FrancophonIA/ELRC3.0 huggingface dataset:
English: 44% (95% CI: 32, 55) for pemetrexed/carboplatin (p-value <0.0001 compared with crizotinib).
Croatian: <0,0001 u usporedbi s krizotinibom) i 44% (95% CI: 32, 55) za pemetreksed/karboplatin (p vrijednost <0,0001 u usporedbi s krizotinibom).
English: Based on the population pharmacokinetic analysis of data in Studies 1001, 1005 and 1007, age has no effect on crizotinib pharmacokinetics.
Croatian: Na temelju populacijske farmakokinetičke analize podataka iz Ispitivanja 1001, 1005 i 1007, dob ne utječe na farmakokinetiku krizotiniba.
English: The demographic and disease characteristics were 50% female, median age of 51 years, baseline ECOG performance status of 0 (32%) or 1 (55%), 61% White and 30% Asian, less than 1% were current smokers, 27% former smokers, 72% never smokers, 94% metastatic, and 98% of the cancers were classified as adenocarcinoma histology.
Croatian: Demografska obilježja i obilježja bolesti bila su: 50% žene, medijan dobi 51 godina, početno opće stanje prema ljestvici ECOG 0 (32%) ili 1 (55%), 61% bijelci i 30% azijati, manje od 1% trenutni pušači, 27% bivši pušači, 72% nikad nisu pušili, metastatska bolest u 94% slučajeva i 98% tumora klasificirano je po histološkom tipu kao adenokarcinom.
English: The median DR was 24.7 months (95% CI: 15.2, 45.3).
Croatian: Medijan trajanja odgovora iznosio je 24,7 mjeseci (95% CI: 15,2; 45,3).
English: Most of the available information is available in patients with some specific histology type of ALK-positive NSCLC (adenocarcinoma) and limited information is available in the other histologies.
Croatian: Većina dostupnih podataka o ovom lijeku odnosi se na bolesnike čiji je ALK-pozitivan rak pluća nemalih stanica po histološkom tipu adenokarcinom.
English: The efficacy and safety of crizotinib for the treatment of patients with ALK-positive metastatic NSCLC, who had not received previous systemic treatment for advanced disease, were demonstrated in a global, randomised, open-label Study 1014.
Croatian: Prethodno neliječeni ALK-pozitivni uznapredovali NSCLC -randomizirano Ispitivanje 1014 faze 3 Djelotvornost i sigurnost krizotiniba u liječenju bolesnika s ALK-pozitivnim, metastatskim NSCLCom, koji nisu primili prethodno sustavno liječenje za uznapredovalu bolest, dokazane su u globalnom, randomiziranom, otvorenom Ispitivanju 1014.
English: XALKORI 200 mg hard capsules XALKORI 250 mg hard capsules crizotinib
Croatian: XALKORI 200 mg tvrde kapsule XALKORI 250 mg tvrde kapsule
English: Less than 0.5% of patients experienced febrile neutropenia in clinical studies with crizotinib.
Croatian: U kliničkim ispitivanjima s krizotinibom, febrilna neutropenija javila se u manje od 0,5% bolesnika.
English: In clinical studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), Grade 4 visual field defect with vision loss has been reported in 4 (0.2%) patients.
Croatian: U kliničkim ispitivanjima s krizotinibom kod bolesnika s ALK-pozitivnim ili ROS1-pozitivnim NSCLC-om (N=1772), ispad vidnog polja stupnja 4 s gubitkom vida prijavljen je kod 4 (0,2 %) bolesnika.
English: 6-Month Survival Probability,e % (95% CI) 1-Year Survival Probability,e % (95% CI)
Croatian: CI) 1-godišnja vjerojatnost preživljenja e, % (95%
English: XALKORI 250 mg hard capsules Each hard capsule contains 250 mg of crizotinib.
Croatian: XALKORI 250 mg: jedna kapsula sadrži 250 mg krizotiniba.
English: QT prolongation may clinically manifest as bradycardia, dizziness, and syncope.
Croatian: Produljenje QT intervala može dovesti do aritmija što je faktor rizika za iznenadnu smrt. QT produljenje može se klinički manifestirati kao bradikardija, omaglica i sinkopa.
