FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefits and potential risks of crizotinib should be considered before beginning therapy in patients with pre-existing bradycardia, who have a history of or predisposition for QTc prolongation, who are taking antiarrhythmics or other medicinal products that are known to prolong QT interval and in patients with relevant pre-existing cardiac disease and/or electrolyte disturbances.
Croatian: Potrebno je razmotriti koristi i moguće rizike krizotiniba prije započinjanja terapije u bolesnika s postojećom bradikardijom, s anamnezom ili sklonošću za produljenje QTc-intervala, koji uzimaju antiaritmike ili druge lijekove za koje je poznato da produljuju QT interval i u bolesnika sa značajnijom postojećom bolešću srca i/ili poremećajem ravnoteže elektrolita.
English: Do not breast-feed during treatment with XALKORI.
Croatian: Nemojte dojiti za vrijeme liječenja lijekom XALKORI.
English: Crizotinib is extensively metabolized in the liver.
Croatian: Krizotinib se opsežno metabolizira u jetri.
English: • Medicines for high blood pressure called beta-blockers such as atenolol, propranolol, labetolol.
Croatian: • lijekovima za liječenje visokog krvnog tlaka koji se zovu beta-blokatori poput atenolola,
English: The European Medicines Agency has waived the obligation to submit the results of studies with XALKORI in all subsets of the paediatric population in NSCLC (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka XALKORI u svim podskupinama pedijatrijske populacije u indikaciji karcinoma pluća nemalih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The primary metabolic pathways in humans were oxidation of the piperidine ring to crizotinib lactam and O-dealkylation, with subsequent Phase 2 conjugation of O-dealkylated metabolites.
Croatian: Osnovni metabolički putevi u ljudi su oksidacija piperidinskog prstena u krizotinib laktam i O-dealkilacija s naknadnom konjugacijom metabolita dobivenih O-dealkilacijom u fazi II.
English: • Methadone, used to treat pain and for the treatment of opioid dependence.
Croatian: • metadonom - koristi se za liječenje boli i za liječenje ovisnosti o opijatima.
English: N=154e
Croatian: N=154
English: There is insufficient information to characterize the risks of resumption of crizotinib in patients with a severe visual loss.
Croatian: Nema dovoljno informacija za karakterizaciju rizika od nastavka terapije krizotinibom kod bolesnika s teškim gubitkom vida.
English: b. Three patients were not evaluable for response in Study 1001, and 42 patients were not evaluable for response in Study 1005. c. Estimated using the Kaplan-Meier method.
Croatian: b. Nije se mogao procijeniti odgovor u 3 bolesnika u Ispitivanju 1001 te u 42 bolesnika u Ispitivanju 1005. c. Procijenjeno Kaplan-Meierovom metodom.
English: • Reduced heart rate.
Croatian: • smanjena brzina srčanih otkucaja.
English: There were no permanent discontinuations associated with vision disorder for any of the 1722 patients treated with crizotinib.
Croatian: Nije došlo do trajnog prekida liječenja povezanog s poremećajem vida niti kod jednog od 1722 bolesnika liječenih krizotinibom.
English: • Mefloquine, used for the prevention of malaria.
Croatian: • meflokinom - koristi se za sprječavanje malarije.
English: • Ergot alkaloids (e.g., ergotamine, dihydroergotamine), used to treat migraine.
Croatian: • ergot alkaloidima (npr. ergotaminom, dihidroergotaminom) - koriste se za liječenje migrene.
English: Withhold until recovery to Grade ≤1 or to heart rate 60 or above
Croatian: Privremeno prekinuti do poboljšanja na stupanj ≤1 ili do otkucaja srca 60 ili više.
English: Caution is therefore recommended in case of coadministration of crizotinib with moderate CYP3A inhibitors.
Croatian: Stoga se preporučuje oprez u slučaju istodobne primjene krizotiniba s umjerenim inhibitorima CYP3A.
English: The primary efficacy endpoint was ORR according to RECIST.
Croatian: Mjera primarnog ishoda djelotvornosti bila je ORR prema RECIST kriterijima.
English: In vitro, crizotinib is not an inhibitor of BSEP at clinically relevant concentrations.
