzimati još kapsula do svoje sljedeće doze prema rasporedu.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE39 
Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE39
- Do not use this medicine after the expiry date which is stated on the carton and the blister foil after EXP. 
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i foliji blistera iza oznake EXP.
36.8 (5.5, NE) 
36,8 (5,5; NP)
Neutropenia and infections 
Neutropenija i infekcije
If QTc interval is not improved in time to start the next cycle do not administer Rydapt during that cycle. 
Ako se QTc interval ne poboljša na vrijeme za početak sljedećeg ciklusa, ne primjenjivati Rydapt tijekom tog ciklusa.
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). 
In vitro podaci ukazuju na to da se KIT receptori divljeg tipa inhibiraju u puno manjoj mjeri pri tim koncentracijama (prosječna postignuta izloženost niža od IC50).
In vitro and in vivo genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of mutagenic or clastogenic activity. 
In vitro i in vivo ispitivanja genotoksičnosti koja su obuhvaćala značajne mjere ishoda genotoksičnosti nisu pokazala nikakve dokaze mutagene ili klastogene aktivnosti.
Midostaurin can cause foetal harm when administered to a pregnant woman. 
Midostaurin može naškoditi fetusu kada se primjenjuje u trudnica.
There are no differences in the pharmacokinetic profile between Caucasian and Black subjects. 
Nema razlika o farmakokinetičkom profilu između ispitanika bijele i crne rase.
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). 
Ključna mjera sekundarnog ishoda bila je preživljenje bez događaja (EFS, engl. event-free survival; događaj EFS-a definira se kao neuspjeh postizanja potpune remisije (CR, engl. complete remission) u roku od 60 dana od početka terapije prema planu ispitivanja, ili relaps, ili smrt bilo kojeg uzroka).
In addition, in patients who achieved complete remission during induction, the cumulative incidence of relapse at 12 months was 26% in the midostaurin arm versus 41% in the placebo arm. 
Uz to, u bolesnika koji su postigli potpunu remisiju tijekom indukcije, kumulativna incidencija relapsa u 12. mjesecu bila je 26% u skupini koja je primala midostaurin u usporedbi s 41% u placebo skupini.
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. 
U bolesnika u dobi ≥ 60 godina Rydapt se smije primjenjivati samo u bolesnika koji su podobni za primanje intenzivne indukcijske kemoterapije s odgovarajućim funkcionalnim statusom i bez značajnih komorbiditeta.
Midostaurin is a compound with good absorption and poor solubility. 
Midostaurin je spoj s dobrom apsorpcijom i slabom topljivošću.
The median age was 64.5 years with half of the patients ≥65 years). 
Medijan dobi bio je 64,5 godine, pri čemu je polovica bolesnika imala ≥ 65 godina).
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. 
Akutna mijeloična leukemija oblik je raka određenih bijelih krvnih stanica (zvanih „mijeloične“ stanice) kod kojeg tijelo prekomjerno proizvodi poremećenu vrstu tih stanica.
Dose modifications (interruption or adjustment) due to ADRs occurred in 31% of patients. 
Do promjene doze (prekida ili prilagodbe) uzrokovane nuspojavama došlo je u 31% bolesnika.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PODACI KOJE SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
In a toxicity study in juvenile rats, midostaurin was administered from days 7 to 70 postpartum. 
U ispitivanju toksičnosti na mladim štakorima, midostaurin se primjenjivao od 7. do 70. dana nakon poroda.
The median age in the primary efficacy population was 64 years with approximately half of the patients ≥65 years. 
Medijan dobi u populaciji za utvrđivanje primarne djelotvornosti bio je 64 godine, pri čemu je otprilike polovica bolesnika imala ≥ 65 godina.
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. 
Liječnik će provoditi redovite krvne pretrage tijekom liječenja Rydaptom kako bi pratio količinu krvnih stanica (bijelih krvnih stanica, crvenih krvnih stanica i trombocita) i elektrolita (npr. kalcija, kalija, magnezija) u Vašem tijelu.
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. 
Bolesnike treba pratiti radi uočavanja znakova i simptoma infekcije, što uključuje i infekcije povezane s uređajem, a ako se dijagnosticira infekcija potrebno je odmah primijeniti odgovarajuću terapiju, što uključuje, ako je potrebno, i obustavu terapije Rydaptom.
The mean AUClast of CGP52421 decreased by 60%. 
Srednja vrijednost AUClast za CGP52421 smanjila se za 60%.
