FrancophonIA/ELRC3.0 huggingface dataset:
English: What Xospata is and what it is used for What Xospata is
Slovenian: Kaj je zdravilo Xospata in za kaj ga uporabljamo
English: In vitro experiments demonstrated that gilteritinib is a P-gp substrate and may potentially inhibit BCRP and P-gp in the small intestine, OCT1 in the liver at clinically relevant concentrations (see section 4.5).
Slovenian: Medsebojno delovanje zdravil, ki vplivajo na prenašalce In vitro poskusi so pokazali, da je gilteritinib substrat P-gp ter lahko zavira BCRP in P-gp v tankem črevesu in OCT1 v jetrih pri klinično pomembnih koncentracijah (glejte poglavje 4.5).
English: Women of childbearing potential are recommended to use effective contraception (methods that result in less than 1% pregnancy rates) during and up to 6 months after treatment.
Slovenian: Priporoča se, da ženske v rodni dobi med zdravljenjem in do 6 mesecev po njem uporabljajo učinkovito kontracepcijo (metode, pri katerih je stopnja zanositve manjša od 1 %).
English: • Please contact your doctor immediately, if you develop any side effects, in particular those listed on this card.
Slovenian: • Če se vam pojavijo kateri koli neželni učinki, zlasti tisti, ki so navedeni na tej kartici, se nemudoma obrnite na zdravnika.
English: In AML, patients develop large numbers of abnormal white blood cells.
Slovenian: Pri bolnikih z AML se razvije veliko število abnormalnih levkocitov.
English: You should not breast-feed during treatment with Xospata and for at least 2 months after stopping the treatment.
Slovenian: Med zdravljenjem z zdravilom Xospata in vsaj 2 meseca po koncu zdravljenja ne smete dojiti.
English: Vistor hf Sími: +354 535 7000
Slovenian: Sími: +354 535 7000
English: Effects of other medicinal products on Xospata
Slovenian: Učinki drugih zdravil na zdravilo Xospata
English: No dose adjustment is required in patients ≥65 years of age (see section 5.2).
Slovenian: Starejši Pri bolnikih, starih 65 let in več, prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
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.
Slovenian: Embrio-fetalne razvojne študije so pokazale, da gilteritinib zavira rast ploda ter inducira smrt zarodka oz. ploda in teratogenost pri podganah, s stopnjami izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti.
English: Additionally, the pharmacokinetics of cephalexin (a sensitive MATE1 substrate) were not significantly (Cmax and AUC decreased by less than 10%) affected after once daily administration of gilteritinib (200 mg) for 15 days in patients with FLT3-mutated relapsed or refractory AML.
Slovenian: Poleg tega se farmakokinetika cefaleksina (občutljivega substrata MATE1) ni bistveno spremenila (vrednosti Cmax in AUC sta se zmanjšali za manj kot 10 %) po 15-dnevnem dajanju gilteritiniba (200 mg) enkrat na dan pri bolnikih s ponovljeno ali neodzivno AML z mutacijo FLT3.
English: Concomitant use of Xospata with strong CYP3A/P-gp inducers (e.g., phenytoin, rifampin and St. John's Wort) should be avoided because they can decrease gilteritinib plasma concentrations.
Slovenian: Izogibati se je treba hkratni uporabi zdravila Xospata z močnimi induktorji CYP3A/P-gp (npr. fenitoin, rifampicin in šentjanževka), ker lahko zmanjšajo koncentracijo gilteritiniba v plazmi.
English: The median time to best response of CR/CRh was 3.8 months (range, 0.9 to 16 months) in the gilteritinib arm and 1.2 months (range: 1 to 2.6 months) in the salvage chemotherapy arm.
Slovenian: Mediana časa do najboljšega odziva pri CR/CRh je bila 3,8 meseca (razpon od 0,9 do 16 mesecev) v skupini zdravljenja z gilteritinibom in 1,2 meseca (razpon od 1 do 2,6 meseca) v skupini reševalnega zdravljenja s kemoterapijo.
English: What Xospata is used for
Slovenian: Za kaj se uporablja zdravilo Xospata
English: Astellas Pharma GmbH Tel.: +49 (0)89 454401
Slovenian: Deutschland Astellas Pharma GmbH Tel.: +49 (0)89 454401
English: Contact your doctor straight away if you have a change in your heartbeat, or if you feel dizzy, lightheaded, or faint.
