FrancophonIA/ELRC3.0 huggingface dataset:
English: It is unknown whether gilteritinib or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se gilteritinib ili njegovi metaboliti u majčino mlijeko.
English: Sixteen patients were randomised but not treated in the study (1 patient in the gilteritinib arm and 15 patients in the chemotherapy arm).
Croatian: Šesnaest je bolesnika bilo randomizirano, ali ne i liječeno u ispitivanju (1 bolesnik u skupini koja je primala gilteritinib i 15 njih u skupini liječenoj kemoterapijom).
English: If you stop taking Xospata
Croatian: Ako prestanete uzimati lijek Xospata
English: - Heart rhythm problems (QT prolongation).
Croatian: - Problemi sa srčanim ritmom (produljenje QT intervala).
English: • Rapid weight gain
Croatian: • naglo povećanje tjelesne težine
English: In this study, 371 patients were randomised in a 2:1 ratio to receive gilteritinib or one of the following salvage chemotherapies (247 in the gilteritinib arm and 124 in the salvage chemotherapy arm):
Croatian: U tom je ispitivanju 371 bolesnik bio randomiziran u omjeru 2:1 za primanje gilteritiniba ili jedne od sljedećih spasonosnih kemoterapija (247 u skupini liječenoj gilteritinibom i 124 u skupini liječenoj spasonosnom kemoterapijom):
English: In situations where satisfactory therapeutic alternatives do not exist, patients should be closely monitored for toxicities during administration of gilteritinib (see section 4.5).
Croatian: Ako ne postoje druge zadovoljavajuće terapijske mogućnosti, bolesnike treba pažljivo nadzirati zbog moguće pojave toksičnosti tijekom primjene gilteritiniba (vidjeti dio 4.5).
English: Xospata should be interrupted and can be resumed at a reduced dose when the signs and symptoms of pancreatitis have resolved (see section 4.2).
Croatian: Liječenje lijekom Xospata treba privremeno prekinuti, a može se nastaviti smanjenom dozom kada se znakovi i simptomi pankreatitisa povuku (vidjeti dio 4.2).
English: Xospata may be re-initiated in patients following haematopoietic stem cell transplantation (HSCT) (see Table 1).
Croatian: Liječenje lijekom Xospata može se ponovno uvesti u bolesnika nakon presađivanja krvotvornih matičnih stanica (engl. haematopoietic stem cell transplantation, HSCT) (vidjeti Tablicu 1).
English: The educational material is aimed at haematologists who treat patients with leukemias including AML, and patients with AML prescribed Xospata to further inform prescribers and patients regarding the important identified risk of differentiation syndrome.
Croatian: Edukacijski materijal namijenjen je hematolozima koji liječe bolesnike s različitim oblicima leukemije, uključujući AML, te bolesnicima s AML-om kojima je propisana Xospata, a njegova je svrha dodatno informirati liječnike koji propisuju lijek i bolesnike o važnom utvrđenom riziku od sindroma diferencijacije.
English: An electrocardiogram (ECG) should be performed before initiation of gilteritinib treatment, on day 8 and 15 of cycle 1 and prior to the start of the next three subsequent months of treatment (see sections 4.4 and 4.8).
Croatian: Elektrokardiogram (EKG) treba učiniti prije uvođenja liječenja gilteritinibom, 8. i 15. dana 1. ciklusa te prije početka sljedeća tri uzastopna mjeseca liječenja (vidjeti dijelove 4.4 i 4.8).
English: The most frequent serious adverse reactions were diarrhoea (4.7%), ALT increased (4.1%), dyspnea (3.4%), AST increased (3.1%) and hypotension (2.8%).
Croatian: Najčešće ozbiljne nuspojave bile su proljev (4,7%), povišene vrijednosti ALT-a (4,1%), dispneja (3,4%), povišene vrijednosti AST-a (3,1%) i hipotenzija (2,8%).
English: - The other ingredients are: mannitol (E421), hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide, iron oxide yellow (E172).
Croatian: Drugi sastojci su: manitol (E421), hidroksipropilceluloza, nisko supstituirana hidroksipropilceluloza, magnezijev stearat, hipromeloza, talk, makrogol, titanijev dioksid, žuti željezov oksid (E172).
