natgillin/translations-raw huggingface dataset:
If you experience any of the following side effects, tell your doctor or pharmacist immediately: Chest pain or discomfort, changes in your heartbeat (fast or slow), light-headedness, fainting, dizziness, blue discoloration of your lips, shortness of breath, swelling of your lower limbs or skin (potential signs or symptoms of heart problems) New or worsening cough with or without mucus, fever, chest pain, trouble breathing or shortness of breath (potential signs of lung problems) Tiredness, itchy skin, yellowing of your skin or the whites of your eyes, nausea (feeling sick) or vomiting, decreased appetite, pain on the right side of your abdomen (belly), dark or brown urine, bleeding or bruising more easily than normal (potential signs or symptoms of liver problems)
Ako primijetite bilo koju od sljedećih nuspojava, odmah se obratite svom liječniku ili ljekarniku: Bol ili nelagoda u prsnom košu, promjene u otkucajima srca (ubrzani ili usporeni), ošamućenost, nesvjestica, omaglica, plave usnice, nedostatak zraka, oticanje donjih udova ili kože (potencijalni znakovi ili simptomi problema sa srcem) Novi ili pogoršani kašalj sa sluzi ili bez nje, vrućica, bol u prsnom košu, poteškoće s disanjem ili nedostatak zraka (potencijalni znakovi problema s plućima) Umor, svrbež kože, žutilo kože ili bjeloočnica, mučnina ili povraćanje, smanjeni apetit, bol na desnoj strani abdomena (trbuha), tamna ili smeđa mokraća, krvarenje ili stvaranje modrica lakše nego što je normalno (potencijalni znakovi ili simptomi problema s jetrom)
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.
Funkcionalno stanje prema ECOG-u bilo je 0/1/2 redom u 46,3%/47,6%/6,1% bolesnika, a 58,0% imalo je metastaze na mozgu na početku ispitivanja.
It is used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC).
Koristi se za liječenje odraslih osoba s uznapredovalim stadijima određene vrste raka pluća koji se zove rak pluća nemalih stanica (engl. nonsmall cell lung cancer, NSCLC).
There are no available data on patients over 85 years of age.
Nema dostupnih podataka o bolesnicima starijima od 85 godina.
Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Potrebno je isključiti druge potencijalne uzroke IBP-a/pneumonitisa (vidjeti dijelove 4.2 i 4.4).
After single oral administration of ceritinib in patients, plasma exposure to ceritinib, as represented by Cmax and AUClast, increased dose-proportionally over the 50 to 750 mg dose range under fasted conditions.
Nakon jednokratne peroralne primjene ceritiniba u bolesnika, izloženost plazme ceritinibu, predstavljena vrijednostima Cmax i AUClast, povećala se proporcionalno dozi u rasponu doze od 50 do 750 mg natašte.
In vitro studies demonstrated that CYP3A was the major enzyme involved in the metabolic clearance of ceritinib.
In vitro ispitivanja pokazala su da je CYP3A glavni enzim uključen u metabolički klirens ceritiniba.
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)
Poremećaji na laboratorijskim pretragama jetre (povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišena gama-glutamiltransferaza, povišeni bilirubin u krvi, povišene transaminaze, povišeni jetreni enzimi, poremećeni test jetrene funkcije, povišene vrijednosti na testu jetrene funkcije, povišena alkalna fosfataza u krvi)
The frequency of selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) are based on patients treated with a dose of 450 mg once-daily with food (N=89).
Učestalost odabranih gastrointestinalnih nuspojava (proljev, mučnina i povraćanje) je temeljena na bolesnicima liječenima dozom od 450 mg jedanput dnevno uz hranu (N=89).
Cases of pancreatitis have been reported in patients treated with ceritinib (see section 4.8).
U bolesnika liječenih ceritinibom prijavljeni su slučajevi pankreatitisa (vidjeti dio 4.8).
Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis have been observed in patients treated with ceritinib.
