FrancophonIA/ELRC3.0 huggingface dataset:
English: Among newly diagnosed patients, the percentage of patients who achieved MR4.0 was 32%, while 28.0% achieved MR4.5.
Maltese: Fost il-pazjenti li għadhom kif ġew iddijanjonizzati, il-perċentwali ta' pazjenti li kisbu MR4.0 kienet ta' 32%, filwaqt li 28.0% kisbu MR4.5.
English: Laboratory abnormalities of mild to moderate transient elevations of aminotransferases and total bilirubin have been observed in children at a higher frequency than in adults, indicating a higher risk of hepatotoxicity in the paediatric population (see section 4.8).
Maltese: Kienu osservati fil-laboratorju żidiet mhux normali minn ħfief sa moderati fl-amminotransferasi u l-ammont tal-bilirubin fit-tfal bi frekwenza ogħla milli fl-adulti, li jindika riskju ogħla ta' epatotossiċità fil-popolazzjoni pedjatrika (ara sezzjoni 4.8).
English: CARTON OF MULTIPACK (WALLET) (INCLUDING BLUE BOX) CARTON OF MULTIPACK (CARTON) (INCLUDING BLUE BOX)
Maltese: IL-KAXXA L-BLU) KARTUNA TAL-PAKKETT B'ĦAFNA (KAXXA TAL-KARTUN) (INKLUŻ
English: Of the patients who achieved CCyR, 85% (95% CI: 78% - 93%) were maintaining response at 24 months.
Maltese: Mill-pazjenti li kisbu CCyR, 85% (95% CI: 78% - 93%) kien għad kellhom ir-rispons fl-24 xahar.
English: The estimated rates of patients alive at 72 months were 91.6%, 95.8% and 91.4%, respectively (HR=0.8934 and stratified log-rank p=0.7085 between nilotinib 300 mg twice daily and imatinib, HR=0.4632 and stratified log-rank p=0.0314 between nilotinib 400 mg twice daily and imatinib).
Maltese: 8% u 91.4%, rispettivament (HR=0.8934 u log-rank stratifikat ta' p=0.7085 bejn 300 mg nilotinib darbtejn kuljum u imatinib, HR=0.4632 u log-rank stratifikat ta' p=0.0314 bejn 400 mg nilotinib darbtejn kuljum u imatinib).
English: The primary endpoint in the CP patients was major cytogenetic response (MCyR), defined as elimination (CCyR, complete cytogenetic response) or significant reduction to <35% Ph+ metaphases (partial cytogenetic response) of Ph+ haematopoietic cells.
Maltese: Ir-riżultat ewlieni f'pazjenti CP kien rispons ċitoġenetiku maġġuri (McyR), definit bħala it-tneħħija (CcyR, rispons ċitoġenetiku komplet) jew tnaqqis sinifikanti għal <35% Ph+ metafażi (rispons ċitoġenetiku parzjali) taċ-ċelluli impoietiċi Ph+.
English: The hard capsule shell is composed of gelatin, titanium dioxide (E171), red and yellow iron oxide (E172) and, shellac, black iron oxide (E172), n-butyl alcohol, propylene glycol, dehydrated ethanol, isopropylalcohol and ammoniumhydroxide for stamping of the imprint.
Maltese: Il-qoxra tal-kapsula iebsa hija magħmula minn gelatin, titanium dioxide (E171), red jew yellow iron oxide (E172) u, shellac, black iron oxide (E172), n-butyl alcohol, propylene glycol, dehydrated ethanol, isopropylalcohol u ammoniumhydroxide għat-timbrar tat-timbru.
English: The MMR rate at 12 months was statistically significantly higher for nilotinib 300 mg twice daily compared to imatinib 400 mg once daily (44.3% versus 22.3%, p<0.0001).
Maltese: Ir-rata tal-MMR fi żmien 12-il xahar kienet statistikament ogħla sew fil-każ ta' 300 mg nilotinib darbtejn kuljum meta mqabbel ma' 400 mg imatinib darba kuljum (44.3% kontra 22.3%, p<0.0001).
