FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Razpoložljivi podatki o testiranju na živalih kažejo, da se gilteritinib in njegovi presnovki izločajo v mleko podgan ter se prek vnosa z mlekom porazdeljujejo v tkivih podganjih mladičev (glejte poglavje 5.3).
English: Gilteritinib has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Zdravljenje z gilteritinibom ni bilo preiskovano pri bolnikih s hudo okvaro jeter (Child-Pugh razreda C).
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.
Slovenian: Mediana starosti ob randomizaciji je bila 62 let (razpon od 20 do 84 let) v skupini zdravljenja z gilteritinibom in 62 let (razpon od 19 do 85 let) v skupini reševalnega zdravljenja s kemoterapijo.
English: There is no clinical experience in patients with severe renal impairment (see section 5.2).
Slovenian: Za bolnike s hudo okvaro ledvic ni kliničnih podatkov (glejte poglavje 5.2).
English: Gilteritinib may reduce the effects of medicinal products that target 5HT2B receptor or sigma nonspecific receptors.
Slovenian: Gilteritinib lahko zmanjša učinke zdravil, ki tarčno delujejo na receptor 5HT2B ali nespecifične receptorje sigma.
English: A dedicated renal impairment study has not been conducted to assess of the effect of renal impairment on gilteritinib pharmacokinetics.
Slovenian: Namenske študije o okvari ledvic za ocenjevanje učinka okvare ledvic na farmakokinetiko gilteritiniba niso bile izvedene.
English: There are no or limited amount of data from the use of gilteritinib in pregnant women.
Slovenian: Podatkov o uporabi gilteritiniba pri nosečnicah ni oziroma so omejeni.
English: What you need to know before you take Xospata Do not take Xospata
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xospata
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).
Slovenian: Zdravilo Xospata je indicirano kot monoterapija za zdravljenje odraslih bolnikov s ponovljeno ali neodzivno akutno mieloično levkemijo (AML) z mutacijo FLT3 (glejte poglavji 4.2 in 5.1).
English: Women of childbearing potential / Contraception in males and females Pregnancy testing is recommended for females of reproductive potential seven days prior to initiating Xospata treatment.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Priporoča se, da ženske v rodni dobi sedem dni pred zdravljenjem z zdravilom Xospata opravijo test nosečnosti.
English: Other medicines and Xospata
Slovenian: Druga zdravila in zdravilo Xospata
English: Gilteritinib fumarate is a FLT3 and AXL inhibitor.
Slovenian: Gilteritinibijev fumarat je zaviralec receptorjev FLT3 in AXL.
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).
Slovenian: Izpostavljenost gilteritinibu se je pri bolnikih s ponovljeno ali neodzivno AML povečala za približno 1,5-krat, ko se je gilteritinib dajal hkrati z močnim zaviralcem CYP3A in/ali P-gp (glejte poglavje 4.4).
English: b. The daily dose can be reduced from 120 mg to 80 mg or from 200 mg to 120 mg. c. Composite complete remission (CRc) is defined as the remission rate of all CR (see section 5.1 for definition of CR), CRp [achieved CR except for incomplete platelet recovery (<100 x 109/L)] and CRi (achieved all criteria for CR except for incomplete haematological recovery with residual neutropenia <1 x 109/L with or without complete platelet recovery).
Slovenian: b. Dnevni odmerek je mogoče zmanjšati s 120 mg na 80 mg ali z 200 mg na 120 mg. c. Sestavljena popolna remisija (CRc - composite complete remission) je opredeljena kot delež remisije vseh CR (za opredelitev CR glejte poglavje 5.1), CRp [dosežen CR z izjemo nepopolnega okrevanja trombocitov (< 100 x 10
English: The in vivo micronucleus test showed that gilteritinib has a potential to induce micronuclei in mice.
Slovenian: Mikrojedrni test in vivo je pokazal, da lahko gilteritinib inducira nastanek mikrojeder pri miših.
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.
Slovenian: Večina bolnikov je imela AML s citogenetsko zmernim tveganjem (73 %), 10 % bolnikov je imelo neugodno tveganje, 1,3 % bolnikov je imelo ugodno tveganje, 15,6 % pa citogenetsko nerazvrščeno tveganje.
English: Xospata 40 mg film-coated tablets
Slovenian: Xospata 40 mg filmsko obložene tablete
English: In dogs, positive faecal occult blood at 10 mg/kg and higher, a decrease in the blood calcium concentration at 30 mg/kg, and salivation and an increase followed by a decrease in the blood calcium concentration at 100 mg/kg were observed.
