FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms of VTE (deep vein thrombosis and pulmonary embolism) In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Dysmenorrhoea
Maltese: Ħakk mifrux
English: When switching from an oral combined contraceptive Treatment with EVRA should begin on the first day of withdrawal bleeding.
Maltese: Meta tuża kontraċettiv ormonali kombinat bħal EVRA inti avżata biex tieqaf tpejjep.
English: Blister (Aclar/polyethylene/PVC)
Maltese: Jittieħed mill-ħalq Folja (Aclar/polyethylene/PVC)
English: EU number
Maltese: Konċentrazzjoni
English: Bottle (polyethylene terephthalate)
Maltese: Jittieħed mill-ħalq Flixkun (polyethylene terephthalate)
English: Bottle (HDPE)
Maltese: Jittieħed mill-ħalq Flixkun (HDPE)
English: 10 mg/ml Oral solution
Maltese: Soluzzjoni orali
English: Concentration Package size
Maltese: Daqs tal-pakkett
English: 2333 BE Leiden The Netherlands
Maltese: 2333 BE Leiden In-Netherlands
English: My name: ________________________________________________________________________ My contact number: ____________________________________________________________ Emergency contact: ________________________________________________________________ Emergency contact number: ________________________________________________________ Name of Haematologist/Oncologist/Oncology Nurse: _____________________________________ Contact number: _______________________________________________________________ After-hours contact number: _____________________________________________________ Name of my Hospital: ______________________________________________________________ My Hospital contact number: ____________________________________________________
Maltese: In-numru ta' kuntatt tiegħi: _________________________________________________________ Kuntatt ta' emerġenza: _____________________________________________________________ Numru tal-kuntatt ta' emerġenza: ____________________________________________________ Isem l-Ematologu/Onkologu/Infermier tal-Onkoloġija: ___________________________________ Numru ta' kuntatt: _________________________________________________________________ Numru ta' kuntatt għal wara s-sigħat tax-xogħol: _______________________________________ Isem l-Isptar tiegħi: ________________________________________________________________
English: ADMIRAL study (2215-CL-0301)
Maltese: Studju ADMIRAL (2215-CL-0301)
English: QTc interval >500 msec
Maltese: Intervall ta' QTc >500 msec
English: CHRYSALIS study (2215-CL-0101)
Maltese: L-istudju CHRYSALIS (2215-CL-0101)
English: Chemotherapy (N=124)
Maltese: Kimoterapija (N=124)
English: Hydroxypropylcellulose Hydroxypropylcellulose, low-substituted
Maltese: Hydroxypropylcellulose Hydroxypropylcellulose, sostitut baxx Magnesium stearate
English: Embryofoetal toxicity and contraception
Maltese: Tossiċità embrijufetali u kontraċettivi
English: Figure 1: Kaplan-Meier plot of overall survival in ADMIRAL study
Maltese: Figura 1: Plot ta' Kaplan-Meier tas-sopravivenza globali fl-istudju ADMIRAL
English: Astellas Pharma a/s Tlf: +45 43 430355
Maltese: Danmark Astellas Pharma a/s Tlf: +45 43 430355
English: Film-coating Hypromellose Talc
Maltese: Kisja tal-pillola Hypromellose Talc
English: - The other ingredients are: mannitol (E421), hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide, iron oxide yellow (E172).
Maltese: - Is-sustanzi mhux attivi l-oħra huma: mannitol (E421), hydroxypropylcellulose, hydroxypropylcellulose b'sostituzzjoni baxxa, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide, iron oxide yellow (E172).
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE54
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, inibituri ta' proteina kinase, Kodiċi ATC:
English: Symptoms of pancreatitis
Maltese: Sintomi ta' pankreatite
English: • azacitidine 75 mg/m2 once daily by SC or IV for 7 days (days 1 through 7)
Maltese: • azacitidine 75 mg/m darba kuljum SC jew IV għal 7 ijiem (jiem 1 sa 7)
English: • Confirm with ECG on day 9.
