FrancophonIA/ELRC3.0 huggingface dataset:
English: Sprague-Dawley rats, radioactivity was readily excreted into breast milk as early as 0.5 hr after dosing.
Maltese: Sprague-Dawley li qed ireddgħu, ir-radjoattività kienet eliminata faċilment fil-ħalib tas-sider l-aktar kmieni daqs 0.5 sigħat wara d-dożaġġ.
English: Patients with serum creatinine > 1.5×ULN were excluded from CML studies.
Maltese: Pazjenti bil-krejatinina fis-serum > 1.5 x ULN kienu esklużi mill-istudji ta' CML.
English: The safety and efficacy of bosutinib in children and adolescents less than 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' bosutinib fi tfal u adolexxenti ta' anqas minn 18-il sena ma ġewx determinati s'issa.
English: In a study of 24 healthy subjects in whom 5 daily doses of 400 mg ketoconazole (a strong CYP3A inhibitor) were co-administered with a single dose of 100 mg bosutinib under fasting conditions, ketoconazole increased bosutinib Cmax by 5.2-fold, and bosutinib AUC in plasma by 8.6-fold, as compared with administration of bosutinib alone.
Maltese: Fi studju ta' 24 individwu b'saħħithom li ngħataw 5 dożi ta' kuljum ta' 400 mg ketoconazole (impeditur ta' CYP3A b'saħħtu) flimkien ma' doża unika ta' 100 mg bosutinib taħt kundizzjonijiet ta' sawm, ketoconazole żied is-Cmax ta' bosutinib b'5.2-darbet, u l-AUC ta' bosutinib fil-plasma bi 8.6darbiet, meta mqabbel mal-għoti ta' bosutinib waħdu.
English: Elevated liver transaminases: If elevations in liver transaminases > 5 × institutional upper limit of normal (ULN) occur, bosutinib should be interrupted until recovery to ≤ 2.5 × ULN and may be resumed at 400 mg once daily thereafter.
Maltese: Żieda fil-livelli ta' transaminases tal-fwied: Jekk ikun hemm żidiet fit-transaminases tal-fwied >5 x logħla limitu istituzzjonali tan-normal (ULN), bosutinib għandu jitwaqqaf sakemm il-livelli jonqsu għal ≤ 2.5 x ULN u wara jista' jerġa' jitkompla b'doża ta' 400 mg darba kuljum.
English: Patients with serum creatinine > 1.5 × ULN were excluded from the CML studies.
Maltese: Pazjenti bil-krejatinina fis-serum >1.5 x ULN kienu esklużi mill-istudji ta' CML.
English: Effects of other medicinal products on bosutinib
Maltese: Effetti ta' prodotti mediċinali oħra fuq Bosulif
English: AP and BP CML patients
Maltese: Pazjenti b'CML f'AP u BP
English: Abbreviations: BCR-ABL=breakpoint cluster region-Abelson; CI=confidence interval; CMH=Cochran-Mantel-Haenszel; CCyR=complete cytogenetic response; mITT=modified intent-to-treat; MMR=major molecular response; N/n=number of patients; Ph+=Philadelphia chromosome-positive.
Maltese: CI=confidence interval (intervall ta' kunfidenza; CMH=Cochran-Mantel-Haenszel; CCyR=complete cytogenetic response (rispons ċitoġeniku komplet); mITT=modified intent-to-treat;
English: The effect of bosutinib 500 mg administration on corrected QTc was evaluated in a randomised, single-dose, double-blind (with respect to bosutinib), crossover, placebo- and open-label moxifloxacin-controlled study in healthy subjects.
Maltese: L-effett tal-amministrazzjoni ta' 500 mg bosutinib fuq l-QTc ikkoreġut kien evalwat f'pazjenti b'saħħithom fi studju randomizzat, b'doża waħda, double-blind (fil-każ ta' Bosulif), crossover, plaċebo- u open-label ikkontrollat minn moxifloxacin.