Croatian: In vitro, krizotinib nije inhibitor pumpe za izbacivanje žučnih soli (BSEP) pri klinički značajnim koncentracijama.
English: Partial responses were observed in 20 of 45 patients with non-adenocarcinoma NSCLC for an ORR of 44%, and 9 of 22 patients with SCC NSCLC for an ORR of 41%, both of which were less than the ORR reported in Study 1005 (54%) for all patients.
Croatian: Djelomičan odgovor zabilježen je u 20 od 45 bolesnika koji su imali NSCLC koji nije bio adenokarcinom za ORR od 44% i 9 od 22 bolesnika sa SCC NSCLC-om za ORR od 41%, što je u oba slučaja manje nego ORR zabilježen u Ispitivanju 1005 (54%) za sve bolesnike.
English: All-causality adverse events associated with permanent treatment discontinuation occurred in 302 (18%) patients of which the most frequent (≥1%) were interstitial lung disease (1%) and elevated transaminases (1%).
Croatian: Nuspojave svih uzroka povezane s trajnom obustavom liječenja, javile su se u 302 (18%) bolesnika, od kojih su najčešće (≥1%) bile intersticijska bolest pluća (1%) i povišene transaminaze (1%).
English: Optic atrophy and optic nerve disorder have been reported as potential causes of vision loss.
Croatian: Optička atrofija i poremećaj vidnog živca prijavljeni su kao mogući uzroci gubitka vida.
English: Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products
Croatian: Ocijenite druge istodobno davane lijekove za koje se zna da uzrokuju bradikardiju, kao i antihipertenzivne lijekove.
English: Of note, no patients with SCC histology were randomised in the crizotinib arm in Study 1007 and no patients with SCC were enrolled in Study 1014 due to pemetrexed-based regimen being used as a comparator.
Croatian: Vrijedno je napomenuti da nijedan bolesnik sa SCC-om po histološkom tipu nije randomiziran u skupinu krizotiniba u Ispitivanju 1007 i da nijedan bolesnik sa SCC-om nije bio uključen u Ispitivanje 1014 zbog režima temeljenog na pemetreksedu koji se koristio kao lijek usporedbe.
English: Hypersensitivity to crizotinib or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na krizotinib ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: m. Elevated transaminases (Alanine aminotransferase increased, Aspartate aminotransferase increased, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Hepatic function abnormal, Liver function test abnormal, Transaminases increased).
Croatian: m. Povišene vrijednosti transaminaza (porast vrijednosti alanin-aminotransferaze, porast vrijednosti aspartat aminotransferaze, porast vrijednosti gama-glutamiltransferaze, porast jetrenih enzima, poremećaj jetrene funkcije, poremećene vrijednosti pretraga funkcije jetre, povišene vrijednosti transaminaza).
English: Patients should be monitored for hepatotoxicity and managed as recommended in sections 4.2 and 4.4.
Croatian: Bolesnike treba nadzirati zbog hepatotoksičnosti i liječiti u skladu s preporukama u dijelovima 4.2 i
English: No safety and efficacy data are available on re-treatment with crizotinib of patients who received crizotinib in previous lines of therapy.
Croatian: Nisu dostupni podaci o sigurnosti i djelotvornosti kod ponovnog liječenja krizotinibom u bolesnika koji su dobili krizotinib u prethodnim linijama liječenja.
English: For most patients, ROS1-positive NSCLC was identified by FISH.
Croatian: Za većinu bolesnika, ROS1-pozitivni NSCLC identificiran je putem FISH-a.
English: The results of an in vitro phototoxicity study demonstrated that crizotinib may have phototoxic potential.
Croatian: Rezultati ispitivanja fototoksičnosti in vitro pokazali su da krizotinib može biti fototoksičan.
English: Increases to Grade 3 or 4 ALT or AST elevations were observed in 187 (11%) and 95 (6%) of patients, respectively.
Croatian: Povišenje ALT-a i AST-a do stupnja 3 ili 4 opaženo je u 187 (11%) odnosno 95 (6%) bolesnika.
English: Crizotinib should be discontinued in patients who develop gastrointestinal perforation.
Croatian: Primjenu krizotiniba treba prekinuti u bolesnika koji su razvili gastrointestinalnu perforaciju.
English: Supportive care should include the use of antiemetic medicinal products.
