FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on in vitro data, ceritinib competitively inhibits the metabolism of a CYP3A substrate, midazolam, and a CYP2C9 substrate, diclofenac.
Maltese: Skont dejta in vitro, ceritinib jinibixxi b'mod kompetittiv il-metaboliżmu tas-sottostrat ta' CYP3A, midazolam, u ta' sottostrat ta' CYP2C9, diclofenac.
English: Manufacturer Novartis Pharma GmbH Roonstraße 25
Maltese: Manifattur Novartis Pharma GmbH
English: Based on available data, ceritinib is eliminated primarily via the liver.
Maltese: Skont id-dejta disponibbli, ceritinib hu eliminat primarjament mill-fwied.
English: Based on in vitro data, ceritinib is predicted to inhibit intestinal P-gp and BCRP at clinically relevant concentrations.
Maltese: Skont dejta in vitro, ceritinib huwa previst li jinibixxi P-gp u BCRP intestinali f'konċentrazzjonijiet klinikament rilevanti.
English: Table 2 shows the frequency category of ADRs reported for Zykadia in patients treated at a dose of 750 mg fasted (N=925) in seven clinical studies.
Maltese: Tabella 2 turi l-kategorija tal-frekwenza tal-ADRs irrappurtati għal Zykadia f'pazjenti ttrattati biddoża ta' 750 mg fi stat sajjem (N=925) f'seba' studji kliniċi.
English: Efficacy results from ASCEND-8 are summarised in Table 5 below.
Maltese: Ir-riżultati tal-effikaċja minn ASCEND-8 huma mqassra fit-Tabella 5 ta' hawn taħt.
English: OS rate at 24 months d, % (95% CI)
Maltese: Rata OS wara 24 xahar d, % (95% CI)
English: No. of patients s till at risk
Maltese: Numru ta' pazjenti f'riskju
English: 90 hard capsules
Maltese: 90 kapsula iebsa
English: A risk for induction of other PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Maltese: Ma jistax jiġi eskluż kompletament riskju għal induzzjoni ta' enzimi oħrajn irregolati minn PXR minbarra CYP3A4.
English: Pericarditis (pericardial effusion, pericarditis)
Maltese: Perikardite (effużjoni perikardjali, perikardite)
English: Progression-free survival (based on BIRC) Number of events, n (%) Median, months d
Maltese: Sopravivenza mingħajr progressjoni (abbażi ta' BIRC) Numru ta' avvenimenti, n (%) Medjan, xhur d
English: The use of Zykadia in the treatment of ALK-positive NSCLC patients previously treated with an ALK inhibitor was investigated in two global, multicentre, open-label, single-arm phase 1/2 studies (Study X2101 and Study A2201).
Maltese: L-użu ta' Zykadia fit-trattament ta' pazjenti b'NSCLC pożittivi għall-ALK, li qabel kienu ttrattati b'inibitur ta' ALK, kien investigat f'żewġ studji globali, multiċentriċi, open-label, fost grupp wieħed ta' fażi 1/2 (Studju X2101 u Studju A2201).
English: The population characteristics across the two arms were: mean age 53 years, age less than 65 (79%), female (57%), Caucasian (54%), Asian (33%), never or former smoker (95%), WHO PS 0 or 1 (93%), adenocarcinoma histology (94%), and metastases to the brain (33%).
Maltese: Il-karatteristiċi tal-popolazzjoni fiż-żewġ fergħat kienu: età medja ta' 53 sena, età inqas minn 65 sena (79 %), nisa (57 %), Kawkasi (54 %), Asjatiċi (33 %), individwi li qatt ma pejpu jew individwi li kienu jpejpu (95 %), WHO PS 0 jew 1 (93 %), istoloġija tal-adenokarċinoma (94 %), u metastasi filmoħħ (33 %).
English: Vomiting e
Maltese: Dardir e
English: The PFS benefit was further supported by local investigator assessment, and analysis of overall response rate (ORR) and disease control rate (DCR).
