natgillin/translations-raw huggingface dataset:
Tmax was delayed for all entities, midostaurin median Tmax was 3 h, and for CGP52421 and CGP62221 Tmax was delayed to 6 and 7 hours respectively.
Tmax je bio odgođen za sve entitete, medijan Tmax za midostaurin bio je 3 h, a za CGP52421, odnosno CGP62221, Tmax je bio odgođen na 6, odnosno 7 sati.
1-sided p-value calculated using log-rank test stratified according to the randomisation FLT3 mutation factor.
1-strana p-vrijednost izračunata koristeći log-rang test stratificiran prema randomizacijskom čimbeniku FLT3 mutacije.
The pharmacokinetics of midostaurin were less than dose proportional with the doses of 30 mg/m and 60 mg/m after single and multiple doses.
Farmakokinetika midostaurina bila je manje nego proporcionalna dozi uz doze od 30 mg/m i 60 mg/m nakon jednokratne i nakon višestrukih doza.
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 (see section 4.6).
Trenutačno nije poznato može li midostaurin umanjiti učinkovitost hormonskih kontraceptiva te stoga žene koje koriste hormonske kontraceptive trebaju dodati mehaničku metodu kontracepcije (vidjeti dio 4.6).
If vomiting occurs, the patient should not take an additional dose of Rydapt, but should take the next scheduled dose.
Ako dođe do povraćanja, bolesnik ne smije uzeti dodatnu dozu Rydapta, već treba uzeti sljedeću dozu prema rasporedu.
The median terminal half-lives of midostaurin, CGP62221 and CGP52421 in plasma are approximately 20.9, 32.3 and 471 hours.
Medijani terminalnih poluvijekova midostaurina, CGP62221 i CGP52421 u plazmi redom su otprilike 20,9, 32,3 i 471 sat.
The majority of patients (77.4%) had FLT3-ITD mutations, most of them (47.6%) with a low allelic ratio (<0.7), and 22.6% of patients had FLT3-TKD mutations.
Većina bolesnika (77,4%) imala je FLT3-ITD mutacije, većina njih (47,6%) s niskim omjerom alela (< 0,7), a 22,6% bolesnika imalo je FLT3-TKD mutacije.
The combination of data on in vivo midostaurin auto-induction upon repeated dosing and increase in plasma 4β-OH cholesterol levels suggest that midostaurin may be at least a moderate CYP3A4 inducer in vivo.
Kombinacija podataka o in vivo autoindukciji midostaurina nakon ponovljenog doziranja i povećanju razina 4β-OH kolesterola u plazmi ukazuje na to da bi midostaurin mogao biti barem umjereni CYP3A4 induktor in vivo.
Nineteen patients (73.1%; 95% CI = [52.2, 88.4]) achieved a response during the first two cycles of treatment (13 MR; 6 PR).
Devetnaest bolesnika (73,1%; 95% CI = [52,2; 88,4]) postiglo je odgovor tijekom prva dva ciklusa liječenja (13 MR; 6 PR).
In embryo-foetal development studies in rats and rabbits, increased numbers of late resorptions, reduced foetal weight and reduced skeletal ossification were observed.
U ispitivanjima embrio-fetalnog razvoja provedenima na štakorima i zečevima, opaženi su povećan broj kasnih resorpcija, smanjenje fetalne težine i smanjenje osifikacije skeleta.
Monitoring during treatment with Rydapt
Praćenje tijekom liječenja Rydaptom
Pale orange, oblong capsule with red imprint “PKC NVR”.
Blijedo narančasta, duguljasta kapsula s crvenom utisnutom oznakom „PKC NVR“.
Based on a phase I study in healthy Japanese volunteers, pharmacokinetic profiles of midostaurin and its metabolites (CGP62221 and CGP52421) are similar compared to those observed in other pharmacokinetic studies conducted in Caucasians and Blacks.