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or 4 neutropenia was observed in 212 (12%) patients treated with crizotinib.
Croatian: U ispitivanjima u bolesnika bilo s ALK-pozitivnim ili ROS1-pozitivnim uznapredovalim NSCLC-om (N=1722), neutropenija stupnja 3 ili 4 opažena je u 212 (12%) bolesnika liječenih krizotinibom.
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or Grade 4 leukopenia was observed in 48 (3%) patients treated with crizotinib.
Croatian: U ispitivanjima u bolesnika bilo s ALK-pozitivnim ili ROS1-pozitivnim uznapredovalim NSCLC-om (N=1722), leukopenija stupnja 3 ili 4 opažena je u 48 (3%) bolesnika liječenih krizotinibom.
English: • Increased levels of the enzyme alkaline phosphatase in the blood (an indicator of organ malfunction or injury, particularly liver, pancreas, bone, thyroid gland, or gall bladder).
Croatian: • povećane razine enzima alkalne fosfataze u krvi (pokazatelj disfunkcije ili oštećenja organa,
English: The efficacy and safety of crizotinib for the treatment of patients with ALK-positive metastatic NSCLC, who had received previous systemic treatment for advanced disease, were demonstrated in a global, randomised, open-label Study 1007.
Croatian: Prethodno liječeni ALK-pozitivni uznapredovali NSCLC -randomizirano Ispitivanje 1007 faze 3 Djelotvornost i sigurnost krizotiniba u liječenju bolesnika s ALK-pozitivnim metastatskim NSCLCom, koji su primali prethodno sustavno liječenje za uznapredovalu bolest, dokazane su u globalnom, randomiziranom, otvorenom Ispitivanju 1007.
English: Across studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), dose reductions associated with transaminase elevations occurred in 76 (4%) patients.
Croatian: U ispitivanjima s krizotinibom u bolesnika s ALK-pozitivnim ili s ROS1-pozitivnim NSCLCom (N=1722), doza je zbog povišenja transaminaza smanjena u 76 (4%) bolesnika.
English: • Permanently discontinue if unable to tolerate XALKORI 250 mg taken orally once daily
Croatian: • ako bolesnik ne podnosi XALKORI 250 mg primijenjen peroralno jedanput na dan, trajno obustaviti primjenu.
English: In clinical studies, prolonged QT interval was observed with crizotinib.
Croatian: U kliničkim je ispitivanjima kod primjene krizotiniba opaženo produljenje QT-intervala.
English: Drug-induced hepatotoxicity (including cases with fatal outcome) has been reported in patients treated with crizotinib across clinical trials (see section 4.8).
Croatian: U bolesnika liječenih krizotinibom u kliničkim ispitivanjima (vidjeti dio 4.8) zabilježena je hepatotoksičnost uzrokovana lijekom (uključujući slučajeve sa smrtnim ishodom).
English: Serial ECGs in triplicate were collected following a single dose and at steady state to evaluate the effect of crizotinib on QT intervals.
Croatian: Kako bi se ocijenio učinak krizotiniba na QT-interval, rađeni su serijski EKG-i u triplikatu nakon primjene jedne doze i u stanju dinamičke ravnoteže.
English: • Pain in the abdomen.
Croatian: • bol u trbuhu
English: Efficacy results from randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC* Response Parameter
Croatian: Tablica 5. Podaci djelotvornosti u randomiziranom Ispitivanju 1007 faze 3 (potpuna analiza populacije) u bolesnika s prethodno liječenim ALK-pozitivnim uznapredovalim NSCLC-om* Parametar odgovora krizotinib N=173
English: XALKORI 200 mg hard capsules
Croatian: XALKORI 200 mg tvrde kapsule
English: XALKORI 250 mg hard capsules
Croatian: XALKORI 250 mg tvrde kapsule
English: Therefore, the concomitant use of strong CYP3A inhibitors (including but not limited to atazanavir, ritonavir, cobicistat, itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, and erythromycin) should be avoided.
