FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on in vitro data, midostaurin and its active metabolites, CGP52421 and CGP62221, are considered inhibitors and may potentially cause increases in exposure of co-administered medicinal products primarily cleared by CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 and CYP3A4/5.
Maltese: Skont deja in vitro, midostaurin u l-metaboliti attivi tiegħu, CGP52421 u CGP62221, jitqiesu inibituri u jistgħu jwasslu biex tiżdied l-espożizzjoni ta' prodotti mediċinali mogħtija flimkien li jitneħħew primarjament minn CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 u CYP3A4/5.
English: The efficacy and safety of midostaurin in combination with standard chemotherapy versus placebo plus standard chemotherapy and as single agent maintenance therapy was investigated in 717 patients (18 to 60 years of age) in a randomised, double-blind, phase III study.
Maltese: L-effikaċja u s-sigurtà ta' midostaurin flimkien ma' kimoterapija standard kontra plaċebo flimkien ma' kimoterapija standard b'terapija ta' manutenzjoni b'aġent waħdieni kienu mistħarrġa f'717il pazjent (età minn 18 sa 60 sena) fi studju randomizzat, double-blind, f'fażi
English: An increased frequency of QTc prolongation was noted in midostaurin-treated patients (see section 4.8), however, a mechanistic explanation for this observation was not found.
Maltese: Frekwenza akbar ta' titwil QTc kienet osservata fil-pazjenti ttrattati b'midostaurin (ara sezzjoni 4.8), madankollu, ma nstabitx spjegazzjoni mekkanistika għal din l-osservazzjoni.
English: Table 4 presents the frequency category of ADRs based on pooled data from two studies in patients with ASM, SM-AHN and MCL.
Maltese: Tabella 4 tirrappreżenta l-kategorija tal-frekwenza tal-ADRs skont dejta miġbura minn żewġ studji fost pazjenti b'ASM, SM-AHN u MCL.
English: Printing ink
Maltese: X'inhu Rydapt
English: Although the study was designed to be assessed with the modified Valent and Cheson criteria, as a post-hoc exploratory analysis, efficacy was also assessed per the 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment - European Competence Network on Mastocytosis (IWG-MRT-ECNM) consensus criteria.
Maltese: Għalkemm l-istudju kien maħsub biex jiġi vvalutat bil-kriterji modifikati ta' Valent u Cheson, bħala analiżi esploratorja post-hoc, l-effikaċja kienet ivvalutata wkoll skont il-kriterji ta' kunsens tal-Grupp ta' Ħidma Internazzjonali tal-2013 - Riċerka u Trattament ta' Neoplażmi MajeloproliferattiviNetwerk ta' Kompetenza Ewropea dwar il-Mastoċitożi (IWG-MRT-ECNM).
English: What Rydapt contains - The active substance is midostaurin.
Maltese: X'fih Rydapt - Is-sustanza attiva hi midostaurin.
English: The median time to response was 0.3 months (range: 0.1 to 3.7 months).
Maltese: Iż-żmien medjan ta' rispons kien ta' 0.3 xhur (firxa: minn 0.1 sa 3.7 xhur).
English: Rydapt 25 mg soft capsules
Maltese: Rydapt 25 mg kapsuli rotob
English: Induction, consolidation and maintenance
Maltese: Induzzjoni, tisħiħ u manutenzjoni
English: Mating index, fertility index and conception rates were reduced at 0, 5 and 15 mg/kg/day, but not at 2 mg/kg/day.
Maltese: L-indiċi tat-tagħmir, l-indiċi talfertilità u r-rati tat-tnissil tnaqqsu b'0, 5 u 15 mg/kg/jum, imma mhux b'2 mg/kg/jum.
English: The pharmacokinetics of midazolam (sensitive CYP3A4 probe) were not affected following three days' dosing of midostaurin in healthy subjects.
Maltese: Il-farmakokinetika ta' midazolam (sottosrat sensittiv ta' CYP3A4) ma kenux affettwati wara tlitt ijiem ta' dożi ta' midostaurin lil suġġetti b'saħħithom.
English: The median age of the patients was 47 years (range: 18 to 60 years), a majority of the patients had ECOG performance status of 0 or 1 (88.3%), and most patients had de novo AML (95%).
Maltese: L-età medjana tal-pazjenti kienet ta' 47 sena (firxa: 18 sa 60 sena), bil-biċċa l-kbira tal-pazjenti kellhom status ta' prestazzjoni ECOG ta' 0 jew 1 (88.3%), u bosta pazjenti kellhom AML de novo (95%).
