FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 10 shows these data for patients who achieved MCyR and MMR at 45 mg; similar data are available for patients who achieved MCyR and MMR at 30 mg.
Maltese: Tabella 10 turi din id-dejta għall-pazjenti li kisbu MCyR u MMR b'45 mg; dejta simili hija disponibbli għallpazjenti li kisbu MCyR u MMR bi 30 mg.
English: The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients and no clinically significant QT prolongation was observed (see section 5.1).
Maltese: Il-potenzjal ta' titwil tal-intervall QT ta' Iclusig kien analizzat f'39 pazjent bil-lewkimja u l-ebda titwil klinikament sinifikanti ma ġie osservat (ara sezzjoni 5.1).
English: Multiple doses of 90 mg per day for 12 days in a patient resulted in pneumonia, systemic inflammatory response, atrial fibrillation, and asymptomatic, moderate pericardial effusion.
Maltese: Dożi multipli ta'90 mg kuljum għal 12-il jum f'pazjent irriżulta f'pnewmonja, rispons infjammatorju sistemiku, fibrilazzjoni atrijali u effużjoni perikardjali asintomatika moderata.
English: Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension
Maltese: Komuni emboliżmu fil-pulmun, effużjoni plewrali, epistassi, disfonija, pressjoni pulmonari għolja
English: Patients aged 65 and over are more likely to be affected by side effects.
Maltese: Huwa aktar probabbli li pazjenti li għandhom 65 sena u aktar jiġu affettwati b'effetti sekondarji.
English: • pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels.
Maltese: • pravastatin, rosuvastatin: mediċini li jbaxxu livelli għolja ta' kolesterol.
English: Very common alanine aminotransferase increased, aspartate aminotransferase increased
Maltese: Komuni ħafna żieda ta' alanine aminotransferase, żieda ta' aspartate aminotransferase
English: Ponatinib did not exhibit genotoxic properties when evaluated in the standard in vitro and in vivo systems.
Maltese: Ponatinib ma wriex karatteristiċi ġenotossiċi meta evalwat fis-sistemi standard in vitro u in vivo.
English: The median dose intensity was 36 mg or, 80% of the expected 45 mg dose.
Maltese: L-intensità tad-doża medjana kienet ta' 36 mg jew 80% tad-doża mistennija ta' 45 mg.
English: The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BP-CML/Ph+ ALL than in patients with CP-CML (see Table 4).
Maltese: Il-frekwenza ta' tromboċitopenja, newtropenja, u anemija ta' Grad 3 jew 4 kienet ogħla f'pazjenti b'AP-CML u BP-CML/Ph+ ALL milli f'pazjenti b'CP-CML (ara Tabella 4).
English: A prior MCyR or better (MCyR, MMR, or CMR) to dasatinib or nilotinib was only achieved in 26% patients with CP-CML and a prior MaHR or better (MaHR, MCyR, MMR, or CMR) was only achieved in 21%, and 24% of AP-CML, and BP-CML/Ph+ALL patients, respectively.
Maltese: MCyR minn qabel jew aħjar (MCyR, MMR, jew CMR) għal dasatinib jew nilotinib inkiseb biss f'26% tal-pazjenti b'CP-CML u Mahrminn qabel jew aħjar (MaHR, MCyR, MMR, jew CMR) kien miksub biss f'21% u 24% tal-pazjenti b'AP-CML, u BP-CML/Ph+ ALL, rispettivament.
English: At therapeutic serum concentrations, ponatinib did not inhibit OATP1B1 or OATP1B3, OCT1 or OCT2, organic anion transporters OAT1 or OAT3, or bile salt export pump (BSEP) in vitro.
Maltese: F'konċentrazzjonijiet terapewtiċi fis-serum, ponatinib ma inibixxiex lil OATP1B1 jew OATP1B3, OCT1 jew OCT2, trasportaturi organiċi tal-anjoni; OCT1 jew OCT3, jew lill-pompa ta' esportazzjoni ta' melħ tal-bili (BSEP - bile salt export pump) in vitro.
English: Neutropenia (ANC decreased)
Maltese: Newtropenja (tnaqqis fl-ANC)
English: Following single and multiple 45 mg doses of Iclusig, the terminal elimination half-life of ponatinib was 22 hours, and steady state conditions are typically achieved within 1 week of continuous dosing.