English: The concomitant use of bosutinib with strong CYP3A inducers (including, but not limited to carbamazepine, phenytoin, rifampicin, St. John's Wort), or moderate CYP3A inducers (including, but not limited to bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided, as a decrease in bosutinib plasma concentration will occur.
Maltese: John's Wort) jew indutturi moderati ta' CYP3A (inkluż, iżda mhux limitati għal bosentan, efavirenz, etravirine, modafinil, nafcillin) għandu jkun evitat, għaliex ikun hemm tnaqqis fil-konċentrazzjoni ta' bosunitib fil-plażma.
English: Of those who were rechallenged, 167 (98%) did not have a subsequent event or did not discontinue bosutinib due to a subsequent event of diarrhoea.
Maltese: Minn dawn li reġgħu ngħataw bosutinib, 167 (98%) ma kellhomx avveniment sussegwenti jew ma waqqfux bosutinib minħabba avveniment sussegwenti ta' dijarea .
English: Diarrhoea: For NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade 3-4 diarrhoea, bosutinib should be interrupted and may be resumed at 400 mg once daily upon recovery to grade ≤ 1 (see section 4.4).
Maltese: Kriterji ta' Terminoloġija Komuni għallReazzjonijiet Avversi (CTCAE), bosutinib għandu jitwaqqaf u jista' jerġa' jinbeda b'doża ta' 400 mg darba kuljum meta d-dijarea tkun naqset għal grad ≤ 1 (ara sezzjoni 4.4).
English: FISH analysis (≥ 200 cells) could be used for post-baseline cytogenetic assessments if ≥ 20 metaphases were not available.
Maltese: Analiżi FISH (≥ 200 ċelloli) tista' tintuża għal evalwazzjonijiet ċitoġenetiċi wara l-linja bażi jekk ma jkunx hemm ≥ 20 metafażi disponibbli.
English: Myelosuppression should/can be managed by withholding bosutinib temporarily, dose reduction, and/or discontinuation of bosutinib (see sections 4.2 and 4.8).
Maltese: Majelosuppressjoni għandha/tista' tiġi kkontrollata billi bosutinib jitwaqqaf temporanjament, titnaqqas id-doża, u/jew jitwaqqaf it-trattament b'bosutinib (ara sezzjonijiet 4.2 u 4.8).
English: Following concomitant administration of a single dose bosutinib with 6 daily doses of 600 mg rifampicin, in 24 healthy subjects in fed state bosutinib exposure (Cmax and AUC in plasma) decreased to 14% and 6%, respectively, of the values when bosutinib 500 mg was administered alone.
Maltese: Wara li doża waħda ta' bosutinib kienet amministrata ma' 6 dożi ta' 600 mg rifampicin kuljum, f'24 pazjent b'saħħtu li jkunu kielu, il-valuri tal-esponiment ta' bosunitib (Cmax u AUC fil-plażma) naqas għal 14% u 6%, rispettivament, meta 500 mg bosutinib kien amministrat waħdu.
English: If cytopoenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment.
Maltese: Jekk jerġa' jkun hemm ċitopenja, naqqas id-doża b'100 mg addizzjonali u erġa' ibda t-trattament.
English: Anti-arrhythmic medicinal products and other substances that may prolong QT Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, domperidone, haloperidol, methadone, and moxifloxacin (see section 4.4).
Maltese: Prodotti mediċinali kontra l-arritmija u sustanzi oħra li jistgħu jtawwlu l-QT Għandha tintuża kawtela meta Bosulif jintuża f'pazjenti li għandhom jew jista' jkollhom titwil tal-QT, inkluż dawk il-pazjenti li qed jieħdu prodotti mediċinali kontra l-arritmija bħal amiodarone, disopyramide, procainamide, quinidine u sotalol jew prodotti mediċinali oħra li jistgħu jwasslu għal titwil tal-QT bħal chloroquine, halofantrine, clarithromycin, domperidone, haloperidol, methadone, u moxifloxacin (ara sezzjoni 4.4)
English: Of the 197 (15%) patients with reports of adverse reactions of neutropenia, 15 patients discontinued bosutinib due to neutropenia.