Maltese: • Ikkonferma b'ECG f'jum 9.
English: Other clinically significant serious adverse reactions included differentiation syndrome (2.2%), electrocardiogram QT prolonged (0.9%) and posterior reversible encephalopathy syndrome (0.6%).
Maltese: Reazzjonijiet avversi serji klinikament sinifikanti oħra inkludew sindrome ta' differenzazzjoni (2.2%), titwil tal-QT fl-elettrokardjogram (0.9%) u sindrome ta' enċefalopatija riversibbli posterjuri (0.6%).
English: CYP3A/P-gp Inducers
Maltese: Indutturi ta' CYP3A/P-gp
English: Alanine aminotransferase increased*
Maltese: Żieda fl-aspartate aminotransferase*
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)
Maltese: • mitoxantrone 8 mg/m 2, etoposide 100 mg/m u cytarabine 1000 mg/m darba kuljum IV
English: Table 2: Adverse reactions Adverse drug reaction
Maltese: Tabella 2: Reazzjonijiet avversi
English: Gilteritinib has been associated with differentiation syndrome (see section 4.8).
Maltese: Gilteritinib ġie assoċjat ma' sindrome ta' differenzazzjoni (ara sezzjoni 4.8).
English: The population estimate of central and peripheral volume of distribution were 1092 L and 1100 L, respectively.
Maltese: L-istima tal-popolazzjoni tal-volum ċentrali u periferali ta' distribuzzjoni kienu 1092 L u 1100 L, rispettivament.
English: Based on in vitro data, gilteritinib is primarily metabolised via CYP3A4.
Maltese: Abbażi ta' data in vitro, gilteritinib huwa primarjament metabolizzat permezz ta' CYP3A4.
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.
Maltese: Inibituri qawwija ta' CYP3A u/jew P-gp (eż., voriconazole, itraconazole, posaconazole, clarithromycin, erythromycin, captopril, carvedilol, ritonavir, azithromycin) jistgħu jżidu lkonċentrazzjonijiet fil-plażma ta' gilteritinib.
English: Serum creatinine, a marker of renal function, was identified as a statistically significant covariate.
Maltese: Il-krejatinina fis-serum, markatur talfunzjoni tal-kliewi, ġiet identifikata bħala kovarjant statistikament sinifikanti.
English: Planned HSCT
Maltese: HSCT ippjanata
English: There have been reports of pancreatitis.
Maltese: Kien hemm rapporti ta' pankreatite.
English: It contains the active substance gilteritinib.
Maltese: Fih is-sustanza attiva gilteritinib.
English: Gilteritinib has been associated with prolonged cardiac ventricular repolarisation (QT Interval) (see sections 4.8 and 5.1).
Maltese: Gilteritinib ġie assoċjat ma' ripolarizzazzjoni ventrikulari kardijaka mtawla (Intervall tal-QT) (ara sezzjonijiet 4.8 u 5.1).
English: Frequency categories are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti kif ġej: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Immune system disorders
Maltese: Disturbi fis-sistema immuni Reazzjoni anafilattika
English: Of 319 patients treated with Xospata in the clinical studies, 11 (3%) experienced differentiation syndrome.
Maltese: Minn 319-il pazjent trattati b'Xospata fl-istudji kliniċi, 11 (3%) esperjenzaw sindrome ta' differenzazzjoni.
English: IMPORTANT INFORMATION FOR HEALTHCARE PROVIDERS
Maltese: INFORMAZZJONI IMPORTANTI
English: EU/1/19/1399/001 84 film coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1399/001 84 pillola miksija b'rita
English: Efficacy and safety was evaluated in the active-controlled, phase 3 study (2215-CL-0301) .
Maltese: L-effikaċja u s-sigurtà ġew evalwati fl-istudju ta' fażi 3 ikkontrollat b'mod attiv (2215-CL-0301).