Maltese: Wara dożi singoli u multipli ta' 45 mg ta' Iclusig, il-half-life terminali ta' eliminazzjoni ta' ponatinib kienet ta' 22 siegħa, u kondizzjonijiet fi stat stabbli huma tipikament milħuqa fi żmien 1 ġimgħa mid-dożaġġ kontinwu.
English: Hypertension may contribute to risk of arterial thrombotic events.
Maltese: Pressjoni għolja tista' tikkontribwixxi għal riskju ta' avvenimenti trombotiċi fl-arterji.
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients (see section 4.8).
Maltese: Reazzjonijiet okklussivi serji fil-vini (frekwenzi li ħarġu mal-kura) seħħew f'4.5% tal-pazjenti (ara sezzjoni 4.8).
English: Iclusig 15 mg film-coated tablets Iclusig 45 mg film-coated tablets
Maltese: Iclusig 15 mg pilloli miksija b'rita Iclusig 45 mg pilloli miksija b'rita
English: Other covariates that show a statistically significant association with the occurrence of vascular occlusive events in this analysis are medical history of ischemia and age.
Maltese: Kovarjanti oħra li juru assoċjazzjoni statistikament sinifikanti mal-okkorrenza ta' avvenimenti okklussivi vaskulari f'din lanaliżi huma l-istorja medika ta' iskemija u l-età.
English: Caution should be exercised with concurrent use of Iclusig and moderate and strong CYP3A inhibitors and moderate and strong CYP3A inducers (see section 4.5).
Maltese: Għandu jkun hemm attenzjoni meta Iclusig jintuża flimkien ma' impedituri moderati u qawwija ta' CYP3A u indutturi moderati u qawwija ta' CYP3A (ara sezzjoni 4.5).
English: Within the range of clinically relevant doses evaluated in patients (15 mg to 60 mg), ponatinib exhibited dose proportional increases in both Cmax and AUC.
Maltese: Fi ħdan il-firxa ta' dożi klinikament rilevanti evalwati f'pazjenti (15 mg sa 60 mg), ponatinib were żidiet proporzjonali fid-doża kemm f'Cmax u AUC.
English: The median duration of treatment with Iclusig was 866 days in CP-CML patients, 590 days in AP-CML patients, and 86 days in BP-CML/Ph+ ALL patients.
Maltese: It-tul medjan ta' trattament b'Iclusig kien ta' 866 jum f'pazjenti b'CP-CML, 590 jum f'pazjenti b'AP-CML pazjenti, u 86 jum f'pazjenti bi BP-CML/Ph+ ALL.
English: Serious vascular occlusion has occurred in patients treated with Iclusig, including cardiovascular, cerebrovascular and peripheral vascular events, and venous thrombotic events.
Maltese: Okklużjoni vaskulari serja seħħet f'pazjenti kkurati b'Iclusig, inkluż avvenimenti kardjovaskulari, ċerebrovaskulari u avvenimenti vaskulari periferali, u avvenimenti trombotiċi fil-vini.
English: Iclusig 45 mg film-coated tablets are approximately 9 mm in diameter with "AP4" on one side.
Maltese: Il-pilloli miksija b'rita ta' Iclusig 45 mg għandhom dijametru ta' madwar 9 mm b'"AP4" fuq naħa waħda.
English: Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased
Maltese: Komuni insuffiċjenza kardijaka, infart mijokardijaku, insuffiċjenza konġestiva tal-qalb, marda tal-arterja koronarja, angina pectoris, effużjoni perikardjali, fibrillazzjoni atrijali, tnaqqis fil-porzjon imbuttat il-barra
English: The clinical relevance of this finding is unknown.
Maltese: Ir-rilevanza klinika ta' dan ir-riżultat għadu mhux magħruf.
English: An in vitro study in human hepatocytes indicated that clinical medicinal product interactions are also unlikely to occur as a result of ponatinib-mediated induction of the metabolism of substrates for CYP1A2, CYP2B6, or CYP3A.
Maltese: Studju in vitro f'epatoċiti umani jindika li interazzjonijiet kliniċi ma' prodott mediċinali wkoll x'aktarx li ma jseħħux bħala riżultat ta' induzzjoni medjata minn ponatinib tal-metaboliżmu tas-sottostrati ta' CYP1A2, CYP2B6, jew CYP3A.
English: • pain in muscles, skeletal system, neck or chest
Maltese: • uġigħ fil-muskoli, sistema skeletali, għonq jew sider
English: Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatmentemergent frequencies) occurred in 9.6%, 7.3%, and 6.9% of Iclusig-treated patients, respectively.