Maltese: Il-benefiċċju għall-PFS kien appoġġjat ukoll permezz ta' valutazzjoni ta' investigatur lokali, u l-analiżi tar-rata ta' rispons globali (ORR) u tar-rata ta' kontroll tal-marda (DCR).
English: Oesophageal disorder (dyspepsia, gastro-oesophageal reflux disease, dysphagia)
Maltese: Disturb esofagali (dispepsja, marda tar-rifless gastroesofagali, disfaġja)
English: The ECOG performance status was 0/1/2 in 46.3%/47.6%/6.1% of patients respectively, and 58.0% had brain metastasis at baseline.
Maltese: L-istatus tal-prestazzjoni tal-ECOG kien 0/1/2 f'46.3%/47.6%/6.1% tal-pazjenti rispettivament, u 58.0% kellhom metastażi fil-moħħ fil-linja bażi.
English: The effect of hepatic impairment on the single-dose pharmacokinetics of ceritinib (750 mg under fasted conditions) was evaluated in subjects with mild (Child-Pugh class A; N=8), moderate (ChildPugh class B; N=7), or severe (Child-Pugh class C; N=7) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Maltese: L-effett tal-indeboliment tal-fwied fuq il-farmakokinetika ta' doża waħda ta' ceritinib (750 mg f'kundizzjonijiet ta' sawm) ġie evalwat f'individwi b'indeboliment tal-fwied ħafif (Child-Pugh klassi B; N = 8), moderat (Child-Pugh klassi B; N = 7), jew sever (Child-Pugh klassi C; N = 7) u fi 8 individwi b'saħħithom b'funzjoni tal-fwied normali.
English: Zykadia 150 mg tablets ceritinib
Maltese: Zykadia 150 mg pilloli ceritinib
English: Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis.
Maltese: Il-pazjenti għandhom ikunu mmonitorati minħabba sintomi pulmonari indikattivi ta' ILD/pulmonite.
English: In vitro studies suggest that ceritinib is a substrate for P-glycoprotein (P-gp), but not of breast cancer resistance protein (BCRP) or multi-resistance protein 2 (MRP2).
Maltese: Studji in vitro jissuġġerixxu li ceritinib hu sottostrat għal P-glkoproteina (Pgp), imma mhux ta' proteina reżistenti għall-kanċer tas-sider (BCRP) jew għal proteina 2 multireżistenti (MRP2).
English: Number of events, n (%) Median, months (95% CI) HR (95% CI)
Maltese: Sopravivenza globalic Numru ta' avvenimenti, n (%) Medjan, xhur (95% CI) HR (95% CI)
English: Persistent hyperglycaemia greater than 250 mg/dl despite optimal anti-hyperglycaemic therapy
Maltese: Ipergliċemija persistenti ta' aktar minn 250 mg/dl minkejja t-terapija ottimali antiipergliċemija
English: The tablets are provided in blisters and are available in a pack containing 84 tablets (4 blisters of 21 tablets).
Maltese: Il-pilloli jiġu f'folji u huma disponibbli f'pakketti li fihom 84 pillola (4 folji ta' 21 pillola).
English: The efficacy of Zykadia 450 mg with food was evaluated in a multicentre, open-label dose optimisation study A2112 (ASCEND-8).
Maltese: L-effikaċja ta' Zykadia 450 mg mal-ikel ġiet evalwata fi studju A2112 multiċentriku, bi prova miftuħa ta' ottimizzazzjoni tad-doża (ASCEND-8).
English: In vitro data show that the IC50 for the inhibitory effect of ceritinib on the hERG potassium channel was 0.4 micromolar.
Maltese: Dejta in vitro turi li l-IC50 għall-effett inibitorju ta' ceritinib fuq il-kanal tal-potassju hERG kien ta' 0.4 mikromolari.
English: If it is not possible to avoid concomitant use with strong CYP3A inhibitors (including, but not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone), reduce the ceritinib dose by approximately one third, rounded to the nearest multiple of the 150 mg dosage strength.
