FrancophonIA/ELRC3.0 huggingface dataset:
English: Midostaurin blocks the action of some enzymes (kinases) in the abnormal cells and stops their division and growth.
Slovenian: Midostavrin zavira delovanje nekaterih encimov (kinaz) v nenormalnih celicah in tako prepreči njihovo delitev in razmnoževanje.
English: 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).
Slovenian: Po podatkih raziskav in vitro pa pri teh koncentracijah zavira receptorje KIT divjega tipa v precej manjši meri (povprečna raven izpostavljenosti je nižja od inhibitorne koncentracije IC50).
English: Acute promyelocytic leukaemia
Slovenian: Akutna promielocitna levkemija
English: Any active serious infection should be under control prior to starting treatment with Rydapt monotherapy.
Slovenian: Če je pri bolniku aktivna katerakoli resna okužba, jo je treba obvladati pred začetkom zdravljenja z zdravilom Rydapt v monoterapiji.
English: 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.
Slovenian: Iz tega razloga so pri neželenih učinkih katerekoli stopnje navedeni podatki samo za bolnike iz študijskih centrov izven Severne Amerike, pri neželenih učinkih 3. oziroma 4. stopnje pa so navedeni podatki vseh bolnikov iz vseh študijskih centrov.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Purified water
Slovenian: Ovojnica kapsule želatina glicerol titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172) prečiščena voda
English: Rydapt is recommended to be administered with food.
Slovenian: Zdravilo Rydapt je priporočeno jemati skupaj s hrano.
English: Alternative medicinal products that do not strongly inhibit CYP3A4 activity should be considered.
Slovenian: Razmisliti je treba o uporabi drugih zdravil, ki aktivnosti encimov CYP3A4 ne zavirajo močno.
English: 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.
Slovenian: Pri bolnikih, ki so jemali zdravilo Rydapt, so poročali o omotičnosti in vrtoglavici, kar je treba upoštevati pri ocenjevanju bolnikove zmožnosti za vožnjo in upravljanje strojev.
English: Safety pharmacology studies indicate that midostaurin is unlikely to interfere with vital functions of the central nervous system.
Slovenian: Rezultati študij farmakološke varnosti kažejo majhno verjetnost, da bi midostavrin lahko vplival na vitalne funkcije centralnega živčevja.
English: 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).
Slovenian: Kliničnih izkušenj uporabe pri bolnikih s hudo okvaro ledvic je malo, o uporabi pri bolnikih s končno ledvično odpovedjo pa ni na voljo nobenih podatkov (glejte poglavji 4.4 in 5.2).
English: What Rydapt is and what it is used for What you need to know before you take Rydapt How to take Rydapt
Slovenian: Kaj je zdravilo Rydapt in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Rydapt Kako jemati zdravilo Rydapt Možni neželeni učinki
English: Other medicines and Rydapt
Slovenian: Druga zdravila in zdravilo Rydapt
English: In vitro, midostaurin did not inhibit hERG channel activity up to the limit of solubility of 12 µM.
Slovenian: In vitro midostavrin ni zaviral delovanja kanalčkov hERG do koncentracije, ki je enaka meji topnosti 12 µM.
English: 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).
Slovenian: Zaenkrat ni znano, ali midostavrin lahko zmanjša učinkovitost hormonskih kontraceptivov, zato morajo ženske, ki uporabljajo hormonsko kontracepcijo, dodatno uporabljati še katero od pregradnih kontracepcijskih metod (glejte poglavje 4.6).
English: In clinical studies, the efficacy and safety of Rydapt were investigated following administration with a light meal.
Slovenian: V kliničnih študijah so učinkovitost in varnost zdravila Rydapt raziskovali v pogojih odmerjanja skupaj z lahkim obrokom.
English: (8.3, NE)
Slovenian: (8,3, NO)
English: 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.
Slovenian: Pri bolnikih, ki so prejemali midostavrin, so opažali povečano pogostnost podaljšanja intervala QTc (glejte poglavje 4.8), vendar razlage mehanizma za ta pojav še niso našli.
English: Single doses of up to 600 mg have been given with acceptable acute tolerability.
Slovenian: Osebe, ki so prejele posamezne odmerke do 600 mg, so jih prenašale z akutnimi simptomi, ki so bili sprejemljivi.
English: Pale orange, oblong capsule with red imprint “PKC NVR”.