Croatian: Stoga treba izbjegavati istodobnu primjenu snažnih inhibitora CYP3A (uključujući, no ne ograničavajući se na atazanavir, , ritonavir, kobicistat, itrakonazol, ketokonazol, posakonazol, vorikonazol, klaritromicin, telitromicin i eritromicin ), osim u slučaju da potencijalna korist za bolesnika nadmašuje rizik, pri čemu bolesnike treba pažljivo pratiti radi moguće pojave štetnih događaja povezanih s primjenom krizotiniba (vidjeti dio 4.4).
English: A total of 149 ALK-positive advanced NSCLC patients, including 125 patients with previously treated ALK-positive advanced NSCLC, were enrolled into Study 1001 at the time of data cutoff for PFS and ORR analysis.
Croatian: Do zaključnog datuma prikupljanja podataka za analize PFS i ORR u Ispitivanje 1001 uključeno je ukupno 149 bolesnika s ALK-pozitivnim uznapredovalim NSCLC-om, uključujući 125 prethodno liječenih bolesnika s ALK-pozitivnim, uznapredovalim NSCLC-om.
English: Efficacy results from randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALK-positive advanced NSCLC* Response Parameter
Croatian: Tablica 4: Podaci djelotvornosti u randomiziranom Ispitivanju 1014 faze 3 (potpuna analiza populacije) u bolesnika s prethodno neliječenim ALK-pozitivnim uznapredovalim NSCLC-om* Parametar odgovora krizotinib N=172
English: e. ORRs were 47% (95% CI: 37, 58) for pemetrexed/cisplatin (p-value <0.0001 compared with crizotinib) and
Croatian: Stope objektivnog odgovora (ORR) bile su 47% (95% CI: 37, 58) za pemetreksed/cisplatin (p-vrijednost
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip (13%)
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered medicinal products that are substrates of P-gp (see section 4.5).
Croatian: Krizotinib je inhibitor P-glikoproteina (P-gp) in vitro te stoga može povećati plazmatske koncentracije istodobno primijenjenih lijekova koji su supstrati za P-gp (vidjeti dio 4.5).
English: • The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC) 4.2 Posology and method of administration
Croatian: • liječenje odraslih s ROS1-pozitivnim uznapredovalim rakom pluća nemalih stanica (NSCLC).
English: What XALKORI looks like and contents of the pack XALKORI 200 mg is supplied as hard gelatin capsules with pink cap and white body, printed with black ink “Pfizer” on the cap, “CRZ 200” on the body.
Croatian: XALKORI 200 mg su tvrde želatinske kapsule s ružičastom kapicom i bijelim tijelom, s crno otisnutom oznakom "Pfizer" na kapici i "CRZ 200" na tijelu.
English: Progression-Free Survival (Based on IRR) Number with event, n (%) Median PFS in months (95% CI)
Croatian: Preživljenje bez progresije bolesti (na temelju IRR-a) Broj s događajem, n (%)
English: Hypophosphataemia (6%)
Croatian: Poremećaji metabolizma i prehrane smanjen apetit (30%) hipofosfatemija (6%)
English: 12-Month Survival Probability,d % (95% CI)
Croatian: HR (95% CI) p-vrijednost 12-mjesečna vjerojatnost preživljenja, d % (95%
English: The central tendency analysis indicated that all upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were <20 msec. A pharmacokinetic/pharmacodynamic analysis suggested a relationship between crizotinib plasma concentration and QTc.
Croatian: Analiza središnje tendencije pokazala je da su sve gornje granice 90%-tnog CI za srednju vrijednost promjene dobivenu metodom najmanjih kvadrata u odnosu na početne vrijednosti QTcF-intervala u svim vremenskim točkama 1. dana 2. ciklusa bile < 20 msek.
English: Oedemap (47%) Fatigue (30%)
Croatian: Opći poremećaji i reakcije na mjestu primjene edem p (47%) umor (30%)
English: • Clonidine, guanfacine, used to treat hypertension.
Croatian: • klonidinom, gvanfacinom - koriste se za liječenje povišenog krvnog tlaka.
English: n. Renal cyst (Renal abscess, Renal cyst, Renal cyst haemorrhage, Renal cyst infection).
