FrancophonIA/ELRC3.0 huggingface dataset:
English: Withhold until recovery to Grade ≤2, then resume at the same dose schedule
Croatian: Privremeno prekinuti do poboljšanja na stupanj ≤2, a zatim nastaviti u istoj dozi.
English: If you stop taking XALKORI
Croatian: Ako prestanete uzimati XALKORI
English: If you forget to take XALKORI What to do if you forget to take a capsule depends on how long it is until your next dose.
Croatian: Što trebate učiniti ako zaboravite uzeti kapsulu, ovisi o tome koliko je vremena preostalo do sljedeće doze.
English: Tell your doctor right away if you have any new or worsening symptoms including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.
Croatian: Odmah obavijestite svog liječnika ako se pojavi bilo koji novi simptom ili se neki simptom pogorša, uključujući otežano disanje ili nedostatak zraka, ili kašalj sa ili bez iskašljavanja sluzi, ili vrućicu.
English: The onset of vision disorders generally started within the first week of drug administration.
Croatian: Poremećaj vida općenito je nastupio u prvom tjednu primjene lijeka.
English: Leukopenia was associated with a dose reduction for <0.5% of patients, and no patients permanently discontinued crizotinib treatment associated with leukopenia.
Croatian: Leukopenija je bila povezana sa smanjenjem doze kod <0,5% bolesnika i niti u jednog bolesnika nije bilo trajnog prekida liječenja povezanog s leukopenijom.
English: Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE16.
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein-kinaze, ATK oznaka: L01XE16.
English: It is not known whether crizotinib and its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se krizotinib i njegovi metaboliti u majčino mlijeko u ljudi.
English: A decision to resume crizotinib should consider the potential benefit to the patient.
Croatian: Prilikom donošenja odluke o nastavku terapije krizotinibom treba uzeti u obzir potencijalnu korist za bolesnika.
English: • If you are currently treated with any of the medicines listed in section Other medicines and
Croatian: • ako ste trenutno liječite nekim od lijekova navedenih u dijelu Drugi lijekovi i XALKORI.
English: Your doctor may stop XALKORI treatment and refer you to an ophthalmologist.
Croatian: Vaš liječnik može prekinuti liječenje lijekom XALKORI i uputiti Vas oftalmologu.
English: • If you have vision disorders (seeing flashes of light, blurred vision, and double vision).
Croatian: • ako imate poremećaje vida (vidite bljeskove svjetlosti, imate zamagljen vid ili dvoslike).
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilacijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Median time to onset of any grade neutropenia was 89 days.
Croatian: Medijan vremena do nastupa neutropenije bilo kojeg stupnja bio je 89 dana.
English: The MAH shall agree the content and format of the educational material with the National Competent Authority.
Croatian: Nositelj odobrenja će s nadležnim nacionalnim tijelom dogovoriti sadržaj i oblik edukacijskog materijala.
English: You should take special care when driving and using machines as patients taking XALKORI may experience visual disturbances, dizziness, and tiredness.
Croatian: Morate biti osobito oprezni prilikom vožnje i rukovanja strojevima jer bolesnici koji uzimaju XALKORI mogu imati poremećaje vida, omaglicu i umor.
English: The No Observed Adverse Effect Levels (NOAEL) for these findings were either subtherapeutic or up to 2.6-fold human clinical exposure based on AUC.
Croatian: No Observed Adverse Effect Levels, NOAEL) kod tih su nalaza bile ili ispod terapijske izloženosti ili do 2,6 puta veće od kliničke izloženosti u ljudi na temelju AUC-a.
English: • Bupropion, used to treat depression and smoking cessation.
Croatian: • bupropionom - koristi se za liječenje depresije i odvikavanje od pušenja.
English: In patients with new onset of severe visual loss (best corrected visual acuity less than 6/60 in one or both eyes), crizotinib treatment should be discontinued (see section 4.2).
Croatian: Kod bolesnika s novom pojavom teškog gubitka vida (najbolja korigirana vidna oštrina manja od 6/60 na jednom ili na oba oka) potrebno je prekinuti liječenje krizotinibom (vidjeti dio 4.2).
English: There were no ROS1-positive patients >85 years old in Study 1001.
