FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 11 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 11 turi din iddejta għall-pazjenti li kisbu MCyR u MMR b'45 mg; dejta simili hija disponibbli għall-pazjenti li kisbu MCyR u MMR bi 30 mg.
English: A brain condition called posterior reversible encephalopathy syndrome (PRES) has been reported in patients treated with ponatinib.
Maltese: Kundizzjoni tal-moħħ imsejħa sindrome ta' enċefalopatija posterjuri riversibbli (PRES, Posterior Reversible Encephalopathy Syndrome) ġiet irrappurtata f'pazjenti ttrattati b'ponatinib.
English: The median time to onset of the first cardiovascular, cerebrovascular, and peripheral vascular arterial occlusive events was 351, 611, and 605 days, respectively.
Maltese: Il-ħin medjan biex jitfaċċaw l-ewwel każijiet okklużivi fl-arterji kardjovaskulari, ċerebrovaskulari, u periferali kien ta' 351, 611 u 605 jum rispettivament.
English: Table 9 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Maltese: Tabella 9 L-effikaċja ta' Iclusig f'pazjenti b'Ph+ ALL reżistenti jew intolleranti
English: With a minimum follow-up of 64 months, 3.4% (9/267) of CP-CML patients experienced transformation of their disease to AP-CML or BP-CML.
Maltese: B'follow-up minimu ta' 64 xahar, 3.4% (9/267) ta' pazjenti b'CP-CML esperjenzaw trasformazzjoni tal-marda tagħhom għal AP-CML jew BP-CML.
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: Titwil tal-QT 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: The median duration of treatment with Iclusig was 32.2 months in CP-CML patients, 19.4 months in AP-CML patients, and 2.9 months in BP-CML/Ph+ ALL patients.
Maltese: It-tul medjan ta' trattament b'Iclusig kien ta' 32.2 xhur f'pazjenti b'CP-CML, 19.4 xhur f'pazjenti b'AP-CML, u 2.9 xhur f'pazjenti bi BP-CML/Ph+ ALL.
English: Table 4 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Maltese: Tabella 4 Reazzjonijiet avversi osservati f'pazjenti b'CML u Ph+ ALL - frekwenza rrappurtati skont l-inċidenza tal-avvenimenti li ħarġu mal-kura
English: Iclusig 45 mg film-coated tablets EU/1/13/839/003
Maltese: Iclusig 45 mg pilloli miksija b'rita EU/1/13/839/003
English: Of the CP-CML patients with no mutation detected at entry, 49% (66/136) achieved a MCyR.
Maltese: Mill-pazjenti b'CP-CML mingħajr mutazzjoni osservata mad-dħul, 49% (66/136) kisbu MCyR.
English: • decreased activity of thyroid gland
Maltese: • attività mnaqqsa tal-glandola tat-tirojde
English: • Breast-feeding
Maltese: • infezzjoni fid-demm
English: • Iclusig should be withheld and resumed at 15 mg after recovery to ≤ Grade 1 (< 1.5 x IULN) Occurrence at 15 mg:
Maltese: • Iclusig għandu jiġi mwaqqaf u jerġa' jiġi mibdi bi 15 mg wara l-irkupru għal ≤ Grad 1 (< 1.5 x IULN)
English: Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4%, neutropenia and anaemia < 1% each).
Maltese: It-twaqqif minħabba l-majelosoppressjoni ma kienx frekwenti (tromboċitopenjia 4%, newtropenija and anemija < 1% kull wieħed).
English: Table 11 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 6 February 2017) Achieved MCyR at 45 mg (N=86)
Maltese: Tabella 11 Manteniment ta' rispons f'pazjenti b'CP-CML li kisbu MCyR jew MMR b'doża ta' 45 mg (estrazzjoni tad-dejta 06 ta' Frar 2017)
English: Iclusig 15 mg film-coated tablets EU/1/13/839/001
Maltese: Iclusig 15 mg pilloli miksija b'rita EU/1/13/839/001
English: There were no effects on male rat fertility parameters.
Maltese: Ma kienx hemm effetti fuq parametri ta' fertilità tal-far raġel.
English: • Iclusig should be withheld and resumed at 30 mg after recovery to ≤ Grade 1 (< 1.5 x IULN) Occurrence at 30 mg:
Maltese: • Iclusig għandu jiġi mwaqqaf u jerġa' jiġi mibdi bi 30 mg wara l-irkupru għal ≤ Grad 1 (< 1.5 x IULN)
English: Iclusig 30 mg film-coated tablets are approximately 8 mm in diameter with "C7" on one side.
