FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of a single 750 mg fasted ceritinib dose with a proton pump inhibitor (esomeprazole) 40 mg daily for 6 days in healthy, fasting subjects decreased ceritinib AUC by 76% and Cmax by 79%.
Maltese: L-għoti flimkien ta' doża waħda ta' ceritinib 750 mg fi stat sajjem ma' inibitur tal-pompa tal-proton (esomeprazole) 40 mg kuljum għal 6 ijiem f'individwi f'saħħithom sawma naqqas l-AUC ta' ceritinib b'76% u s-Cmax b'79%.
English: Novartis Pharma GmbH Roonstraße 25
Maltese: Roonstraße 25
English: There were 58 patients (6.3%) with a QTc increase from baseline >60 msec. A central tendency analysis of the QTc data at average steady-state concentration from Study A2301 demonstrated that the upper bound of the 2-sided 90% CI for QTc increase from baseline was 15.3 msec at Zykadia 750 mg fasted.
Maltese: Analiżi tat-tendenza ċentrali tad-dejta QTc fil-konċentrazzjoni medja fi stat wieqaf millIstudju A2301 uriet lil-limitu superjuri taż-żewġ naħat tad-90% CI għaż-żieda ta' QTc mil-linja bażi kienet ta' 15.3 msek b'750 mg Zykadia fi stat sajjem.
English: Ceritinib AUCinf values were approximately 39% and 64% higher (Cmax approximately 42% and 58% higher) in healthy subjects when a single 750 mg ceritinib dose (tablet) was administered with a low fat meal (containing approximately 330 kcalories and 9 grams of fat) and a high fat meal (containing approximately 1000 kcalories and 58 grams of fat), respectively, as compared with the fasted state.
Maltese: Il-valuri AUCinf ta' ceritinib kienu madwar 39% u 64% ogħla (Cmax ta' madwar 42% u 58% ogħla) f'individwi b'saħħithom meta ngħatat doża waħda ta' ceritinib ta' 750 mg (pillola) ma' ikla b'livell baxx ta' xaħam (li fiha madwar 330 kilokalorija u 9 grammi ta' xaħam) u ikla b'livell għoli ta' xaħam (li fiha madwar 1000 kilokalorija u 58 mg ta' xaħam), rispettivament, meta mqabbel mal-istat sajjem.
English: One hundred and eighty-nine (189) patients were randomised to ceritinib and one hundred eightyseven (187) were randomised to chemotherapy.
Maltese: Mija u tmienja u disgħin (189) pazjent kienu randomizzati għal ceritinib u mija sebgħa u tmenin (187) kienu randomizzati għall-kimoterapija.
English: In the event of vomiting, diarrhoea, dehydration or impaired renal function, correct electrolytes as clinically indicated.
Maltese: F'każ ta' rimettar, dijarrea, deidratazzjoni jew indeboliment tal-funzjoni tal-kliewi kkoreġi l-elettroliti kif indikat klinikament.
English: Table 5 ASCEND-8 (Study A2112) - Efficacy results in patients with previously untreated ALK-positive locally advanced or metastatic NSCLC by BIRC
Maltese: ASCEND-8 (Studju A2112) - Ir-riżultati tal-effikaċja f'pazjenti b'NSCLC lokalment avvanzat jew metastatiku pożittiv għal ALK li qabel kienu ttrattati mill-BIRC
English: The potential for QT interval prolongation of ceritinib was assessed in seven clinical studies with Zykadia.
Maltese: Il-potenzjal ta' titwil tal-intervall QT għal ceritinib kien evalwat f'seba' studji kliniċi b'Zykadia.
English: 52, median TTD 11.1 months [95% CI: 7.1, 14.2] in the ceritinib arm versus 2.1 months [95% CI: 1.0, 5.6] in the chemotherapy arm).
Maltese: 34; 95% CI: 0.22, 0. 52, TTD medjan 11.1 xhur [95% CI: 7.1, 14.2] fil-grupp ta' ceritinib meta mqabbel ma' 2.1 xhur [95% CI: 1.0, 5.6] fil-grupp tal-kimoterapija).
