natgillin/translations-raw huggingface dataset:
As these non-clinical effects were mild, variable and inconsistent, the relationship between ceritinib and thyroid gland changes in animals is unclear.
Budući da su ti neklinički učinci bili blagi, promjenjivi i nedosljedni, odnos između ceritiniba i promjena štitne žlijezde u životinja nije jasan.
Zykadia with food and drink
Zykadia s hranom i pićem
Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Testiranje za ALK-pozitivan NSCLC mora se provoditi u laboratorijima s dokazanim stručnim znanjem o specifičnoj tehnologiji koja se za to koristi.
Other factors apart from study treatment could have impacted on observed events of hepatic encephalopathy, however, the relation between study treatment and events cannot be fully ruled out.
Osim ispitivanog liječenja, na uočene slučajeve hepatičke encefalopatije mogli su utjecati i drugi čimbenici, međutim, veza između ispitivanog liječenja i događaja ne može se u potpunosti isključiti.
The effectiveness of concomitant administration of oral contraceptives may be reduced.
Učinkovitost istodobne primjene oralnih kontraceptiva mogla bi biti smanjena.
A key secondary efficacy endpoint was ORR according to RECIST 1.1 as evaluated by BIRC.
Ključna mjera djelotvornosti sekundarnog ishoda bio je ORR prema RECIST-u 1.1, prema procjeni BIRC-a.
Agents that are substrates of transporters
Tvari koje su supstrati transportera
If adequate glucose control cannot be achieved with optimal medical management, permanently discontinue Zykadia.
Ako se ne može postići odgovarajuća kontrola glukoze uz optimalno medicinsko zbrinjavanje, trajno prekinuti primjenu Zykadie.
Bradycardia a
Bradikardija a
Secondary biotransformation pathways involving the primary biotransformation products included glucuronidation and dehydrogenation.
Putevi sekundarne biotransformacije koji uključuju produkte primarne biotransformacije uključivali su glukuronidaciju i dehidrogenaciju.
Based on the stratified Cox proportional hazards analysis.
Na temelju stratificirane Coxove analize proporcionalnih hazarda.
QT corrected for heart rate (QTc) >500 msec on at least 2 separate electrocardiograms (ECGs)
QT korigiran za srčanu frekvenciju (QTc) >500 msec na najmanje 2 zasebna elektrokardiograma (EKG-a)
A total of 55.8% of patients were female.
Ukupno je 55,8% bolesnika bilo ženskog spola.
The ORR, DOR and PFS (by BIRC assessment) for patients with brain metastases at baseline were in line with those reported for the overall population of these studies.
ORR, DOR i PFS (prema ocjeni BIRC-a) za bolesnike s metastazama na mozgu na početku bili su u skladu s onima zabilježenima za cjelokupnu populaciju ovih ispitivanja.
Blood tests during treatment with Zykadia
Krvne pretrage tijekom liječenja Zykadiom
Patients were allowed to continue the assigned study treatment beyond initial progression in case of continued clinical benefit as per the investigator's opinion.
Bolesnici su smjeli nastaviti dodijeljeno ispitivano liječenje nakon početne progresije u slučaju kontinuirane kliničke koristi prema mišljenju ispitivača.
The capsules should be swallowed whole with water and should not be chewed or crushed.
Kapsule se trebaju progutati cijele s vodom i ne smiju se žvakati ili drobiti.
Study X2101: Responses assessed using RECIST 1.0 Study A2201: Responses assessed using RECIST 1.1 *Includes only patients with confirmed CR, PR
Ispitivanje X2101: Odgovori ocijenjeni koristeći RECIST 1.0 Ispitivanje A2201: Odgovori ocijenjeni koristeći RECIST 1.1 *Uključuje samo bolesnike s potvrđenim CR-om, PR-om
The majority of cases were manageable with dose interruption and/or dose reduction.
Većina slučajeva mogla se kontrolirati privremenim prekidom primjene i/ili smanjenjem doze.
System organ class Preferred term
Klasifikacija organskih sustava Preporučeni izraz
In contrast with single-dose data, pre-dose concentration (Cmin) after repeated daily dosing appeared to increase in a greater than dose-proportional manner.
