FrancophonIA/ELRC3.0 huggingface dataset:
English: In healthy subjects given a single intravenous dose of 120 mg bosutinib, the mean (%CV) terminal elimination half-life was 35.5 (24) hours, and the mean (%CV) clearance was 61.9 (26) L/h.
Maltese: F' suġġetti b'saħħithom mogħtija doża unika ġol-vina ta' 120 mg bosutinib, il-medja tal-half life taleliminazzjoni terminali (%CV) kienet 35.5 (24) siegħa, u t-tneħħija (%CV) medja kienet 61.9 (26) L/h.
English: Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
Maltese: Tabella 6 - Rispons skont l-istatus tal-mutazzjoni ta' BCR-ABL fil-linja bażi f'popolazzjoni CP CML evalwata: imatinib u dasatinib u/jew nilotinib minn qabel (it-tielet linja)
English: Following administration of single or multiple doses of bosutinib (400 or 500 mg) to humans, the major circulating metabolites appeared to be oxydechlorinated (M2) and N-desmethylated (M5) bosutinib, with bosutinib N-oxide (M6) as a minor circulating metabolite.
Maltese: Wara amministrazzjoni ta' doża waħda jew ħafna dożi ta' bosutinib (400 jew 500 mg) lill-bnedmin, il-metaboliti maġġuri li jiċċirkolaw kienu oxydechlorinated (M2) u N-desmethylated (M5) bosutinib, b'bosutinib N-oxide (M6) bħala l-metabolit minuri li jiċċirkola.
English: The solubility of bosutinib is pH-dependent and absorption is reduced when gastric pH is increased (see section 4.5).
Maltese: Is-solubbilità ta' bosutinib fl-ilma hija dipendenti mill-pH u lassorbiment jitnaqqas meta l-pH gastriku jiżdied (ara sezzjoni 4.5).
English: Bosulif 500 mg film-coated tablets EU/1/13/818/003
Maltese: Bosulif 500 mg pilloli miksijin b'rita EU/1/13/818/003
English: Bosutinib treatment reduced the size of CML tumours growing in nude mice and inhibited growth of murine myeloid tumours expressing imatinib-resistant forms of BCR-ABL. Bosutinib also inhibits receptor tyrosine kinases c-Fms, EphA and B receptors, Trk family kinases, Axl family kinases, Tec family kinases, some members of the ErbB family, the non-receptor tyrosine kinase Csk, serine/threonine kinases of the Ste20 family, and 2 calmodulin-dependent protein kinases.
Maltese: Bosutinib jinibixxi wkoll ir-riċettur tal-kinasi tyrosine c-Fms, EphA u rriċetturi B, il-grupp ta' kinasi Trk, il-grupp ta' kinasi Axl, il-grupp ta' kinasi Tec, xi membri tal-grupp ErbB, il-kinasi tyrosine Csk li mhux riċettur, il-kinasi serine/threonine tal-grupp Ste20 u 2 proteini kinasi dipendenti minn calmodulin.
English: Treatment with bosutinib may be associated with fluid retention including pericardial effusion, pleural effusion, pulmonary oedema and/or peripheral oedema.
Maltese: Trattament b'bosutinib jista' jkun assoċjat ma' ritenzjoni tal-fluwidi inkluż effużjoni fil-perikardju, effużjoni fil-plewra, edema pulmonari u/jew edema periferali.
English: Bosutinib 400 mg study
Maltese: Studju dwar bosutinib 400 mg
English: Complete haematological response (CHR for AP and BP CML: WBC less than or equal to institutional upper limit of normal (ULN), platelets greater than or equal to 100,000/mm and less than 450,000/mm 3, absolute neutrophil count (ANC) greater than or equal to 1.0×10
Maltese: Rispons ematoloġiku komplet (CHR) għal AP u BP CML: WBC anqas minn jew ekwivalenti għal-limitu ta' fuq tan-normal (ULN) istituzzjonali, plejtlits akbar minn jew ekwivalenti għal 100,000/mm 3 u anqas minn 450,000/mm 3, għadd assolut tan-newtrofili (ANC) akbar minn jew ekwivalenti għal 1.0 x 10
English: EU/1/13/818/006 (28 film-coated tablets) EU/1/13/818/007 (30 film-coated tablets)
Maltese: EU/1/13/818/006 (28 pillola miksijin b'rita) EU/1/13/818/007 (30 pillola miksijin b'rita)
English: Of these patients, 268 (400 mg starting dose) and 248 (500 mg starting dose) are from the 2 Phase 3 studies in previously untreated CML patients, 570 and 63 are from 2 Phase 1/2 studies in previously treated Ph+ leukaemias, and 123 patients from a Phase 4 study in previously treated CML.
