FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, concomitant use of gilteritinib with strong CYP3A4/P-gp inducers should be avoided (see section 4.5).
Slovenian: Zato se je treba izogibati hkratni uporabi gilteritiniba z močnimi induktorji CYP3A4/P-gp (glejte poglavje 4.5).
English: Co-administration of CYP3A/P-gp inducers may lead to decreased gilteritinib exposure and consequently a risk for lack of efficacy.
Slovenian: Sočasna uporaba induktorjev CYP3A/P-gp lahko povzroči manjšo izpostavljenost gilteritinibu in posledično tveganje za pomanjkanje učinkovitosti.
English: The pharmacological activity of the metabolites against FLT3 and AXL receptors is unknown.
Slovenian: Farmakološka aktivnost presnovkov proti receptorjema FLT3 in AXL ni znana.
English: Covariate analysis indicated that age (20 years to 90 years), and body weight (36 kg to 157 kg) were statistically significant; however predicted change in gilteritinib exposure was less than 2-fold.
Slovenian: Analiza spremenljivk je pokazala, da sta starost (od 20 let do 90 let) in telesna masa (od 36 kg do 157 kg) statistično pomembna, vendar pa je bila predvidena sprememba izpostavljenosti gilteritinibu manj kot 2-kratna.
English: The MAH shall ensure that in each Member State where Xospata is marketed, haematologists who are expected to prescribe Xospata, and patients who are expected to use Xospata are provided with the following educational materials:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer je zdravilo Xospata na trgu, vsi hematologi, ki bodo predvidoma predpisovali zdravilo Xospata, in vsi bolniki, ki ga bodo predvidoma uporabljali zdravilo Xospata, prejeli naslednja izobraževalna gradiva:
English: Corticosteroids can be tapered after resolution of symptoms and should be administered for a minimum of 3 days.
Slovenian: Odmerek kortikosteroidov se lahko po odpravi simptomov zmanjša, dajati pa jih je treba vsaj 3 dni.
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).
Slovenian: Zato se je treba izogibati hkratni uporabi gilteritiniba s temi zdravili, razen če je njihova uporaba bistvena za oskrbo bolnika (glejte poglavje 4.5).
English: Gilteritinib as an inhibitor or inducer
Slovenian: Gilteritinib kot zaviralec ali induktor
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE54
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz, oznaka ATC: L01XE54
English: Xospata belongs to a class of cancer medicines called protein kinase inihibitors.
Slovenian: Xospata sodi v skupino zdravil za zdravljenje raka, ki se imenujejo zaviralci proteinskih kinaz.
English: Xospata may cause a heart problem called QT prolongation (may affect up to 1 in 10 people).
Slovenian: Zdravilo Xospata lahko povzroči težavo s srcem, ki se imenuje podaljšanje intervala QT (pojavi se lahko pri največ 1 od 10 bolnikov).
English: - Description of signs or symptoms of the safety concern and when to seek medical care if differentiation syndrome is suspected - A warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Xospata.
Slovenian: - Opis znakov ali simptomov tega tveganja in kdaj poiskati zdravniško pomoč, če obstaja sum na sindrom diferenciacije - Opozorilo zdravnikom, ki kadar koli zdravijo bolnika (vključno s primeri nujnega zdravljenja), da bolnik uporablja zdravilo Xospata.
English: Gilteritinib inhibits FLT3 receptor signalling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and it induced apoptosis in leukemic cells expressing FLT3-ITD.
Slovenian: Gilteritinib zavira signalizacijo prek receptorja FLT3 in proliferacijo celic z eksogeno ekspresijo FLT3, vključno s FLT3-ITD, FLT3-D835Y in FLT3-ITD-D835Y, ter na ta način inducira apoptozo levkemičnih celic, ki izražajo FLT3-ITD.
English: LoDAC and azacitidine were given in continuous 4-week cycles until unacceptable toxicity or lack of clinical benefit.