English: Caution is required when concomitantly prescribing with midostaurin medicinal products that are strong inhibitors of CYP3A4, such as, but not limited to, antifungals (e.g. ketoconazole), certain antivirals (e.g. ritonavir), macrolide antibiotics (e.g. clarithromycin) and nefazodone because they can increase the plasma concentrations of midostaurin especially when (re-)starting with midostaurin treatment (see section 4.5).
Maltese: Hija meħtieġa attenzjoni meta jiġi ordnat biex jingħata flimkien ma' prodotti mediċinali li fihom midostaurin li huma inibituri qawwija ta' CYP3A4, bħal, iżda mhux limitati għal, antifungali (eż. ketoconazole), ċerti antivirali (eż. ritonavir), antibijotiċi makrolidi (eż. clarithromycin) u nefazodone għaliex dawn jistgħu jżidu l-konċentrazzjonijiet ta' midostaurin fil-plażma speċjalment meta (jerġa') jinbeda t-trattament b'midostaurin (ara sezzjoni 4.5). Prodotti mediċinali alternattivi li ma jinibixxux b'mod qawwi l-attività ta' CYP3A4 għandhom jiġu kkunsidrati.
English: The efficacy of midostaurin in patients with ASM, SM-AHN and MCL, collectively referred to as advanced systemic mastocytosis (SM), was evaluated in two open-label, single-arm, multicentre studies (142 patients in total).
Maltese: L-effikaċja ta' midostaurin f'pazjenti b'ASM, SM-AHN u MCL, magħrufa kollettivament bħala mastoċitożi sistemika (SM), kienet evalwata f'żewġ studji open-label, ma' grupp wieħed, multiċentriċi (142 pazjent b'kollox).
English: In the repeat-dose studies, target organs for toxicity were the gastrointestinal tract (emesis in dogs and monkeys, diarrhoea and mucosal alteration), testes (decreased spermatogenesis), bone marrow (hypocellularity) and lymphoid organs (depletion/atrophy).
Maltese: Fi studju dwar dożi ripetuti, l-organi fil-mira għal tossiċità kienu l-passaġġ gastrointestinali (emeżi filklieb u x-xadini, dijarrea u alterazzjoni mukożali), it-testikoli (tnaqqis fl-ispermatoġeneżi), ilmudullun (ipoċellularità) u l-organi limfatiċi (tnaqqis/atrofija).
English: The study demonstrated a statistically significant improvement in OS with a 23% risk reduction of death for midostaurin plus standard chemotherapy over placebo plus standard chemotherapy (see Table 6 and Figure 1).
Maltese: L-istudju wera titjib qawwi statistikament sinifikanti fl-OS bi tnaqqis ta' 23% tar-riskju ta' mewt għall-grupp mogħti midostaurin flimkien ma' kimoterapija standard fuq il-grupp mogħti l-plaċebo flimkien ma' kimoterapija standard (ara Tabella 6 u Figura 1).
English: Total bilirubin increased*
Maltese: Żieda tat-total tal-bilirubina*
English: In general, midostaurin and its metabolites showed no major deviation from dose-proportionality after a single dose in the range of 25 mg to 100 mg.
Maltese: B'mod ġenerali, midostaurin u l-metaboliti tiegħu ma wrewx devjazzjoni ewlenija mill-proporzjonalità tad-doża wara doża singola fil-medda ta' bejn 25 mg u 100 mg.
English: Platelet count less than 50 x 10
Maltese: Għadd ta' plejtlits inqas minn 50 x 10
English: At baseline, 88.5% had >1 C finding and 69.2% had received at least one prior anti-neoplastic regimen.
Maltese: Fil-linja bażi, 88.5% kellhom sejba C mkejla ta' >1 u 69.2% ngħataw mill-inqas reġim wieħed antineoplastiku minn qabel.
English: Based on in vitro data, midostaurin and its active metabolites, CGP52421 and CGP62221, are also considered inducers and may cause decreases in exposure of co-administered medicinal products primarily cleared by CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4/5 (see section 4.5).
Maltese: Skont deja in vitro, midostaurin u l-metaboliti attivi tiegħu, CGP52421 u CGP62221, jitqiesu wkoll indutturi u jistgħu jwasslu biex tonqos l-espożizzjoni ta' prodotti mediċinali mogħtija flimkien li jitneħħew primarjament minn CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 u CYP3A4/5 (ara sezzjoni 4.5).
