FrancophonIA/ELRC3.0 huggingface dataset:
English: Particular care should be exercised when administering ceritinib to patients with an increased risk of experiencing torsade de pointes during treatment with a QTc-prolonging medicinal product.
Croatian: Potreban je poseban oprez kod primjene ceritiniba u bolesnika s povećanim rizikom od torsade de pointes tijekom liječenja lijekom koji produljuje QTc.
English: The capsules should be administered orally once daily with food at the same time every day.
Croatian: Kapsule se trebaju uzimati peroralno jedanput na dan uz hranu, svakoga dana u isto vrijeme.
English: Women of childbearing potential should be advised to use a highly effective method of contraception while taking Zykadia and for up to 3 months after discontinuing treatment (see section 4.5).
Croatian: Žene reproduktivne dobi treba uputiti da koriste visoko učinkovitu metodu kontracepcije dok uzimaju Zykadiu te do 3 mjeseca nakon prekida liječenja (vidjeti dio 4.5).
English: Patients should be monitored and managed using standards of care, including anti-diarrhoeals, anti-emetics or fluid replacement, as clinically indicated.
Croatian: Bolesnike treba pratiti i zbrinjavati standardnom skrbi koja uključuje antidijaroike, antiemetike ili nadomjestak tekućine, prema kliničkim indikacijama.
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.
Croatian: Podaci o OS-u nisu bili zreli s 48 (41,7%) događaja u ceritinib skupini i 50 (43,1%) događaja u kemoterapijskoj skupini, što iznosi otprilike 50% potrebnih događaja za konačnu analizu OS-a.
English: Zykadia is only given to patients whose disease is due to a defect in a gene called ALK (anaplastic lymphoma kinase).
Croatian: Zykadia se daje samo bolesnicima čija je bolest uzrokovana oštećenjem na genu koji se zove ALK (kinaza anaplastičnog limfoma).
English: The majority of patients were Caucasian (60.0%) or Asian (37.9%).
Croatian: Većina bolesnika bili su bijelci (60,0%) ili Azijati (37,9%).
English: Strong CYP3A and P-gp inducers
Croatian: Snažni CYP3A i P-gp induktori
English: Table 2 ADRs in patients treated with Zykadia
Croatian: Tablica 2 Nuspojave u bolesnika liječenih Zykadiom
English: If dose reduction is required due to an adverse drug reaction (ADR) not listed in Table 1, then this should be achieved by decrements of 150 mg daily.
Croatian: Ako je potrebno smanjenje doze zbog nuspojave na lijek koja nije navedena u Tablici 1, to se treba napraviti smanjenjima doze od 150 mg dnevno.
English: In the event of vomiting, diarrhoea, dehydration or impaired renal function, correct electrolytes as clinically indicated.
Croatian: U slučaju povraćanja, proljeva, dehidracije ili oštećene bubrežne funkcije potrebno je korigirati elektrolite prema kliničkim indikacijama.
English: Dose must be adjusted properly, i.e for patients treated with 450 mg or 300 mg with food, the dose should be increased to 750 mg or 450 mg taken on an empty stomach, respectively (see section 5.2) and for patients treated with 150 mg with food treatment should be discontinued.
Croatian: Doza se mora prikladno prilagoditi, npr. za bolesnike koji se liječe dozom od 450 mg, odnosno 300 mg uz hranu, doza se mora povisiti na 750 mg, odnosno 450 mg na prazan želudac (vidjeti dio 5.2), a za bolesnike liječene dozom od 150 mg uz hranu liječenje se mora prekinuti.
English: Patients receiving ceritinib showed significant improvements over chemotherapy in general Quality of Life and global Health Status measures (LCSS [p<0.001], QLQ-C30, [p<0.001] and EQ-5D-5L index [p<0.001]).