Teška, po život opasna ili smrtonosna intersticijska bolest pluća (IBP)/pneumonitis uočeni su u bolesnika liječenih ceritinibom.
The PFS benefit of Zykadia was consistent across various subgroups including age, gender, race, smoking class, ECOG performance status, and presence of brain metastases or prior response to crizotinib.
Korist Zykadie za PFS bila je dosljedna u različitim podskupinama uključujući podskupine prema dobi, spolu, rasi, pušačkim navikama, funkcionalnom stanju po ECOG-u, prisutnosti metastaza na mozgu ili prethodnom odgovoru na krizotinib.
If you vomit after you swallow the Zykadia tablets, do not take any more tablets until your next scheduled dose.
Ako povratite nakon što progutate Zykadia tablete, nemojte uzimati nove tablete do sljedeće doze po rasporedu.
Light blue, round, biconvex film-coated tablet with bevelled edges, without score, debossed with “NVR” on one side and “ZY1” on the other side.
Svijetlo plava, okrugla, bikonveksna filmom obložena tableta sa zaobljenim rubovima, bez ureza, s utisnutom oznakom „NVR“ na jednoj strani i „ZY1“ na drugoj strani.
Caution should be exercised with concomitant use of CYP2A6 and CYP2E1 substrates and ADRs carefully monitored.
Potreban je oprez kod istodobne primjene CYP2A6 i CYP2E1 supstrata te pažljivo praćenje nuspojava.
A total of 81 previously untreated patients with ALK-positive locally advanced or metastatic NSCLC were randomised to receive Zykadia 450 mg once daily with food (N=41) or Zykadia 750 mg once daily under fasted conditions (N=40).
Ukupno 81 prethodno neliječeni bolesnik s ALK-pozitivnim lokalno uznapredovalim ili metastatskim NSCLC-om bio je randomiziran u skupinu koja je primala Zykadiu od 450 mg jedanput dnevno uz hranu (N=41) ili Zykadiu od 750 mg jedanput dnevno natašte (N=40).
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.
Nuspojave stupnja 3-4 s incidencijom ≥5% u bolesnika liječenih Zykadiom od 750 mg natašte bile su abnormalnosti na laboratorijskim pretragama jetre, umor, povraćanje, hiperglikemija, mučnina i proljev.
Chemotherapy (N=187)
Kemoterapija (N=187)
The recommended dose of Zykadia is 450 mg taken orally once daily with food at the same time each day.
Preporučena doza Zykadie je 450 mg koja se uzima peroralno jedanput na dan uz hranu, svakoga dana u isto vrijeme.
No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see section 4.2).
Nije potrebno prilagođavanje doze u bolesnika s blagim ili umjerenim oštećenjem jetre (vidjeti dio 4.2).
Monitoring of fasting serum glucose is required prior to the start of ceritinib treatment and periodically thereafter as clinically indicated.
Potrebno je praćenje glukoze u serumu natašte prije početka liječenja ceritinibom te periodički nakon toga prema kliničkim indikacijama.
Pericarditis (pericardial effusion, pericarditis)
Perikarditis (perikardijalni izljev, perikarditis)
Co-administration of ceritinib with substrates primarily metabolised by CYP2C9 or CYP2C9 substrates known to have narrow therapeutic indices (e.g. phenytoin and warfarin) should be avoided.
Potrebno je izbjegavati istodobnu primjenu ceritiniba sa supstratima koji se primarno metaboliziraju putem CYP2C9 ili CYP2C9 supstratima za koje se zna da imaju uski terapijski indeks (npr. fenitoin i varfarin).
Permanently discontinue Zykadia if no contributing concomitant medicinal product is identified.
Trajno prekinuti primjenu Zykadie ako se ne identificira nijedan istodobno primijenjeni lijek koji doprinosi bradikardiji.
Based on in vitro data, ceritinib is predicted to inhibit intestinal P-gp and BCRP at clinically relevant concentrations.
Na temelju in vitro podataka, za ceritinib se predviđa da inhibira crijevni P-gp i BCRP pri klinički značajnim koncentracijama.