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. 
Stoga je sažetak štetnih događaja svih stupnjeva naveden samo za bolesnike u ispitivačkim centrima izvan Sjeverne Amerike, dok je za 3. i 4. stupanj napravljen sažetak za sve bolesnike u svim centrima.
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. 
Lijekovi ili tvari za koje je poznato da utječu na aktivnost CYP3A4 mogu utjecati na koncentracije midostaurina u plazmi te posljedično i na sigurnost primjene i/ili djelotvornost Rydapta.
At the start of treatment in AML Rydapt is always used together with chemotherapy (medicines for treating cancer). 
Na početku liječenja kod AML-a, Rydapt se uvijek koristi zajedno s kemoterapijom (lijekovima za liječenje raka).
Available animal data have shown that midostaurin and its active metabolites pass into the milk of lactating rats. 
Dostupni podaci iz ispitivanja na životinjama pokazali su da midostaurin i njegovi aktivni metaboliti prelaze u mlijeko štakora u laktaciji.
Environmental risk assessment studies have shown that midostaurin has the potential to be persistent, bioaccumulative and toxic to the environment. 
Ispitivanja procjene rizika za okoliš pokazala su da midostaurin ima potencijal da bude perzistentan, bioakumulativan i toksičan za okoliš.
Figure 1 Kaplan-Meier curve for overall survival, non-censored for SCT 
Slika 1 Kaplan-Meierova krivulja za ukupno preživljenje, necenzurirana za TMS
Injury, poisoning and procedural complications Contusion 
Ozljede, trovanja i proceduralne komplikacije Kontuzija često
Forty-eight per cent were male in the midostaurin arm and 41% in the placebo arm. 
Četrdeset i osam posto su bili muškarci u skupini koja je primala midostaurin, a 41% u placebo skupini.
Strong CYP3A4 inhibitors may increase midostaurin blood concentrations. 
Snažni CYP3A4 inhibitori mogu povećati koncentracije midostaurina u krvi.
Midostaurin inhibited OATP1B1, BCRP and P-glycoprotein (P-gp) in vitro (see section 5.2). 
Midostaurin je inhibirao OATP1B1, BCRP i P-glikoprotein (P-gp) in vitro (vidjeti dio 5.2).
Kaplan-Meier estimates at 5 years (95% CI) 
Kaplan-Meierove procjene u 5. godini (95% CI)
All animal findings described below were observed at midostaurin exposure significantly lower than therapeutic levels. 
Svi rezultati ispitivanja na životinjama opisani u nastavku opaženi su kod značajno manje izloženosti midostaurinu od terapijskih razina.
Your doctor may need to adjust, temporarily stop or completely discontinue your treatment with Rydapt. 
Liječnik će možda morati prilagoditi, privremeno ili trajno prekinuti Vaše liječenje Rydaptom.
If you forget to take Rydapt 
Ako ste zaboravili uzeti Rydapt
Due to dose-limiting toxicity, clinical therapeutic exposure levels could not be reached in animals. 
Zbog toksičnosti koja ograničava doziranje, kod životinja nisu mogle biti dosegnute kliničke terapijske razine izloženosti.
Cumulative incidence of relapse (CIR) 
Cumulative Incidence of Relapse)
Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate. 
Jedna meka kapsula sadrži približno 83 mg bezvodnog etanola i 415 mg makrogolglicerolhidroksistearata.
Midostaurin was administered orally at 100 mg twice daily until disease progression or intolerable toxicity. 
Midostaurin se primjenjivao peroralno u dozi od 100 mg dvaput na dan do progresije bolesti ili nepodnošljive toksičnosti.
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. 
Na temelju analiza populacijskog farmakokinetičkog modela za učinak spola na klirens midostaurina i njegovih aktivnih metabolita, nije bilo statistički značajnog nalaza, a predviđene promjene u izloženosti (< 20%) nisu se smatrale klinički značajnima.
At baseline, 88.5% had >1 C finding and 69.2% had received at least one prior anti-neoplastic regimen. 
Na početku je 88,5% imalo > 1 C nalaz, a 69,2% primilo je barem jedan prethodni antineoplastični režim.
Most of the haematological abnormalities reported occurred during the induction and consolidation phase when the patients received Rydapt or placebo in combination with chemotherapy. 
Većina hematoloških abnormalnosti zabilježena je tijekom indukcijske i konsolidacijske faze kada su bolesnici primali Rydapt ili placebo u kombinaciji s kemoterapijom.
