natgillin/translations-raw huggingface dataset:
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). 
Zdravljenje s krizotinibom je treba prekiniti pri bolnikih, pri katerih se na novo pojavi huda izguba vida (najboljša vidna ostrina s korekcijo manj kot 6/60 na enem ali obeh očesih) (glejte poglavje 4.2).
Body Weight and Gender 
Telesna masa in spol
Findings observed in the male reproductive tract included testicular pachytene spermatocyte degeneration in rats given ≥50 mg/kg/day for 28 days (approximately 1.1-fold human clinical exposure based on AUC). 
Ugotovitve, ki so jih opažali na rodilih pri samcih, so vključevale degeneracijo spermatocitov v pahitenski fazi v modih pri podganah, ki so 28 dni prejemale odmerek ≥ 50 mg/kg/dan (približno 1,1-kratnik klinične izpostavljenosti pri ljudeh, na osnovi vrednosti AUC).
In clinical studies with crizotinib, events of gastrointestinal perforations were reported. 
V kliničnih študijah s krizotinibom so poročali o perforacijah v prebavilih.
If QTc increases by greater than or equal to 60 msec from baseline but QTc is <500 msec, crizotinib should be withheld and cardiologist advice should be sought. 
Če se interval QTc podaljša za 60 ms ali več v primerjavi z izhodiščno vrednostjo, vendar je QTc < 500 ms, je treba zdravljenje s krizotinibom začasno prekiniti in se posvetovati s kardiologom.
Crizotinib significantly prolonged progression-free survival (PFS), the primary objective of the study, compared to chemotherapy as assessed by IRR. 
Krizotinib je v primerjavi s kemoterapijo pomembno podaljšal preživetje brez napredovanja bolezni (PFS - Progression-Free Survival), primarni cilj študije, ki se je ocenil s pregledom IRR.
All-causality, all grade, vision disorder, most commonly visual impairment, photopsia, vision blurred, and vitreous floaters, was experienced by 1084 (63%) of 1722 patients treated with crizotinib. 
Do motenj vida vseh stopenj zaradi vseh vzrokov (najpogosteje poslabšanja vida, fotopsije, zamegljenega vida in motnjav v steklovini) je prišlo pri 1.084 (63 %) od 1.722 bolnikov, zdravljenih s krizotinibom.
The absolute bioavailability of crizotinib was determined to be 43% following the administration of a single 250 mg oral dose. 
Ugotovili so, da absolutna biološka uporabnost krizotiniba po jemanju enkratnega 250 mg peroralnega odmerka znaša 43 %.
The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, and presence of brain metastases. 
Koristni učinek krizotiniba na PFS je bil konsistenten v vseh podskupinah bolnikov glede na izhodiščne značilnosti, kot so starost, spol, rasa, kadilski status, čas od diagnoze, telesno stanje po ECOG in prisotnost možganskih metastaz.
The concomitant use of crizotinib with strong CYP3A4 inhibitors or with strong and moderate CYP3A4 inducers should be avoided (see section 4.5). 
Sočasni uporabi krizotiniba skupaj z močnimi zaviralci ali močnimi in zmernimi induktorji CYP3A4 se je treba izogibati (glejte poglavje 4.5).
p-valueg Duration of Response Mediane, Months (95% CI) 
vrednost p Trajanje odziva Mediana e, meseci (95 % IZ)
You should take special care when driving and using machines as patients taking XALKORI may experience visual disturbances, dizziness, and tiredness. 
Vpliv na sposobnost upravljanja vozil in strojev Pri upravljanju vozil in strojev morate biti zelo pazljivi, ker se lahko pri bolnikih, ki jemljejo zdravilo XALKORI, pojavijo motnje vida, omotičnost in utrujenost.
• Irinotecan, a chemotherapy drug used to treat cancer of the colon and rectum. 
• irinotekan, kemoterapija, ki se uporablja za zdravljenje raka debelega črevesa in danke,
Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized by CYP2B6 (e.g., bupropion, efavirenz). 
