FrancophonIA/ELRC3.0 huggingface dataset:
English: e. Vision disorder (Diplopia, Halo vision, Photophobia, Photopsia, Vision blurred, Visual acuity reduced, Visual brightness, Visual impairment, Visual perseveration, Vitreous floaters).
Maltese: Disturb fil-vista (Diplopja, Tara qishom dijademi madwar l-oġġetti, Fotofobija, Fotopsija, Vista mċajpra,
English: Crizotinib also demonstrated marked antitumour activity in mouse xenograft studies, where tumours were generated using a panel of NIH-3T3 cell lines engineered to express key ROS1 fusions identified in human tumours.
Maltese: Crizotinib wera wkoll attività konsiderevoli kontra t-tumuri fi studji ta' xenograft fil-ġrieden, fejn it-tumuri kienu ġġenerati bl-użu ta' bordta' linji ta' ċelluli NIH-3T3 maħduma sabiex jesprimu fużjonijiet ewlenin ta' ROS1 identifikati f'tumuri talbniedem.
English: Findings observed in the female reproductive tract included single-cell necrosis of ovarian follicles of a rat given 500 mg/kg/day for 3 days.
Maltese: Is-sejbiet osservati fl-apparat riproduttiv tannisa kienu jinkludu nekrożi ta' ċellola waħda tal-follikoli tal-ovarji ta' far mogħti 500 mg/kg/jum għal 3 ijiem.
English: • Pimozide, used to treat mental illness.
Maltese: • Pimozide, użat sabiex jittratta mard mentali.
English: Gastrointestinal perforationl
Maltese: Perforazzjoni gastrointestinalil
English: All upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were <20 msec.
Maltese: Il-limiti kollha ta' fuq tad-90% CL għall-bidla medja tal-LS mil-Linja Bażi tal-QTcF fil-punti kollha ta' żmien ta' Jum 1 ta' Ċiklu 2 kienu ta' <20 msec.
English: No starting dose adjustment is recommended for patients with mild (60≤ creatinine clearance [CLcr] <90 mL/min) or moderate (30≤ CLcr <60 mL/min) renal impairment, since the population pharmacokinetic analysis indicated no clinically meaningful changes in steady-state crizotinib exposure in these patients.
Maltese: Ma huwa rakkomandat l-ebda aġġustament fid-doża tal-bidu għall-pazjenti b'indeboliment renali ħafif (60≤ tneħħija tal-kreatinina [CLcr] <90 mL/min) jew indeboliment tal-kliewi moderat (30≤ CLcr <60 mL/min), minħabba li l-analiżi farmakokinetika tal-popolazzjoni indikat li ma kien hemm l-ebda tibdil klinikament sinifikanti fl-esponiment ta' crizotinib fl-istat fiss f'dawn il-pazjenti.
English: A total of 53 ROS1-positive advanced NSCLC patients were enrolled in the study at the time of data cutoff, including 46 patients with previously treated ROS1-positive advanced NSCLC and a limited number of patients (N=7) who had no prior systemic treatment.
Maltese: Total ta' 53 pazjent b'NSCLC avvanzat pożittiv għal ROS1 ġew irreġistrati f'dawn l-istudji fiż-żmien tal-għeluq tad-dejta, inkluż 46 pazjent b'NSCLC avvanzat pożittiv għal ROS1 ittrattati minn qabel u numru limitat ta' pazjenti (N=7) li ma kellhomx trattament sistemiku minn qabel.
English: The demographic and disease characteristics were 57% female, median age of 53 years, baseline ECOG performance status of 0/1 (82%) or 2/3 (18%), 52% White and 44% Asian, 4% current smokers, 30% former smokers, 66% never smokers, 92% metastatic, and 94% of the cancers were classified as adenocarcinoma histology.
