FrancophonIA/ELRC3.0 huggingface dataset:
English: The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, and presence of brain metastases.
Maltese: Il-benefiċċju ta' PFS ta' crizotinib kien konsistenti fis-sottogruppi kollha tal-karatteristiċi tal-pazjenti fil-linja bażi, bħall-età, is-sess talpersuna, ir-razza, klassi ta' tipjip, żmien minn meta tkun saret id-dijanjosi, l-istat ta' prestazzjoni ECOG, u l-preżenza ta' metastasijiet fil-moħħ.
English: (HR=0.45; p-value <0.0001 for crizotinib compared with pemetrexed/carboplatin).
Maltese: 0001 għal crizotinib meta mqabbel ma' pemetrexed/carboplatin).
English: Kaplan-Meier curves for progression-free survival (based on IRR) by treatment arm in randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC
Maltese: Kurvi ta' Kaplan-Meier għas-sopravivenza bla progressjoni tal-marda (ibbażata fuq l-IRR) skont it-trattament li ngħata fl-Istudju 1007 ta' Fażi 3 magħmul b'għażla każwali (popolazzjoni sħiħa tal-analiżi) f'pazjenti b'NSCLC avvanzat pożittiv għall-ALK li rċevew trattament qabel
English: In vitro studies in human liver microsomes demonstrated that crizotinib is a time-dependent inhibitor of CYP2B6 and CYP3A (see section 4.5).
Maltese: Studji in vitro fil-mikrożomi tal-fwied tal-bniedem wrew li crizotinib huwa inibitur ta' CYP2B6 u CYP3A li jiddependi fuq iż-żmien (ara sezzjoni 4.5).
English: In patients with new onset of severe visual loss (best corrected visual acuity less than 6/60 in one or both eyes), crizotinib treatment should be discontinued (see section 4.2).
Maltese: F'pazjenti b'bidu ġdid ta' telf qawwi fil-vista (akutezza viżiva kkorreġuta bl-aħjar mod ta' inqas minn 6/60 f'waħda mill-għajnejn jew it-tnejn li huma), it-trattament bi crizotinib għandu jitwaqqaf (ara sezzjoni 4.2).
English: Number of deaths, n (%) Overall Survivalc [median (95% CI)] months
Maltese: Rata ta' Rispons Oġġettiv [% (95% CI)]
English: Ophthalmological evaluation is recommended if vision disorder persists or worsens in severity (see sections 4.2 and 4.4).
Maltese: Hija rrakkomandata evalwazzjoni oftalmoloġika jekk id-disturb fil-vista jippersisti jew imur għall-agħar (ara sezzjonijiet 4.2 u 4.4).
English: (HR=0.30; p-value <0.0001 for crizotinib compared with docetaxel).
Maltese: 0001 għal crizotinib meta mqabbel ma' docetaxel).
English: Pfizer Innovations AB Tel: + 46 (0)8 550 520 00
Maltese: Tel: + 46 (0)8 550-52000
English: In vitro studies in human hepatocytes indicated that crizotinib may induce pregnane X receptor (PXR)and constitutive androstane receptor (CAR)-regulated enzymes (e.g., CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
Maltese: CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
English: a. Neutropenia (Febrile neutropenia, Neutropenia, Neutrophil count decreased).
Maltese: Polinewropatija, Disturb sensorju, Sensazzjoni ta' ħruq fil-ġilda).
English: Cardiac disorders
Maltese: Kontraċettivi orali
English: Crizotinib significantly prolonged progression-free survival (PFS), the primary objective of the study, compared to chemotherapy as assessed by IRR.
Maltese: Crizotinib tawwal b'mod sinifikanti s-sopravivenza bla progressjoni (PFS), l-għan primarju tal-istudju, meta mqabbel ma' kimoterapija kif evalwat minn IRR.
English: • Oedema (excess fluid in body tissue, causing swelling of the hands and feet).