The population pharmacokinetic analysis indicated that the absorption in patients was less than dose proportional at doses >50 mg twice daily. 
Populacijska farmakokinetička analiza ukazala je da je apsorpcija u bolesnika bila manja od proporcionalne s dozom pri dozama > 50 mg dvaput na dan.
The primary endpoint of the study was overall survival (OS), measured from the date of randomisation until death by any cause. 
Mjera primarnog ishoda u ispitivanju bilo je ukupno preživljenje (OS, engl. overall survival), mjereno od datuma randomizacije do smrti od bilo kojeg uzroka.
Resume Rydapt at the initial dose in the next cycle provided that QTc interval improves to ≤470 msecs at the start of that cycle. 
Nastaviti primjenu Rydapta u početnoj dozi u sljedećem ciklusu pod uvjetom da se QTc interval poboljša do ≤ 470 msec na početku tog ciklusa.
Patients who received non-study anti-neoplastic therapy were considered as having progressed at the time of the new therapy. 
Za bolesnike koji su primali antineoplastičnu terapiju van ispitivanja smatra se da su progredirali u vrijeme uvođenja nove terapije.
Rydapt contains ethanol anhydrous (alcohol) 
Rydapt sadrži bezvodni etanol (alkohol)
Of these, 73 patients had ASM (57 with an AHN) and 16 patients had MCL (6 with an AHN). 
Od toga, 73 bolesnika imalo je ASM (57 s AHN-om), a 16 bolesnika imalo je MCL (6 s AHN-om).
White blood cell counts (WBCs) should be monitored regularly, especially at treatment initiation. 
Broj leukocita (Lkc) potrebno je redovito pratiti, osobito na početku liječenja.
Sensitivity analyses for both OS and EFS when censored at the time of SCT also supported the clinical benefit with midostaurin plus standard chemotherapy over placebo. 
Analize osjetljivosti za OS i EFS, kada su bile cenzurirane u vrijeme TMS-a, također su podupirale kliničku korist midostaurina plus standardna kemoterapija u odnosu na placebo.
Population pharmacokinetic analyses were conducted using data from clinical studies in patients with AML (n=180) and ASM, SM-AHN and MCL (n=141). 
Populacijske farmakokinetičke analize provedene su koristeći podatke iz kliničkih ispitivanja u bolesnika s AML-om (n=180) i ASM-om, SM-AHN-om i MCL-om (n=141).
Women using hormonal contraceptives should add a barrier method of contraception. 
Žene koje koriste hormonske kontraceptive trebaju dodati mehaničku metodu kontracepcije.
Rydapt has not been studied in patients with acute promyelocytic leukaemia and therefore its use is not recommended in this patient population. 
Rydapt nije bio ispitivan u bolesnika s akutnom promijelocitnom leukemijom te se stoga njegova primjena u ovoj bolesničkoj populaciji ne preporučuje.
They should not be opened, crushed or chewed to ensure proper dosing and avoid the unpleasant taste of the capsule content. 
Ne smiju se otvarati, drobiti ili žvakati, kako bi se osiguralo pravilno doziranje te kako bi se izbjegao neugodan okus sadržaja kapsule.
Caution is warranted in patients at risk of QTc prolongation (e.g. due to concomitant medicinal products and/or electrolyte disturbances). 
Potreban je oprez u bolesnika pod rizikom od produljenja QTc intervala (npr. zbog istodobno primijenjenih lijekova i/ili poremećaja elektrolita).
Activated partial thromboplastin time prolonged 
Produljeno aktivirano parcijalno tromboplastinsko vrijeme
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. 
Simptomi nastaju kada previše mastocita uđe u organe kao što su jetra, koštana srž ili slezena, te otpuštaju u krv tvari poput histamina.
Clinical experience in patients with severe renal impairment is limited and no data are available in patients with end-stage renal disease (see sections 4.4 and 5.2). 
Kliničko iskustvo u bolesnika s teškim oštećenjem bubrega ograničeno je i nema dostupnih podataka u bolesnika s bolešću bubrega u završnom stadiju (vidjeti dijelove 4.4 i 5.2).
Rydapt is not recommended during pregnancy or in women of childbearing potential not using contraception. 
Ne preporučuje se koristiti lijek Rydapt tijekom trudnoće ili u žena reproduktivne dobi koje ne koriste kontracepciju.