Maltese: Minn dawn il-pazjenti, 268 (doża tal-bidu ta' 400 mg) u 248 (doża tal-bidu ta' 500 mg) huma minn 2 studji tal-Fażi 3 f'pazjenti b'CML li ma rċevewx trattament preċedenti, 570 u 63 huma minn 2 studji tal-Fażi 1/2 ta' Ph+ lewkimji li rċevew trattament preċedenti, u 123 pazjent minn studju ta' Fażi 4 f'pazjenti li ġew ittrattati għal CML fil-passat.
English: Among the 994 patients with diarrhoea, 180 patients (18%) were managed with treatment interruption and of these 170 (94%) were rechallenged with bosutinib.
Maltese: Fost id-994 pazjent bid-dijarea, 180 pazjenti (18%) kienu mmaniġġjati b'interruzzjoni tat-trattament u minn dawn 170 (94%) reġgħu ingħataw bosutinib.
English: CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy In patients with moderate renal impairment (CLCr 30 to 50 mL/min, calculated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 400 mg daily (see sections 4.4 and 5.2).
Maltese: CP, AP, jew BP Ph+ CML b'reżistenza jew intolleranza għal terapija fil-passat F'pazjenti b'indeboliment moderat tal-kliewi (CLCr 30 sa 50 mL/min, ikkalkulata skont il-formula Cockcroft-Gault), id-doża rakkomandata ta' bosutinib hi ta' 400 mg kuljum (ara sezzjonijiet 4.4 u 5.2).
English: In vitro studies indicate that clinical drug-drug interactions are unlikely to occur at therapeutic doses as a result of inhibition by bosutinib on the metabolism of medicinal products that are substrates for CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5.
Maltese: Studji in vitro jindikaw li probabbilment ma jkunx hemm interazzjonijiet bejn mediċina u oħra fiddożi terapewtiċi bħala riżultat tal-induzzjoni b'bosutinib fuq il-metaboliżmu ta' mediċini li huma sustratti ta' CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, jew CYP3A4/5
English: Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL expressed in murine myeloid cell lines.
Maltese: Bosutinib inibixxa 16 minn 18 il-forma ta' BCR-ABL reżistenti għal imatinib espressi fuq illinji taċ-ċelloli tal-murine majelojd.
English: Following administration of a single intravenous dose of 120 mg bosutinib to healthy subjects, bosutinib had a mean (% coefficient of variation [CV]) volume of distribution of 2,331 (32) L, suggesting that bosutinib is extensively distributed to extra vascular tissue.
Maltese: Wara l-amministrazzjoni ta' doża waħda ġol-vina ta' 120 mg bosutinib lil suġġetti b'saħħithom, bosutinib kellu volum (% koeffiċjent ta' varjazzjoni [CV]) medju tad-distribuzzjoni ta' 2,331 (32) L, li jissuġġerixxi li bosutinib huwa mqassam b'mod estensiv fit-tessut extra-vaskulari.
English: Cytogenetic Response criteria: Major Cytogenetic Response included Complete [0% Ph+ metaphases from bone marrow or < 1% positive cells from fluorescent in situ hybridisation (FISH)] or partial (1%-35%) cytogenetic responses.
Maltese: Rispons Ċitoġenetiku Maġġuri kien jinkludi rispons ċitoġenetiku Komplet [0% Ph+ metafażi mill-mudullun jew < 1% ċelloli pożittivi minn -ibridizzazzjoni fluworexxenti in-situ (FISH)] jew parzjali (1%-35%).