English: A population pharmacokinetic analysis was performed to evaluate the impact of intrinsic and extrinsic covariates on the predicted exposure of gilteritinib in patients with relapsed or refractory AML.
Croatian: Provedena je populacijska farmakokinetička analiza kako bi se ocijenio utjecaj intrinzičnih i ekstrinzičnih kovarijata na predviđenu izloženost gilteritinibu u bolesnika s relapsirajućim ili refraktornim AML-om.
English: The recommended starting dose is 120 mg gilteritinib (three 40 mg tablets) once daily.
Croatian: Preporučena početna doza je 120 mg gilteritiniba (tri tablete od 40 mg) jedanput na dan.
English: Gilteritinib plasma concentrations declined in a bi-exponential manner with a population mean estimated half-life of 113 hours.
Croatian: Plazmatske koncentracije gilteritiniba opadale su bieksponencijalno, uz procijenjenu srednju vrijednost poluvijeka u populaciji od 113 sati.
English: • Dizziness or lightheadedness
Croatian: • omaglicu ili ošamućenost
English: Round, light yellow film-coated tablet, debossed with the company logo and ‘235' on the same side.
Croatian: Okrugla, svjetložuta, filmom obložena tableta, s utisnutim logotipom proizvođača i oznakom ‘235' na istoj strani.
English: Patients randomised to the gilteritinib arm had significantly longer survival compared to the chemotherapy arm (HR 0.637; 95% CI 0.490 - 0.830; 1 sided p-value: 0.0004).
Croatian: Bolesnici randomizirani u skupinu liječenu gilteritinibom imali su značajno dulje preživljenje nego oni u skupini koja je primala kemoterapiju (HR: 0,637; 95% CI: 0,490 - 0,830; jednostrana p-vrijednost: 0,0004).
English: Each pack contains 84 film-coated tablets.
Croatian: Jedno pakiranje sadrži 84 filmom obložene tablete.
English: If you forget to take Xospata
Croatian: Ako ste zaboravili uzeti lijek Xospata
English: Blood chemistries, including creatine phosphokinase, should be assessed prior to initiation of treatment, on day 15 and monthly for the duration of treatment.
Croatian: Potrebno je odrediti biokemijske parametre krvi, uključujući kreatin fosfokinazu, prije uvođenja liječenja, 15. dana i zatim jednom mjesečno tijekom trajanja liječenja.
English: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.
Croatian: Sindrom diferencijacije povezan je s brzom proliferacijom i diferencijacijom mijeloidnih stanica te može biti opasan po život ili smrtonosan ako se ne liječi.
English: Differentiation syndrome can happen any time during the first 3 months of treatment from as early as 2 days after starting treatment.
Croatian: Sindrom diferencijacije može nastupiti u bilo kojem trenutku tijekom prva 3 mjeseca liječenja, počevši već 2 dana nakon početka liječenja.
English: Prior to treatment with gilteritinib, 39.4% of patients had primary refractory AML and the majority of these patients were classified as refractory after 1 cycle of chemotherapy induction treatment, 19.7% had relapsed AML after an allogeneic haematopoietic stem cell transplant (HSCT) and 41% had relapsed AML with no allogeneic HSCT.
Croatian: Prije liječenja gilteritinibom 39,4% bolesnika imalo je primarni refraktorni AML i većina je njih svrstana u kategoriju bolesnika s refraktornom bolešću nakon 1 ciklusa uvodnog kemoterapijskog liječenja, 19,7% njih imalo je relaps AML-a nakon alogenog presađivanja krvotvornih matičnih stanica (HSCT), a 41% bolesnika imalo je relaps AML-a bez alogenog HSCT-a.
English: Therefore, concomitant use of gilteritinib with these products should be avoided unless use is considered essential for the care of the patient (see section 4.5).
Croatian: Stoga istodobnu primjenu gilteritiniba s tim lijekovima treba izbjegavati, osim u slučajevima kada se ona smatra neophodnom za liječenje bolesnika (vidjeti dio 4.5).