Croatian: Bolesnici koji su primali ceritinib imali su značajna poboljšanja u odnosu na kemoterapiju u pogledu opće kvalitete života i mjera općeg zdravstvenog stanja (LCSS [p<0,001], QLQ-C30, [p<0,001] i u indeksu EQ-5D-5L [p<0,001]).
English: Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili postoje vidljivi znakovi neovlaštenog otvaranja.
English: ECG studies in monkeys after 4- or 13-weeks of dosing with ceritinib have not shown QT prolongation or abnormal ECGs.
Croatian: EKG ispitivanja u majmuna nakon 4-tjednog ili 13-tjednog doziranja ceritinibom nisu pokazala produljenje QT intervala ili poremećene EKG-ove.
English: The risk of hyperglycaemia was higher in patients with diabetes mellitus and/or concurrent steroid use.
Croatian: Rizik od hiperglikemije bio je viši u bolesnika sa šećernom bolešću i/ili istodobnom uporabom steroida.
English: Ceritinib inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of downstream signalling proteins and proliferation of ALK-dependent cancer cells both in vitro and in vivo.
Croatian: Ceritinib inhibira autofosforilaciju ALK-a, ALK-om posredovanu fosforilaciju silaznih signalnih proteina i proliferaciju stanica raka ovisnih o ALK-u in vitro i in vivo.
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).
Croatian: Ograničeno iskustvo u ovih bolesnika pokazalo je pogoršanje podležećeg stanja (hepatičke encefalopatije) u 2 od 10 bolesnika izloženih jednokratnim dozama od 750 mg ceritiniba natašte (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Study A2201 ceritinib 750 mg
Croatian: Ispitivanje A2201 ceritinib 750 mg
English: Therefore, clinical drug-drug interactions as a result of ceritinib-mediated inhibition of substrates for these transporters are unlikely to occur.
Croatian: Stoga je malo vjerojatno da će doći do kliničkih interakcija među lijekovima kao rezultat inhibicije supstrata za te transportere posredovane ceritinibom.
English: The benefits and potential risks of ceritinib should be considered before beginning therapy in patients who have pre-existing bradycardia (heart rate less than 60 beats per minute [bpm]), patients who have a history of or predisposition for QTc prolongation, patients who are taking anti-arrhythmics or other medicinal products that are known to prolong the QT interval and patients with relevant pre-existing cardiac disease and/or electrolyte disturbances.
Croatian: Potrebno je razmotriti koristi i potencijalne rizike ceritiniba prije početka terapije u bolesnika koji imaju od ranije prisutnu bradikardiju (srčanu frekvenciju nižu od 60 otkucaja u minuti), bolesnika koji imaju predispoziciju za produljenje QT intervala ili produljeni QT interval u anamnezi, bolesnika koji uzimaju antiaritmike ili druge lijekove za koje je poznato da produljuju QT interval i bolesnika koji imaju od ranije prisutnu relevantnu srčanu bolest i/ili poremećaje elektrolita.
English: Increases to grade 3 or 4 ALT elevations were observed in 25% of patients.
Croatian: Povećanja do stupnja 3 ili 4 povišenja ALT-a bila su uočena u 25% bolesnika.
English: OUTER CARTON OF PACK (INCLUDING BLUE BOX) CONTAINING 150 (3 PACKS OF 50) HARD CAPSULES
Croatian: VANJSKA KUTIJA PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR) KOJE SADRŽI 150 (3 PAKIRANJA OD 50) TVRDIH KAPSULA
English: Children and adolescents The use of Zykadia in children and adolescents up to 18 years of age is not recommended.
Croatian: Ne preporučuje se primjena Zykadie u djece i adolescenata do 18 godina starosti.
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.
Croatian: Istodobna povišenja ALT-a ili AST-a veća od 3x GGN i ukupnog bilirubina veća od 2x GGN bez povišene alkalne fosfataze uočeni su u manje od 1% bolesnika u kliničkim ispitivanjima s ceritinibom.
English: Agents that affect gastric pH
Croatian: Tvari koje utječu na želučani pH
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.