English: * Frequency is based on central laboratory values.
Maltese: * Il-frekwenza hija bbażata fuq valuri tal-laboratorju ċentrali.
English: • Interrupt gilteritinib.
Maltese: Interrompi t-trattament b'gilteritinib.
English: 17.2 7.2 Very common
Maltese: 7.2 Komuni ħafna
English: In rats, decreased urination at 30 mg/kg and higher and decreased defecation at 100 mg/kg were observed.
Maltese: Fil-firien, tnaqqis fl-awrina fi 30 mg/kg u ppurgar ogħla u mnaqqas f'100 mg/kg kienu osservati.
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%).
Maltese: 4%), dardir (29.8%), stitikezza (28.2%), sogħla (28.2%), edema periferali (24.1%), qtugħ ta' nifs (24.1%), sturdament (20.4%), pressjoni baxxa (17.2%), uġigħ fl-estremitajiet (14.7%), astenja (13.8%), artralġja (12.5%) u majalġja (12.5%).
English: Of the 319 patients treated with Xospata in the clinical studies, 0.6% experienced posterior reversible encephalopathy syndrome (PRES).
Maltese: Mit-319-il pazjent trattati b'Xospata fl-istudji kliniċi, 0.6% esperjenzaw sindrome ta' enċefalopatija riversibbli posterjuri (PRES).
English: CYP3A and/or P-gp inhibitors
Maltese: Inibituri ta' CYP3A u/jew P-gp
English: Gilteritinib fumarate is a FLT3 and AXL inhibitor.
Maltese: Gilteritinib fumarate huwa inibitur ta' FLT3 u AXL.
English: Each film-coated tablet contains 40 mg gilteritinib (as fumarate).
Maltese: Kull pillola miksija b'rita fiha 40 mg ta' gilteritinib (bħala fumarate).
English: Patients had the following confirmed mutations: FLT3-ITD alone (88.4%), FLT3-TKD alone (8.4%) or both FLT3-ITD and FLT3-TKD (1.9%).
Maltese: FLT3-ITD biss (88.4%), FLT3-TKD biss (8.4%) jew kemm FLT3-ITD kif ukoll FLT3-TKD (1.9%).
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.
Maltese: Gilteritinib jinibixxi s-sinjalazzjoni u l-proliferazzjoni ta' riċettur ta' FLT3 f'ċelluli li jesprimu mutazzjonijiet FLT3 b'mod esoġenu inkluż FLT3-ITD, FLT3-D835Y, u FLT3-ITD-D835Y, u kien induttur ta' apoptożi f'ċelloli lewkemiċi li jesprimu FLT3-ITD.
English: Gastrointestinal disorders
Maltese: Disturbi gastro-intestinali Dijarea
English: Efficacy was further supported by the rate of complete remission (CR)/complete remission with partial haematologic recovery (CRh) (Table 3, Figure 1).
Maltese: L-effikaċja kienet appoġġjata aktar bir-rata ta' remissjoni kompleta (CR, complete remission)/remissjoni kompleta bi rkupru ematoloġiku parzjali (CRh) (Tabella 3, Figura 1).
English: QTc interval increased by >30 msec on ECG on day 8 of cycle 1
Maltese: L-intervall tal-QTc żdied bi >30 msec fuq l-ECG f'jum 8 ta' ċiklu 1
English: Gilteritinib did not induce gene mutation or chromosomal aberrations in vitro.
Maltese: Gilteritinib ma kienx induttur ta' mutazzjoni fil-ġeni jew aberrazzjonijiet kromożomali in vitro.
English: - Differentiation syndrome.
Maltese: - Sindrome ta' differenzazzjoni.
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/.
Maltese: Jekk jogħġbok ikkuntattja lill-Ematologu/Onkologu tal-pazjent għal aktar informazzjoni u kkonsulta lInformazzjoni dwar il-Prodott għal gilteritinib disponibbli fuq https://www.ema.europa.eu/.
