FrancophonIA/ELRC3.0 huggingface dataset:
English: Prophylactic antiemetics should be administered in accordance with local medical practice as per patient tolerance.
Croatian: Profilaktički antiemetici moraju se primjenjivati u skladu s lokalnom medicinskom praksom ovisno o bolesnikovoj podnošljivosti.
English: AUCtau was decreased by 28% and 20% on day 7, respectively.
Croatian: AUCtau se smanjio za 28% odnosno za 20% 7. dana.
English: Single doses of up to 600 mg have been given with acceptable acute tolerability.
Croatian: Jednokratne doze do 600 mg davale su se s prihvatljivom akutnom podnošljivošću.
English: Finally, the long-term data from patients were analysed using a population pharmacokinetic approach.
Croatian: Naposljetku, dugoročni podaci o bolesnicima analizirani su pristupom populacijske farmakokinetike.
English: If you become pregnant or think you are pregnant, tell your doctor right away.
Croatian: Ako zatrudnite ili mislite da ste trudni, odmah obavijestite svog liječnika.
English: The protocol includes a comprehensive collection of baseline data (including biomarkers), post-study treatments, and evaluation of minimal residual disease (MRD).
Croatian: Protokol uključuje sveobuhvatno skupljanje početnih podataka (uključujući biomarkere), liječenje nakon ispitivanja i procjenu minimalne rezidualne bolesti (MRD).
English: Some other medicines can also affect how Rydapt works.
Croatian: Neki drugi lijekovi također mogu utjecati na to kako Rydapt djeluje.
English: NE
Croatian: No.
English: Median overall survival was 40.0 months (patients were only followed up for one year after treatment discontinuation for survival).
Croatian: Medijan ukupnog preživljenja bio je 40,0 mjeseci (u bolesnika se preživljenje pratilo samo godinu dana nakon obustave liječenja).
English: Rydapt (100 mg twice daily) N=142
Croatian: Rydapt (100 mg dvaput na dan) N=142
English: Your heart and lung function will also be checked regularly.
Croatian: Redovito će Vam se kontrolirati i funkcija pluća i srca.
English: The median time to response was 0.3 months (range: 0.1 to 3.7 months).
Croatian: Medijan vremena do odgovora bio je 0,3 mjeseca (raspon: 0,1 do 3,7 mjeseci).
English: Of the patients with race information reported, 88.1% were Caucasian.
Croatian: Od bolesnika za koje su prijavljeni podaci o rasi, 88,1% bili su bijelci.
English: QTc interval >470 msecs and ≤500 msecs
Croatian: QTc interval > 470 msec i ≤ 500 msec
English: Response to Rydapt was determined using a computational algorithm applied without any adjudication.
Croatian: Odgovor na Rydapt utvrđen je pomoću komputacijskog algoritma primijenjenog bez ikakvog prosuđivanja.
English: These medicines must be avoided during treatment with Rydapt.
Croatian: Ovi se lijekovi moraju izbjegavati tijekom liječenja Rydaptom.
English: The safety and efficacy of Rydapt in children and adolescents below 18 years have not been established (see section 5.1).
Croatian: Sigurnost i djelotvornost Rydapta u djece i adolescenata mlađih od 18 godina nisu ustanovljene (vidjeti dio 5.1).
English: - Patients with AML
Croatian: - Bolesnici s AML-om
English: Your doctor will ask you to take a pregnancy test before you start treatment with Rydapt to make sure you are not pregnant.
Croatian: Liječnik će Vas zamoliti da napravite test na trudnoću prije nego počnete liječenje Rydaptom kako biste bili sigurni da niste trudni.
English: In vitro evaluation of drug-drug interaction potential
Croatian: In vitro evaluacija potencijala interakcije između lijekova
English: Depending on how you respond to Rydapt, your doctor may lower your dose or temporarily interrupt the treatment.
Croatian: Ovisno o Vašem odgovoru na Rydapt, liječnik Vam može sniziti dozu ili privremeno prekinuti liječenje.
English: Any active serious infection should be under control prior to starting treatment with Rydapt monotherapy.