Slovenian: Bledo oranžna podolgovata kapsula z rdečo natisnjeno oznako “PKC NVR”.
English: 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.
Slovenian: Zaenkrat ni znano, ali midostavrin lahko zmanjša učinkovitost hormonskih kontraceptivov, zato morajo ženske, ki uporabljajo hormonsko kontracepcijo, dodatno uporabljati še katero od pregradnih kontracepcijskih metod.
English: 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.
Slovenian: Večina bolnikov (77,4 %) je imela mutacijo FLT3-ITD, večina med njimi (47,6 %) z nizkim razmerjem med aleli (<0,7), 22,6 % bolnikov pa je imelo mutacijo FLT3-TKD.
English: If you stop taking Rydapt
Slovenian: Če ste prenehali jemati zdravilo Rydapt
English: QTc interval >470 msecs and ≤500 msecs
Slovenian: QTc >470 milisekund in ≤500 milisekund
English: 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.
Slovenian: V analizah modela populacijske farmakokinetike niso opažali pomembnega vpliva starosti na farmakokinetiko midostavrina in njegovih dveh aktivnih metabolitov pri bolnikih v starosti od 65 do 85 let.
English: Rydapt is not recommended during pregnancy or in women of childbearing potential not using contraception.
Slovenian: Uporaba zdravila Rydapt ni priporočljiva pri nosečnicah oziroma pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: The mean apparent plasma clearance (CL/F) was 2.4-3.1 l/h in healthy subjects.
Slovenian: Povprečna vrednost navideznega očistka iz plazme (CL/F) je bila pri zdravih preiskovancih 2,4-3,1 l/h.
English: Instead, wait until it is time for your next dose.
Slovenian: Počakajte in vzemite zdravilo, ko bo čas za naslednji odmerek.
English: ADRs are listed according to MedDRA system organ class.
Slovenian: Neželeni učinki so navedeni po organskih sistemih v skladu s klasifikacijo MedDRA.
English: Alcohol may be harmful in patients with alcohol-related problems, epilepsy or liver problems or during pregnancy or breast-feeding.
Slovenian: Alkohol lahko škoduje bolnikom, ki imajo težave z uživanjem alkohola, epilepsijo ali težave z jetri, in v času nosečnosti ali dojenja.
English: For all other adverse events, only grades 3 and 4 were collected.
Slovenian: Pri vseh drugih neželenih učinkih so zbirali podatke samo za neželene učinke 3. oziroma 4. stopnje.
English: 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.
Slovenian: Midostavrin se veže na katalitično domeno navedenih kinaz in zavira mitogeno signaliziranje vpletenih rastnih dejavnikov v celicah, kar zaustavi rast celic.
English: In situations where satisfactory therapeutic alternatives do not exist, patients should be closely monitored for midostaurin-related toxicity.
Slovenian: V primerih, ko ni na voljo drugih zadovoljivih možnosti zdravljenja, je bolnika treba skrbno spremljati in biti pozoren na pojavljanje toksičnega delovanja midostavrina.
English: ANC <1.0 x 10
Slovenian: AŠN <1,0 x 10
English: Time to peak concentration was also delayed in the presence of a high-fat meal.
Slovenian: Tudi čas za doseganje najvišje koncentracije je bil daljši pri odmerjanju skupaj z obrokom z veliko vsebnostjo maščob.
English: (34.7, NE)
Slovenian: (34,7, NO)
English: Cmin of CGP52421 was increased by 1.3-fold, whereas no significant effect in exposure of CGP62221 was observed (see section 4.4).
Slovenian: Cmin metabolita CGP52421 se je zvišala 1,3-kratno, pri čemer niso opažali pomembnega vpliva na izpostavljenost metabolitu CGP62221 (glejte poglavje 4.4).
English: If you think you may be allergic, ask your doctor for advice.
Slovenian: Če menite, da ste morda alergični na to zdravilo, se posvetujte z zdravnikom.
English: 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).
Slovenian: Midostavrin poleg tega zavira več drugih receptorskih tirozin kinaz, kot sta receptor za rastni dejavnik iz trombocitov (PDFGFR - platelet-derived growth factor receptor) in receptor za žilni endotelni rastni dejavnik 2 (VEGFR2 - vascular endothelial growth factor receptor 2), pa tudi encime iz skupine serin/treonin kinaz med protein kinazami C (PKC).
English: If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Rydapt.