Maltese: Total ta' 934 pazjent b'NSCLC avvanzat pożittiv għall-ALK ingħataw trattament bi crizotinib flIstudju 1005 fiż-żmien ta' meta ttieħdet l-aħħar dejta għall-analiżi ta' PFS u ORR. Il-karatteristiċi demografiċi u tal-marda kienu 57% nisa, età medjana ta' 53 sena, status tal-prestazzjoni tal-ECOG fillinja bażi ta' 0/1 (82%) jew 2/3 (18%), 52% Bojod u 44% Asjatiċi, 4% kienu persuni jpejpu f'dak ilmument, 30% persuni li kienu jpejpu fl-imgħoddi,66% persuni li qatt ma pejpu, 92% metastatika u 94% tal-kanċers kienu kklassifikati bħala istoloġija ta' adenokarċinoma.
English: Cardiac electrophysiology
Maltese: Colloidal anhydrous silica
English: Crizotinib resulted in symptom benefits by significantly prolonging TTD compared to chemotherapy (median 2.1 months versus 0.5 months; HR=0.59; 95% CI: 0.45, 0.77; Hochberg-adjusted log-rank 2-sided p-value =0.0005).
Maltese: HR=0.59; 95% CI: 0.45, 0.77; Hochberg-log-rank 2-sided valur p aġġustat=0.0005).
English: Supportive care for diarrhoea and constipation should include the use of standard antidiarroheal and laxative medicinal products, respectively.
Maltese: It-trattamentta' appoġġ għad-dijarea u l-istitikezza għandha tinkludi l-użu ta' prodotti mediċinali standard kontra ddijarea u lassattivi, rispettivament.
English: Grapefruit or grapefruit juice should be avoided during treatment with crizotinib (see sections 4.2 and
Maltese: Il-meraq tal-grejpfrut jew tal-grejpfrut għandu jiġi evitat waqt it-trattament b'crizotinib (ara sezzjonijiet 4.2 u 4.5).
English: In vitro studies in human hepatocytes indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated induction of the metabolism of medicinal products that are substrates for CYP1A2.
Maltese: Studji in vitro f'epatoċiti tal-bniedem indikaw li mhuwiex probabbli li jseħħu interazzjonijiet kliniċi bejn il-mediċini minħabba l-induzzjoni, medjata minn crizotinib, tal-metaboliżmu ta' prodotti mediċinali li huma sustratti għal CYP1A2.
English: Crizotinib was aneugenic in an in vitro micronucleus assay in Chinese Hamster Ovary cells and in an in vitro human lymphocyte chromosome aberration assay.
Maltese: Crizotinib ma kienx mutaġeniku in vitro fit-test tal-mutazzjoni batterika b'lura (Ames). Crizotinib kien anewġeniku f'test tal-mikronukleju in vitro f'ċelloli tal-Ovarji ta' Hamster Ċiniż u f'test in vitro talaberrazzjoni tal-kromożomi ta' limfoċiti tal-bniedem.
English: White opaque and pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 200” on the body.
Maltese: Kapsula iebsa, bajda opaka u roża opaka, b'“Pfizer” fuq l-għatu u “CRZ 200” fuq il-biċċa l-oħra.
English: Based on the population pharmacokinetic analysis of data in Studies 1001, 1005 and 1007, age has no effect on crizotinib pharmacokinetics.
Maltese: Ibbażat fuq lanaliżi farmakokinetika tal-popolazzjoni ta' dejta fi studji 1001, 1005 u 1007, l-età m'għandha l-ebda effett fuq il-farmakokinetika ta' crizotinib.
English: The most common adverse reactions (≥25%) in patients with either ALK-positive or ROS1-positive NSCLC were vision disorder, nausea, diarrhoea, vomiting, oedema, constipation, elevated transaminases, fatigue, decreased appetite, dizziness, and neuropathy.
Maltese: L-aktar reazzjonijiet avversi komuni (≥25%) f'pazjenti b'NSCLC pożittiv jew għall-ALK jew għal ROS1 kienu disturb fil-vista, dardir, dijarea, rimettar, edima, stitikezza, żieda fit-transaminases, għeja, nuqqas ta' aptit, sturdament u newropatija.