English: Including clonal evolution as a criterion for progression, a total of 25 patients progressed to accelerated phase or blast crisis on treatment by the cut-off date (3 in the nilotinib 300 mg twice daily group, 5 in the nilotinib 400 mg twice daily group and 17 in the imatinib 400 mg once daily group).
Maltese: Wara li fost il-kriterji ta' progress kienet inkluża l-evoluzzjoni klonali, total ta' 25 pazjent ipprogressaw għall-fażi aċċellerata jew kriżi blastika fit-trattament sad-data ta' interruzzjoni (3 fil-grupp mogħti 300 mg nilotinib darbtejn kuljum, 5 fil-grupp mogħti 400 mg nilotinib darbtejn kuljum u 17 fil-grupp mogħti 400 mg imatinib darba kuljum).
English: Night sweats, eczema, urticaria, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform)
Maltese: Tegħreq ħafna matul il-lejl, ekżema, urtikarja, iperidrożi, tbenġil, akne, dermatite (inkluż allerġika, eksfoljattiva u akneiforma)
English: Nilotinib should be used with caution in patients who have or may develop prolongation of the QT interval, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, haloperidol, methadone and moxifloxacin (see section 4.4).
Maltese: Nilotinib għandu jintuża b'attenzjoni f'pazjenti li jkollhom jew ikunu jistgħu jiżviluppaw titwil tal-intervall QT inklużi dawk il-pazjenti li jkunu qed jieħdu prodotti mediċinali kontra l-arritmiji bħal amiodarone, disopyramide, procainamide, quinidine u sotalol jew prodotti mediċinali oħra li jistgħu jtawlu l-QT bħal chloroquine, halofantrine, clarithromycin, haloperidol, methadone u moxifloxacin (ara sezzjoni 4.4).
English: Cumulative incidence of MR4.5 (BCR-ABL ≤0.0032% on the nternational scale), %
Maltese: Inċidenza kumulattiva ta' MR4.5 (BCR-ABL ≤0.0032% fuq l-iskala Internazzjonali), %
English: Eligible patients who are confirmed to express the typical BCR-ABL transcripts, e13a2/b2a2 or e14a2/b3a2, can be considered for treatment discontinuation.
Maltese: Eliġibilità għat-twaqqif għal kollox tat-trattament Pazjenti eliġibbli li huma kkonfermati li jesprimu t-traskritti tipiċi ta' BCR--ABL, e13a2/b2a2 jew e14a2/b3a2, jistgħu jitqiesu għat-twaqqif għal kollox tat-trattament.
English: Pneumonia, urinary tract infection, gastroenteritis, bronchitis, herpes virus infection, candidiasis (including oral candidiasis)
Maltese: Pulmonite, infezzjoni tal-passaġġ tal-awrina, gastro-enterite, bronkite, infezzjoni bil-virus tal-erpete, kandidijażi (inkluż kandidijażi orali)
English: Tasigna 50 mg hard capsules
Maltese: Tasigna 50 mg kapsuli iebsa
English: Hyperparathyroidism secondary, thyroiditis Metabolism and nutrition disorders Very common:
Maltese: Iperparatirojdiżmu sekondarju, tirojdite Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna:
English: Separate treatment arms were also included in the Phase II study to investigate Tasigna in a group of CP and AP patients who had been extensively pre-treated with multiple therapies including a tyrosine kinase inhibitor agent in addition to imatinib.
Maltese: II sabiex jiġi investigat Tasigna fi grupp ta' pazjenti CP u pazjenti AP li qabel kienu ġew ikkurati b'mod estensiv b'ħafna terapiji inkluż l-inibitur ta' tyrosine kinase flimkien ma' imatinib.
English: Available toxicological data in animals have shown excretion of nilotinib in milk (see section 5.3).
Maltese: Dejta tossikoloġika disponibbli fl-annimali uriet li kien hemm eliminazzjoni ta' nilotinib fil-ħalib tas-sider (ara sezzjoni 5.3).