Slovenian: Takoj se obrnite na zdravnika, če imate spremenjen srčni ritem ali če se pojavi omotica, vrtoglavica ali nezavest.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON WITH BLUE BOX
Slovenian: ZUNANJA ŠKATLA Z MODRIM OKENCEM
English: Some possible side effects may be serious:
Slovenian: Nekateri možni neželeni učinki so lahko resni: - Sindrom diferenciacije.
English: If differentiation syndrome is suspected, corticosteroid therapy should be initiated along with hemodynamic monitoring until symptom resolution.
Slovenian: V primeru suma na sindrom diferenciacije je treba uvesti kortikosteroidno terapijo s hemodinamičnim spremljanjem in jo izvajati do odprave simptomov.
English: Alanine aminotransferase increased*
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanje ravni alanin aminotransferaze*
English: Astellas Pharma Puh/Tel: +358 (0)9 85606000
Slovenian: Suomi/Finland Astellas Pharma Puh/Tel: +358 (0)9 85606000
English: The pharmacokinetics of midazolam (a sensitive CYP3A4 substrate) were not significantly (Cmax and AUC increased approximately 10%) affected after once-daily administration of gilteritinib (300 mg) for 15 days in patients with FLT3-mutated relapsed or refractory AML.
Slovenian: Farmakokinetika midazolama (občutljivega substrata CYP3A4) se ni bistveno spremenila (vrednosti Cmax in AUC sta se povečali za približno 10 %) po 15-dnevnem dajanju gilteritiniba (300 mg) enkrat na dan pri bolnikih s ponovljeno ali neodzivno AML z mutacijo FLT3.
English: • mitoxantrone 8 mg/m2, etoposide 100 mg/m2 and cytarabine 1000 mg/m2 once daily by IV for 5 days (days 1 through 5) (MEC)
Slovenian: 7. dne); • 8 mg/m mitoksantrona, 100 mg/m etopozida in 1.000 mg/m citarabina enkrat dnevno, 5 dni apliciranih intravensko (od 1. do 5. dne) (MEC);
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
English: How to take Xospata
Slovenian: Kako jemati zdravilo Xospata
English: No dose adjustment is necessary in patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic prilagajanje odmerka ni potrebno.
English: A single, 10 mg dose of gilteritinib co-administered with itraconazole (200 mg once daily for 28 days), a strong CYP3A and/or P-gp inhibitor, to healthy subjects resulted in an approximate 20% increase in mean Cmax and 2.2-fold increase in mean AUCinf relative to subjects administered a single dose of gilteritinib alone.
Slovenian: Z enkratnim odmerkom 10 mg gilteritiniba, danim zdravim preiskovancem skupaj z itrakonazolom (200 mg enkrat dnevno 28 dni), močnim zaviralcem CYP3A in/ali P-gp, se je povprečna vrednost Cmax povečala za približno 20 %, povprečna vrednost AUCinf pa za 2,2-krat v primerjavi s preiskovanci, ki so prejeli samo enkratni odmerek gilteritiniba.
English: Symptoms of differentiation syndrome
Slovenian: Simptomi sindroma diferenciacije
English: Differentiation syndrome
Slovenian: Sindrom diferenciacije
English: c. CRh was defined as marrow blasts <5%, partial haematologic recovery absolute neutrophil count ≥0.5
Slovenian: CRh je bila opredeljena kot: manj kot 5 % blastov v kostnem mozgu, delno hematološko okrevanje z absolutnim številom nevtrofilcev ≥ 0,5 x 10
English: • azacitidine 75 mg/m2 once daily by SC or IV for 7 days (days 1 through 7)
Slovenian: • 75 mg/m azacitidina enkrat dnevno, 7 dni apliciranega subkutano ali intravensko (od 1. do
English: Females of reproductive potential should be advised to have a pregnancy test within seven days prior to starting treatment with Xospata and to use effective contraception during treatment with Xospata and for at least 6 months after stopping treatment.