English: • This patient is being treated with Xospata (gilteritinib), which can cause differentiation syndrome.
Maltese: • Dan il-pazjent qed jiġi ttrattat b'Xospata (gilteritinib), li jista' jikkawża sindrome ta' differenzazzjoni.
English: Xospata should be interrupted in patients who have a QTcF >500 msec (see section 4.2).
Maltese: Xospata għandu jiġi interrott f'pazjenti li għandhom QTcF > 500 msec (ara sezzjoni 4.2).
English: The gastrointestinal tract was identified as one of the target organs similar as in adult rats.
Maltese: Il-passaġġ gastrointestinali kien identifikat bħala wieħed mill-organi fil-mira simili bħal f'firien adulti.
English: IMPORTANT SAFETY INFORMATION FOR PATIENTS Xospata may cause serious side effects, including differentiation syndrome.
Maltese: Xospata jista' jikkawża effetti sekondarji serji, inkluż is-sindrome ta' differenzazzjoni.
English: If PRES is suspected, it should be confirmed by brain imaging, preferably magnetic resonance imaging (MRI).
Maltese: Jekk PRES huwa suspettat, għandu jiġi kkonfermat permezz ta' immaġni talmoħħ, preferibbilment immaġni b'reżonanza manjetika (MRI, magnetic resonance imaging).
English: Prolonged QT interval
Maltese: Intervall tal-QT imtawwal
English: България Астелас Фарма ЕООД
Maltese: Астелас Фарма ЕООД Teл.:
English: For recommendations in case of suspected differentiation syndrome see sections 4.2 and 4.4.
Maltese: Għal rakkomandazzjonijiet f'każ ta' sindrome ta' differenzazzjoni suspettat ara sezzjonijiet 4.2 u 4.4.
English: Most patients in the study were Caucasian (59.3%); 27.5% Asian, 5.7% Black, 4% other races and 3.5% unknown.
Maltese: Il-biċċa l-kbira tal-pazjenti fl-istudju kienu Kawkasi (59.3%); 27.5% kienu Asjatiċi, 5.7% kienu Suwed, 4% razez oħra u 3.5% mhux magħrufa.
English: - Description of the signs and symptoms of differentiation syndrome.
Maltese: - Deskrizzjoni tas-sinjali u s-sintomi ta' sindrome ta' differenzazzjoni.
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.
Maltese: Qabel jieħdu gilteritinib, pazjenti li għandhom AML li rkadiet jew refrattorja, irid ikollhom konferma ta' mutazzjoni ta' tyrosine kinase 3 (FLT3) li qisha FMS (duplikazzjoni tandem interna [ITD, internal tandem duplication] jew dominju ta' tyrosine kinase [TKD, tyrosine kinase domain]) permezz ta' test validat.
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).
Maltese: Pazjenti li ntgħażlu b'mod każwali għall-grupp ta' gilteritinib kellhom sopravivenza sinifikament itwal meta mqabbla mal-grupp ta' kimoterapija (HR 0.637; 95% CI 0.490 - 0.830; valur p b'naħa waħda: 0.0004).
English: • Rapid weight gain
Maltese: • Żieda rapida fil-piż
English: Gilteritinib has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Gilteritinib ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh Klassi Ċ).
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.
Maltese: F'pazjenti b'AML li rkadiet jew refrattorja li jirċievu gilteritinib 120 mg, inibizzjoni sostanzjali (> 90%) ta' FLT3 phosphorylation kienet rapida (fi żmien 24 siegħa wara l-ewwel doża) u nżammet, kif ikkaratterizzata minn assaġġ ta' attività ta' inibizzjoni fil-plażma (PIA, plasma inhibitory activity) ex vivo.