Maltese: Mill-197 (15%) pazjent b'rapporti ta' avvenimenti avversi ta' newtropenja, 15-il pazjent waqqfu bosutinib minħabba newtropenja.
English: 28 Film-coated tablets.
Maltese: 28 pillola miksijin b'rita.
English: - if you have fluid retention.
Maltese: Ritenzjoni ta' fluwidu
English: In faeces, bosutinib and N-desmethyl bosutinib were the major drug-related components.
Maltese: Fil-ħmieġ tal-imsaren, bosutinib u N-desmethyl bosutinib kienu l-komponimenti maġġuri relatati malmediċina.
English: Proarrhythmic potential
Maltese: Potenzjal proarritmiku
English: In the entire development program, concurrent elevation in transaminases ≥ 3 × ULN and bilirubin > 2 × ULN with alkaline phosphatase < 2 × ULN occurred without alternative causes in 1/1,611 (< 0.1%) subjects treated with bosutinib.
Maltese: Fil-programm kollu ta' żvilupp, żieda konkorrenti fit-transaminases ta' ≥ 3 x ULN u ta' bilirubin > 2 x ULN b'alkaline phosphatase <2 x ULN seħħet mingħajr kawżi alternattivi ovvji f'1/1,611 (<0.
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of bosutinib (see section 4.8).
Maltese: Minħabba l-possibbiltà li sseħħ is-sindrome tal-lisi tat-tumur (TLS, tumour lysis syndrome), huwa rrakkomandat korrezzjoni ta' deidratazzjoni klinikament sinifikanti u trattament ta' livelli għoljin ta' uric acid qabel il-bidu ta' bosutinib (ara sezzjoni 4.8).
English: After a minimum of 12 months of follow-up in the mITT population, discontinuations due to disease progression to AP or BP CML for bosutinib-treated patients were 0.4% compared to 1.7% for imatinib-treated patients.
Maltese: Wara minimu ta' 12-il xahar ta' segwitu fil-popolazzjoni mITT, it-twaqqif minħabba l-progressjoni tal-marda għal AP jew BP CML għal pazjenti ttrattati bi bosutinib kien ta' 0.4% meta mqabbel ma' 1.7% għal pazjenti ttrattati b'imatinib.
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A inhibition potential, if possible, is recommended.
Maltese: Għażla ta' prodotti mediċinali konkomitanti alternattivi mingħajr jew b'potenzjal minimu ta' inibizzjoni ta' CYP3A, jekk possibbli, huwa rrakkomandat.
English: Bosulif 500 mg film-coated tablets Each carton contains 28 or 30 tablets.
Maltese: Bosulif 500 mg pilloli miksijin b'rita Kull kartuna fiha 28 jew 30 pillola.
English: There were 570 patients treated with bosutinib in this trial including CP CML patients previously treated with only 1 prior TKI (imatinib), CP CML patients previously treated with imatinib and at least 1 additional TKI (dasatinib and/or nilotinib), CML patients in accelerated or blast phase previously treated with at least 1 TKI (imatinib) and patients with Ph+ ALL previously treated with at least 1 TKI (imatinib).
Maltese: Kien hemm 570 individwu li rċevew trattament b'bosutinib f'din il-prova, inkluż pazjenti b'CP CML li rċevew trattament preċedenti b'TKI 1 (imatinib), pazjenti b'CP CML li rċevew trattament preċedenti b'imatinib u tal-anqas TKI 1 addizzjonali (dasatinib u/jew nilotinib), pazjenti b'CML filfażi mgħaġġla jew blast li rċevew trattament preċedenti b'tal-anqas TKI 1 (imatinib) u pazjenti b'Ph+ ALL li rċevew trattament preċedenti b'tal-anqas TKI wieħed (imatinib).