English: Tumour response (based on BIRC) Overall response rate (95% CI) Duration of response (based on BIRC) Number of responders Median, months d
Maltese: Rispons għat-tumur (abbażi ta' BIRC) Rata globali tar-rispons (95% CI) Tul tar-rispons (abbażi ta' BIRC) Numru ta' pazjenti li rrispondew Medjan, xhur d
English: The median PFS in patients without brain metastases was 26.3 months (95% CI: 15.4, 27.7) versus 8.3 months (95% CI: 6.0, 13.7) in the ceritinib and chemotherapy arms, respectively, with HR=0.48 (95% CI: 0.33, 0.69).
Maltese: Il-PFS medjana f'pazjenti mingħajr metastażijiet fil-moħħ kienet ta' 26.3 xhur (95% CI: 15.4, 27.7) meta mqabbla ma' 8.3 xhur (95% CI: 6.0, 13.7) fil-gruppi ta' ceritinib u tal-kimoterapija, rispettivament, b'HR=0.
English: Serial ECGs were collected following a single dose and at steady-state to evaluate the effect of ceritinib on the QT interval in 925 patients treated with Zykadia 750 mg once daily fasted.
Maltese: Inġabret serje ta' ECGs wara l-għoti ta' doża singola u waqt stat wieqaf sabiex issir evalwazzjoni taleffett ta' ceritinib fuq l-intervall tal-QT f'925 pazjent ittrattati b'Zykadia 750 mg darba kuljum fi stat sajjem.
English: Co-administration of ceritinib with substrates primarily metabolised by CYP2C9 or CYP2C9 substrates known to have narrow therapeutic indices (e.g. phenytoin and warfarin) should be avoided.
Maltese: Jekk dan ma jistax iseħħ, wieħed għandu jikkunsidra tnaqqis tad-doża f'każ ta' prodotti mediċinali mogħtija flimkien li huma sottostrati ta' CYP2C9 b'indiċijiet terapewtiċi dojoq.
English: The potential for Zykadia to cause infertility in male and female patients is unknown (see section 5.3).
Maltese: Il-potenzjal għal Zykadia li jikkawża infertilità f'pazjenti rġiel u nisa mhijiex magħrufa (ara sezzjoni 5.3).
English: A total of 81 previously untreated patients with ALK-positive locally advanced or metastatic NSCLC were randomised to receive Zykadia 450 mg once daily with food (N=41) or Zykadia 750 mg once daily under fasted conditions (N=40).
Maltese: Total ta' 81 pazjent li ma kinux ittrattati qabel b'NSCLC avvanzat jew metastatiku pożittiv għal ALK kienu randomizzati biex jirċievu Zykadia 450 mg darba kuljum mal-ikel (N=41) jew Zykadia 750 mg darba kuljum f'kundizzjonijiet ta' sawm (N=40).
English: Significantly decreased urine flow (potential sign of a kidney problem)
Maltese: Ħruq ta' stonku (sinjal potenzjali ta' disturb fil-passaġġ diġestiv)
English: Limited information is available in ALK-positive NSCLC patients with non-adenocarcinoma histology.
Maltese: Teżisti informazzjoni limitata f'pazjenti b'NSCLC pożittivi għal ALK b'istoloġija mhux adenokarċinoma.
English: Permanently discontinue Zykadia if no contributing concomitant medicinal product is identified.
Maltese: Waqqaf għal kollox Zykadia jekk il-prodott mediċinali konkomitanti kontributorju mhuwiex identifikat.
English: In study X2101 a total of 246 ALK-positive NSCLC patients were treated at a Zykadia dose of 750 mg once daily fasted: 163 who had received prior treatment with an ALK inhibitor and 83 who were ALK inhibitor naïve.
Maltese: Fl-Istudju X2101 total ta' 246 pazjent b'NSCLC pożittivi għal ALK kienu ttrattati b'doża ta' Zykadia ta' 750 mg darba kuljum fi stat sajjem: 163 li kienu rċevew trattament minn qabel b'inibitur tal-ALK u 83 li kienu naivi għall-inibitur tal-ALK.