English: OPA/aluminium/PVC/aluminium blisters containing 21 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-OPA/aluminium/PVC/aluminium li fihom 21 pillola miksija b'rita.
English: You will also find this information in the Patient Alert Card that is included in the packaging.
Maltese: Din l-informazzjoni tista' ssibha wkoll fil-Kartuna ta' Twissija tal-Pazjent li hija inkluża fil-pakkett.
English: Xospata 40 mg film-coated tablets gilteritinib
Maltese: Xospata 40 mg pilloli miksija b'rita gilteritinib
English: Deaths, n (%)
Maltese: Sopravivenza totali Imwiet, n (%)
English: Symptoms of differentiation syndrome
Maltese: Sindrome ta' differenzazzjoni
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).
Maltese: cytarabine 2000 mg/m darba kuljum IV għal 5 ijiem (jiem 2 sa 6), idarubicin 10 mg/m darba kuljum IV għal 3 ijiem (jiem 2 sa 4) (FLAG-Ida).
English: These may be signs of a condition called differentiation syndrome (see section 4 - Possible side effects).
Maltese: Dawn jistgħu jkunu sinjali ta' kundizzjoni magħrufa bħala sindrome ta' differenzazzjoni (ara sezzjoni 4 - Effetti sekondarji possibbli).
English: The effect of severe renal impairment on gilteritinib exposure has not been investigated (see section 4.2).
Maltese: L-effett ta' indeboliment talkliewi sever fuq l-esponiment għal gilteritinib ma ġiex investigat (ara sezzjoni 4.2).
English: Astellas Pharma B.V.
Maltese: Astellas Pharma B.V. Branch
English: Xospata belongs to a class of cancer medicines called protein kinase inihibitors.
Maltese: Xospata huwa parti minn klassi ta' mediċini għall-kanċer magħrufa bħala inibituri tal-proteina kinase.
English: The primary metabolites in humans include M17 (formed via N-dealkylation and oxidation), M16 and M10 (both formed via N-dealkylation) and were observed in animals.
Maltese: Ilmetaboliti primarji fil-bnedmin jinkludu M17 (iffurmat permezz ta' N-dealkylation u ossidazzjoni), M16 u M10 (it-tnejn iffurmati permezz ta' N-dealkylation) u ġew osservati fl-annimali.
English: Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment.
Maltese: Is-sintomi ta' sindrome ta' differenzazzjoni jistgħu jerġgħu jitfaċċaw bi twaqqif prematur tat-trattament bil-kortikosterojdi.
English: In vivo plasma protein binding in humans is approximately 90% and gilteritinib is primarily bound to albumin.
Maltese: It-twaħħil tal-proteina tal-plażma in vivo fil-bnedmin hu madwar 90% u gilteritinib primarjament jeħel ma' albumin.
English: The median OS was 7.2 months and 7.1 months for the 120 mg dose and the combined dose levels, respectively.
Maltese: L-OS medjan kien 7.2 xhur u 7.1 xhur għal-livelli tad-doża ta' 120 mg u ddoża kombinata, rispettivament.
English: In the juvenile toxicity study in rats, the minimum lethal dose level (2.5 mg/kg/day) was much lower than that of adult rats (20 mg/kg/day).
Maltese: Fl-istudju dwar it-tossiċità ġuvenili fil-firien, il-livell minimu ta' doża letali (2.5 mg/kg/jum) kien ħafna inqas minn dik ta' firien adulti (20 mg/kg/jum).
English: Median in months (95% CI) Hazard Ratio (95% CI) p-value (1-sided) 1 year survival rate, % (95% CI)
Maltese: Medjan f'xhur (95% CI) Proporzjon ta' Periklu (95% CI) valur p (b'naħa waħda)
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.
Maltese: Il-maġġoranza tal-pazjenti kellhom AML b'ċitoġenetika ta' riskju intermedju (73%), 10% kellhom ċitoġenetika mhux favorevoli, 1.3% favorevoli u 15.