Maltese: • Edima (fluwidu żejjed fit-tessut tal-ġisem, li jikkawża nefħa fl-idejn u fis-saqajn).
English: In particular, the following medicines may increase the risk of side effects with XALKORI:
Maltese: B'mod partikolari, il-mediċini li ġejjin jistgħu jżidu r-riskju ta' effetti sekondarji b'XALKORI:
English: Increases to Grade 3 or 4 ALT or AST elevations were observed in 187 (11%) and 95 (6%) of patients, respectively.
Maltese: Żidiet fl-livelli aktar għoljin tal-ALT jew AST ta' Grad 3 jew 4 ġew osservati f'187 (11%) u 95 (6%) tal-pazjenti rispettivament li kienu qegħdin jirċievu crizotinib.
English: The starting crizotinib dose for patients with moderate hepatic impairment (any AST and total bilirubin >1.5 × ULN and 3 × ULN) is recommended to be 200 mg twice daily.
Maltese: Id-doża tal-bidu ta' crizotinib għal pazjenti b'indeboliment epatiku moderat (kwalunkwe AST u bilirubina totali >1.5 × ULN u 3 × ULN) hija rakkomandata li tkun 200 mg darbtejn kuljum.
English: In Study 1007, the median duration of study treatment was 48 weeks for patients in the crizotinib arm (N=172).
Maltese: Fi Studju 1007, it-tul medjan tat-trattament tal-istudju kien ta' 48 ġimgħa għall-pazjenti fil-fergħa ta' crizotinib (N=172).
English: The primary metabolic pathways in humans were oxidation of the piperidine ring to crizotinib lactam and O-dealkylation, with subsequent Phase 2 conjugation of O-dealkylated metabolites.
Maltese: Il-mogħdijiet metaboliċi primarji fil-bnedmin kienu l-ossidazzjoni tal-piperidine ring għal crizotinib lactam u O-dealkilazzjoni, bil-konjugazzjoni sussegwenti tal-Fażi 2 ta' metaboliti
English: Interstitial lung diseasei
Maltese: Mediċini oħra u XALKORI
English: Crizotinib resulted in a significantly lower deterioration from baseline in peripheral neuropathy (Cycles 6 to 20; p-value <0.05), dysphagia (Cycles 5 to 11; p-value <0.05) and sore mouth (Cycle 2 to 20; p-value <0.05) compared to chemotherapy.
Maltese: Crizotinib wera titjib sinifikament akbar mil-linja bażi meta mqabbel mal-kimoterapija fl-alopeċja (Ċikli 2 sa 15; valur p <0.05), is-sogħla (Ċikli 2 sa 20; valur p <0.
English: Vivian Corporation Ltd. Tel: + 356 21344610
Maltese: Tel: + 356 21344610
English: Crizotinib significantly prolonged PFS, the primary objective of the study, compared to chemotherapy as assessed by IRR.
Maltese: Crizotinib tawwal b'mod sinifikanti l-PFS, l-għan primarju tal-istudju, meta mqabbel mal-kimoterapija kif valutat permezz tal-IRR.
English: In 1722 patients treated with crizotinib with either ALK-positive or ROS1-positive NSCLC across clinical studies, the most frequent adverse reactions (≥3%) associated with dosing interruptions were neutropenia, elevated transaminases, vomiting, and nausea.
Maltese: F'1722 pazjenti ttrattati bi crizotinib jew b'NSCLC pożittiv għallALK jew għal ROS1 fl-istudji kliniċi, l-aktar reazzjonijiet avversi frekwenti (≥3%) assoċjati ma' interruzzjonijiet tad-dożaġġ kienu newtropenija, żieda fit-transaminases, rimettar u dardir.
English: Vision disordere (63%)
Maltese: Disgewżja (21%)
English: A high-fat meal reduced crizotinib AUCinf and Cmax by approximately 14% when a 250 mg single dose was given to healthy volunteers.
Maltese: Ikla b'ħafna xaħam naqqset l-AUCinf u s-Cmax ta' crizotinib bi kważi 14% meta ngħatat doża waħda ta' 250 mg lil voluntiera b'saħħithom.