Na temelju ispitivanja faze I u zdravih japanskih dobrovoljaca, farmakokinetički profili midostaurina i njegovih metabolita (CGP62221 i CGP52421) slični su u usporedbi s onima opaženima u drugim farmakokinetičkim ispitivanjima provedenim na ispitanicima bijele i crne rase.
The absolute bioavailability of midostaurin following oral administration is not known.
Apsolutna bioraspoloživost midostaurina nakon peroralne primjene nije poznata.
Rydapt has minor influence on the ability to drive and use machines.
Rydapt malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Women of childbearing potential should be informed that animal studies show midostaurin to be harmful to the developing foetus.
Žene reproduktivnog potencijala potrebno je obavijestiti kako ispitivanja na životinjama pokazuju da je midostaurin štetan za plod u razvoju.
Haemoglobin less than 8 g/dl attributed to Rydapt in patients without MCL, or life-threatening anaemia attributed to Rydapt in patients with baseline haemoglobin value of 8-10 g/dl
Hemoglobin niži od 8 g/dl koji se pripisuje Rydaptu u bolesnika bez MCL-a, ili po život opasna anemija koja se pripisuje Rydaptu u bolesnika s početnom vrijednošću hemoglobina od 8-10 g/dl
In the randomised AML study no difference in CHF was observed between the Rydapt + chemotherapy and placebo + chemotherapy arms.
U randomiziranom ispitivanju AML-a nije bila opažena nikakva razlika u KZS-u između skupina koje su primale Rydapt + kemoterapiju i placebo + kemoterapiju.
Skin and subcutaneous tissue disorders Dermatitis exfoliative
Poremećaji kože i potkožnog tkiva Eksfolijativni dermatitis
The capsules are provided in blisters and are available in packs containing 56 capsules (2 packs of 28 capsules) or 112 capsules (4 packs of 28 capsules).
Kapsule se nalaze u blisterima i dostupne su u pakiranjima koja sadrže 56 kapsula (2 pakiranja po 28 kapsula) ili 112 kapsula (4 pakiranja po 28 kapsula).
Peak midostaurin concentration (Cmax) was reduced by 20% with a standard meal and by 27% with a high-fat meal versus on an empty stomach (see section 5.2).
Vršna koncentracija midostaurina (Cmax) smanjila se za 20% uz standardni obrok i za 27% uz obrok s visokim udjelom masti u usporedbi s primjenom na prazan želudac (vidjeti dio 5.2).
Rydapt is dosed on days 8-21 of induction and consolidation chemotherapy cycles, and then for patients in complete response every day as single agent maintenance therapy until relapse for up to 12 cycles of 28 days each (see section 4.1).
Rydapt se daje od 8. do 21. dana ciklusa indukcijske i konsolidacijske kemoterapije, a zatim bolesnicima s potpunim terapijskim odgovorom svakog dana kao monoterapija održavanja do relapsa tijekom razdoblja od najviše 12 ciklusa od po 28 dana svaki (vidjeti dio 4.1).
(34.7, NE)
(34,7; NP)
In a fertility study in rats, midostaurin was associated with reduced fertility, testicular degeneration and atrophy, reduced sperm motility, oligo- and aspermia, increased resorptions, decreased pregnancy rate, number of implants and live embryos.
U jednom ispitivanju plodnosti na štakorima, midostaurin je bio povezan sa smanjenom plodnošću, degeneracijom i atrofijom testisa, smanjenjem motiliteta spermija, oligospermijom i aspermijom, povećanom resorpcijom, smanjenom stopom trudnoća, broja implantacija i živih embrija.
Although the study was designed to be assessed with the modified Valent and Cheson criteria, as a post-hoc exploratory analysis, efficacy was also assessed per the 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment - European Competence Network on Mastocytosis (IWG-MRT-ECNM) consensus criteria.
kao post-hoc eksploratorna analiza, djelotvornost se procjenjivala i prema konsenzus kriterijima Međunarodne radne skupine za istraživanje i liječenje mijeloproliferativnih neoplazmi - Europske mreže kompetencija za mastocitozu (IWG-MRT-ECNM) iz 2013.