Slovenian: Zdravljenji z LoDAC in azacitidinom sta se izvajali v neprekinjenih 4-tedenskih ciklih, dokler se ni ugotovila nedopustna toksičnost ali odsotnost klinične koristi.
English: Of the patients who were pre-selected to receive salvage chemotherapy, 60.5% were randomised to high intensity and 39.5% to low intensity.
Slovenian: Od bolnikov, ki so bili predhodno izbrani za reševalno zdravljenje s kemoterapijo, jih je bilo 60,5 % randomiziranih v skupino zdravljenja z visoko intenzivno, 39,5 % pa v skupino zdravljenja z nizko intenzivno kemoterapijo.
English: Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated in a timely manner.
Slovenian: Sindrom diferenciacije je bolezensko stanje, ki vpliva na vaše krvne celice in je lahko življenje ogrožajoče ali povzroči smrt, če se ne zdravi pravočasno.
English: Gilteritinib was given orally at a starting dose of 120 mg daily until unacceptable toxicity or lack of clinical benefit.
Slovenian: Gilteritinib se je dajal peroralno z začetnim odmerkom 120 mg na dan, dokler se ni ugotovila nedopustna toksičnost ali odsotnost klinične koristi.
English: Please contact the patient's Haematologist/Oncologist for more information and consult the Product Information for gilteritinib available at https://www.ema.europa.eu/.
Slovenian: Za več informacij se obrnite na bolnikovega hematologa/onkologa in si preberite informacije o gilteritinibu, ki so dostopne na https://www.ema.europa.eu/.
English: What Xospata is and what it is used for What you need to know before you take Xospata How to take Xospata
Slovenian: Kaj je zdravilo Xospata in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xospata Kako jemati zdravilo Xospata Možni neželeni učinki
English: EU/1/19/1399/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/19/1399/001
English: - Heart rhythm problems (QT prolongation).
Slovenian: - Težave s srčnim ritmom (podaljšanje intervala QT).
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%).
Slovenian: Najpogostejši resni neželeni učinki so bili driska (4,7 %), zvišanje ravni ALT (4,1 %), dispneja (3,4 %), zvišanje ravni AST (3,1 %) in hipotenzija (2,8 %).
English: Patients included were relapsed or refractory after first line AML therapy and were stratified by response to prior AML treatment and preselected chemotherapy i.e. high or low intensity.
Slovenian: Vključeni bolniki so obsegali bolnike s ponovljeno ali neodzivno boleznijo po prvi liniji zdravljenja AML in so bili stratificirani glede na odziv na prejšnje zdravljenje AML in glede na predhodno izbrano kemoterapijo, tj. visokointenzivno ali nizkointenzivno.
English: Median in months (95% CI) Hazard Ratio (95% CI) p-value (1-sided) 1 year survival rate, % (95% CI)
Slovenian: Celokupno preživetje smrti, N (%) mediana v mesecih (95 % IZ) razmerje ogroženosti (95 % IZ) p-vrednost (enostranska) stopnja preživetja po 1 letu, % (95 % IZ)
English: Physician educational material:
Slovenian: Izobraževalno gradivo za zdravnike:
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).
Slovenian: Pri bolnikih, ki so jemali zdravilo Xospata, so poročali o omotici, kar je treba upoštevati pri ocenjevanju bolnikove sposobnosti vožnje ali upravljanja strojev (glejte poglavje 4.8).
English: Based on in vitro data, gilteritinib is primarily metabolised via CYP3A4.
Slovenian: Na podlagi podatkov in vitro preiskav se gilteritinib primarno presnavlja z encimom CYP3A4.
English: Symptoms have resolved after discontinuation of treatment (see sections 4.2 and 4.4).
Slovenian: Simptomi so po ustavitvi zdravljenja izzveneli (glejte poglavji 4.2 in 4.4).