Slovenian: Ženskam v rodni dobi je treba priporočiti, da sedem dni pred začetkom zdravljenja z zdravilom Xospata opravijo test nosečnosti ter da med zdravljenjem z zdravilom Xospata in vsaj 6 mesecev po njem uporabljajo učinkovito kontracepcijo.
English: - collection of fluid around the heart, which, if severe, can decrease the heart's ability to pump blood (pericardial effusion) - a vague feeling of discomfort, feeling unwell (malaise) - a severe life-threatening allergic reaction, e.g., swelling in the mouth, tongue, face and throat, itching, hives (anaphylactic reaction) - muscle stiffness - passing less urine, swelling in the legs (signs of sudden kidney injury)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - kopičenje tekočine okoli srca, ki lahko v hujših primerih zmanjša sposobnost srca za črpanje krvi (perikardialni izliv), - nejasen občutek nelagodja, splošno slabo počutje, - huda življenje ogrožajoča alergijska reakcija, npr. oteklina v ustih, na jeziku, na obrazu in v grlu, srbečica, koprivnica (anafilaktična reakcija), - okorelost mišic, - odvajanje manjše količine urina kot običajno, otekanje nog (znaki nenadne okvare ledvic).
English: How Xospata works
Slovenian: Kako deluje zdravilo Xospata
English: Symptoms of posterior reversible encephalopathy syndrome
Slovenian: Simptomi sindroma posteriorne reverzibilne encefalopatije
English: • cytarabine 20 mg twice daily by subcutaneous (SC) or intravenous (IV) for 10 days (days 1 through 10) (LoDAC)
Slovenian: • 20 mg citarabina dvakrat dnevno, 10 dni apliciranega subkutano ali intravensko (od 1. do
English: Contact your doctor straight away if you have any of the following symptoms: fever, trouble breathing, rash, dizziness or lightheadedness, rapid weight gain, swelling of your arms or legs.
Slovenian: Takoj se obrnite na zdravnika, če imate katerega koli od naslednjih simptomov: zvišana telesna temperatura, oteženo dihanje, izpuščaji, omotica ali vrtoglavica,
English: In healthy subjects, co-administration of rifampicin (600 mg), a strong CYP3A/P-gp inducer, to steady state with a single 20 mg dose of gilteritinib decreased gilteritinib mean Cmax by 27% and mean AUCinf by 70%, respectively, compared to subjects administered a single dose of gilteritinib alone (see section 4.4).
Slovenian: Pri zdravih preiskovancih se je s hkratnim dajanjem rifampicina (600 mg), močnim induktorjem CYP3A/P-gp, v stanju dinamičnega ravnovesja, in enkratnega odmerka 20 mg gilteritiniba povprečna vrednost Cmax zmanjšala za 27 %, povprečna vrednost AUCinf pa za 70 % v primerjavi s preiskovanci, ki so prejeli samo enkratni odmerek gilteritiniba (glejte poglavje 4.4).
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.
Slovenian: PRES je redka, reverzibilna nevrološka motnja, pri kateri so lahko prisotni simptomi, ki hitro napredujejo in vključujejo epileptične napade, glavobol, zmedenost, motnje vida in nevrološke motnje.
English: After a single dose of [14C] -gilteritinib, gilteritinib is primarily excreted in faeces with 64.5% of the total administered dose recovered in faeces.
Slovenian: C]-gilteritiniba se gilteritinib primarno izloča z blatom, pri čemer se z blatom izloči 64,5 % skupnega apliciranega odmerka.
English: България Астелас Фарма ЕООД
Slovenian: Астелас Фарма ЕООД Teл.
English: - diarrhoea - nausea - constipation - tiredness - swelling due to fluid retention (oedema) - loss of energy, weakness (asthenia) - abnormal blood test results: high levels of blood creatine phosphokinase (indicative of muscle or heart function), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or blood alkaline phosphatase (indicative of liver function) - pain in limbs - joint pain (arthralgia) - muscle pain (myalgia) - cough - shortness of breath (dyspnoea) - dizziness - low blood pressure (hypotension)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - driska, - slabost, - zaprtje, - utrujenost, - otekanje zaradi zadrževanja tekočine (edem), - izguba energije, šibkost (astenija), - abnormalni rezultati krvnih preiskav: visoke ravni kreatin fosfokinaze v krvi (nakazuje delovanje mišic in srca), alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) in/ali alkalne fosfataze v krvi (nakazuje delovanje jeter), - bolečine v okončinah, - bolečine v sklepih (artralgija), - bolečine v mišicah (mialgija), - kašelj, - zasoplost (dispneja), - omotica, - nizek krvni tlak (hipotenzija).