English: Erythema multiforme, erythema nodosum, skin ulcer, palmar-plantar erythrodysaesthesia syndrome, petechiae, photosensitivity, blister, dermal cysts, sebaceous hyperplasia, skin atrophy, skin discolouration, skin exfoliation, skin hyperpigmentation, skin hypertrophy, hyperkeratosis, psoriasis
Maltese: Eritima multiforma, erythema nodosum, ulċera tal-ġilda, sindrome ta' palmar-plantar eritrodisastesija, petechiae, sensittività għad-dawl, nuffata, ċesti fil-ġilda, iperplasija sebaċea, atrofija tal-ġilda, il-ġilda titlef il-kulur, il-ġilda ssir qxur qxur, iperpigmentazzjoni tal-ġilda, ipertrofija tal-ġilda, iperkeratosi, psorjasi
English: In a Phase II clinical study with newly diagnosed adult patients with Ph+ CML in chronic phase (N=190), musculoskeletal symptoms were reported within a year of Tasigna discontinuation in 24.7% versus 16.3% within the previous year on nilotinib treatment.
Maltese: Waqt studju kliniku f'Fażi II fost pazjenti adulti b'dijanjosi ġdida ta' CML fil-fażi kronika b'Ph+ (N=190), is-sintomi muskoluskeletriċi kienu rrappurtati fi żmien sena mit-twaqqif għal kollox ta' Tasigna f'24.7% kontra s-16.3% fis-sena ta' qabel waqt li kienu qed jingħataw trattament b'nilotinib.
English: Detailed information on this medicine is available on the European Medicines Agency web site: 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: Tasigna 200 mg hard capsules nilotinib
Maltese: Tasigna 200 mg kapsuli ibsin nilotinib
English: A red imprint is stamped on each hard capsule (“NVR/TKI”).
Maltese: Timbru aħmar huwa stampat fuq kull kapsula iebsa (“NVR/TKI”).
English: In the 26-week Tg.rasH2 mouse carcinogenicity study, in which nilotinib was administered at 30, 100 and 300 mg/kg/day, skin papillomas/carcinomas were detected at 300 mg/kg, representing approximately 30 to 40 times (based on AUC) the human exposure at the maximum approved dose of 800 mg/day (administered as 400 mg twice daily).
Maltese: Tg.rasH2 li dam għaddej 26 ġimgħa, li fih nilotinib ingħata f'dożi ta' 30, 100 u 300 mg/kg/kuljum, dehru papillomi/karċinomi fil-ġilda meta ngħataw 300 mg/kuljum, li jirrappreżentaw madwar 30 sa 40 darba (skond l-AUC) l-espożizzjoni fil-bniedem tad-doża massima approvata ta' 800 mg/kuljum (mogħtija bħala 400 mg darbtejn kuljum).
English: Alopecia, muscle spasms, decreased appetite, arthralgia, abdominal pain, bone pain, peripheral oedema, asthenia, upper abdominal pain, dry skin, erythema and pain in extremity were observed less commonly (<10% and ≥5%) and have been of mild to moderate severity (Grade 1 or 2).
Maltese: Stitikezza, ġilda xotta, astejna, spażmi fil-muskoli, dijarea, artralġja, uġigħ addominali, rimettar u edima periferali dehru b'mod anqas komuni (<10% u ≥ 5%), kienu ħfief jew moderati fis-severità tagħhom, maneġibbli u ġeneralment ma kenux jeħtieġu tnaqqis tad-doża.
English: 120 (3 packs of 40) hard capsules.
Maltese: 120 kapsula iebsa (3 pakketti ta' 40).
English: 9/l and/or platelets >50 x 10 9/l.
Maltese: 9/l u/jew għadd tal-plejtlits <50 x 10 9/l
English: Muscle spasms
Maltese: Mewt zoptu
English: 392 (14 packs of 28) hard capsules.
Maltese: 392 kapsula iebsa (14-il pakkett ta' 28).
English: Skin papilloma
Maltese: Popolazzjoni pedjatrika
English: 2 Very common
Maltese: 2 Komuni ħafna
English: Lipid profiles should be determined prior to initiating nilotinib therapy, assessed at month 3 and 6 after initiating therapy and at least yearly during chronic therapy.