English: Alternative medicinal products that do not strongly inhibit CYP3A and/or P-gp activity should be considered.
Slovenian: Razmisliti je treba o uporabi drugih zdravil, ki niso močni zaviralci aktivnosti encima CYP3A in/ali P-gp.
English: The recommended starting dose is 120 mg gilteritinib (three 40 mg tablets) once daily.
Slovenian: Priporočeni začetni odmerek je 120 mg gilteritiniba (tri 40 mg tablete) enkrat dnevno.
English: Table 3: ADMIRAL study overall survival and complete remission in patients with relapsed or refractory AML
Slovenian: Preglednica 3: Celokupno preživetje in popolna remisija v okviru študije ADMIRAL pri bolnikih s ponovljeno ali neodzivno AML
English: Differentiation syndrome occurred as early as two days and up to 75 days after Xospata initiation and has been observed with or without concomitant leukocytosis.
Slovenian: Do sindroma diferenciacije je prišlo od 2 do 75 dni po začetku zdravljenja z zdravilom Xospata, z ali brez sočasne levkocitoze.
English: - Description of the signs and symptoms of differentiation syndrome.
Slovenian: - Opis znakov in simptomov sindroma diferenciacije.
English: Xospata is used to treat adults with acute myeloid leukaemia (AML), a cancer of certain white blood cells.
Slovenian: Xospata se uporablja za zdravljenje odraslih z akutno mieloično levkemijo (AML), obliko raka določenih belih krvničk (levkocitov).
English: - Posterior reversible encephalopathy syndrome (PRES).
Slovenian: - Sindrom posteriorne reverzibilne encefalopatije (PRES).
English: Each pack contains 84 film-coated tablets.
Slovenian: Eno pakiranje vsebuje 84 filmsko obloženih tablet.
English: The most frequent adverse reactions with gilteritinib were blood creatine phosphokinase increased (93.4%), alanine aminotransferase (ALT) increased (82.1%), aspartate aminotransferase (AST) increased (80.6%), blood alkaline phosphatase increased (68.7%), diarrhoea (35.1%), fatigue (30.4%), nausea (29.8%), constipation (28.2%), cough (28.2%), peripheral oedema (24.1%), dyspnea (24.1%), dizziness (20.4%), hypotension (17.2%), pain in extremity (14.7%), asthenia (13.8%), arthralgia (12.5%) and myalgia (12.5%).
Slovenian: Najpogostejši neželeni učinki gilteritiniba so bili zvišanje ravni kreatin fosfokinaze v krvi (93,4 %), zvišanje ravni alanin aminotransferaze (ALT) (82,1 %), zvišanje ravni aspartat aminotransferaze (AST) (80,6 %), zvišanje ravni alkalne fosfataze v krvi (68,7 %), driska (35,1 %), utrujenost (30,4 %), navzea (29,8 %), zaprtje (28,2 %), kašelj (28,2 %), periferni edem (24,1 %), dispneja (24,1 %), omotica (20,4 %), hipotenzija (17,2 %), bolečina v okončinah (14,7 %), astenija (13,8 %), artralgija (12,5 %) in mialgija (12,5 %).
English: CYP3A/P-gp Inducers
Slovenian: Induktorji CYP3A/P-gp
English: Titanium dioxide Iron oxide yellow (E172)
Slovenian: Filmska obloga hipromeloza smukec makrogol titanov dioksid rumeni železov oksid (E172)
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).
Slovenian: Preiskavo z elektrokardiogramom (EKG) je treba opraviti pred začetkom zdravljenja z gilteritinibom, na 8. in 15. dan prvega ciklusa in pred začetkom naslednjih treh mesecev zdravljenja (glejte poglavji 4.4 in 4.8).
English: - The other ingredients are: mannitol (E421), hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide, iron oxide yellow (E172).