English: Median steady-state maximum concentration (Cmax) is 282.0 ng/mL (CV% = 50.8), and area under the plasma concentration curve during 24-hour dosing interval (AUC0-24) is 6180 ng·h/mL (CV% = 46.4) after once-daily dosing of 120 mg gilteritinib.
Slovenian: Mediana najvišje koncentracije v stanju dinamičnega ravnovesja (Cmax) znaša 282,0 ng/ml (CV% = 50,8) in površina pod krivuljo plazemske koncentracije v 24-urnem intervalu odmerjanja (AUC0-24) znaša 6.180 ng·h/ml (CV% = 46,4) po odmerjanju 120 mg gilteritiniba enkrat na dan. Plazemske ravni v stanju dinamičnega ravnovesja se dosežejo v 15 dneh z odmerjanjem enkrat na dan, s približno 10-kratnim kopičenjem.
English: No dose adjustment is required for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Slovenian: Pri bolnikih z blago (Child-Pugh razred A) ali zmerno (Child-Pugh razred B) okvaro jeter prilagajanje odmerka ni potrebno.
English: The predicted mean change from baseline of QTcF at the mean steady-state Cmax (282.0 ng/mL) at the 120 mg daily dose was 4.96 msec with an upper 1-sided 95% CI = 6.20 msec.
Slovenian: Predvidena povprečna sprememba QTcF glede na izhodiščno vrednost, pri povprečni Cmax v stanju dinamičnega ranovesja (282,0 ng/ml) in 120 mg dnevnem odmerku, je znašala 4,96 milisekund, pri čemer je zgornja meja enostranskega 95-odstotnega intervala zaupanja (IZ) znašala 6,20 milisekund.
English: • If differentiation syndrome is suspected, corticosteroid therapy should be initiated along with hemodynamic monitoring until symptom resolution.
Slovenian: • V primeru suma na sindrom diferenciacije je treba uvesti in kortikosteroidno terapijo s hemodinamičnim spremljanjem in jo izvajati do odprave simptomov.
English: Caution is required when concomitantly prescribing gilteritinib with medicinal products that are strong inhibitors of CYP3A and/or P-gp (such as, but not limited to, voriconazole, itraconazole, posaconazole and clarithromycin ) because they can increase gilteritinib exposure.
Slovenian: Pri hkratnem predpisovanju gilteritiniba z zdravili, ki so močni zaviralci CYP3A in/ali P-gp (kot so med drugim vorikonazol, itrakonazol, posakonazol in klaritromicin), je potrebna previdnost, ker lahko povečajo izpostavljenost gilteritinibu.
English: • Rapid weight gain
Slovenian: • hitro pridobivanje telesne mase,
English: Symptoms and clinical findings of differentiation syndrome in patients treated with Xospata included fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Slovenian: Simptomi in klinični dokazi sindroma diferenciacije so pri bolnikih, zdravljenih z zdravilom Xospata, vključevali zvišano telesno temperaturo, dispnejo, plevralni izliv, perikardialni izliv, pljučni edem, hipotenzijo, hitro pridobivanje telesne mase, periferni edem, izpuščaj in ledvično disfunkcijo.
English: Males with female partners of reproductive potential should be advised to use effective contraception during treatment and for at least 4 months after the last dose of Xospata.
Slovenian: Moškim s partnericami v rodni dobi je treba priporočiti, da med zdravljenjem in vsaj 4 mesece po zadnjem odmerku zdravila Xospata uporabljajo učinkovito kontracepcijo.
English: These may be signs of a condition called PRES (see section 4.
Slovenian: To so lahko znaki bolezenskega stanja, ki se imenuje PRES (glejte poglavje 4 - Možni neželeni učinki).
English: Hydroxypropylcellulose Hydroxypropylcellulose, low-substituted
Slovenian: Jedro tablete manitol (E421) hidroksipropilceluloza hidroksipropilceluloza, nizko substituirana magnezijev stearat
English: If you have any further questions about your treatment, please contact your doctor.