Maltese: Jekk ma jkunx possibbli li jiġi evitat l-użu flimkien b'inibituri qawwija ta' CYP3A (inkluż, iżda mhux limitat biss għal, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole u nefazodone), naqqas id-doża ta' ceritinib b'madwar terz, imqarrba sal-eqreb multiplu tal-qawwa tad-doża ta' 150 mg.
English: Ceritinib was demonstrated to be effective against EML4-ALK activity in a NSCLC cell line (H2228), resulting in inhibition of cell proliferation in vitro and regression of tumours in H2228-derived xenografts in mouse and rat.
Maltese: Intwera li Ceritinib kien effettiv kontra l-attività EML4-ALK fil-linja ċellulari NSCLS (H2228), li jwassal għal inibizzjoni talproliferazzjoni taċ-ċellula in vitro u għal rigressjoni tat-tumuri fi ksenotrapjanti minħabba H2228 filġrieden u l-firien.
English: The geometric mean AUCinf (unbound AUCinf) of ceritinib was increased by 18% (35%) and 2% (22%) in subjects with mild and moderate hepatic impairment, respectively, compared to subjects with normal hepatic function.
Maltese: L-AUCinf medju ġeometriku (AUCinf mhux marbut) ta' ceritinib żdied bi 18 % (35 %) u 2 % (22 %) f'individwi b'indeboliment tal-fwied ħafif u moderat, rispettivament, meta mqabbel ma' individwi b'funzjoni tal-fwied normali.
English: Cardiac disorders Pericarditis b
Maltese: Disturbi fil-qalb Perikardite b
English: Pack containing 84 film-coated tablets (4 blisters per pack).
Maltese: Pakkett li fih 84 pillola miksija b'rita (4 folji f'kull pakkett).
English: Addition of a thiol group to O-dealkylated ceritinib was also observed.
Maltese: Kienet osservata wkoll iż-żieda ta' grupp tjolu ma' ceritinib O-dealkylated.
English: Probability (%) of event-free
Maltese: Probabbiltà (%) li ma jkunx hemm avvenimenti
English: The frequency of these selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) is based on patients treated with the recommended dose of ceritinib 450 mg with food (N=89) in the study A2112 (ASCEND-8) (see subsection ‘Gastrointestinal adverse reactions' below)
Maltese: Il-frekwenza ta' dawn l-ADRs gastrointestinali magħżula (dijarea, dardir u rimettar) hija bbażata fuq pazjenti ttrattati bid-doża rrakkomandata ta' ceritinib 450 mg mal-ikel (N=89) fl-istudju A2112 (ASCEND-8) (ara s-sottosezzjoni “Reazzjonijiet gastrointestinali avversi” hawn taħt)
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blister containing 21 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih PVC/PCTFE (polyvinylchloride/poliklorotriflworotilena) - Folji tal-aluminju li fihom 21 pillola miksija b'rita.
English: Liver laboratory test abnormalities (alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, blood bilirubin increased, transaminases increased, hepatic enzyme increased, liver function test abnormal, liver function test increased, blood alkaline phosphatase increased)
Maltese: Testijiet fil-laboratorju dwar anormalitajiet fil-fwied (żieda fl-alanina aminotransferasi, żieda flaspartate aminotransferasi, żieda fil-gammaglutamiltransferasi, żieda fil-bilirubin fid-demm, żieda fittransaminasi, żieda fl-enzima epatika, test anormali tal-funzjoni tal-fwied, żieda fit-test tal-funzjoni tal-fwied, żieda fl-alkaline phosphatase fid-demm)
English: QTc >500 msec or >60 msec change from baseline and torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia
Maltese: Bidla fil-QTc ta' >500 msek jew >60 msek mil-linja bażi u torsade de pointes jew takikardja ventrikulari polimorfika jew sinjali/sintomi ta' arritmija serja
English: Zykadia is a cancer medicine that contains the active substance ceritinib.
Maltese: Zykadia huwa mediċina kontra l-kanċer li fiha s-sustanza attiva ceritinib.
English: In contrast, the steady-state AUC (90% CI) and Cmax (90% CI) for the 600 mg with food arm (N=30) increased by 24% (3%, 49%) and 25% (4%, 49%), respectively, compared to the 750 mg fasted arm.