Slovenian: - Druge sestavine zdravila so: manitol (E421), hidroksipropilceluloza, nizko substituirana hidroksipropilceluloza, magnezijev stearat, hipromeloza, smukec, makrogol, titanov dioksid, rumeni železov oksid (E172).
English: These may be signs of a condition called differentiation syndrome (may affect up to 1 in 10 people).
Slovenian: To so lahko znaki bolezenskega stanja, ki se imenuje sindrom diferenciacije (pojavi se lahko pri največ 1 od 10 bolnikov).
English: If you take more tablets than you should, contact your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Xospata, kot bi smeli Če ste vzeli več tablet, kot bi smeli, se obrnite na zdravnika.
English: Gilteritinib is primarily metabolised by CYP3A enzymes, which can be induced or inhibited by a number of concomitant medicinal products.
Slovenian: Gilteritinib primarno presnavljajo encimi CYP3A, ki jih lahko inducira ali zavira več sočasno uporabljenih zdravil.
English: The gastrointestinal tract was identified as one of the target organs similar as in adult rats.
Slovenian: Ugotovljeno je bilo, da so prebavila eden od tarčnih organov, podobno kot pri odraslih podganah.
English: Gilteritinib plasma concentrations declined in a bi-exponential manner with a population mean estimated half-life of 113 hours.
Slovenian: Plazemske koncentracije gilteritiniba so se zmanjšale bieksponentno, pri čemer je bil ocenjen povprečni razpolovni čas 113 ur.
English: • Resume treatment with gilteritinib at a reduced dose (80 mg or 120 mgb).
Slovenian: • Zdravljenje z gilteritinibom nadaljujte z zmanjšanim odmerkom (80 mg ali 120 mg b).
English: Differentiation syndrome can happen any time during the first 3 months of treatment from as early as 2 days after starting treatment.
Slovenian: Sindrom diferenciacije se lahko pojavi kadar koli v prvih 3 mesecih zdravljenja - že po 2 dneh zdravljenja.
English: Gilteritinib has been associated with prolonged cardiac ventricular repolarisation (QT Interval) (see sections 4.8 and 5.1).
Slovenian: Gilteritinib je povezan s podaljšano repolarizacijo srčnih prekatov (interval QT) (glejte poglavji 4.8 in 5.1).
English: - Take Xospata once a day at the same time each day.
Slovenian: Jemanje zdravila Xospata - Zdravilo Xospata vzemite enkrat na dan, in sicer vsak dan ob istem času.
English: Your doctor will monitor you, may pause your treatment and/or may give you a medicine to treat your condition.
Slovenian: Zdravnik bo spremljal vaše zdravstveno stanje, lahko pa tudi prekine zdravljenje in/ali vam lahko da zdravila za zdravljenje bolezenskega stanja.
English: Women using hormonal contraceptives should add a barrier method of contraception.
Slovenian: Ženske, ki uporabljajo hormonske kontraceptive, morajo hkrati uporabljati še pregradno metodo kontracepcije.
English: She or he may also pause Xospata treatment until symptoms are reduced.
Slovenian: Zdravnik lahko zdravljenje z zdravilom Xospata tudi prekine, dokler se simptomi ne zmanjšajo.
English: If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, Xospata should be interrupted until signs and symptoms are no longer severe (see sections 4.2 and 4.8).
Slovenian: Če hudi znaki in/ali simptomi vztrajajo več kot 48 ur po začetku uporabe kortikosteroidov, je treba zdravljenje z zdravilom Xospata prekiniti, dokler znaki in simptomi niso več hudi (glejte poglavji 4.2 in 4.8).
English: • Resume gilteritinib at the same dose when signs and symptoms improve to Grade 2a or lower.
Slovenian: • Zdravljenje z gilteritinibom nadaljujte z enakim odmerkom, ko se znaki in simptomi izboljšajo do 2. stopnje a ali nižje stopnje resnosti.
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.