Maltese: Il-profili tal-lipidi għandhom ikunu determinati sabiex tinbeda t-terapija b'nilotinib, evalwati f'xahar 3 u 6 wara l-bidu tat-terapija u mill-inqas kull sena matul terapija kronika.
English: Herpes virus infection, oral candidiasis, subcutaneous abscess, anal abscess, tinea pedis, hepatitis B reactivation Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Maltese: Infezzjoni bil-virus tal-erpete, kandidijażi orali, axxess taħt il-ġilda, axxess anali, fungu fis-saqajn, riattivazzjoni tal-epatite B Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Komuni:
English: A total of 69 paediatric patients (from 2 to <18 years of age) with either newly diagnosed Ph+ CML in chronic phase (n=25) or imatinib/dasatinib resistant or imatinib-intolerant Ph+ CML in chronic phase (n=44) received nilotinib treatment at a dose of 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg).
Maltese: Total ta' 69 pazjent pedjatriku (minn sentejn sa <18-il sena) li għadhom kif ġew iddijanjonizzati b'Ph+ b'CML fil-fażi kronika (n=25) jew b'Ph+ b'CML fil-fażi kronika reżistenti għal imatinib/disatinib jew intolleranti għal imatinib (n=44) mogħtija trattament b'nilotinib f'doża ta' 230 mg/m darbtejn kuljum, imdawra għall-eqreb doża ta' 50 mg (sa doża waħda massima ta'
English: Erythema, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform), night sweats, eczema
Maltese: Eritema, iperidrożi, tbenġil, akne, dermatite (inkluż allerġika, eksfoljattiva u akneiforma), togħroq ħafna matul il-lejl, ekżema
English: Based on Kaplan-Meier estimates, the proportions of patients who were maintaining response for 72 months among patients who achieved CCyR were 99.1% (95% CI: 97.9-100%) in the nilotinib 300 mg twice daily group, 98.7% (95% CI: 97.1-100%) in the nilotinib 400 mg twice daily group and 97.0% (95% CI: 94.7-99.4%) in the imatinib 400 mg once daily group.
Maltese: Imsejsa fuq l-istimi ta' Kaplan-Meier, il-proporzjonijiet ta' pazjenti li baqgħu juru reazzjoni għal 72 xahar fost pazjenti li laħqu CcyR kienu 99.1% (95% CI: 97.9-100%) mill-grupp mogħti 300 mg nilotinib darbtejn kuljum, 98.7% (95% CI: 97.
English: Tasigna 150 mg hard capsules nilotinib
Maltese: Tasigna 150 mg kapsuli ibsin nilotinib
English: Hyperkalaemia, dyslipidaemia, gout
Maltese: Iperkalimja, dislipidemija, gotta
English: A total of 322 (38.1%) of all patients were not evaluable for MMR at 60 months (99 in the nilotinib 300 mg twice daily group, 93 in the nilotinib 400 mg twice daily group and 130 in the imatinib group) due to missing/unevaluable PCR assessments (n=9), atypical transcripts at baseline (n=8) or discontinuation prior to the 60-month time point (n=305).
Maltese: Total ta' 322 (38.1%) tal-pazjenti kollha ma setgħux ikunu evalwati għal MMR fis-60 xahar (99 fil-grupp mogħti 300 mg nilotinib darbtejn kuljum, 93 fil-grupp mogħti 400 mg imatinib darbtejn kuljum u 130 fil-grupp mogħti imatinib) minħabba nuqqas ta' evalwazzjonijiet tal-PCR (n=9), traskrizzjonijiet atipiċi fil-linja bażi (n=8), jew twaqqif qabel il-perjodu ta' 60 xahar (n=305).
English: A total of 55 patients died during treatment or during the follow-up after discontinuation of treatment (21 in the nilotinib 300 mg twice daily group, 11 in the nilotinib 400 mg twice daily group and 23 in the imatinib 400 mg once daily group).
Maltese: Total ta' 55 pazjent mietu matul it-trattament jew wara li twaqqaf it-trattament (21 fil-grupp mogħti 300 mg nilotinib darbtejn kuljum, 11 fil-grupp mogħti 400 mg nilotinib darbtejn kuljum u 23 fil-grupp mogħti 400 mg imatinib darba kuljum).