English: Withhold Zykadia until recovery to baseline ALT/AST levels or to ≤3 times ULN, then reinitiate with dose reduced by 150 mg.
Maltese: Ieqaf ħu Zykadia sakemm terġa' tasal sal-livelli ALT/AST fil-linja bażi jew sa ≤3 darbiet l-ULN, imbagħad issokta billi tnaqqas id-doża b'150 mg.
English: Ceritinib AUCinf values were approximately 58% and 73% higher (Cmax approximately 43% and 41% higher) in healthy subjects when a single 500 mg ceritinib dose was administered with a low fat meal (containing approximately 330 kcalories and 9 grams of fat) and a high fat meal (containing approximately 1000 kcalories and 58 grams of fat), respectively, as compared with the fasted state.
Maltese: Il-valuri AUCinf ta' ceritinib kienu madwar 58% u 73% ogħla (Cmax ta' madwar 43% u 41% ogħla) f'individwi b'saħħithom meta ngħatat doża waħda ta' ceritinib ta' 500 mg ma' ikla b'livell baxx ta' xaħam (li fiha madwar 330 kilokalorija u 9 grammi ta' xaħam) u ikla b'livell għoli ta' xaħam (li fiha madwar 1000 kilokalorija u 58 mg ta' xaħam), rispettivament, meta mqabbel mal-istat sajjem.
English: The median age was 51 years (range: 29-80 years); 87.1% of patients were younger than 65 years and 50.0% were female.
Maltese: L-età medja kienet ta' 51 sena (firxa: 29-80 sena); 87.1% tal-pazjenti kellhom inqas minn 65 sena u 50.0% kienu nisa.
English: Complete Response (CR), Partial Response (PR) confirmed by repeat assessments performed not less than 4 weeks after response criteria were first met Overall response rate determined based on BIRC assessment per RECIST 1.1 Exact binomial 95% confidence interval
Maltese: Rata ta' rispons globali ddeterminata abbażi ta' valutazzjoni BIRC skont RECIST 1.1 Intervall ta' kunfidenza ta' 95 % b'binomju eżatt
English: Of the 163 ALK-positive NSCLC patients who had received prior treatment with an ALK inhibitor, the median age was 52 years (range: 24-80 years); 86.5% were younger than 65 years and 54% were female.
Maltese: Minn fost il-163 pazjent b'NSCLC pożittivi għall-ALK li kienu ngħataw trattament minn qabel b'inibitur ta' ALK, l-età medja kienet ta' 52 sena (firxa: 24-80 sena); 86.5% kellhom inqas minn 65 sena u 54% kienu nisa.
English: Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Maltese: Zykadia bħala monoterapija hu indikat għat-trattament ta' pazjenti adulti b'kanċer avvanzat taċ-ċelluli mhux żgħar tal-pulmun (NSCLC) pożittiv għall-kinasi tal-limfoma anaplastika (ALK) li fl-imgħoddi kienu ttrattati bi crizotinib.
English: Ceritinib significantly prolonged time to deterioration for the lung cancer specific symptoms of interest of cough, pain and dyspnoea (composite endpoint LCSS: HR=0.40; 95% CI: 0.25, 0.65, median Time to Deterioration [TTD] 18.0 months [95% CI: 13.4, NE] in the ceritinib arm versus 4.4 months [95% CI: 1.6, 8.6] in the chemotherapy arm; LC13: HR=0.34; 95% CI: 0.22, 0.
Maltese: HR=0.40; 95% CI: 0.25, 0.65, Żmien medjan għal Detorjazzjoni [TTD] 18.0 xhur [95% CI: 13.4, NE] fil-grupp ta' ceritinib meta mqabbel ma' 4.4 xhur [95% CI: 1.6, 8.6] fil-grupp tal-kimoterapija;
English: Zykadia dosing
Maltese: Kif jaħdem Zykadia
English: colchicine, a medicine used to treat gout.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Figure 1 ASCEND-4 (Study A2301) - Kaplan-Meier curves of progression-free survival as assessed by BIRC
Maltese: (Studju A2301) - Kurvi Kaplan-Meier ta' sopravivenza mingħajr progressjoni kif ivvalutat minn BIRC
English: The PFS benefit of Zykadia was consistent across various subgroups including age, gender, race, smoking class, ECOG performance status, and presence of brain metastases or prior response to crizotinib.
