FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that the lipid profiles be determined before initiating treatment with nilotinib, assessed at month 3 and 6 after initiating therapy and at least yearly during chronic therapy (see section 4.2).
Maltese: Hu rrakkomandat li l-profili tal-lipidi jkunu determinati qabel ma jitnieda t-trattament b'nilotinib, evalwati f'xahar 3 u 6 wara l-bidu tat-terapija u mill-inqas kull sena matul terapija kronika (ara sezzjoni 4.2).
English: The estimated rates of patients free from progression to accelerated phase or blast crisis at 72 months were 99.3%, 98.7% and 95.2%, respectively (HR=0.1599 and stratified log-rank p=0.0059 between nilotinib 300 mg twice daily and imatinib once daily, HR=0.2457 and stratified log-rank p=0.0185 between nilotinib 400 mg twice daily and imatinib once daily).
Maltese: Ir-rati stmati ta' pazjenti li ma pprogressawx għall-fażi aċċellerata jew kriżi blastika fit-72 xahar kienu ta' 99.3%, 98.7% u 95.2%, rispettivament (HR=0.1599 u log-rank stratifikat ta' p=0.0059 bejn 300 mg nilotinib darbtejn kuljum u imatinib darba kuljum, HR=0.2457 u log-rank stratifikat ta' p=0.0185 bejn 400 mg nilotinib darbtejn kuljum u imatinib darba kuljum).
English: Due to possible occurrence of tumour lysis syndrome (TLS) correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiating nilotinib therapy (see section 4.8).
Maltese: Minħabba l-possibbiltà li jista' jkun hemm sindrome tad-diżintegrazzjoni tat-tumur (TLS), huwa rrakkomandat li ssir korrezzjoni tad-deidrazzjoni klinikament sinifikanti u li jkun hemm kura tal-livelli għoljin tal-aċidu uriku qabel ma tingħata terapija b'nilotinib (ara sezzjoni 4.8).
English: Clinical studies in newly diagnosed CML in chronic phase An open-label, multicentre, randomised Phase III study was conducted to determine the efficacy of nilotinib versus imatinib in 846 adult patients with cytogenetically confirmed newly diagnosed Philadelphia chromosome positive CML in the chronic phase.
Maltese: Studji kliniċi b'dijanjosi ġdida ta' CML fil-fażi kronika Sar studju tal-Fażi III multiċentriku, open-label u randomizzat sabiex tinsab l-effikaċja ta' nilotinib meta mqabbel ma' imatinib fost 846 pazjent adulti b'dijanjosi ġdida kkonfermata ċitoġenetikament għall-kromosoma pożittiva ta' Filadelfja CML fil-fażi kronika.
English: Dehydration, increased appetite, gout, dyslipidaemia
Maltese: Deidratazzjoni, żieda fl-aptit, gotta, dislipidemija
English: Of the patients who achieved MCyR, 77% (95% CI: 70% - 84%) were maintaining response at 24 months.
Maltese: Mill-pazjenti li kisbu MCyR, 77% (95% CI: 70% - 84%) kien għad kellhom ir-rispons fl-24 xahar.
English: Of the 190 patients who entered the TFR phase, 98 patients (51.6% [95% CI: 44.2, 58.9]) were in MMR at 48 weeks.
Maltese: Mill-190 pazjent li daħlu fil-fażi ta' TFR, 98 pazjent (51.6% [95% CI: 44.2, 58.9]) kienu fl-MMR fit-48 ġimgħa.
English: Median age was 47 years in both nilotinib arms and 46 years in the imatinib arm, with 12.8%, 10.0% and 12.4% of patients were ≥65 years of age in the nilotinib 300 mg twice daily, nilotinib 400 mg twice daily and imatinib 400 mg once daily treatment arms, respectively.
Maltese: 0% u 12.4% tal-pazjenti b'età ta' ≥65 sena fil-gruppi kkurati bi 300 mg nilotinib darbtejn kuljum, 400 mg nilotinib darbtejn kuljum u 400 mg imatinib darba kuljum, rispettivament.
English: Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid leukaemia (Ph-positive CML).