Maltese: Reazzjonijiet avversi okklussivi vaskulari fl-arterji kardjovaskulari, ċerebrovaskulari, u periferali (frekwenzi li ħarġu mal-kura) seħħew f'9.6%, 7.3%, u 6.9% tal-pazjenti kkurati b'Iclusig, rispettivament.
English: • colchicine: a medicine to treat gout attacks.
Maltese: • colchicine: mediċina għall-kura ta' attakki tal-gotta.
English: Ponatinib at doses of 3, 10, and 30 mg/kg produced increases in urine output and electrolyte excretions and caused a decrease in gastric emptying in safety pharmacology studies in rats.
Maltese: Ponatinib b'dożi ta' 3, 10, u 30 mg/kg ipproduċa żidiet fit-tneħħija ta' awrina u l-eliminazzjoni ta' elettroliti u ġab tnaqqis fl-iżvojtar gastriku fi studji dwar is-sigurtà farmakoloġika fil-firien.
English: Ponatinib is metabolized to an inactive carboxylic acid by esterases and/or amidases, and metabolized by CYP3A4 to an N-desmethyl metabolite that is 4 times less active than ponatinib.
Maltese: Ponatinib huwa metabolizzat għal carboxylic acid inattiv minn esterases u/jew amidases, u metabolizzati minn CYP3A4 għal metabolit N-desmethyl li huwa 4 darbiet inqas attiv minn ponatinib.
English: Achieved MCyR at 45 mg (N=87)
Maltese: MCyR intlaħaq b'45 mg (N=87)
English: Sodium starch glycolate
Maltese: Sodium imnaqqas
English: • hot flush, flushing
Maltese: • żamma ta' fluwidu
English: In each Member State, the Marketing Authorisation Holder shall agree the format and content of the educational programme, including communication media, distribution modalities, and any other aspects of the programme with the National Competent Authority.
Maltese: F'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jaqbel malAwtorità Kompetenti Nazzjonali dwar id-disinn u l-kontenut tal-programm edukattiv, inkluż mezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm.
English: R/I Cohort (N=38)
Maltese: Koorti R/I (N = 38)
English: Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 6.7%, 5.6%, and 5.1% of Iclusig treated patients, respectively.
Maltese: Reazzjonijiet avversi okklussivi vaskulari serji fl-arterji kardjovaskulari, ċerebrovaskulari, u periferali (frekwenzi li ħarġu mal-kura) seħħew f'6.7%, 5.6%, u 5.1% tal-pazjenti kkurati b'Iclusig, rispettivament.
English: c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Maltese: ċ MCyR jikkombina risponsi ċitoġenetiċi kemm kompluti (l-ebda ċellula Ph+ osservata) kif ukoll parzjali (1% sa 35% ċelluli Ph+).
English: The adverse reactions described in this section were identified in a single-arm, open-label, international, multicenter trial in 449 CML and Ph+ ALL patients who were resistant or intolerant to prior TKI therapy including those with a BCR-ABL T315I mutation.
Maltese: Ir-reazzjonijiet avversi deskritti f'din is-sezzjoni ġew identifikati fi prova ta' driegħ wieħed, bit-tikketta tidher, internazzjonali u multiċentrika f'449 pazjent b'CML u Ph+ ALL pazjenti li kienu reżistenti jew intolleranti għal terapija ta' TKI minn qabel inkluż dawk bi mutazzjoni BCR-ABL T315I.
English: Compared to patients < 65 years, older patients are more likely to experience adverse reactions.
Maltese: Meta mqabbla ma' pazjenti < 65 sena, il-pazjenti anzjani huma aktar probabbli li jkollhom reazzjonijiet avversi.
English: Baseline demographic characteristics are described in Table 5 below.
Maltese: Karatteristiċi demografiċi fil-linja bażi huma deskritti fit-Tabella 5 hawn taħt.
English: R/I Cohort (N=65)
Maltese: Koorti R/I (N = 65)
English: At daily doses of 45 mg, the geometric mean (CV%) apparent steady state volume of distribution is 1101 L (94%) suggesting that ponatinib is extensively distributed in the extravascular space.
Maltese: F'dożi ta' kuljum ta' 45 mg, il-medja ġeometrika apparenti (CV%) f'volum ta' distribuzzjoni fi stadju fiss huwa ta' 1101 L (94%) li jissuġġerixxi li ponatinib huwa distribwit b'mod estensiv fl-ispazju extravaskulari.