Maltese: 600 mg mal-ikel (N=30) żdiedu b'24 % (3 %, 49 %) u b'25 % (4 %, 49 %), rispettivament, meta mqabbla mal-fergħa ta' 750 mg fi stat sajjem.
English: Figure 4 ASCEND-5 (Study A2303) - Kaplan-Meier plot of overall survival by treatment arm
Maltese: Figura 4 ASCEND-5 (Studju A2303) - Plott Kaplan-Meier ta' sopravivenza globali skont ilgrupp ta' trattament
English: The majority of patients were Caucasian (60.0%) or Asian (37.9%).
Maltese: Ilmaġġoranza tal-pazjenti kienu Kawkasji (60.0%) jew Asjatiċi (37.9%).
English: Cases of pancreatitis have been reported in patients treated with ceritinib (see section 4.8).
Maltese: F'pazjenti trattati b'ceritinib kienu irrappurtati każijiet ta' pankreatite (ara sezzjoni 4.8).
English: Main biotransformation pathways identified in healthy subjects included mono-oxygenation, O-dealkylation, and N-formylation.
Maltese: Il-mogħdijiet ewlenin tal-bijotrasformazzjoni identifikati f'suġġetti b'saħħithom inkludew mono-oxygenation, O-dealkylation, u N-formylation.
English: Patients who completed 4 cycles of chemotherapy (induction) without progressive disease subsequently received pemetrexed (500 mg/m2) as single-agent maintenance therapy every 21 days.
Maltese: Il-pazjenti li temmew 4 ċikli ta' kimoterapija (induzzjoni) mingħajr mard progressiv sussegwentement ingħataw pemetrexed (500 mg/m2) bħala terapija ta' manteniment b'aġent wieħed kull 21 jum.
English: Caution should be exercised with concomitant use of BCRP substrates (e.g. rosuvastatin, topotecan, sulfasalazine) and P-gp substrates (digoxin, dabigatran, colchicine, pravastatin) and ADRs carefully monitored.
Maltese: Wieħed għandu joqgħod attent meta juża flimkien sottostrati ta' BCRP (eż. rosuvastatin, topotecan, sulfasalazine) u sottostrati ta' P-gp (digoxin, dabigatran, colchicine, pravastatin) u għandu jkun hemm monitoraġġ għaqli tal-ADRs.
English: ADRs with an incidence of ≥10% in patients treated with Zykadia 750 mg fasted were diarrhoea, nausea, vomiting, fatigue, liver laboratory test abnormalities, abdominal pain, decreased appetite, weight decreased, constipation, blood creatinine increased, rash, anaemia and oesophageal disorder.
Maltese: ADRs b'inċidenza ta' ≥10% f'pazjenti ttrattati b'Zykadia 750 mg fi stat sajjem kienu dijarrea, dardir, rimettar, għeja, testijiet fil-laboratorju dwar anormalitajiet fil-fwied, uġigħ addominali, tnaqqis fl-aptit, tnaqqis fil-piż, konstipazzjoni, żieda fil-kreatinina tad-demm, raxx, anemija disturbi esofagali.
English: Based on a population pharmacokinetic analysis of 345 patients with mild renal impairment (CLcr 60 to <90 ml/min), 82 patients with moderate renal impairment (CLcr 30 to <60 ml/min) and 546 patients with normal renal function (≥90 ml/min), ceritinib exposures were similar in patients with mild and moderate renal impairment and normal renal function, suggesting that no dose adjustment is necessary in patients with mild to moderate renal impairment.
Maltese: Skont analiżi farmakokinetika tal-popolazzjoni ta' 345 pazjent b'indeboliment renali ħafif (CLcr 60 sa <90 ml/min), 82 pazjent b'indeboliment renali moderat (CLcr 30 sa <60 ml/min) u 546 pazjent b'funzjoni renali normali (≥90 ml/min), l-espożizzjonijiet għal ceritinib kienu jixxiebhu bejn ilpazjenti b'indeboliment ħafif u moderat u b'funzjoni renali normali, li jissuġġerixxi li mhux meħtieġ aġġustament tad-doża f'pazjenti b'indeboliment renali ħafif sa moderat.