English: In a mass-balance study with oral bosutinib, an average of 94.6% of the total dose was recovered in 9 days; faeces (91.3%) was the major route of excretion, with 3.29% of the dose recovered in urine.
Maltese: 6% tad-doża totali kienet rkuprata wara 9 ijiem; l-ippurgar (91.3% tad-doża) kien il-mod ewlieni ta' eliminazzjoni, b'3.29% tad-doża rkuprata fl-awrina.
English: Cumulative haematological responsed
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: Blast phase with prior treatment of at least imatinib
Maltese: Fażi Blast b'trattament preċedenti b'tal-anqas imatinib
English: Бъ лгария
Maltese: U L-UŻU
English: Mutation assessed No mutation At least 1 mutation Dasatinib resistant mutations E255K/V F317L Nilotinib resistant mutations c
Maltese: Mutazzjonijietreżistenti għal dasatinib E255K/V
English: Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets bosutinib
Maltese: BOSULIF 100 mg pilloli miksijin b'rita BOSULIF 400 mg pilloli miksijin b'rita BOSULIF 500 mg pilloli miksijin b'rita bosutinib
English: A 200 mg dose of bosutinib administered with food was evaluated in a cohort of 18 hepatically impaired subjects (Child-Pugh classes A, B, and C) and 9 matched healthy subjects.
Maltese: Fi studju ta' doża waħda mill-ħalq, bosutinib (200 mg) amministrat mal-ikel kien evalwat fi 18-il pazjent li għandhom indeboliment fil-fwied (Kategoriji Child-Pugh A, B u C) u 9 pazjenti b'saħħithom.
English: Clinical study in CP previously untreated CML
Maltese: Studju kliniku dwar CP f'CML li ma ġietx ittrattata fil-passat
English: Bosulif 400 mg film-coated tablets Each carton contains 28 or 30 tablets.
Maltese: Bosulif 400 mg pilloli miksijin b'rita Kull kartuna fiha 28 jew 30 pillola.
English: Bosulif 400 mg film-coated tablets Polyvinyl alcohol
Maltese: Bosulif 400 mg pilloli miksijin b'rita Polyvinyl alcohol
English: Bosulif 500 mg film-coated tablets are red, oval biconvex, debossed with “Pfizer” on one side and “500” on the other side.
Maltese: Bosulif 500 mg pilloli miksijin b'rita huma ħomor, ovali, bikonvessi,mnaqqxa b'“Pfizer” fuq naħa waħda u “500” fuq in-naħa l-oħra.
English: It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy with bosutinib, with particular attention in those patients who have pre-existing renal compromise or in those patients exhibiting risk factors for renal dysfunction, including concomitant use of medicinal products with potential for nephrotoxicity, such as diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Maltese: Hu importanti li l-funzjoni tal-kliewi tiġi evalwata qabel il-bidu tat-trattament u li lfunzjoni tal-kliewi tiġi mmonitorjata mill-qrib matul it-terapija b'bosutinib, u li tingħata attenzjoni partikulari f'dawk il-pazjenti li jkollhom kompromess renali li kien jeżisti minn qabel jew f'dawk ilpazjenti li juru fatturi ta' riskju għal disfunzjoni tal-kliewi, li tinkludi l-użu fl-istess ħin ta' prodotti mediċinali bil-potenzjal għal nefrotossiċità, bħal dijuretiċi, inibituri tal-enzimi li jibdlu l-angiotensin (ACE), imblokkaturi tar-riċettur ta' angiotensin, u mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs).
English: Liver function abnormalities
Maltese: Informazzjoni għall-utent
English: The median time to first event was 59 days (range: 27 to 505 days), and the median duration per event was 15 days (range: 1 to 913 days).