Slovenian: V primeru nadaljnjih vprašanj glede zdravljenja se obrnite na zdravnika.
English: Symptoms and clinical findings of differentiation syndrome include fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Slovenian: Simptomi in klinični dokazi sindroma diferenciacije vključujejo zvišano telesno temperaturo, dispnejo, plevralni izliv, perikardialni izliv, pljučni edem, hipotenzijo, hitro pridobivanje telesne mase, periferni edem, izpuščaje in disfunkcijo ledvic.
English: The population estimate of central and peripheral volume of distribution were 1092 L and 1100 L, respectively.
Slovenian: Ocenjeni porazdelitveni volumen v centralnem in perifernem prostoru pri populaciji je znašal 1092 l oziroma 1100 l. Ti podatki nakazujejo, da se gliteritinib obširno porazdeli zunaj plazme, kar lahko kaže na obsežno porazdelitev v tkivih.
English: In general, gilteritinib exhibited linear, dose-proportional pharmacokinetics after single and multiple dose administration at doses ranging from 20 to 450 mg in patients with relapsed or refractory AML.
Slovenian: Na splošno je bila po dajanju enkratnega in večkratnih odmerkov med 20 in 450 mg bolnikom s ponovljeno ali neodzivno AML ugotovljena linearna farmakokinetika gilteritiniba, sorazmerna z velikostjo odmerka.
English: Of the 317 patients treated with gilteritinib at 120 mg with a post-baseline QTC value in clinical studies, 4 patients (1%) experienced a QTcF >500 msec. Additionally, across all doses, 12 patients (2.3%) with relapsed/refractory AML had a maximum post-baseline QTcF interval >500 msec (see sections 4.2, 4.4 and 5.1).
Slovenian: Od 317 bolnikov, zdravljenih s 120 mg gilteritiniba ter z izmerjeno vrednostjo QTC po izhodiščnem stanju v kliničnih študijah, je pri 4 bolnikih (1 %) prišlo do vrednosti QTcF > 500 milisekund.
English: • Discontinue gilteritinib.
Slovenian: • Zdravljenje z gilteritinibom ustavite.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Izločanje Po enkratnem odmerku [
English: • Interrupt gilteritinib.
Slovenian: • Zdravljenje z gilteritinibom prekinite.
English: • granulocyte colony-stimulating factor 300 mcg/m2 once daily by SC for 5 days (days 1 to 5), fludarabine 30 mg/m2 once daily by IV for 5 days (days 2 through 6), cytarabine 2000 mg/m2 once daily by IV for 5 days (days 2 through 6), idarubicin 10 mg/m2 once daily by IV for 3 days (days 2 through 4) (FLAG-Ida).
Slovenian: • 300 μg/m granulocitne kolonije stimulirajočega faktorja enkrat dnevno, 5 dni apliciranega subkutano (od 1. do 5. dne), 30 mg/m fludarabina enkrat dnevno, 5 dni apliciranega intravensko
English: Do not stop taking this medicine unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Xospata Ne prenehajte jemati zdravila Xospata, dokler vam tega ne naroči zdravnik.
English: In clinical studies, 12 patients had QTcF >500 msec. Three patients interrupted and reinitiated treatment without recurrence of QT prolongation.
Slovenian: Zdravljenje treh bolnikov so prekinili in znova uvedli, pri tem pa ni prišlo do ponovitve podaljšanja intervala QT.
English: Women taking Xospata who are able to become pregnant should use an effective method of contraception during treatment with Xospata and for at least 6 months after stopping Xospata.
Slovenian: Ženske, ki jemljejo zdravilo Xospata in lahko zanosijo, morajo med zdravljenjem z zdravilom Xospata in vsaj 6 mesecev po koncu zdravljenja uporabljati učinkovito metodo kontracepcije.
English: Table 2: Adverse reactions Adverse drug reaction
Slovenian: Preglednica 2: Neželeni učinki
English: Hypokalaemia or hypomagnesaemia may increase the QT prolongation risk.