A dedicated study to evaluate the effect of gastric acid-reducing agents on the bioavailability of ceritinib under steady state has not been conducted.
Posebno ispitivanje za ocjenjivanje učinka tvari koje smanjuju lučenje želučane kiseline na bioraspoloživost ceritiniba u stanju dinamičke ravnoteže nije provedeno.
Ceritinib demonstrates pH-dependent solubility and becomes poorly soluble as pH increases in vitro.
Ceritinib ima topivost ovisnu o pH i postaje slabo topiv kada se pH povećava in vitro.
What to do if you forget to take a dose depends on how long it is until your next dose.
Ako ste zaboravili uzeti Zykadiu Što trebate učiniti ako ste zaboravili uzeti dozu ovisi o tome kada je predviđena Vaša sljedeća doza.
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).
Ispitivanju A2303, u 133 bolesnika s metastazama na mozgu na početku ispitivanja (66 bolesnika u Zykadia skupini i 67 bolesnika u kemoterapijskoj skupini) BIRC-ov neuroradiolog ocijenio je intrakranijalni odgovor prema modificiranim kriterijima RECIST 1.1 (tj. do 5 lezija na mozgu).
Cases of hyperglycaemia (all grades) have been reported in less than 10% of patients treated with ceritinib in clinical studies; grade 3-4 hyperglycaemia was reported in 5.4% of patients.
Slučajevi hiperglikemije (svih stupnjeva) prijavljeni su u manje od 10% bolesnika liječenih ceritinibom u kliničkim ispitivanjima; hiperglikemija stupnja 3-4 prijavljena je u 5,4% bolesnika.
Printing ink: Shellac (bleached, de-waxed) glaze 45%, iron oxide black (E172), propylene glycol and ammonium hydroxide 28%.
Tinta za označavanje: šelak (izbijeljen, bez voska) glazura 45%, crni željezov oksid (E172), propilenglikol i amonijev hidroksid 28%.
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.
Nasuprot tome, AUC u stanju dinamičke ravnoteže (90% CI) za skupinu koja je primala 600 mg uz hranu (N=30) povećan je za 24% (3%, 49%), a Cmax (90% CI) za 25% (4%, 49%), u usporedbi sa skupinom koja je primala 750 mg natašte.
Mixed cell/neutrophilic inflammation of the extra-hepatic ducts extended to the pancreas and/or duodenum at higher doses.
Miješana/neutrofilna upala ekstrahepatičkih žučnih vodova proširila se na gušteraču i/ili dvanaesnik pri višim dozama.
After discontinuation of a strong CYP3A inhibitor, resume at the dose that was taken prior to initiating the strong CYP3A inhibitor.
Nakon prekida primjene snažnog CYP3A inhibitora nastavlja se s dozom koja se primjenjivala prije uvođenja snažnog CYP3A inhibitora.
Efficacy data from Study A2303 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
Podaci o djelotvornosti iz Ispitivanja A2303 sažeti su u Tablici 4, a Kaplan-Meierove krivulje za PFS i OS prikazane su na Slici 3, odnosno 4.
Patients randomised to the chemotherapy arm could further crossover to receive Zykadia upon RECIST-defined disease progression confirmed by BIRC.
Bolesnici randomizirani u skupinu koja prima kemoterapiju mogli su prijeći na Zykadiu nakon što je BIRC potvrdio progresiju bolesti prema definiciji RECIST-a.
40 hard capsules 90 hard capsules
40 tvrdih kapsula 90 tvrdih kapsula
Across the seven clinical studies, bradycardia and/or sinus bradycardia (heart rate less than 60 bpm) events (all grade 1) were reported in 2.3% of patients.
U sedam kliničkih ispitivanja, događaji (svi stupnja 1) bradikardije i/ili sinusne bradikardije (srčane frekvencije niže od 60 otkucaja u minuti) bili su prijavljeni u 2,3% bolesnika.
Patients randomised to the chemotherapy arm could cross-over to receive ceritinib upon RECIST-defined disease progression confirmed by blinded independent review committee (BIRC).