Croatian: Nije bilo ROS1-pozitivnih bolesnika starijih od 85 godina u Ispitivanju 1001.
English: ALK and ROS1 testing
Croatian: Testiranje na ALK i ROS1
English: • If you are experiencing severe stomach or abdominal pain, fever, chills, shortness of breath, fast heartbeat, partial or complete loss of vision (in one or both eyes) or changes in bowel habits.
Croatian: • Ako osjetite jake bolove u želucu ili trbuhu, vrućicu, zimicu, nedostatak zraka, brze otkucaje srca, djelomični ili potpuni gubitak vida (na jednom ili na oba oka) ili promjene u pražnjenju crijeva.
English: b. Based on the Cox proportional hazards stratified analysis.
Croatian: b. Na temelju Coxove stratificirane analize proporcionalnih hazarda.
English: The dose may be increased to 200 mg twice daily based on individual safety and tolerability after at least 4 weeks of treatment (see sections 4.4 and 5.2).
Croatian: Nakon barem 4 tjedna liječenja doza se može povisiti na 200 mg dvaput dnevno ovisno o sigurnosti i podnošljivosti za pojedinog bolesnika (vidjeti dijelove 4.4 i 5.2).
English: • Hypophosphataemia (low blood phosphate levels that can cause confusion or muscle weakness).
Croatian: • hipofosfatemija (niska razina fosfata u krvi što može uzrokovati smetenost ili slabost u mišićima).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2012
Croatian: Datum prvog odobrenja: 23. listopada 2012.
English: Intracranial Disease Control Rate (IC-DCR) at 12 weeks was 65% and 46% for crizotinib and chemotherapy-treated patients, respectively.
Croatian: Intrakranijalna stopa kontrole bolesti (IC-DCR) nakon 12 tjedna bila je 65% i 46% za bolesnike liječene krizotinibom, odnosno kemoterapijom.
English: d. PFS data from Study 1005 included 807 patients in the safety analysis population who were identified by the FISH assay (data cutoff date 15 February 2012).
Croatian: d. Podaci o PFS-u i OS-u iz Ispitivanja 1005 uključivali su 807 bolesnika u analizi sigurnosnih podataka populacije utvrđenih testom FISH (zaključni datum prikupljanja podataka 15. veljače 2012.). e. Prema zaključnom datumu prikupljanja podataka 30. studenog 2013.
English: Crizotinib can be administered with or without food (see section 4.2).
Croatian: Krizotinib se može uzimati s hranom ili bez nje (vidjeti dio 4.2).
English: XALKORI must be permanently discontinued in case of further Grade 4 recurrence.
Croatian: Primjena lijeka XALKORI mora se trajno obustaviti u slučaju ponovne pojave toksičnosti stupnja 4.
English: Other medicines and XALKORI
Croatian: Drugi lijekovi i XALKORI
English: XALKORI 250 mg hard capsules EU/1/12/793/003
Croatian: XALKORI 250 mg tvrde kapsule EU/1/12/793/003
English: * PFS, Objective Response Rate and Duration of Response are based on the data cutoff date of 30 March 2012;
Croatian: *PFS, stopa objektivnog odgovora i trajanje odgovora temelje se na podacima zaključnog datuma prikupljanja podataka od 30. ožujka 2012.; OS se temelji na podacima zaključnog datuma prikupljanja podataka od 31. kolovoza 2015.
English: • Neuropathy (feeling of numbness or pins and needles in the joints or extremities).
Croatian: • neuropatija (osjećaj utrnulosti ili trnaca i bockanja u zglobovima ili udovima).
English: In addition, a decrease in heart rate was found to be associated with increasing crizotinib plasma concentration (see section 4.4), with a maximum mean reduction of 17.8 beats per minute (bpm) after 8 hours on Cycle 2 Day 1.
Croatian: Nadalje, smanjenje srčane frekvencije bilo je povezano s povećanjem koncentracije krizotiniba u plazmi (vidjeti dio 4.4), s maksimalnom srednjom vrijednosti smanjenja od 17,8 otkucaja u minuti nakon 8 sati 1.dana 2.ciklusa.
