FrancophonIA/ELRC3.0 huggingface dataset:
English: • Educational tool targeting prescribers o Educational tool targeting prescribers: - Information on Xospata, including the approved indication according to the SmPC.
Maltese: - Informazzjoni dwar Xospata, inkluża l-indikazzjoni approvata skont l-SmPC.
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.
Maltese: FLT3 trattati b'jew 1 jew >1 linji tat-trattament preċedenti fil-grupp tad-doża kkombinata (jiġifieri, 80 mg, 120 mg jew 200 mg); 31.2% irċivew linja tat-trattament preċedenti waħda u 68.8% irċivew >1 linji tat-trattament preċedenti.
English: Adverse reactions not observed in clinical studies, but seen in animals (safety pharmacology/repeat dose toxicity) at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Maltese: Ma dehrux effetti mhux mixtieqa waqt studji kliniċi, iżda dehru f'annimali (sigurtà farmakoloġika/tossiċità minn dożi repetuti) f'livelli ta' esponiment simili għal-livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku kif spjegat:
English: Each film-coated tablet contains 40 mg gilteritinib (as fumarate) For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija b'rita fiha 40 mg ta' gilteritinib (bħala fumarate) Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
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).
Maltese: F'individwi f'saħħithom, l-għoti flimkien ma' rifampicin (600 mg), induttur qawwi ta' CYP3A/P-gp, għal stat fiss b'doża waħda ta' 20 mg ta' gilteritinib, naqqas is-Cmass medju ta' gilteritinib b'27% u l-AUCinf medju b'70%, rispettivament, meta mqabbel ma' individwi li ngħataw doża waħda ta' gilteritinib waħdu (ara sezzjoni 4.4).
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.
Maltese: L-età medjana fl-għażla każwali kienet ta' 62 sena (medda ta' 20 sa 84 sena) fil-grupp ta' gilteritinib u 62 sena (medda ta' 19 sa 85 sena) fil-grupp ta' kimoterapija ta' salvataġġ.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Sturdament
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.
Maltese: Analiżi tal-kovarjanti indikat li l-età (20 sena sa 90 sena), u l-piż tal-ġisem (36 kg sa 157 kg) kienu statistikament sinifikanti; madankollu, il-bidla mbassra fl-esponiment għal gilteritinib kienet inqas minn darbtejn.
English: • Discontinue gilteritinib.
Maltese: (gilteritinib)
English: • cytarabine 20 mg twice daily by subcutaneous (SC) or intravenous (IV) for 10 days (days 1 through 10) (LoDAC)
Maltese: intravenous) għal 10 ijiem (jiem 1 sa 10) (LoDAC)
English: The estimated apparent clearance (CL/F) based on the population PK model is 14.85 L/h.
Maltese: It-tneħħija apparenti stmata (CL/F) bbażata fuq il-mudell farmakokinetiku tal-popolazzjoni hija 14.85 L/h.
English: Gilteritinib as an inhibitor or inducer
Maltese: Gilteritinib bħala inibitur jew induttur
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).
Maltese: Xospata huwa indikat bħala monoterapija fit-trattament ta' pazjenti adulti li għandhom lewkimja talmijelojde akuta (AML, acute myeloid leukemia) li rkadiet jew refrattorja b'mutazzjoni FLT3 (ara sezzjonijiet 4.2 u 5.1).
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.
Maltese: Mill-pazjenti li ntgħażlu minn qabel biex jirċievu kimoterapija ta' salvataġġ, 60.5% intgħażlu b'mod każwali għal intensità għolja u 39.5% għal intensità baxxa.
English: Discontinuation of Xospata in patients who develop PRES is recommended (see sections 4.2 and 4.8).
Maltese: Ittwaqqif ta' Xospata f'pazjenti li jiżviluppaw PRES huwa rakkomandat (ara sezzjonijiet 4.2 u 4.8).
English: • Interrupt gilteritinib until pancreatitis is resolved.
Maltese: • Interrompi t-trattament b'gilteritinib sakemm il pankreatite tgħaddi.
English: Each pack contains 84 film-coated tablets.
Maltese: Kull pakkett fih 84 pilloli miksija b'rita.
English: 1.3 1.3 Common
Maltese: 1.3 Komuni ħafna
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.