Slovenian: Populacijska farmakokinetična analiza je bila izvedena za vrednotenje učinka intrinzičnih in ekstrinzičnih spremenljivk na predvideno izpostavljenost gilteritinibu pri bolnikih s ponovljeno ali neodzivno AML.
English: Xospata should be interrupted in patients who have a QTcF >500 msec (see section 4.2).
Slovenian: Zdravljenje z zdravilom Xospata je treba prekiniti pri bolnikih, ki imajo vrednost QTcF > 500 milisekund (glejte poglavje 4.2).
English: It is unknown whether gilteritinib or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se gilteritinib oz. njegovi presnovki izločajo v materino mleko.
English: Xospata is taken by mouth as tablets.
Slovenian: Zdravilo Xospata se zaužije v obliki tablet.
English: Prolonged QT interval
Slovenian: Podaljšan interval QT
English: Of 319 patients treated with Xospata in the clinical studies, 11 (3%) experienced differentiation syndrome.
Slovenian: Od 319 bolnikov, zdravljenih z zdravilom Xospata v kliničnih študijah, je pri 11 (3 %) prišlo do sindroma diferenciacije.
English: While the study included patients with various AML-related cytogenetic abnormalities, patients with acute promyelocytic leukaemia (APL) or therapy-related AML were excluded.
Slovenian: Študija je sicer vključila bolnike z različnimi citogenetskimi nenormalnostmi, povezanimi z AML, a izključeni so bili bolniki z akutno promielocitno levkemijo (APL) ali AML, povezano z zdravljenjem.
English: Xospata is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Slovenian: Zdravila Xospata ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
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):
Slovenian: V tej študiji je bilo 371 bolnikov randomiziranih tako, da so v razmerju 2 : 1 prejemali gilteritinib ali eno od naslednjih reševalnih zdravljenj s kemoterapijo (247 v skupini zdravljenja z gilteritinibom in 124 v skupini reševalnega zdravljenja s kemoterapijo):
English: Of the 319 patients treated with Xospata in the clinical studies, 0.6% experienced posterior reversible encephalopathy syndrome (PRES).
Slovenian: Od 319 bolnikov, zdravljenih z zdravilom Xospata v kliničnih študijah, je pri 0,6 % prišlo do sindroma posteriorne reverzibilne encefalopatije (PRES).
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).
Slovenian: V primeru, da ustrezna nadomestna terapija ne obstaja, je treba bolnike med dajanjem gilteritiniba pozorno nadzorovati in spremljati glede razvoja toksičnosti (glejte poglavje 4.5).
English: The ADMIRAL study is a Phase 3, open-label, multicentre, randomised clinical study of adult patients with relapsed or refractory AML with a FLT3 mutation as determined by the LeukoStrat® CDx FLT3 Mutation Assay.
Slovenian: Študija ADMIRAL je odprta, multicentrična, randomizirana klinična študija 3. faze pri odraslih bolnikih s ponovljeno ali neodzivno AML z mutacijo FLT3, določeno z LeukoStrat
English: Xospata is for oral use.
Slovenian: Zdravilo Xospata je namenjeno za peroralno uporabo.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov PROIZVAJALCA, odgovornega za sproščanje serij
English: Following oral administration of gilteritinib, peak plasma concentrations are observed at a median tmax approximately between 4 and 6 hours in healthy volunteers and patients with relapsed or refractory AML.
Slovenian: Po peroralnem dajanju gilteritiniba so najvišje plazemske koncentracije opažene pri mediani vrednosti tmax približno 4-6 ur pri zdravih prostovoljcih in bolnikih s ponovljeno ali neodzivno AML.
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.
Slovenian: Pri bolnikih s ponovljeno ali neodzivno AML, ki so prejemali 120 mg gilteritiniba, je bilo znatno (> 90 %) zaviranje fosforilacije FLT3 hitro (v 24 urah po prvem odmerku) in dolgotrajno, kar je pokazal ex vivo preskus inhibicije aktivnosti v plazmi (PIA - plasma inhibitory activity).