Croatian: Svaka aktivna ozbiljna infekcija treba biti pod kontrolom prije početka monoterapije Rydaptom.
English: The KIT D816V mutation was detected in 82% of patients.
Croatian: KIT D816V mutacija detektirana je u 82% bolesnika.
English: Out of 116 patients, 113 had a C-finding as defined by IWG response criteria (excluding ascites as a C-finding).
Croatian: Od 116 bolesnika, 113 je imalo C-nalaz definiran kriterijima IWG-a za odgovor (isključujući ascites kao C-nalaz).
English: Response rates were assessed based on the modified Valent and Cheson criteria and responses were adjudicated by a study steering committee.
Croatian: Stope odgovora bile su procijenjene na temelju modificiranih kriterija Valenta i Chesona, a odgovore je prosudio upravni odbor za ispitivanje.
English: The primary endpoint was ORR evaluated by the Valent criteria during the first two cycles of treatment.
Croatian: Mjera primarnog ishoda bio je ORR ocijenjen prema Valentovim kriterijima tijekom prva dva ciklusa liječenja.
English: The primary endpoint was overall response rate (ORR).
Croatian: Mjera primarnog ishoda bila je ukupna stupa odgovora (ORR, engl. overall response rate).
English: These are disorders in which the body produces too many mast cells, a type of white blood cell.
Croatian: To su poremećaji kod kojih tijelo proizvodi previše mastocita, vrste bijelih krvnih stanica.
English: Patients with symptomatic congestive heart failure were excluded from clinical studies.
Croatian: Bolesnici sa simptomatskim kongestivnim zatajenjem srca bili su isključeni iz kliničkih ispitivanja.
English: If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Croatian: Ako koristite hormonski kontraceptiv, morate također koristiti mehaničku metodu kontracepcije kao što je kondom ili dijafragma.
English: Other medicines and Rydapt
Croatian: Drugi lijekovi i Rydapt
English: Take special care when driving and using machines as you may develop dizziness and vertigo while you are taking Rydapt.
Croatian: Budite posebno oprezni kad upravljate vozilima i strojevima budući da možete osjetiti omaglicu i vrtoglavicu dok uzimate Rydapt.
English: Rydapt is not recommended to be used in children and adolescents (see section 4.2).
Croatian: Rydapt se ne preporučuje za upotrebu u djece i adolescenata (vidjeti dio 4.2).
English: In vitro, midostaurin did not inhibit hERG channel activity up to the limit of solubility of 12 µM.
Croatian: In vitro midostaurin nije inhibirao aktivnost hERG kanala do granice topivosti od 12 µM.
English: What Rydapt is and what it is used for
Croatian: Što je Rydapt i za što se koristi
English: - Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Croatian: - Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvo oštećenje pakiranja ili ako ima znakova neovlaštenog otvaranja.
English: Probability of Survival (%)
Croatian: Vjerojatnost preživljenja (%)
English: There is no known specific antidote for midostaurin.
Croatian: Ne postoji specifičan antidot za midostaurin.
English: Mating index, fertility index and conception rates were reduced at 0, 5 and 15 mg/kg/day, but not at 2 mg/kg/day.
Croatian: Indeks parenja, indeks plodnosti i stope začeća bile su smanjene pri 0, 5 i 15 mg/kg/dan, ali ne pri 2 mg/kg/dan.
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first, using the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Unutar svakog organskog sustava nuspojave su poredane po učestalosti, počevši od najučestalijih, prema sljedećoj konvenciji (CIOMS III): vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Stopping your treatment with Rydapt may cause your condition to become worse.
Croatian: Prekidanje liječenja Rydaptom može uzrokovati pogoršanje Vašeg stanja.
English: - If you are being treated for ASM, SM-AHN or MCL, you will receive Rydapt as a long-term treatment, possibly lasting for months or years.
Croatian: - Ako se liječite zbog ASM-a, SM-AHN-a ili MCL-a, primat ćete Rydapt kao dugoročnu terapiju koja bi mogla trajati mjesecima ili godinama.
English: Midostaurin has a tissue distribution of geometric mean of 95.2 l (Vz/F).