English: • Morphine, used to treat acute and cancer pain.
Croatian: • morfinom - koristi se u liječenju akutnih bolova i bolova kod karcinoma.
English: The NOAEL for aneugenicity was approximately 1.8-fold human clinical exposure based on AUC.
Croatian: NOAEL razina za aneugenost bila je približno 1,8 puta veća od razine kliničke izloženosti u ljudi na temelju AUC-a.
English: If a dose is missed, then it should be taken as soon as the patient remembers unless it is less than 6 hours until the next dose, in which case the patient should not take the missed dose.
Croatian: Propusti li bolesnik dozu lijeka, treba je uzeti čim se sjeti, osim ako do sljedeće doze nije preostalo manje od 6 sati.
English: Other findings included an effect on the liver (elevation of liver transaminases) and retinal function, and potential for phospholipidosis in multiple organs without correlative toxicities.
Croatian: Drugi nalazi uključuju učinke na jetru (povišene vrijednosti jetrenih transaminaza) i mrežnicu te moguću fosfolipidozu u više organa bez korelacijske toksičnosti.
English: 47.5 (32.2, NR)
Croatian: 47,5 (32,2; ND)
English: The geometric mean volume of distribution (Vss) of crizotinib was 1772 L following intravenous administration of a 50 mg dose, indicating extensive distribution into tissues from the plasma.
Croatian: Geometrijska sredina volumena distribucije (Vss) krizotiniba iznosila je 1772 l nakon intravenske primjene doze od 50 mg, što upućuje na opsežnu raspodjelu iz plazme u tkiva.
English: • Oedema (excess fluid in body tissue, causing swelling of the hands and feet).
Croatian: • edem (prekomjerna količina tekućine u tkivima, što uzrokuje oticanje šaka i stopala).
English: If necessary, your doctor may decide to reduce the dose to 200 mg to be taken orally twice daily (total amount 400 mg) and if further dose reduction is necessary, to reduce it to 250 mg to be taken orally once daily.
Croatian: Ako bude potrebno, liječnik može odlučiti smanjiti dozu na 200 mg koja se uzima kroz usta dvaput na dan (ukupna količina 400 mg na dan), a ako je potrebno daljnje smanjenje doze, može odlučiti smanjiti dozu na 250 mg kroz usta jedanput na dan.
English: • Do not use any pack that is damaged or shows signs of tampering.
Croatian: • Ne smije se koristiti pakiranje koje je oštećeno ili se vidi da je prethodno otvarano.
English: ROS1-Positive Advanced NSCLC
Croatian: ROS1-pozitivni uznapredovali NSCLC
English: The disease characteristics of the overall study population were metastatic disease in 98% of patients, 92% of patients' tumours were classified as adenocarcinoma histology, and 27% of patients had brain metastases.
Croatian: Obilježja bolesti ukupne ispitivane populacije bila su: metastatska bolest u 98% bolesnika, 92% tumora bolesnika po histološkom tipu bilo je klasificirano kao adenokarcinom, a 27% bolesnika imalo je moždane metastaze.
English: The primary efficacy endpoint in both studies was objective response rate (ORR) according to RECIST.
Croatian: Primarna mjera ishoda za djelotvornost u oba je ispitivanja bila objektivna stopa odgovora (ORR) prema kriterijima za procjenu odgovora kod solidnih tumora (RECIST).
English: Crizotinib dose adjustment according to Child-Pugh classification has not been studied in patients with hepatic impairment.
Croatian: Prilagodba doze krizotiniba prema Child-Pugh klasifikaciji nije ispitivana u bolesnika s oštećenjem jetre.
English: All-causality bradycardia was reported in clinical studies in 13% of patients treated with crizotinib.
Croatian: Bradikardija svih uzroka bila je prijavljena u kliničkim ispitivanjima u 13% bolesnika liječenih krizotinibom.
English: Seven (0.4%) patients had temporary treatment discontinuation and 2 (0.1%) patients had a dose reduction associated with vision disorder.
Croatian: U sedam (0,4%) bolesnika liječenje je privremeno prekinuto, a u 2 (0,1%) bolesnika došlo je do smanjenja doze povezanog s poremećajem vida.
