FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Iclusig in CML and Ph+ ALL patients who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy were evaluated in a single-arm, open-label, international, multicenter trial.
Maltese: Is-sigurtà u l-effikaċja tal-Iclusig fil-pazjenti b'CML u Ph+ ALL li kienu reżistenti jew intolleranti minn qabel għal terapija bl-impeditur ta' tyrosine kinase (TKI -thyrosine kinase inhibitor) kienu evalwati fi prova single-arm, bit-tikketta tidher, internazzjonali u multiċentriku.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
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, mnn dawk osservati ta' meta ponatinib ġie mogħti waħdu.
English: T315I Cohort (N=18)
Maltese: Koorti T315I (N = 18)
English: Tablet coating Talc
Maltese: Il-kisi tal-pillola Talc
English: Intolerance was defined as the discontinuation of dasatinib or nilotinib due to toxicities despite optimal management in the absence of a complete cytogenetic response for CP CML patients or major haematological response for AP CML, BP CML, or Ph+ ALL patients.
Maltese: Intolleranza kien definit bħala l-waqfien ta' dasatinib jew nilotinib minħabba tossiċitajiet minkejja l-aqwa ġestjoni fin-nuqqas ta' rispons ċitoġenetiku komplut għall-pazjenti b'CP CML jew rispons ematoloġiku maġġuri għal pazjenti b'AP CML, BP CML, jew Ph+ ALL.
English: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Maltese: • lewkimja limfoblastika akuta pożittiva għal kromosoma Philadelphia (Ph+ ALL- Philadelphia chromosome positive acute lymphoblastic leukaemia) li huma reżistenti għal dasatinib; li huma intolleranti għal dasatinib u għal dawk li għalihom kura sussegwenti b'imatinib mhix klinikament xierqa; jew għal dawk li għandhom il-mutazzjoni T315I.
English: Continue Iclusig at the same dose
Maltese: tnemnim u ħakk
English: In the phase 2 trial, arterial and venous occlusive adverse reactions have occurred in 23% of patients (treatment-emergent frequencies).
Maltese: Fil-prova ta' fażi 2, reazzjonijiet okklussivi avversi fl-arterji u l-vini seħħew fi 23% tal-pazjenti (frekwenzi li ħarġu mal-kura).
English: In the phase 2 trial, 87 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, 87 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: At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median duration of MaHR for AP-CML (median duration of treatment: 590 days) BP-CML (median duration of treatment: 89 days), and Ph+ ALL (median duration of treatment: 81 days) patients was estimated as 13.1 months (range: 1.2 to 35.8+ months), 6.1 months (range: 1.8 to 31.8+ months), and 3.3 months (range: 1.8 to 13.0 months), respectively.
Maltese: 89 jum), u Ph+ ALL (tul medjan tal-kura: 81 jum) kien stmat bħala 13.1 xhur (firxa: 1.2 sa 35.8+ xhur), 6.1 xhur (firxa: 1.8 sa 31.8+ xhur), u 3.3 xhur (firxa: 1.8 sa 13.0-il xahar),
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: 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: Patients were assigned to one of six cohorts based on disease phase (CP-CML; AP-CML; or BP-CML/Ph+ ALL), resistance or intolerance (R/I) to dasatinib or nilotinib, and the presence of the T315I mutation.
Maltese: Il-pazjenti kienu assenjati għal wieħed mis-sitt gruppi ta' koorti bbażati fuq il-fażi tal-marda (CP-CML; AP-CML, jew BP-CML/Ph + ALL), reżistenza jew intolleranza (R/I) għal dasatinib jew nilotinib, u l-preżenza tal-mutazzjoni T315I.
English: Available pharmacodynamic and toxicological data cannot exclude potential excretion in human milk.
Maltese: Id-dejta farmakodinamika u tossikoloġika disponibbli ma tistax teskludi l-eliminazzjoni potenzjali fil-ħalib uman.
English: Of the CP-CML patients with no mutation detected at entry, 46% (63/136) achieved a MCyR.
Maltese: Mill-pazjenti b'CP-CML mingħajr mutazzjoni osservata mad-dħul, 46% (63/136) kisbu MCyR.
English: Venous occlusive reactions (treatment-emergent frequencies) occurred in 5.0% of patients.
Maltese: Reazzjonijiet okklussivi fil-vini (frekwenzi li ħarġu mal-kura) seħħew f'5.0% talpazjenti.
English: OUTER CARTON AND BOTTLE LABEL
Maltese: KARTUNA TA' BARRA U TIKKETTA TAL-FLIXKUN
English: However, a thorough QT study has not been performed; therefore a clinically significant effect on QT cannot be excluded.