English: • If your next dose is in 6 hours or more, take the missed capsule as soon as you remember.
Maltese: • Jekk għad-doża li jmissek ikun għad baqa' inqas minn 6 sigħat, aqbeż il-kapsula li nsejt tieħu.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Fifty-two (52) patients treated with crizotinib and 57 chemotherapy-treated patients with previously treated or untreated asymptomatic brain metastases were enrolled in randomised Phase 3 Study 1007.
Maltese: Tnejn u ħamsin (52) pazjent ittrattati bi crizotinib u 57 pazjent ittrattati bil-kimoterapija b'metastasijiet fil-moħħ mingħajr sintomi, li rċevew jew ma rċevewx trattament qabel, ġew irreġistrati fi Studju 1007, ta' Fażi 3, li fih l-parteċipanti ntgħażlu b'mod każwali.
English: Leukopenia was associated with a dose reduction for <0.5% of patients, and no patients permanently discontinued crizotinib treatment associated with leukopenia.
Maltese: Il-lewkopenija kienet assoċjata ma' tnaqqis fid-doża għal <0.5% tal-pazjenti, u l-ebda pazjenti ma waqqfu b'mod permanenti t-trattament bi crizotinib assoċjat ma' lewkopenija.
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or Grade 4 leukopenia was observed in 48 (3%) patients treated with crizotinib.
Maltese: Fi studji f'pazjenti b'NSCLC avvanzat jew pożittiv għall-ALK jew pożittiv għal ROS1 (N=1,722), lewkopenija ta' Grad 3 jew Grad 4 kienet osservata fi 48 (3%) tal-pazjenti ttrattati bi crizotinib.
English: When assessing either ALK or ROS1 status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Maltese: Fil-valutazzjoni jew tal-istatus tal-ALK jew ta' ROS1 ta' pazjent, huwa importanti li tingħażel metodoloġija validata tajjeb u robusta sabiex ikunu evitati determinazzjonijiet negattivi foloz jew pożittivi foloz.
English: Patients randomised to chemotherapy could cross over to receive crizotinib upon RECIST-defined disease progression confirmed by independent radiology review (IRR).
Maltese: Pazjenti li ntgħażlu b'mod każwali għal kimoterapija, setgħu jaqilbu biex jirċievu crizotinib hekk kif kien hemm progressjoni talmarda kif definit minn RECIST, ikkonfermat minn reviżjoni radjoloġika indipendenti (independent radiology review (IRR)).
English: Following 28 days of crizotinib dosing at 250 mg taken twice daily in cancer patients, the oral midazolam AUCinf was 3.7-fold of those seen when midazolam was administered alone, suggesting that crizotinib is a moderate inhibitor of CYP3A.
Maltese: Wara 28 jum ta' crizotinib b'dożaġġ ta' 250 mg meħud darbtejn kuljum minn pazjenti bil-kanċer, lAUC ta' midazolam orali kienet 3.7 darbiet akbar minn dawk li dehru meta midazolam ġie amministrat waħdu, u dan jissuġġerixxi li crizotinib huwa inibitur moderat ta' CYP3A.
English: Post-implantation loss was increased at doses ≥50 mg/kg/day (approximately 0.4 times the AUC at the recommended human dose) in rats, and reduced fetal body weights were considered adverse effects in the rat and rabbit at 200 and 60 mg/kg/day, respectively (approximately 1.2-fold human clinical exposure based on AUC).
Maltese: Kien hemm żieda fit-telf ta' wara l-impjantazzjoni b'dożi ta' ≥50 mg/kg/jum (bejn wieħed u ieħor 0.4 darbiet tal-AUC tad-doża rrakomandata fil-bniedem) f'firien, u t-tnaqqis fil-piż tal-ġisem tal-fetu tqies bħala effett avvers fil-far u l-fenek b'200 u 60 mg/kg/jum, rispettivament (bejn wieħed u ieħor 1.2 darbiet akbar millespożizzjoni klinika tal-bniedem fuq il-bażi tal-AUC).