Croatian: Ukupno je 231 bolesnik s uznapredovalim ALK pozitivnim NSCLC-om koji su primali prethodnu terapiju krizotinibom i kemoterapijom (jedan ili dva režima uključujući dvojnu terapiju na temelju platine) bio uključen u analizu.
English: Cardiac disorders Pericarditis b
Croatian: Srčani poremećaji Perikarditis b
English: Ceritinib also has a slight preferential distribution to red blood cells, relative to plasma, with a mean in vitro blood-to-plasma ratio of 1.35.
Croatian: Ceritinib se također neznatno više distribuira u crvene krvne stanice, u odnosu na plazmu, sa srednjim omjerom koncentracija u krvi i plazmi in vitro od 1,35.
English: The study met its primary objective demonstrating a statistically significant improvement in PFS by BIRC with an estimated 51% risk reduction in the ceritinib arm compared to chemotherapy arm (see Table 4 and Figure 3).
Croatian: Ispitivanje je ispunilo svoj primarni cilj dokazavši statistički značajno poboljšanje u PFS-u prema BIRC-u s procijenjenim smanjenjem rizika za 51% u ceritinib skupini u usporedbi s kemoterapijskom skupinom (vidjeti Tablicu 4 i Sliku 3).
English: Ceritinib is an orally highly selective and potent ALK inhibitor.
Croatian: Ceritinib je peroralni visoko selektivan i potentan inhibitor ALK-a.
English: The liver was also affected in both species, at exposures that approximate clinical exposures at the recommended human dose, and included minimal increases in liver transaminases in a few animals and vacuolation of the intra-hepatic bile duct epithelium.
Croatian: U obje je vrste bilo i učinaka na jetri, pri izloženostima koje otprilike odgovaraju kliničkim izloženostima pri preporučenoj dozi u ljudi, a učinci su uključivali minimalna povišenja razina jetrenih transaminaza u nekoliko životinja te vakuolizaciju epitela intrahepatičkog žučnog voda.
English: A pharmacokinetic analysis suggested that ceritinib causes concentration-dependent increases in QTc (see section 4.4).
Croatian: Farmakokinetička analiza ukazala je na to da ceritinib uzrokuje povećanja QTc intervala ovisna o koncentraciji (vidjeti dio 4.4).
English: Patient reported outcome questionnaires (Lung cancer symptom scale [LCSS], EORTC-QLQ-C30 [C30], EORTC QLQ-LC13 [LC13] and EQ-5D-5L) were completed by 80% or more of patients in the ceritinib and chemotherapy arms for all questionnaires at most of the time-points during the course of the study.
Croatian: Lung cancer symptom scale, LCSS], EORTC-QLQ-C30 [C30], EORTC QLQ-LC13 [LC13] i EQ-5D5L) popunilo je 80% ili više bolesnika u skupinama liječenim ceritinibom ili kemoterapijom za sve upitnike u većini vremenskih točaka tijekom ispitivanja.
English: Study X2101 ceritinib 750 mg
Croatian: Ispitivanje X2101 ceritinib 750 mg
English: Treatment with ceritinib is not recommended in patients who have congenital long QT syndrome or who are taking medicinal products known to prolong the QTc interval (see sections 4.4 and 4.5).
Croatian: Liječenje ceritinibom ne preporučuje se u bolesnika koji imaju kongenitalni sindrom produljenog QT-a ili koji uzimaju lijekove za koje se zna da produljuju QTc interval (vidjeti dijelove 4.4 i 4.5).
English: Seven patients (7.9%) required study drug interruption due to diarrhoea or nausea.
Croatian: Sedam bolesnika (7,9%) zahtijevalo je privremeni prekid primjene ispitivanog lijeka zbog proljeva ili mučnine.
English: Systemic exposure of ceritinib was increased when administered with food.
Croatian: Sistemska izloženost ceritinibu bila je povećana kada se on primjenjivao uz hranu.