English: Most events were mild to moderate in severity.
Croatian: Većina tih događaja bila je blage do umjerene težine.
English: Nausea (57%), diarrhoea (54%), vomiting (51%), and constipation (43%) were the most commonly reported all-causality gastrointestinal events.
Croatian: Mučnina (57%), proljev (54%), povraćanje (51%) i konstipacija (43%) bile su najčešće prijavljene gastrointestinalne nuspojave svih uzroka.
English: No visual disturbances associated with crizotinib appeared to be related to changes in best corrected visual acuity, the vitreous, the retina, or the optic nerve.
Croatian: Čini se da nijedna smetnja vida povezana s krizotinibom nije bila povezana s promjenama u najboljoj korigiranoj vidnoj oštrini, staklovini, mrežnici ili optičkom živcu.
English: Objective Response Rate (Based on IRR) Objective Response Rate % (95% CI)
Croatian: Stopa objektivnog odgovora (na temelju IRR-a) Stopa objektivnog odgovora % (95% CI)
English: • Pilocarpine, used to treat glaucoma (a severe eye disease).
Croatian: • pilokarpinom - koristi se za liječenje glaukoma (teške očne bolesti).
English: Based on the Visual Symptom Assessment Questionnaire (VSAQ-ALK), patients treated with crizotinib in Study 1007 and Study 1014 reported a higher incidence of visual disturbances compared to patients treated with chemotherapy.
Croatian: Na temelju upitnika Visual Symptom Assessment Questionnaire (VSAQ-ALK), bolesnici liječeni krizotinibom u Ispitivanju 1007 i Ispitivanju 1014 prijavili su višu incidenciju poremećaja vida u usporedbi s bolesnicima liječenima kemoterapijom.
English: Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation with Grade ≤1 total bilirubin
Croatian: Porast vrijednosti alanin-aminotransferaze (ALT) ili aspartat-aminotransferaze (AST) stupnja 3 ili 4, uz vrijednosti ukupnog bilirubina stupnja ≤1.
English: What you need to know before you take XALKORI
Croatian: Što morate znati prije nego počnete uzimati XALKORI
English: Adverse reactions reported in crizotinib clinical studies (N=1722) System organ class
Croatian: Tablica 3: Nuspojave prijavljene u kliničkim ispitivanjima s krizotinibom (N=1722) Klasifikacija organskih sustava
English: • Rifabutin, rifampicin, used to treat tuberculosis.
Croatian: • rifabutin, rifampicin - koriste se za liječenje tuberkuloze.
English: Your doctor may do blood tests to check your liver function, and if the results are abnormal, your doctor may decide to reduce the dose of XALKORI or stop your treatment.
Croatian: Liječnik može napraviti krvne pretrage kako bi Vam provjerio funkciju jetre, a ako rezultati odstupaju od normalnih, liječnik može odlučiti smanjiti dozu lijeka XALKORI ili prekinuti liječenje.
English: QTc prolongation has been observed in clinical studies in patients treated with crizotinib (see sections 4.8 and 5.2) which may lead to an increased risk for ventricular tachyarrhythmias (e.g., Torsade de Pointes) or sudden death.
Croatian: Zabilježeno je produljenje QTc-intervala u kliničkim ispitivanjima u bolesnika liječenih krizotinibom (vidjeti dijelove 4.8 i 5.2), koje može dovesti do povećanog rizika za nastanak ventrikularnih tahiaritmija (npr. torsade de pointes) ili iznenadne smrti.
English: q. Blood testosterone decreased (Blood testosterone decreased, Hypogonadism, Secondary hypogonadism).
Croatian: q. Smanjene vrijednosti testosterona u krvi (smanjene vrijednosti testosterona u krvi, hipogonadizam, sekundarni hipogonadizam).
English: Crizotinib should be administered with caution in these patients and periodic monitoring of electrocardiograms (ECG), electrolytes and renal function is required.
Croatian: Krizotinib treba primjenjivati uz oprez u tih bolesnika i potrebne su povremene kontrole elektrokardiograma (EKG), elektrolita i funkcije bubrega.
English: It is available in blister packs of 60 hard capsules and in plastic bottles of 60 hard capsules.