Maltese: Tasigna jintuża biex jikkura tip ta' lewkemija imsejjħa lewkemija majelojde kronika pożittiva għall-kromosoma ta' Filadelfja (CML Ph-pożittiva).
English: Dyspnoea exertional, pleurisy, epistaxis, oropharyngeal pain Gastrointestinal disorders
Maltese: Qtugħ ta' nifs waqt sforz, plewriżi, epistassi, uġigħ orofarinġali Disturbi gastro-intestinali
English: Multipack: 112 (4 packs of 28) hard capsules.
Maltese: Pakkett b'ħafna: 112-il kapsula iebsa (4 pakketti ta' 28).
English: Paediatric patients with newly diagnosed CML in chronic phase at 230 mg/m twice daily and imatinib-resistant or intolerant CML in chronic phase at 230 mg/m twice daily
Maltese: Pazjenti pedjatriċi b'dijanjosi ġdida ta' CML fil-fażi kronika b'230 mg/m darbtejn kuljum u reżistenti għal imatinib jew CML intolleranti fil-fażi kronika b'230 mg darbtejn kuljum
English: Pancreatitis, abdominal discomfort, abdominal distension, dysgeusia, flatulence
Maltese: Pankreatite, fastidju fl-addome, nefħa fl-addome, disgweżja, gass
English: A total of 199 (35.2%) of all patients were not evaluable for MMR at 36 months (87 in the nilotinib 300 mg twice daily group and 112 in the imatinib group) due to missing/unevaluable PCR assessments (n=17), atypical transcripts at baseline (n=7), or discontinuation prior to the 36-month time point (n=175).
Maltese: Total ta' 199 (35.2%) tal-pazjenti kollha ma setgħux ikunu evalwati għal MMR fis-36 xahar (87 fil-grupp mogħti 300 mg nilotinib darbtejn kuljum u 112 fil-grupp mogħti imatinib) minħabba nuqqas ta' evalwazzjonijiet tal-PCR (n=17), traskrizzjonijiet atipiċi fil-linja bażi (n=7), jew twaqqif qabel il-perjodu ta' 36 xahar (n=175).
English: Oesophageal ulcer, gastric ulcer, oesophageal pain, stomatitis, dry mouth, enterocolitis, haemorrhoids, hiatus hernia, rectal haemorrhage, gingivitis Hepatobiliary disorders Very common:
Maltese: Ulċera fl-esofagu, ulċera gastrika, uġigħ fl-esofagu, stomatite, ħalq xott, enterokolite, murliti, hiatus hernia, fsada rettali, infjammazzjoni tas-snien Disturbi fil-fwied u fil-marrara Komuni ħafna:
English: 3 years.
Maltese: 13 mikroM).
English: Sepsis, subcutaneous abscess, anal abscess, furuncle, tinea pedis, hepatitis B reactivation Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Maltese: Sepsis, axxess taħt il-ġilda, axxess anali, furunklu, fungu fis-saqajn, riattivazzjoni tal-epatite B Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Komuni:
English: The rate of MMR at 12 months, was also statistically significantly higher for nilotinib 400 mg twice daily compared to imatinib 400 mg once daily (42.7% versus 22.3%, p<0.0001).
Maltese: Ir-rata tal-MMR fi żmien 12-il xahar, kienet ukoll statistikament ogħla sew fil-każ ta' 400 mg nilotinib darbtejn kuljum meta mqabbel ma' 400 mg imatinib darba kuljum (42.7% kontra 22.3%, p<0.0001).
English: By 6 years 79%; P < .0001
Maltese: Sa 6 snin 79%; P < .0001
English: Molecular responses of ≤0.01% and ≤0.0032% by IS correspond to a ≥4 log reduction and ≥4.5 log reduction, respectively, of BCR-ABL transcripts from a standardised baseline.
Maltese: 0032% b'IS korrispondenti għal riduzzjoni log ≥4 u għal riduzzjoni log ≥4.5, rispettivament, tat-traskrizzjonijiet BCR-ABL minn linja bażi standardizzata.
English: The median time on treatment was approximately 70 months in the nilotinib treatment groups and 64 months in the imatinib group.