English: The central tendency analysis indicated that the largest mean change from baseline in QTcF was 12.3 msec (95% CI 5.1-19.5 msec, least squares mean [LS] from Analysis of Variance [ANOVA]) and occurred at 6 hours post-dose on Cycle 2 Day 1.
Maltese: L-analiżi tat-tendenza ċentrali indikat li l-akbar bidla medja millinja bażi fil-QTcF kienet ta' 12.3 msec (95% CI 5.1-19.5 msec, medja tal-least squares [LS] minn Analiżi ta' Varjanza
English: Administration of a single 250 mg crizotinib dose following treatment with esomeprazole 40 mg once daily for 5 days resulted in an approximately 10% decrease in crizotinib total exposure (AUCinf) and no change in peak exposure (Cmax); the extent of the change in total exposure was not clinically meaningful.
Maltese: L-għoti ta' doża waħda ta' 250 mg ta' crizotinib wara trattament b'esomeprazole 40 mg darba kuljum għal 5 ijiem, irriżulta fi tnaqqis ta' madwar 10% fl-esponiment totali għal crizotinib (AUCinf) u fl-ebda bidla fl-esponiment massimu (Cmax); il-medda tal-bidla fl-esponiment totali ma kienx klinikament sinifikanti.
English: Electrolyte disturbances, dehydration and bradycardia may further increase the risk of QTc prolongation and thus, periodic monitoring of ECG and electrolyte levels is recommended in patients with GI toxicity (see section 4.4).
Maltese: Disturbi fl-eletrolitti, deidratazzjoni u bradikardija jista' jżid aktar ir-riskju tat-titwil ta' QTc u għalhekk, monitoraġġ perjodiku tal-ECG u tal-livelli ta' tal-eletrolitti huwa rrakomandat f'pazjenti li għandhom tossiċità tal-GI (ara sezzjoni 4.4).
English: The recommended dose schedule of XALKORI is 250 mg twice daily (500 mg daily) taken continuously.
Maltese: L-iskeda tad-dożaġġ irrakkomandata ta' XALKORI hija 250 mg darbtejn kuljum (500 mg kuljum) meħuda b'mod kontinwu.
English: Information is available from 45 response-evaluable patients with previously treated non-adenocarcinoma NSCLC (including 22 patients with SCC) in Study 1005.
Maltese: Informazzjoni hija disponibbli biss minn 45 pazjent b'NSCLC (li jinkludu 22 pazjent b'SCC) mhux tat-tip ta' adenokarċinoma ttrattati qabel b'rispons evalwabbli fi Studju 1005.
English: Capsule shell Gelatin
Maltese: Propylene glycol
English: Limited information is available in patients with ALK-positive and ROS1-positive NSCLC with non-adenocarcinoma histology, including squamous cell carcinoma (SCC) (see section 5.1).
Maltese: Informazzjoni disponibbli fuq pazjenti b'NSCLC pożittiv għal ALK u għal ROS1 b'istoloġija mhux tat-tip ta' adenokarċinoma hija limitata, li jinkludu karċinoma taċ-ċelloli skwamużi (SCC) (ara sezzjoni 5.1).
English: Grade 3 and 4 transaminase elevations were generally reversible upon dosing interruption.
Maltese: Iż-żidiet fit-transaminase ta' Grad 3 u 4 kienu ġeneralment riversibbli wara li waqfet tingħata d-doża.
English: One hundred seventy-three (173) patients were randomised to crizotinib and 174 patients were randomised to chemotherapy (either pemetrexed or docetaxel).
Maltese: Mija u tlieta u sebgħin (173) pazjent intgħażlu b'mod każwali għal crizotinib, u 174 pazjent intgħażlu b'mod każwali għal kimoterapija (jew pemetrexed jew docetaxel).