Maltese: Il-benefiċċju tal-PFS ta' Zykadia kien konsistenti fid-diversi sottogruppi inklużi l-età, is-sess, ir-razza, il-klassi ta' tipjip, l-istatus ta' prestazzjoni ECOG, u l-preżenza ta' metastażijiet fil-moħħ jew rispons minn qabel għal crizotinib.
English: Effects on the thyroid were observed in both rat (mild increases in thyroid stimulating hormone and triiodothyronine/thyroxine T3/T4 concentrations with no microscopic correlate) and monkey (depletion of colloid in males in 4-week study, and one monkey at high dose with diffuse follicular cell hyperplasia and increased thyroid stimulating hormone in 13-week study).
Maltese: L-effetti fuq it-tirojde kienu osservati kemm fil-firien (żidiet ħfief fl-ormonju li jistimola t-tirojde u konċentrazzjonijiet ta' triiodothyronine/thyroxine T3/T4 mingħajr ebda korrelazzjoni mikroskopika) kif ukoll fix-xadini (tnaqqis ta' kollojde fl-irġiel fi studju ta' 4 ġimgħat, u xadina waħda b'doża għolja b'iperplasija diffuża fiċ-ċelloli follikulari u żieda fl-ormonju li jistimola t-tirojde fi studju ta' 13-il ġimgħa).
English: In healthy subjects, co-administration of a single 450 mg fasted ceritinib dose with ketoconazole (200 mg twice daily for 14 days), a strong CYP3A/P-gp inhibitor, resulted in 2.9-fold and 1.2-fold increase in ceritinib AUCinf and Cmax, respectively, compared to when ceritinib was given alone.
Maltese: F'pazjenti b'saħħithom, l-għoti ta' doża waħda ta' 450 mg ceritinib fi stat sajjem ma' ketoconazole (200 mg darbtejn kuljum għal 14-il jum), inibitur qawwi ta' CYP3A/P-gp, wassal għal żieda ta' 2.9 drabi u 1.2 drabi fl-AUCinf u s-Cmax ta' ceritinib, rispettivament, imqabbel ma' meta ceritinib ingħata waħdu.
English: Patients should be monitored for lipase and amylase elevations prior to the start of Zykadia treatment and periodically thereafter as clinically indicated (see sections 4.2 and 4.8).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal żidiet ta' lipase u amylase qabel il-bidu ta' trattament b'Zykadia u wara dan perjodikament kif indikat klinikament (ara sezzjonijiet 4.2 u 4.8).
English: Renal failure (acute renal injury, renal failure)
Maltese: Insuffiċjenza renali (ħsara renali akuta, insuffiċjenza renali)
English: Use of Zykadia in combination with other agents known to cause bradycardia (e.g. beta blockers, non-dihydropyridine calcium channel blockers, clonidine and digoxin) should be avoided as far as possible.
Maltese: L-użu ta' Zykadia flimkien ma' aġenti oħrajn magħrufin li jikkawżaw bradikardija (eż. imblukkaturi beta, imblukkaturi tal-kanal tal-kalċju mhux diidropiridini, klonidina u digoksina) għandhom ikunu evitati kemm jista' jkun.
English: Capsule with white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body, containing white to almost white powder.
Maltese: Kapsula b'qafas opak abjad u b'tapp opak blu, b'“LDK 150MG” stampata fuq it-tapp u b'“NVR” fuq il-qafas, li fiha trab abjad għal kważi abjad.