Maltese: Iż-żmien medju tal-kura kien ta' madwar 70 xahar fil-gruppi ta' trattament ta' nilotinib u 64 xahar fil-grupp ta' imatinib.
English: (Best response rate)
Maltese: (L-aqwa rata ta' rispons)
English: Repeated-dose toxicity studies in dogs of up to 4 weeks' duration and in cynomolgus monkeys of up to 9 months' duration revealed the liver as the primary target organ of toxicity of nilotinib.
Maltese: Studji dwar tossiċità minn dożi ripetuti fi klieb sa' 4 ġimgħat u f'xadini cynomolgus sa' 9 xhur wrew li l-fwied huwa l-organu ewlieni li jintlaqat b'tossiċità minn nilotinib.
English: Figure 4 Kaplan-Meier estimate of treatment-free survival after start of TFR (full analysis set)
Maltese: Figura 4 L-istima skont Kaplan-Meier tas-sopravivenza ħielsa minn trattament wara t-tnedija ta' TFR (sett ta' analiżi sħiħa)
English: Single dose administration of 200 mg of nilotinib resulted in increases in AUC of 35%, 35% and 19% in subjects with mild, moderate and severe hepatic impairment, respectively, compared to a control group of subjects with normal hepatic function.
Maltese: L-għoti ta' dożi waħdiet ta' 200 mg ta' nilotinib wassal għal żidiet fl-AUC ta' 35%, 35% u 19% f'pazjenti b'indeboliment tal-fwied ħafif, moderat u sever, rispettivament, meta mqabbel ma' grupp ta' individwi bħala kontroll b'funzjoni tal-fwied normali.
English: Treatment discontinuation in adult CML patients in chronic phase who have achieved a sustained deep molecular response on nilotinib treatment following prior imatinib therapy In an open-label, single-arm study, 163 adult patients with Ph+ CML in chronic phase taking tyrosine kinase inhibitors (TKIs) for ≥3 years (imatinib as initial TKI therapy for more than 4 weeks without documented MR4.5 on imatinib at the time of switch to nilotinib, then switched to nilotinib for at least two years), and who achieved MR4.5 on nilotinib treatment as measured with the MolecularMD MRDx BCR-ABL test were enrolled to continue nilotinib treatment for additional 52 weeks (nilotinib consolidation phase).
Maltese: Twaqqif għal kollox tat-trattament f'pazjenti adulti b'CML fil-fażi kronika li kisbu rispons molekulari ewlieni profond sostenibbli bit-trattament b'nilotinib wara li ngħataw terapija b'imatinib Fi studju open-label fost grupp wieħed ta' pazjenti, 163 pazjent adulti b'CML fil-fażi kronika b'Ph+ mogħtija inibituri ta' tyrosine kinase (TKIs) għal ≥3 snin (imatinib bħala terapija inizjali b'TKI għal aktar minn 4 ġimgħat mingħajr MR4.5 iddokumentat meta mogħti imatinib fil-perjodu meta wieħed għadda għal nilotinib, u wara reġa' għadda għal nilotinib għal mill-inqas sentejn), u li kisbu MR4.5 meta mogħti trattament b'nilotinib kif imkejjel bit-test MolecularMD MRDx BCR-ABL issieħbu sabiex ikomplu t-trattament b'nilotinib għal 52 ġimgħa oħra (fażi ta' tisħiħ b'nilotinib). 126 minn 163 pazjent (77.3%) daħlu fil-fażi
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galaktosju, nuqqas ta' Lapp lactase jew malassorbiment tal-glukosju-galaktosju m'għandhomx jieħdu din il-mediċina.
English: A total of 305 (36.1%) of all patients were not evaluable for MMR at 48 months (98 in the nilotinib 300 mg BID group, 88 in the nilotinib 400 mg BID group and 119 in the imatinib group) due to missing/unevaluable PCR assessments (n=18), atypical transcripts at baseline (n=8), or discontinuation prior to the 48-month time point (n=279).