English: Avoid using crizotinib in combination with other bradycardic agents, medicinal products that are known to prolong QT interval and/or antiarrhythmics (see section 4.4 QT interval prolongation, Bradycardia, and section 4.5).
Maltese: Għandu jiġi evitat l-użu ta' crizotinib flimkien ma' sustanzi bradikardijaċi oħra, prodotti mediċinali li huma magħrufa li jtawlu l-intervall QT u/jew sustanzi kontra l-arritmiji (ara sezzjoni 4.4
English: j. Abdominal pain (Abdominal discomfort, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness).
Maltese: Uġigħ addominali (Skonfort addominali, Uġigħ addominali, Uġigħ addominali fil-parti t'isfel, Uġigħ addominali fil-parti ta' fuq, Sensittività addominali).
English: QT prolongation may clinically manifest as bradycardia, dizziness, and syncope.
Maltese: Titwil tal-intervall QT, Bradikardija, u sezzjoni 4.5).
English: An adjustment of the dose of crizotinib is recommended when administering crizotinib to patients with moderate or severe hepatic impairment (see sections 4.2 and 4.4).
Maltese: Huwa rakkomandat aġġustament fid-doża ta' crizotinib meta crizotinib jingħata lil pazjenti b'indeboliment epatiku moderat jew sever (ara sezzjonijiet 4.2 u 4.4).
English: Kaplan-Meier curves for progression-free survival (based on IRR) by treatment arm in randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALK-positive advanced NSCLC
Maltese: Kurvi ta' Kaplan-Meier għal sopravivenza bla progressjoni (ibbażata fuq IRR) skont il-fergħa tat-trattament, fi Studju 1014, ta' Fażi 3 magħmul b'għażla każwali (popolazzjoni sħiħa tal-analiżi), f'pazjenti b'NSCLC avvanzat pożittiv għall-ALK, li ma rċevewx trattament qabel
English: Overall Survivald
Maltese: Bijotrasformazzjoni
English: d. Neuropathy (Burning sensation, Dysaesthesia, Formication, Gait disturbance, Hyperaesthesia, Hypoaesthesia, Hypotonia, Motor dysfunction, Muscle atrophy, Muscular weakness, Neuralgia, Neuritis, Neuropathy peripheral, Neurotoxicity, Paraesthesia, Peripheral motor neuropathy, Peripheral sensorimotor neuropathy, Peripheral sensory neuropathy, Peroneal nerve palsy, Polyneuropathy, Sensory disturbance, Skin burning sensation).
Maltese: Newropatija periferali, Newrotossiċità, Parasteżija, Newropatija periferali tal-moviment, Newropatija periferali sensorja u tal-moviment, Newropatija periferali sensorja, Paralisi tan-nervaturi peroneali,
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are substrates of OCT1 or OCT2 (see section 4.5).
Maltese: Għalhekk, crizotinib jista' jkollu l-potenzjal li jżid ilkonċentrazzjonijiet fil-plażma ta' mediċini mogħtija fl-istess żmien u li huma substrati ta' OCT1 jew OCT2 (ara sezzjoni 4.5).
English: Blood creatinine increase and creatinine clearance decreased were observed in patients in clinical studies with crizotinib.
Maltese: Żieda fil-kreatinina tad-demm u tnaqqis fl-eliminazzjoni tal-kreatinina ġew osservati f'pazjenti fi studji kliniċi bi crizotinib.
English: Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE16.
Maltese: Sustanzi antineoplastiċi, inibitur tal-protein-tyrosine kinase;
English: • Colchicine, used to treat gout.
Maltese: • Colchicine, użat sabiex jittratta l-gotta.