Discontinue Rydapt if toxicity is not resolved to Grade ≤2 within 21 days or severe toxicity recurs at a reduced dose of Rydapt.
Obustaviti primjenu Rydapta dok se toksičnost ne ublaži do ≤ 2. stupnja unutar 21 dana ili ako se ponovo javi teška toksičnost uz smanjenu dozu
Alcohol may be harmful if you have alcohol-related problems, epilepsy or liver problems, or if you are pregnant or breast-feeding.
Alkohol može biti štetan ako imate probleme povezane s alkoholom, epilepsiju ili probleme s jetrom te ako ste trudni ili dojite.
What Rydapt is
Što je Rydapt
Confirmed responses were observed in both KIT D816V mutation positive patients (ORR=63%) and KIT D816V wild type or unknown patients (ORR=43.8%).
Potvrđeni odgovori bili su opaženi i u bolesnika pozitivnih na KIT D816V mutaciju (ORR=63%) i u onih s KIT D816V mutacijom divljeg ili nepoznatog tipa (ORR=43,8%).
Results for OS by SCT status are shown in Figure 2.
Rezultati za OS prema statusu TMS-a prikazani su na Slici 2.
The Human Mass Balance study results indicated that faecal excretion is the major route of excretion (78% of the dose), and mostly as metabolites (73% of the dose), while unchanged midostaurin accounts for 3% of the dose.
Rezultati ispitivanja masene ravnoteže u ljudi ukazali su na to da je glavni način izlučivanja putem fecesa (78% doze), te većinom u obliku metabolita (73% doze), dok nepromijenjeni midostaurin predstavlja 3% doze.
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Unutar svake skupine po učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
In vitro data indicate that midostaurin inhibits D816V mutant KIT receptors at exposure levels achieved in patients (average achieved exposure higher than IC50).
In vitro podaci ukazuju na to da midostaurin inhibira KIT receptore s mutacijom D816V pri razinama izloženosti koje se postižu u bolesnika (prosječna postignuta izloženost viša od IC50).
An increase in liver enzymes (ALT and AST) was seen consistently in rats, and in dogs and monkeys in long-term studies of ≥3 months duration, without histopathological correlates.
Povišenje jetrenih enzima (ALT i AST) dosljedno se uočavalo u štakora te u pasa i majmuna u dugoročnim ispitivanjima koja su trajala ≥ 3 mjeseca, bez histopatoloških korelata.
Interstitial lung disease (ILD) and pneumonitis, in some cases fatal, have occurred in patients treated with Rydapt monotherapy or in combination with chemotherapy.
Intersticijska bolest pluća (IBP) i pneumonitis, u nekim slučajevima smrtonosni, pojavili su se u bolesnika liječenih Rydaptom u monoterapiji ili u kombinaciji s kemoterapijom.
HR (95% CI) - SCT HR (95% CI) - no SCT
HR (95% CI) - TMS HR (95% CI) - bez TMS-a
Effect of other medicinal products on Rydapt
Učinak drugih lijekova na Rydapt
Dizziness and vertigo have been reported in patients taking Rydapt and should be considered when assessing a patient's ability to drive or use machines.
U bolesnika koji uzimaju Rydapt prijavljene su omaglica i vrtoglavica, što treba uzeti u obzir kada se procjenjuje bolesnikova sposobnost da upravlja vozilima ili radi sa strojevima.
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).
Zbog mogućnosti ozbiljnih nuspojava Rydapta u dojenčadi, žene trebaju prekinuti dojenje tijekom liječenja Rydaptom te najmanje 4 mjeseca nakon prestanka liječenja (vidjeti dio 4.6).
In the repeat-dose studies in dogs, a decrease in heart rate, prolongation of the P-Q interval, and sporadically occurring atrioventricular blocks were seen in individual animals.