English: In patients with newly-diagnosed CP CML treated with 400 mg, the median decline from baseline in eGFR was 4.9 ml/min/1.73 m2 at 3 months, 9.2 ml/min/1.73 m2 at 6 months and 11.1 ml/min/1.73 m2 at 12 months.
Maltese: F'pazjenti li ġew iddijanjostikati għall-ewwel darba b'CP CML, ittrattati b'doża ta' 400 mg, it-tnaqqis medjan mil-linja bażi f'eGFR kien ta' 4.9 mL/min/1.73 m2 wara 3 xhur, 9.2 mL/min/1.73 m2 wara 6 xhur, u 11.1 mL/min/1.73 m2 wara 12il xahar.
English: CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy The recommended dose is 500 mg bosutinib once daily.
Maltese: CP, AP, jew BP Ph+ CML b'reżistenza jew intolleranza għal terapija fil-passat Id-doża rakkomandata hija ta' 500 mg ta' bosutinib darba kuljum.
English: Uncommon Anaphylactic shock, Hypersensitivity Metabolism and nutrition disorders Very common Decreased appetite Common
Maltese: Xokk anafilattiku, Sensittività eċċessiva Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna Tnaqqis fl-aptit Komuni
English: Overall haematological response (OHR)=major haematological response (complete haematological response + no evidence of leukaemia) or return to chronic phase (RCP).
Maltese: Rispons ematoloġiku globali (OHR) = rispons ematoloġiku maġġuri (rispons ematoloġiku komplet + l-ebda evidenza ta' lewkimja) jew ritorn għall-fażi kronika (RCP).
English: In a study of the central nervous system (CNS), bosutinib treated rats displayed decreased pupil size and impaired gait.
Maltese: Fi studju dwar s-sistema nervuża ċentrali (CNS), firien trattati b'bosutinib wrew tnaqqis fid-daqs tal-pupilla u indeboliment fil-mixi.
English: Bosulif 100 mg film-coated tablets EU/1/13/818/001
Maltese: Bosulif 100 mg pilloli miksijin b'rita EU/1/13/818/001
English: Note: MMR was defined as ≤ 0.1% BCR-ABL/ABL ratio by international scale (corresponding to ≥ 3 log reduction from standardised baseline) with a minimum of 3,000 ABL transcripts assessed by the central laboratory.
Maltese: Nota: MMR kien definit bħala proporzjon ta' ≤ 0.1% BCR-ABL/ABL skont skala internazzjonali (li jikkorrispondi għal tnaqqis ta' ≥ 3 log mil-linja bażi standardizzata) b'minimu ta' 3,000 ABL transcripts kif evalwati mil-laboratorju ċentrali.
English: 112 film-coated tablets.
Maltese: 112 pillola miksijin b'rita.
English: The median duration of an event was 18 days (range: 1 to 775 days), and 15 days (range: 1 to 803 days) for ALT and AST, respectively.
Maltese: It-tul medjan ta' avveniment kien ta' 18-il jum (firxa: 1 sa 775 jum), u 15-il jum (firxa: 1 sa 803 jum għal ALT u AST rispettivament.
English: One patient with the E255V mutation previously treated with nilotinib achieved CHR as best response.
Maltese: Pazjent bil-mutazzjoni E255V li rċieva trattament preċedenti b'nilotinib kiseb CHR bħala l-aqwa rispon.
English: - if you have heart problems.
Maltese: - Jekk inti għandek problemi tal-qalb.
English: Five bosutinib patients and 7 imatinib patients transformed to AP CML or BP CML.
Maltese: Ħames pazjenti fuq bosutinib u 7 pazjenti fuq imatinib ittrasformaw għal AP CML jew BP CML.
English: Includes patients (N) with a valid baseline assessment.
Maltese: Jinkludi pazjenti (N) b'evalwazzjoni valida fil-linja bażi.
English: Population pharmacokinetic analyses in patients with Ph+ leukaemia or malignant solid tumour indicate that there are no clinically relevant effects of age, gender, body weight, race.