English: Table 6: ALK-positive advanced NSCLC efficacy results from Studies 1001 and 1005 Efficacy Parameter
Maltese: Riżultati tal-effikaċja tal-NSCLC avvanzat pożittiv għall-ALK mill-Istudji 1001 u Parametru tal-Effikaċja
English: Time to Deterioration (TTD) was prespecified as the first occurrence of a ≥10-point increase in scores from baseline in symptoms of pain in chest, cough, or dyspnoea as assessed by EORTC QLQ-LC13.
Maltese: Żmien għal Aggravament (Time to Deterioration (TTD)) ġie speċifikat minn qabel bħala l-ewwel okkorrenza ta' żieda ta' ≥10 punti fil-punteġġi mil-linja bażi fis-sintomi ta' wġigħ fis-sider, sogħla, jew qtugħ ta' nifs kif evalwat minn EORTC QLQ-LC13.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg crizotinib.
Maltese: Kull kapsula iebsa fiha 200 mg crizotinib.
English: • Reduction in the number of red blood cells (anaemia).
Maltese: • Tnaqqis fin-numru ta' ċelloli ħomor tad-demm (anemija).
English: Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension), vision disorder, or fatigue while taking XALKORI (see sections 4.2, 4.4 and 4.8).
Maltese: Għandha ssir attenzjoni meta persuna ssuq jew tħaddem magni peress li l-pazjenti jistgħu jesperjenzaw bradikardija bis-sintomi (eż. sinkope, sturdament, pressjoni baxxa), disturbi fil-vista, jew għeja meta jkunu qegħdin jieħdu XALKORI (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: Neuropathyd (25%) Dysgeusia (21%)
Maltese: Newropatijad (25%)
English: The use of single-agent crizotinib in the treatment of ROS1-positive advanced NSCLC was investigated in multicenter, multinational, single-arm Study 1001.
Maltese: L-użu tas-sustanza unika crizotinib fit-trattament ta' NSCLC avvanzat pożittiv għal ROS1 ġie investigat fi Studju 1001 multiċentriku, multinazzjonali, ta' fergħa waħda.
English: • The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
Maltese: • Fl-adulti għat-trattament ta' kanċer avvanzat taċ-ċelloli mhux żgħar tal-pulmun (NSCLC)
English: In clinical studies with crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 4 visual field defect with vision loss has been reported in 4 (0.2%) patients.
Maltese: Fi studji kliniċi b'crizotinib f'pazjenti b'NSCLC pożittivi jew għal ALK jew għal ROS1 (N=1,722), ġie rrapportat difett fil-kamp viżwali ta' Grad 4 b'telf viżwali f'4 pazjenti (0.2%).
English: Table 3.
Maltese: Tabella 6.
English: Thirty-four of 1619 patients (2.1%) with at least 1 postbaseline ECG assessment were found to have QTcF ≥500 msec, and 79 of 1585 patients (5.0%) with a baseline and at least 1 postbaseline ECG assessment had an increase from baseline QTcF ≥60 msec by automated machine-read evaluation of ECG (see section 4.4).
Maltese: Inġabru ECGs serjali triplikati wara li ngħatat doża waħda u fi stat stabbli sabiex jiġi evalwat l-effett ta' crizotinib fuq lintervalli QT. Erba' u tletin minn 1,619-il pazjent (2.1%) b'mill-anqas valutazzjoni tal-ECG wara llinja bażi kellhom QTcF ≥500 msec, u 79 minn 1,585 pazjent (5.0%) b'linja bażi jew mill-anqas valutazzjoni tal-ECG wara l-linja bażi kellhom żieda mill-QTcF≥60 msec fil-linja bażi b'evalwazzjoni moqrija minn apparat awtomatizzat tal-ECG (ara sezzjoni 4.4).
English: Number of deaths, n (%) Median OS in months (95% CI)
Maltese: Rata ta' Rispons Oġġettiv % (95% CI)
English: • If you have vision disorders (seeing flashes of light, blurred vision, and double vision).
Maltese: • Jekk għandek disturbi fil-vista (tara raġġi qawwijin ta' dawl, vista mċajpra, u tara doppju).