U ispitivanjima na psima s ponovljenim dozama, opaženo je smanjenje srčane frekvencije, produljenje P-Q intervala i sporadična pojava atrioventrikularnih blokova u pojedinih životinja.
Midostaurin binds to the catalytic domain of these kinases and inhibits the mitogenic signalling of the respective growth factors in cells, resulting in growth arrest.
Midostaurin se veže za katalitičku domenu tih kinaza te inhibira mitogenu signalizaciju odgovarajućih čimbenika rasta u stanicama, što rezultira zastojem rasta.
The study demonstrated a statistically significant improvement in OS with a 23% risk reduction of death for midostaurin plus standard chemotherapy over placebo plus standard chemotherapy (see Table 6 and Figure 1).
Ispitivanje je pokazalo statistički značajno poboljšanje OS-a sa smanjenjem rizika od smrti za 23% za midostaurin plus standardna kemoterapija u odnosu na placebo plus standardna kemoterapija (vidjeti Tablicu 6 i Sliku 1).
- For patients with AML, Rydapt is taken with chemotherapy medicines.
- Za bolesnike s AML-om, Rydapt se uzima s lijekovima za kemoterapiju.
Midostaurin inhibits FLT3 receptor signalling and induces cell cycle arrest and apoptosis in leukaemic cells expressing FLT3 ITD or TKD mutant receptors or over-expressing FLT3 wild type receptors.
Midostaurin inhibira signaliziranje FLT3 receptora i inducira zastoj staničnog ciklusa i apoptozu u leukemijskim stanicama koje eksprimiraju FLT3 ITD ili TKD mutirane receptore ili prekomjerno eksprimiraju FLT3 receptore divljeg tipa.
Table 5 Efficacy of midostaurin in AML
Tablica 5 Djelotvornost midostaurina kod AML-a
In healthy subjects, midostaurin absorption (AUC) was increased by an average of 22% when Rydapt was co-administered with a standard meal and by an average of 59% when co-administered with a high-fat meal.
U zdravih ispitanika apsorpcija midostaurina (AUC) u prosjeku se povećala za 22% kada se Rydapt primjenjivao istodobno sa standardnim obrokom te u prosjeku za 59% kada se primjenjivao istodobno uz obrok s visokim udjelom masti.
Sexually active women of childbearing potential are advised to have a pregnancy test within 7 days prior to starting treatment with Rydapt and that they should use effective contraception (methods that result in less than 1% pregnancy rates) when using Rydapt and for at least 4 months after stopping treatment with Rydapt.
Spolno aktivnim ženama reproduktivnog potencijala savjetuje se da naprave test na trudnoću unutar 7 dana prije početka liječenja Rydaptom te da koriste učinkovitu kontracepciju (metode koje rezultiraju stopama trudnoće koje su manje od 1%) kada uzimaju Rydapt te najmanje 4 mjeseca nakon prestanka liječenja Rydaptom.
Stop taking Rydapt and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction: - difficulty breathing or swallowing - dizziness - swelling of the face, lips, tongue or throat - severe itching of the skin, with a red rash or raised bumps
Prestanite uzimati Rydapt i odmah se obratite liječniku ako primijetite bilo što od sljedećeg, budući da bi to mogli biti znakovi alergijske reakcije: - poteškoće s disanjem ili gutanjem - omaglica - oticanje lica, usnica, jezika ili grla - jaki svrbež kože, s crvenim osipom ili izdignutim kvržicama.
Out of the 321 patients included, 177 patients showed pre-existing mild (n=113), moderate (n=60) or severe (n=4) renal impairment (15 ml/min ≤ creatinine clearance [CrCL] <90 ml/min).
Od 321 uključenog bolesnika, 177 bolesnika pokazalo je već postojeće blago (n=113), umjereno (n=60) ili teško (n=4) oštećenje bubrega (15 ml/min ≤ klirens kreatinina [CrCL] < 90 ml/min).