English: Dizziness, hypoaesthesia, peripheral neuropathy
Maltese: Sturdament, ipoesteżija, newropatija periferali
English: Papilloedema, chorioretinopathy, diplopia, photophobia, eye swelling, blepharitis, eye pain, conjunctivitis allergic, ocular surface disease Ear and labyrinth disorders Common:
Maltese: Papilloedema, korjoretinopatija, diplopja, fotofobija, għajnejn minfuħin, blefarite, uġigħ fl-għajnejn, konġunktivite allerġika, mard fuq barra tal-għajn Disturbi fil-widnejn u fis-sistema labirintika Komuni:
English: A black imprint is stamped on each hard capsule (“NVR/BCR”).
Maltese: Timbru iswed huwa stampat fuq kull kapsula iebsa (“NVR/BCR”).
English: Leukopenia, eosinophilia, febrile neutropenia, pancytopenia, lymphopenia
Maltese: Lewkopenija, eosinofilija, newtropenja bid-deni, panċitopenja, limfopenija
English: PVC/PVDC/Alu [in carton] 120 hard capsules
Maltese: PVC/PVDC/Alu [f'kaxxa tal-kartun] 120 kapsula iebsa
English: The median TFS has not yet been reached (Figure 5); 74 of 126 patients (58.7%) did not have a TFS event.
Maltese: Il-medja tat-TFS għadha ma ntlaħqitx (Figura 5); 74 tal-126 pazjent (58.7%) ma kellhomx episodju ta' TFS.
English: In the same study as above, administration of an antacid (aluminium hydroxide/magnesium hydroxide/simethicone) 2 hours before or after a single 400 mg dose of nilotinib also did not alter nilotinib pharmacokinetics.
Maltese: Fl-istess studju t'hawn fuq, l-għoti ta' antaċidu (aluminium hydroxide/magnesium hydroxide/simethicone) sagħtejn qabel jew wara doża waħda ta' 400 mg ta' nilotinib ukoll ma biddilx il-farmakokinetika ta' nilotinib.
English: As a result, the systemic exposure of other medicinal products primarily metabolised by CYP3A4 (e.g. certain HMG-CoA reductase inhibitors) may be increased when co-administered with nilotinib.
Maltese: Bħala riżultat, l-esponiment sistemiku għal prodotti mediċinali oħra metabolizzati primarjament minn CYP3A4 (eż., ċerti inibituri ta' HMG CoA reductase) jista' jiżdied meta jingħataw flimkien ma' nilotinib.
English: 88.6-96.4%) in the nilotinib 300 mg twice daily group, 92.2% (95% CI: 88.5-95.9%) in the nilotinib 400 mg twice daily group and 88.0% (95% CI: 83.0-93.1%) in the imatinib 400 mg once daily group.
Maltese: Imsejsa fuq l-istimi ta' Kaplan-Meier tat-tul tal-ewwel MMR, il-proporzjonijiet ta' pazjenti li baqgħu juru reazzjoni għal 72 xahar fost pazjenti li laħqu MMR kienu 92.5% (95% CI: 88.6-96.4%) mill-grupp mogħti 300 mg nilotinib darbtejn kuljum, 92.2% (95% CI: 88.5-95.9%) mill-grupp mogħti 400 mg nilotinib darbtejn kuljum u 88.0% (95% CI: 83.0-93.1%) mill-grupp mogħti 400 mg imatinib darba kuljum.
English: The safety and efficacy of Tasigna in paediatric patients with Philadelphia chromosome positive CML in chronic phase from 2 to less than 18 years of age have been established (see sections 4.8, 5.1 and 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' Tasigna f'pazjenti pedjatriċi pożittivi għall-kromosoma ta' Filadelfja b'CML fil-fażi kronika minn sentejn sa anqas minn 18-il sena ġew stabbiliti (ara sezzjonijiet 4.8, 5.1 u 5.2).