English: In the phase 2 trial, dose reductions were recommended following adverse events; in addition in October 2013 new recommendations for prospective dose reduction in all CP-CML patients in the absence of adverse events were introduced in this trial with the aim of reducing the risk of vascular occlusive events.
Maltese: Fil-prova ta' fażi 2, tnaqqis fid-dożi kien irrakkomandat wara avvenimenti avversi; barra dan f'Ottubru 2013 rakkomandazzjonijiet ġodda għal tnaqqis prospettiv fid-doża fil-pazjenti kollha b'CP-CML finnuqqas ta' avvenimenti avversi kienu introdotti f'din il-prova bil-għan li jitnaqqas ir-riskju ta' avvenimenti okklussivi vaskulari.
English: Common pneumonia, sepsis, folliculitis
Maltese: Komuni pulmonite, sepsi, follikulite
English: In a study in rats, diffuse corneal edema with neutrophilic cell infiltration, and hyperplastic changes in the lenticular epithelium suggestive of a mild phototoxic reaction were observed in animals treated with 5 and 10 mg/kg ponatinib
Maltese: Fi studji fil-firien, edema korneali diffuża b'infiltrazzjoni ċellulari newtrofilika, u bidliet iperplastiċi fl-epitilju lentikulari li jissġerixxu reazzjoni fotossika ħafifa kienu osservati fil-firien trattati b'5 u 10 mg/kg ponatinib.
English: Achieved MCyR at 30 mg (N=45)
Maltese: MCyR intlaħaq b'30 mg (N=45)
English: Frequency categories are very common (≥ 1/10), common (≥1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi rrappurtati fil-pazjenti kollha b'CML u Ph+ ALL huma ppreżentati fit-Tabella 3. Il-kategoriji ta' frekwenza huma komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa ≤1/100), rari (≥ 1/10,000 sa ≤ 1/1,000), rari ħafna (≤ 1/10,000), mhux magħruf (ma tistax tittieħed stima mill-informazzjoni disponibbli).
English: Management of toxicities:
Maltese: Immaniġġjar ta' tossiċitajiet:
English: Vascular Disorders
Maltese: Okklużjoni vaskulari
English: For all patients in the phase 2 trial, the dose intensity-safety relationship indicated that there are significant increases in grade ≥ 3 adverse events (cardiac failure, arterial thrombosis, hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression) over the dose range of 15 to 45 mg once-daily.
Maltese: Għall-pazjenti kollha fil-prova ta' fażi 2, ir-relazzjoni bejn l-intensità u s-sigurtà tad-doża tindika li hemm żidiet sinifikanti fl-avvenimenti avversi ta' grad ≥ 3 (insuffiċjenza tal-qalb, trombożi fl-arterji, pressjoni għolja, tromboċitopenija, pankreatite, newtropenija, raxx, żieda fl-ALT, żieda fl-AST, żieda fil-lipase, majelosoppressjoni) fuq il-firxa ta' doża ta' 15 sa 45 mg darba kuljum.
English: Ponatinib elicited tumour shrinkage and prolonged survival in mice bearing tumours expressing native or T315I mutant BCR-ABL.
Maltese: Ponatinib qanqal biex it-tumur jinxtorob u tawwal is-sopravivenza fil-ġrieden li jġorru tumuri li jesprimu l-mutant nattiv jew dak T315I, BCR-ABL.
English: In cynomolgus monkeys, systolic heart murmurs with no macroscopic or microscopic correlates were noted in individual animals treated with 5 and 45 mg/kg in the single dose toxicity study and at 1, 2.5 and 5 mg/kg in the 4-week repeat-dose toxicity study.
Maltese: Fix-xadini ċinomolgus, tnewwiħ sistoliku tal-qalb mingħajr korrelati makroskopiċi jew mikroskopiċi kienu nnotati f'annimali individwali trattati b'5 u 45 mg/kg fl-istudju dwar it-tossiċità minn doża unika u fl-istudju ta' 4 ġimgħat dwar it-tossiċità minn doża ripetuta b'1, 2.5 u 5 mg/kg.
English: Ponatinib-related microscopic findings in the ovaries (increased follicular atresia) and testes (minimal germ cell degeneration) in animals treated with 5 mg/kg ponatinib were noted in repeat-dose toxicity studies in cynomolgus monkeys.