Bolesnici randomizirani u skupinu koja prima kemoterapiju mogli su prijeći na ceritinib nakon što je odbor za slijepo neovisno ocjenjivanje (BIRC) potvrdio progresiju bolesti prema definiciji RECIST-a.
50 hard capsules.
50 tvrdih kapsula.
Increasing the frequency of international normalised ratio (INR) monitoring may be considered if co-administration with warfarin is unavoidable.
Ako je istodobna primjena s varfarinom neizbježna, može se razmotriti povećanje učestalosti praćenja međunarodnog normaliziranog omjera (INR).
OS analysis was not adjusted for the effects of cross-over.
Analiza OS-a nije bila prilagođena za učinke prijelaza na drugu terapiju.
Oesophageal disorder (dyspepsia, gastro-oesophageal reflux disease, dysphagia)
Poremećaj jednjaka (dispepsija, gastroezofagealna refluksna bolest, disfagija)
Respiratory, thoracic and mediastinal disorders Pneumonitis d
Poremećaji dišnog sustava, prsišta i sredoprsja Pneumonitis d
Concomitant use of strong CYP3A inducers should be avoided; this includes, but is not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum).
Istodobnu primjenu snažnih CYP3A induktora treba izbjegavati; to uključuje, između ostalih, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin i gospinu travu (Hypericum perforatum).
If you accidentally take too many capsules, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
Ako slučajno uzmete previše kapsula, ili ako netko slučajno uzme
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.
Nuspojave s incidencijom ≥10% u bolesnika liječenih Zykadiom od 750 mg natašte bile su proljev, mučnina, povraćanje, umor, abnormalnosti na laboratorijskim pretragama jetre, bol u abdomenu, smanjeni apetit, smanjena tjelesna težina, konstipacija, povišeni kreatinin u krvi, osip, anemija i poremećaj funkcije jednjaka.
- If your next dose is in 12 hours or more, take the missed tablets as soon as you remember.
Ako sljedeću dozu morate uzeti za 12 ili više sati, uzmite propuštene tablete čim se sjetite.
Avoid concomitant use of strong CYP3A inhibitors during treatment with Zykadia.
Potrebno je izbjegavati istodobnu primjenu snažnih CYP3A inhibitora tijekom liječenja Zykadiom.
Ceritinib 750 mg fasted (N=40)
Ceritinib 750 mg natašte (N=40)
Efficacy data from Study A2301 are summarised in Table 3, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and Figure 2, respectively.
Podaci o djelotvornosti iz ispitivanja A2301 sažeti su u Tablici 3, a Kaplan-Meierove krivulje za PFS i OS prikazane su na Slici 1, odnosno Slici 2.
OS analysis was not adjusted for the potentially confounding effects of cross over.
Analiza OS-a nije bila prilagođena za potencijalno zbunjujuće učinke prijelaza na drugu terapiju.
Recovery of unchanged ceritinib in the faeces accounts for a mean 68% of an oral dose.
Količina nepromijenjenog ceritiniba izlučenog u stolici iznosi srednju vrijednost od 68% peroralne doze.
How much to take The recommended dose is 450 mg (three capsules) taken once daily with food, although your doctor could modify this recommendation if needed.
Preporučena doza je 450 mg (3 kapsule) jedanput na dan uz hranu, no Vaš liječnik može prilagoditi tu preporuku prema potrebi.
Withhold Zykadia until recovery to asymptomatic (grade ≤1) bradycardia or to a heart rate of 60 beats per minute (bpm) or above.
Privremeno prekinuti primjenu Zykadie do oporavka do asimptomatske (stupanj ≤1) bradikardije ili do srčane frekvencije od 60 otkucaja u minuti ili više.
If you accidentally take too many tablets, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
Ako slučajno uzmete previše tableta, ili ako netko slučajno uzme
How much to take The recommended dose is 450 mg (three tablets) taken once daily with food, although your doctor could modify this recommendation if needed.