Za razliku od podataka koji se odnose na jednokratnu dozu, izgleda da se koncentracija prije doze (Cmin) nakon ponavljanog svakodnevnog doziranja povećava više nego proporcionalno dozi.
Population pharmacokinetic analyses showed that age, gender and race had no clinically meaningful influence on ceritinib exposure.
Populacijske farmakokinetičke analize pokazale su da dob, spol i rasa nemaju klinički značajan utjecaj na izloženost ceritinibu.
A total of 57.4% of patients were female.
Ukupno je 57,4% bolesnika bilo ženskog spola.
General supportive measures should be initiated in all cases of overdose.
U svim slučajevima predoziranja potrebno je započeti opće suportivne mjere.
Few events required discontinuation of treatment.
Mali je broj događaja zahtijevao trajni prekid liječenja.
Bradycardia c
Bradikardija c
If you have questions about how long to take Zykadia, talk to your doctor or pharmacist.
Ako imate pitanja o tome koliko dugo uzimati Zykadiu, obratite se svom liječniku ili ljekarniku.
If a dose is missed, the patient should make up that dose, unless the next dose is due within 12 hours.
Ako propusti dozu, bolesnik treba nadoknaditi tu dozu, osim ako sljedeću dozu mora uzeti unutar 12 sati.
What Zykadia is and what it is used for What you need to know before you take Zykadia How to take Zykadia
Što je Zykadia i za što se koristi Što morate znati prije nego počnete uzimati Zykadiu Kako uzimati Zykadiu
In patients with ALK defects, an abnormal protein is produced that stimulates the growth of the cancer cells.
U bolesnika s oštećenjima ALK-a proizvodi se abnormalni protein koji stimulira rast stanica raka.
Patients with severe renal impairment (CLcr <30 ml/min) were not included in the clinical studies of Zykadia (see section 4.2).
Bolesnici s teškim oštećenjem bubrega (CLcr <30 ml/min) nisu bili uključeni u klinička ispitivanja Zykadie (vidjeti dio 4.2).
Zykadia should not be used during pregnancy unless the clinical condition of the woman requires treatment with ceritinib.
Zykadia se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje ceritinibom.
Do not change the dose without talking to your doctor.
Ne mijenjajte dozu ako niste prije o tome razgovarali sa svojim liječnikom.
ALK-positive NSCLC status should be established prior to initiation of Zykadia therapy.
Status ALK-pozitivnog NSCLC-a potrebno je utvrditi prije uvođenja terapije Zykadiom.
Other medicines and Zykadia
Drugi lijekovi i Zykadia
The PFS benefit was further supported by local investigator assessment, and analysis of overall response rate (ORR) and disease control rate (DCR).
Tu su korist za PFS dodatno poduprli ocjena lokalnog ispitivača te analiza stope ukupnog odgovora (engl. overall response rate, ORR) i stope kontrole bolesti (engl. disease control rate, DCR).
Probability (%) of event-free
Vjerojatnost (%) izostanka događaja
Significantly decreased urine flow (potential sign of a kidney problem)
Značajno smanjeno mokrenje (potencijalni znak problema s bubrezima)
Early identification and management of ADRs with standard supportive care measures should be considered.
Valja razmotriti rano prepoznavanje i zbrinjavanje nuspojava uz standardne mjere suportivne skrbi.
For subsequent dose adjustment and management recommendations for ADRs, please follow table 1 (see section 4.2).
Za naredno prilagođavanje doza i preporuke za zbrinjavanje nuspojava, molimo slijediti upute u Tablici 1 (vidjeti dio 4.2).
Hazard Ratio = 0.55
Omjer hazarda = 0,55
Log rank p-value = <0.001
Log rang p-vrijednost = <0,001
Dose adjustment due to adverse reactions
Prilagođavanje doze zbog nuspojava
In addition, 81 patients (69.8%) in the chemotherapy arm received subsequent Zykadia as first antineoplastic therapy after study treatment discontinuation.