English: Asymptomatic cases of bradycardia (heart rate less than 60 bpm) have been observed in 21 out of 925 (2.3%) patients treated with ceritinib in clinical studies.
Maltese: Kienu osservati każijiet asintomatiċi ta' bradikardija (rata tat-taħbit tal-qalb ta' inqas minn 60 bpm) f'21 minn 925 (2.3%) pazjent ittrattati b'ceritinib waqt studji kliniċi.
English: The majority of patients were Caucasian (66.3%) or Asian (28.8%).
Maltese: Il-maġġoranza tal-pazjenti kienu Kawkasji (66.3%) jew Asjatiċi (28.8%).
English: Medicines which may increase the risk of side effects with Zykadia: medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir).
Maltese: Mediċini li jistgħu jżidu r-riskju ta' effetti sekondarji b'Zykadia: mediċini użati biex jittrattaw l-AIDS/HIV (e.g. ritonavir, saquinavir). mediċini użati biex jittrattaw l-infezzjonijiet.
English: In a dose optimisation study A2112 (ASCEND-8) in patients comparing Zykadia 450 mg or 600 mg daily with food (approximately 100 to 500 kcalories and 1.5 to 15 grams of fat) to 750 mg daily under fasted conditions (dose and food condition of administration initially authorised), there was no clinically meaningful difference in the systemic steady-state exposure of ceritinib for the 450 mg with food arm (N=36) compared to the 750 mg fasted arm (N=31), with only small increases in steady-state AUC (90% CI) by 4% (-13%, 24%) and Cmax (90% CI) by 3% (-14%, 22%).
Maltese: Fi studju A2112 ta' ottimizzazzjoni tad-doża (ASCEND-8) fil-pazjenti li qabbel Zykadia 450 mg jew 600 mg mogħti kuljum mal-ikel (madwar 100 sa 500 kilokaloriji u 1.5 sa 15-il gramma ta' xaħam) ma' 750 mg kuljum f'kundizzjonijiet ta' sawn (id-doża u l-kondizzjoni tal-ikel tal-għoti awtorizzat inizjalment), ma kien hemm l-ebda differenza klinikament sinifikanti fl-espożizzjoni sistemika fi stat fiss ta' ceritinib għall-fergħa ta'450 mg mal-ikel (N=36) meta mqabbel ma' dik ta' 750 mg fi stat sajjem (N=31), b'żidiet żgħar biss fl-AUC fi stat fiss (90 % CI) b'4 % (-13 %, 24 %) u s-Cmax (90 % CI) bi 3 % (-14 %, 22 %).
English: Population pharmacokinetic analyses showed that age, gender and race had no clinically meaningful influence on ceritinib exposure.
Maltese: Analiżijiet farmakokinetiċi tal-popolazzjoni wrew li l-età, is-sess u r-razza ma kellhom l-ebda influwenza sinjifikanti klinikament fuq l-espożizzjoni għal ceritinib.
English: Pneumonitis (interstitial lung disease, pneumonitis)
Maltese: Pulmonite (mard tal-pulmun interstizzjali, pulmonite)
English: Lipase and/or amylase elevations
Maltese: Żidiet ta' lipase u/jew amylase
English: Duration of follow-up Median (months) (min - max) Progression-free survival (based on BIRC) Number of events, n (%) Median, months (95% CI) HR (95% CI)
Maltese: Tul tas-segwitu Medjan (xhur) (min - mass) Sopravivenza mingħajr progessjoni (abbażi ta' BIRC) Numru ta' avvenimenti, n (%) Medjan, xhur (95% CI) HR (95% CI)
English: In clinical studies, QT prolongation was observed with ceritinib.
Maltese: Kien osservat titwil tal-QTc f'pazjenti ttrattati b'ceritinib.