Maltese: L-analiżi talfarmakokinetika tal-popolazzjoni f'pazjenti b'Ph+ lewkimja jew tumuri solidi malinni indikat li ma kien hemm l-ebda effetti klinikament rilevanti fuq l-età, sess, piż tal-ġisem, razza.
English: The antiemetic agent, domperidone, has the potential to increase QT interval (QTc) prolongation and to induce “torsade de pointes”- arrhythmias; therefore, co-administration with domperidone should be avoided.
Maltese: L-aġent antiemetiku, domperidone, għandu l-potenzjal li jżid it-titwil tal-intervall tal-QT (QTc) u jinduċi "torsade de pointes" - arritmiji, għalhekk, l-għoti flimkien ma' domperidone għandu jiġi evitat.
English: An in vitro study indicates that drug-drug interactions are unlikely to occur at therapeutic doses as a result of induction by bosutinib on the metabolism of medicinal products that are substrates for CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4.
Maltese: Studju in vitro jindika li probabbilment ma jkunx hemm interazzjonijiet bejn mediċina u oħra fid-dożi terapewtiċi bħala riżultat tal-induzzjoni b'bosutinib fuq il-metaboliżmu ta' mediċini li huma sustratti ta' CYP1A2, CYP2B6, CYP2C9, CYP2C19, u CYP3A4.
English: Elevation in serum lipase has been observed.
Maltese: Ġiet osservata żieda fil-livelli tal-lipase fis-serum.
English: White opaque 3-ply PVC/Polychlorotrifluoroethene/PVC blister sealed with push-through foil backing containing either 14 or 15 tablets.
Maltese: Folja bajda opaka tat-3-ply PVC/ Polychlorotrifluoroethene/PVC magħmula minn bżieżaq singoli li timbotta li fiha jew14 jew 15-il pillola.
English: Repeated-dose toxicity
Maltese: Effett tossiku minn dożi ripetuti
English: A total of 1,272 leukaemia patients received at least 1 dose of single-agent bosutinib.
Maltese: Total ta' 1,272 pazjent lewkimja rċevew mill-anqas doża 1 ta' bosutinib bħala aġent uniku.
English: Red oval (width: 9.5 mm; length: 18.3 mm) biconvex, film-coated tablet debossed with “Pfizer” on one side and “500”on the other side.
Maltese: Pillola ħamra b'forma ovali (wisa': 9.5 mm; tul: 18.3 mm), bikonvessa, miksija b'rita, imnaqqxa b'“Pfizer” fuq naħa waħda u “500” fuq in-naħa l-oħra.
English: Acute kidney injury, Renal failure, Renal impairment General disorders and administration site conditions Very common Pyrexia, Asthenia, Oedema (including Face oedema, Localised oedema, Oedema peripheral), Fatigue (including Malaise)
Maltese: Ħsara akuta fil-kliewi, Insuffiċjenza renali, Indeboliment renali Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna Deni, Astenija, Edema (li tinkludi edema fil-wiċċ, Edema lokalizzata, Edema periferali), Għeja (li tinkludi Telqa)
English: The dose at which no adverse reproductive effects were observed in males (30 mg/kg/day) and females (3 mg/kg/day) resulted in exposures equal to 0.6-times and 0.3-times, respectively, the human exposure resulting from the clinical dose of 400 mg, and 0.5-times and 0.2-times, respectively, the human exposure resulting from the clinical dose of 500 mg (based on unbound AUC in the respective species).
Maltese: Id-doża fejn ma kienu osservati l-ebda effetti avversi fuq is-sistema riproduttiva fl-irġiel (30 mg/kg/kuljum) u fin-nisa (3 mg/kg/kuljum) irriżultat f'esponimenti daqs 0.6 darbiet u 0.3 darbiet, rispettivament, talesponiment uman, li jirriżulta mid-doża klinika ta' 400 mg, u 0.5 darbiet u 0.2 darbiet, rispettivament, l-esponiment fil-bnedmin li rriżulta mid-doża klinika ta' 500 mg (fuq bażi tal-AUC mhux mwaħħal flispeċi rispettivi).