English: The effect of mild or moderate renal impairment was evaluated using a population pharmacokinetic model.
Croatian: Učinak blagog ili umjerenog oštećenja bubrežne funkcije ocjenjivao se modelom populacijske farmakokinetičke analize.
English: Gilteritinib is not an inhibitor or inducer of CYP3A4 or and inhibitor of MATE1 in vivo.
Croatian: In vivo gilteritinib nije ni inhibitor ni induktor CYP3A4, kao ni inhibitor prijenosnika MATE1.
English: Dizziness has been reported in patients taking Xospata and should be considered when assessing a patient's ability to drive or use machines (see section 4.8).
Croatian: U bolesnika koji su uzimali lijek Xospata prijavljena je omaglica, što treba uzeti u obzir prilikom ocjenjivanja bolesnikove sposobnosti upravljanja vozilima ili rada sa strojevima (vidjeti dio 4.8).
English: The median OS was 9.3 months for patients receiving gilteritinib and 5.6 months for those receiving chemotherapy.
Croatian: Medijan OS-a iznosio je 9,3 mjeseca u bolesnika koji su primali gilteritinib te 5,6 mjeseci u onih liječenih kemoterapijom.
English: The in vivo micronucleus test showed that gilteritinib has a potential to induce micronuclei in mice.
Croatian: Mikronukleusni test in vivo pokazao je da gilteritinib može inducirati mikronukleuse u miševa.
English: Of the 319 patients treated with Xospata in the clinical studies, 0.6% experienced posterior reversible encephalopathy syndrome (PRES).
Croatian: Od 319 bolesnika liječenih lijekom Xospata u kliničkim ispitivanjima, njih 0,6% imalo je sindrom posteriorne reverzibilne encefalopatije (PRES).
English: Caution is warranted in patients with relevant cardiac history.
Croatian: Nužan je oprez u bolesnika s relevantnim srčanim stanjima u anamnezi.
English: Xospata should be interrupted in patients who have a QTcF >500 msec (see section 4.2).
Croatian: Primjenu lijeka Xospata treba privremeno prekinuti u bolesnika kojima je QTcF > 500 ms (vidjeti dio 4.2).
English: While the study included patients with various AML-related cytogenetic abnormalities, patients with acute promyelocytic leukaemia (APL) or therapy-related AML were excluded.
Croatian: Iako su u ispitivanju sudjelovali bolesnici s različitim citogenetskim abnormalnostima povezanima s AML-om, u njega nisu bili uključeni bolesnici s akutnom promijelocitnom leukemijom (APL) ili AML-om povezanim s liječenjem.
English: Xospata is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Croatian: Primjena lijeka Xospata ne preporučuje se u trudnica i žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju.
English: Each film-coated tablet contains 40 mg gilteritinib (as fumarate) For the full list of excipients, see section 6.1.
Croatian: Jedna filmom obložena tableta sadrži 40 mg gilteritiniba (u obliku fumarata) Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2 and 5.1).
Croatian: Xospata je indicirana kao monoterapija za liječenje odraslih bolesnika s relapsirajućom ili refraktornom akutnom mijeloičnom leukemijom (AML) i mutacijom gena FLT3 (vidjeti dijelove 4.2 i 5.1).
English: Women using hormonal contraceptives should add a barrier method of contraception.
Croatian: Žene koje primjenjuju hormonske kontraceptive trebaju uz njih koristiti i mehaničku metodu kontracepcije.
English: Available animal data have shown excretion of gilteritinib and its metabolites in the animal milk of lactating rats and distribution to the tissues in infant rats via the milk (see section 5.3).
Croatian: Dostupni podaci iz ispitivanja na životinjama pokazali su da su se gilteritinib i njegovi metaboliti izlučivali u mlijeko ženki štakora u laktaciji i da su se putem mlijeka distribuirali u tkiva mladunčadi štakora (vidjeti dio 5.3).
English: Avoid concomitant use of these medicinal products with Xospata unless use is considered essential for the care of the patient.