English: • in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);
Maltese: • biex jingħata flimkien ma' kimoterapija standard ta' induzzjoni b'daunorubicin u cytarabine u ta' tisħiħ b'doża għolja ta' cytarabine, u għal pazjenti li qed jirreaġixxu b'mod sħiħ segwita b'Rydapt terapija ta' manutenzjoni b'aġent waħdieni, lil pazjenti adulti li għadhom kemm ġew dijanjosati li għandhom lewkimja majelojde akuta (AML) u li huma pożittivi għall-mutazzjoni FLT3 (ara sezzjoni 4.2);
English: Rydapt is dosed on days 8-21 of induction and consolidation chemotherapy cycles, and then for patients in complete response every day as single agent maintenance therapy until relapse for up to 12 cycles of 28 days each (see section 4.1).
Maltese: Rydapt jingħata fil-ġranet 8-21 taċ-ċikli ta' kimoterapija ta' induzzjoni u tisħiħ, u wara għal pazjenti li qed jirreaġixxu b'mod sħiħ kuljum bħala terapija b'aġent waħdieni ta' manutenzjoni sa ma jkun hemm rikaduta sa 12-il ċiklu ta' 28 jum (ara sezzjoni 4.1) kull wieħed.
English: Figure 1 Kaplan-Meier curve for overall survival, non-censored for SCT
Maltese: Kaplan-Meier għas-sopravivenza globali, mhux iċċensurata għal SCT
English: known as hyperglycaemia) - muscle weakness, drowsiness, confusion, convulsions, impaired consciousness (signs of high level of sodium in the blood, known as hypernatraemia) - muscle weakness, muscle spasms, abnormal heart rhythm (signs of low levels of potassium in the blood, known as hypokalaemia) - bruising and bleeding (defect in blood clotting) - abnormal blood test results which can indicate to your doctor how well certain parts of your body are functioning: high levels of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (indicative of liver function)
Maltese: zokkor fid-demm, magħrufa bħala ipergliċemija) - muskoli dgħajfa, sturdament, konfużjoni, konvulżjonijiet, telfien tas-sensi (sinjali ta' livell għoli ta'sodju fid-demm, magħrufa bħala ipernatremija) - muskoli dgħajfa, spażmi fil-muskoli, ritmu tal-qalb anormali (sinjali ta' livelli baxxi ta' potassju fid-demm, magħrufin bħala ipokalemija) - tbenġil u fsada (difett fil-mod kif jagħqad id-demm) - riżultati tat-testijiet tad-demm mhux normali li jistgħu jindikaw lit-tabib tiegħek kemm ċerti partijiet ta' ġismek qed jaħdmu tajjeb: livelli għoljin ta' alanina aminotransferasi (ALT) u/jew ta' aspartat aminotransferasi (AST) (xhieda tal-funzjoni tal-fwied)
English: - Patients with ASM, SM-AHN or MCL
Maltese: - Pazjenti b'ASM, SM-AHN jew MCL
English: Based on in vitro data, midostaurin and/or its metabolites have the potential to inhibit CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 and CYP3A4/5 enzymes.
Maltese: CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 u CYP3A4/5.
English: PAES: In order to investigate the efficacy in elderly patients, the MAH should conduct and submit the results of a randomised, double-blind E2301 study of midostaurin versus placebo in combination with chemotherapy during induction and consolidation, followed by 12 months of midostaurin monotherapy in adult patients (aged ≥18 years) with newly diagnosed AML, without FLT3 mutation.
Maltese: Sabiex issir investigazzjoni tal-effikaċja f'pazjenti anzjani, l-MAH għandha twettaq u tissottometti r-riżultati ta' studju E2301 randomizzat u double-blind dwar midostaurin kontra l-plaċebo flimkien ma' kimoterapija matul l-induzzjoni u t-tisħiħ, segwita bi 12-il xahar monoterapija b'midostaurin f'pazjenti adulti (li għandhom ≥18-il sena) b'dijanjosi ġdida ta' AML, mingħajr mutazzjoni tal-FLT3.
English: Interrupt Rydapt for the remainder of the cycle.
Maltese: Waqqaf jew interrompi Rydapt għallkumplament taċ-ċiklu.
English: Persistent Grade 1/2 toxicity Persistent Grade 1 or 2 toxicity that patients deem unacceptable may prompt an interruption for as many as 28 days.