English: Bosutinib displays pH-dependent aqueous solubility in vitro.
Maltese: In vitro, bosutinib juri solubbilità fl-ilma dipendenti mill-pH.
English: - acute inflammation of the pancreas (acute pancreatitis).
Maltese: Pankreatite (li tinkludi pankreatite akuta)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Hepatotoxicity (including Hepatitis, Hepatitis toxic, Liver disorder), Hepatic function abnormal (including Liver function test abnormal, Liver function test increased, Transaminases increased), Blood bilirubin increased (including Hyperbilirubinaemia), Gamma-glutamyltransferase increased Uncommon Liver injury (including Drug-induced liver injury) Skin and subcutaneous tissue disorders
Maltese: Epatotossiċità (li tinkludi Epatite, Epatite tossika, Disturb tal-fwied), Funzjoni anormali tal-fwied (li tinkludi test tal-funzjoni tal-fwied b'riżultat anormali, Żieda fit-test tal-funzjoni tal-fwied, Żieda fit-transaminases), Żieda tal-bilirubina fid-demm (li tinkludi iperbilirubinemija), Żieda f'gamma-glutamyltransferase
English: CMH=Cochran-Mantel-Haenszel; CML=chronic myelogenous leukaemia; mITT=modified intent-to-treat; MMR=major molecular response; Ph+=Philadelphia chromosome-positive.
Maltese: MMR=major molecular response (rispons molekulari maġġuri); Ph+=Philadelphia chromosome-positive.
English: Bosulif 400 mg film-coated tablets are orange, oval biconvex, debossed with “Pfizer” on one side and “400” on the other side.
Maltese: Bosulif 400 mg pilloli miksijin b'rita huma oranġjo, ovali, bikonvessi,mnaqqxa b'“Pfizer” fuq naħa waħda u “400” fuq in-naħa l-oħra.
English: Bosulif 100 mg film-coated tablets Each carton contains 28, 30 or 112 tablets.
Maltese: Bosulif 100 mg pilloli miksijin b'rita Kull kartuna fiha 28, 30 jew 112 pillola.
English: Following a single oral (10 mg/kg) administration of [
Maltese: Wara amministrazzjoni orali waħda (10 mg/kg) ta' radiolabelled bosutinib [
English: - if you suffer from bleeding problems.
Maltese: - Jekk tbati minn problemi ta' fsada.
English: Following administration of a single oral dose of bosutinib 500 mg (therapeutic dose) and bosutinib 500 mg with ketoconazole 400 mg (to achieve supratherapeutic concentrations of bosutinib) in healthy subjects, the upper bound of the 1-sided 95% confidence interval (CI) around the mean change in QTc was less than 10 ms at all post-dose time points, and no adverse events suggestive of QTc prolongation were observed.
Maltese: Wara amministrazzjoni ta' doża orali waħda ta' Bosulif 500 mg (doża terapewtika) u Bosulif 500 mg ma' ketoconazole 400 mg (biex tilħaq konċentrazzjonijiet ta' bosutinib aktar għoljin minn dawk terapewtiċi) f'pazjenti b'saħħithom, l-ogħla limitu ta' 95% intervall talkunfidenza (CI) ta' naħa 1 madwar il-bidla medja tal-QTc kienet inqas minn 10 ms wara kull punt talħin wara d-doża, u l-ebda avvenimenti avversi li jissuġġerixxu titwil tal-QTc ma kienu osservati.
English: In the Phase 1/2 clinical study in patients with CML who were resistant or intolerant to prior therapy who started treatment at ≤ 500 mg, 93 (93/558; 16.7%) patients had dose escalations to 600 mg daily.
Maltese: Fl-istudju kliniku ta' Fażi 1/2 f'pazjenti b'CML li kienu reżistenti jew intolleranti għal terapija filpassat li bdew it-trattament f'doża ta' ≤ 500 mg, 93 (93/558; 16.7%), il-pazjenti kellhom żidiet fiddoża għal 600 mg kuljum.