Croatian: Midostaurin ima distribuciju u tkivu geometrijske srednje vrijednosti od 95,2 l (Vz/F).
English: - If you are being treated for AML, after you finish taking Rydapt with chemotherapy medicines,
Croatian: - Ako se liječite zbog AML-a, nakon što završite uzimanje Rydapta s lijekovima za kemoterapiju,
English: Rydapt should be taken orally twice daily at approximately 12-hour intervals.
Croatian: Rydapt treba uzimati peroralno dvaput na dan u razmacima od otprilike 12 sati.
English: Secondary endpoints included duration of response, time to response, and overall survival.
Croatian: Mjere sekundarnog ishoda uključivale su trajanje odgovora, vrijeme do odgovora te ukupno preživljenje.
English: Talk to your doctor if you are told that you have to start taking one of them during Rydapt treatment.
Croatian: Obratite se svom liječniku ako Vam je rečeno da morate početi uzimati neki od njih tijekom liječenja Rydaptom.
English: ADRs that led to treatment discontinuation occurred in 9.2% of patients.
Croatian: Nuspojave koje su dovele do obustave liječenja pojavile su se u 9,2% bolesnika.
English: Final CSR: June 2023
Croatian: Završni CSR: lipanj 2023
English: The median duration of exposure to Rydapt was 11.4 months (range: 0 to 81 months).
Croatian: Medijan trajanja izloženosti Rydaptu bio je 11,4 mjeseca (raspon: 0 do 81 mjeseca).
English: ANC: Absolute Neutrophil Count
Croatian: ABN: apsolutni broj neutrofila
English: In situations where satisfactory therapeutic alternatives do not exist, patients should be closely monitored for midostaurin-related toxicity.
Croatian: U situacijama kad ne postoje zadovoljavajuće druge terapijske mogućnosti, bolesnike je potrebno pažljivo pratiti zbog mogućih toksičnosti povezanih s midostaurinom.
English: Safety pharmacology studies indicate that midostaurin is unlikely to interfere with vital functions of the central nervous system.
Croatian: Ispitivanja sigurnosne farmakologije ukazuju na to kako je malo vjerojatno da midostaurin ometa vitalne funkcije središnjeg živčanog sustava.
English: In clinical studies, the efficacy and safety of Rydapt were investigated following administration with a light meal.
Croatian: U kliničkim ispitivanjima, djelotvornost i sigurnost primjene Rydapta istražene su nakon primjene uz lagani obrok.
English: Rydapt may be held for as many cycles as necessary until QTc improves.
Croatian: Rydapt se može uskratiti koliko je god ciklusa potrebno dok se QTc ne popravi.
English: Total bilirubin increased*
Croatian: Povišen ukupni bilirubin*
English: Do not open, crush or chew them to ensure proper dosing and avoid the unpleasant taste of the capsule content.
Croatian: Nemojte ih otvarati, drobiti ili žvakati kako biste osigurali pravilno doziranje i izbjegli neugodan okus sadržaja kapsule.
English: In a subgroup analysis, no apparent OS benefit was observed in females, however, a treatment benefit was observed in females in all secondary efficacy endpoints (see Table 6).
Croatian: U analizi podskupina nije bila opažena vidljiva korist za OS kod žena, međutim, terapijska korist opažena je kod žena u pogledu svih mjera sekundarnog ishoda djelotvornosti (vidjeti Tablicu 6).
English: CTCAE severity: Grade 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.
Croatian: Težina prema CTCAE-u: 1. stupanj = blagi simptomi; 2. = umjereni simptomi; 3. = teški simptomi; 4. = simptomi opasni po život.
English: Final CSR: December
Croatian: Završni CSR: prosinac
English: Median Survival (months)
Croatian: Medijan preživljenja (mjeseci)
English: You should also tell your doctor if you are already taking Rydapt and you are prescribed a new medicine that you have not previously taken during treatment with Rydapt.
Croatian: Također trebate obavijestiti svog liječnika ako već uzimate Rydapt, a bude Vam propisan novi lijek kojeg niste ranije uzimali za vrijeme liječenja Rydaptom.