English: Efficacy data from ROS1-positive advanced NSCLC patients from Study 1001 are provided in Table 7.
Maltese: Id-dejta dwar l-effikaċja minn pazjenti b'NSCLC avvanzat pożittiv għal ROS1 mill-Istudju 1001 hija pprovduta f'Tabella 7.
English: • If you are allergic to crizotinib or any of the other ingredients of this medicine (listed in Section 6, “What XALKORI contains”).
Maltese: • Jekk inti allerġiku għal crizotinib jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6, “X'fih XALKORI”).
English: The demographic and disease characteristics were 50% female, median age of 51 years, baseline ECOG performance status of 0 (32%) or 1 (55%), 61% White and 30% Asian, less than 1% were current smokers, 27% former smokers, 72% never smokers, 94% metastatic, and 98% of the cancers were classified as adenocarcinoma histology.
Maltese: Total ta' 149 pazjent b'NSCLC avvanzat pożittiv għall-ALK, li jinkludu 125 pazjent b'NSCLC avvanzat pożittiv għall-ALK ittrattati minn qabel ġew irreġistrati fl-Istudju 1001 fiż-żmien ta' meta ttieħdet l-aħħar dejta għall-analiżi ta' PFS u ORR. Il-karatteristiċi demografiċi u tal-marda kienu 50% nisa, età medjana ta' 51 sena, status tal-prestazzjoni tal-ECOG fil-linja bażi ta' 0 (32%) jew 1 (55%), 61% Bojod u 30% Asjatiċi, anqas minn 1% kienu persuni jpejpu f'dak il-mument, 27% persuni li kienu jpejpu fl-imgħoddi, 72% persuni li qatt ma pejpu, 94% metastatika u 98% kienu kklassifikati bħala istoloġija ta' adenokarċinoma.
English: Grapefruit or grapefruit juice should be avoided since it may increase crizotinib plasma concentration; St. John's wort should be avoided since it may decrease crizotinib plasma concentration (see section 4.5).
Maltese: Il-grejpfrut jew il-meraq talgrejpfrut għandu jiġi evitat peress li jista' jżid il-konċentrazzjoni ta' crizotinib fil-plażma; il-fexfiex tar-raba' (St. John's wort) għandu jiġi evitat peress li jista' jnaqqas il-konċentrazzjoni ta' crizotinib filplażma (ara sezzjoni 4.5).
English: In Study 1014, the median duration of study treatment was 47 weeks for patients in the crizotinib arm (N=171); the median duration of treatment was 23 weeks for patients who crossed over from the chemotherapy arm to receive crizotinib treatment (N=109).
Maltese: Fi Studju 1014, it-tul medjan tat-trattament tal-istudju kien ta' 47 ġimgħa għall-pazjenti filfergħa ta' crizotinib (N=171); it-tul medjan tat-trattament kien ta' 23 ġimgħa għall-pazjenti li qalbu mill-fergħa tal-kimoterapija biex jirċievu trattament bi crizotinib (N=109).
English: • Stomach upset, including vomiting, diarrhoea, nausea.
Maltese: • Stonku mqalleb, inkluż rimettar, dijarea, dardir.
English: Hypersensitivity to crizotinib or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal crizotinib jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Renal failure and acute renal failure were reported in patients treated with crizotinib in clinical trials and during post marketing.
Maltese: Indeboliment renali u indeboliment renali akut ġew irrapportati f'pazjenti ttrattati bi crizotinib fi provi kliniċi u matul wara t-tqegħid fis-suq.
English: If necessary, your doctor may decide to reduce the dose to 200 mg to be taken orally twice daily (total amount 400 mg) and if further dose reduction is necessary, to reduce it to 250 mg to be taken orally once daily.
Maltese: Jekk ikun hemm bżonn, it-tabib tiegħek jista' jiddeċiedi li jnaqqas id-doża għal 200 mg li għandha tittieħed darbtejn kuljum b'mod orali (ammont totali ta' 400 mg) u jekk ikun hemm bżonn ta' tnaqqis ulterjuri, jista' jnaqqasha għal 250 mg li għandha tittieħed darba kuljum b'mod orali.