Maltese: Madankollu, studju komprensiv tal-QT ma twettaqx; għalhekk effett klinikament sinifikanti fuq QT ma jistax jiġi eskluż.
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: Kawtela hija rakkomandata meta jingħata Iclusig lil pazjenti bi tneħħija tal-kreatinina stmata f'< 50 mL/min jew fl-aħħar stadju ta' mard renali (ara sezzjoni 4.2).
English: How to take Iclusig
Maltese: X'fih Iclusig
English: b Measured in peripheral blood.
Maltese: b Imkejjel b'demm periferali.
English: If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2).
Maltese: Jekk livelli ogħla ta' lipase jkunu akkumpanjati minn sintomi addominali, Iclusig għandu jitwaqqaf u l-pazjenti għandhom jiġu evalwati għal evidenza ta' pankreatite (ara sezzjoni 4.2).
English: • a heart rhythm disorder, abnormal pulse
Maltese: • disturb fir-ritmu tal-qalb, polz mhux normali
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: In cynomolgus monkeys, thyroid gland follicular atrophy mostly accompanied by a reduction in T3 levels and a tendency toward increased TSH levels were observed in the 4-week repeat-dose toxicity study in cynomolgus monkeys.
Maltese: Fix-xadini ċinomolgus, atrofija follikulari tal-glandola tat-tirojdi kienet akkumpanjata bi tnaqqis fil-livelli ta' T3 u tendenza lejn żieda fil-livelli ta' TSH kienet osservata fl-istudju ta' 4 ġimgħat dwar it-tossiċità minn dożi ripetuti f'xadini ċinomolgus.
English: Iclusig should not be used in patients with a history of myocardial infarction, prior revascularization or stroke, unless the potential benefit of treatment outweighs the potential risk (see sections 4.2 and 4.8).
Maltese: Iclusig m'għandux jintuża f'pazjenti b'passat ta' infart mijokardijaku, vaskularizzazzjoni mill-ġdid preċedenti jew puplesija, sakemm il-benefiċċju potenzjali tal-kura ma jkunx akbar mir-riskju potenzjali (ara sezzjonijiet 4.2 u 4.8).
English: The blood/plasma ratio of ponatinib is 0.96.
Maltese: Il-proporzjon ta' demm/plażma ta' ponatinib huwa ta' 0.96.
English: B. PACKAGE LEAFLET
Maltese: Tabella 6
English: In CP-CML patients who achieved MCyR, the median time to MCyR was 84 days (range: 49 to 334 days) and in patients who achieved MMR, the median time to MMR was 167 days (range: 55 to 421 days).
Maltese: F'pazjenti b'CP-CML li kisbu MCyR, iż-żmien medju għal MCyR kien ta' 84 jum (firxa: 49 sa 334 jum) u f'pazjenti li kisbu MMR, iż-żmien medjan għal MMR kien ta' 167 jum (firxa: 55 sa 421 jum).
English: T315I Cohort (N=24)
Maltese: Koorti T315I (N = 24)
English: T315I Cohort (N=22)
Maltese: Koorti T315I (N=22)
English: If a dose reduction is considered, the following factors should be to taken into account in the individual benefit-risk 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: Jekk jiġi kkunsidrat tnaqqis fid-doża, il-fatturi li ġejjin għandhom jiġu kkunsidrati fil-valutazzjoni tal-benefiċċju u r-riskju individwali: riskju kardjovaskulari, effetti sekondarji tat-terapija ta' ponatinib, ħin sa rispons ċitoġenetiku, u l-livelli tat-traskrizzjoni ta' BCRABL (ara sezzjonijiet 4.4 u 5.1).
English: Uncommon myocardial ischemia, acute coronary syndrome, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction, atrial flutter
Maltese: Mhux komuni iskemija mijokardijaka, sindrome tal-koronarji akut, skumdità fil-qalb, kardjomijopatija iskemika, spażmi fl-arterji koronarji, disfunzjoni tal-ventrikolu tax-xellug, taħbit mhux normali tal-qalb ikkawżat mill-atriju
English: • Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): a type of leukaemia involving too many immature white blood cells in the blood and blood forming bone marrow.
Maltese: • lewkimja limfoblastika akuta pożittiva għal kromosoma Philadelphia (Ph+ ALL - Philadelphia chromosome positive acute lymphoblastic leukaemia): tip ta' lewkimja li tinvolvi ammont għoli ta' ċelluli bojod immaturi tad-demm fid-demm u fil-mudullum fejn jiġi ffurmat id-demm.