Croatian: Potporno liječenje treba obuhvaćati primjenu antiemetika.
English: Symptomatic bradycardia (e.g., syncope, dizziness, hypotension) can occur in patients receiving crizotinib.
Croatian: Simptomatska bradikardija (npr. sinkopa, omaglica, hipotenzija) može se pojaviti u bolesnika koji primaju krizotinib.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving XALKORI.
Croatian: Ženama reproduktivne dobi treba savjetovati da izbjegavaju začeće dok uzimaju XALKORI.
English: Blood creatinine increase and creatinine clearance decreased were observed in patients in clinical studies with crizotinib.
Croatian: Porast kreatinina u krvi i smanjen klirens kreatinina uočeni su kod bolesnika u kliničkim ispitivanjima s krizotinibom.
English: Pre-existing ophthalmic abnormalities and concomitant medical conditions which could be contributory to ocular findings were noted in many patients, and no conclusive causal relationship to crizotinib could be determined.
Croatian: Prethodno postojeći oftalmološki poremećaji i istodobno postojeća zdravstvena stanja koja bi mogla pridonijeti oftalmološkim nalazima zabilježena su kod mnogo bolesnika, te se nije mogla uspostaviti uvjerljiva uzročno-posljedična veza s krizotinibom.
English: These medicines should be avoided during your treatment with XALKORI.
Croatian: Primjenu ovih lijekova potrebno je izbjegavati tijekom liječenja lijekom XALKORI.
English: Pregnant women, or patients becoming pregnant while receiving crizotinib, or treated male patients as partners of pregnant women, should be apprised of the potential hazard to the foetus.
Croatian: Trudnice ili bolesnice koje zatrudne dok primaju krizotinib, odnosno muške bolesnike koji se liječe, a partnerica im je trudna, treba upozoriti na moguće rizike za plod.
English: • If you have been told that you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval.
Croatian: • ako su Vam nakon snimanja elektrokardiograma (EKG) rekli da imate nepravilnost električne aktivnosti srca koja se zove produljenje QT-intervala.
English: No starting dose adjustment is recommended for patients with mild (60≤ creatinine clearance [CLcr] <90 mL/min) or moderate (30≤ CLcr <60 mL/min) renal impairment, since the population pharmacokinetic analysis indicated no clinically meaningful changes in steady-state crizotinib exposure in these patients.
Croatian: Nije potrebno prilagođavati početnu dozu lijeka u bolesnika s blagim (60≤ klirens kreatinina [CLcr] <90 ml/min) ili umjerenim (30≤ CLcr <60 ml/min) oštećenjem funkcije bubrega, budući da populacijska farmakokinetička analiza nije pokazala klinički značajne promjene u tih bolesnika kod izloženosti krizotinibu u stanju dinamičke ravnoteže.
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, the predicted area under the plasma concentration-time curve at steady-state (AUCss) (95% CI) was 23%-37% higher in Asian patients (N=523) than in non-Asian patients (N=691).
Croatian: Na temelju populacijske farmakokinetičke analize podataka iz Ispitivanja 1001, 1005 i 1007, očekivana površina ispod krivulje koncentracije u plazmi tijekom vremena (AUCss) u stanju dinamičke ravnoteže (95% CI) bila je 23%--37% veća u bolesnika azijskog podrijetla (N=523) nego u bolesnika drugih rasa (N=691).
English: Final OS analysis was not adjusted for the potentially confounding effects of crossover (154 [89%] patients received subsequent crizotinib treatment).
Croatian: Konačna analiza OS-a nije prilagođena za potencijalno zbunjujuće učinke križne zamjene (154 [89%] bolesnika primilo je naknadno liječenje krizotinibom).
English: Electrolyte disturbances, dehydration and bradycardia may further increase the risk of QTc prolongation and thus, periodic monitoring of ECG and electrolyte levels is recommended in patients with GI toxicity (see section 4.4).
Croatian: Promjene elektrolita, dehidracija i bradikardija mogu u budućnosti dovesti do povećanja rizika QTc produljenja i zbog toga se preporučuje periodičko praćenje EKG-a i razine elektrolita u bolesnika sa gastrointestinalnom toksičnošću (vidjeti dio 4.4).