English: Crizotinib should be discontinued in patients who develop gastrointestinal perforation.
Maltese: Crizotinib għandu jitwaqqaf f'pazjenti li jiżviluppaw perforazzjoni gastrointestinali.
English: ROS1-Positive Advanced NSCLC
Maltese: NSCLC Avvanzat Pożittiv għal ROS1
English: A monitoring of the QT interval should be made in case of combinations of such medicinal products (see sections 4.2 and 4.4).
Maltese: Għandu jsir monitoraġġ tal-intervall QT f'każ ta' kombinazzjonijiet ta' prodotti mediċinali bħal dawn (ara sezzjonijiet 4.2 u 4.4).
English: Withhold until recovery to Grade 1 or baseline, then resume at 250 mg once daily and escalate to 200 mg twice daily if clinically toleratedb,c
Maltese: Waqqaf sakemm isir irkupru għall-Grad 1 jew għall-linja bażi, imbagħad kompli b'250 mg darba kuljum u żid għal 200 mg darbtejn kuljum jekk ikun ittollerat klinikamentb,c
English: Significantly greater improvement in global QOL was observed in the crizotinib arm compared to the chemotherapy arm (overall difference in change from baseline scores 13.8; p-value <0.0001).
Maltese: Titjib akbar b'mod sinifikanti fil-QOL globali ġie osservat filfergħa ta' crizotinib, meta mqabbel mal-fergħa tal-kimoterapija (differenza globali fil-bidla millpunteġġi fil-linja bażi ta' 13.8; valur p <0.
English: • Permanently discontinue if unable to tolerate XALKORI 250 mg taken orally once daily
Maltese: • Waqqaf b'mod permanenti jekk il-pazjent ma jkunx jista' jittollera XALKORI 250 mg meħud mill-ħalq darba kuljum
English: Of the 53 ROS1-positive NSCLC patients in single arm Study 1001, 15 (28%) were 65 years or older.
Maltese: Mit-53 pazjent pożittiv għal NSCLC fi Studju 1001 ta' fergħa waħda, 15 (28%) kellhom 65 sena jew aktar.
English: Ophthalmological evaluation is recommended if vision disorder persists or worsens in severity (see section 4.8).
Maltese: Hija rrakkomandata evalwazzjoni oftalmoloġika jekk id-distub fil-vista jippersisti jew imur għallagħar fis-severità (ara sezzjoni 4.8).
English: Patients could continue treatment as assigned beyond the time of RECIST-defined disease progression at the discretion of the investigator if the patient was perceived to be experiencing clinical benefit.
Maltese: Il-pazjenti setgħu jkomplu t-trattament kif assenjat wara ż-żmien tal-progressjoni tal-marda definita minn RECIST fid-diskrezzjoni tal-investigatur jekk il-pazjent kien ipperċepit li kien qed ikollu benefiċċju kliniku.
English: Grade 4 Ocular Disorder (Visual Loss)
Maltese: Disturb tal-Għajnejn ta' Grad 4 (Telf Viżwali)
English: CTCAEa Grade
Maltese: Magnesium stearate
English: f. Permanently discontinue for recurrence.
Maltese: Waqqaf b'mod permanenti minħabba rikorrenza.
English: Median time to onset of increased Grade 3 or 4 transaminases was 43 days.
Maltese: Iż-żmien medjan sal-bidu tażżieda fit-transaminases ta' Grad 3 jew 4 kien ta' 43 ġurnata.
English: Grade 3 QTc prolongation
Maltese: Titwil fil-QTc ta' Grad 3
English: XALKORI is an anticancer medicine containing the active substance crizotinib used to treat adults with a type of lung cancer called non-small cell lung cancer, that presents with a specific rearrangement or defect in either a gene called anaplastic lymphoma kinase (ALK) or a gene called ROS1.