Slovenian: Pri psih so opazili pozitivno okultno kri v blatu (pri 10 mg/kg in več), zmanjšano koncentracijo kalcija v krvi (pri 30 mg/kg) ter salivacijo in povečanje koncentracije kalcija v krvi, ki mu je sledilo zmanjšanje (pri 100 mg/kg).
English: • Resume gilteritinib at a reduced dose (80 mg or 120 mgb) when QTc interval returns to within 30 msec of baseline or ≤ 480 msec.
Slovenian: • Zdravljenje z gilteritinibom nadaljujte z zmanjšanim odmerkom (80 mg ali 120 mg b), ko se interval QTc vrne znotraj 30 milisekund od izhodiščne vrednosti ali na ≤ 480 milisekund.
English: If you forget to take Xospata at the usual time, take your usual dose as soon as you remember on the same day and take your next dose at the usual time on the following day.
Slovenian: Če ste pozabili vzeti zdravilo Xospata ob običajnem času, vzemite običajni odmerek še isti dan takoj, ko se spomnite.
English: - Needs to be carried all the time and presented to any healthcare professional.
Slovenian: - Potreba, da ima bolnik kartico vedno pri sebi in jo pokaže vsem zdravstvenim delavcem.
English: Your doctor will carry out regular blood tests before and during treatment with Xospata.
Slovenian: Dodatno spremljanje varnosti med zdravljenjem z zdravilom Xospata Zdravnik bo pred in med zdravljenjem z zdravilom Xospata redno opravljal preiskave krvi.
English: These may be signs of a condition called differentiation syndrome (see section 4 - Possible side effects).
Slovenian: To so lahko znaki bolezenskega stanja, ki se imenuje sindrom diferenciacije (glejte poglavje 4Možni neželeni učinki).
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.
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.
English: In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: - medicines used to treat tuberculosis, such as rifampicin; - medicines used to treat epilepsy, such as phenytoin; - medicines used to treat fungal infections such as voriconazole, posaconazole or itraconazole; - medicines used to treat bacterial infections such as erythromycin, clarithromycin or azithromycin; - medicines used to treat high blood pressure (hypertension) such as captopril or carvedilol; - medicines used to treat infections with the human immunodeficiency virus (HIV) such as ritonavir; - medicines used to treat depression such as escitalopram, fluoxetine or sertraline; - St. John's wort (also known as Hypericum perforatum), a herbal medicine used to treat depression.
Slovenian: Zdravnika, farmacevta ali medicinsko sestro še posebej obvestite, če jemljete katero od naslednjih zdravil: - zdravila za zdravljenje tuberkuloze, kot je rifampicin; - zdravila za zdravljenje epilepsije, kot je fenitoin; - zdravila za zdravljenje glivičnih okužb, kot so vorikonazol, pozakonazol ali itrakonazol; - zdravila za zdravljenje bakterijskih okužb, kot so eritromicin, klaritromicin ali azitromicin; - zdravila za zdravljenje visokega krvnega tlaka (hipertenzije), kot sta kaptopril ali karvedilol; - zdravila za zdravljenje okužb z virusom humane imunske pomanjkljivosti (HIV), kot je ritonavir; - zdravila za zdravljenje depresije, kot so escitalopram, fluoksetin ali sertralin; - šentjanževko (znano tudi kot Hypericum perforatum), zdravilo rastlinskega izvora za zdravljenje depresije.
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.
Slovenian: Zato je treba preiskavo z elektrokardiogramom (EKG) opraviti pred začetkom zdravljenja, na 8. in 15. dan prvega ciklusa in pred začetkom naslednjih treh mesecev zdravljenja.
English: If vomiting occurs after dosing, patients should not take another dose but should return to the normal schedule the following day.
Slovenian: Če bolnik po odmerjanju bruha, ne sme vzeti še enega odmerka, temveč mora zdravilo vzeti naslednji dan po običajnem razporedu.
English: - if you are allergic to gilteritinib or any of the other ingredients of this medicine (listed in section
Slovenian: Ne jemljite zdravila Xospata - če ste alergični na gilteritinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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.
Slovenian: Močni zaviralci CYP3A in/ali P-gp (kot so vorikonazol, itrakonazol, posakonazol, klaritromicin, eritromicin, kaptopril, karvedilol, ritonavir, azitromicin) lahko povečajo koncentracijo gilteritiniba v plazmi.
English: Xospata 40 mg film-coated tablets gilteritinib
Slovenian: Xospata 40 mg filmsko obložene tablete gilteritinib
English: Before taking gilteritinib, relapsed or refractory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.
