natgillin/translations-raw huggingface dataset:
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.
Alcohol may be harmful in patients with alcohol-related problems, epilepsy or liver problems or during pregnancy or breast-feeding.
Alkohol može biti štetan u bolesnika s problemima povezanim s alkoholom, epilepsijom ili problemima s jetrom te tijekom trudnoće ili dojenja.
Spleen volume decreased by ≥10% in 68.9% of patients with at least 1 post-baseline assessment (26.7% of patients had a reduction of ≥35%, which correlates with a 50% decrease by palpation).
Volumen slezene smanjio se za ≥ 10% u 68,9% bolesnika s najmanje 1 procjenom nakon početka (26,7% bolesnika imalo je smanjenje ≥ 35%, koje korelira sa smanjenjem od 50% utvrđenim palpacijom).
In patients at risk, Rydapt should be used with caution and the patient closely monitored by assessing LVEF when clinically indicated (at baseline and during treatment).
U bolesnika izloženih riziku, Rydapt se mora primjenjivati oprezno, a bolesnike je potrebno pažljivo nadzirati procjenjivanjem LVEF-a kada je to klinički indicirano (na početku i tijekom liječenja).
Based on an interim analysis, the EFS rate at 2 years (primary endpoint) was 27.1% (95% CI: 16.6, 44.1) and the median OS was 15.5 months in patients older than 60 years of age (46 out of 145 patients).
Na temelju interim analize, stopa EFS-a nakon 2. godine (mjera primarnog ishoda) bila je 27,1% (95% CI: 16,6; 44,1), a medijan OS-a bio je 15,5 mjeseci u bolesnika starijih od 60 godina (46 od 145 bolesnika).
In the ASM, SM-AHN and MCL population, 25.4% of patients had at least one ECG measurement with a QTcF greater than 450 ms and 4.7% greater than 480 ms.
Kod populacije s ASM-om, SM-AHN-om i MCL-om 25,4% bolesnika imalo je barem jedno mjerenje EKG-om na kojem je QTcF bio veći od 450 ms, a u 4,7% bio je veći od 480 ms.
Patients were stratified by FLT3 mutation status: TKD, ITD with allelic ratio <0.7, and ITD with allelic ratio ≥0.7.
Bolesnici su bili stratificirani prema statusu FLT3 mutacije: TKD, ITD s omjerom alela < 0,7, i ITD s omjerom alela ≥ 0,7.
Acute promyelocytic leukaemia
Akutna promijelocitna leukemija
Based on population pharmacokinetic analyses no significant impact of age on the pharmacokinetics of midostaurin and its two active metabolites was identified for patients aged between 65 and 85 years.
Na temelju populacijskih farmakokinetičkih analiza nije bio uočen nikakav značajan utjecaj dobi na farmakokinetiku midostaurina i njegova dva aktivna metabolita u bolesnika u dobi od 65 do 85 godina.
Pregnant women should be informed of the potential risk to a foetus; females of reproductive potential should be advised to have a pregnancy test within 7 days prior to starting treatment with Rydapt and to use effective contraception during treatment with Rydapt and for at least 4 months after stopping treatment.
Trudnice je potrebno obavijestiti o mogućem riziku za fetus; ženama reproduktivnog potencijala treba savjetovati da obave test na trudnoću unutar 7 dana prije nego što započnu liječenje Rydaptom i da koriste učinkovitu kontracepciju tijekom liječenja Rydaptom te najmanje 4 mjeseca nakon prestanka liječenja.
The most frequent serious ADR in both arms was febrile neutropenia (16%).
Najučestalija ozbiljna nuspojava u bolesnika u objema skupinama bila je febrilna neutropenija (16%).
Twenty (76.9%) patients had ASM (17 [85%] with AHN) and 6 patients (23.1%) had MCL (2 [33.3%] with AHN).
Dvadeset (76,9%) bolesnika imalo je ASM (17 [85%] uz AHN), a 6 bolesnika (23,1%) imalo je MCL (2 [33,3%] uz AHN).
AUC0-12 was decreased by 39% and 36% in subjects with mild and moderate hepatic impairment, respectively.
AUC0-12 se smanjio za 39%, odnosno 36%, u ispitanika s blagim, odnosno umjerenim oštećenjem jetre.
It is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception.
Trenutačno nije poznato može li midostaurin umanjiti učinkovitost hormonskih kontraceptiva pa stoga žene koje koriste hormonske kontraceptive trebaju dodati mehaničku metodu kontracepcije.
Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.
Prije uzimanja midostaurina, bolesnici s AML-om moraju imati potvrdu FLT3 mutacije (unutarnje uzastopne duplikacije [ITD, engl. internal tandem duplication] ili tirozin kinaznu domenu [TKD]) dobivenu validiranim testom.
In addition, midostaurin inhibits several other receptor tyrosine kinases such as PDGFR (platelet-derived growth factor receptor) or VEGFR2 (vascular endothelial growth factor receptor 2), as well as members of the serine/threonine kinase family PKC (protein kinase C).
Uz to, midostaurin inhibira nekoliko drugih receptorskih tirozin kinaza kao što su PDGFR (receptor fibroblastnih čimbenika rasta porijeklom iz trombocita) ili VEGFR2 (receptor vaskularnog endotelnog čimbenika rasta 2), kao i članove obitelji serin/treonin kinaza PKC (protein kinaza C).
In the ASM, SM-AHN and MCL studies cardiac dysfunction such as congestive heart failure (CHF) (including some fatalities) and transient decreases in left ventricular ejection fraction (LVEF) occurred.
U ispitivanjima ASM-a, SM-AHN-a i MCL-a pojavile su se srčane disfunkcije kao što su kongestivno zatajenje srca (KZS) (uključujući neke smrtne slučajeve) i prolazna smanjenja ejekcijske frakcije lijeve klijetke (LVEF).
ASM SM-AHN MCL Subtype unknown
ASM SM-AHN MCL Podtip nepoznat
Reproductive studies in rats and rabbits demonstrated that midostaurin induced foetotoxicity (see section 5.3).
Reproduktivna ispitivanja provedena na štakorima i zečevima pokazala su da je midostaurin inducirao fetotoksičnost (vidjeti dio 5.3).