English: An integrated population pharmacokinetic analysis completed for ponatinib suggests that age may be predictive of variability for ponatinib apparent oral clearance (CL/F).
Maltese: Analiżi integrata tal-farmakokinetika tal-popolazzjoni li ntemmet għal ponatinib tissuġġerixxi li l-età tista' tbassar il-varjabilità tat-tneħħija orali apparenti (CL/F) ta' ponatinib.
English: • methotrexate: a medicine to treat severe joint inflammation (rheumatoid arthritis), cancer and the skin disease psoriasis.
Maltese: • methotrexate: mediċina għall-kura ta' infjammazzjoni severa tal-ġogi (artrite rewmatika),
English: Other medicines and Iclusig
Maltese: Mediċini oħra u Iclusig
English: The secondary efficacy endpoints in CPCML 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: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients.
Maltese: Reazzjonijiet okklussivi serji fil-vini (frekwenzi li ħarġu mal-kura) seħħew f'4.5% talpazjenti.
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: Il-frekwenza ta' dawn il-każijiet huwa akbar f'pazjenti b'CML fil-fażi aċċellerata (AP-CML) jew CML fil-fażi blast (BP-CML)/Ph+ ALL milli fil-fażi kronika ta' CML (CP-CML).
English: Ponatinib Cmax was comparable in patients with mild hepatic impairment and healthy volunteers with normal hepatic function.
Maltese: Cmax ta' Ponatinib kienet komparabbli f'pazjenti b'indeboliment epatiku ħafif u f'voluntiera f'saħħithom b'funzjoni epatika normali.
English: In rats, inflammatory changes accompanied by increases in neutrophils, monocytes, eosinophils, and fibrinogen levels were found in the preputial and clitoral glands following chronic dosing.
Maltese: Fil-firien, bidliet infjammatorji kienu akkumpanjati b'żidiet fin-newtrofili, monoċiti, esinofili, u livelli ta' fibrinogen instabu fil-glandoli preputijali u klitoali wara teħid ta' dożi kroniċi.
English: A benefit -risk consideration should guide a decision to restart Iclusig therapy (see sections 4.2 and 4.8).
Maltese: Konsiderazzjoni tal-benefiċċju u r-riskju għandu jiggwida d-deċiżjoni biex terġa' tinbeda t-terapija ta' Iclusig (ara sezzjonijiet 4.2 u 4.8).
English: Each 45 mg film-coated tablet contains 45 mg ponatinib (as ponatinib hydrochloride).
Maltese: Kull pillola miksija b'rita ta' 45 mg fiha 45 mg ponatinib (bħala ponatinib hydrochloride).
English: In the phase 2 trial, serious arterial and venous occlusive adverse reactions occurred in 18% of patients (treatment-emergent frequencies).
Maltese: Fil-prova ta' fażi 2, reazzjonijiet okklussivi avversi serji fl-arterji u l-vini seħħew fi 18% tal-pazjenti (frekwenzi li ħarġu mal-kura).
English: The safety and efficacy of Iclusig in patients less than 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Iclusig f'pazjenti b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Depletion of lymphoid organs was observed in repeat-dose toxicity studies in rats and cynomolgus monkeys.
Maltese: Tnaqqis tal-organi limfojdi ġie osservat fi studji ta' dożi ripetuti fil-firien u xandini ċinomolgus.
English: Common side effects (affects 1 to 10 users in 100):
Maltese: Effetti sekondarji komuni (jaffettwaw utent wieħed sa 10 minn kull 100):
English: Co-administration of a single 45 mg dose of Iclusig in the presence of rifampin (600 mg daily), a strong CYP3A inducer, to 19 healthy volunteers, decreased the AUC0-∞ and Cmax of ponatinib by 62% and 42%, respectively, when compared to administration of ponatinib alone.
Maltese: Għoti fl-istess waqt ta' doża waħda ta' 45 mg ta' Iclusig fil-preżenza ta' rifampin (600 mg kuljum), induttur qawwi ta' CYP3A, lil 19-il voluntier f'saħħithom, naqqas l-AUC0-∞ u Cmax ta' ponatinib b'62% u 42%, rispettivament, meta mqabbel mal-għoti ta' ponatinib waħdu.
English: cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Maltese: (1% sa 35% ċelluli ta' Ph+).