Croatian: Lijek je dostupan u blister pakiranjima sa 60 tvrdih kapsula i u plastičnim bocama sa 60 tvrdih kapsula.
English: • Clarithromycin, telithromycin, erythromycin, antibiotics used to treat bacterial infections.
Croatian: • klaritromicin, telitromicin, eritromicin - antibiotici koji se koriste za liječenje bakterijskih infekcija.
English: Due to the small size of the increases in crizotinib exposure (5%-15%), no starting dose adjustment is recommended for patients with mild or moderate renal impairment.
Croatian: Zbog malih povećanja izloženosti krizotinibu (5%-15%), nije potrebno prilagođavati početnu dozu u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: All-causality Grade 3 or 4 Electrocardiogram QT prolonged was reported in 27 (1.6%) out of 1722 patients (see sections 4.2, 4.4, 4.5 and 5.2).
Croatian: Produljenje QT-intervala na EKG-u stupnja 3 ili 4 svih uzroka prijavljeno je u 27 (1,6%) od 1722 bolesnika (vidjeti dijelove 4.2, 4.4, 4.5 i 5.2).
English: Most events were mild in severity.
Croatian: Većina događaja bila je umjerene težine.
English: XALKORI may cause foetal harm when administered to a pregnant woman.
Croatian: XALKORI može uzrokovati oštećenja ploda kada se primjenjuje kod trudnica.
English: Liver function tests including ALT, AST, and total bilirubin should be monitored once a week during the first 2 months of treatment, then once a month and as clinically indicated, with more frequent repeat testing for Grades 2, 3 or 4 elevations.
Croatian: Testove jetrene funkcije, uključujući ALT, AST i ukupni bilirubin, treba raditi jednom tjedno u prva 2 mjeseca liječenja, a zatim jedanput mjesečno, odnosno sukladno kliničkoj indikaciji, s tim da testove treba ponavljati češće u slučaju porasta vrijednosti stupnja 2, 3 ili 4.
English: Thirty-eight (70.4%) of the 54 patients experienced an Eye Disorders System Organ Class treatment-emergent allcausality adverse event of which 30 patients had ophthalmic examinations.
Croatian: Trideset i osam (70,4%) od 54 bolesnika doživjelo je štetan događaj svih uzroka nastao tijekom liječenja iz skupine poremećaja oka prema klasifikaciji organskih sustava, od čega je 30 bolesnika pristupilo oftalmološkim pregledima.
English: In Study 1001, patients were required to have advanced ROS1-positive advanced NSCLC prior to entering the clinical trial.
Croatian: U ispitivanju 1001, bolesnici su morali imati uznapredovali ROS1-pozitivni uznapredovali NSCLC prije uključivanja u kliničko ispitivanje.
English: • Pravastatin, used to reduce cholesterol levels.
Croatian: • pravastatinom - koristi se za snižavanje razine kolesterola.
English: Grade 2, 3 Bradycardiad,e Symptomatic, may be severe and medically significant, medical intervention indicated
Croatian: Simptomatska, može biti teška i medicinski značajna, indicirana je medicinska intervencija.
English: Transaminase elevations generally occurred within the first 2 months of treatment.
Croatian: Do porasta transaminaza obično je dolazilo u prva dva mjeseca liječenja.
English: Physiologically-based pharmacokinetic (PBPK) simulations predicted a 17% increase in crizotinib steady-state AUC after treatment with the moderate CYP3A inhibitors, diltiazem or verapamil.
Croatian: Farmakokinetičke simulacije temeljene na fiziologiji (engl. physiologically-based pharmacokinetic, PBPK) predviđaju 17%-tno povećanje AUC krizotiniba u stanju dinamičke ravnoteže nakon liječenja umjerenim inhibitorima CYP3A, diltiazemom ili verapamilom.
English: d. Neuropathy (Burning sensation, Dysaesthesia, Formication, Gait disturbance, Hyperaesthesia, Hypoaesthesia, Hypotonia, Motor dysfunction, Muscle atrophy, Muscular weakness, Neuralgia, Neuritis, Neuropathy peripheral, Neurotoxicity, Paraesthesia, Peripheral motor neuropathy, Peripheral sensorimotor neuropathy, Peripheral sensory neuropathy, Peroneal nerve palsy, Polyneuropathy, Sensory disturbance, Skin burning sensation).