Maltese: Riżultati mikroskopiċi marbuta ma' ponatinib fl-ovarji (atresja follikulari ogħla) u fit-testikoli (deġenrazzjoni minima ta' ċelluli ġerminali) f'annimali trattati b' 5 mg/kg ponatinib kienu nnotati fi studji ta' tossiċità b'doża ripetuta fix-xadini ċinomolgus.
English: Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4.5%, neutropenia and anaemia <1% each).
Maltese: It-twaqqif minħabba l-majelosoppressjoni ma kienx frekwenti (tromboċitopenjia 4.5%, newtropenija and anemija < 1% kull wieħed).
English: Common blood bilirubin increased, blood alkaline phosphatase increased, gammaglutamyltransferase increased
Maltese: Komuni żieda tal-bilirubin fid-demm, żieda ta' alkaline phosphatase fid-demm, żieda ta' gamma-glutamyltransferase
English: Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig.
Maltese: Il-pazjenti għandhom jiġu monitorjati għal sinjali jew sintomi konsistenti ma' insuffiċjenza tal-qalb u għandhom jiġu kkurati kif indikat klinikament, inkluż interruzzjoni ta' Iclusig.
English: Single doses of 165 mg and an estimated 540 mg in two patients did not result in any clinically significant adverse reactions.
Maltese: Dożi waħdenin ta'165 mg u doża stmata ta'540 mg f'żewġ pazjenti ma rriżultatx f'reazzjonijiet avversi klinikament sinifikanti.
English: Recurrence at 30 mg:
Maltese: F'każ li jseħħ bi 30 mg:
English: The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 21 days (range: 12 to 176 days), 29 days (range: 12 to 113 days), and 20 days (range: 11 to 168 days), respectively.
Maltese: Iż-żmien medjan għal MaHR f'pazjenti b'AP-CML, BP-CML, u Ph+ ALL kien ta' 21 jum (firxa: 12 sa 176 jum), 29 jum (firxa: 12 sa 113-il jum), u 20 jum (firxa: 11 sa 168 jum), rispettivament.
English: Common cerebrovascular accident, cerebral infarction, neuropathy peripheral, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack
Maltese: Komuni inċident ċerebrovaskulari, infart ċerebrali, newropatija periferali, letarġija, emigranja, iperestesija, ipoestesija, parestesija, attakk iskemiku temporanju
English: Although renal excretion is not a major route of ponatinib elimination, the potential for moderate or severe renal impairment to affect hepatic elimination has not been determined (see section 4.2).
Maltese: Għalkemm it-tneħħija renali mhix rotta prinċipali tal-eliminazzjoni ta' ponatinib, il-potenzjal li indeboliment renali moderat jew sever jaffettwa l-eliminazzjoni epatika ma ġiex determinat (ara sezzjoni 4.2).
English: T315I Cohort (N=64)
Maltese: Koorti T315I (N = 64)
English: Vascular occlusion
Maltese: Disturbi vaskulari
English: In patients with moderate or severe hepatic impairment, ponatinib Cmax and AUC0-∞ were lower and ponatinib plasma elimination half-life was longer in patients with mild, moderate, and severe hepatic impairment but not clinically significantly different than in healthy volunteers with normal hepatic function.
Maltese: F'pazjenti b'indeboliment epatiku moderat jew sever, Cmax u l-AUC0-∞ ta' ponatinib kienu aktar baxxi u l-half-life tal-eliminazzjoni mill-plasma ta' ponatinib kienet itwal f'pazjenti b'indeboliment epatiku ħafif, moderat, u sever iżda ma kinux differenti b'mod klinikament sinifikanti minn dawk f'voluntiera f'saħħithom b'funzjoni epatika normali.
English: Therefore, ponatinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) or BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine) and may increase their therapeutic effect and adverse reactions.
Maltese: Għalhekk, ponatinib jista' jkollu l-potenzjal li jżid l-konċentrazzjonijiet fil-plażma ta' sottostrati koamministrati ta' P-gp (eż. digoxin, dabigatran, colchicine, pravastatin) jew BCRP (eż. methotrexate, rosuvastatin, sulfasalazine), u jista' jżid l-effett terapewtiku tagħhom u r-reazzjonijiet avversi.
English: The trial enrolled 449 patients of which 444 were eligible for analysis: 267 CP-CML patients (R/I Cohort: n=203, T315I Cohort: n=64), 83 AP-CML patients (R/I Cohort: n=65, T315I Cohort: n=18), 62 BP-CML (R/I Cohort: n=38, T315I Cohort: n=24) and 32 Ph+ ALL patients (R/I Cohort: n=10, T315I Cohort: n=22).