English: If you stop taking Rydapt
Croatian: Ako prestanete uzimati Rydapt
English: There is limited experience with midostaurin in AML patients aged 60-70 years and no experience in AML patients above 70 years.
Croatian: Postoje ograničena iskustva s midostaurinom u oboljelih od AML-a u dobi od 60-70 godina, a s oboljelima od AML-a starijima od 70 godina nema nikakvih iskustava.
English: CGP62221 exhibited a similar pattern.
Croatian: CGP62221 je pokazao sličan obrazac.
English: In general, midostaurin and its metabolites showed no major deviation from dose-proportionality after a single dose in the range of 25 mg to 100 mg.
Croatian: Općenito, midostaurin i njegovi metaboliti nisu pokazali veća odstupanja od proporcionalnosti s dozom nakon jednokratne doze u rasponu od 25 mg do 100 mg.
English: Due to the limited pharmacokinetic data in paediatric patients, no comparison with midostaurin pharmacokinetics in adults can be made.
Croatian: Zbog ograničenih farmakokinetičkih podataka u pedijatrijskih bolesnika, nije moguće napraviti usporedbu s farmakokinetikom midostaurina u odraslih.
English: Midostaurin blocks the action of some enzymes (kinases) in the abnormal cells and stops their division and growth.
Croatian: Midostaurin blokira djelovanje nekih enzima (kinaza) u poremećenim stanicama i zaustavlja njihovu diobu i rast.
English: Overall survival n/N (%)
Croatian: Ukupno preživljenje n/N (%)
English: Stable disease, n (%) Progressive disease, n
Croatian: Djelomični odgovor, n (%) Stabilna bolest, n (%) Progresivna bolest, n
English: Months Midostaurin Placebo
Croatian: Mjeseci Midostaurin Placebo
English: If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Rydapt.
Croatian: Ako uzimate bilo koji od ovih lijekova, liječnik će Vam možda propisati drugi lijek tijekom liječenja Rydaptom.
English: Talk to your doctor, pharmacist or nurse before taking Rydapt: - if you have any infections.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Rydapt: - ako imate bilo kakve infekcije. - ako imate srčani poremećaj.
English: 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.
Croatian: Perzistentna toksičnost stupnja 1. ili 2. koju bolesnici smatraju neprihvatljivom može biti povod za prekid primjene sve do 28 dana.
English: 9/l) persists >2 weeks and is suspected to be related to Rydapt, discontinue Rydapt.
Croatian: 9/l) ustraje > 2 tjedna i sumnja se da je povezana s Rydaptom, obustaviti primjenu Rydapta.
English: Overall survival (months)
Croatian: Ukupno preživljenje (mjeseci)
English: In vitro data showed midostaurin is more than 98% bound to plasma proteins, such as albumin, α1-acid glycoprotein (AGP) and lipoprotein.
Croatian: 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.
English: - If you vomit after you swallow the capsules, do not take any more capsules until your next scheduled dose.
Croatian: - Ako povratite nakon što ste progutali kapsule, nemojte uzimati još kapsula do svoje sljedeće doze prema rasporedu.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE39
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE39
English: - Do not use this medicine after the expiry date which is stated on the carton and the blister foil after EXP.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i foliji blistera iza oznake EXP.
English: 36.8 (5.5, NE)
Croatian: 36,8 (5,5; NP)
English: Neutropenia and infections
Croatian: Neutropenija i infekcije
English: If QTc interval is not improved in time to start the next cycle do not administer Rydapt during that cycle.
Croatian: Ako se QTc interval ne poboljša na vrijeme za početak sljedećeg ciklusa, ne primjenjivati Rydapt tijekom tog ciklusa.
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).
Croatian: 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).
English: In vitro and in vivo genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of mutagenic or clastogenic activity.
Croatian: In vitro i in vivo ispitivanja genotoksičnosti koja su obuhvaćala značajne mjere ishoda genotoksičnosti nisu pokazala nikakve dokaze mutagene ili klastogene aktivnosti.
English: Midostaurin can cause foetal harm when administered to a pregnant woman.
Croatian: Midostaurin može naškoditi fetusu kada se primjenjuje u trudnica.