Midostaurin (n=360) Median: 74.7 months Placebo (n=357) Median: 25.6 months HR: 0.774 (95% CI, 0.629-0.953) P = 0.0078
Midostaurin (n=360) Medijan: 74,7 mjeseci Placebo (n=357) Medijan: 25,6 mjeseci HR: 0,774 (95% CI, 0,629-0,953) P = 0,0078
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Purified water
Ovojnica kapsule želatina glicerol titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172) pročišćena voda
Midostaurin was administered orally at 100 mg twice daily in cycles of 28 days.
Midostaurin se primjenjivao peroralno u dozi od 100 mg dvaput na dan u ciklusima od 28 dana.
No midostaurin dose adjustment is required based on ethnicity.
Nije potrebna prilagodba doze midostaurina na temelju etničke pripadnosti.
CIR (CR induction) (HR) *Odds ratio calculated as (No complete remission in treatment/Complete remission in treatment) / (No complete remission in placebo/complete remission in placebo) HR= Hazard ratio; OR=odds ratio
CIR (Indukcija CR-a) (HR) *Omjer izgleda izračunat kao (bez potpune remisije uz liječenje/potpuna remisija uz liječenje) / (bez potpune remisije uz placebo/potpuna remisija uz placebo) HR= omjer hazarda; OR=omjer izgleda
In proliferation assays with FLT3-ITD expressing cells, CGP62221 showed similar potency compared to the parent compound, however CGP52421 was approximately 10-fold less potent.
U testovima proliferacije sa stanicama koje eksprimiraju FLT3-ITD, CGP62221 je pokazao sličnu potentnost u usporedbi s ishodišnim spojem, međutim CGP52421 je bio otprilike 10 puta manje potentan.
Rydapt contains about 14 vol. % ethanol anhydrous, which corresponds to up to 333 mg alcohol per dose.
Rydapt sadrži oko 14 vol. % bezvodnog etanola, što odgovara količini od do 333 mg alkohola po dozi.
Discontinuation due to any adverse reaction occurred in 3.1% of patients in the Rydapt arm versus 1.3% in the placebo arm.
Do obustave terapije zbog bilo koje nuspojave došlo je u 3,1% bolesnika u Rydapt skupini u usporedbi s 1,3% u placebo skupini.
Interrupt Rydapt until toxicities considered at least possibly related to Rydapt have resolved to Grade ≤2, then resume Rydapt.
Prekinuti primjenu Rydapta dok se toksičnosti za koje se smatra da je barem moguće da su povezane s Rydaptom ne povuku do ≤ 2. stupnja, zatim opet nastaviti s Rydaptom.
Figure 2 Kaplan Meier curve for overall survival by SCT status in AML
Slika 2 Kaplan-Meierova krivulja za ukupno preživljenje prema statusu TMS-a kod AML-a
2key secondary endpoint; NE: Not Estimated Hazard ratio (HR) estimated using Cox regression model stratified according to the randomisation FLT3 mutation factor.
2ključna mjera sekundarnog ishoda; NP: nije procijenjeno Omjer hazarda (HR, engl. hazard ratio) procijenjen pomoću Coxovog regresijskog modela stratificiranog prema randomizacijskom čimbeniku FLT3 mutacije.
Rydapt + chemo n=229
Rydapt + kemo n=229
The European Medicines Agency has deferred the obligation to submit the results of studies with Rydapt in one or more subsets of the paediatric population in the treatment of acute myeloid leukaemia (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Rydapt u jednoj ili više podskupina pedijatrijske populacije u liječenju akutne mijeloične leukemije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
In patients receiving a haematopoietic stem cell transplant (SCT), Rydapt should be discontinued 48 hours prior to the conditioning regimen for SCT.
U bolesnika koji primaju transplantaciju hematopoetskih matičnih stanica (TMS), Rydapt se treba prestati primjenjivati 48 sati prije terapije kondicioniranja za TMS.
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.