English: Other medicines and Bosulif
Maltese: Mediċini oħra u Bosulif
English: The cumulative incidence of CCyR adjusted for the competing risk of treatment discontinuation without CCyR was higher in the bosutinib treatment group compared to the imatinib treatment group in the mITT population (79.1% [95% CI: 73.4%, 83.7%] versus 67.3% [95% CI: 60.9%, 72.8%] at Week 48; HR: 1.38, [95% CI: 1.13, 1.68]; 1-sided p-value=0.0003).
Maltese: L-inċidenza kumulattiva ta' CCyR meta wieħed jaġġusta għar-riskju li jikkompeti tat-twaqqif tattrattament mingħajr CCyR, kienet ogħla fil-grupp ta' trattament ta' bosutinib meta mqabbla mal-grupp ta' trattament ta' imatinib fil-popolazzjoni mITT (79.1% [95% CI: 73.4%, 83.7%] kontra 67.3% [95% CI: 60.9%, 72.8%] f'Ġimgħa 48;
English: At least 1 Grade 3 or Grade 4 adverse reaction was reported for 814 (63.9%) patients.
Maltese: Tal-anqas reazzjoni avversa waħda ta' Grad 3 jew ta' Grad 4 kienet irrapportata għal 814 (63.9%) pazjent.
English: When a single oral dose of bosutinib (400 mg) was co-administered with multiple-oral doses of lansoprazole (60 mg) in a study of 24 healthy fasting subjects, bosutinib Cmax and AUC decreased to 54% and 74%, respectively, of the values seen when bosutinib (400 mg) was given alone.
Maltese: Meta doża orali waħda ta' bosutinib (400 mg) kienet amministrata ma' aktar minn doża orali waħda ta' lansoprazole (60 mg) fi studju li sar f'24 pazjent b'saħħtu sajjem, is-Cmax u l-AUC ta' bosunitib naqsu għal 54% u 74%, rispettivament, tal-valuri li dehru meta Bosulif (400 mg) kien amministrat waħdu.
English: At Month 12, the MR4 rate (defined as ≤ 0.01% BCR-ABL [corresponding to ≥ 4 log reduction from standardised baseline] with a minimum of 9,800 ABL transcripts) was higher in the bosutinib treatment group compared to the imatinib treatment group in the mITT population (20.7% [95% CI: 15.7%, 25.8%] versus 12.0% [95% CI: 7.9%, 16.1%], respectively, 1-sided p-value=0.0052).
Maltese: 4 (definita bħala ≤ 0.01% BCR-ABL [li jikkorrispondi għal tnaqqis ta' ≥ 4 log mil-linja bażi standardizzata] b'minimu ta' 9,800 ABL transcripts), kienet ogħla fil-grupp ta' trattament ta' bosutinib meta mqabbla mal-grupp ta' trattament ta' imatinib fil-popolazzjoni mITT (20.7% [95% CI: 15.
English: 1-sided p-value a
Maltese: Rispons ċitoġeniku kumulattiv a
English: Pneumonia (including Atypical pneumonia), Influenza, Bronchitis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uncommon Tumour lysis syndrome**
Maltese: Pnewmonja (li tinkludi Pnewmonja atipika), Influwenza, Bronkite Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Mhux komuni
English: Whereas, in the Phase 3 study in patients with newly-diagnosed CP CML treated with bosutinib 400 mg, dose escalations by 100 mg increments to a maximum of 600 mg once daily with food were permitted if the patient failed to demonstrate breakpoint cluster region-Abelson (BCR-ABL) transcripts ≤ 10% at Month 3, did not have a Grade 3 or 4 adverse reaction at the time of escalation, and all Grade 2 non-haematological toxicities were resolved to at least Grade 1.
Maltese: Billi, fl-istudju ta' Fażi 3 f'pazjenti li ġew iddijanjostikati għall-ewwel darba b'CP CML, ittrattati bi bosutinib 400 mg, kienu permessi żidiet fid-doża f'inkrementi ta' 100 mg sa massimu ta' 600 mg darba kuljum mal-ikel, jekk il-pazjent ma rnexxilux juri breakpoint cluster region-Abelson (BCR-ABL) transcripts ta' ≤ 10% f'Xahar 3, ma kellux reazzjoni avversa ta' Grad 3 jew 4 fil-ħin taż-żieda, u t-tossiċitajiet mhux ematoloġiċi kollha ta' Grad 2 naqsu għal mill-inqas Grad 1.