Maltese: Iż-żmien medjan għall-ewwel avveniment kien ta' 59 jum (firxa: 27 sa 505 jum) u t-tul medjan ta' kull avveniment kien ta' 15-il jum (firxa: 1 sa 913 jum).
English: Abbreviations: BCR-ABL=breakpoint cluster region-Abelson; CP=chronic phase; CML=chronic myelogenous leukaemia; MCyR=major cytogenetic response; N/n=number of patients; Resp=responders; Eval=evaluable.
Maltese: CML=chronic myelogenous leukaemia (lewkimja majeloġena kronika); MCyR = rispons ċitoġenetiku maġġuri; N/n= numru ta' pazjenti;
English: Discontinuations due to suboptimal response or treatment failure as assessed by the investigator occurred for 2.0% of patients in the bosutinib-treated group compared to 6.3% of patients in the imatinib-treated group.
Maltese: It-twaqqif minħabba rispons subottimali jew trattament li ma rnexxiex, kif evalwat mill-investigatur, seħħ fi 2.0% tal-pazjenti fil-grupp ittrattat bi bosutinib meta mqabbel ma' 6.3% tal-pazjenti fil-grupp ittrattat b'imatinib.
English: Bosulif 500 mg film-coated tablets Polyvinyl alcohol
Maltese: Bosulif 500 mg pilloli miksijin b'rita Polyvinyl alcohol
English: Table 4 - Comparison of MMR at Months 3, 6, and 9 by treatment in the mITT population
Maltese: Tabella 4 - Paragun tar-rispons molekulari maġġuri (MMR, major molecular response) f'Xhur 3, 6, u 9 skont it-trattament fil-popolazzjoni mITT
English: Bosulif 500 mg: each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Maltese: Bosulif 500 mg: kull pillola miksija b'rita fiha 500 mg bosutinib (bħala monoidrat).
English: Paediatric population Bosulif has not yet been studied in children and adolescents less than 18 years of age.
Maltese: Popolazzjoni pedjatrika Bosulif għadu ma ġiex studjat fi tfal u adolexxenti ta' inqas minn 18-il sena.
English: In the Phase 1/2 clinical study in patients with CML who were resistant or intolerant to prior therapy, dose escalations from 500 mg to 600 mg once daily with food were allowed in patients who failed to demonstrate complete haematological response (CHR) by Week 8 or complete cytogenetic response (CCyR) by Week 12 and did not have Grade 3 or higher adverse events possibly-related to the investigational product.
Maltese: Fl-istudju kliniku ta' Fażi 1/2 f'pazjenti b'CML li kienu reżistenti jew intolleranti għal terapija filpassat, żidiet fid-doża minn 500 mg għal 600 mg darba kuljum mal-ikel kienu permessi f'pazjenti li ma rnexxilhomx juru rispons ematoloġiku komplet (CRP, complete haematological response) sa Ġimgħa 8, jew rispons ċitoġenetiku komplet (CCyR, complete cytogenetic response) sa Ġimgħa 12, u li ma kellhomx avvenimenti avversi ta' Grad 3 jew ogħla li kienu possibbilment relatati mal-prodott li kien qed jiġi investigat.
English: The study results indicate that bosutinib does not exhibit clinically relevant P-gp inhibitory effects.
Maltese: Ir-riżultati tal-istudju jindikaw li bosutinib ma jurix effetti inibitorji ta' P-gp klinikament rilevanti.
English: Newly-diagnosed CP Ph+ CML
Maltese: CP Ph+ CML iddijanjostikata għall-ewwel darba
English: Treatment with bosutinib may result in a clinically significant decline in renal function in CML patients.
Maltese: It-trattament b'bosutinib jista' jirriżulta fi tnaqqis klinikament sinifikanti fil-funzjoni tal-kliewi f'pazjenti b'CML.