Maltese: Total ta' 305 (36.1%) tal-pazjenti kollha ma setgħux ikunu evalwati għal MMR fit-48 xahar (98 fil-grupp mogħti 300 mg nilotinib darbtejn kuljum, 88 fil-grupp mogħti 400 mg imatinib darbtejn kuljum u 119 fil-grupp mogħti imatinib) minħabba nuqqas ta' evalwazzjonijiet tal-PCR (n=18), traskrizzjonijiet atipiċi fil-linja bażi (n=8), jew twaqqif qabel il-perjodu ta' 48 xahar (n=279).
English: Hypophosphataemia (including blood phosphorus decreased)
Maltese: Ipofospatemija (inkluż tnaqqis tal-fosfru fid-demm)
English: Pulmonary oedema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain, throat irritation
Maltese: Edema fil-pulmun, effużjoni fil-plewra, mard fl-interstizzju tal-pulmun, uġigħ fil-plewra, plewriżi, uġigħ fil-farinġi u fil-larinġi, irritazzjoni fil-grieżem
English: Tasigna is available in a pack containing 120 hard capsules (3 packs of 40 hard capsules).
Maltese: Tasigna jiġi f'pakkett li fih 120 kapsula iebsa (3 pakketti ta' 40 kapsula iebsa).
English: Nilotinib therapy should be re-initiated at either 300 mg or 400 mg twice daily.
Maltese: It-terapija b'nilotinib għandha terġa' titnieda bi 300 mg jew 400 mg darbtejn kuljum.
English: Monitoring of BCR-ABL transcript levels must be performed with a quantitative diagnostic test validated to measure molecular response levels on the International Scale (IS) with a sensitivity of at least MR4.5 (BCR-ABL/ABL ≤0.0032% IS).
Maltese: Għandu jitwettaq monitoraġġ tal-livelli tat-traskritti BCR--ABL b'test dijanjostiku kwantitattiv ivvalidat biex jitkejlu l-livelli ta' rispons molekulari fuq l-Iskala Internazzjonali (IS) b'sensittività ta' mill-inqas MR4.5 (BCR--ABL/ABL ≤0.0032% IS).
English: Hypertension, flushing, peripheral artery stenosis
Maltese: Pressjoni għolja, fwawar, stenożi tal-arterja periferali
English: 9/l and/or platelet counts <10 x 10
Maltese: 9/l u/jew għadd tal-plejtlits <10 x 10
English: Muscle spasms Common
Maltese: Funzjoni tal-fwied mhux normali
English: Posology for Philadelphia chromosome positive CML paediatric patients Dosing in paediatric patients is individualised and is based on body surface area (mg/m2).
Maltese: Pożoloġija għal pazjenti pedjatriċi bi kromosoma pożittiva ta' Filadelfja CML Id-doża mogħtija lil pazjenti pedjatriċi hi personalizzata u tinħadem skont l-area tas-superfiċi tal-ġisem (mg/m2).
English: The median duration of exposure was 60.5 months (range 0.1-70.8 months).
Maltese: Il-medja tat-tul tal-esponiment kienet ta' 60.5 xhur (medda ta' 0.1-70.
English: H2 blockers should be taken approximately 10 hours before and approximately 2 hours after you take Tasigna; - antacids such as those containing aluminium hydroxide, magnesium hydroxide and simethicone, which neutralise high acidity in the stomach.
Maltese: għandhom jittieħdu madwar 10 sigħat qabel u madwar sagħtejn wara li inti tieħu Tasigna; - antaċidi bħal dawk li fihom aluminium hydroxide, magnesium hydroxide u simethicone, li jinnewtralizzaw aċidita` qawwija fl-istonku.
English: In paediatric patients, the frequency, type and severity of adverse reactions observed have been generally consistent with those observed in adults, with the exception of the laboratory abnormalities hyperbilirubinaemia (Grade 3/4: 13.0%) and transaminase elevation (AST Grade 3/4: 1.4%, ALT Grade 3/4: 8.7%) which were reported at a higher frequency than in adult patients.