Croatian: n. Bubrežna cista (bubrežni apsces, bubrežna cista, krvarenje bubrežne ciste, infekcija bubrežne ciste).
English: • Naloxone, used to treat opiate drug addiction and withdrawal.
Croatian: • naloksonom - koristi se u liječenju ovisnosti o opijatima i pri prestanku njihovog uzimanja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg crizotinib.
Croatian: Jedna tvrda kapsula sadrži 200 mg krizotiniba.
English: Colloidal anhydrous silica Microcrystalline cellulose Anhydrous calcium hydrogen phosphate Sodium starch glycolate (Type A) Magnesium stearate
Croatian: Sadržaj kapsule silicijev dioksid, koloidni, bezvodni celuloza, mikrokristalična kalcijev hidrogenfosfat bezvodni natrijev škroboglikolat, vrsta A magnezijev stearat
English: j. Abdominal pain (Abdominal discomfort, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness).
Croatian: Intersticijska bolest pluća (sindrom akutnog respiracijskog distresa, alveolitis, intersticijska bolest pluća, pneumonitis). j. Bol u abdomenu (nelagoda u abdomenu, bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena, osjetljivost abdomena).
English: Rash (13%)
Croatian: d % (95%
English: Geriatric
Croatian: Kemoterapija
English: Kaplan-Meier curves for overall survival by treatment arm in randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC
Croatian: Kaplan-Meierove krivulje za ukupno preživljenje po liječenoj skupini u randomiziranom Ispitivanju 1007 faze 3 (potpuna analiza populacije) u bolesnika s prethodno liječenim ALK-pozitivnim uznapredovalim NSCLC-om
English: Kaplan-Meier curves for progression-free survival (based on IRR) by treatment arm in randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC
Croatian: Kaplan-Meierove krivulje za preživljenje bez progresije (na temelju IRR-a) po liječenoj skupini u randomiziranom Ispitivanju 1007 faze 3 (potpuna analiza populacije) u bolesnika s prethodno liječenim ALK-pozitivnim uznapredovalim NSCLC-om
English: XALKORI 200 mg: each capsule contains 200 mg crizotinib XALKORI 250 mg: each capsule contains 250 mg crizotinib
Croatian: XALKORI 200 mg: jedna kapsula sadrži 200 mg krizotiniba.
English: Re-treatment with crizotinib
Croatian: Ponovno liječenje krizotinibom
English: Capsule content
Croatian: zatajenje jetre
English: Kaplan-Meier curves for progression-free survival (based on IRR) by treatment arm in randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALK-positive advanced NSCLC
Croatian: Kaplan-Meierove krivulje za preživljenje bez progresije (na temelju IRR-a) po liječenoj skupini u randomiziranom Ispitivanju 1014 faze 3 (potpuna analiza populacije) u bolesnika s prethodno neliječenim ALK-pozitivnim uznapredovalim NSCLC-om
English: A high-fat meal reduced crizotinib AUCinf and Cmax by approximately 14% when a 250 mg single dose was given to healthy volunteers.
Croatian: Primjena jedne doze od 250 mg u zdravih dobrovoljaca uz punomastan obrok smanjila je AUCinf i Cmax krizotiniba za približno 14%.
English: Duration of Response Monthsg (95% CI)
Croatian: p-vrijednost Trajanje odgovora Mjeseci g (95% CI)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 250 mg crizotinib.
Croatian: Jedna tvrda kapsula sadrži 250 mg krizotiniba.
English: Kaplan-Meier curves for overall survival by treatment arm in randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALKpositive advanced NSCLC
Croatian: Kaplan-Meierove krivulje za ukupno preživljenje po liječenoj skupini u randomiziranom Ispitivanju 1014 faze 3 (potpuna analiza populacije) u bolesnika s prethodno neliječenim ALK-pozitivnim uznapredovalim NSCLC-om
English: Twenty-one patients with previously untreated and 12 patients with previously treated advanced ALK-positive non-adenocarcinoma histology NSCLC were enrolled in randomised Phase 3 Studies 1014 and 1007, respectively.