Maltese: Ilfarmakokinetika ta' midazolam (substrat sensittiv ta' CYP3A4) ma ġietx affettwata b'mod sinifikanti (Cmass u AUC żdiedu b'madwar 10%) wara l-għoti ta' darba kuljum ta' gilteritinib (300 mg) għal 15-il jum f'pazjenti b'AML b'mutazzjoni FLT3 li rkadiet jew refrattorja.
English: Symptoms of posterior reversible encephalopathy syndrome
Maltese: Sintomi ta' sindrome ta' enċefalopatija riversibbli posterjuri
English: A risk to the breast-fed children cannot be excluded.
Maltese: Riskju gћat-tfal li qed jiġu mredda' mhux eskluż.
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.
Maltese: L-effett ta' indeboliment tal-fwied fuq il-farmakokinetika ta' gilteritinib ġie studjat f'individwi b'indeboliment tal-fwied ħafif (Child-Pugh Klassi A) u moderat (Child-Pugh Klassi B).
English: Of the 11 patients who experienced differentiation syndrome, 9 (82%) recovered after treatment or after dose interruption of Xospata.
Maltese: Mill-11il pazjent li esperjenzaw sindrome ta' differenzazzjoni, 9 (82%) irkupraw wara t-trattament jew wara interruzzjoni fid-doża ta' Xospata.
English: Astellas Pharma s.r.o.
Maltese: Česká republika Astellas Pharma s.r.o.
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).
Maltese: Barra minn hekk, fost id-dożi kolha, 12il pazjent (2.3%) b'AML li rkadiet/refrattorja kellhom intervall tal-QTcF wara l-linja bażi massimu ta' >500 msec (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: The median OS was 9.3 months for patients receiving gilteritinib and 5.6 months for those receiving chemotherapy.
Maltese: L-OS medjan kien 9.3 xhur għal pazjenti li rċivew gilteritinib u 5.6 xhur għal dawk li rċivew kimoterapija.
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).
Maltese: Għandu jsir elettrokardjogram (ECG) qabel il-bidu tat-trattament b'gilteritinib, f'jum 8 u 15 ta' ċiklu 1 u qabel il-bidu tat-tliet xhur sussegwenti ta' trattament (ara sezzjonijiet 4.4 u 4.8).
English: A concentration-related increase in change from baseline of QTcF was observed across gilteritinib doses ranging from 20 to 450 mg.
Maltese: Żieda relatata mal-konċentrazzjoni fil-bidla mil-linja bażi ta' QTcF kienet osservata fost id-dożi ta' gilteritinib minn 20 sa 450 mg.
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.
Maltese: Eliminazzjoni Wara doża waħda ta' [14C] -gilteritinib, gilteritinib hu primarjament eliminat mal-ippurgar b' 64.5%
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.
Maltese: Qabel it-trattament b'gilteritinib, 39.4% tal-pazjenti kellhom AML refrattorja primarja u l-maġġoranza ta' dawn il-pazjenti kienu kklassifikati bħala refrattorji wara ċiklu wieħed ta' trattament ta' induzzjoni ta' kimoterapija, 19.7% kellhom AML li rkadiet wara trapjant taċ-ċelluli staminali ematopojetiċi (HSCT) alloġeniċi u 41% kellhom AML li rkadiet mingħajr HSCT alloġeniċi.
English: The in vivo micronucleus test showed that gilteritinib has a potential to induce micronuclei in mice.
Maltese: It-test tal-mikronukleu in vivo wera li gilteritinib għandu potenzjal li jkun induttur ta' mikronuklei filġrieden.
English: • Interrupt gilteritinib until toxicity resolves or improves to Grade 1a.
Maltese: • Interrompi t-trattament b'gilteritinib sakemm it tossiċità tgħaddi jew titjieb għal Grad 1a.
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.
Maltese: Gilteritinib wera soppressjoni fit-tkabbir tal-fetu, u wassal għal imwiet embrijufetali u teratogeneċità fl-istudji tal-iżvilupp embrijufetali fil-firien f'livelli ta' esponiment simili għal-livelli ta' esponiment kliniku.
English: Xospata dosing
Maltese: X'inhu Xospata
English: The patient alert card will be integrated in the packaging and the content will be agreed as part of the labelling (Annex III).
Maltese: Il-kartuna ta' twissija tal-pazjent se tiġi integrata fil-pakkett u l-kontenut se jkun maqbul bħala parti mit-tikkettar (Anness III).