English: Abbreviations: CI=confidence interval; N/n=number of patients.
Croatian: Kratice: CI = interval pouzdanosti; N/n=broj bolesnika.
English: Concurrent elevations in ALT and/or AST ≥3 × ULN and total bilirubin ≥2 × ULN without significant elevations of alkaline phosphatase (≤2 × ULN) have been observed in less than 1% patients treated with crizotinib.
Croatian: Istodobni porast ALT-a i/ili AST-a ≥3× GGN i ukupnog bilirubina ≥2× GGN, bez značajnih porasta alkalne fosfataze (≤2× GGN), opažen je u manje od 1% bolesnika liječenih krizotinibom.
English: • Skin rash.
Croatian: • kožni osip.
English: Oesophagitisk (2%) Dyspepsia (8%)
Croatian: ezofagitis k (2 %) dispepsija (8%)
English: Optic atrophy and optic nerve disorder have been reported as potential causes of vision loss (see section 4.4).
Croatian: Optička atrofija i poremećaj vidnog živca prijavljeni su kao mogući uzroci gubitka vida (vidjeti dio 4.4).
English: Crizotinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay.
Croatian: Krizotinib se nije pokazao mutagenim in vitro u testu reverzne mutacije bakterija (Amesov test).
English: a. Neutropenia (Febrile neutropenia, Neutropenia, Neutrophil count decreased).
Croatian: Neutropenija (febrilna neutropenija, neutropenija, smanjen broj neutrofila).
English: • Antipsychotics, used to treat mental illness.
Croatian: • antipsihoticima - koriste se za liječenje psihičkih bolesti.
English: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of 1722 patients treated with crizotinib across clinical trials.
Croatian: Hepatotoksičnost izazvana lijekom, sa smrtnim ishodom, dogodila se u 0,1% od 1722 bolesnika liječenih krizotinibom u kliničkim ispitivanjima.
English: When using crizotinib, ECG and electrolytes (e.g., calcium, magnesium, potassium) should be obtained as close as possible prior to the first dose and periodic monitoring with ECGs and electrolytes is recommended, especially at the beginning of treatment in case of vomiting, diarrhoea, dehydration or impaired renal function.
Croatian: Kod primjene krizotiniba, rezultati EKG-a i elektrolita (npr. kalcij, magnezij, kalij) trebaju biti dobiveni neposredno prije prve doze i preporučuju se povremene kontrole EKG-a i elektrolita, naročito na početku liječenja u slučaju povraćanja, proljeva, dehidracije ili oštećenja funkcije bubrega.
English: Crizotinib should be used with caution in patients at risk for gastrointestinal perforation (e.g., history of diverticulitis, metastases to the gastrointestinal tract, concomitant use of medicinal products with a recognized risk of gastrointestinal perforation).
Croatian: Krizotinib treba upotrebljavati s oprezom u bolesnika koji su pod rizikom od gastrointestinalne perforacije (primjerice bolesnici s anamnezom divertikulitisa, metastaze u gastrointestinalnom traktu, istovremena uporaba lijekova s prepoznatim rizikom za gastrointestinalnu perforaciju).
English: • Pimozide, used to treat mental illness.
Croatian: • pimozidom - koristi se za liječenje psihičkih bolesti.
English: b. Anaemia (Anaemia, Haemoglobin decreased, Hypochromic anaemia).
Croatian: b. Anemija (anemija, snižene vrijednosti hemoglobina, hipokromna anemija).
English: In particular, the following medicines may increase the risk of side effects with XALKORI:
Croatian: Osobito, sljedeći lijekovi mogu povećati rizik od nuspojava lijeka XALKORI:
English: Of the 30 patients, an ophthalmic abnormality of any type was reported in 14 (36.8%) patients and no ophthalmic finding was seen in 16 (42.1%) patients.
Croatian: Od tih 30 bolesnika, oftalmološki poremećaj bilo kojeg oblika prijavljen je u 14 (36,8%) bolesnika, a u 16 (42,1%) bolesnika nije bilo nalaza oftalmološkog poremećaja.
English: No specific studies with crizotinib have been conducted in animals to evaluate the effect on fertility; however, crizotinib is considered to have the potential to impair reproductive function and fertility in humans based on findings in repeat-dose toxicity studies in the rat.