English: Side effects with Bosulif may include:
Maltese: Effetti sekondarji b'Bosulif jinkludu:
English: MMR was defined as ≤ 0.1% BCR-ABL/ABL ratio by international scale (corresponding to ≥ 3 log reduction from standardised baseline) with a minimum of 3,000 ABL transcripts as assessed by the central laboratory.
Maltese: MMR kien definit bħala proporzjon ta' ≤ 0.1% BCR-ABL/ABL fuq l-iskala internazzjonali (li jikkorrispondi għal tnaqqis ta' ≥ 3 log mil-linja bażi standardizzata) b'minimu ta' 3,000 ABL transcripts kif evalwati mil-laboratorju ċentrali.
English: Clinical data are very limited (n = 3) for CML patients with moderate renal impairment receiving an escalated dose of 600 mg bosutinib.
Maltese: Dejta klinika hi limitata ħafna (n = 3) għal pazjenti b'CML li jkollhom indeboliment moderat talkliewi u li jkunu qed jirċievu doża miżjuda ta' 600 mg ta' bosutinib.
English: In these patients, the maximum toxicity of Grade 1 or 2 was experienced in 174 (58%) patients, Grade 3 in 96 patients (32%), and Grade 4 in 27 (9%) patients.
Maltese: F'dawn il-pazjenti t-tossiċità massima ta' Grad 1 jew 2 kienet esperjenzata f'174 (58%) pazjent, ta' Grad 3 f'96 pazjent (32%), u ta' Grad 4 f'27 (9%) pazjent.
English: Patients with uncontrolled or significant cardiovascular disease including QTc prolongation, at baseline, were not included in clinical studies (see sections 5.1 and 5.3).
Maltese: Pazjenti b'mard kardjovaskulari mhux ikkontrollat jew sinifikanti, inkluż titwil tal-QTc, fil-linja bażi, ma ġewx inklużi fl-istudji kliniċi (ara sezzjonijiet 5.1 u 5.3).
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A enzyme inhibition potential, if possible, is recommended.
Maltese: Għażla ta' prodotti mediċinali konkomitanti alternattivi mingħajr jew b'potenzjal minimu ta' inibizzjoni tal-enzimi ta' CYP3A, jekk possibbli, huwa rrakkomandat.
English: In CML patients at steady state, Cmax (geometric mean, coefficient of variation [CV]%) was 145 (14) ng/mL, and AUCss (geometric mean, CV%) was 2,700 (16) ng•h/mL after daily administration of bosutinib at 400 mg with food.
Maltese: F'pazjenti b'CML fl-istat fiss, is-Cmax (medja ġeometrika, il-koeffiċjent ta' varjazzjoni [CV]%) kien ta' 145 (14) ng/mL, u l-AUCss (medja ġeometrika, CV%) kien ta' 2,700 (16) ng•h/mL wara l-għoti kuljum ta' bosutinib f'doża ta' 400 mg mal-ikel.
English: Years 2 (Month 24) and 5 (60 months) for CP treated with imatinib only and Years 1 (Month 12) and 4 (48 months) for CP treated with imatinib and at least 1 other TKI, AP, and BP.
Maltese: Snin 2 (Xahar 24) u 5 (60 xahar) għal pazjenti b'CP ittrattati b'imatinib biss, u Sena 1 (Xahar 12) u 4 (48 xahar) għal pazjenti b'CP ittrattati b'imatinib u b'mill-inqas 1 TKI AP-BP ieħor.
English: EU/1/13/818/003 28 film-coated tablets EU/1/13/818/004 30 film-coated tablets
Maltese: EU/1/13/818/003 (28 pillola miksijin b'rita) EU/1/13/818/004 (30 pillola miksijin b'rita)