Preporučena doza je 450 mg (3 tablete) jedanput na dan uz hranu, no Vaš liječnik može prilagoditi tu preporuku prema potrebi.
The PFS benefit of ceritinib was consistent by investigator assessment and across various subgroups including age, gender, race, smoking class, ECOG performance status and disease burden.
Korist ceritiniba u pogledu PFS-a bila je u skladu s ocjenom ispitivača te prisutna u različitim podskupinama, uključujući podskupine prema dobi, spolu, rasi, pušačkom statusu, funkcionalnom stanju po ECOG-u i opterećenosti bolešću.
Hazard Ratio = 1.00 95% CI (0.67;1.49)
Omjer hazarda = 1,00 95% CI (0,67;1,49)
Capsule shell: gelatin, indigotine (E132) and titanium dioxide (E171).
Ovojnica kapsule: želatina, indigotin (E132) i titanijev dioksid (E171).
Zykadia dosing
Doza Zykadie
After discontinuation of a strong CYP3A inhibitor, resume the ceritinib dose that was taken prior to initiating the strong CYP3A inhibitor.
Nakon prekida primjene snažnog CYP3A inhibitora nastavlja se s dozom ceritiniba koja se primjenjivala prije uvođenja snažnog CYP3A inhibitora.
The geometric mean apparent clearance (CL/F) of ceritinib was lower at steady-state (33.2 litres/hour) after 750 mg daily oral dosing than after a single 750 mg oral dose (88.5 litres/hour), suggesting that ceritinib demonstrates non-linear pharmacokinetics over time.
Geometrijska srednja vrijednost prividnog klirensa (CL/F) ceritiniba bila je niža u stanju dinamičke ravnoteže (33,2 litre/sat) nakon peroralne doze od 750 mg dnevno nego nakon jednokratne peroralne doze od 750 mg (88,5 litara/sat), što ukazuje na to da ceritinib pokazuje nelinearnu farmakokinetiku tijekom vremena.
Caution should be exercised with concomitant use of P-gp inhibitors and ADRs carefully monitored.
Potreban je oprez kod istodobne primjene P-gp inhibitora te pažljivo praćenje nuspojava.
Therefore, ceritinib may have the potential to increase plasma concentrations of co-administered medicinal products transported by these proteins.
Stoga ceritinib može potencijalno povećati koncentracije u plazmi lijekova koji se istodobno primjenjuju, a transportiraju se putem tih proteina.
new or worsening cough with or without mucus, fever, chest pain, trouble breathing or shortness of breath.
To mogu biti znakovi ili simptomi problema s jetrom. novi ili pogoršani kašalj sa sluzi ili bez nje, vrućica, bol u prsnom košu, poteškoće s disanjem ili nedostatak zraka.
- If your next dose is in 12 hours or more, take the missed capsules as soon as you remember.
Ako sljedeću dozu morate uzeti za 12 ili više sati, uzmite propuštene kapsule čim se sjetite.
In clinical studies, QT prolongation was observed with ceritinib.
U kliničkim ispitivanjima uočeno je produljenje QT intervala uz ceritinib.
An accurate and validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
Za odabir bolesnika s ALK-pozitivnim NSCLC-om nužno je provesti točan i validiran test za ALK (vidjeti dio 5.1).
Hazard Ratio = 0.49 95% CI (0.36;0.67)
Omjer hazarda = 0,49 95% CI (0,36;0,67)
Tell your doctor or pharmacist immediately if you get any of the following signs or symptoms during treatment with Zykadia: tiredness, itchy skin, yellowing of your skin or the whites of your eyes, nausea (feeling sick) or vomiting, decreased appetite, pain on the right side of your abdomen (belly), dark or brown urine, bleeding or bruising more easily than normal.
Odmah se obratite svom liječniku ili ljekarniku ako primijetite bilo koji od niže navedenih znakova ili simptoma tijekom liječenja Zykadiom: umor, svrbež kože, žutilo kože ili bjeloočnica, mučnina ili povraćanje, smanjeni apetit, bol na desnoj strani abdomena (trbuha), tamna ili smeđa mokraća, krvarenje ili stvaranje modrica lakše nego što je normalno.