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.
Maltese: Il-bidla medja mil-linja bażi mbassra ta' QTcF fl-istat fiss medju ta' Cmax (282.0 ng/mL) fid-doża ta' kuljum ta' 120 mg kienet 4.96 msec b'95% CI b'naħa waħda massima = 6.20 msec.
English: Xospata may be re-initiated in patients following haematopoietic stem cell transplantation (HSCT) (see Table 1).
Maltese: Xospata jista' jerġa' jinbeda f'pazjenti wara trapjant taċ-ċelluli staminali ematopojetiċi (HSCT, haematopoietic stem cell transplantation) (ara Tabella 1).
English: EU/1/19/1399/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1399/001
English: These data indicate gilteritinib distributes extensively outside of plasma, which may indicate extensive tissue distribution.
Maltese: Din id-data tindika li gilteritinib jiġi distribwit b'mod estensiv barra mill-plażma, li tista' tindika distribuzzjoni estensiva fit-tessut.
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.
Maltese: Ir-rata tar-rispons (CR/CRh) osservata fi Studju 2215-CL-0101 fil-pazjenti li rċivew aktar minn linja waħda ta' terapija preċedenti kienet 21.4% u 15.7% għal-livelli tad-doża ta' 120 mg u d-doża kombinata, rispettivament.
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%).
Maltese: Ir-reazzjonijiet avversi serji l-aktar frekwenti kienu dijarea (4.7%), żieda fl-ALT (4.1%), qtugħ ta' nifs (3.4%), żieda fl-AST (3.1%) u pressjoni baxxa (2.8%).
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).
Maltese: Interazzjonijiet bejn mediċina trasportatur u mediċina oħra Esperimenti in vitro wrew li gilteritinib huwa substrat ta' P-gp u potenzjalment jista' jinibixxi BCRP u P-gp fil-musrana ż-żgħira, OCT1 fil-fwied f'konċentrazzjonijiet klinikament rilevanti (ara sezzjoni 4.5).
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).
Maltese: Fl-istudji tat-tossiċità minn dożi ripetuti fil-firien u l-klieb, l-organi fil-mira tat-tossiċità kienu lpassaġġ gastrointestinali (emorraġija fil-klieb), is-sistema limfoematopojetika (nekrożi tal-limfoċiti u ipoċellularità fil-mudullun b'bidliet fil-parametri ematoloġiċi), l-għajn (infjammazzjoni u opaċità tallenti fil-firien, tibdil fil-kulur tal-fundus fil-klieb, vakwolazzjoni retinali), il-pulmun (pulmonite interstizjali fil-firien u infjammazzjoni fil-klieb), il-kliewi (tibdil fit-tubi żgħar tal-kliewi b'reazzjoni pożittiva tad-demm moħbi fl-awrina) u l-fwied (vakwolazzjoni epatoċita), il-bużżieqa tal-awrina (vakwolazzjoni epiteljali), it-tessut epiteljali (ulċera u infjammazzjoni), u fosfolipidożi (pulmun u kliewi fil-firien).
English: While the study included patients with various AML-related cytogenetic abnormalities, patients with acute promyelocytic leukaemia (APL) or therapy-related AML were excluded.
Maltese: Filwaqt li l-istudju inkluda pazjenti b'diversi anormalitajiet ċitoġenetiċi relatati mal-AML, pazjenti b'lewkimja promijeloċitika akuta (APL, acute promyelocytic leukaemia) jew AML relatata mat-terapija ġew esklużi.
English: Effects of other medicinal products on Xospata
Maltese: Effetti ta' prodotti mediċinali oħrajn fuq Xospata
English: Table 3: ADMIRAL study overall survival and complete remission in patients with relapsed or refractory AML
Maltese: Tabella 3: Sopravivenza globali u remissjoni kompleta f'pazjenti b'AML li rkadiet jew refrattorja fl-istudju ADMIRAL