Uz to, 81 bolesnik (69,8%) u kemoterapijskoj skupini primao je naknadno Zykadiu kao prvu antineoplastičnu terapiju nakon prekida ispitivanog liječenja.
For patients who develop a concurrent medical condition and are unable to take Zykadia with food, Zykadia can be taken on an empty stomach as the alternate continued treatment regimen, in which no food should be eaten for at least two hours before and one hour after the dose.
Za bolesnike koji razviju istodobno medicinsko stanje te nisu u mogućnosti uzeti Zykadiu uz hranu, Zykadia se može uzimati na prazan želudac kao alternativni kontinuirani režim liječenja po kojem se nikakva hrana ne smije uzimati barem dva sata prije i jedan sat nakon uzimanja doze.
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.
U bolesnika liječenih Zykadiom od 450 mg uz hranu, 10% bolesnika imalo je štetni događaj koji je zahtijevao najmanje jedno smanjenje doze i 42% bolesnika imalo je štetni događaj koji je zahtijevao barem jedan prekid doziranja.
Your doctor should also perform blood tests to check the functioning of your pancreas and the level of sugar in your blood before you start treatment with Zykadia and regularly during treatment.
Liječnik bi Vam također trebao obaviti krvne pretrage kako bi Vam provjerio funkcioniranje gušterače i razinu šećera u krvi prije nego započnete liječenje Zykadiom te redovito tijekom liječenja.
Lipase or amylase elevation grade ≥3
Povišenje lipaze ili amilaze stupnja ≥3
Formal non-clinical studies on the potential effects of ceritinib on fertility have not been conducted.
Formalna neklinička ispitivanja potencijalnih učinaka ceritiniba na plodnost nisu provedena.
Based on available data, ceritinib elimination via the kidney is negligible (1.3% of a single oral administered dose).
Na temelju dostupnih podataka, eliminacija ceritiniba putem bubrega je zanemariva (1,3% jednokratne peroralno primijenjene doze).
The tablets should be swallowed whole with water and should not be chewed or crushed.
Tablete se trebaju progutati cijele s vodom i ne smiju se žvakati ili drobiti.
No patients had diarrhoea, nausea, or vomiting that required dose reduction or discontinuation of study drug.
Nijedan bolesnik nije imao proljev, mučninu ili povraćanje koji su zahtijevali smanjenje doze ili prekid primjene ispitivanog lijeka.
75% or more of patients in the ceritinib and chemotherapy arms completed the LCSS questionnaires at most of the time points during the course of the study.
75% ili više bolesnika u skupinama liječenim ceritinibom ili kemoterapijom popunilo je LCSS upitnike u većini vremenskih točaka tijekom ispitivanja.
Oral absorption was estimated to be ≥25% based on metabolite percentages in the faeces.
Peroralna apsorpcija bila je procijenjena na ≥25% na temelju postotaka metabolita u stolici.
Significant improvements were reported for the majority of lung cancer specific symptoms for Zykadia compared to chemotherapy (four out of six LCSS and 10 out of 12 QLQ-LC13 symptom scores).
Značajna su poboljšanja bila zabilježena za većinu simptoma specifičnih za rak pluća uz Zykadiu u usporedbi s kemoterapijom (četiri od šest rezultata za simptome na LCSS-u i deset od dvanaest na QLQ-LC13).
Based on available data, ceritinib is eliminated primarily via the liver.
Na temelju dostupnih podataka, ceritinib se primarno eliminira putem jetre.
The maximum allowable dose under fasted condition is 750 mg (see section 5.2).
Najviša dopuštena doza natašte iznosi 750 mg (vidjeti dio 5.2).
A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Zykadia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see section 5.3).
Mora se donijeti odluka da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Zykadia uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu (vidjeti dio 5.3).
There are no data related to brain-to-blood exposure ratio in humans.
Nema podataka o omjeru izloženosti mozga i krvi u ljudi.
The study met its primary objective demonstrating a statistically significant improvement in progression free survival (PFS) by BIRC (see Table 3 and Figure 1).
Ispitivanje je ostvarilo svoj primarni cilj dokazavši statistički značajno poboljšanje u preživljenju bez progresije (PFS) prema ocjeni BIRC-a (vidjeti Tablicu 3 i Sliku 1).