Maltese: F'pazjenti pedjatriċi, il-frekwenza, it-tip u l-gravità tar-reazzjonijiet avversi osservati kienu ġeneralment konsistenti ma' dawk osservati fl-adulti, ħlief għall-anormalitajiet fil-laboratorju tal-iperbilirubinemija (Grad 3/4: 13.0%) u ż-żidiet fit-transaminase (AST Grad 3/4: 1.4%, ALT
English: Among the 21 resistant or intolerant CML patients who were in MMR at any time on treatment, the median time to first MMR was 2.76 months (95% CI: 0.03, 5.55).
Maltese: Fost il-21 pazjent b'CML reżistenti jew intolleranti li kellhom MMR fi kwalunkwe żmien tat-trattament, iż-żmien medjan għall-ewwel MMR kien ta' 2.76 xhur (95% CI: 0.03, 5.55).
English: Very common:
Maltese: Frekwenza rari:
English: Biochemistry parameters - Elevated creatinine - Elevated lipase - Elevated SGOT (AST) - Elevated SGPT (ALT) - Hypophosphataemia - Elevated bilirubin (total) - Elevated glucose - Elevated cholesterol (total) - Elevated triglycerides *Percentages with one decimal precision are used and rounded to integer for presentation in this table **Parameters not collected
Maltese: Parametri bijokimiċi - Kreatinina għolja - Lipase għoli - SGOT (AST) għoli - SGPT (ALT) għoli - Ipofosfatemija - Bilirubin (totali) għoli - Glukosju għoli - Kolesterol (total) għoli - Trigliċeridi għolja * Fejn tidħol il-preżentazzjoni f'din it-tabella, qed jintużaw persentaġġi bi preċiżjoni għal numru wieħed deċimali u mqarrba għall-eqreb numru sħiħ. **Parametri mhux miġbura
English: Multipack: 120 (3 packs of 40) hard capsules.
Maltese: Pakkett b'ħafna: 120 kapsula iebsa (3 pakketti ta' 40).
English: Tasigna 150 mg hard capsules
Maltese: Tasigna 150 mg kapsuli ibsin
English: Visual impairment, vision blurred, conjunctival haemorrhage, visual acuity reduced, eyelid oedema, photopsia, hyperaemia (scleral, conjunctival, ocular), eye irritation
Maltese: Indeboliment fil-vista, vista mċajpra, emorraġija konġunktivali, tnaqqis fl-akkutezza viżiva, edema mal-kappell tal-għajnejn, fotopsja, iperimija (sklerali, konġunktivali, tal-għajn), irritazzjoni tal-għajnejn
English: Nilotinib is mainly metabolised in the liver with CYP3A4 expected to be the main contributor to the oxidative metabolism.
Maltese: Nilotinib jiġi metabolizzat fil-parti l-kbira fil-fwied bis-CYP3A4 mistenni li jkun il-kontributur ewlieni għall-metaboliżmu ossidattiv.
English: Nilotinib has pH dependent solubility, with lower solubility at higher pH.
Maltese: Is-solubilità ta' nilotinib tiddependi mill-pH, b'solubilità aktar baxxa f'pH ogħla.
English: Gastrointestinal haemorrhage, melaena, mouth ulceration, gastroesophageal reflux, stomatitis, oesophageal pain, dry mouth, gastritis, sensitivity of teeth
Maltese: Emorraġija gastro-intestinali, melenja, ulċeri fil-ħalq, ittella' mill-istonku, stomatite, uġigħ fl-esofagu, ħalq xott, gastrite, sensittività tas-snien
English: Steady-state conditions were essentially achieved by day 8.
Maltese: Kondizzjonijiet ta' stat fiss essenzjalment kienu miksuba sa jum 8.
English: The data described below reflect exposure to nilotinib in 279 adult patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated with 300 mg of nilotinib twice daily.
Maltese: Id-dejta deskritta hawn taħt tirrifletti l-esponiment għal nilotinib f'279 pazjent adult minn studju randomizzat tal-Fażi III fost pazjenti b'dijanjosi ġdida ta' Ph+ CML fil-fażi kronika kkurati bi 300 mg ta' nilotinib darbtejn kuljum.