English: Tumour responses (based on BIRC) Objective response rate (95% CI) Duration of response Number of responders Median, months d
Maltese: Risponsi għat-tumuri (abbażi ta' BIRC) Rata ta' rispons oġġettiva (95% CI) Tul tar-rispons Numru ta' pazjenti li rrispondew Medjan, xhur d
English: In the dose optimisation study A2112 (ASCEND-8) in both previously treated and untreated patients with ALK-positive advanced NSCLC at the recommended dose of ceritinib 450 mg taken with food (N=89), adverse events of diarrhoea, nausea and vomiting were mainly grade 1 (49.4%).
Maltese: Fl-istudju A2112 ta' ottimizzazzjoni tad-doża (ASCEND-8) kemm f'pazjenti li kienu ttrattati qabel kif ukoll f'dawk mhux ittrattati qabel b'NSCLC avvanzat pożittiv għal ALK fid-doża rrakkomandata ta' ceritinib 450 mg meħuda mal-ikel (N=89), avvenimenti avversi ta' dijarea, dardir u rimettar kienu prinċipalment ta' grad 1 (49.4 %).
English: Ceritinib has been classified in vivo as a weak CYP2C9 inhibitor.
Maltese: Kienet osservata wkoll l-inibizzjoni ta' CYP3A dipendenti fuq il-ħin.
English: Across seven clinical studies, 168 out of 925 patients (18.2%) treated with Zykadia were aged 65 years or older.
Maltese: Mis-seba' studji kliniċi li saru, 168 minn 925 pazjent (118.2%) ttrattati b'Zykadia kellhom 65 sena jew aktar.
English: Reproductive toxicology studies (i.e. embryo-foetal development studies) in pregnant rats and rabbits indicated no foetotoxicity or teratogenicity after dosing with ceritinib during organogenesis; however, maternal plasma exposure was less than that observed at the recommended human dose.
Maltese: Studji tossikoloġiċi riproduttivi (i.e. studji dwar l-iżvilupp embrijofetali) f'firien u fniek tqal ma indikaw l-ebda fetotossiċità jew teratoġeniċità wara l-għoti ta' ceritinib matul l-organoġenesi; madanakollu, espożizzjoni għall-plażma maternali kien anqas minn dak osservat meta ngħatat id-doża rrakkomandata fil-bniedem.
English: In patients treated with Zykadia 450 mg with food, 10% of patients had an adverse event that required at least one dose reduction and 42% of patients had an adverse event that required at least one dose interruption.
Maltese: F'pazjenti ttrattati b'Zykardia 450 mg mal-ikel, 10 % tal-pazjenti kellhom avveniment avvers li kien jeħtieġ mill-inqas tnaqqis ta' doża waħda u 42 % tal-pazjenti kellhom avveniment avvers li kien jeħtieġ tal-inqas twaqqif ta' doża waħda.
English: Patient reported outcome questionnaires were collected using the EORTC QLQ C30/LC13, LCSS and EQ-5D-5L.
Maltese: Il-kwestjonarji tal-eżiti rrapportati mill-pazjenti (Skala tas-sintomi ta' kanċer fil-pulmun [LCSS], EORTC-QLQ-C30 [C30], EORTC
English: Diarrhoea, nausea, or vomiting occurred in 74.2% of 89 patients treated with Zykadia at the recommended dose of 450 mg taken with food in a dose optimisation study and were mainly grade 1 events (49.4%).
Maltese: Dijarea, dardir jew rimettar seħħew f'74.2 % mid-89 pazjent ittrattati b'Zykadia bid-doża rrakkomandata ta' 450 mg meħuda mal-ikel fi studju ta' ottimizzazzjoni tad-doża u kienu prinċipalment avvenimenti ta' grad 1 (49.4%).
English: Other potential causes of ILD/pneumonitis should be excluded, and Zykadia permanently discontinued in patients diagnosed with any grade treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Maltese: ILD/pulmonite riżultat tat-trattament ta' kwalunkwe grad mogħti (ara sezzjonijiet 4.2 u 4.8).
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali mhux biżżejjed biex juru xi effetti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: The frequency of selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) are based on patients treated with a dose of 450 mg once-daily with food (N=89).