Slovenian: Če jemljete katero od navedenih zdravil, vam bo zdravnik v času zdravljenja z zdravilom Rydapt morda moral predpisati druga zdravila.
English: Alcohol may be harmful if you have alcohol-related problems, epilepsy or liver problems, or if you are pregnant or breast-feeding.
Slovenian: Alkohol vam lahko škoduje, če imate težave z uživanjem alkohola, epilepsijo ali težave z jetri ali če ste noseči ali dojite.
English: 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).
Slovenian: Volumen vranice se je zmanjšal za ≥10 % pri 68,9 % tistih bolnikov, pri katerih so po izhodiščnem opravili še najmanj eno ocenjevanje (pri 26,7 % bolnikov je prišlo do zmanjšanja vranice za ≥35 %, kar ustreza 50-odstotnemu zmanjšanju pri palpaciji).
English: Rydapt + chemo n=229
Slovenian: Rydapt + kemoterapija n=229
English: 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).
Slovenian: Zdravilo Rydapt je treba odmerjati od 8. do 21. dne ciklusov indukcijske in konsolidacijske kemoterapije, nato pa pri bolnikih s popolnim odzivom vsak dan kot edino zdravilo vzdrževalnega zdravljenja do ponovitve bolezni največ 12 ciklusov po 28 dni (glejte poglavje 4.1).
English: In vitro and in vivo genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of mutagenic or clastogenic activity.
Slovenian: V študijah genotoksičnosti in vitro in in vivo, v katerih so proučevali ustrezne cilje opazovanja za oceno genotoksičnosti, ni bilo nobenih znakov za mutageno ali klastogeno delovanja zdravila.
English: The absolute bioavailability of midostaurin following oral administration is not known.
Slovenian: Absolutna biološka uporabnost midostavrina po peroralnem odmerjanju ni znana.
English: Your doctor may need to adjust, temporarily stop or completely discontinue your treatment with Rydapt.
Slovenian: Zdravnik vam bo moral morda spremeniti ali začasno prekiniti odmerjanje zdravila Rydapt ali pa zdravilo dokončno ukiniti.
English: CTCAE severity: Grade 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.
Slovenian: AŠN: absolutno število nevtrofilcev izraženost po kriterijih CTCAE: 1. stopnja = blagi simptomi; 2. stopnja = zmerni simptomi; 3. stopnja = hudi simptomi; 4. stopnja = življenjsko nevarni simptomi
English: Midostaurin and its metabolites are distributed mainly in plasma rather than red blood cells.
Slovenian: Midostavrin in njegovi metaboliti se porazdelijo večinoma v plazmi in manj v eritrocitih.
English: 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.
Slovenian: Med bolniki, ki so stari 60 let ali več, se sme zdravilo Rydapt uporabljati samo pri tistih, ki so primerni za intenzivno indukcijsko kemoterapijo, imajo ustrezno stanje zmogljivosti in nimajo pomembnih drugih sočasnih bolezni.
English: Most of the haematological abnormalities reported occurred during the induction and consolidation phase when the patients received Rydapt or placebo in combination with chemotherapy.
Slovenian: Do hematoloških nepravilnosti, o katerih so poročali, je večinoma prišlo v fazi indukcijskega oziroma konsolidacijskega zdravljenja, ko so bolniki prejemali zdravilo Rydapt ali placebo v kombinaciji s kemoterapijo.
English: The most frequent Grade 3/4 adverse reaction leading to discontinuation in the Rydapt arm was exfoliative dermatitis (1.2%).
Slovenian: Najbolj pogost neželeni učinek 3. oziroma 4. stopnje, zaradi katerega je bila v skupini z zdravilom Rydapt potrebna prekinitev zdravljenja, je bil eksfoliativni dermatitis (1,2 %).
English: - 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.
Slovenian: - Druge sestavine so: makrogolglicerol hidroksistearat, želatina, makrogol, glicerol, brezvodni etanol, mono-di-trigliceridi koruznega olja, titanov dioksid (E171), vseracemni-alfa-tokoferol, rumeni železov oksid (E172), rdeči železov oksid (E172), karmin (E120), hipromeloza, propilenglikol, prečiščena voda.
English: Rydapt is used to treat acute myeloid leukaemia (AML) in adults who have a defect in a gene called FLT3.
Slovenian: Zdravilo Rydapt uporabljamo za zdravljenje akutne mieloične levkemije (AML) pri odraslih, ki imajo okvarjen gen z imenom FLT3.