There are no or limited amount of data from the use of ceritinib in pregnant women.
Nema podataka ili su podaci o primjeni ceritiniba u trudnica ograničeni.
All patients were treated with prior crizotinib.
Svi su se bolesnici prethodno liječili krizotinibom.
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)
Učestalost odabranih gastrointestinalnih nuspojava (proljev, mučnina i povraćanje) je temeljena na bolesnicima liječenima preporučenom dozom ceritiniba od 450 mg uz hranu (N=89) u ispitivanju A2112 (ASCEND-8) (vidjeti pododjeljak „Gastrointestinalne nuspojave“ ispod)
No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
Nije potrebno prilagođavanje doze u bolesnika s blagim ili umjerenim oštećenjem jetre.
Therefore, ceritinib should be used with caution in patients who have or may develop prolongation of the QT interval, including those patients taking anti-arrhythmic medicinal products such as class I (e.g. quinidine, procainamide, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) anti-arrhythmics or other medicinal products that may lead to QT prolongation such as domperidone, droperidol, chloroquine, halofantrine, clarithromycin, haloperidol, methadone, cisapride and moxifloxacin.
Stoga je ceritinib potrebno primjenjivati s oprezom u bolesnika koji imaju ili u kojih može doći do produljenja QT intervala, uključujući one bolesnike koji uzimaju antiaritmike kao što su antiaritmici klase I (npr. kinidin, prokainamid, dizopiramid) ili klase III (npr. amiodaron, sotalol, dofetilid, ibutilid) ili druge lijekove koji mogu dovesti do produljenja QT intervala kao što su domperidon, droperidol, klorokin, halofantrin, klaritromicin, haloperidol, metadon, cisaprid i moksifloksacin.
Across the seven clinical studies, any grade ILD/pneumonitis has been reported in 2.1% of patients treated with ceritinib, and grade 3 or 4 events have been reported in 1.2% of patients.
U sedam kliničkih ispitivanja, IBP/pneumonitis bilo kojeg stupnja bio je prijavljen u 2,1% bolesnika liječenih ceritinibom, a događaji stupnja 3 ili 4 bili su prijavljeni u 1,2% bolesnika.
The median age was 54.0 years (range: 28 to 84 years); 77.1% of patients were younger than 65 years.
Medijan dobi bio je 54,0 godine (raspon: 28 do 84 godine); 77,1% bolesnika bilo je mlađe od 65 godina.
Medicines which may increase the risk of side effects with Zykadia: medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir).
Lijekovi koji mogu povećati rizik od nuspojava sa Zykadiom: lijekovi koji se koriste za liječenje AIDS-a/HIV-a (npr. ritonavir, sakvinavir). lijekovi koji se koriste za liječenje infekcija.
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).
Primjena Zykadie u liječenju bolesnika s ALK-pozitivnim NSCLC-om koji su prethodno bili liječeni ALK inhibitorom ispitivana je u dva globalna, multicentrična, otvorena ispitivanja faze 1/2 s jednom skupinom (Ispitivanje X2101 i Ispitivanje A2201).
In Study A2301, 44 patients with measurable brain metastasis at baseline and at least one post-baseline brain radiological assessment (22 patients in the ceritinib arm and 22 patients in the chemotherapy arm) were assessed for intracranial response by BIRC neuro-radiologist per modified RECIST 1.1 (i.e.
U ispitivanju A2301, u 44 bolesnika s mjerljivim metastazama na mozgu na početku i najmanje jednom radiološkom pretragom mozga nakon početka ispitivanja (22 bolesnika u ceritinib skupini i 22 bolesnika u kemoterapijskoj skupini) BIRC-ov neuroradiolog ocijenio je intrakranijalni odgovor prema modificiranim kriterijima RECIST 1.1 (tj. do 5 lezija na mozgu).