Maltese: n = 18), 62 pazjent b'BP-CML(Koorti R/I: n=38, Koorti T315I: n=24) u 32 b'Ph+ ALL (Koorti R/I:
English: Table 10 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 7 April 2014)
Maltese: Tabella 10 Manteniment ta' rispons f'pazjenti b'CP-CML li kisbu MCyR jew MMR b'doża ta' 45 mg (estrazzjoni tad-dejta 7 ta' April 2014)
English: Iclusig 15 mg film-coated tablets are approximately 6 mm in diameter with "A5" on one side.
Maltese: Il-pilloli miksija b'rita ta' Iclusig 15 mg għandhom dijametru ta' madwar 6 mm b' "A5" fuq naħa waħda.
English: • carbamazepine: a medicine to treat epilepsy, euphoric/depressive stages and certain pain conditions.
Maltese: • carbamazepine: mediċina li tintuża għal kura ta' epilessija, stadji ewferiċi/dipressivi u ċertu tip ta' kundizzjonijiet ta' uġigħ.
English: Achieved MMR at 45 mg (N=63)
Maltese: MMR milħuq b'45 mg (N=63)
English: (95% CI) a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines complete haematological responses and no evidence of leukaemia.
Maltese: (95% CI) a Il-punt tat-tmiem ta' effikaċja primarju f'l-AP-CML u BP-CML/Ph+ ALL Koorti kien rispons ematoloġiku maġġuri (MaHR - major haematological response), li jikkombina risponsi ematoloġiċi kompluti u l-ebda evidenza ta' lewkimja.
English: See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 Situations where an alternative treatment may be considered.
Maltese: Ara sezzjonijiet 4.2 Valutazzjoni tal-istat kardjovaskulari qabel il-bidu tat-terapija u 4.4 Sitwazzjonijiet fejn kura alternattiva tista' tiġi kkunsidrata.
English: The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Maltese: Linċidenza ta' avvenimenti serji ta' fsada kienet ogħla f'pazjenti b'AP-CML, BP-CML u Ph+ ALL.
English: Maintained MCyR
Maltese: McyR Miżmum
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Common musculoskeletal pain, neck pain, musculoskeletal chest pain
Maltese: Komuni uġigħ muskolu-skeletriku, uġigħ fl-għonq, uġigħ muskuloskeletriku
English: The primary efficacy endpoint in AP-CML and BP-CML/Ph+ ALL was major haematological response (MaHR), defined as either a complete haematological response (CHR) or no evidence of leukaemia (NEL).
Maltese: Il-punt tat-tmiem ta' effikaċja primarju f'l-AP-CML u BP-CML/Ph+ ALL kien rispons ematoloġiku maġġuri (MaHR-major maematological response), definit bħala jew rispons ematoloġiku komplut (CHR) jew l-ebda evidenza ta' lewkimja (NEL-no evidence of leukaemia).
English: Myelosuppression was generally reversible and usually managed by withholding Iclusig temporarily or reducing the dose (see section 4.2).
Maltese: Il-majelosuppressjoni kienet ġeneralment riversibbli u ġeneralment ġestita billi Iclusig jiġi mwaqqaf temporanjament jew titnaqqas id-doża (ara sezzjoni 4.2).
English: Common peripheral arterial occlusive disease, peripheral ischaemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing
Maltese: Komuni mard okklussiv tal-arterji periferali, iskemija periferali, stenosi tal-arterji periferali, klawdikazzjoni intermittenti, trombożi fil-vini l-fondi, fwawar sħan, fwawar
English: At doses of 30 mg or greater plasma steady state trough concentrations of ponatinib typically exceed 21 ng/mL (40 nM).
Maltese: F'dożi ta' 30 mg jew aktar l-istat fiss tal-plażma fil-konċentrazzjoni l-aktar baxxi kien ġeneralment jaqbeż il-21 ng/mL (40 nM).
English: • heart problems, including heart failure, irregular heartbeats, and QT prolongation
Maltese: • problemi fil-qalb, inkluż insuffiċjenza tal-qalb, taħbit irregolari tal-qalb, u titwil ta' QT
English: • low calcium, phosphate or potassium levels in the blood
Maltese: • livelli baxxi ta' kalċju, fosfat jew potassju fid-demm