Interval assessments of QT by ECG should be considered if Rydapt is taken concurrently with medicinal products that can prolong QT interval. 
Potrebno je razmotriti procjene QT intervala pomoću EKG-a ako se Rydapt uzima istodobno s lijekovima koji mogu produljiti QT interval.
The pharmacokinetics of midazolam (sensitive CYP3A4 probe) were not affected following three days' dosing of midostaurin in healthy subjects. 
Farmakokinetika midazolama (osjetljivog supstrata CYP3A4) nije bila promijenjena nakon tri dana doziranja midostaurina u zdravih ispitanika.
The most frequent ADRs that led to dose modification (incidence ≥5%) were nausea and vomiting. 
Najučestalije nuspojave koje su dovele do promjene doze (incidencija ≥ 5%) bile su mučnina i povraćanje.
Midostaurin is metabolised by CYP3A4 mainly via oxidative pathways. 
Midostaurin se metabolizira putem CYP3A4 i to uglavnom oksidativnim putevima.
An increased frequency of QTc prolongation was noted in midostaurin-treated patients (see section 4.8), however, a mechanistic explanation for this observation was not found. 
U bolesnika liječenih midostaurinom primijećena je povećana učestalost produljenja QTc intervala (vidjeti dio 4.8), međutim, nije pronađeno mehanističko objašnjenje za ovo opažanje.
You must use an effective method of contraception while taking Rydapt and for at least 4 months after you have stopped taking it. 
Morate koristiti učinkovitu metodu kontracepcije dok uzimate Rydapt te još najmanje 4 mjeseca nakon što ga prestanete uzimati.
While Table 3 provides the incidence for ADRs over the total duration of the study, when the maintenance phase (single agent Rydapt or placebo) was assessed separately, a difference in the type and severity of ADRs was observed. 
Iako je u Tablici 3 navedena incidencija za nuspojave za cijelog trajanja ispitivanja, kada se faza održavanja (monoterapija Rydaptom ili placebo) zasebno ocjenjivala, opažena je razlika u vrsti i težini nuspojava.
If you forget to take Rydapt, skip the missed dose and take your next dose at the usual time. 
Ako zaboravite uzeti Rydapt, preskočite propuštenu dozu i uzmite sljedeću dozu u uobičajeno vrijeme.
No dose adjustment is required in patients aged over 65 years (see section 5.2). 
U bolesnika starijih od 65 godina nije potrebna prilagodba doze (vidjeti dio 5.2).
The two major human metabolites GGP52421 and CGP62221 (also tested at the limit of solubility) inhibited hERG current with moderate safety margins. 
Dva glavna ljudska metabolita GGP52421 i CGP62221 (također ispitivana na granici topljivosti) inhibirala su hERG struju s umjerenim sigurnosnim marginama.
Resume Rydapt at the same dose when infiltrate resolves to Grade ≤1. 
Ponovno nastaviti s Rydaptom u istoj dozi kad se infiltrat smanji do ≤ 1. stupnja.
Rydapt is used to treat acute myeloid leukaemia (AML) in adults who have a defect in a gene called FLT3. 
Rydapt se koristi za liječenje akutne mijeloične leukemije (AML) u odraslih koji imaju defekt na genu koji se zove FLT3.
Renal elimination is a minor route of elimination for midostaurin. 
Eliminacija putem bubrega manje je važan put eliminacije midostaurina.
In patients who develop unexplained severe neutropenia, treatment with Rydapt should be interrupted until ANC is ≥1.0 x 10 
U bolesnika u kojih se razvije neobjašnjena teška neutropenija, liječenje Rydaptom treba prekinuti dok ABN ne bude ≥ 1,0 x 10
In humans, the absorption of midostaurin was rapid after oral administration, with Tmax of total radioactivity observed at 1-3 hours post dose. 
U ljudi je apsorpcija midostaurina nakon peroralne primjene bila brza, pri čemu je Tmax ukupne radioaktivnosti bio opažen 1-3 sata nakon doze.
Alternative medicinal products that do not strongly inhibit CYP3A4 activity should be considered. 
Potrebno je razmotriti zamjenske lijekove koji ne inhibiraju snažno aktivnost CYP3A4.
Herpes zoster 
Herpes zoster često
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%. 
Četrdeset šest posto bolesnika imalo je smanjenje u infiltraciji koštane srži za više od 50%, a 58% imalo je sniženje razina serumske triptaze za više od 50%.