English: ADRs are listed according to MedDRA system organ class.
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava.
English: Film-coating: hypromellose; titanium dioxide (E171); macrogol; talc; indigo carmine aluminium lake (E132).
Croatian: Film ovojnica: hipromeloza; titanijev dioksid (E171); makrogol; talk; indigo carmine aluminium lake (E132).
English: Zykadia is a cancer medicine that contains the active substance ceritinib.
Croatian: Zykadia je lijek protiv raka koji sadrži djelatnu tvar ceritinib.
English: Hepatotoxicity (drug-induced liver injury, hepatitis cholestatic, hepatocellular injury, hepatotoxicity)
Croatian: Hepatotoksičnost (ozljeda jetre izazvana lijekom, kolestatski hepatitis, hepatocelularna ozljeda, hepatotoksičnost)
English: Based on in vitro data, ceritinib also inhibits CYP2A6 and CYP2E1 at clinically relevant concentrations.
Croatian: Na temelju in vitro podataka, ceritinib također inhibira CYP2A6 i CYP2E1 pri klinički relevantnim koncentracijama.
English: You should take special care when driving and using machines when taking Zykadia as you may experience visual disturbances or tiredness.
Croatian: Morate biti posebno oprezni kada upravljate vozilima i strojevima tijekom uzimanja Zykadie, budući da biste mogli osjetiti smetnje u vidu ili umor.
English: Carcinogenicity studies have not been performed with ceritinib.
Croatian: Ispitivanja karcinogenosti nisu bila provođena s ceritinibom.
English: The absolute bioavailability of ceritinib has not been determined.
Croatian: Apsolutna bioraspoloživost ceritiniba nije utvrđena.
English: Patients should be instructed to avoid grapefruit and grapefruit juice as they may inhibit CYP3A in the gut wall and may increase the bioavailability of ceritinib.
Croatian: Bolesnike treba uputiti da izbjegavaju grejp i sok od grejpa, budući da oni mogu inhibirati CYP3A u stijenci crijeva te mogu povećati bioraspoloživost ceritiniba.
English: QTc >500 msec or >60 msec change from baseline and torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia
Croatian: QTc >500 msec ili promjena >60 msec u odnosu na početnu vrijednost i torsade de pointes ili polimorfna ventrikularna tahikardija ili znakovi/simptomi ozbiljne aritmije
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.
Croatian: Primjena Zykadie u kombinaciji s drugim tvarima za koje je poznato da uzrokuju bradikardiju (npr. beta blokatori, nedihidropiridinski blokatori kalcijevih kanala, klonidin i digoksin) treba se izbjegavati koliko god je moguće.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Zykadia in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Zykadia u svim podskupinama pedijatrijske populacije u raku pluća (raku malih stanica i raku nemalih stanica) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: What Zykadia contains
Croatian: Što Zykadia sadrži
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.
Croatian: Kod 163 bolesnika s ALK-pozitivnim NSCLC-om koji su se prethodno liječili ALK inhibitorom, medijan dobi bio je 52 godine (raspon: 24-80 godina); 86,5% bilo je mlađe od 65 godina, a 54% bolesnika bilo je ženskog spola.
English: Dose interruption and dose reduction should be employed as necessary (see sections 4.2 and 4.8).
Croatian: Prekid doziranja i smanjivanje doze treba primjenjivati prema potrebi (vidjeti dijelove 4.2 i 4.8).