Croatian: Nisu provedena posebna ispitivanja na životinjama kako bi se ocijenio učinak na plodnost, no na temelju nalaza ispitivanja toksičnosti ponovljenih doza na štakorima smatra se da krizotinib može štetno djelovati na reproduktivnu funkciju i plodnost ljudi.
English: In studies in patients with ALK-positive advanced NSCLC (N=1669), the following adverse reactions were reported with an absolute difference of ≥10% in Asian patients (N=753) than in non-Asian patients (N=916): elevated transaminases, decreased appetite, neutropenia, and leukopenia.
Croatian: U ispitivanjima u bolesnika s ALK-pozitivnim uznapredovalim NSCLC-om (N=1669), sljedeće nuspojave prijavljivane su s apsolutnom razlikom od ≥10% u bolesnika azijskog podrijetla (N=753), za razliku od bolesnika drugih rasa (N=916): povišene transaminaze, oslabljen apetit, neutropenija i leukopenija.
English: Based on nonclinical safety findings, male and female fertility may be compromised by treatment with XALKORI (see section 5.3).
Croatian: Na temelju nalaza iz nekliničkih ispitivanja liječenje lijekom XALKORI može ugroziti plodnost muškaraca i žena (vidjeti dio 5.3).
English: Withhold if ILD/pneumonitis is suspected, and permanently discontinue if treatment-related ILD/pneumonitis is diagnosedd
Croatian: Privremeno prekinuti u slučaju sumnje na IBP/pneumonitis, a trajno obustaviti ako se dokaže IBP/pneumonitis povezan s liječenjem
English: Crizotinib was not shown to be teratogenic in pregnant rats or rabbits.
Croatian: Krizotinib se nije pokazao teratogenim u skotnih ženki štakora i kunića.
English: p. Oedema (Face oedema, Generalised oedema, Local swelling, Localised oedema, Oedema, Oedema peripheral, Periorbital oedema).
Croatian: p. Edem (edem lica, generalizirani edem, lokalno oticanje, lokalizirani edem, edem, periferni edem, periorbitalni edem).
English: • Ketoconazole, itraconazole, posaconazole, voriconazole, used to treat fungal infections.
Croatian: • ketokonazol, itrakonazol, posakonazol, vorikonazol - koriste se za liječenje gljivičnih infekcija.
English: Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with crizotinib.
Croatian: Teška, po život opasna ili smrtonosna intersticijska bolest pluća (IBP)/pneumonitis može se javiti u bolesnika liječenih krizotinibom.
English: A total of 259 (16%) of 1666 patients with at least 1 postbaseline vital sign assessment had a pulse rate <50 bpm.
Croatian: Ukupno 259 (16%) od 1666 bolesnika s najmanje 1 procjenom vitalnih znakova nakon početka ispitivanja, imalo je srčanu frekvenciju <50 otkucaja u minuti.
English: Patients with mild (60≤ CLcr <90 mL/min) and moderate (30≤ CLcr <60 mL/min) renal impairment were enrolled in single-arm Studies 1001 and 1005.
Croatian: Bolesnici s blagim (60≤ CLcr <90 ml/min) i umjerenim (30≤ CLcr <60 ml/min) oštećenjem funkcije bubrega uključeni su u Ispitivanja 1001 i 1005 s jednom skupinom bolesnika.
English: In vitro studies demonstrated that CYP3A4/5 were the major enzymes involved in the metabolic clearance of crizotinib.
Croatian: Ispitivanja in vitro pokazala su da su CYP3A4/5 glavni enzimi uključeni u metabolički klirens krizotiniba.
English: In vitro studies in human hepatocytes indicated that crizotinib may induce pregnane X receptor (PXR)and constitutive androstane receptor (CAR)-regulated enzymes (e.g., CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
Croatian: In vitro ispitivanja na ljudskim hepatocitima pokazala su da krizotinib može inducirati enzime koje reguliraju receptor pregnana X (engl. pregnane X receptor, PXR) i konstitutivni androstan receptor (CAR) (npr. CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
English: In ALK-positive NSCLC patients, the frequency of adverse reactions was generally similar for patients <65 years of age and patients 65 years of age with the exception of oedema and constipation, which were reported with greater frequency (≥15% difference) in Study 1014 among patients treated with crizotinib 65 years of age.