English: The risk of vascular occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Maltese: Ir-riskju ta' avvenimenti okklussivi vaskulari x'aktarx li huwa relatat mad-doża (ara sezzjonijiet 4.2 u
English: Potassium increased
Maltese: Potassium imnaqqas
English: Dose reduction in CP-CML patients
Maltese: Tnaqqis fid-doża f'pazjenti b'CP-CML
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: • uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris)
Maltese: • pressjoni skomda, tħossok mimli, għafis jew uġigħ fiċ-ċentru tas-sider (Anġina pectoris)
English: Microcrystalline cellulose
Maltese: Potassium ogħla
English: Disposal:
Maltese: Immaniġġar:
English: Uncommon retinal vein thrombosis, retinal vein occlusion, retinal artery occlusion, visual impairment
Maltese: Mhux komuni trombożi fil-vina tar-retina, okklużjoni tal-vina tar-retina, okklużjoni tal-arterja tar-retina, indeboliment fil-vista
English: Concomitant use of ponatinib with anti-clotting agents should be approached with caution in patients who may be at risk of bleeding events (see “Myelosuppression” and “Haemorrhage”).
Maltese: L-użu ta' ponatinib flimkien ma' sustanzi kontra t-tagħqid tad-demm għandu jsir b'kawtela f'pazjenti li jistgħu jkunu f'riskju ta' avvenimenti ta' fsada (ara “Majelosoppressjoni” u “Emorraġija”).
English: Uncommon hepatotoxicity, jaundice
Maltese: Komuni ħafna raxx, ġilda xotta
English: A single dose of 30 mg ponatinib was administered to patients with mild, moderate, or severe hepatic impairment and to healthy volunteers with normal hepatic function.
Maltese: Doża waħda ta' 30 mg ponatinib ingħatat lil pazjenti b'indeboliment epatiku ħafif, moderat jew sever u lil voluntiera f'saħħithom b'funzjoni epatika normali.
English: Iclusig with food and drink Avoid grapefruit products such as grapefruit juice.
Maltese: Iclusig ma' ikel u xorb Evita prodotti bil-grejpfrut bħal meraq tal-grejpfrut.
English: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
Maltese: • lewkimja mjelojda kronika (CML - Chronic Myeloid Leukaemia) fil-fażi kronika, fażi aċċellerata, jew fażi blast li huma reżistenti għal dasatinib jew nilotinib; li huma intolleranti għal dasatinib jew nilotinib, u għal dawk li għalihom kura sussegwenti b'imatinib mhix klinikament xierqa; jew għal dawk li għandhom il-mutazzjoni T315I.
English: Uncommon side effects (affects 1 to 10 users in 1,000):
Maltese: Effetti sekondarji mhux komuni (jaffettwaw utent wieħed sa 10 minn kull 1,000):
English: Fatal and serious heart failure or left ventricular dysfunction occurred in Iclusig-treated patients, including events related to prior vascular occlusive events.
Maltese: Insuffiċjenza tal-qalb fatali u serja jew disfunzjoni tal-ventriklu tax-xellug seħħew f'pazjenti kkurati b'Iclusig, inklużi avvenimenti marbuta ma' avvenimenti okklussivi vaskulari preċedenti.
English: Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled (see section 4.2).
Maltese: Kura b'Iclusig għandha titwaqqaf temporanjament jekk il-pressjoni għolja ma tkunx ikkontrollata bil-mediċini (ara sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets Ponatinib
Maltese: Iclusig 45 mg pilloli miksija b'rita Ponatinib
English: Overall, the most common adverse reactions (≥20%) were platelet count decreased, rash, dry skin, and abdominal pain.
Maltese: B'mod ġenerali, l-aktar reazzjonijiet avversi komuni kienu tnaqqis fl-għadd ta' plejtlits (≥ 20%), raxx, ġilda xotta, u uġigħ addominali.
English: Unchanged ponatinib accounted for 24% and <1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Maltese: Ponatib mhux mibdul kien jgħodd għal 24% u < 1% tad-doża amministrata fl-ippurgar u l-awrina rispettivament, bil-kumplament tad-doża tikkomprendi metaboliti.
English: Table 9 Vascular Occlusive First Adverse Events in CP-CML Patients who Achieved MCyR at 45 mg or 30 mg (data extraction 7 April 2014) Most Recent Dose at Onset of First Vascular Occlusive Event
Maltese: Vaskulari f'Pazjenti b'CP-CML li Kisbu MCyR b'45 mg jew 30 mg (estrazzjoni tad-dejta 7 ta' April 2014)
English: Iclusig belongs to a group of medicines called tyrosine kinase inhibitors.
Maltese: Iclusig jappartjeni għal grupp ta' mediċini li jissejħu impedituri ta' tyrosine kinase.