English: Strong CYP3A inhibitors
Croatian: Snažni CYP3A inhibitori
English: Duration of follow-up Median (months) (min - max) Overall response rate Investigator (95% CI) BIRC (95% CI) Duration of response* Investigator (months, 95% CI) BIRC (months, 95% CI) Progression-free survival Investigator (months, 95% CI) BIRC (months, 95% CI) Overall survival (months, 95% CI)
Croatian: Trajanje praćenja Medijan (mjeseci) (min - maks) Stopa ukupnog odgovora Ispitivač (95% CI) BIRC (95% CI) Trajanje odgovora* Ispitivač (mjeseci, 95% CI) BIRC (mjeseci, 95% CI) Preživljenje bez progresije Ispitivač (mjeseci, 95% CI) BIRC (mjeseci, 95% CI) Ukupno preživljenje (mjeseci, 95% CI)
English: If vomiting occurs during the course of treatment, the patient should not take an additional dose, but should continue with the next scheduled dose.
Croatian: Ako dođe do povraćanja tijekom liječenja, bolesnik ne smije uzeti dodatnu dozu, već nastaviti sa sljedećom dozom po rasporedu.
English: The efficacy of Zykadia 450 mg with food was evaluated in a multicentre, open-label dose optimisation study A2112 (ASCEND-8).
Croatian: Djelotvornost Zykadie od 450 mg uz hranu bila je procijenjena u multicentričnom, otvorenom ispitivanju optimizacije doze A2112 (ASCEND-8).
English: Patients should be monitored with liver laboratory tests (including ALT, AST and total bilirubin) prior to the start of treatment, every 2 weeks during the first three months of treatment and monthly thereafter.
Croatian: Bolesnike treba pratiti laboratorijskim pretragama jetre (uključujući ALT, AST i ukupni bilirubin) prije početka liječenja, svaka 2 tjedna tijekom prva tri mjeseca liječenja te svaki mjesec nakon toga.
English: Based on in vitro data, ceritinib competitively inhibits the metabolism of a CYP3A substrate, midazolam, and a CYP2C9 substrate, diclofenac.
Croatian: Na temelju in vitro podataka, ceritinib kompetitivno inhibira metabolizam CYP3A supstrata, midazolama, te CYP2C9 supstrata, diklofenaka.
English: Zykadia should not be used during breast-feeding.
Croatian: Zykadia se ne smije uzimati tijekom dojenja.
English: There are no safety data in patients older than 85 years of age.
Croatian: Nema podataka o sigurnosti u bolesnika starijih od 85 godina.
English: Particular caution should be exercised when treating patients with severe hepatic impairment and the dose should be reduced by approximately one third, rounded to the nearest multiple of the 150 mg dosage strength (see sections 4.4 and 5.2).
Croatian: Potreban je poseban oprez kod liječenja bolesnika s teškim oštećenjem jetre te je dozu potrebno smanjiti za otprilike jednu trećinu, zaokruženo na najbliži višekratnik doze jačine 150 mg (vidjeti dijelove 4.4 i 5.2).
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%).
Croatian: Karakteristike populacije u obje skupine bile su: srednja vrijednost dobi 53 godine, dob manja od 65 (79%), žene (57%), bijelci (54%), Azijati (33%), nepušači ili bivši pušači (95%), WHO PS 0 ili 1 (93%), histologija adenokarcinoma (94%), i metastaze na mozgu (33%).
English: Eye disorders Vision disorder a
Croatian: Poremećaji oka Poremećaj vida a
English: Abdominal pain f
Croatian: Bol u abdomenu f
English: How long to take Zykadia
Croatian: Koliko dugo uzimati Zykadiu
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.
Croatian: Kapsula s bijelim neprozirnim tijelom i plavom neprozirnom kapicom, s oznakom „LDK 150MG“ otisnutom na kapici i „NVR“ na tijelu, koja sadrži bijeli do gotovo bijeli prašak.
English: Chemotherapy (N=116)
Croatian: Kemoterapija (N=116)
English: Co-administration of ceritinib with strong CYP3A/P-gp inducers decreases ceritinib plasma concentrations.
Croatian: Istodobna primjena ceritiniba sa snažnim CYP3A/P-gp induktorima smanjuje koncentracije ceritiniba u plazmi.