English: h. Cardiac failure (Cardiac failure, Cardiac failure congestive, Ejection fraction decreased, Left ventricular failure, Pulmonary oedema).
Maltese: Tnaqqis fl-akutezza viżwali, Dija viżwali, Indeboliment tal-vista, Preservazzjoni viżwali, Floaters vitrużi).
English: Other medicines and XALKORI
Maltese: Kif taħżen XALKORI
English: Across studies in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), 50 (3%) patients treated with crizotinib had any grade all-causality ILD, including 18 (1%) patients with Grade 3 or 4, and 8 (<1%) patients with fatal cases.
Maltese: Fi studji f'pazjenti b'NSCLC jew pożittiv għall-ALK jew pożittiv għal ROS1 (N=1,722), 50 (3%) pazjent ittratti bi crizotinib kellhom ILD ta' kwalunkwe grad tal-kawżi kollha, inkluż 18-il pazjent (1%) bi Grad 3 jew 4, u 8 (<1%) pazjenti b'każijiet fatali.
English: XALKORI 200 mg hard capsules XALKORI 250 mg hard capsules crizotinib
Maltese: XALKORI 200 mg kapsuli iebsin XALKORI 250 mg kapsuli iebsin crizotinib
English: b. Based on the Cox proportional hazards stratified analysis.
Maltese: Ibbażat fuq l-analiżi stratifikata tal-perikli proporzjonali Cox.
English: f. Dizziness (Balance disorder, Dizziness, Dizziness postural, Presyncope).
Maltese: f. Sturdament (Disturb fil-bilanċ, Sturdament li jiddependi mill-qagħda, Presinkope).
English: XALKORI 200 mg hard capsules
Maltese: XALKORI 200 mg kapsuli ibsin
English: The majority of patients on the crizotinib arm in randomised Phase 3 Studies 1007 and 1014 (>50%) reported visual disturbances; which occurred at a frequency of 4 to 7 days each week, lasted up to 1 minute, and had mild or no impact (scores 0 to 3 out of a maximum score of 10) on daily activities as captured by the VSAQ-ALK questionnaire.
Maltese: Il-maġġoranza tal-pazjenti li ħadu crizotinib fl-Istudji 1007 u 1014 ta' Fażi 3 magħmulin b'għażla każwali (> 50%) irrappurtaw disturbi fil-vista; li seħħew bi frekwenza ta' 4 sa 7 ijiem kull ġimgħa, damu sa minuta, u ma kellhom l-ebda impatt jew kellhom impatt ħafif biss (punteġġi ta' 0 sa 3 minn punteġġ massimu ta' 10) fuq l-attivitajiet ta' kuljum kif miġbura millkwestjonarju VSAQ-ALK.
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or 4 neutropenia was observed in 212 (12%) patients treated with crizotinib.
Maltese: Fi studji f'pazjenti b'NSCLC avvanzat jew pożittiv għall-ALK jew pożittiv għal ROS1 (N=1,722), newtropenija ta' Grad 3 jew 4 kienet osservata f'212-il pazjent (12%) tal-pazjenti ttrattati bi crizotinib.
English: What XALKORI looks like and contents of the pack XALKORI 200 mg is supplied as hard gelatin capsules with pink cap and white body, printed with black ink “Pfizer” on the cap, “CRZ 200” on the body.
Maltese: XALKORI 200 mg jiġi bħala kapsuli ibsin tal-ġelatina b'għatu roża u korp abjad, bil-kliem “Pfizer” stampat b'linka sewda fuq l-għatu u “CRZ 200” fuq il-korp.
English: XALKORI 200 mg hard capsules crizotinib
Maltese: XALKORI 200 mg kapsuli iebsin crizotinib
English: • Bupropion, used to treat depression and smoking cessation.
Maltese: • Bupropion, użat għat-trattament ta' dipressjoni u għat-twaqqif mit-tipjip.