Croatian: Neuropatija (osjećaj žarenja, dizestezija, mravinjanje, poremećaj hoda, hiperestezija, hipoestezija, hipotonija, motorna disfunkcija, atrofija mišića, slabost mišića, neuralgija, neuritis, periferna neuropatija, neurotoksičnost, parestezije, periferna motorna neuropatija, periferna senzorno-motorna neuropatija, periferna senzorna neuropatija, paraliza peronealnog živca, polineuropatija, poremećaj osjeta, osjećaj žarenja na koži).
English: Seventy-seven of 106 patients (73%) continued crizotinib treatment for at least 3 weeks after objective disease progression.
Croatian: Sedamdeset sedam od 106 bolesnika (73%) nastavilo je liječenje krizotinibom najmanje 3 tjedna nakon objektivne progresije bolesti.
English: • If you have severe kidney disease.
Croatian: • ako imate tešku bolest bubrega.
English: Study 1001 N=53a
Croatian: Ispitivanje 1001 N=53
English: Time to Deterioration (TTD) was prespecified as the first occurrence of a ≥10-point increase in scores from baseline in symptoms of pain in chest, cough, or dyspnoea as assessed by EORTC QLQ-LC13.
Croatian: Vrijeme do pogoršanja bilo je unaprijed određeno kao prva pojava povećanja ≥10 bodova u odnosu na početne vrijednosti u simptomima boli u prsištu, kašlja ili dispneje kao što je procijenjeno upitnikom EORTC QLQ-LC13.
English: f. Based on the stratified Cochran-Mantel-Haenszel test (2-sided).
Croatian: f. Na temelju stratificiranog Cochran-Mantel-Haenszelovog testa (2-stranog).
English: Your doctor may do blood tests and if the results are abnormal, your doctor may decide to reduce the dose of XALKORI.
Croatian: Vaš liječnik može zatražiti krvne pretrage i ako su rezultati neuobičajeni, može odlučiti smanjiti dozu lijeka XALKORI.
English: Close clinical surveillance is recommended when crizotinib is administered with these medicinal products.
Croatian: Preporučuje se pažljiv klinički nadzor kad se krizotinib primjenjuje s tim lijekovima.
English: XALKORI can be prescribed to you if your disease is at an advanced stage and previous treatment has not helped to stop your disease.
Croatian: Liječnik Vam može propisati XALKORI ako je Vaša bolest uznapredovala, a prethodno liječenje je nije moglo zaustaviti.
English: The majority of patients on the crizotinib arm in randomised Phase 3 Studies 1007 and 1014 (>50%) reported visual disturbances; which occurred at a frequency of 4 to 7 days each week, lasted up to 1 minute, and had mild or no impact (scores 0 to 3 out of a maximum score of 10) on daily activities as captured by the VSAQ-ALK questionnaire.
Croatian: Većina bolesnika (>50%) u skupini koja je primala krizotinib u randomiziranim ispitivanjima faze 3, 1007 i 1014, prijavila je poremećaje vida; oni su se javljali učestalošću od 4 do 7 dana svakog tjedna, trajali su do 1 minute i imali su blagi utjecaj, ili nisu imali utjecaj (bodovi 0 do 3 od najviše 10 bodova) na dnevne aktivnosti kako je zabilježeno u upitniku VSAQ-ALK.
English: In patients with new onset of Grade 4 visual loss, crizotinib treatment should be discontinued and ophthalmological evaluation should be performed.
Croatian: Kod bolesnika s novim nastupom gubitka vida stupnja 4, potrebno je prekinuti liječenje krizotinibom i napraviti oftalmološki pregled.
English: c. Based on the stratified log-rank test (1-sided).
Croatian: c. Na temelju stratificiranog log-rang testa (1-stranog).
English: Therefore, administration of crizotinib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.
Croatian: Stoga primjena krizotiniba s lijekovima koji su supstrati za P-gp (npr. digoksin, dabigatran, kolhicin, pravastatin) može pojačati njihov terapijski učinak i nuspojave.