English: Liver laboratory tests including ALT, AST and total bilirubin should be performed prior to the start of treatment, every 2 weeks during the first three months of treatment and monthly thereafter, with more frequent testing for grade 2, 3 or 4 elevations.
Croatian: Laboratorijske pretrage jetre koje uključuju ALT, AST i ukupni bilirubin trebaju se obaviti prije početka liječenja, svaka 2 tjedna tijekom prva tri mjeseca liječenja te svaki mjesec nakon toga, uz učestalije pretrage za povišenja stupnja 2, 3 ili 4.
English: Based on in vitro data, ceritinib is a substrate of the efflux transporter P-glycoprotein (P-gp).
Croatian: Na temelju in vitro podataka, ceritinib je supstrat efluksnog transportera P-glikoproteina (P-gp).
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).
Croatian: Učinci na štitnjaču bili su uočeni i u štakora (blaga povišenja koncentracija tireotropnog hormona i trijodtironina/tiroksina T3/T4 bez mikroskopskog korelata) i u majmuna (deplecija koloida u mužjaka u 4-tjednom ispitivanju, te jedan majmun pri visokoj dozi s difuznom hiperplazijom folikularnih stanica i povišenim tireotropnim hormonom u 13-tjednom ispitivanju).
English: The majority of patients had adenocarcinoma (97.0%) and had either never smoked or were former smokers (96.1%).
Croatian: Velika većina bolesnika imala je adenokarcinom (97,0%) te ili nikada nisu pušili ili su bili bivši pušači (96,1%).
English: ALK translocation determines expression of the resulting fusion protein and consequent aberrant ALK signaling in NSCLC.
Croatian: Translokacija ALK-a određuje ekspresiju rezultirajućeg fuzijskog proteina i posljedičnu poremećenu signalizaciju ALK-a kod NSCLC-a.
English: The principal toxicity related to ceritinib administration in rats and monkeys was inflammation of the extra-hepatic bile ducts accompanied by increased neutrophil counts in the peripheral blood.
Croatian: Glavna toksičnost povezana s primjenom ceritiniba u štakora i majmuna bila je upala ekstrahepatičkih žučnih vodova popraćena povećanim brojem neutrofila u perifernoj krvi.
English: Therefore, ceritinib may have the potential to increase plasma concentrations of co-administered medicinal products that are predominantly metabolised by these enzymes.
Croatian: Stoga bi ceritinib mogao imati potencijal povećavanja koncentracija u plazmi istodobno primijenjenih lijekova koji se pretežno metaboliziraju putem tih enzima.
English: A total of 376 patients were randomised in a 1:1 ratio (stratified by WHO performance status, prior adjuvant/neoadjuvant chemotherapy and presence/absence of brain metastasis at screening) to receive either ceritinib (750 mg daily, fasted) or chemotherapy (based on investigator's choice - pemetrexed [500 mg/m2] plus cisplatin [75 mg/m2] or carboplatin [AUC 5-6], administered every 21 days).
Croatian: Ukupno je 376 bolesnika bilo randomizirano u omjeru 1:1 (stratificirano prema funkcionalnom statusu po SZO-u, prethodnoj adjuvantnoj/neoadjuvantnoj kemoterapiji i prisutnosti/odsutnosti metastaza na mozgu kod probira) na primanje ili ceritiniba (750 mg na dan, natašte) ili kemoterapije (na temelju ispitivačevog izbora - pemetreksed [500 mg/m2] plus cisplatin [75 mg/m2] ili karboplatin [AUC 5-6], primijenjeni svakih 21 dan).
English: The maximum recommended dose with food is 450 mg taken orally once daily.
Croatian: Maksimalna preporučena doza uz hranu je 450 mg koja se uzima peroralno jedanput dnevno.
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.
Croatian: Asimptomatski slučajevi bradikardije (srčane frekvencije niže od 60 otkucaja u minuti) uočeni su u 21 od 925 (2,3%) bolesnika liječenih ceritinibom u kliničkim ispitivanjima.