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).
Slovenian: Glede na podatke in vitro preiskav lahko gilteritinib zmanjša učinke zdravil, ki ciljajo na receptor 5HT2B ali nespecifični receptor sigma (npr. escitalopram, fluoksetin, sertralin).
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).
Slovenian: Čas preživetja bolnikov, randomiziranih v skupino zdravljenja z gilteritinibom, je bil bistveno daljši v primerjavi s časom preživetja bolnikov v skupini zdravljenja s kemoterapijo (razmerje ogroženosti (HR - hazard ratio): 0,637; 95 % IZ: 0,490-0,830; enostranska p-vrednost: 0,0004).
English: • Educational tool targeting prescribers o Educational tool targeting prescribers: - Information on Xospata, including the approved indication according to the SmPC.
Slovenian: • Izobraževalni pripomoček, namenjen zdravnikom, ki predpisujejo zdravilo: o Izobraževalni pripomoček, namenjen zdravnikom, ki predpisujejo zdravilo: - Informacije o zdravilu Xospata, vključno z odobreno indikacijo v skladu s povzetkom glavnih značilnosti zdravila.
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.
Slovenian: Pred zdravljenjem z gilteritinibom je imelo 39,4 % bolnikov primarno neodzivno AML in večina teh bolnikov je bila po 1 ciklusu indukcijskega zdravljenja s kemoterapijo opredeljena kot neodzivnih, 19,7 % jih je imelo ponovljeno AML po alogeni presaditvi krvotvornih matičnih celic (PKMC), 41 % pa ponovljeno AML brez alogene PKMC.
English: - Do not break or crush the tablets.
Slovenian: - Tablet ne smete lomiti ali drobiti.
English: Serum creatinine, a marker of renal function, was identified as a statistically significant covariate.
Slovenian: Za statistično pomembno spremenljivko se je izkazal serumski kreatinin, ki je indikator delovanja ledvic.
English: Do not break or crush the tablets.
Slovenian: Tablet ne smete lomiti ali drobiti.
English: • Patient Alert Card
Slovenian: • Opozorilno kartica za bolnika
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.
Slovenian: Delež odziva (CR/CRh) v študiji 2215-CL-0101 pri bolnikih, ki so prejeli več kot 1 linijo predhodnega zdravljenja, je bil z odmerkom 120 mg 21,4 % in s kombiniranimi ravnmi odmerkov 15,7 %.
English: QTc interval increased by >30 msec on ECG on day 8 of cycle 1
Slovenian: Interval QTc na EKG je 8. dan 1. ciklusa podaljšan za > 30 milisekund
English: The supportive Phase 1/2 dose-escalation study 2215-CL-0101 included 157 patients with FLT3 mutated AML treated with either 1 or >1 prior lines of treatment in the combined dose group (i.e. 80 mg, 120 mg or 200 mg); 31.2% received 1 prior line of treatment and 68.8% received >1 prior lines of treatment.
Slovenian: faze 2215-CL-0101 s povečevanjem odmerkov je vključila 157 bolnikov, ki so imeli AML z mutacijo FLT3, zdravljenih ali z 1 ali > 1 predhodno linijo zdravljenja v skupini s kombiniranim odmerkom (tj. 80 mg, 120 mg ali 200 mg); 31,2 % jih je prejemalo 1 predhodno linijo zdravljenja in 68,8 % jih je prejemalo > 1 predhodno linijo zdravljenja.
English: Astellas Pharma a/s Tlf: +45 43 430355
Slovenian: Danmark Astellas Pharma a/s Tlf: +45 43 430355
English: Xospata may be re-initiated in patients following haematopoietic stem cell transplantation (HSCT) (see Table 1).
Slovenian: Zdravilo Xospata je mogoče ponovno uvesti bolnikom po presaditvi krvotvornih matičnih celic (PKMC) (glejte preglednico 1).