English: 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%).
Slovenian: Mediana starost pri bolnikih je bila 47 let (od 18 do 60 let), večina bolnikov je imela oceno stanja zmogljivosti po lestvici ECOG 0 ali 1 (88,3 %) in večina bolnikov je imela na novo odkrito akutno mieloično levkemijo (95 %).
English: These medicines must be avoided during treatment with Rydapt.
Slovenian: V času zdravljenja z zdravilom Rydapt se je treba izogibati uporabi navedenih zdravil.
English: Other Grade 3/4 non-haematological toxicities
Slovenian: drugi znaki ne-hematoloških toksičnih učinkov 3. oziroma 4. stopnje
English: 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).
Slovenian: Zdravilo Rydapt je treba povsem ukiniti bolnikom, pri katerih se razvije ponavljajoča se ali dolgotrajna huda nevtropenija, za katero obstaja sum, da je povezana z zdravilom Rydapt (glejte poglavje 4.2).
English: Contains macrogolglycerol hydroxystearate and ethanol anhydrous.
Slovenian: Vsebuje makrogolglicerol hidroksistearat in brezvodni etanol.
English: It is unknown whether midostaurin or its active metabolites are excreted in human milk.
Slovenian: Ni znano, ali se midostavrin in njegovi aktivni metaboliti izločajo v materino mleko.
English: If QTc improves to ≤470 msecs just prior to the next cycle, resume Rydapt at the initial dose.
Slovenian: Če se dolžina intervala QTc izboljša na ≤470 milisekund tik pred začetkom naslednjega ciklusa, je mogoče zdravilo Rydapt ponovno uvesti z začetnim odmerkom.
English: 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).
Slovenian: Med 321 vključenimi bolniki jih je 177 že prej imelo blago (n=133), zmerno (n=60) oziroma hudo (n=4) okvaro ledvic (z očistkom kreatinina med ≤15 ml/min in <90 ml/min).
English: The median terminal half-lives of midostaurin, CGP62221 and CGP52421 in plasma are approximately 20.9, 32.3 and 471 hours.
Slovenian: Mediani končni razpolovni časi midostavrina, CGP62221 in CGP52421 v plazmi so približno 20,9 ure, 32,3 ure oziroma 471 ur.
English: Discontinuation due to any adverse reaction occurred in 3.1% of patients in the Rydapt arm versus 1.3% in the placebo arm.
Slovenian: Do prekinitve zdravljenja zaradi kateregakoli neželenega učinka je prišlo pri 3,1 % bolnikov v skupini z zdravilom Rydapt v primerjavi z 1,3 % v skupini s placebom.
English: 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.
Slovenian: Vrednosti farmakokinetičnih parametrov midostavrina so se zviševale manj kot sorazmerno z odmerjanjem posameznih in večkratnih odmerkov 30 mg/m in 60 mg/m2.
English: Neutropenia has occurred in patients receiving Rydapt as monotherapy and in combination with chemotherapy (see section 4.8).
Slovenian: Do nevtropenije je pri bolnikih, ki so prejemali zdravilo Rydapt, prišlo tako pri jemanju zdravila v monoterapiji kot v kombinaciji s kemoterapijo (glejte poglavje 4.8).
English: 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.
Slovenian: Po podatkih študije faze I pri zdravih japonskih prostovoljcih so farmakokinetični profili midostavrina in njegovih metabolitov (CGP62221 in CGP52421) pri teh preiskovancih podobni tistim, ki so jih opažali v drugih farmakokinetičnih študijah, v katere so bili vključeni pripadniki bele in črne rase.
English: If you forget to take Rydapt, skip the missed dose and take your next dose at the usual time.
Slovenian: Če pozabite vzeti odmerek zdravila Rydapt, izpustite pozabljeni odmerek in vzemite naslednjega ob običajnem času.
English: Embryofoetal toxicity and breast-feeding
Slovenian: Embriofetalna toksičnost in dojenje
English: - If you vomit after you swallow the capsules, do not take any more capsules until your next scheduled dose.
Slovenian: - Če po zaužitju kapsule bruhate, ne vzemite naslednje kapsule, dokler ni čas za naslednji odmerek na razporedu.
English: Midostaurin was administered orally at 100 mg twice daily until disease progression or intolerable toxicity.