English: Co-administration of CYP3A/P-gp inducers may lead to decreased gilteritinib exposure and consequently a risk for lack of efficacy.
Maltese: L-għoti flimkien ma' indutturi ta' CYP3A/P-gp jista' jwassal għal tnaqqis fl-esponiment għal gilteritinib u konsegwentement għal riskju ta' nuqqas ta' effikaċja.
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.
Maltese: B'mod ġenerali, gilteritinib wera farmakokinetika lineari u proporzjonali għad-doża wara l-għoti ta' doża waħda u dożi multipli f'dożi li jvarjaw minn 20 sa 450 mg f'pazjenti b'AML li rkadiet jew refrattorja.
English: Therefore, concomitant use of gilteritinib with strong CYP3A4/P-gp inducers should be avoided (see section 4.5).
Maltese: Għalhekk, l-użu fl-istess ħin ta' gilteritinib ma' indutturi qawwija ta' CYP3A4/P-gp għandu jiġi evitat (ara sezzjoni 4.5).
English: BATCH NUMBER
Maltese: CRh c
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.
Maltese: L-istudju ADMIRAL huwa studju kliniku ta' Fażi 3 fejn il-pazjenti ntgħażlu b'mod każwali, open-label u multiċentrika ta' pazjenti adulti b'AML li rkadiet jew refrattorja b'mutazzjoni ta' FLT3 kif determinata mill-Assaġġ tal-Mutazzjoni FLT3 ta' LeukoStrat
English: The tablets are provided in blisters and are available in packs containing 84 film-coated tablets (4-blisters of 21 film-coated tablets).
Maltese: Il-pilloli jiġu pprovduti f'folji u huma disponibbli f'pakketti li fihom 84 pillola miksija b'rita (4 -folji ta' 21 pillola miksija b'rita).
English: No dose adjustment is required for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ f'pazjenti b'indeboliment tal-fwied ħafif (Child-Pugh Klassi A) jew moderat (Child-Pugh Klassi B).
English: • Resume treatment with gilteritinib at a reduced dose (80 mg or 120 mgb).
Maltese: Kompli t-trattament b'gilteritinib b'doża mnaqqsa (80 mg jew 120 mg b).
English: Xospata is used to treat adults with acute myeloid leukaemia (AML), a cancer of certain white blood cells.
Maltese: Xospata jintuża biex jiġu trattati adulti b'lewkimja tal-mijelojde akuta (AML, acute myeloid leukemia), kanċer ta' ċerti ċelluli tad-demm bojod.
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.
Maltese: Kompli gilteritinib b'doża mnaqqsa (80 mg jew 120 mg b) meta l-intervall ta' QTc jirritorna għallmedda ta' 30 msec tal-linja bażi jew għal ≤480 msec.
English: Other medicines and Xospata
Maltese: Mediċini oħra u Xospata
English: A dedicated renal impairment study has not been conducted to assess of the effect of renal impairment on gilteritinib pharmacokinetics.
Maltese: Ma sarx studju tal-indeboliment tal-kliewi dedikat biex jivvaluta l-effett tal-indeboliment tal-kliewi fuq il-farmakokinetika ta' gilteritinib.
English: Xospata may cause a heart problem called QT prolongation (may affect up to 1 in 10 people).
Maltese: Xospata jista' jikkawża problema tal-qalb magħrufa bħala titwil tal-QT (tista' taffettwa sa 1 minn kull 10 persuni).
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).
Maltese: Remissjoni kompleta komposta (CRc, composite complete remission) hija definita bħala r-rata ta' remissjoni ta' kull CR (ara sezzjoni 5.1 għad-definizzjoni ta' CR), CRp [inkisbet CR ħlief għal irkupru mhux komplet tal-plejtlits (<100 x 10
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON WITH BLUE BOX
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA BIL-KAXXA BLU
English: Gilteritinib is not an inhibitor or inducer of CYP3A4 or and inhibitor of MATE1 in vivo.
Maltese: Gilteritinib mhuwiex inibitur jew induttur ta' CYP3A4 jew inibitur ta' MATE1 in vivo.