English: In a Phase II clinical study with adult patients with Ph+ CML in chronic phase on nilotinib treatment and previously treated with imatinib (N=126), musculoskeletal symptoms were reported within a year of discontinuation in 42.1% versus 14.3% within the previous year on nilotinib treatment.
Maltese: Waqt studju kliniku f'Fażi II fost pazjenti adulti b'CML fil-fażi kronika b'Ph+ fuq trattament b'nilotinib u li qabel kienu ttrattati b'imatinib (N=126), is-sintomi muskoluskeletriċi kienu rrappurtati fi żmien sena mit-twaqqif għal kollox f'42.1% kontra l-14.3% fis-sena ta' qabel waqt li kienu qed jingħataw trattament b'nilotinib.
English: The estimated rates of patients free from progression to accelerated phase or blast crisis including clonal evolution at 72 months were 98.7%, 97.9% and 93.2%, respectively (HR=0.1626 and stratified log-rank p=0.0009 between nilotinib 300 mg twice daily and imatinib once daily, HR=0.2848 and stratified log-rank p=0.0085 between nilotinib 400 mg twice daily and imatinib once daily).
Maltese: Ir-rati stmati ta' pazjenti li ma pprogressawx għall-fażi aċċellerata jew kriżi blastika inkluż evoluzzjoni klonali fit-72 xahar kienu ta' 98.7%, 97.9% u 93.2%, rispettivament (HR=0.1626 u log-rank stratifikat ta' p=0.0009 bejn 300 mg nilotinib darbtejn kuljum u imatinib darba kuljum, HR=0.2848 u log-rank stratifikat ta' p=0.0085 bejn 400 mg nilotinib darbtejn kuljum u imatinib darba kuljum.
English: Multipack: 112 (4 wallets of 28) hard capsules.
Maltese: Pakkett b'ħafna: 112-il kapsula iebsa (4 wolits ta' 28).
English: Time since TFR (weeks)
Maltese: Żmien minn TFR (ġimgħat)
English: Pleural and pericardial effusions, regardless of causality, occurred in 2% and <1% of patients, respectively, receiving nilotinib 300 mg twice daily.
Maltese: Efużjonijiet fil-plewra u perikardijaċi, irrispettivament hux ikkawżati, seħħew f'2% u <1% tal-pazjenti, rispettivament, li kienu qed jirċievu nilotinib 300 mg darbtejn kuljum.
English: Thereafter, if the prior dose was 230 mg/m twice daily, treatment can be resumed at 230 mg/m once daily.
Maltese: Għaldaqstant, jekk id-doża ta' qabel kienet ta' 230 mg/m darbtejn kuljum, it-trattament jista' jitkompla minn 230 mg/m darba kuljum.
English: In the Phase II study in imatinib-resistant and intolerant CML patients in chronic and accelerated phase receiving 400 mg nilotinib twice daily, the change from baseline in mean time-averaged QTcF interval at steady state was 5 and 8 msec, respectively.
Maltese: Fl-istudju tal-Fażi II f'pazjenti reżistenti għal imatinib u CML intolleranti fil-fażi kronika u aċċelerata li kienu qed jirċievu 400 mg nilotinib darbtejn kuljum, il-bidla mill-linja bażi għall-medja tal-ħin medju tal-intervall QTcF fi stat fiss kien 5 u 8 msek, rispettivament.
English: Alterations included increased alanine aminotransferase and alkaline phosphatase activity and histopathology findings (mainly sinusoidal cell or Kupffer cell hyperplasia/hypertrophy, bile duct hyperplasia and periportal fibrosis).
Maltese: Tibdil kien jinkludi żiediet tal-alanine aminotransferase u l-attività tal-alkaline phosphatase u sejbiet istopatoloġiċi (l-aktar taċ-ċelluli sinusojdali jew iperplażja/ipertrofija taċ-ċelluli Kupffer, iperplażja tat-tubu tal-marrara u fibrożi periportali).
English: Biochemistry parameters - Elevated creatinine - Elevated lipase - Elevated SGOT (AST) - Elevated SGPT (ALT) - Hypophosphataemia - Elevated bilirubin (total) - Elevated glucose - Elevated cholesterol (total) - Elevated triglycerides *Percentages with one decimal precision are used and rounded to integer for presentation in this table.