Maltese: Il-pilloli miksija b'rita ta' Iclusig 30 mg għandhom dijametru ta' madwar 8 mm b' "C7" fuq naħa waħda.
English: Baseline demographic characteristics are described in Table 6 below.
Maltese: Karatteristiċi demografiċi fil-linja bażi huma deskritti fit-Tabella 6 hawn taħt.
English: In the phase 2 trial (with a minimum of 64 months follow-up), venous thromboembolic adverse reactions have occurred in 6% of patients (treatment-emergent frequencies).
Maltese: Fil-prova ta' fażi 2 (b'minimu ta' 64 xahar follow-up), reazzjonijiet tromboembliċi venużi avversi ġew osservati f'6% tal-pazjenti (frekwenzi li tfaċċaw mit-trattament).
English: c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells)
Maltese: c MCyR jikkombina risponsi ċitoġenetiċi kemm kompluti (l-ebda ċellula ta' Ph+ osservata) u parzjali (1% sa 35% ċelluli ta' Ph+).
English: How to take Iclusig
Maltese: Tieħux Iclusig
English: The median dose intensity was 28 mg/day in CP-CML patients or, 63% of the expected 45 mg dose; median dose intensity was greater in advanced disease states (32 mg/day in the AP-CML patients and 44 mg/day in the BP CML/Ph+ ALL patients).
Maltese: 63% tad-doża mistennija ta' 45 mg; l-intensità tad-doża medjana kienet akbar fi stati ta' mard avvanzati (32 mg/jum f'pazjenti b'AP-CML u 44 mg/jum f'pazjenti b'BP CML/Ph+ ALL)
English: The secondary efficacy endpoints in CP-CML were complete haematological response (CHR) and major molecular response (MMR).
Maltese: Il-punt tat-tmiem ta' effikaċja sekondarju fis-CP-CML kien rispons ċitoġeniku komplut (CHR) u rispons molekulari maġġuri (MMR).
English: Reducing the dose of Iclusig to 15 mg should be considered for CP-CML patients who have achieved a major cytogenetic response taking the following factors into account in the individual patient assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1).
Maltese: Iclusig għal 15 mg għandu jiġi kkunsidrat għal pazjenti b'CP-CML li jkunu kisbu rispons ċitoġeniku maġġuri b'konsiderazzjoni tal-fatturi li ġejjin fil-valutazzjoni tal- tal-pazjent individwali: riskju kardjovaskulari, effetti sekondarji tat-terapija ta' ponatinib, ħin sa rispons ċitoġenetiku, u l-livelli tattraskrizzjoni ta' BCR-ABL (ara sezzjonijiet 4.4 u 5.1).
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: For CP-CML patients overall (N=267), as well as for CP-CML R/I Cohort A patients (N=203) and T315I Cohort B patients (N=64), the median OS has not yet been reached.
Maltese: Għall-pazjenti b'CP-CML b'mod globali (N=267), kif ukoll għall-pazjenti b'CP-CML Koorti R/I A (N=203) u pazjenti Koorti B T3151 (N=64), l-OS medjan għadu ma ntlaħaqx.
English: In a two-year carcinogenicity study in male and female rats, oral administration of ponatinib at 0.05, 0.1 and 0.2 mg/kg/day in males and at 0.2 and 0.4 mg/kg/day in females did not result in any tumorigenic effects.
Maltese: Fi studju dwar il-karċinoġeniċità li dam sejjer sentejn fuq firien irġiel u nisa, l-għoti mill-ħalq ta' ponatinib f'dożi ta' 0.05, 0.1 u 0.2 mg/kg/jum f'irġiel u f'0.2 u 0.4 mg/kg/jum f'nisa ma rriżultawx f'effetti tumoriġeniċi.
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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali humamniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Caution should be exercised and a reduction of the starting dose of Iclusig to 30 mg should be considered with concurrent use of strong CYP3A inhibitors such as clarithromycin, indinavir,
Maltese: Għandha tingħata attenzjoni u għandu jiġi kkunsidrat tnaqqis fid-doża tal-bidu ta' Iclusig għal 30 mg bl-użu fl-istess waqt ta' impedituri qawwija ta' CYP3A bħal clarithromycin, indinavir, itraconazole,
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: bit-tikketta tidher, internazzjonali u multiċentrika f'449 pazjent b'CML u Ph+ ALL pazjenti li kienu r eżistenti jew intolleranti għal terapija ta' TKI minn qabel inkluż dawk bi mutazzjoni BCR-ABL T315I.