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):
Maltese: F'dan l-istudju, 371 pazjent ntgħażlu b'mod każwali bi proporzjon ta' 2:1 biex jirċievu gilteritinib jew waħda mill-kimoterapiji ta' salvataġġ li ġejjin (247 fil-grupp ta' gilteritinib u 124 fil-grupp ta' kimoterapija ta' salvataġġ):
English: The recommended starting dose is 120 mg gilteritinib (three 40 mg tablets) once daily.
Maltese: Id-doża rakkomandata tal-bidu hija ta' 120 mg gilteritinib (tliet pilloli ta' 40 mg) darba kuljum.
English: Gilteritinib is primarily metabolised by CYP3A enzymes, which can be induced or inhibited by a number of concomitant medicinal products.
Maltese: Gilteritinib huwa primarjament metabolizzat minn enzimi ta' CYP3A, li tista' ssirilhom induzzjoni jew inibizzjoni minn numru ta' prodotti mediċinali mogħtija fl-istess ħin.
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).
Maltese: Data disponibbli fl-annimali wriet l-eliminazzjoni ta' gilteritinib u l-metaboliti tiegħu fil-ħalib tal-annimali ta' firien li qed ireddgħu u distribuzzjoni lit-tessuti f'firien tat-twelid permezz tal-ħalib (ara sezzjoni 5.3).
English: Due to in vitro binding to 5HT2B (see section 4.5), there is a potential impact on cardiac development in patients less than 6 months of age.
Maltese: Minħabba twaħħil in vitro ma' 5HT2B (ara sezzjoni 4.5), hemm impatt potenzjali fuq l-iżvilupp kardijaku f'pazjenti li għandhom età ta' inqas minn 6 xhur.
English: Caution is warranted in patients with relevant cardiac history.
Maltese: Hija meħtieġa attenzjoni f'pazjenti bi storja kardijaka rilevanti.
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.
Maltese: F'adulti f'saħħithom, gilteritinib Cmass u AUC naqsu b'madwar 26% u inqas minn 10%, rispettivament, meta doża waħda ta' 40 mg ta' gilteritinib ingħatat fl-istess ħin ma' ikla b'kontenut għoli ta' xaħam meta mqabbla ma' esponiment għal gilteritinib fi stat ta' sawm.
English: • Patient alert card o Patient alert card: - Information for patients that Xospata treatment may cause differentiation syndrome.
Maltese: • Kartuna ta' Twissija tal-Pazjent o Kartuna ta' Twissija tal-Pazjent: - Informazzjoni għall-pazjenti li t-trattament b'Xospata jista' jikkawża sindrome ta' differenzazzjoni.
English: These may be signs of an inflammation of the pancreas (pancreatitis).
Maltese: Dawn jistgħu jkunu sinjali ta' infjammazzjoni tal-frixa (pankreatite).
English: CONTENT OF PATIENT ALERT CARD PATIENT ALERT CARD XOSPATA® (gilteritinib)
Maltese: Informazzjoni għall-pazjent Xospata 40 mg pilloli miksija b'rita gilteritinib
English: b. The 95% CI rate was calculated using the exact method based on binomial distribution.
Maltese: Ir-rata ta' 95% CI kienet ikkalkolata bl-użu tal-metodu eżatt ibbażat fuq distribuzzjoni binomjali.
English: The majority of patients (83.8%) had an ECOG performance status score of 0 or 1.
Maltese: Il-maġġoranza tal-pazjenti (83.8%) kellhom punteġġ tal-istat ta' prestazzjoni ECOG ta' 0 jew 1.
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)
Maltese: Komuni ħafna (jistgħu jaffettwaw iktar minn 1 minn kull 10 persuni): - dijarea - dardir - stitikezza - għeja - nefħa minħabba żamma ta' fluwidu (edema) - telf ta' enerġija, dgħufija (astenja) - riżultati ta' testijiet tad-demm mhux normali: livelli għoljin tal-creatine phosphokinase fid demm (li jindikaw il-funzjoni tal-muskoli jew tal-qalb), alanine aminotransferase (ALT),
English: Teл.
Maltese: Kft.
English: 29.8 1.9 Very common
Maltese: 1.9 Komuni ħafna
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.
Maltese: Iż-żmien medjan għall-aħjar rispons ta' CR/CRh kien 3.8 xhur (medda, 0.9 sa 16-il xahar) fil-grupp ta' gilteritinib u 1.2 xhur (medda: 1 sa 2.6 xhur) fil-grupp ta' kimoterapija ta' salvataġġ.