Slovenian: Hipokaliemija ali hipomagneziemija lahko poveča tveganje za podaljšanje intervala QT. Hipokaliemijo ali hipomagneziemijo je torej treba odpraviti pred zdravljenjem z zdravilom Xospata in med njim.
English: • Swelling of your arms or legs
Slovenian: • otekanje rok ali nog.
English: 14.7 0.6 Very common
Slovenian: 0,6 zelo pogosti
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).
Slovenian: Kasneje, ko se znaki in simptomi pankreatitisa odpravijo, se lahko zdravljenje nadaljuje z zmanjšanim odmerkom (glejte poglavje 4.2).
English: Men taking Xospata whose partners are able to become pregnant should use an effective method of contraception during treatment of Xospata and for at least 4 months after stopping the treatment.
Slovenian: Moški, ki se zdravijo z zdravilom Xospata in imajo partnerico, ki lahko zanosi, morajo med zdravljenjem z zdravilom Xospata in vsaj 4 mesece po njem uporabljati učinkovito metodo kontracepcije.
English: Talk to your doctor, pharmacist or nurse before taking Xospata: - if you have a heart rhythm disorder, such as an irregular heartbeat or a condition called QT prolongation (see section 4.
Slovenian: Pred začetkom jemanja zdravila Xospata se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če imate motnje srčnega ritma, kot je neenakomerno bitje srca, ali bolezensko stanje, ki se imenuje podaljšanje intervala QT (glejte poglavje 4 - Možni neželeni učinki); - če ste imeli v preteklosti nizke ravni kalijevih ali magnezijevih soli v krvi, ker se lahko zaradi tega poveča tveganje za nepravilen srčni ritem; - če imate hude bolečine v zgornjem delu trebuha in hrbta ali se pojavita slabost in bruhanje.
English: Grades
Slovenian: Stopnje
English: Breast-feeding should be discontinued during treatment with Xospata and for at least two months after the last dose.
Slovenian: Med zdravljenjem z zdravilom Xospata in vsaj dva meseca po zadnjem odmerku mora biti dojenje prekinjeno.
English: 24.1 4.4 Very common
Slovenian: 4,1 zelo pogosti navzea
English: Talk to you doctor, pharmacist or nurse straight away: - if you have any of the following symptoms: fever, trouble breathing, rash, dizziness or lightheadedness, rapid weight gain, swelling of your arms or legs.
Slovenian: Takoj se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če imate katerega koli od naslednjih simptomov: zvišana telesna temperatura, oteženo dihanje,
English: Dose modifications
Slovenian: Prilagajanje odmerka
English: 29.8 1.9 Very common
Slovenian: 1,9 zelo pogosti zaprtje
English: • Interrupt gilteritinib if severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids.
Slovenian: • Če hudi znaki in/ali simptomi vztrajajo več kot 48 ur po začetku uporabe kortikosteroidov, prekinite zdravljenje z gilteritinibom.
English: Blood alkaline phosphatase increased* 68.7 1.6 Very common Pain in extremity
Slovenian: 6,3 zelo pogosti zvišanje ravni alkalne fosfataze v krvi*
English: Contact your doctor straight away if you have a seizure, quickly worsening headache, confusion, or other vision problems.There have been uncommon reports of a condition involving the brain, in patients treated with Xospata, called PRES (may affect up to 1 in 100 people).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Xospata, so poročali o občasnih primerih bolezenskega stanja, povezanega z možgani, ki se imenuje PRES (pojavi se lahko pri največ 1 od 100 bolnikov).
English: Astellas Pharma Ltd. Tel: +44 (0) 203 379 8700
Slovenian: Tel: +44 (0) 203 379 8700
English: 12.5 0.3 Very common
Slovenian: 10,3 zelo pogosti
English: CRa (95% CIb) CRhc (95% CIb) CR/CRh (95% CIb) CI: confidence interval a. CR was defined as an absolute neutrophil count ≥1.0 x 109/L, platelets ≥100 x 109/L, normal marrow differential with <5% blasts, must have been red blood cells, platelet transfusion independent and no evidence of extramedullary leukemia.
Slovenian: 9/l, diferencialna krvna slika normalnega kostnega mozga z manj kot 5 % blastov, neodvisnost od transfuzije eritrocitov in trombocitov ter brez dokazov ekstramedularne levkemije.