Slovenian: Midostavrin so bolniki prejemali peroralno v odmerku 100 mg dvakrat na dan do napredovanja bolezni ali razvoja nesprejemljive toksičnosti.
English: Midostaurin inhibited OATP1B1, BCRP and P-glycoprotein (P-gp) in vitro (see section 5.2).
Slovenian: Midostavrin je in vitro zaviral prenašalce OATP1B1 in BCRP ter P-glikoprotein (P-gp) (glejte poglavje 5.2).
English: 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
Slovenian: Prenehajte jemati zdravilo Rydapt in takoj obvestite zdravnika, če opazite katero od naslednjih težav, saj so to lahko znaki alergijske reakcije: - oteženo dihanje ali požiranje - omotičnost - otekanje v obraz, ustnice, jezik ali grlo oziroma žrelo - zelo srbeča koža z rdečim izpuščajem ali oteklimi lisami na koži
English: If QTc interval is not improved in time to start the next cycle do not administer Rydapt during that cycle.
Slovenian: Če se dolžina intervala QTc ne izboljša do začetka naslednjega ciklusa, se v tem ciklusu zdravila Rydapt ne sme odmerjati.
English: ANC: Absolute Neutrophil Count
Slovenian: AŠN: absolutno število nevtrofilcev
English: N.E.
Slovenian: N.O.
English: There are no differences in the pharmacokinetic profile between Caucasian and Black subjects.
Slovenian: Farmakokinetični profili se med pripadniki bele in črne rase ne razlikujejo.
English: Rydapt has not been studied in patients with acute promyelocytic leukaemia and therefore its use is not recommended in this patient population.
Slovenian: Uporabe zdravila Rydapt pri bolnikih z akutno promielocitno levkemijo niso proučevali, zato pri tej skupini bolnikov uporaba zdravila Rydapt ni priporočena.
English: 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.
Slovenian: Spremljanje v času zdravljenja z zdravilom Rydapt V času zdravljenja z zdravilom Rydapt vam bo zdravnik redno pregledoval kri, da bo lahko spremljal število krvnih celic (levkocitov, eritrocitov in trombocitov) in vrednosti elektrolitov (npr. kalcija, kalija in magnezija) v telesu.
English: 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
Slovenian: znižanje vrednosti hemoglobina na manj kot 8 g/dl zaradi zdravila Rydapt pri bolnikih, ki nimajo mastocitne levkemije, oziroma življenjsko nevarna anemija zaradi zdravila Rydapt pri bolnikih z izhodiščno vrednostjo hemoglobina 8-10 g/dl
English: The pivotal study was a multicentre, single-arm phase II study in 116 patients with advanced SM (Study CPKC412D2201).
Slovenian: Ključna študija je bila multicentrična študija faze II z eno študijsko skupino s 116 bolniki z napredovalo sistemsko mastocitozo (študija CPKC412D2201).
English: Otherwise continue Rydapt 50 mg once daily.
Slovenian: V nasprotnem primeru je treba nadaljevati zdravljenje z zdravilom Rydapt v odmerku 50 mg enkrat na dan.
English: Rydapt is not recommended to be used in children and adolescents (see section 4.2).
Slovenian: Pri otrocih in mladostnikih uporaba zdravila Rydapt ni priporočena (glejte poglavje 4.2).
English: 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.
Slovenian: Pri zdravih osebah je bila absorpcija midostavrina (AUC) za povprečno 22 % večja pri odmerjanju zdravila Rydapt skupaj s standardnim obrokom hrane in za povprečno 59 % večja pri odmerjanju zdravila skupaj z obrokom z veliko vsebnostjo maščob.
English: The median age was 64.5 years with half of the patients ≥65 years).
Slovenian: Mediana starost bolnikov je bila 64,5 let, pri čemer je bila polovica bolnikov stara najmanj 65 let.
English: Forty-eight per cent were male in the midostaurin arm and 41% in the placebo arm.
Slovenian: V skupini z midostavrinom je bilo moških 48 %, v skupini s placebom pa 41 %.
English: 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.
Slovenian: Po podatkih študije masnega ravnovesja pri ljudeh (The Human Mass Balance study) je izločanje z blatom najpomembnejši način izločanja (78 % danega odmerka), in sicer se večina odmerka izloči v obliki metabolitov (73 % danega odmerka), medtem kot nespremenjeni midostavrin predstavlja samo 3 % danega odmerka.