English: Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively (see section 4.8).
Maltese: Reazzjonijiet avversi okklussivi vaskulari serji fl-arterji kardjovaskulari, ċerebrovaskulari, u periferali (frekwenzi li ħarġu mal-kura) seħħew f'10%, 7%, u 9% tal-pazjenti kkurati b'Iclusig, rispettivament (ara sezzjoni 4.8).
English: • Iclusig should be withheld and resumed at 15 mg after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
Maltese: • Iclusig għandu jiġi mwaqqaf u jerġa' jiġi mibdi fl-istess doża wara l-irkupru sa ANC ≥ 1.5 x 109/L u plejtlets ≥ 75 x 109/L
English: Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively.
Maltese: Ponatinib jimpedixxi l-attività ta' tyrosine kinase ta' ABL u l-mutanti T315I ABL
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: Haemorrhage
Maltese: suffejra
English: The frequency of these events is greater in patients with accelerated phase CML (AP-CML) or blast phase CML (BP-CML)/Ph+ ALL than in chronic phase CML (CP-CML).
Maltese: fil-fażi aċċellerata (AP-CML) jew CML fil-fażi blast (BP-CML)/Ph+ ALL milli fil-fażi kronika ta' CML (CP-CML).
English: Venous thromboembolic reactions (treatment-emergent frequencies) occurred in 6% of patients.
Maltese: Reazzjonijiet tromboemboliċi venużi (frekwenzi li tfaċċaw bit-trattament) ġew osservati f'6% ta' pazjenti.
English: In addition, the pharmacokinetic-pharmacodynamic models show no exposure-effect relationship, with an estimated QTcF mean change of -6.4 ms (upper confidence interval -0.9 ms) at Cmax for the 60 mg group.
Maltese: b'bidla medja fil-QTcF stmata ta' -6.4 ms (intervall ta' kunfidenza ta' fuq -0.9 ms) f'Cmax għall-grupp tas-60 mg.
English: Each film-coated tablet contains 80 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 80 mg ta' lactose monohydrate.
English: Bottles of Iclusig 15 mg contain either 30, 60 or 180 film-coated tablets.
Maltese: Fliexken ta' Iclusig 15 mg fihom jew 30, 60 jew 180 pillola miksija b'rita.
English: Common cerebrovascular accident, cerebral infarction, neuropathy peripheral, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack
Maltese: newropatija periferali, letarġija, emigranja, iperestesija, ipoestesija, parestesija, attakk iskemiku temporanju
English: Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension
Maltese: Komuni emboliżmu fil-pulmun, effużjoni plewrali,
English: ≥ 6 month reduction at 15 mg
Maltese: ≥ 6 xhur ta' tnaqqis għal 15 mg
English: Statistical significance was achieved in the correlation of PFS and OS with a MCyR at the 12-month landmark (p=<0.0001 and p=0.0012, respectively).
Maltese: 0001 u p=0.0012, rispettivament).
English: 180 tablets
Maltese: 30 pillola 60 pillola 180 pillola
English: Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased, acute coronary syndrome, atrial flutter
Maltese: Komuni insuffiċjenza kardijaka, infart mijokardijaku, insuffiċjenza konġestiva tal-qalb, marda tal-arterja koronarja, angina pectoris,
English: A statistically significant increased incidence of squamous cell carcinoma of the clitoral gland was observed at that dose.
Maltese: Inċidenza statistikament sinjifikanti ogħla ta' karċinoma ta' ċelluli skwamużi tal-glandola tal-klitoride ġiet osservata f'dik id-doża.
English: Uncommon myocardial ischemia, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction,
Maltese: Mhux komuni iskemija mijokardijaka, skumdità fil-qalb, kardjomijopatija iskemika, spażmi fl-arterji koronarji, disfunzjoni tal-ventrikolu tax-xellug,
English: Occurrence at 45 mg:
Maltese: F'każ f'45 mg:
English: Arterial occlusions, including fatal myocardial infarction, stroke, retinal arterial occlusions associated in some cases with permanent visual impairment or vision loss, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, renal artery stenosis (associated with worsening, labile or treatment-resistant hypertension), and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Maltese: Okklużjoni fl-arterji, inkluż infart mijokardijaku fatali, puplesija, okklużjonijiet arterjali fir-retina assoċjati f'ċerti każijiet ma' indeboliment viżiv permanenti jew telf tal-vista, stenosi tal-kanali tal-arterji l-kbar tal-moħħ, mard vaskulari periferali sever, stenosi tal-arterja renali (assoċjata ma' pressjoni għolja li taggrava, mhix stabbli jew reżistenti għal trattament), u l-ħtieġa ta' proċeduri ta' rivaskularizzazzjoni urġenti seħħew f'pazjenti kkurati b'Iclusig.