English: Median, weeks (95% CI)
Maltese: Medjan, xhur (95% CI)
English: Your doctor will be aware of this and may ensure you are adequately hydrated and give you other medicines to help prevent it.
Maltese: Dan ifisser li għadha mistennija aktar evidenza dwar dan il-prodott mediċinali.
English: At Months 3, 6, and 9, the proportion of patients with MMR was higher in the bosutinib treatment group compared to the imatinib treatment group (Table 4).
Maltese: F'Xhur 3, 6, u 9, il-proporzjon ta' pazjenti b'MMR kien ogħla fil-grupp ta' trattament ta' bosutinib meta mqabbel mal-grupp ta' trattament b'imatinib (Tabella 4).
English: In patients with severe renal impairment (CLCr < 30 mL/min, calculated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 300 mg daily (see sections 4.4 and 5.2).
Maltese: F'pazjenti b'indeboliment sever tal-kliewi (CLCr ta' < 30 mL/min, ikkalkulata skont il-formula Cockcroft-Gault), id-doża rakkomandata ta' bosutinib hi ta' 300 mg kuljum (ara sezzjonijiet 4.4 u 5.2).
English: In addition, 5.6% of patients in the bosutinib treatment group had further dose escalations to 600 mg.
Maltese: Barra minn hekk, 5.6% tal-pazjenti fil-grupp ta' trattament bi bosutinib, kellhom żidiet addizzjonali fid-doża għal 600 mg.
English: Bosulif 400 mg film-coated tablets bosutinib
Maltese: Bosulif 400 mg pilloli miksijin b'rita bosutinib
English: Transformation to AP/BPf On--treatment transformation, n
Maltese: Trasformazzjoni għalAP/BP
English: MCyR attained or maintained Resp/Eval b
Maltese: MCyR miksub jew miżmum Resp/Eval b (%) N=112
English: Bosulif 100 mg film-coated tablets Polyvinyl alcohol
Maltese: Bosulif 100 mg pilloli miksijin b'rita Polyvinyl alcohol
English: A proarrhythmic potential of bosutinib cannot be ruled out.
Maltese: Potenzjal proarritmiku ta' Bosulif ma jistax jiġi eskluż.
English: The median time to CCyR (responders only) was 23.9 weeks in the bosutinib group compared to the 24.3 weeks imatinib group.
Maltese: Iżżmien medjan għal CCyR (persuni li rrispondew biss) kien ta' 23.9 ġimgħat fil-grupp ta' bosutinib meta mqabbel ma' 24.3 ġimgħa fil-grupp ta' imatinib.
English: - skin eruption.
Maltese: Mhux applikabbli.
English: In a study of 27 healthy subjects, in whom a single dose of 500 mg bosutinib was co-administered with a single dose of 150 mg dabigatran etexilate mesylate (a P-glycoprotein [P-gp] substrate) under fed conditions, bosutinib did not increase Cmax or AUC of dabigatran in plasma, as compared with administration of dabigatran etexilate mesylate alone.
Maltese: Fi studju ta' 27 individwub'saħħtu, li ngħataw doża waħda ta' 500 mg bosutinib ma' doża waħda ta' 150 mg dabigatran etexilate mesylate (sustrat ta' P-glycoprotein [P-gp]) f'kundizzjonijiet mitmugħin, bosutinib ma żiedx is-Cmax jew l-AUC ta' dabigatran fil-plażma, meta mqabbel mal-għoti ta' dabigatran etexilate mesylate waħdu.
English: Bosulif 500 mg film-coated tablets bosutinib
Maltese: Bosulif 500 mg pilloli miksijin b'rita bosutinib
English: Breast-feeding should be discontinued during treatment with bosutinib.
Maltese: Ittreddigħ għandu jitwaqqaf waqt it-trattament b'bosutinib.
English: Bosulif 400 mg: each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Maltese: Bosulif 400 mg: kull pillola miksija b'rita fiha 400 mg bosutinib (bħala monoidrat).