English: In healthy volunteers, Cmax and area under the serum concentration-time curve (AUC) of nilotinib are increased by 112% and 82%, respectively, compared to fasting conditions when Tasigna is given with food.
Maltese: F'voluntiera b'saħħithom, is-Cmax u l-erja taħt il-kurva tal-konċentrazzjoni tas-serum-ħin (AUC) ta' nilotinib jiżdiedu b'112% u 82%, rispettivament, mqabbla ma' kundizzjonijiet ta' sawm meta Tasigna jingħata ma' l-ikel.
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a mutagenic potential of nilotinib.
Maltese: Studji dwar ġenotossiċità fuq sistemi bil-batteri in vitro u fuq sistemi mammali in vitro u in vivo b'attivazzjoni metabolika jew mingħajrha ma wrew l-ebda evidenza li nilotinib jista' jkollu effett mutaġeniku.
English: PVC/PVDC/Alu [in wallet] 28 hard capsules
Maltese: PVC/PVDC/Alu [f'wolit] 28 kapsula iebsa
English: Newly diagnosed CML-CP 300 mg twice daily n=279
Maltese: Pazjenti b'dijanjosi ġdida ta' CML-CP 300 mg darbtejn kuljum n=279
English: Cerebrovascular accident, basilar artery stenosis, syncope, tremor, lethargy, dysaesthesia, restless legs syndrome, hyperaesthesia
Maltese: Inċident ċerebrovaskulari, stenożi tal-arterja basilari, sinkope, tregħid, letarġija, disesteżija, sindrome tas-saqajn mingħajr serħan, iperesteżija
English: Tasigna 50 mg hard capsules nilotinib
Maltese: Tasigna 50 mg kapsuli ibsin nilotinib
English: Patients were randomised 1:1:1 to receive either nilotinib 300 mg twice daily (n=282), nilotinib 400 mg twice daily (n=281) or imatinib 400 mg once daily (n=283).
Maltese: Il-pazjenti tqassmu kif ġie ġie 1:1:1 biex jingħataw jew 300 mg nilotinib darbtejn kuljum (n=282), 400 mg nilotinib darbtejn kuljum (n=281) jew 400 mg darba kuljum (n=283).
English: A total of 395 (46.7%) of all patients were not evaluable for MMR at 72 months (130 in the nilotinib 300 mg twice daily group, 110 in the nilotinib 400 mg twice daily group and 155 in the imatinib group) due to missing/unevaluable PCR assessments (n=25), atypical transcripts at baseline (n=8) or discontinuation prior to the 72-month time point (n=362).
Maltese: Total ta' 395 (46.7%) mill-pazjenti kollha ma setgħux jiġu evalwati għal MMR fit-72 xahar (130 fil-grupp ta' nilotinib 300 mg darbtejn kuljum, 110 fil-grupp ta' nilotinib 400 mg darbtejn kuljum u 155 fil-grupp ta' imatinib) minħabba valutazzjonijiet ta' PCR nieqsa/li ma jistgħux jiġu evalwati (n=25), traskrizzjonijiet atipiċi fil-linja bażi (n=8) jew twaqqif qabel il-perjodu ta' 72 xahar (n=362).
English: Thrombocythaemia, leukocytosis Immune system disorders Not known:
Maltese: Tromboċitemja, lewkoċitożi Disturbi fis-sistema immuni Mhux magħruf:
English: The Kaplan-Meier (KM) estimated median time on nilotinib treatment to regain MMR and MR4.5 was 7.9 weeks (95% CI: 5.1, 8.0) and 13.1 weeks (95% CI: 12.3, 15.7), respectively.
Maltese: Iż-żmien medju stmat skont il-Kaplan-Meier (KM) għal pazjenti ttrattati b'nilotinib sabiex jiksbu MMR u MR4.5 kien ta' 7.9 ġimgħat (95% CI: 5.1, 8.0) u 13.1 ġimgħat (95% CI: 12.3, 15.
English: Safety pharmacology studies
Maltese: Kategorija farmakoterapewtika:
English: Of the patients who achieved HR, 53% (95% CI: 39% - 67%) were maintaining response at 24 months.