Slovenian: Pred jemanjem gilteritiniba je treba pri bolnikih s ponovljeno ali neodzivno AML z validirano preiskavo potrditi prisotnost mutacije FLT3 (FMS-like tyrosine kinase 3) (notranja tandemska podvojitev (ITD - internal tandem duplication) v domeni tirozin kinaze (TKD - tyrosine kinase domain)).
English: - Management of differentiation syndrome.
Slovenian: - Obvladovanje sindroma diferenciacije.
English: If it occurs, your doctor will monitor you and may give you a medicine to treat your condition.
Slovenian: Če se pojavi pri vas, bo zdravnik spremljal vaše zdravstveno stanje in vam lahko predpisal zdravilo za zdravljenje tega sindroma.
English: Gilteritinib was excreted into the milk of lactating rats with milk concentrations being higher than in maternal plasma.
Slovenian: Gilteritinib se je v mleku doječih podgan izločal v koncentraciji, ki je bila večja od koncentracije v materini plazmi.
English: 82.1 12.9 Very common Aspartate aminotransferase increased* 80.6 10.3 Very common
Slovenian: 12,9 zelo pogosti zvišanje ravni aspartat aminotransferaze*
English: - Continue taking Xospata for as long as your doctor tells you.
Slovenian: - Zdravilo Xospata jemljite tako dolgo, kot vam je naročil zdravnik.
English: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.
Slovenian: Sindrom diferenciacije je povezan s hitro proliferacijo in diferenciacijo celic mieloične vrste in je lahko življenjsko nevaren, če se ne zdravi.
English: • Interrupt gilteritinib until pancreatitis is resolved.
Slovenian: • Zdravljenje z gilteritinibom prekinite, dokler se pankreatitis ne pozdravi.
English: Effects of Xospata on other medicinal products
Slovenian: Učinki zdravila Xospata na druga zdravila
English: IMPORTANT SAFETY INFORMATION FOR PATIENTS Xospata may cause serious side effects, including differentiation syndrome.
Slovenian: Zdravilo Xospata lahko povzroči resne neželene učinke, vključno s sindromom diferenciacije.
English: It contains the active substance gilteritinib.
Slovenian: Vsebuje učinkovino gilteritinib.
English: In healthy adults, gilteritinib Cmax and AUC decreased by approximately 26% and less than 10%, respectively, when a single 40 mg dose of gilteritinib was co-administered with a high fat meal compared to gilteritinib exposure in fasted state.
Slovenian: Pri zdravih odraslih se je vrednosti gilteritiniba Cmax zmanjšala za približno 26 %, AUC pa za manj kot 10 %, ko je bil enkratni odmerek 40 mg gilteritiniba apliciran skupaj z obrokom z visoko vsebnostjo maščob, v primerjavi z izpostavljenostjo gilteritinibu na tešče.
English: • Dizziness or lightheadedness
Slovenian: • omotica ali vrtoglavica,
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xospata in one or more subsets of the paediatric population in the treatment of acute myeloid leukaemia.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Xospata za eno ali več podskupin pediatrične populacije za zdravljenje akutne mieloične levkemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Discontinuation of Xospata in patients who develop PRES is recommended (see sections 4.2 and 4.8).
Slovenian: Pri bolnikih, pri katerih se razvije PRES, se priporoča ustavitev zdravljenja z zdravilom Xospata (glejte poglavji 4.2 in 4.8).
English: The effect of hepatic impairment on gilteritinib pharmacokinetics was studied in subjects with mild (Child-Pugh Class A) and moderate (Child-Pugh Class B) hepatic impairment.
Slovenian: Učinek okvare jeter na farmakokinetiko gilteritiniba so preiskovali pri bolnikih z blago (Child-Pugh razred A) in zmerno (Child-Pugh razred B) okvaro jeter.
English: Symptoms of pancreatitis
Slovenian: Simptomi pankreatitisa
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.
Slovenian: Rezultati kažejo, da je izpostavljenost nevezanemu gilteritinibu pri bolnikih z blago ali zmerno okvaro jeter primerljiva z izpostavljenostjo pri bolnikih z normalnim delovanjem jeter.
English: Planned HSCT
Slovenian: Načrtovana PKMC
English: PRES is a rare, reversible, neurological disorder which can present with rapidly evolving symptoms including seizure, headache, confusion, visual and neurological disturbances, with or without associated hypertension and altered mental status.
Slovenian: PRES je redka, reverzibilna nevrološka motnja, pri kateri so lahko prisotni simptomi, ki se hitro razvijajo in vključujejo epileptične napade, glavobol, zmedenost, motnje vida in nevrološke motnje, s pridruženo hipertenzijo in spremenjenim duševnim stanjem ali brez njiju.