Maltese: Tossiċità bi Grad 1/2 persistenti
English: PAES: In order to investigate the efficacy in elderly patients, the MAH should submit the final results of a phase II ADE02T study of midostaurin in combination with intensive induction, consolidation including allogenic SCT and single agent maintenance in patients aged 18-70 with FLT3 ITD mutated AML.
Maltese: II, ta' grupp wieħed, mibdi mill-investigatur flimkien ma' tnedija u konsolidazzjoni intensiva inklużi SCT alloġenejiku u manutenzjoni f'pazjenti b'sustanza waħda b'AML b'mutazzjoni FLT3-ITD.
English: Rydapt is for oral use.
Maltese: Rydapt huwa għal użu orali.
English: Packs containing 56 (2 packs of 28) or 112 (4 packs of 28) soft capsules.
Maltese: (2 pakketti ta' 28) jew 112-il (4 pakketti ta' 28) kapsula ratba.
English: In a fertility study in rats, midostaurin was associated with reduced fertility, testicular degeneration and atrophy, reduced sperm motility, oligo- and aspermia, increased resorptions, decreased pregnancy rate, number of implants and live embryos.
Maltese: Skont studju dwar il-fertilità fil-firien, midostaurin kien assoċjat ma' tnaqqis fil-fertilità, kienu osservati deġenerazzjoni u atrofija tat-testikoli, tnaqqis fil-motilità tal-isperma, oligo- u aspermija, kien hemm żieda fir-riassorbiment, tnaqqis fir-rata ta' tqala, fl-għadd ta' impjanti u ta' embrijuni ħajjin.
English: Interrupt Rydapt until haemoglobin greater than or equal to 8 g/dl, then resume Rydapt at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.
Maltese: Interrompi Rydapt sakemm l-emoglobina tkun akbar jew ugwali għal 8 g/dl, imbagħad kompli Rydapt b'50 mg darbtejn kuljum u, jekk ittollerata, żid għal 100 mg darbtejn kuljum.
English: In the randomised AML study no difference in CHF was observed between the Rydapt + chemotherapy and placebo + chemotherapy arms.
Maltese: Waqt l-istudju AML randomizzat ma kien hemm ebda differenza fisCHF bejn il-gruppi mogħtija Rydapt + kimoterapijakimoterapija u plaċebo + kimoterapija.
English: - Do not use this medicine after the expiry date which is stated on the carton and the blister foil after EXP.
Maltese: - Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara “JIS/EXP”.
English: No study has been completed in patients with severe (Child-Pugh C) hepatic impairment (see section 4.4).
Maltese: Ma ntemm l-ebda studju fost pazjenti b'indeboliment epatiku sever (Child-Pugh C) (ara sezzjoni 4.4).
English: Table 4 Adverse drug reactions observed in the ASM, SM-AHN and MCL clinical studies
Maltese: Tabella 4 Reazzjonijiet avversi tal-mediċina osservata waqt l-istudji kliniċi dwar ASM,
English: Cmin of CGP52421 was increased by 1.3-fold, whereas no significant effect in exposure of CGP62221 was observed (see section 4.4).
Maltese: Is-Cmin ta' CGP52421 żdied b'1.3 drabi, filwaqt li ma deher l-ebda effett sinjifikanti flespożizzjoni ta' CGP62221 (ara sezzjoni 4.4).
English: A reduction in body weight, haemorrhage and mixed cell infiltration in the lungs, and erythrocytosis/erythrophagocytosis in the mesenteric lymph nodes were seen.
Maltese: Dehru tnaqqis fil-piż tal-ġisem, emorraġija u infiltrazzjoni ta' ċelluli mħallta fil-pulmun, u eritroċitożi/eritrofagoċitożi fl-għenqied limfatiċi tal-mindil meta ngħataw.
English: However, there was a less than dose-proportional increase in exposure after multiple doses within the dose range of 50 mg to 225 mg daily.
Maltese: Madanakollu, kien hemm żieda flespożizzjoni anqas minn dik proporzjonali għad-doża wara dożi multipli fi ħdan il-firxa ta' bejn 50 mg u 225 mg kuljum.
English: Cough
Maltese: Xhur
English: Haemorrhoids
Maltese: Pożoloġija
English: PA/Al/PVC-Al blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PA/Al/PVC-Al.
English: Patients with symptomatic congestive heart failure were excluded from clinical studies.