English: OS data was immature with 48 (41.7%) events in the ceritinib arm and 50 (43.1%) events in the chemotherapy arm, corresponding to approximately 50% of the required events for the final OS analysis.
Maltese: Id-dejta OS kienet immatura bi 48 (41.7%) avveniment fil-grupp ta' ceritinib u 50 (43.1%) avveniment fil-grupp tal-kimoterapija, li jikkorrispondu għal madwar 50% tal-avvenimenti meħtieġa għall-analiżi OS finali.
English: One hundred fifteen (115) patients were randomised to Zykadia and one hundred sixteen (116) were randomised to chemotherapy (either pemetrexed or docetaxel).
Maltese: Mija u ħmistax-il (115) pazjent kienu randomizzati għal Zykadia u mija u sittax (116) kienu randomizzati għal kimoterapija (pemetrexed jew docetaxel).
English: The incidence and severity of gastrointestinal adverse drug reactions were reduced for patients treated with Zykadia 450 mg with food (diarrhoea 56%, nausea 45%, vomiting 35%; 1.1% reported a grade 3/4 event) compared to 750 mg fasted (diarrhoea 76%, nausea 50%, vomiting 56%; 12% reported a grade 3/4 event).
Maltese: L-inċidenza u s-severità tar-reazzjonijiet gastrointestinali avversi għall-mediċina tnaqqsu għal pazjenti ttrattati b'Zykadia 450 mg mal-ikel (dijarea 56 %, dardir 45 %, rimettar 35 %; 1.1 % irrappurtaw avveniment ta' grad 3/4) meta mqabbel ma' 750 mg fi stat sajjem (dijarea 76 %, dardir 50 %, rimettar 56 %; 12 % irrappurtaw avveniment ta' grad 3/4).
English: Strong CYP3A and P-gp inducers
Maltese: Indutturi qawwija ta' CYP3A u P-gp
English: Study X2101: Responses assessed using RECIST 1.0 Study A2201: Responses assessed using RECIST 1.1 *Includes only patients with confirmed CR, PR
Maltese: Studju A2201: Rispons evalwat bl-użu ta' RECIST 1.1 *Jinkludi biss pazjenti b'CR, PR ikkonfermati
English: Zykadia 150 mg hard capsules
Maltese: Zykadia 150 mg kapsuli iebsa
English: Following single oral doses of ceritinib under fasted conditions, the geometric mean apparent plasma terminal half-life (T½) of ceritinib ranged from 31 to 41 hours in patients over the 400 to 750 mg dose range.
Maltese: Wara dożi singoli orali ta' ceritinib f'kundizzjonijiet ta' sawn, il-medja ġeometrika tal-half life terminali apparenti tal-plażma (T½) ta' ceritinib kienet ta' bejn 31 u 41 siegħa f'pazjenti mogħtija doża ta' aktar minn bejn 400 u 750 mg.
English: Adverse drug reactions (ADRs) described below reflect exposure to Zykadia 750 mg once daily fasted in 925 patients with ALK-positive advanced NSCLC across a pool of seven clinical studies including two randomised, active-controlled, phase 3 studies (studies A2301 and A2303).
Maltese: Ir-reazzjonijiet avversi għall-mediċina (ADRs) deskritti hawn taħt jirriflettu l-espożizzjoni ta' Zykadia 750 mg darba kuljum fi stat sajjem f'925 pazjent b'NSCLC b'ALK-pożittiv ittrattati f'ġabra ta' seba' studji kliniċi inklużi żewġ studji randomizzati, ikkontrollati b'mod attiv, ta' fażi 3 (studji A2301 u A2303).
English: Across the seven clinical studies, 9.7% of patients treated with ceritinib had events of QT prolongation (any grade), including grade 3 or 4 events in 2.1% of patients.
Maltese: Matul s-seba' studji kliniċi li saru, 9.7% talpazjenti ttrattati b'ceritinib kellhom avvenimenti ta' titwil tal-QT (fi kwalunkwe grad), inklużi avvenimenti tal-grad 3 jew 4 f'2.1% tal-pazjenti.