Maltese: Il-frekwenza ta' ADRs gastrointestinali magħżula (dijarea, dardir u rimettar) huma bbażati fuq pazjenti ttrattati b'doża ta' 450 mg darba kuljum mal-ikel (N=89).
English: The incidence and severity of gastrointestinal adverse drug reactions were higher for patients treated with Zykadia 750 mg fasted (diarrhoea 76%, nausea 50%, vomiting 56%; 12% reported a grade 3/4 event) compared to 450 mg with food (diarrhoea 56%, nausea 45%, vomiting 35%; 1.1% reported a grade 3/4 event).
Maltese: Pazjent wieħed (1.1%) kellu dijarea ta' grad 3. Seba' pazjenti (7.9%) kienu jeħtieġu interruzzjoni tal-mediċina tal-istudju minħabba dijarea jew dardir. Linċidenza u s-severità ta' reazzjonijiet gastrointestinali avversi tal-mediċina kienu ogħla għal pazjenti ttrattati b'Zykadia 750 mg fi stat sajjem (dijarea 76%, dardir 50%, rimettar 56%; 12% irrappurtaw avveniment ta' grad 3/4) meta mqabbla ma' 450 mg mal-ikel (dijarea 56%, dardir 45%, rimettar 35%; 1.1% irrappurtaw avveniment ta' grad 3/4).
English: Recovery of unchanged ceritinib in the faeces accounts for a mean 68% of an oral dose.
Maltese: L-irkupru ta' ceritinib mhux mibdul fl-ippurgar ilaħħaq medja ta' 68% tad-doża orali.
English: Hazard Ratio = 0.49 95% CI (0.36;0.67)
Maltese: Proporzjon ta' Periklu = 0.49 95% CI (0.
English: Severe, life-threatening or fatal ILD/pneumonitis have been observed in patients treated with ceritinib in clinical studies.
Maltese: ILD/pulmonite gravi u ta' theddida għall-ħajja jew fatali f'pazjenti ttrattati b'ceritinib waqt studji kliniċi.
English: Nausea e
Maltese: Tqala u treddigħ
English: Nausea, diarrhoea and vomiting were among the most commonly reported gastrointestinal events.
Maltese: Id-dardir, id-dijarrea u r-rimettar kienu fost l-aktar avvenimenti gastrointestinali komuni li ġew irrapportati.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara “EXP/JIS”.
English: In the majority of NSCLC cases, EML4 is the translocation partner for ALK; this generates an EML4-ALK fusion protein containing the protein kinase domain of ALK fused to the N-terminal part of EML4.
Maltese: Fil-biċċa l-kbira tal-każijiet NSCLC, EML4 hu l-imsieħeb fit-translokazzjoni għal ALK; dan jiġġenera l-fużjoni tal-proteina EML4-ALK li fiha d-dominju talproteina tal-kinai ta' ALK magħġuna mal-parti terminali-N ta' EML4.
English: Concurrent elevations of ALT or AST greater than 3× ULN and total bilirubin greater than 2× ULN without elevated alkaline phosphatase have been observed in less than 1% of patients in clinical studies with ceritinib.
Maltese: Kienu osservati elevazzjonijiet fl-istess ħin ta' ALT jew AST ta' aktar minn 3× ULN u bilirubin totali ta' aktar minn 2× ULN mingħajr fosfatażi alkalina elevata f'inqas minn 1% tal-pazjenti fi studji kliniċi b'ceritinib.
English: How to store Zykadia
Maltese: Kemm iddum tieħu Zykadia
English: A total of 231 patients with advanced ALK positive NSCLC who have received prior treatment with crizotinib and chemotherapy (one or two regimen including a platinum-based doublet) were included in the analysis.
Maltese: Total ta' 231 pazjent b'NSCLC avvanzat b'ALK-pożittiv li ngħataw trattament minn qabel b'crizotinib u b'kimoterapija (kors wieħed jew tnejn li jinkludi doublet ibbażata fuq il-platinu) kienu inklużi fl-analiżi.
English: Log rank p-value = <0.001
Maltese: Valur-p tal-logrank = <0.