Maltese: XALKORI huwa mediċina għal kontra l-kanċer li fih s-sustanza attiva crizotinib li tittratta adulti li għandhom tip ta' kanċer tal-pulmun li jissejjaħ kanċer tal-pulmun b'ċelloli mhux żgħar, li jippreżenta ruħu b'arranġament mill-ġdid jew difett speċifiku jew f'ġene msejjaħ kinase tal-limfoma anaplastika (ALK) jew ġene msejjaħ ROS1.
English: In clinical studies with crizotinib and during post marketing surveillance, severe, life-threatening, or fatal adverse reactions of cardiac failure were reported (see section 4.8).
Maltese: Fi studji kliniċi bi crizotinib u waqt is-sorveljanza wara t-tqegħid fis-suq, kienu rrapportati reazzjonijiet avversi severi, ta' theddida għall-ħajja jew fatali ta' insuffiċjenza tal-qalb (ara sezzjoni 4.8).
English: Assessment should be performed by laboratories with demonstrated proficiency in the specific technology being utilised (see section 4.4).
Maltese: Il-valutazzjoni għandha titwettaq minn laboratorji bi profiċjenza murija fit-teknoloġija speċifika użata (ara sezzjoni 4.4).
English: After a single 250 mg dose in subjects with severe renal impairment (CLcr <30 mL/min) not requiring peritoneal dialysis or haemodialysis, crizotinib AUCinf and Cmax increased by 79% and 34%, respectively, compared to those with normal renal function.
Maltese: Wara doża waħda ta' 250 mg f'suġġetti b'indeboliment renali sever (CLcr <30 mL/min) li m'għandhomx bżonn ta' dijaliżi fil-peritonew jew emodijaliżi, l-AUC u Cmax ta' crizotinib żdiedu b'79% u 24%, rispettivament, meta mqabbla ma' dawk b'funzjoni normali tal-kliewi.
English: An ECG substudy using blinded manual ECG measurements was conducted in 52 ALK-positive NSCLC patients who received crizotinib 250 mg twice daily.
Maltese: Twettaq sottostudju dwar l-ECG bl-użu ta' kejl manwali blinded tal-ECG fi 52 pazjent b'NSCLC pożittiv għall-ALK li rċevew crizotinib 250 mg darbtejn kuljum.
English: Abbreviations: CI=confidence interval; N/n=number of patients.
Maltese: CI=intervall ta' kunfidenza; N/n=numru ta' pazjenti; a.
English: There were no permanent discontinuations associated with vision disorder for any of the 1722 patients treated with crizotinib.
Maltese: Ma kien hemm l-ebda waqfien permanenti assoċjat ma' disturb fil-vista għal kwalunkwe mill-1,722 pazjent ittrattati bi crizotinib.
English: A total of 162 patients in the crizotinib arm and 151 patients in the chemotherapy arm had completed the EORTC QLQ-C30 and LC13 questionnaires at baseline and at least 1 postbaseline visit.
Maltese: Total ta' 162 pazjent mill-pazjenti li rċivew crizotinib u 151 pazjent millpazjent li rċivew il-kimoterapija kienu lestew il-kwestjonarji
English: 2013; OS is based on the last patient last visit date of 30 November 2016, and is based on a median follow up of approximately 46 months.
Maltese: L-OS hija bbażata fuq id-data tal-aħħar vista tal-aħħar pazjent tat-30 ta' Novembru 2016, u hija bbażata fuq segwitu medjan ta' madwar 46 xahar.
English: Therefore, clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the hepatic or renal uptake of medicinal products that are substrates for these transporters.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: XALKORI 250 mg hard capsules Each hard capsule contains 250 mg of crizotinib.
Maltese: Kull kapsula iebsa fiha 250 mg crizotinib.
English: MA (EU) number (Invented) name
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 10 November 2017
Maltese: 10 ta' Novembru 2017
English: It contains the active substance pembrolizumab.
Maltese: Dan fih is-sustanza attiva pembrolizumab.