Maltese: Mill-pazjenti li kisbu HR, 53% (95% CI: 39% - 67%) kien għad kellhom ir-rispons fl-24 xahar.
English: For the 17 newly diagnosed CML patients who achieved MMR, the median time to first MMR was 5.55 months (95% CI: 5.52, 5.75).
Maltese: Għas-17-il pazjent b'CML li għadhom kif ġew iddijanjonizzati u li kisbu MMR, iż-żmien medjan għall-ewwel MMR kien ta' 5.55 xhur (95% CI: 5.52, 5.75).
English: Considering only CML-related deaths as events, the estimated rates of overall survival at 72 months were 97.7%, 98.5% and 93.9%, respectively (HR=0.3694 and stratified log-rank p=0.0302 between nilotinib 300 mg twice daily and imatinib, HR=0.2433 and stratified log-rank p=0.0061 between nilotinib 400 mg twice daily and imatinib).
Maltese: Jekk inqisu bħala episodji biss dawk l-imwiet relatati ma' CML, ir-rati ġenerali stmati ta' pazjenti li ma mitux fit-72 xahar kienu ta' 97.7%, 98.5% u 93.9%, rispettivament (HR=0.3694 u log-rank stratifikat ta' p=0.0302 bejn 300 mg nilotinib darbtejn kuljum u imatinib, HR=0.2433 u log-rank stratifikat ta' p=0.0061 bejn 400 mg nilotinib darbtejn kuljum u imatinib).
English: Patients must have typical BCR-ABL transcripts to allow quantitation of BCR-ABL, evaluation of the depth of molecular response, and determination of a possible loss of molecular remission after discontinuation of treatment with nilotinib.
Maltese: Il-pazjenti għandu jkollhom traskritti tipiċi ta' BCR--ABL li jippermettu l-kwantifikazzjoni ta' BCR--ABL, l-evalwazzjoni tar-rispons molekulari profond, u d-determinazzjoni ta' nuqqas ta' remissjoni molekulari possibbli wara t-twaqqif għal kollox tat-trattament b'nilotinib.
English: Of the patients who achieved MCyR, 63% (95% CI: 45% - 80%) were maintaining response at 24 months.
Maltese: Mill-pazjenti li kisbu MCyR, 63% (95% CI: 45% - 80%) kien għad kellhom ir-rispons fl-24 xahar.
English: Significant prolongation of the QT interval may occur when nilotinib is inappropriately taken with strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong the QT interval, and/or food (see section 4.5).
Maltese: Jista' jkun hemm titwil sinifikanti fl-intervall QT meta nilotinib jittieħed b'mod mhux xieraq ma' impedituri CYP3A4 qawwija u/jew prodotti mediċinali li huma magħrufa li jistgħu jtawlu l-intervall tal-QT, u/jew l-ikel (ara sezzjoni 4.5).
English: Appropriate monitoring and dose adjustment may be necessary for medicinal products that are CYP3A4 substrates and have a narrow therapeutic index (including but not limited to alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, sirolimus and tacrolimus) when co-administered with nilotinib.
Maltese: Għandu mnejn ikun meħtieġ monitoraġġ xieraq u aġġustament fid-doża għal prodotti mediċinali li huma sottostrati ta' CYP3A4 u li għandhom indiċi terapewtiku dejjaq (inklużi iżda mhux limitat għal alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, sirolimus u tacrolimus) meta jingħataw flimkien ma' nilotinib.
English: QTcF exceeding 500 msec was observed in <1% of patients.
Maltese: QTcF li qabżet il-500 msek dehret f'<1% tal-pazjenti.
English: Angina pectoris, arrhythmia (including atroventricular block, tachycardia, atrial fibrillation, ventricular extrasystoles, bradycardia), electrocardiogram QT prolonged, palpitations, myocardial infarction
Maltese: Anġina pettorali, arritmija (inkluż imblokk atrijoventrikulari, takikardija, fibrillazzjoni arterjali, ekstrasistoli verntrikolari, bradikardija), QT tal-elettrokardjogramma mtawwal, palpitazzjonijiet, infart mijokardijaku