English: An ophthalmology substudy using specific ophthalmic assessments at specified time points was conducted in 54 patients with NSCLC who received crizotinib 250 mg twice daily.
Maltese: Sottostudju oftalmoloġiku bl-użu ta' evalwazzjonijiet oftalmiċi speċifiċi f'punti ta' żmien speċifiċi twettaq fuq 54 pazjent b'NSCLC li rċivew crizotinib 250 mg darbtejn kuljum.
English: However, there was no observed induction in vivo when crizotinib was coadministered with the CYP3A probe substrate midazolam.
Maltese: Madankollu, ma kienet osservata l-ebda induzzjoni in vivo meta crizotinib ingħata fl-istess ħin mas-substrat sonda ta' CYP3A4, midazolam.
English: XALKORI 250 mg hard capsules
Maltese: XALKORI 250 mg kapsuli ibsin
English: Most of the available information is available in patients with some specific histology type of ALK-positive NSCLC (adenocarcinoma) and limited information is available in the other histologies.
Maltese: Ħafna mill-informazzjoni disponibbli hija disponibbli f'pazjenti b'xi tip istoloġiku speċifiku talNSCLC pożittiv għal ALK (adenokarċinoma) u informazzjoni limitata hija disponibbli f'istoloġiji oħra.
English: • Pilocarpine, used to treat glaucoma (a severe eye disease).
Maltese: • Pilocarpine, użat sabiex jittratta l-glawkoma (marda serja fl-għajnejn).
English: • Clonidine, guanfacine, used to treat hypertension.
Maltese: • Clonidine, guanfacine, użati sabiex jittrattaw pressjoni għolja.
English: Median times to onset for diarrhoea and constipation were 13 and 17 days, respectively.
Maltese: Iż żminijiet medji għall-bidu tad-dijarea u l-istitikezza kienu 13 u 17-il jum, rispettivament.
English: a. Per data cutoff date30 June 2018. b. Estimated using the Kaplan-Meier method.
Maltese: Inħarġet stima billi ntuża l-metodu Kaplan-Meier.
English: The median duration of treatment was 22.4 months (95% CI: 15.0, 35.9).
Maltese: It-tul taż-żmien medjan tat-trattament kien ta' 22.4 xhur (95% CI: 15.
English: Symptomatic bradycardia (e.g., syncope, dizziness, hypotension) can occur in patients receiving crizotinib.
Maltese: Bradikardija bis-sintomi tista' sseħħ (e.ż., sinkope, sturdament, pressjoni baxxa) fil-pazjenti li jkunu qegħdin jirċievu crizotinib.
English: XALKORI 250 mg is supplied as hard gelatin capsules with pink cap and body, printed with black ink “Pfizer” on the cap, “CRZ 250” on the body.
Maltese: XALKORI 250 mg jiġi bħala kapsuli ibsin tal-ġelatina b'għatu u korp roża, bil-kliem “Pfizer” stampat b'linka sewda fuq l-għatu u “CRZ 200” fuq il-korp.
English: For ROS1-positive NSCLC patients in Study 1001 (N=53), the median duration of treatment was 101 weeks.
Maltese: Għal pazjenti b'NSCLC pożittivi għal ROS1 fi Studju 1001 (N=53), it-tul medjan tat-trattament kien ta' 101 ġimgħa.
English: Progression-Free Survival (Based on IRR) Number with event, n (%) Median PFS in months (95% CI)
Maltese: Sopravivenza bla Progressjoni (Ibbażata fuq IRR) Numru bl-avveniment, n (%)
English: Grade 4 QTc prolongation
Maltese: Titwil fil-QTc ta' Grad 4
English: Withhold until recovery to Grade ≤2, then resume at the next lower dosed,e a. Except lymphopenia (unless associated with clinical events, e.g., opportunistic infections).
Maltese: Minbarra linfopenija (sakemm ma tkunx assoċjata ma' avvenimenti kliniċi, e.ż.. infezzjonijiet opportunistiċi). b.