Maltese: Il-pazjenti b'insuffiċjenza tal-qalb konġestiva sintomatika kienu esklużi mill-provi kliniċi.
English: 9/l, then resume Rydapt at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.
Maltese: 9/l, imbagħad kompli Rydapt b'50 mg darbtejn kuljum u, jekk ittollerata, żid għal 100 mg darbtejn kuljum.
English: Interrupt Rydapt until platelet count greater than or equal to 50 x 10
Maltese: Interrompli Rydapt sakemm l-għadd ta' plejtlits ikun aktar jew ugwali għal 50 x 10
English: If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Maltese: Jekk tuża kontraċettiv ormonali, għandek tuża wkoll metodu ta' barriera, bħalma hu kondom jew dijaframma.
English: Dose modifications in ASM, SM-AHN and MCL
Maltese: Tibdiliet fid-doża f'ASM, SM-AHN u MCL
English: Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.
Maltese: Qabel ma jittieħed midostaurin, il-pazjenti b'AML għandhom ikunu kkonfermati li għandhom mutazzjoni tal-FLT3 (duplikazzjoni interna in tandem [ITD] jew tyrosine kinase domain [TKD]) billi jintuża test validu.
English: The major plasma components included midostaurin and two major active metabolites, CGP62221 (via O-demethylation) and CGP52421 (via hydroxylation), accounting for 27.7±2.7% and 38.0±6.6%, respectively, of the total plasma exposure at 96 hours after a single 50 mg dose of midostaurin.
Maltese: Il-komponenti ewlenin tal-plażma kienu jinkludu midostaurin u żewġ metaboliti attivi ewlenin, CGP62221 (permezz ta' O-demetillazzjoni) u CGP52421 (permezz ta' idrosillazzjoni), li jikkorrispondu għal 27.
English: Pale orange, oblong capsule with red imprint “PKC NVR”.
Maltese: Kapsula tawwalija oranġjo ċar bil-kliem “PKC
English: Interrupt Rydapt for 3 days (6 doses), then resume at 50 mg twice daily and, if tolerated, gradually increase to 100 mg twice daily.
Maltese: Interrompi Rydapt għal 3 ijiem (6 dożi), imbagħad kompli b'50 mg darbtejn kuljum u, jekk ittollerata, żid gradwalment għal 100 mg darbtejn kuljum.
English: General disorders and administration site conditions Oedema peripheral
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Edema periferali
English: Haemoglobin less than 8 g/dl attributed to Rydapt in patients without MCL, or life-threatening anaemia attributed to Rydapt in patients with baseline haemoglobin value of 8-10 g/dl
Maltese: Emoglobina inqas minn 8 g/dl attribwita għal Rydapt f'pazjenti mingħajr MCL, jew anemija ta' periklu għall-ħajja attribwita għal Rydapt f'pazjenti b'valur ta' emogloblina fil-linja bażi ta' 8-10 g/dl
English: Table 2 Rydapt dose interruption, reduction and discontinuation recommendations in patients with ASM, SM-AHN or MCL
Maltese: Tabella 2 Rakkomandazzjonijiet dwar interruzzjoni, tnaqqis u twaqqif għal kollox tad-doża f'pazjenti b'ASM, SM-AHN u MCL
English: Blood and lymphatic system disorders Febrile neutropenia
Maltese: Disturbi tad-demm u tas-sistema limfatika Newtropenja febbrili
English: However, CGP52421 concentrations increased up to 2.5-fold for ASM, SM-AHN and MCL and up to 9-fold for AML, compared to midostaurin after one month of treatment.
Maltese: Madanakollu, ilkonċentrazzjonijiet ta' CGP52421 żdiedu sa 2.5 drabi għal ASM, SM-AHN u MCL u sa 9 darbiet għall-AML, imqabbel ma' midostaurin wara xahar wieħed ta' trattament.
English: Constipation
Maltese: Kollha
English: AST increased*
Maltese: Żieda tal-ALT*
English: While the study included patients with various AML-related cytogenetic abnormalities, patients with acute promyelocytic leukaemia (M3) or therapy-related AML were excluded.
Maltese: Filwaqt li l-istudju inkluda pazjenti b'anormalitajiet ċitoġenetiċi varji relatati ma' AML, pazjenti b'lewkimja promieloċitika akuta (M3) jew terapija b'rabta ma' AML ġew esklużi.
English: In vitro and in vivo genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of mutagenic or clastogenic activity.