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
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: Resistant or Intolerant R/I Cohort (N=203)
Maltese: Koorti R/I (N = 203)
English: The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is completed.
Maltese: L-attività antilewkimika ta' Iclusig kienet ukoll evalwata fi studju ta' żieda dożali ta' fażi 1 li kienet tinkludi 65 pazjent b'CML u Ph+ ALL; l-istudju huwa lest.
English: The risk of arterial occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Maltese: Ir-riskju ta' avvenimenti okklussivi arterjali x'aktarx li huwa relatat mad-doża (ara sezzjonijiet 4.2 u
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: Iclusig should be interrupted immediately in case of thromboembolism.
Maltese: Iclusig għandu jitwaqqaf immedjatament f'każ ta' tromboemboliżmu.
English: Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis, hypertensive crisis, renal artery stenosis
Maltese: Mhux komuni ċirkolazzjoni periferali ħażina, infart tal-milsa, embolu fil-vini, trombożi fil-vini, kriżi ipertensiva, stenosi tal-arterja renali
English: • cough
Maltese: sawm.
English: Cohort (N=65)
Maltese: Koorti R/I (N = 65)
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 64 months, the median duration of MaHR for AP-CML (median duration of treatment: 19.4 months) BP-CML (median duration of treatment: 2.9 months), and Ph+ ALL (median duration of treatment: 2.7 months) patients was estimated as 12.9 months (range: 1.2 to 68.4 months), 6.0 months (range: 1.8 to 59.6 months), and 3.2 months (range: 1.8 to 12.8 months), respectively.
Maltese: 2.7 xhur) kien stmat bħala 12.9 xhur (firxa: 1.2 sa 68.4 xahar), 6.0 xhur (firxa: 1.8 sa 59.6 xhur), u 3.2 xhur (firxa: 1.8 sa 12.8 xhur), rispettivament.
English: Iclusig 45 mg film-coated tablets
Maltese: Iclusig 45 mg pilloli miksija b'rita
English: Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone.
Maltese: L-għoti fl-istess waqt ta' doża orali waħda ta' 15 mg ta' Iclusig fil-preżenza ta' ketoconazole (400 mg kuljum), impeditur qawwi ta' CYP3A, irriżulta f'żidiet modesti fl-espożizzjoni sistemika ta' ponatinib, b'AUC0-∞ u Cmax ma' ponatinib li kienu 78% u 47% ogħla, rispettivament, minn dawk osservati ta' meta ponatinib ġie mogħti waħdu.
English: Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 13%, 9%, and 11% of Iclusig-treated patients, respectively.
Maltese: Reazzjonijiet avversi okklussivi vaskulari fl-arterji kardjovaskulari, ċerebrovaskulari, u periferali (frekwenzi li ħarġu mal-kura) seħħew fi 13%, 9%, u 11% tal-pazjenti kkurati b'Iclusig, rispettivament.
English: Iclusig with food and drink Avoid grapefruit products such as grapefruit juice.
Maltese: Evita prodotti bil-grejpfrut bħal meraq tal-grejpfrut.
English: In CP-CML patients who achieved MCyR, the median time to MCyR was 2.8 months (range: 1.6 to 11.3 months) and in patients who achieved MMR, the median time to MMR was 5.5 months (range: 1.8 to 55.5 months).
Maltese: F'pazjenti b'CP-CML li kisbu MCyR, iż-żmien medju għal MCyR kien ta' 2.8 xhur (firxa: 1.6 sa 11.3 xhur) u f'pazjenti li kisbu MMR, iż-żmien medjan għal MMR kien ta' 5.5 xhur (firxa: 1.8 sa 55.5 xahar).
English: Uncommon cerebral artery stenosis, cerebral haemorrhage, haemorrhage intracranial, posterior reversible encephalopathy syndrome *
Maltese: Mhux komuni stenosi tal-arterja tal-moħħ, emorraġija ċerebrali, emorraġija intrakranjali, sindrome ta' enċefalopatija posterjuri riversibbli *
English: ≥ 18 month day reduction at 15 mg ≥ 24 month reduction at 15 mg 32
Maltese: ≥ 24 xahar ta' tnaqqis għal 15 mg ≥ 36 xahar ta' tnaqqis għal 15 mg
English: The 0.8 mg/kg/day dose in females resulted in a plasma exposure level generally lower or equivalent to the human exposure at the range of dose from 15 mg to 45 mg daily.