English: None of these three metabolites exceeded 10% of overall parent exposure.
Maltese: L-ebda minn dawn it-tliet metaboliti ma qabeż l-10% tal-esponiment oriġinali globali.
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.
Maltese: Ilkonċentrazzjoni massima fl-istat fiss medjana (Cmass) hija 282.0 ng/mL (CV% = 50.8), u l-erja taħt ilkurva tal-konċentrazzjoni fil-plażma waqt intervall tad-dożaġġ ta' 24 siegħa (AUC0-24)
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.
Maltese: Is-sintomi u s-sejbiet kliniċi ta' sindrome ta' differenzazzjoni jinkludu deni, qtugħ ta' nifs, effużjoni mill-plewra, effużjoni millperikardju, edema pulmonari, pressjoni baxxa, żieda rapida fil-piż, edema periferali, raxx, u funzjoni ħażina tal-kliewi.
English: Alternative medicinal products that do not strongly inhibit CYP3A and/or P-gp activity should be considered.
Maltese: Prodotti mediċinali alternattivi li ma jinibixxux b'mod qawwi l-attività ta' CYP3A u/jew P-gp għandhom jiġu kkunsidrati.
English: 80 mg or 120 mgb.
Maltese: Id-doża ta' kuljum tista' titnaqqas minn 120 mg għal 80 mg jew minn 200 mg għal 120 mg.
English: Xospata 40 mg film-coated tablets
Maltese: Xospata 40 mg pilloli miksija b'rita
English: LoDAC and azacitidine were given in continuous 4-week cycles until unacceptable toxicity or lack of clinical benefit.
Maltese: LoDAC u azacitidine ngħataw f'ċikli kontinwi ta' 4 ġimgħat sakemm kien hemm tossiċità inaċċettabbli jew nuqqas ta' benefiċċju kliniku.
English: Additional monitoring during treatment with Xospata
Maltese: Monitoraġġ addizzjonali waqt it-trattament b'Xospata
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).
Maltese: L-esponiment għal gilteritinib żdied b'madwar 1.5 darbiet f'pazjenti b'AML li rkadiet jew refrattorja meta ngħata flimkien ma' inibitur qawwi ta' CYP3A u/jew P-gp (ara sezzjoni 4.4).
English: • Symptoms include fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Maltese: • Is-sintomi jinkludu deni, qtugħ ta' nifs, effużjoni mill-plewra, effużjoni mill-perikardju, edema pulmonari, pressjoni baxxa, żieda rapida fil-piż, edema periferali, raxx, u funzjoni ħażina talkliewi.
English: It is unknown whether gilteritinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception.
Maltese: Mhux magħruf jekk gilteritinib jistax inaqqas l-effettività tal-kontraċettivi ormonali, u għalhekk nisa li jkunu qed jużaw kontraċettivi ormonali għandhom iżidu metodu barriera ta' kontraċezzjoni.
English: c. CRh was defined as marrow blasts <5%, partial haematologic recovery absolute neutrophil count ≥0.5
Maltese: CRh kienet definita bħala blasts fil-mudullun ta' <5%, għadd assolut tan-newtrofili fl-irkupru ematoloġiku parzjali ta' ≥0.5 x 10
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.
Maltese: Gilteritinib jagħmel assorbiment tal-ewwel ordni b'rata ta' assorbiment stmata (ka) ta' 0.43 h b'dewmien ta' 0.34 sigħat ibbażat fuq mudellar farmakokinetiku tal-popolazzjoni.
English: Biocodex UAB Tel.: +370 37 408 681
Maltese: Tel.: +37 408 681
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.
Maltese: Doża waħda ta' 10 mg ta' gilteritinib mogħtija flimkien ma' itraconazole (200 mg darba kuljum għal 28 jum), inibitur qawwi ta' CYP3A u/jew P-gp, lil individwi f'saħħithom irriżultat f'żieda ta' madwar 20% fis-Cmass medju u żieda ta' 2.2 darbiet flAUCinf medju relattiv għal individwi mogħtija doża waħda ta' gilteritinib waħdu.
English: The pharmacological activity of the metabolites against FLT3 and AXL receptors is unknown.
Maltese: L-attività farmakoloġika talmetaboliti kontra riċetturi ta' FLT3 u AXL mhix magħrufa.