English: Reproductive studies in rats have shown that gilteritinib caused suppressed foetal growth, embryo-foetal deaths and teratogenicity (see section 5.3).
Slovenian: Študije reprodukcije pri podganah so pokazale, da gilteritinib zavira rast ploda, povzroča smrt zarodka oz. ploda in teratogenost (glejte poglavje 5.3).
English: x 109/L and platelets ≥50 x 109/L, no evidence of extramedullary leukemia and could not have been classified as CR.
Slovenian: 9/l, brez dokazov ekstramedularne levkemije, obenem pa je ni bilo mogoče razvrstiti kot CR.
English: Each film-coated tablet contains 40 mg gilteritinib (as fumarate).
Slovenian: Ena filmsko obložena tableta vsebuje 40 mg gilteritiniba (v obliki fumarata).
English: Differentiation syndrome can happen any time during the first 3months of Xospata treatment from as early as 2 days after starting.
Slovenian: Sindrom diferenciacije se lahko pojavi kadar koli v prvih 3 mesecih zdravljenja z zdravilom Xospata - že po 2 dneh zdravljenja.
English: Gilteritinib undergoes first-order absorption with an estimated absorption rate (ka) of 0.43 h-1 with a lag time of 0.34 hours based on population PK modelling.
Slovenian: Gilteritinib je podvržen absorpciji prvega reda, pri čemer ocenjena hitrost absorpcije (ka) na podlagi populacijske farmakokinetične analize znaša 0,43 h
English: If Xospata is re-introduced at a reduced dose, ECG should be performed after 15 days of dosing, and prior to the start of the next three subsequent months of treatment.
Slovenian: Če se zdravljenje z zdravilom Xospata znova uvede z zmanjšanim odmerkom, je treba preiskavo z elektrokardiogramom (EKG) izvesti po 15 dneh uporabe in pred začetkom naslednjih treh mesecev zdravljenja.
English: • Trouble Breathing
Slovenian: • oteženo dihanje,
English: The effect of mild hepatic impairment [as defined by NCI-ODWG] on gilteritinib exposure was also assessed using the population PK model and the results demonstrate little difference in predicted steady-state gilteritinib exposure relative to a typical patient with relapsed or refractory AML and normal liver function.
Slovenian: Vpliv blage okvare jeter (po klasifikaciji NCI-ODWG) na izpostavljenost gilteritinibu je bil ocenjen tudi s populacijsko farmakokinetično analizo, rezultati pa kažejo majhne razlike v predvideni izpostavljenosti gilteritinibu v stanju dinamičnega ravnovesja v primerjavi s tipičnim bolnikom s ponovljeno ali neodzivno AML in normalnim delovanjem jeter.
English: CYP3A and/or P-gp inhibitors
Slovenian: Zaviralci CYP3A in/ali P-gp
English: • Please ensure you show this card to any doctor, pharmacist or nurse for any medical treatment or at any visits to the hospital or clinic.
Slovenian: • V primeru kakršnega koli zdravljenja oziroma obiskov bolnišnice ali klinike to kartico pokažite zdravniku, farmacevtu ali medicinski sestri.
English: In rats, decreased urination at 30 mg/kg and higher and decreased defecation at 100 mg/kg were observed.
Slovenian: Pri podganah sta bila ugotovljena zmanjšano izločanje urina (pri odmerkih 30 mg/kg in več) in zmanjšano izločanje blata (pri 100 mg/kg).
English: The median OS was 7.2 months and 7.1 months for the 120 mg dose and the combined dose levels, respectively.
Slovenian: Mediano celokupno preživetje (OS) je bilo z odmerkom 120 mg 7,2 meseca in s kombiniranimi ravnmi odmerkov 7,1 meseca.
English: A concentration-related increase in change from baseline of QTcF was observed across gilteritinib doses ranging from 20 to 450 mg.
Slovenian: Od koncentracije odvisno zivišanje vrednosti QTcF glede na izhodiščno stanje so opazili pri vseh odmerkih gilteritiniba od 20 do 450 mg.
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.
Slovenian: Izgled zdravila Xospata in vsebina pakiranja Xospata 40 mg filmsko obložene tablete so okrogle, svetlo rumene filmsko obložene tablete z logotipom podjetja in številko „235“, ki sta vtisnjena na eni strani tablete.
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).
Slovenian: Moškim s partnericami v rodni dobi je treba priporočiti uporabo učinkovite kontracepcije med zdravljenjem in vsaj 4 mesece po zadnjem odmerku zdravila Xospata (glejte poglavje 4.4).