Maltese: Parametri bijokimiċi - Kreatinina għolja - Lipase għoli - SGOT (AST) għoli - SGPT (ALT) għoli - Ipofosfatemija - Bilirubin (totali) għoli - Glukosju għoli - Kolesterol (total) għoli - Trigliċeridi għolja * Fejn tidħol il-preżentazzjoni f'din it-tabella, qed jintużaw persentaġġi bi preċiżjoni għal numru wieħed deċimali u mqarrba għall-eqreb numru sħiħ.
English: Adult patients with imatinib-resistant or intolerant CML in accelerated phase at 400 mg twice daily
Maltese: Pazjenti adulti b'reżistenti għal imatinib u CML intolleranti fil-fażi aċċellerata b'400 mg darbtejn kuljum
English: In a study in the CML paediatric population, growth retardation has been documented in patients treated with nilotinib (see section 4.8).
Maltese: Fi studju fost ilpopolazzjoni pedjatrika b'CML, kien iddokumentat dewmien fir-rata tat-tkabbir f'pazjenti ttrattati b'nilotinib (ara sezzjoni 4.8).
English: Hard capsule
Maltese: Qoxra tal-kapsula
English: Uncommon cases (0.1 to 1%) of sudden deaths have been reported in Tasigna clinical trials and/or compassionate use programs in patients with imatinib-resistant or intolerant CML in chronic phase or accelerated phase with a past medical history of cardiac disease or significant cardiac risk factors (see section 4.4).
Maltese: Każijiet mhux komuni (0.1 to 1%) ta' mwiet zoptu kienu rrappurtati fi provi kliniċi b'Tasigna u/jew fi programmi ta' użu ta' kompassjoni f'pazjenti li b'reżistenza għal imatinib jew CML intolleranti fil-fażi kronika jew fil-fażi aċċellerata bi storja medika ta' mard tal-qalb jew fatturi sinifikanti ta' riskju tal-qalb (ara sezzjoni 4.4).
English: Nilotinib has been shown to prolong cardiac ventricular repolarisation as measured by the QT interval on the surface ECG in a concentration-dependent manner in adult and paediatric patients.
Maltese: Intwera li nilotinib jtawwal ir-ripolarizzazzjoni ventrikulari kardijaka hekk kif imkejjel mill-intervall QT fuq l-ECG tas-superfiċi b'mod dipendenti mill-konċentrazzjoni f'pazjenti adulti u pedjatriċi.
English: The safety and efficacy of nilotinib in paediatric patients with Ph+ CML in chronic phase have been investigated in two studies.
Maltese: Is-sigurtà u l-effikaċja ta' nilotinib f'pazjenti pedjatriċi b'PH+ b'CML fil-fażi kronika ġew investigati f'żewġ studji.
English: The substance binds with high affinity to the ATP-binding site in such a manner that it is a potent inhibitor of wild-type BCR-ABL and maintains activity against 32/33 imatinib-resistant mutant forms of BCR-ABL. As a consequence of this biochemical activity, nilotinib selectively inhibits the proliferation and induces apoptosis in cell lines and in primary Philadelphia-chromosome positive leukaemia cells from CML patients.
Maltese: Minħabba din l-attività bijokimika, nilotinib jinibixxi b'mod silettiv il-proliferazzjoni u jinduċi apoptożi f'linji ta' ċelluli u f'ċelluli ta' lewkemija pożittivi għall-kromosoma ta' Filadelfja primarja minn pazjenti b'CML.
English: The dose was 400 mg twice daily and dose escalation to 600 mg twice daily was allowed.
Maltese: Id-doża kienet 400 mg darbtejn kuljum u kien permess li d-doża titella sa 600 mg darbtejn kuljum.
English: Shock haemorrhagic, hypotension, thrombosis Respiratory, thoracic and mediastinal disorders Common:
Maltese: Xokk emorraġiku, pressjoni baxxa, trombożi Disturbi respiratorji, toraċiċi u medjastinali Komuni: