natgillin/translations-raw huggingface dataset:
The potential for Zykadia to cause infertility in male and female patients is unknown (see section 5.3).
Potencijal Zykadie da uzrokuje neplodnost u muških ili ženskih bolesnika nije poznat (vidjeti dio 5.3).
An in vivo telemetry study in monkeys showed a modest QT prolongation in 1 of 4 animals after receiving the highest dose of ceritinib.
In vivo telemetrijsko ispitivanje u majmuna pokazalo je skromno produljenje QT intervala u 1 od 4 životinje nakon primanja najviše doze ceritiniba.
93.3% had adenocarcinoma and 96.9% had either never been or were former smokers.
93,3% imalo je adenokarcinom, a 96,9% nikada nije pušilo ili su bili bivši pušači.
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).
Oni uključuju lijekove koji liječe gljivične infekcije (antimikotike kao što su ketokonazol, itrakonazol, vorikonazol, posakonazol) i lijekove koji liječe određene vrste bakterijskih infekcija (antibiotike kao što je telitromicin).
Limited information is available in ALK-positive NSCLC patients with non-adenocarcinoma histology.
Dostupne su ograničene informacije u bolesnika s ALK-pozitivnim NSCLC-om s histologijom ne-adenokarcinoma.
Low level of phosphate in the blood (this would be detected during blood tests) High level of enzymes called lipase and/or amylase in the blood (this would be detected during blood tests)
Niska razina fosfata u krvi (to se otkriva tijekom krvnih pretraga) Visoka razina enzima u krvi koji se zovu lipaza i/ili amilaza (to se otkriva tijekom krvnih pretraga)
Your doctor should perform blood tests before you start treatment, every 2 weeks during the first three months of treatment and monthly therafter.
Liječnik bi Vam trebao obaviti krvne pretrage prije nego što započnete liječenje, svaka 2 tjedna tijekom prva tri mjeseca liječenja te mjesečno nakon toga.
If you stop taking Zykadia
Ako prestanete uzimati Zykadiu
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.
Ispitivanja reproduktivne toksikologije (tj. ispitivanja embrio-fetalnog razvoja) u skotnih štakora i kunića nisu ukazala ni na kakvu fetotoksičnost ili teratogenost nakon doziranja s ceritinibom tijekom organogeneze; međutim, izloženost majčinske plazme bila je manja od izloženosti uočene pri preporučenoj dozi u ljudi.
Pack containing 84 film-coated tablets (4 blisters per pack).
Pakiranje sadrži 84 filmom obloženih tableta (4 blistera po pakiranju).
It is unknown whether ceritinib/metabolites are excreted in human milk.
Nije poznato izlučuju li se ceritinib/metaboliti u majčino mlijeko.
NE = not estimable
NP = ne može se procijeniti
8.3 (3.5, NE)
8,3 (3,5; NP)
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.
U većini slučajeva NSCLC-a, EML4 je translokacijski partner za ALK; to stvara fuzijski protein EML4-ALK koji sadrži domenu protein kinaze u ALK-u fuzioniranu s N-terminalnim dijelom EML4.
Patient reported outcome questionnaires were collected using the EORTC QLQ C30/LC13, LCSS and EQ-5D-5L.
Upitnici o ishodima na temelju procjene bolesnika prikupljeni su koristeći EORTC QLQ C30/LC13, LCSS i EQ-5D-5L.
CYP2A6 and CYP2E1 substrates
CYP2A6 i CYP2E1 supstrati
Across seven clinical studies, 168 out of 925 patients (18.2%) treated with Zykadia were aged 65 years or older.
U sedam kliničkih ispitivanja, 168 od 925 bolesnika (18,2%) liječenih Zykadiom bilo je u dobi od 65 godina ili starije.
Talk to your doctor or pharmacist before taking Zykadia: if you have problems with your liver.
Obratite se svom liječniku ili ljekarniku prije nego uzmete Zykadiu: ako imate probleme s jetrom. ako imate probleme s plućima ili probleme s disanjem.
Cases of hepatotoxicity occurred in 1.1% of patients receiving ceritinib in clinical studies.
Slučajevi hepatotoksičnosti javili su se u 1,1% bolesnika koji su primali ceritinib u kliničkim ispitivanjima.
In vitro data show that the IC50 for the inhibitory effect of ceritinib on the hERG potassium channel was 0.4 micromolar.
In vitro podaci pokazuju da je IC50 za inhibitorni učinak ceritiniba na kalijev kanal hERG bio 0,4 μmol/L.
64.5% of the study population were Caucasian, 29.4% Asian, 0.4% Black and 2.6% other races.
64,5% ispitivane populacije bili su bijelci, 29,4%, Azijati, 0,4% crnci, a 2,6% ostalih rasa.
Zykadia is for oral use.
Zykadia je namijenjena za peroralnu primjenu.
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).
In vitro ispitivanja ukazuju na to da je ceritinib supstrat za P-glikoprotein (P-gp), ali ne za protein koji uzrokuje rezistenciju raka dojke na lijekove (engl. breast cancer resistance protein, BCRP) ili protein višestruke rezistencije na lijekove 2 (MRP2).
All except one patient received prior chemotherapy (including a platinum doublet) for advanced disease; 11.3% of the patients in the ceritinib arm and 12.1% of the patients in the chemotherapy arm were treated with two prior chemotherapy regimen for advanced disease.
Svi osim jednog bolesnika primali su prethodno kemoterapiju (uključujući dvojnu terapiju na temelju platine) za uznapredovalu bolest; 11,3% bolesnika u ceritinib skupini i 12,1% bolesnika u kemoterapijskoj skupini liječilo se s dva prethodna kemoterapijska režima za uznapredovalu bolest.
No signs of mutagenicity or clastogenicity were observed in other in vitro and in vivo genotoxicity studies with ceritinib.
Nisu uočeni nikakvi znakovi mutagenosti ili klastogenosti u drugim in vitro i in vivo ispitivanjima genotoksičnosti s ceritinibom.
If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose by approximately one third (dose not clinically verified), rounded to the nearest multiple of the 150 mg dosage strength.
Ako je istodobna primjena snažnog CYP3A inhibitora neizbježna, dozu treba smanjiti za otprilike jednu trećinu (doza koja nije klinički provjerena), zaokruženo na najbliži višekratnik jačine doze od 150 mg.
Monitoring of the QT interval is indicated in the event of combinations of such medicinal products (see sections 4.2 and
Praćenje QT intervala je indicirano u slučaju kombinacije takvih lijekova (vidjeti dijelove 4.2 i 4.4).
The drug-drug interaction study was designed to observe the impact of proton pump inhibitor in the worst scenario, but in clinical use the impact of proton pump inhibitor on ceritinib exposure appears to be less pronounced.
Ispitivanje interakcije među lijekovima bilo je dizajnirano da uoči učinak inhibitora protonske pumpe u najlošijem scenariju, ali izgleda da je u kliničkoj primjeni učinak inhibitora protonske pumpe na izloženost ceritinibu slabije izražen.
Ceritinib has been classified in vivo as a strong CYP3A4 inhibitor and has the potential to interact with medicinal products that are metabolised by CYP3A, which may lead to increased serum concentrations of the other product.
Ceritinib je in vivo klasificiran kao snažan CYP3A4 inhibitor te ima potencijal ući u interakciju s lijekovima koji se metaboliziraju putem CYP3A, što može dovesti do povećane koncentracije drugog lijeka u serumu.
Abnormal liver function test (hepatic function abnormal, hyperbilirubinaemia)
Poremećeni test jetrene funkcije (abnormalna jetrena funkcija, hiperbilirubinemija)
Caution is advised with concomitant use of proton pump inhibitors, as exposure of ceritinib may be reduced.
Savjetuje se oprez kod istodobne primjene inhibitora protonske pumpe, jer se izloženost ceritinibu može smanjiti.
Ceritinib 750 mg 115 87 68 40 31 18 12 9 Chemotherapy
Ceritinib 750 mg 115 87 68 40 31 18 12 9 Kemoterapija
The primary route of excretion of ceritinib and its metabolites is in the faeces.
Primarni put izlučivanja ceritiniba i njegovih metabolita je stolicom.
If ceritinib is administered with medicinal products that inhibit P-gp, an increase in ceritinib concentration is likely.
Ako se ceritinib primjenjuje s lijekovima koji inhibiraju P-gp, vjerojatno je povećanje koncentracije ceritiniba.
Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Unutar svakog organskog sustava nuspojave su razvrstane po učestalosti, pri čemu su najučestalije navedene prve.
QTc prolongation has been observed in clinical studies in patients treated with ceritinib (see sections 4.8 and 5.2), which may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death.
Produljenje QTc intervala uočeno je u kliničkim ispitivanjima u bolesnika liječenih ceritinibom (vidjeti dijelove 4.8 i 5.2), što može dovesti do povećanog rizika od ventrikularnih tahiaritmija (npr. torsade de pointes) ili iznenadne smrti.
Hepatotoxicity events were managed with dose interruptions or reductions in 40.6% of patients.
Hepatotoksični događaji su se zbrinjavali prekidima doziranja ili smanjenjima doze u 40,6% bolesnika.
26.2 (22.8, NE)
26,2 (22,8, NP)
Alveolar foamy macrophages (confirmed phospholipidosis) were seen in the lungs of rats, but not in monkeys, and the lymph nodes of rats and monkeys had macrophage aggregates.
Alveolarni pjenasti makrofagi (potvrđena fosfolipidoza) uočeni su u plućima štakora, ali ne u majmuna, a limfni čvorovi štakora i majmuna imali su nakupine makrofaga.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation >5 times upper limit of normal (ULN) with concurrent total bilirubin ≤2 times ULN
Povišenje alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) >5 puta iznad gornje granice normale (GGN) uz istodobni ukupni bilirubin ≤2 puta GGN
The median duration of exposure to Zykadia 750 mg fasted was 44.9 weeks (range: 0.1 to 200.1 weeks).
Medijan trajanja izloženosti Zykadii od 750 mg natašte bio je 44,9 tjedana (raspon: 0,1 do 200,1 tjedana).
Table 6 ALK-positive advanced NSCLC - overview of efficacy results from Studies X2101 and A2201
Tablica 6 ALK-pozitivan uznapredovali NSCLC - pregled rezultata djelotvornosti iz Ispitivanja X2101 i A2201
The potential for QT interval prolongation of ceritinib was assessed in seven clinical studies with Zykadia.
Potencijal ceritiniba da produlji QT interval bio je ocijenjen u sedam kliničkih ispitivanja sa Zykadiom.
Peak plasma levels (Cmax) of ceritinib are achieved approximately 4 to 6 hours after a single oral administration in patients.
Vršne razine ceritiniba u plazmi (Cmax) postižu se otprilike 4 do 6 sati nakon jednokratne peroralne primjene u bolesnika.
Abnormal results of blood tests to check kidney function (high level of creatinine) Heartburn (potential sign of a disorder of the digestive tract) Reduction in the number of red blood cells, known as anaemia
Poremećeni rezultati krvnih pretraga za provjeru bubrežne funkcije (visoka razina kreatinina) Žgaravica (potencijalni znak poremećaja probavnog sustava) Smanjenje broja crvenih krvnih stanica, poznato kao anemija
Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products.
Ocijeniti istodobno primijenjene lijekove za koje je poznato da uzrokuju bradikardiju, kao i antihipertenzive.
Caution should be exercised when driving or using machines during treatment as patients may experience fatigue or vision disorders.
Potreban je oprez kod upravljanja vozilima ili rada sa strojevima tijekom liječenja budući da bolesnici mogu osjetiti umor ili poremećaje vida.
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.
Potreban je poseban oprez kod primjene ceritiniba u bolesnika s povećanim rizikom od torsade de pointes tijekom liječenja lijekom koji produljuje QTc.
The capsules should be administered orally once daily with food at the same time every day.
Kapsule se trebaju uzimati peroralno jedanput na dan uz hranu, svakoga dana u isto vrijeme.
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).
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).
Patients should be monitored and managed using standards of care, including anti-diarrhoeals, anti-emetics or fluid replacement, as clinically indicated.
Bolesnike treba pratiti i zbrinjavati standardnom skrbi koja uključuje antidijaroike, antiemetike ili nadomjestak tekućine, prema kliničkim indikacijama.
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.
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.
Zykadia is only given to patients whose disease is due to a defect in a gene called ALK (anaplastic lymphoma kinase).
Zykadia se daje samo bolesnicima čija je bolest uzrokovana oštećenjem na genu koji se zove ALK (kinaza anaplastičnog limfoma).
The majority of patients were Caucasian (60.0%) or Asian (37.9%).
Većina bolesnika bili su bijelci (60,0%) ili Azijati (37,9%).
Strong CYP3A and P-gp inducers
Snažni CYP3A i P-gp induktori
Table 2 ADRs in patients treated with Zykadia
Tablica 2 Nuspojave u bolesnika liječenih Zykadiom
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.
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.
In the event of vomiting, diarrhoea, dehydration or impaired renal function, correct electrolytes as clinically indicated.
U slučaju povraćanja, proljeva, dehidracije ili oštećene bubrežne funkcije potrebno je korigirati elektrolite prema kliničkim indikacijama.
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.
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.
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]).
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]).
Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili postoje vidljivi znakovi neovlaštenog otvaranja.
ECG studies in monkeys after 4- or 13-weeks of dosing with ceritinib have not shown QT prolongation or abnormal ECGs.
EKG ispitivanja u majmuna nakon 4-tjednog ili 13-tjednog doziranja ceritinibom nisu pokazala produljenje QT intervala ili poremećene EKG-ove.
The risk of hyperglycaemia was higher in patients with diabetes mellitus and/or concurrent steroid use.
Rizik od hiperglikemije bio je viši u bolesnika sa šećernom bolešću i/ili istodobnom uporabom steroida.
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.
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.
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).
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).
Study A2201 ceritinib 750 mg
Ispitivanje A2201 ceritinib 750 mg
Therefore, clinical drug-drug interactions as a result of ceritinib-mediated inhibition of substrates for these transporters are unlikely to occur.
Stoga je malo vjerojatno da će doći do kliničkih interakcija među lijekovima kao rezultat inhibicije supstrata za te transportere posredovane ceritinibom.
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.
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.
Increases to grade 3 or 4 ALT elevations were observed in 25% of patients.
Povećanja do stupnja 3 ili 4 povišenja ALT-a bila su uočena u 25% bolesnika.
OUTER CARTON OF PACK (INCLUDING BLUE BOX) CONTAINING 150 (3 PACKS OF 50) HARD CAPSULES
VANJSKA KUTIJA PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR) KOJE SADRŽI 150 (3 PAKIRANJA OD 50) TVRDIH KAPSULA
Children and adolescents The use of Zykadia in children and adolescents up to 18 years of age is not recommended.
Ne preporučuje se primjena Zykadie u djece i adolescenata do 18 godina starosti.
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.
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.
Agents that affect gastric pH
Tvari koje utječu na želučani pH
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.
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.
Cardiac disorders Pericarditis b
Srčani poremećaji Perikarditis b
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.
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.
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).
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).
Ceritinib is an orally highly selective and potent ALK inhibitor.
Ceritinib je peroralni visoko selektivan i potentan inhibitor ALK-a.
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.
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.
A pharmacokinetic analysis suggested that ceritinib causes concentration-dependent increases in QTc (see section 4.4).
Farmakokinetička analiza ukazala je na to da ceritinib uzrokuje povećanja QTc intervala ovisna o koncentraciji (vidjeti dio 4.4).
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.
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.
Study X2101 ceritinib 750 mg
Ispitivanje X2101 ceritinib 750 mg
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).
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).
Seven patients (7.9%) required study drug interruption due to diarrhoea or nausea.
Sedam bolesnika (7,9%) zahtijevalo je privremeni prekid primjene ispitivanog lijeka zbog proljeva ili mučnine.
Systemic exposure of ceritinib was increased when administered with food.
Sistemska izloženost ceritinibu bila je povećana kada se on primjenjivao uz hranu.
ADRs are listed according to MedDRA system organ class.
Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava.
Film-coating: hypromellose; titanium dioxide (E171); macrogol; talc; indigo carmine aluminium lake (E132).
Film ovojnica: hipromeloza; titanijev dioksid (E171); makrogol; talk; indigo carmine aluminium lake (E132).
Zykadia is a cancer medicine that contains the active substance ceritinib.
Zykadia je lijek protiv raka koji sadrži djelatnu tvar ceritinib.
Hepatotoxicity (drug-induced liver injury, hepatitis cholestatic, hepatocellular injury, hepatotoxicity)
Hepatotoksičnost (ozljeda jetre izazvana lijekom, kolestatski hepatitis, hepatocelularna ozljeda, hepatotoksičnost)
Based on in vitro data, ceritinib also inhibits CYP2A6 and CYP2E1 at clinically relevant concentrations.
Na temelju in vitro podataka, ceritinib također inhibira CYP2A6 i CYP2E1 pri klinički relevantnim koncentracijama.
You should take special care when driving and using machines when taking Zykadia as you may experience visual disturbances or tiredness.
Morate biti posebno oprezni kada upravljate vozilima i strojevima tijekom uzimanja Zykadie, budući da biste mogli osjetiti smetnje u vidu ili umor.
Carcinogenicity studies have not been performed with ceritinib.
Ispitivanja karcinogenosti nisu bila provođena s ceritinibom.
The absolute bioavailability of ceritinib has not been determined.
Apsolutna bioraspoloživost ceritiniba nije utvrđena.