Permanently discontinue Zykadia.
Trajno prekinuti primjenu Zykadie.
Number of events, n (%) Median, months d
Broj događaja, n (%) Medijan, mjeseci d
In Studies X2101 and A2201, brain metastases were seen in 60.1% and 71.4% of patients, respectively.
Ispitivanjima X2101 i A2201, metastaze na mozgu bile su uočene u 60,1% odnosno 71,4% bolesnika.
The limited data on the safety and efficacy of ceritinib in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see section 5.2).
Ograničeni podaci o sigurnosti i djelotvornosti ceritiniba u bolesnika u dobi od 65 godina i starijih ne ukazuju na potrebu za prilagođavanjem doze u starijih bolesnika (vidjeti dio 5.2).
Zykadia has minor influence on the ability to drive or use machines.
Zykadia malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Overall Response Rate (ORR: CR+PR), n (%) (95% CI)
Stopa ukupnog odgovora (ORR: CR+PR), n (%) (95% CI)
Treatment with Zykadia should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products.
Liječenje Zykadiom mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
Pharmacotherapeutic group: antineoplasic and immunomodulating agents, ATC code: L01XE28.
Farmakoterapijska skupina: antineoplastici i imunomodulatori, ATK oznaka: L01XE28.
A categorical outlier analysis of ECG data demonstrated new QTc >500 msec in 12 patients (1.3%).
Kategorička analiza ekstremnih vrijednosti podataka s EKG-a pokazala je novi QTc >500 msek u 12 bolesnika (1,3%).
Periodic monitoring with ECGs and periodic monitoring of electrolytes (e.g. potassium) is recommended in these patients.
Preporučuje se periodičko praćenje EKG-om i periodičko praćenje elektrolita (npr. kalija) u tih bolesnika.
Vision problems
Problemi s vidom
Event-free probability estimate at 9 months d
Procjena vjerojatnosti izostanka događaja nakon 9 mjeseci d
Lipase and/or amylase elevations
Povišenja lipaze i/ili amilaze
The median duration of follow-up was 16.5 months (from randomisation to data cut-off date).
Medijan trajanja praćenja bio je 16,5 mjeseci (od randomizacije do isključnog datuma).
Main biotransformation pathways identified in healthy subjects included mono-oxygenation, O-dealkylation, and N-formylation.
Glavni putevi biotransformacije identificirani u zdravih ispitanika uključivali su monooksigenaciju, O-dealkilaciju i N-formilaciju.
INTERMEDIATE CARTON OF PACK (WITHOUT BLUE BOX) CONTAINING 50 HARD CAPSULES
SREDNJA KUTIJA PAKIRANJA (BEZ PLAVOG OKVIRA) KOJE SADRŽI 50 TVRDIH KAPSULA
One hundred and eighty-nine (189) patients were randomised to ceritinib and one hundred eightyseven (187) were randomised to chemotherapy.
Sto osamdeset i devet (189) bolesnika bilo je randomizirano na ceritinib, a sto osamdeset i sedam (187) bilo je randomizirano na kemoterapiju.
The median duration of follow-up was 19.7 months (from randomisation to cut-off date).
Medijan trajanja praćenja bio je 19,7 mjeseci (od randomizacije do isključnog datuma).
In the ceritinib arm, 115 patients were treated with 750 mg once daily fasted.
U ceritinib skupini bilo je liječeno 115 bolesnika s 750 mg jedanput dnevno natašte.
For patients who develop a concurrent medical condition and are unable to take Zykadia with food please refer to section 4.5.
Za bolesnike koji razviju istodobno medicinsko stanje te nisu u mogućnosti uzeti Zykadiu uz hranu, molimo pogledajte dio 4.5.
1% of patients required permanent discontinuation of treatment in clinical studies with ceritinib (see sections 4.2 and 4.4).
1% bolesnika zahtijevalo je trajni prekid liječenja u kliničkim ispitivanjima s ceritinibom (vidjeti dijelove 4.2 i 4.4).
PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blisters containing 10 hard capsules.
PVC/PCTFE (polivinilklorid/poliklorotrifluoroetilen) - aluminijski blisteri koji sadrže 10 tvrdih kapsula.
Gastrointestinal events were managed primarily with concomitant medicinal products including anti-emetic/anti-diarrhoeal medicinal products.
Gastrointestinalni događaji su se zbrinjavali u prvom redu istodobnom primjenom drugih lijekova uključujući antiemetike/antidijaroike.
Patients with symptomatic CNS (central nervous system) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms, were excluded from the study.
Bolesnici sa simptomatskim metastazama u SŽS-u (središnjem živčanom sustavu) koji su bili neurološki nestabilni ili su im bile potrebne sve veće doze steroida unutar 2 tjedna prije probira radi kontroliranja simptoma SŽS-a bili su isključeni iz ispitivanja.
If long-term concomitant treatment with a strong CYP3A inhibitor is necessary and the patient tolerates the reduced dose well, the dose may be increased again with careful monitoring for safety, to avoid potential under-treatment.
Ako je dugoročno istodobno liječenje snažnim CYP3A inhibitorom nužno, a bolesnik dobro podnosi smanjenu dozu, doza se može ponovo povećati uz pažljivo motrenje radi sigurnosti, kako bi se izbjeglo potencijalno nedostatno davanje terapije.
Zykadia should be discontinued in patients unable to tolerate 150 mg daily taken with food.
Liječenje Zykadiom mora se prekinuti u bolesnika koji ne podnose 150 mg dnevno uzeto uz hranu.
CARTON OF UNIT PACK CONTAINING 40 OR 90 HARD CAPSULES
KUTIJA JEDINIČNOG PAKIRANJA KOJA SADRŽI 40 ILI 90 TVRDIH KAPSULA
Based on in vitro data, ceritinib does not inhibit apical efflux transporter MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Na temelju in vitro podataka, ceritinib ne inhibira apikalni efluksni transporter MRP2, transportere unosa u jetru OATP1B1 ili OATP1B3, bubrežne transportere za unos organskih aniona OAT1 i OAT3, ili transportere za unos organskih kationa OCT1 ili OCT2 pri klinički relevantnim koncentracijama.
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.
Ceritinib se pokazao djelotvornim protiv aktivnosti EML4-ALK-a u staničnoj liniji NSCLC-a (H2228), što rezultira inhibicijom proliferacije stanica in vitro i regresijom tumora u ksenograftima izvedenima iz H2228 u miševa i štakora.
In rats, ceritinib crosses the intact blood brain barrier with a brain-to-blood exposure (AUCinf) ratio of about 15%.
U štakora ceritinib prelazi neoštećenu krvno-moždanu barijeru s omjerom izloženosti mozga i krvi (AUCinf) od oko 15%.
PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blister containing 21 film-coated tablets.
PVC/PCTFE (polivinilklorid/poliklorotrifluoroetilen) - aluminijski blister koji sadrži 21 filmom obloženu tabletu.
Ceritinib has been classified in vivo as a weak CYP2C9 inhibitor.
Ceritinib je in vivo klasificiran kao slab CYP2C9 inhibitor.
The bioavailability of ceritinib is increased in the presence of food.
Bioraspoloživost ceritiniba povećava se u prisutnosti hrane.
150 (3 packs of 50) hard capsules.
150 (3 pakiranja od 50) tvrdih kapsula.
The capsules are provided in blisters and are available in packs containing 40, 90 or 150 (3 packs of 50) capsules.
Kapsule se isporučuju u blisterima i dostupne su u pakiranjima koja sadrže 40, 90 ili 150 (3 pakiranja od 50) kapsula.
Following a single oral administration of radioactive ceritinib dose at 750 mg fasted, ceritinib was the main circulating component in human plasma.
Nakon jednokratne peroralne primjene doze radioaktivnog ceritiniba od 750 mg natašte, ceritinib je bio glavna cirkulirajuća komponenta u ljudskoj plazmi.
A grade 3 event of diarrhoea was reported in one patient (1.1%).