English: Very common hypertension
Maltese: GĦAMLA KWALITATTIVA
English: Efficacy results are summarized in Table 6, Table 7, and Table 8.
Maltese: Ir-riżultati tal-effikaċja huma miġbura fil-qosor f'Tabella 6, Tabella 7 u Tabella 8.
English: Very common insomnia
Maltese: Komuni impotenza
English: Resistance in AP-CML and BP-CML/Ph+ ALL was defined as failure to achieve either a major haematological response (AP-CML by 3 months, BP-CML/Ph+ ALL by 1 month), loss of major haematological response (at any time), or development of kinase domain mutation in the absence of a major haematological response while on dasatinib or nilotinib.
Maltese: Reżistenza f'AP-CML u BP -CML/Ph+ ALL kien definit bħala nuqqas li jinkiseb jew rispons ematoloġiku maġġuri (AP-CML sa 3 xhur, BP-CML/Ph+ ALL sa xahar), telf ta' rispons ematoloġiku maġġuri (fi kwalunkwe ħin), jew l-iżvilupp ta' mutazzjoni ta' dominju ta' kinase fin-nuqqas ta' rispons ematoloġiku maġġuri waqt it-teħid ta' dasatinib jew nilotinib.
English: Vascular occlusive adverse events were more frequent with increasing age and in patients with prior history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Maltese: Avvenimenti avversi ta' okklużjoni vaskulari kienu aktar frekwenti b'żieda fl-età u f'pazjenti bi storja preċedenti ta' iskemija, pressjoni għolja, dijabete, jew iperlipidemija.
English: How to store Iclusig
Maltese: Jekk tieqaf tieħu Iclusig
English: Each 15 mg film-coated tablet contains 15 mg ponatinib (as ponatinib hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 15 mg ponatinib (bħala hydrochloride).
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: Barra minn hekk, il-mudelli farmakodinamiċi-farmakokinetiċi ma juru l-ebda rabta bejn espożizzjoni-effett, 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: Caution is recommended when administering Iclusig to patients with severe hepatic impairment (see section 5.2).
Maltese: Kawtela hija rakkomandata meta Iclusig jingħata lil pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 5.2).
English: Do not pass it on to others.
Maltese: Komuni ħafna nuqqas ta' rqad
English: NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets Ponatinib
Maltese: Iclusig 15 mg pilloli miksija b'rita Ponatinib
English: Age Median, years (range) Gender, n (%) Male Race, n (%) Asian Black/African American White Other ECOG Performance Status, n (%) ECOG=0 or 1 Disease History Median time from diagnosis to first dose, years (range) Resistant to Prior TKI Therapy*, n (%) Prior TKI therapy- number of regimens, n (%)
Maltese: Iż-żmien medjan mid-dijanjosi sal-ewwel doża, snin (firxa) Reżistenti għal Terapija minn Qabel b'TKI Therapy*, n (%) Terapija minn Qabel b'TKI-numru ta' programmi ta' kura, n (%)
English: • Withhold Iclusig and resume at 15 mg after recovery to ≤ Grade 1
Maltese: • Waqqaf Iclusig u erġa' ibda bi 15 mg wara l-irkupru għal
English: • Withhold Iclusig and resume at 30 mg after recovery to ≤ Grade 1
Maltese: • Waqqaf Iclusig u erġa' ibda bi 30 mg wara l-irkupru għal
English: Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth
Maltese: Komuni pankreatite, żieda fl-amylase fid-demm, mard ta' rifluss gastroesofagali, stomatite, dispepsja, nefħa addominali, skonfort addominali, ħalq xott
English: • Consider discontinuing Iclusig
Maltese: • Ikkonsidra li twaqqaf Iclusig
English: Serious side effects (common: affects 1 to 10 users in 100):
Maltese: Effetti sekondarji serji (komuni jaffettwaw utent wieħed sa 10 minn kull 100):
English: • a history of alcohol abuse
Maltese: • storja ta' abbuż ta' alkoħol
English: Uncommon tumour lysis syndrome
Maltese: Sindrome tal-lisi tat-tumur
English: In this kind of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, the Philadelphia chromosome.
Maltese: F'din it-tip ta' lewkimja, parti mid-DNA (materjal ġenetiku) ġie irranġat mill-ġdid biex jifforma kromosoma anormali, il-kromosoma Philadelphia.
English: Very common fatigue, asthenia, oedema peripheral, pyrexia, pain
Maltese: Komuni ħafna għeja, astenja, edima periferali, deni, uġigħ