Midostaurin undergoes extensive hepatic metabolism mainly through CYP3A4 enzymes which are either induced or inhibited by a number of concomitant medicinal products. 
Midostaurin je podvrgnut ekstenzivnom hepatičkom metabolizmu uglavnom putem CYP3A4 enzima koje ili induciraju ili inhibiraju određeni istodobno primijenjeni lijekovi.
Table 6 Overview of OS, EFS, CR, DFS and CIR by gender in AML 
Tablica 6 Pregled OS-a, EFS-a, CR-a, DFS-a i CIR-a prema spolu kod AML-a
However, CGP52421 concentrations increased up to 2.5-fold for ASM, SM-AHN and MCL and up to 9-fold for AML, compared to midostaurin after one month of treatment. 
Međutim, koncentracije CGP52421 povećale su se do 2,5 puta za ASM, SM-AHN i MCL i do 9 puta za AML, u usporedbi s midostaurinom nakon mjesec dana liječenja.
The pharmacokinetics of the CGP62221 metabolite showed a similar trend. 
Farmakokinetika metabolita CGP62221 pokazala je sličan trend.
If QTc improves to ≤470 msecs just prior to the next cycle, resume Rydapt at the initial dose. 
Ako se QTc poboljša do ≤ 470 msec netom prije sljedećeg ciklusa, nastaviti primjenu Rydapta u početnoj dozi.
In ASM, SM-AHN and MCL patients these events led to dose adjustment or interruption in 26% and to discontinuation in 4.2% of the patients. 
U bolesnika s ASM-om, SM-AHN-om i MCL-om ti su događaji doveli do prilagodbe doze ili prekida primjene u 26%, a do obustave terapije u 4,2% bolesnika.
The mean apparent plasma clearance (CL/F) was 2.4-3.1 l/h in healthy subjects. 
Srednja vrijednost prividnog klirensa iz plazme (CL/F) bila je 2,4-3,1 l/h u zdravih ispitanika.
Table 8 Efficacy of midostaurin in ASM, SM-AHN and MCL per IWG-MRT-ECNM consensus criteria using an algorithmic approach 
Tablica 8 Djelotvornost midostaurina kod ASM-a, SM-AHN-a i MCL-a prema konsenzus kriterijima IWG-MRT-ECNM-a koristeći algoritamski pristup
Cmin of CGP52421 was increased by 1.3-fold, whereas no significant effect in exposure of CGP62221 was observed (see section 4.4). 
Cmin za CGP52421 povećao se za 1,3 puta, a nije bio primijećen značajan učinak kod izloženosti CGP62221 (vidjeti dio 4.4).
Some side effects in patients with AML could be serious. 
Neke nuspojave u oboljelih od AML-a mogu biti ozbiljne.
Cardiac dysfunction 
Srčana disfunkcija
Withhold or interrupt Rydapt for the remainder of the cycle. 
Uskratiti ili prekinuti primjenu Rydapta do kraja ciklusa.
Overall, there was no clinically relevant increase in exposure (AUC) to plasma midostaurin in subjects with mild or moderate hepatic impairment compared to subjects with normal hepatic function. 
Ukupno gledajući nije bilo klinički značajnog povećanja izloženosti (AUC) midostaurinu u plazmi u ispitanika s blagim ili umjerenim oštećenjem jetre u usporedbi s ispitanicima s normalnom funkcijom jetre.
Midostaurin inhibits multiple receptor tyrosine kinases, including FLT3 and KIT kinase. 
Midostaurin inhibira više receptorskih tirozin kinaza, uključujući FLT3 i KIT kinazu.
9.4 (7.5, NE) 
9,4 (7,5; NP)
144 patients showed normal renal function (CrCL >90 ml/min) at baseline. 
144 bolesnika imalo je normalnu bubrežnu funkciju (CrCL > 90 ml/min) na početku.
1: MIDOSTAURIN - SCT 2: PLACEBO - SCT 3: MIDOSTAURIN - no SCT 4: PLACEBO - no SCT Censored 
1: MIDOSTAURIN - TMS 2: PLACEBO - TMS 3: MIDOSTAURIN - bez TMS-a 4: PLACEBO - bez TMS-a Cenzurirano
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. 
U slučaju predoziranja bolesnike je potrebno pažljivo pratiti zbog mogućih znakova ili simptoma nuspojava te započeti odgovarajuću simptomatsku i suportivnu terapiju.