Croatian: Kod bolesnika s ALK-pozitivnim NSCLC-om, učestalost nuspojava bila je općenito slična za bolesnike <65 godina starosti i bolesnike 65 godina starosti s izuzetkom edema i konstipacije, koji su prijavljivani s većom učestalosti (razlika ≥15%) u Ispitivanju 1014 među bolesnicima liječenima krizotinibom 65 godina starosti.
English: Efficacy data from randomised Phase 3 Study 1014 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and 2, respectively.
Croatian: Podaci o djelotvornosti u Ispitivanju 1014 faze 3 sažeti su u Tablici 4, a Kaplan-Meierove krivulje za PFS i OS prikazane su na Slici 1, odnosno 2.
English: Avoid using crizotinib in combination with other bradycardic agents, medicinal products that are known to prolong QT interval and/or antiarrhythmics (see section 4.4 QT interval prolongation, Bradycardia, and section 4.5).
Croatian: Izbjegavajte primjenu krizotiniba u kombinaciji s drugim lijekovima koji uzrokuju bradikardiju, s lijekovima za koje je poznato da produljuju QT interval i/ili s antiaritmicima (vidjeti dio 4.4 Produljenje QT intervala, Bradikardija i dio 4.5).
English: Crizotinib also demonstrated marked antitumour activity in mouse xenograft studies, where tumours were generated using a panel of NIH-3T3 cell lines engineered to express key ROS1 fusions identified in human tumours.
Croatian: Krizotinib je također iskazao izraženu antitumorsku aktivnost u ispitivanju ksenografta u miševa u kojih su tumori izazvani primjenom panela NIH-3T3 staničnih linija modificiranih kako bi eksprimirale ključne ROS1-fuzije identificirane kod ljudskih tumora.
English: In vitro, crizotinib did not inhibit the human hepatic uptake transport proteins organic anion transporting polypeptide (OATP)1B1 or OATP1B3 or the renal uptake transport proteins organic anion transporter (OAT)1 or OAT3 at clinically relevant concentrations.
Croatian: Krizotinib u klinički značajnim koncentracijama nije in vitro inhibirao humane jetrene transportne proteine unosa: polipeptide za prijenos organskih aniona (OATP)1B1 ili OATP1B3, niti bubrežne transportne proteine unosa: transportere organskih aniona (OAT)1 ili OAT3.
English: • Moxifloxacine, used to treat bacterial infections.
Croatian: • moksifloksacinom - koristi se za liječenje bakterijskih infekcija.
English: Administration of a single 250 mg crizotinib dose following treatment with esomeprazole 40 mg once daily for 5 days resulted in an approximately 10% decrease in crizotinib total exposure (AUCinf) and no change in peak exposure (Cmax); the extent of the change in total exposure was not clinically meaningful.
Croatian: Primjena jedne doze od 250 mg krizotiniba nakon liječenja esomeprazolom 40 mg jednom dnevno tijekom 5 dana dovela je do približno 10% smanjenja ukupne izloženosti krizotinibu (AUCinf), a nije bilo promjene u vršnoj izloženosti (Cmax); opseg promjene u ukupnoj izloženosti nije bio klinički značajan.
English: HDPE bottles with a polypropylene closure containing 60 hard capsules.
Croatian: HDPE boce s polipropilenskim zatvaračem koje sadrže 60 tvrdih kapsula.
English: The antitumour efficacy of crizotinib was dose-dependent and demonstrated a correlation with inhibition of ROS1 phosphorylation in vivo.
Croatian: Antitumorska djelotvornost krizotiniba bila je ovisna o dozi i pokazala je korelaciju s inhibicijom ROS1 fosforilacije in vivo.
English: Other side effects of XALKORI may include:
Croatian: Druge nuspojave lijeka XALKORI mogu biti:
English: Nervous system effects
Croatian: Učinci na živčani sustav
English: For patients who develop QTc prolongation, see sections 4.2, 4.8 and 5.2.
Croatian: Za bolesnike u kojih dođe do produljenja QTc-intervala, vidjeti dijelove 4.2, 4.8 i 5.2.