English: Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Maltese: Kawżi potenzjali oħrajn ta' ILD/pulmonite għandhom jiġu esklużi (ara sezzjonijiet 4.2 u 4.4).
English: Grade 3-4 ADRs with an incidence of ≥5% in patients treated with Zykadia 750 mg fasted were liver laboratory test abnormalities, fatigue, vomiting, hyperglycaemia, nausea and diarrhoea.
Maltese: ADRs fi grad 3-4 b'inċidenza ta' ≥5% f'pazjenti ttrattati b'Zykadia 750 mg fi stat sajjem kienu testijiet fil-laboratorju dwar anormalitajiet fil-fwied, għeja, rimettar, ipergliċemija, dardir u dijarrea.
English: Co-administration of a single dose of warfarin (a CYP2C9 substrate) following 3 weeks of ceritinib dosing in patients (750 mg daily fasted) increased the S-warfarin AUCinf (90% CI) by 54% (36%, 75%) compared to warfarin alone.
Maltese: L-għoti flimkien ta' doża waħda ta' warfarina (sottostrat ta' CYP2C9) wara 3 ġimgħat ta' dożi ta' ceritinib f'pazjenti (750 mg kuljum fi stat sajjem) żied l-AUCinf (90% CI) tal-warafarina-S b'54% (36%, 75%) imqabbel mal-warfarina waħidha.
English: Interstitial lung disease/Pneumonitis
Maltese: Marda tal-pulmun interstizzjali/Pulmonite
English: Lipase increased
Maltese: Żieda tal-lipase
English: Skin and subcutaneous tissue disorders Rash j
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Raxx j
English: Cases of hepatotoxicity occurred in 1.1% of patients receiving ceritinib in clinical studies.
Maltese: Kien hemm każijiet ta' epatotossiċità li seħħew f'1.1% tal-pazjenti mogħtija ceritinib waqt studji kliniċi.
English: A key secondary efficacy endpoint was ORR according to RECIST 1.1 as evaluated by BIRC.
Maltese: Punt aħħari tal-effikaċja sekondarja ewlieni kien l-ORR skont RECIST 1.1 kif evalwat mill-BIRC.
English: These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin).
Maltese: Dawn jinkludu mediċini li jittrattaw infezzjonijiet fungali (antifungali bħal ketoconazole, itraconazole, voriconazole, posaconazole) u mediċini li jittrattaw ċerti tipi ta' infezzjoni batterika (antibjotiċi bħal telithromycin).
English: Avoid concomitant use of strong CYP3A inhibitors during treatment with Zykadia (see section 4.5).
Maltese: Evita l-użu konkomitanti ta' inibituri qawwija ta' CYP3A matul it-trattament b'Zykadia (ara sezzjoni 4.5).
English: Renal impairment
Maltese: Intervall ta' Kunfidenza
English: Based on in vitro data, ceritinib also inhibits CYP2A6 and CYP2E1 at clinically relevant concentrations.
Maltese: Skont dejta in vitro, ceritinib jinibixxi wkoll lis-CYP2A6 u CYP2E1 f'konċentrazzjonijiet relevanti b'mod kliniku.
English: In Study A2303, 133 patients with baseline brain metastasis (66 patients in the Zykadia arm and 67 patients in the chemotherapy arm) were assessed for intracranial response by BIRC neuroradiologist (per modified RECIST 1.1 (i.e. up to 5 lesions in the brain).
Maltese: Fl-Istudju A2303, 133 pazjent b'metastażi fil-moħħ fil-linja bażi (66 pazjent fil-grupp ta' Zykadia u 67 pazjent fil-grupp tal-kimoterapija) kienu vvalutati għal rispons intrakranjali minn newroradjologu BIRC skont RECIST 1.1 modifikati (jiġifieri sa 5 leżjonijiet fil-moħħ).
English: Censoring Times Ceritinib 750 mg (n/N = 48/115) Chemotherapy (n/N = 50/116)
Maltese: Żminijiet ta' Ċensura Ceritinib 750 mg (n/N = 48/115) Kimoterapija (n/N = 50/116)