Maltese: Studji in vitro u in vivo dwar l-effett tossiku fuq il-ġeni li jkopru l-endpoints ġenotossiċi relevanti ma wrew l-ebda evidenza ta' attività mutaġenika jew klastoġenika.
English: One blister contains 4 soft capsules.
Maltese: Folja waħda fiha 4 kapsuli rotob.
English: A dedicated QT study in 192 healthy subjects with a dose of 75 mg twice daily did not reveal clinically significant prolongation of QT by midostaurin and CGP62221 but the study duration was not long enough to estimate the QTc prolongation effects of the long-acting metabolite CGP52421.
Maltese: Studju ddedikat għall-QT fost 192 suġġett b'saħħithom b'doża ta' 75 mg darbtejn kuljum ma wrietx titwil klinikament sinjifkanti tal-QT b'midostaurin u CGP62221 imma t-tul ta' żmien tal-istudju ma kienx twil biżżejjed sabiex ikejjel l-effetti tat-titwil tal-QTc tal-metabolit CGP52421 b'azzjoni mtawla.
English: At the median peak Cmin concentrations attained at a dose of 100 mg twice daily, neither midostaurin, CGP62221 nor CGP52421 showed a potential to cause clinically significant QTcF prolongation, since the upper bounds of predicted change at these concentration levels were less than 10 msecs (5.8, 2.4, and 4.0 msecs, respectively).
Maltese: Fil-quċċata tal-medjan tal-konċentrazzjonijiet tas-Cmin miksuba b'doża ta' 100 mg darbtejn kuljum, la midostaurin, la CGP62221 u lanqas CGP52421 ma wrew il-potenzjal li jikkawżaw titwil sinjifikanti klinikament tal-QTcF, minħabba li l-ogħla faxex tat-tibdil imbassar għal dawn il-livelli ta' konċentrazzjonijiet kien anqas minn 10 msecs (5.8, 2.4, u 4.0 msecs, rispettivament).
English: Finally, the long-term data from patients were analysed using a population pharmacokinetic approach.
Maltese: Fl-aħħar nett, kienet analizzata d-dejta fuq perjodu twil ta' żmien minn pazjenti billi ntuża metodu farmakokinetiku tal-popolazzjoni.
English: The pharmacokinetics of midostaurin in paediatric patients were explored in a phase I dose escalation monotherapy study with 22 patients (12 aged 0-2 years and 10 aged 10-17 years) with AML or MLL-rearranged ALL using a population pharmacokinetic approach.
Maltese: Ilfarmakokinetiċi ta' midostaurin fil-pazjenti pedjatriċi kienet mistħarrġa fi studju monoterapewtiku f'fażi I marbut ma' żieda fid-doża bi 22 pazjent (12 li kellhom bejn 0 snin u sentejn u 10 li kellhom bejn 10 snin u 17-il sena) b'AML jew b'MLL ristrutturat mill-ġdid billi LKOLL użaw is-sistema talfarmakokinetiċi tal-popolazzjoni.
English: PAES: In order to investigate the efficacy in elderly patients, the MAH should conduct and submit the results of A2408, a study to assess the efficacy and safety of midostaurin in combination with standard chemotherapy during induction and consolidation, followed by 12 months of midostaurin monotherapy in adult patients (aged ≥18 years) with newly diagnosed FLT3-mutated AML.
Maltese: Sabiex issir investigazzjoni tal-effikaċja f'pazjenti anzjani, l-MAH għandha twettaq u tissottometti r-riżultati aħħarija ta' A2408, studju biex jevalwa l-effikaċja u s-sigurtà ta' midostaurin flimkien ma' kimoterapija standard matul l-induzzjoni u t-tisħiħ, segwita bi 12il xahar monoterapija b'midostaurin f'pazjenti adulti (li għandhom ≥18-il sena) b'dijanjosi ġdida ta' AML b'mutazzjoni tal-FLT3.
English: Neck pain
Maltese: Waqt studji
English: Catheter-related thrombosis
Maltese: Trombożi minħaba l-catheter
English: In vitro data indicate that midostaurin inhibits D816V mutant KIT receptors at exposure levels achieved in patients (average achieved exposure higher than IC50).
Maltese: Dejta in vitro tindika li midostaurin jinibixxi r-riċetturi KIT talmutant D816V f'livelli ta' espożizzjoni miksuba mill-pazjenti (il-medja tal-espożizzjoni miksuba hi ogħla minn dik ta' IC50).
English: EU/1/17/1218/001-002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1218/001-002