Croatian: U randomizirana Ispitivanja 1014, odnosno 1007 faze 3 uključen je 21 bolesnik s prethodno neliječenim i 12 bolesnika s prethodno liječenim, uznapredovalim, ALK-pozitivnim NSCLC-om koji po histološkom tipu nije bio adenokarcinom.
English: p-valuef
Croatian: Dob
English: Abbreviations: CI=confidence interval; HR=hazard ratio; IRR=independent radiology review; N/n=number of patients; NR=not reached; PFS=progression-free survival; OS=overall survival.
Croatian: Kratice: CI= interval pouzdanosti; HR= omjer hazarda; IRR= neovisna radiološka procjena; N/n=broj bolesnika; ND= nije dostignuto; PFS= preživljenje bez progresije bolesti; OS= ukupno preživljenje. * PFS, stopa objektivnog odgovora i trajanje odgovora temelje se na podacima zaključnog datuma prikupljanja, 30. studenog 2013.; OS se temelji na podacima prikupljenim do datuma zadnjeg posjeta zadnjeg bolesnika, 30. studenog 2016. i na medijanu praćenja od približno 46 mjeseci. a.
English: Vivian Corporation Ltd. Tel: + 356 21344610
Croatian: Tel: + 356 21344610
English: XALKORI 200 mg hard capsules crizotinib
Croatian: XALKORI 200 mg tvrde kapsule krizotinib
English: XALKORI 250 mg hard capsules crizotinib
Croatian: XALKORI 250 mg tvrde kapsule krizotinib
English: Summary of Product Characteristics and Package Leaflet.
Croatian: Kako XALKORI izgleda i sadržaj pakiranja
English: • Indigestion.
Croatian: • umor.
English: Number of deaths, n (%) Median OS in months (95% CI)
Croatian: Medijan PFS-a u mjesecima (95% CI)
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Razine izloženosti pri kojima nisu opaženi štetni učinci (engl.
English: A total of 934 patients with ALK-positive advanced NSCLC were treated with crizotinib in Study 1005 at the time of data cutoff for PFS and ORR analysis.
Croatian: Do zaključnog datuma prikupljanja podataka za analize PFS i ORR, u ispitivanje 1005 ukupno 934 bolesnika s ALK-pozitivnim uznapredovalim NSCLC-om liječeno je krizotinibom.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava neutropenija a (22%)
English: Objective Response Rateb [% (95% CI)] Time to Tumour Response [median (range)] weeks Duration of Responsec [median (95% CI)] weeks Progression-Free Survivalc [median (95% CI)] months
Croatian: Vrijeme do postizanja tumorskog odgovora [medijan (raspon)] u tjednima Trajanje odgovora c [medijan (95% CI)] u tjednima 48,1 (35,7; 64,1) Preživljenje bez progresije bolesti c [medijan (95%
English: PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
Croatian: 60 tvrdih kapsula
English: Hepatobiliary disorders
Croatian: Oralni kontraceptivi
English: ROS1-positive advanced NSCLC efficacy results from Study 1001 Efficacy Parameter
Croatian: Rezultati djelotvornosti za ROS1-pozitivni uznapredovali NSCLC iz ispitivanja
English: 18-Month Survival Probability,d % (95% CI) 48-Month Survival Probability,d % (95% CI) Objective Response Rate (Based on IRR) Objective Response Rate % (95% CI)
Croatian: HR (95% CI) p-vrijednost Ukupno preživljenje Broj smrtnih slučajeva, n (%) Medijan OS-a u mjesecima (95% CI) HR (95% CI) p-vrijednost 6-mjesečna vjerojatnost preživljenja e, % (95%
English: The crizotinib starting dose should be adjusted to 250 mg taken orally once daily in patients with severe renal impairment not requiring peritoneal dialysis or haemodialysis.
Croatian: U bolesnika s teškim oštećenjem bubrega koji ne zahtijeva peritonealnu dijalizu ili hemodijalizu početnu dozu krizotiniba treba prilagoditi na 250 mg jednom dnevno primijenjenog peroralno.
English: 10 November 2017
Croatian: 10. studenoga 2017.