Događaj proljeva stupnja 3 bio je prijavljen u jednog bolesnika (1,1%).
The tablets are provided in blisters and are available in a pack containing 84 tablets (4 blisters of 21 tablets).
Tablete se isporučuju u blisterima i dostupne su u pakiranju koje sadrži 84 tablete (4 blistera po 21 tableta).
Binding of ceritinib to human plasma proteins in vitro is approximately 97% in a concentration independent manner, from 50 ng/ml to 10,000 ng/ml.
Vezanje ceritiniba za proteine u ljudskoj plazmi in vitro otprilike iznosi 97% i to neovisno o koncentraciji, od 50 ng/ml do 10 000 ng/ml.
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.
Bolesnici koji su dovršili 4 ciklusa kemoterapije (indukcija) bez progresivne bolesti naknadno su primali pemetreksed (500 mg/m2) kao monoterapiju održavanja svakih 21 dan.
Safety pharmacology studies indicate that ceritinib is unlikely to interfere with vital functions of the respiratory and central nervous systems.
Sigurnosna farmakološka ispitivanja upućuju na to da je mala vjerojatnost da će ceritinib ometati vitalne funkcije dišnog i središnjeg živčanog sustava.
if you have problems with your heart, including reduced heart rate, or if the results of an electrocardiogram (ECG) have shown that you have an abnormality of the electrical activity of your heart known as “prolonged QT interval”.
ako imate probleme sa srcem, uključujući sniženu srčanu frekvenciju, ili ako su rezultati elektrokardiograma (EKG) pokazali da imate poremećaj električne aktivnosti srca koji se naziva „produljeni QT interval“. ako imate šećernu bolest (visoku razinu šećera u krvi).
One hundred fifteen (115) patients were randomised to Zykadia and one hundred sixteen (116) were randomised to chemotherapy (either pemetrexed or docetaxel).
Sto petnaest (115) bolesnika bilo je randomizirano na Zykadiu, a sto šesnaest (116) je bilo randomizirano na kemoterapiju (ili pemetreksed ili docetaksel).
The majority of patients were Caucasian (66.3%) or Asian (28.8%).
Većina bolesnika bili su bijelci (66,3%) ili Azijati (28,8%).
Acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) can alter the solubility of ceritinib and reduce its bioavailability.
Tvari koje smanjuju kiselost (npr. inhibitori protonske pumpe, antagonisti H2-receptora, antacidi) mogu promijeniti topivost ceritiniba i smanjiti njegovu bioraspoloživost.
59.5% of patients with brain metastasis at baseline received no prior radiotherapy to the brain.
59,5% bolesnika s metastazama na mozgu na početku nije prethodno primalo radioterapiju za mozak.
Daily oral dosing of ceritinib results in achievement of steady-state by approximately 15 days and remains stable afterwards, with a geometric mean accumulation ratio of 6.2 after 3 weeks of daily dosing.
Svakodnevna peroralna doza ceritiniba rezultira postizanjem stanja dinamičke ravnoteže nakon približno 15 dana i ostaje stabilna nakon toga, uz geometrijsku srednju vrijednost omjera akumulacije od 6,2 nakon 3 tjedna svakodnevnog doziranja.
Caution should be used in patients with severe renal impairment, as there is no experience with ceritinib in this population (see section 5.2).
Potreban je oprez u bolesnika s teškim oštećenjem bubrega, budući da nema iskustva s ceritinibom u ovoj populaciji (vidjeti dio 5.2).
What you need to know before you take Zykadia
Što morate znati prije nego počnete uzimati Zykadiu
Only 1.3% of the administered oral dose is recovered in the urine.
Samo 1,3% primijenjene peroralne doze izlučuje se mokraćom.
One hundred and five (105) patients out of the 145 patients (72.4%) that discontinued treatment in the chemotherapy arm received subsequent ALK inhibitor as first antineoplastic therapy.
Sto pet (105) bolesnika od 145 bolesnika (72,4%) koji su prekinuli liječenje u kemoterapijskoj skupini primalo je naknadno ALK inhibitor kao prvu antineoplastičnu terapiju.