Maltese: Id-doża ta' 0.8 mg/kg/jum fin-nisa rriżultat f'livell ta' esponiment fil-plażma ġeneralment aktar baxx jew ekwivalenti għall-esponiment tal-bniedem fil-firxa ta' dożi minn 15 mg għal 45 mg kuljum.
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 5% of patients.
Maltese: Reazzjonijiet okklussivi serji fil-vini (frekwenzi li ħarġu mal-kura) seħħew f'5% tal-pazjenti.
English: In juvenile rats, mortality related to inflammatory effects was observed in animals treated with 3 mg/kg/day, and reductions in body weight gain were observed at doses of 0.75, 1.5 and 3 mg/kg/day during the pre-weaning and early post-weaning treatment phases.
Maltese: F'firien ta' età żgħira, kienet osservata mortalità relatata ma' effetti ta' infjammazzjoni f'annimali kkurati bi 3 mg/kg/jum, u kien osservat tnaqqis fiż-żieda fil-piż tal-ġisem b'dożi ta' 0.75, 1.5 u 3 mg/kg/jum matul il-fażijiet ta' kura qabel il-ftim u l-fażijiet ta' kura bikrija wara l-ftim.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Lactose Dan il-prodott mediċinali fih lactose monohydrate. pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: In the phase 2 trial, 86 CP-CML patients achieved MCyR at a dose of 45 mg, 45 CP-CML patients achieved MCyR after a dose reduction to 30 mg, mostly for adverse events.
Maltese: Fil-prova ta' fażi 2, 86 pazjent b'CP-CML kisbu MCyR b'doża ta' 45 mg, 45 pazjent b'CP-CML kisbu MCyR wara tnaqqis fid-doża għal 30 mg, il-biċċa l-kbira minħabba avvenimenti avversi.
English: Table 5 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥ 2% of patients in any disease group from the Phase 2 Trial (N=449): minimum follow-up of 64 month for all ongoing patients Laboratory test
Maltese: Inċidenza ta' abnormalitajiet tal-laboratorju klinikament rilevanti ta' Grad 3/4* f' ≥ 2% ta' pazjenti f'kull grupp ta' mard mill-prova ta' Fażi
English: Iclusig 30 mg film-coated tablets
Maltese: Iclusig 30 mg pilloli miksija b'rita
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
English: Patients should be monitored for signs or symptoms consistent with heart failure and they should be treated 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: Common musculoskeletal pain, neck pain, musculoskeletal chest pain
Maltese: Komuni uġigħ muskolu-skeletriku, uġigħ fl-għonq, uġigħ muskuloskeletriku fis-sider
English: Iclusig 15 mg film-coated tablets
Maltese: Iclusig 15 mg pilloli miksija b'rita
English: In preclinical mutagenesis studies, 40 nM was determined as the concentration of ponatinib sufficient to inhibit viability of cells expressing all tested BCR-ABL mutants by > 50% (including T315I) and suppress the emergence of mutant clones.
Maltese: Fi studji ta' mutaġenisi ta' qabel l-użu kliniku, 40 nM kien stabbilit bħala l-konċentrazzjoni ta' biżżejjed biex timpedixxi l-vijabilità ta' ċelluli li jesprimu l-mutanti BCR-ABL testjatikollha b'> 50% (li jinkludi T315I) u jrażżan il-ħruġ ta' klones mutanti.
English: Uncommon hepatotoxicity, hepatic failure, jaundice
Maltese: konġunktivitè, indeboliment fil-vista
English: Monitoring for evidence of thromboembolism should be performed.
Maltese: Għandu jkun hemm monitoraġġ għal evidenza ta' tromboemboliżmu.
English: Caution is recommended in when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min or end-stage renal disease (see section 4.2).
Maltese: Indeboliment tal-kliewi Kawtela hija rakkomandata meta jingħata Iclusig lil pazjenti bi tneħħija tal-kreatinina stmata f'< 50 mL/min jew fl-aħħar stadju ta' mard tal-kliewi (ara sezzjoni 4.2).
English: Hypertension may contribute to risk of arterial thrombotic events, including renal artery stenosis.
Maltese: Pressjoni għolja Pressjoni għolja tista' tikkontribwixxi għal riskju ta' avvenimenti trombotiċi fl-arterji, li jinkludu stenosi tal-arterja renali.