English: Keytruda has been authorised in the EU since July 2015.
Croatian: Lijek Keytruda odobren je u Europskoj uniji (EU) od srpnja 2015.
English: Further information on Keytruda's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Dodatne informacije o trenutačnim primjenama lijeka Keytruda nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance pembrolizumab.
Croatian: Sadržava djelatnu tvar pembrolizumab.
English: The measures of effectiveness were the number of patients whose cancer shrank in size (overall response rate) and the time patients lived without their disease getting worse (progression free survival).
Croatian: Mjerila djelotvornosti bila su broj bolesnika u kojih se smanjila veličina tumora (ukupna stopa odgovora) i vrijeme koje su bolesnici proživjeli bez pogoršanja bolesti (preživljenje bez progresije).
English: What is Keytruda?
Croatian: Što je Keytruda?
English: Keytruda is also authorised to treat melanoma (a skin cancer), classical Hodgkin lymphoma (a blood cancer) and urothelial cancer (a cancer of the bladder and urinary tract).
Croatian: Lijek Keytruda također je odobren za liječenje melanoma (rak kože), klasičnog Hodgkinova limfoma (rak krvi) i urotelijalnog karcinoma (rak mokraćnog mjehura i urinarnog trakta).
English: The CHMP's main concern was that the available data did not allow firm conclusions on the effectiveness and safety of Keytruda in these patients and further data from ongoing studies were needed in order to assess its benefits and risks.
Croatian: Glavni razlog za zabrinutost CHMP-a bila je činjenica da dostupni podatci ne omogućuju donošenje pouzdanih zaključaka o učinkovitosti i sigurnosti lijeka Keytruda u tih bolesnika, te su bili potrebni dodatni podatci iz ispitivanja koja su u tijeku kako bi se ocijenili koristi i rizici lijeka.
English: Some cancers can make proteins called PD-L1 and PD-L2 that combine with PD-1 to switch off the activity of certain cells of the immune system (the body's natural defences) preventing them from attacking the cancer.
Croatian: Neke vrste raka mogu proizvesti proteine koji se nazivaju PD-L1 i PD-L2 i koji se kombiniraju s receptorom PD-1 i onemogućuju aktivnost određenih stanica imunosnog sustava (prirodne obrane tijela) sprječavajući ih da napadnu rak.
English: By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.
Croatian: Inhibirajući djelovanje receptora PD-1, pembrolizumab zaustavlja rak tako što isključuje te imunosne stanice, čime povećava sposobnost imunosnog sustava da ubija stanice raka.
English: There are no consequences on the use of Keytruda in its authorised uses.
Croatian: Nema posljedica na primjenu lijeka Keytruda za odobrene primjene.
English: On 11 October 2017, Merck Sharp & Dohme officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Keytruda in nonsmall cell lung cancer (NSCLC) to include metastatic non-squamous NSCLC in combination with chemotherapy.
Croatian: Dana 11. listopada 2017., tvrtka Merck Sharp & Dohme službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za proširenje primjene lijeka Keytruda za liječenje raka pluća nemalih stanica (NSCLC) kako bi se uvrstila primjena u kombinaciji s kemoterapijom za liječenje metastatskog neskvamoznog NSCLC-a.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Keytruda.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Keytruda.
English: Keytruda is used specifically when the tumour produces a protein known as PD-L1 and is advanced or has spread to other parts of the body (metastatic).
Croatian: Lijek Keytruda koristi se posebno u situacijama kada tumor proizvodi protein koji se naziva PD-L1 te je uznapredovao ili se proširio na druge dijelove tijela (metastatski tumor).
English: The applicant presented data from a study involving 123 patients with locally advanced or metastatic NSCLC, which compared Keytruda taken together with pemetrexed and carboplatin chemotherapy with chemotherapy alone.
Croatian: Podnositelj zahtjeva dostavio je podatke iz ispitivanja koje je uključivalo 123 bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om, a u kojem je uspoređena primjena lijeka Keytruda zajedno s kemoterapijom lijekovima pemetreksed i karboplatin s liječenjem samo kemoterapijom.