English: There are no differences in the pharmacokinetic profile between Caucasian and Black subjects.
Croatian: Nema razlika o farmakokinetičkom profilu između ispitanika bijele i crne rase.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
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.
Croatian: 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.
English: Midostaurin is a compound with good absorption and poor solubility.
Croatian: Midostaurin je spoj s dobrom apsorpcijom i slabom topljivošću.
English: The median age was 64.5 years with half of the patients ≥65 years).
Croatian: Medijan dobi bio je 64,5 godine, pri čemu je polovica bolesnika imala ≥ 65 godina).
English: 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.
Croatian: Akutna mijeloična leukemija oblik je raka određenih bijelih krvnih stanica (zvanih „mijeloične“ stanice) kod kojeg tijelo prekomjerno proizvodi poremećenu vrstu tih stanica.
English: Dose modifications (interruption or adjustment) due to ADRs occurred in 31% of patients.
Croatian: Do promjene doze (prekida ili prilagodbe) uzrokovane nuspojavama došlo je u 31% bolesnika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJE SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: In a toxicity study in juvenile rats, midostaurin was administered from days 7 to 70 postpartum.
Croatian: U ispitivanju toksičnosti na mladim štakorima, midostaurin se primjenjivao od 7. do 70. dana nakon poroda.
English: The median age in the primary efficacy population was 64 years with approximately half of the patients ≥65 years.
Croatian: Medijan dobi u populaciji za utvrđivanje primarne djelotvornosti bio je 64 godine, pri čemu je otprilike polovica bolesnika imala ≥ 65 godina.
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.
Croatian: 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.
English: 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.
Croatian: 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.
English: The mean AUClast of CGP52421 decreased by 60%.
Croatian: Srednja vrijednost AUClast za CGP52421 smanjila se za 60%.
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.
Croatian: 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.
English: 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.
Croatian: 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.
English: At the start of treatment in AML Rydapt is always used together with chemotherapy (medicines for treating cancer).
Croatian: Na početku liječenja kod AML-a, Rydapt se uvijek koristi zajedno s kemoterapijom (lijekovima za liječenje raka).
English: Available animal data have shown that midostaurin and its active metabolites pass into the milk of lactating rats.
Croatian: Dostupni podaci iz ispitivanja na životinjama pokazali su da midostaurin i njegovi aktivni metaboliti prelaze u mlijeko štakora u laktaciji.
English: Environmental risk assessment studies have shown that midostaurin has the potential to be persistent, bioaccumulative and toxic to the environment.
Croatian: Ispitivanja procjene rizika za okoliš pokazala su da midostaurin ima potencijal da bude perzistentan, bioakumulativan i toksičan za okoliš.
English: Figure 1 Kaplan-Meier curve for overall survival, non-censored for SCT
Croatian: Slika 1 Kaplan-Meierova krivulja za ukupno preživljenje, necenzurirana za TMS
English: Injury, poisoning and procedural complications Contusion
Croatian: Ozljede, trovanja i proceduralne komplikacije Kontuzija često
English: Forty-eight per cent were male in the midostaurin arm and 41% in the placebo arm.
Croatian: Četrdeset i osam posto su bili muškarci u skupini koja je primala midostaurin, a 41% u placebo skupini.
English: Strong CYP3A4 inhibitors may increase midostaurin blood concentrations.
Croatian: Snažni CYP3A4 inhibitori mogu povećati koncentracije midostaurina u krvi.
English: Midostaurin inhibited OATP1B1, BCRP and P-glycoprotein (P-gp) in vitro (see section 5.2).
Croatian: Midostaurin je inhibirao OATP1B1, BCRP i P-glikoprotein (P-gp) in vitro (vidjeti dio 5.2).
English: Kaplan-Meier estimates at 5 years (95% CI)
Croatian: Kaplan-Meierove procjene u 5. godini (95% CI)
English: All animal findings described below were observed at midostaurin exposure significantly lower than therapeutic levels.
Croatian: Svi rezultati ispitivanja na životinjama opisani u nastavku opaženi su kod značajno manje izloženosti midostaurinu od terapijskih razina.