Croatian: Potrebno je izbjegavati istodobnu primjenu tih lijekova i lijeka Xospata, osim u slučajevima kada se ona smatra neophodnom za liječenje bolesnika.
English: - inflammation of the heart (pericarditis) - heart failure
Croatian: - upala srca (perikarditis) - zatajenje srca
English: If you have any further questions about your treatment, please contact your doctor.
Croatian: Ako imate bilo kakvih dodatnih pitanja o svom liječenju, obratite se svom liječniku.
English: Steady-state plasma levels are reached within 15 days of once-daily dosing with an approximate 10-fold accumulation.
Croatian: Razine u plazmi u stanju dinamičke ravnoteže postižu se unutar 15 dana primjene jedanput na dan, uz približno deseterostruku akumulaciju.
English: How Xospata works
Croatian: Kako Xospata djeluje
English: Contact your doctor straight away if you have a change in your heartbeat, or if you feel dizzy, lightheaded, or faint.
Croatian: Odmah se obratite svom liječniku ako primijetite promjenu u kucanju srca, ili osjećate omaglicu, ošamućenost ili nesvjesticu.
English: Astellas Pharma a/s Tlf: +45 43 430355
Croatian: Danmark Astellas Pharma a/s Tlf: +45 43 430355
English: OPA/aluminium/PVC/aluminium blisters containing 21 film-coated tablets.
Croatian: 6.5 Vrsta i sadržaj spremnika OPA/Al/PVC/Al blisteri koji sadrže 21 filmom obloženu tabletu.
English: Males of reproductive potential should be advised to use effective contraception during treatment and for at least 4 months after the last dose of Xospata (see section 4.4).
Croatian: Muškarcima reproduktivne dobi preporučuje se da koriste učinkovitu kontracepciju tijekom liječenja i još najmanje 4 mjeseca nakon posljednje doze lijeka Xospata (vidjeti dio 4.4).
English: Of 319 patients treated with Xospata in the clinical studies, 11 (3%) experienced differentiation syndrome.
Croatian: Od 319 bolesnika liječenih lijekom Xospata u kliničkim ispitivanjima, u njih 11 (3%) javio se sindrom diferencijacije.
English: The median OS was 7.2 months and 7.1 months for the 120 mg dose and the combined dose levels, respectively.
Croatian: Medijan OS-a iznosio je 7,2 mjeseca za dozu od 120 mg te 7,1 mjesec za objedinjene doze.
English: Strong inhibitors of CYP3A and/or P-gp (e.g., voriconazole, itraconazole, posaconazole, clarithromycin, erythromycin, captopril, carvedilol, ritonavir, azithromycin) can increase gilteritinib plasma concentrations.
Croatian: Snažni inhibitori CYP3A i/ili P-gp-a (npr. vorikonazol, itrakonazol, posakonazol, klaritromicin, eritromicin, kaptopril, karvedilol, ritonavir, azitromicin) mogu povisiti plazmatske koncentracije gilteritiniba.
English: A majority of patients had AML with intermediate risk cytogenetics (73%), 10% had unfavourable, 1.3% had favourable and 15.6% had unclassified cytogenetics.
Croatian: Većina je bolesnika imala AML srednjeg citogenetskog rizika (73%), 10% njih imalo je nepovoljnu citogenetiku, 1,3% imalo je povoljnu citogenetiku, a u 15,6% bolesnika citogenetski rizik nije bio klasificiran.
English: Gilteritinib exposure increased approximately 1.5-fold in patients with relapsed or refractory AML when co-administered with a strong CYP3A and/or P-gp inhibitor (see section 4.4).
Croatian: Izloženost gilteritinibu u bolesnika s relapsirajućim ili refraktornim AML-om povećala se približno 1,5 puta kada se primjenjivao istodobno sa snažnim inhibitorom CYP3A i/ili P-gp-a (vidjeti dio 4.4).
English: IMPORTANT SAFETY INFORMATION FOR PATIENTS Xospata may cause serious side effects, including differentiation syndrome.
Croatian: Xospata može uzrokovati ozbiljne nuspojave, uključujući sindrom diferencijacije.