English: In the repeated dose toxicity studies in rats and dogs, target organs of toxicity were the gastrointestinal tract (heamorrhage in dogs), lymphohaematopoietic system (lymphocyte necrosis and bone marrow hypocellularity with changes in haematological parameters), eye (inflammation and lens opacity in rats, fundus colour change in dogs, retinal vacuolation), lung (interstitial pneumonia in rats and inflammation in dogs), kidney (renal tubule changes with a positive urine occult blood reaction) and liver (hepatocyte vacuolation), urinary bladder (epithelial vacuolation), epithelial tissue (ulcer and inflammation), and phospholipidosis (lung and kidney in rats).
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih pri podganah in psih so bili ciljni organi toksičnosti prebavni trakt (krvavitev pri psih), hematopoetski in limfni sistem (nekroza limfocitov in hipocelularnost kostnega mozga s spremembami v hematoloških parametrih), oči (vnetje in motnost leče pri podganah, sprememba barve očesnega ozadja pri psih, vakuolizacija mrežnice), pljuča (intersticijska pljučnica pri podganah in vnetje pri psih), ledvice (spremembe ledvičnih tubulov z reakcijo pozitivne okultne krvi v urinu) in jetra (vakuolizacija hepatocitov), sečni mehur (vakuolizacija epitelija), epitelijsko tkivo (razjeda in vnetje) in fosfolipidoza (pljuča in ledvice pri podganah).
English: • If differentiation syndrome is suspected, administer corticosteroids and initiate hemodynamic monitoring (see section 4.4).
Slovenian: • V primeru suma na sindrom diferenciacije uvedite kortikosteroidno terapijo in hemodinamično spremljanje (glejte poglavje 4.4).
English: Astellas Pharma Kft. Tel.: +36 1 577 8200
Slovenian: Magyarország Astellas Pharma Kft. Tel.: +36 1 577 8200
English: Gilteritinib was distributed through the breast milk to different tissues, except for the brain, of suckling rats.
Slovenian: Gilteritinib se je iz materinega mleka porazdelil v različna tkiva dojenih podgan z izjemo možganov.
English: If a dose is missed or not taken at the usual time, the dose should be administered as soon as possible on the same day, and patients should return to the normal schedule the following day.
Slovenian: Če bolnik odmerek pozabi ali ga ne vzame ob običajnem času, ga mora vzeti še isti dan, takoj ko je to mogoče, naslednji dan pa se mora vrniti na normalni urnik jemanja.
English: 17.2 7.2 Very common
Slovenian: 7,2 zelo pogosti
English: Caution is warranted in patients with relevant cardiac history.
Slovenian: Pri bolnikih z relevantno anamnezo težav s srcem je potrebna previdnost.
English: Relapsed or refractory AML
Slovenian: Ponovljena ali neodzivna AML
English: Xospata dose interruption, reduction and discontinuation recommendations in patients with relapsed or refractory AML
Slovenian: Priporočila o prekinitvi zdravljenja, zmanjšanju odmerka ter ustavitvi zdravljenja z zdravilom zdravila Xospata pri bolnikih s ponovljeno ali neodzivno AML Kriteriji
English: Gilteritinib can cause foetal harm when administered to pregnant women.
Slovenian: Če se gilteritinib daje nosečnicam, lahko škoduje plodu.
English: The patient information pack:
Slovenian: Paket izobraževalnih gradiv za bolnika:
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.
Slovenian: Pri podganah je bil dokazano prehajanje gilteritiniba skozi placento, ki je povzročilo prenos radioaktivnosti na plod, tako da je bila ta podobna kot v materini plazmi.
English: Blood creatine phosphokinase increased*
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zvišanje ravni kreatin fosfokinaze v krvi*
English: Gilteritinib is not an inhibitor or inducer of CYP3A4 or and inhibitor of MATE1 in vivo.
Slovenian: In vivo preiskave so pokazale, da gilteritinib ni niti zaviralec niti induktor encima CYP3A4 niti zaviralec MATE1.
English: For patients who achieved a CR/CRh, the median time to first response was 3.7 months (range, 0.9 to 10.6 months) in the gilteritinib arm and 1.2 months (range: 1 to 2.6 months) in the salvage chemotherapy arm.
Slovenian: Pri bolnikih, ki so dosegli CR/CRh, je bila mediana časa do prvega odziva 3,7 meseca (razpon od 0,9 do 10,6 meseca) v skupini zdravljenja z gilteritinibom in 1,2 meseca (razpon od 1 do 2,6 meseca) v skupini reševalnega zdravljenja s kemoterapijo.
English: There have been reports of posterior reversible encephalopathy syndrome (PRES) in patients receiving Xospata (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Xospata, so poročali o sindromu posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome) (glejte poglavje 4.8).