English: Bosulif 100 mg: each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Maltese: Bosulif 100 mg: kull pillola miksija b'rita fiha 100 mg bosutinib (bħala monoidrat).
English: How to take Bosulif
Maltese: X'fih Bosulif
English: The descriptions included below are based on the safety population of 1,272 patients who received at least 1 dose of bosutinib for either newly-diagnosed CP CML or were resistant or intolerant to prior therapy with CP, AP, or BP CML, or Ph+ ALL.
Maltese: Id-deskrizzjonijiet inklużi hawn taħt huma bbażati fuq il-popolazzjoni ta' sigurtà ta' 1,272 pazjent li rċevew tal-anqas doża waħda ta' bosutinib jew għal pazjenti li ġew iddijanjostikati għall-ewwel darba b'CP CML, jew li kienu reżistenti jew intolleranti għal terapija fil-passat b'CP, AP, jew BP CML, jew Ph+ ALL.
English: Grapefruit products, including grapefruit juice and other foods that are known to inhibit CYP3A should be avoided (see section 4.5).
Maltese: Prodotti tal-grejpfrut, inkluż meraq tal-grejpfrut u ikel ieħor li huwa magħruf li jinibixxi CYP3A għandu jkun evitat (ara sezzjoni 4.5).
English: In an intravenous study in dogs, transient increases in heart rate and decreases in blood pressure and minimal prolongation of the QTc (< 10 msec) were observed at exposures ranging from approximately 6-times to 20-times the human exposure resulting from the clinical dose of 400 mg and 4-times to 15-times the human exposure resulting from the clinical dose of 500 mg (based on unbound Cmax in the respective species).
Maltese: Fi studju fil-vini fil-klieb, żidiet temporanji fir-rata tal-qalb u tnaqqis fil-pressjoni taddemm u titwil minimu tal-QTc (< 10 msec) kien osservat f'esponimenti madwar 6 sa 20 darba tal-esponiment uman, li jirriżulta mid-doża klinika ta' 400 mg, u 4 darbiet sa 15-il darba talesponiment uman, li jirriżulta mid-doża klinika ta' 500 mg (ibbażat fuq Cmax mhux imwaħħal fl-ispeċi rispettivi).
English: Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets
Maltese: Bosulif 100 mg pilloli miksijin b'rita Bosulif 400 mg pilloli miksijin b'rita Bosulif 500 mg pilloli miksijin b'rita
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artiklu 14(7) talRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: Among patients with thrombocytopenia reactions, the median time to first event was 28 days (range: 1 to 1,688 days), and median duration per event was 15 days (range: 1 to 1,762 days).
Maltese: Fost individwi b'reazzjonijiet ta' trombocitopenija, iż-żmien medjan għall-ewwel avveniment kien ta' 28 jum (firxa: 1 sa 1,688 jum) u t-tul medjan ta' kull avveniment kien ta' 15-il jum (firxa: 1 sa 1,762 jum).
English: In a renal impairment study, a single dose of 200 mg bosutinib was administered with food to 26 subjects with mild, moderate, or severe renal impairment and to 8 matching healthy volunteers.
Maltese: Fi studju dwar indeboliment tal-kliewi, doża waħda ta' 200 mg ta' bosutinib ingħatat mal-ikel lil 26 individwu b'indeboliment ħafif, moderat, jew sever tal-kliewi, u lil 8 voluntiera b'saħħithom korrispondenti.
English: Vivian Corporation Ltd. Tel: +356 21344610
Maltese: Tel: +356 21344610
English: Other efficacy endpoints include transformation to AP/BP, progression free survival and OS for all cohorts.
Maltese: Endpoints oħra tal-effikaċja jinkludu trasformazzjoni għal AP/BP, sopravivenza ħielsa mill-progressjoni u sopravivenza globali (OS) għall-gruppi kollha.