English: Of 172 ALK-positive patients treated with crizotinib in randomised Phase 3 Study 1007, 27 (16%) were 65 years or older.
Maltese: Mill-172 pazjent pożittiv għall-ALK ittrattati bi crizotinib fl-Istudju 1007 ta' Fażi 3 magħmul b'għażla każwali, 27 (16%) kellhom 65 sena jew aktar.
English: OS analysis was not adjusted for the potentially confounding effects of cross over (144 [84%] patients in the chemotherapy arm received subsequent crizotinib treatment).
Maltese: Analiżi OS ma ġietx aġġustata għall-effetti potenzjalment li jfixlu lil dak li jkun tal-crossover (144 [84%] pazjent fil-fergħa tal-kimoterapija rċevew trattament sussegwenti bi crizotinib).
English: For patients who develop transaminase elevations, see section 4.2.
Maltese: Għall-pazjenti li jiżviluppaw żidiet fit-transaminase, ara sezzjoni 4.2.
English: Dose adjustments
Maltese: Sopravivenza Globalid
English: XALKORI may increase side effects associated with the following medicines:
Maltese: XALKORI jista' jżid l-effetti sekondarji assoċjati mal-mediċini li ġejjin:
English: 6-Month Survival Probability,e % (95% CI) 1-Year Survival Probability,e % (95% CI)
Maltese: Probabbiltà ta' Sopravivenza għal 6 xhur,e % (95%
English: Based on the National Cancer Institute (NCI) classification, no starting dose adjustment of crizotinib is recommended for patients with mild hepatic impairment (either AST > Upper Limit of Normal (ULN) and total bilirubin ≤ULN or any AST and total bilirubin >ULN but 1.5 × ULN).
Maltese: Ibbażat fuq il-klassifikazzjoni ta l-Istitut Nazzjonali tal-Kanċer (NCI), mhu rakkomandat l-ebda aġġustament fid-doża tal-bidu ta' crizotinib għal pazjenti b'indeboliment epatiku ħafif (jew AST > LOgħla Limitu tan-Normal (ULN) u bilirubina totali ≤ULN jew kwalunwke AST u bilirubina totali >ULN iżda 1.5 × ULN).
English: Crizotinib resulted in overall global quality of life benefits with a significantly greater improvement from baseline observed in the crizotinib arm compared to the chemotherapy arm (Cycles 2 to 20; p-value <0.05).
Maltese: Crizotinib wassal għal benefiċċji globali fil-kwalità ġenerali tal-ħajja b'titjib sinifikament akbar millinja bażi li kien osservat fil-pazjenti li rċivew crizotinib meta mqabbel mal-pazjenti li rċivew ilkimoterapija (Ċikli 2 sa 20; valur p <0.05).
English: Other potential causes of ILD/pneumonitis should be excluded, and crizotinib should be permanently discontinued in patients diagnosed with treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Maltese: Kawżi potenzjali oħra ta' pulmonite għandhom ikunu esklużi, u crizotinib għandu jitwaqqaf b'mod permanenti f'pazjenti djanjostikati b'ILD/pulmonite relatati mat-trattament (ara sezzjonijiet 4.2 u 4.8).
English: Colloidal anhydrous silica Microcrystalline cellulose Anhydrous calcium hydrogen phosphate Sodium starch glycolate (Type A) Magnesium stearate
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Decreased bone formation in growing long bones was observed in immature rats at 150 mg/kg/day following once daily dosing for 28 days (approximately 3.3 times human clinical exposure based on AUC).
Maltese: Ġie osservat tnaqqis fil-formazzjoni tal-għadam fl-għadam twil li qed jikber f'firien immaturi b'150 mg/kg/jum wara dożaġġ darba kuljum għal 28 jum (bejn wieħed u ieħor 3.3 darbiet akbar millespożizjoni klinika tal-bniedem fuq il-bażi tal-AUC).