English: Gilteritinib has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Gilteritinib se nije ispitivao u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
English: These may be signs of a condition called differentiation syndrome (see section 4 - Possible side effects).
Croatian: To mogu biti znakovi stanja koje se zove sindrom diferencijacije (pogledajte dio 4. - Moguće nuspojave).
English: Gilteritinib may reduce the effects of medicinal products that target 5HT2B receptor or sigma nonspecific receptors.
Croatian: Gilteritinib može oslabiti učinke lijekova koji djeluju ciljano na receptor 5HT2B ili nespecifične sigma receptore.
English: Alternative medicinal products that do not strongly inhibit CYP3A and/or P-gp activity should be considered.
Croatian: Treba razmotriti primjenu drugih lijekova koji nisu snažni inhibitori CYP3A i/ili P-gp-a.
English: Other Grade 3a or higher toxicity considered related to treatment.
Croatian: a ili višeg stupnja koje se smatraju povezanima s liječenjem
English: She or he may also pause Xospata treatment until symptoms are reduced.
Croatian: Liječnik će također možda privremeno prekinuti liječenje lijekom Xospata dok se simptomi ne ublaže.
English: Gilteritinib has been associated with prolonged cardiac ventricular repolarisation (QT Interval) (see sections 4.8 and 5.1).
Croatian: Gilteritinib je povezan s produljenjem repolarizacije srčane klijetke (QT intervala) (vidjeti dijelove 4.8 i 5.1).
English: Xospata 40 mg film-coated tablets are round, light yellow film-coated tablets with the company logo and ‘235' debossed on one side of the tablet.
Croatian: Xospata 40 mg filmom obložene tablete su okrugle, svjetložute filmom obložene tablete s utisnutim logotipom proizvođača i oznakom ‘235' na jednoj strani.
English: Xospata 40 mg film-coated tablets gilteritinib
Croatian: Xospata 40 mg filmom obložene tablete gilteritinib
English: The effect of severe renal impairment on gilteritinib exposure has not been investigated (see section 4.2).
Croatian: Nije se ocjenjivao učinak teškog oštećenja bubrežne funkcije na izloženost gilteritinibu (vidjeti dio 4.2).
English: Gilteritinib was excreted into the milk of lactating rats with milk concentrations being higher than in maternal plasma.
Croatian: Gilteritinib se izlučio u mlijeko ženki štakora u laktaciji, pri čemu su koncentracije u mlijeku bile više od onih u majčinoj plazmi.
English: Results indicate unbound gilteritinib exposure in subjects with mild or moderate hepatic impairment is comparable to that observed in subjects with normal hepatic function.
Croatian: Rezultati ukazuju na to da je izloženost nevezanom gilteritinibu u ispitanika s blagim ili umjerenim oštećenjem jetrene funkcije usporediva s onom u ispitanika s normalnom jetrenom funkcijom.
English: Based on in vitro data, gilteritinib may reduce the effects of medicinal products that target 5HT2B receptor or sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline).
Croatian: Prema podacima in vitro, gilteritinib može smanjiti učinke lijekova koji ciljano djeluju na receptor 5HT2B ili nespecifičan sigma receptor (npr. escitalopram, fluoksetin, sertralin).
English: 80 mg or 120 mgb.
Croatian: 120 mg b
English: Placental transfer of gilteritinib was shown in the rat resulting in transfer of radioactivity to the foetus similar to that observed in maternal plasma.
Croatian: U štakora je opažen prijenos gilteritiniba kroz posteljicu, što je dovelo do prijenosa radioaktivnosti na fetus, koja je bila slična onoj opaženoj u majčinoj plazmi.
English: The response rate (CR/CRh) observed in Study 2215-CL-0101 in the patients who received more than 1 line of prior therapy was 21.4% and 15.7% for the 120 mg dose and the combined dose levels, respectively.
Croatian: Stopa odgovora (CR/CRh) opažena u ispitivanju 2215-CL-0101 u bolesnika koji su prethodno primili više od jedne linije liječenja iznosila je 21,4% za dozu od 120 mg te 15,7% za objedinjene doze.
English: In rats, decreased urination at 30 mg/kg and higher and decreased defecation at 100 mg/kg were observed.
Croatian: U štakora je opaženo smanjeno mokrenje pri dozama od 30 mg/kg i više te smanjena defekacija pri dozi od 100 mg/kg.
English: • If differentiation syndrome is suspected, administer corticosteroids and initiate hemodynamic monitoring (see section 4.4).
Croatian: • Posumnja li se na sindrom diferencijacije, primijeniti kortikosteroide i uvesti praćenje hemodinamičkih parametara (vidjeti dio 4.4)
English: • Resume gilteritinib at the same dose when signs and symptoms improve to Grade 2a or lower.
Croatian: • Nastaviti liječenje gilteritinibom u istoj dozi kada se znakovi i simptomi ublaže do 2.
English: • Interrupt gilteritinib until pancreatitis is resolved.
Croatian: • Privremeno prekinuti primjenu gilteritiniba dok se pankreatitis ne povuče.
English: If it occurs, your doctor will monitor you and may give you a medicine to treat your condition.
Croatian: Ako nastupi, liječnik će pratiti Vaše stanje i možda Vam dati lijek za liječenje tog sindroma.
English: Each film-coated tablet contains 40 mg gilteritinib (as fumarate).
Croatian: Jedna filmom obložena tableta sadrži 40 mg gilteritiniba (u obliku fumarata).
English: The median age at randomisation was 62 years (range 20 to 84 years) in the gilteritinib arm and 62 years (range 19 to 85 years) in the salvage chemotherapy arm.
Croatian: Medijan dobi u trenutku randomizacije iznosio je 62 godine (raspon: 20 - 84 godine) u skupini liječenoj gilteritinibom te 62 godine (raspon: 19 - 85 godina) u skupini koja je primala spasonosnu kemoterapiju.
English: Gilteritinib showed suppressed foetal growth, and induced embryo-foetal deaths and teratogenicity in the embryo-foetal development studies in rats at exposure levels similar to clinical exposure levels.
Croatian: Gilteritinib je uzrokovao supresiju rasta fetusa, inducirao smrt embrija i fetusa te se pokazao teratogenim u ispitivanjima embriofetalnog razvoja na štakorima pri razinama izloženosti sličnima kliničkim razinama izloženosti.
English: Xospata dose interruption, reduction and discontinuation recommendations in patients with relapsed or refractory AML
Croatian: Preporuke za privremeni prekid primjene, smanjenje doze i obustavu liječenja lijekom Xospata u bolesnika s relapsirajućim ili refraktornim AML-om
English: In patients with relapsed or refractory AML receiving gilteritinib 120 mg, substantial (> 90%) inhibition of FLT3 phosphorylation was rapid (within 24 hours after first dose) and sustained, as characterised by an ex vivo plasma inhibitory activity (PIA) assay.
Croatian: U bolesnika s relapsirajućim ili refraktornim AML-om koji su primali gilteritinib u dozi od 120 mg brzo je postignuta (unutar 24 sata nakon prve doze) značajna (> 90%) i održana inhibicija fosforilacije FLT3, što je okarakterizirano testom inhibicijske aktivnosti u plazmi ex vivo.
English: Effects of other medicinal products on Xospata
Croatian: Učinci drugih lijekova na lijek Xospata
English: Therefore, electrocardiogram (ECG) should be performed prior to initiation of treatment, on day 8 and 15 of cycle 1, and prior to the start of the next three subsequent months of treatment.
Croatian: Stoga je potrebno učiniti elektrokardiogram (EKG) prije uvođenja liječenja, 8. i 15. dana 1. ciklusa i prije početka sljedeća tri uzastopna mjeseca liječenja.
English: There are no or limited amount of data from the use of gilteritinib in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni gilteritiniba u trudnica ograničeni.
English: What Xospata is and what it is used for What Xospata is
Croatian: Što je Xospata i za što se koristi
English: If vomiting occurs after dosing, patients should not take another dose but should return to the normal schedule the following day.
Croatian: Ako bolesnik povrati nakon primjene, ne smije uzeti još jednu dozu, nego sutradan nastaviti s primjenom prema uobičajenom rasporedu.