English: Following a single oral administration of radioactive ceritinib dose at 750 mg fasted, ceritinib was the main circulating component in human plasma.
Maltese: Wara l-għoti mill-ħalq ta' doża radjoattiva ta' 750 mg ceritinib fi stat sajjem, certinib kien ilkomponent ċirkulatorju ewlieni fil-plażma umana.
English: What Zykadia looks like and contents of the pack Zykadia film-coated tablets are light blue, round, biconvex with bevelled edges, without score, debossed with “NVR” on one side and “ZY1” on the other side.
Maltese: Il-pilloli miksija b'rita Zykadia huma ċelesti, tondi, bikonvessi bix-xfar imċanfra, mingħajr qasma, blittri “NVR” imbuzzati fuq naħa waħda u b'“ZY1” fuq in-naħa l-oħra.
English: Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Maltese: Zykadia huwa indikat bħala monoterapija għat-trattament primarju ta' pazjenti adulti b'kanċer avvanzat taċ-ċelluli mhux żgħar tal-pulmun (NSCLC) pożittiv għall-kinasi tal-limfoma anaplastika (ALK).
English: Cases of hyperglycaemia (all grades) have been reported in less than 10% of patients treated with ceritinib in clinical studies; grade 3-4 hyperglycaemia was reported in 5.4% of patients.
Maltese: Kienu rrappurtati każijiet ta' ipergliċemija (il-gradi kollha) f'anqas minn 10% tal-pazjenti ttrattati b'ceritinib waqt studji kliniċi; kienet irrappurtata ipergliċemijia fi grad 3-4 f'5.4% tal-pazjenti.
English: If the concomitant medicinal product can be adjusted or discontinued, Zykadia should be reinitiated with dose reduced by 150 mg on recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, with frequent monitoring (see sections 4.2 and 4.8).
Maltese: Jekk il-prodott mediċinali konkomitanti jista' jkun aġġustat jew imwaqqaf, Zykadia għandu jerġa' jinbeda b'doża mnaqqsa b'150 mg meta jkun hemm irkupru għal bradikardija asintomatika jew għal rata tal-qalb ta' 60 bpm jew aktar, b'monitoraġġ frekwenti (ara sezzjonijiet 4.2 u 4.8).
English: The overall survival (OS) data was not mature with 107 deaths representing approximately 42.3% of the required events for the final OS analysis.
Maltese: Id-dejta ta' sopravivenza globali (OS) ma kinitx matura b'107 imwiet li jirrappreżentaw madwar 42.3% tal-avvenimenti meħtieġa għall-analiżi OS finali.
English: What Zykadia contains The active substance of Zykadia is ceritinib.
Maltese: X'fih Zykadia Is-sustanza attiva ta' Zykadia hi ceritinib.
English: Limited experience in these patients showed a worsening of the underlying condition (hepatic encephalopathy) in 2 out of 10 patients exposed to 750 mg single doses of ceritinib under fasted conditions (see sections 4.2, 4.8 and 5.2).
Maltese: Esperjenza limitata f'dawn il-pazjenti wriet li l-kundizzjoni sottostanti (enċefalopatija tal-fwied) sejra għall-agħar f'2 minn kull 10 pazjenti esposti għal dożi waħdanija ta' 750 mg ta' ceritinib f'kundizzjonijiet ta' sawm (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: Kaplan-Meier medians (95% CI) (Months) ceritinib 750 mg: 16.6 (12.6, 27.2) Chemotherapy: 8.1 (5.8, 11.1) Logrank p-value = <0.001
Maltese: 95% CI (0.42, 0.73) Medjani Kaplan-Meier (95% CI) (Xhur) ceritinib 750 mg: 16.6 (12.6, 27.2) Kimoterapija:
English: Each film-coated tablet contains 150 mg ceritinib.
Maltese: Kull pillola miksija b'rita fiha 150 mg ceritinib.
English: Avoid concomitant use of strong CYP3A inhibitors during treatment with Zykadia.
Maltese: Evita l-użu konkomitanti ta' inibituri qawwija ta' CYP3A waqt it-trattament b'Zykadia.