Zato lahko krizotinib zveča plazemske koncentracije sočasno uporabljenih zdravil, ki jih presnavlja CYP2B6 (npr. bupropion, efavirenz).
Of 154 and 1063 ALK-positive NSCLC patients in single arm studies 1001 and 1005, 22 (14%) and 173 (16%) were 65 years or older, respectively. 
Izmed 154 in 1.063 bolnikov z ALK-pozitivnim NSCLC v Študijah 1001 in 1005 z eno skupino bolnikov jih je bilo 22 (14 %) oziroma 173 (16 %) starih 65 let ali več.
Dizzinessf (26%) Bradycardiag (13%) 
Srčne bolezni omotica f (26 %) bradikardijag (13 %)
q. Blood testosterone decreased (Blood testosterone decreased, Hypogonadism, Secondary hypogonadism). 
periorbitalni edem) q. zmanjšana koncentracija testosterona v krvi (zmanjšana koncentracija testosterona v krvi, hipogonadizem,
In clinical studies, prolonged QT interval was observed with crizotinib. 
V kliničnih študijah so pri uporabi krizotiniba opazili podaljšanje intervala QT.
Nervous system effects 
Vplivi na živčevje
In Study 1001, the adjusted geometric mean of plasma Ctrough, ss in mild (N=35) and moderate (N=8) renal impairment patients were 5.1% and 11% higher, respectively, than those in patients with normal renal function. 
V Študiji 1001 je bilo prilagojeno geometrično povprečje plazemske Ctrough, ss pri bolnikih z blago (n = 35) in zmerno (n = 8) okvaro ledvic 5,1 % in 11 % večje kot pri bolnikih z normalnim delovanjem ledvic.
There was one ALK-positive patient >85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2). 
V enoskupinski Študiji 1001 je bil en bolnik z ALK-pozitivnim NSCLC od 154 bolnikov starejši od 85 let (glejte tudi poglavji 4.2 in 5.2).
The most frequent adverse reactions (≥3%) associated with dose reductions were elevated transaminases and neutropenia. 
Najpogostejša neželena učinka (≥ 3 %), povezana z zmanjšanjem odmerka, sta bila povečana vrednost transaminaz in nevtropenija.
Vomiting (51%) Diarrhoea (54%) Nausea (57%) Constipation (43%) Abdominal painj 
Bolezni prebavil bruhanje (51 %) diareja (54 %) navzea (57 %) zaprtje (43 %) bolečina v trebuhu ezofagitis k (2 %) dispepsija (8 %)
Progression-Free Survival (Based on IRR) Number with event, n (%) Median PFS in months (95% CI) 
Preživetje brez napredovanja (na podlagi IRR) Število z dogodkom, n (%) Mediano PFS v mesecih (95 % IZ)
Across studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC, median time to onset of increased Grade 1 or 2 transaminases was 23 days. 
V študijah krizotiniba pri bolnikih z ALK-pozitivnim ali ROS1-pozitivnim NSCLC je bil mediani čas do pojava povečanja vrednosti transaminaz stopnje 1 ali 2 23 dni.
Information is available from 45 response-evaluable patients with previously treated non-adenocarcinoma NSCLC (including 22 patients with SCC) in Study 1005. 
Na voljo so podatki za 45 bolnikov s predhodno zdravljenim NSCLC, ki glede na histologijo ni bil adenokarcinom (vključno z 22 bolniki s SCC), pri katerih je bilo v Študiji 1005 odziv na zdravljenje mogoče ovrednotiti.
There were no ROS1-positive patients >85 years old in Study 1001. 
V Študiji 1001 ni bilo ROS1-pozitivnih bolnikov, starejših od 85 let.
The central tendency analysis indicated that the largest mean change from baseline in QTcF was 12.3 msec (95% CI 5.1-19.5 msec, least squares mean [LS] from Analysis of Variance [ANOVA]) and occurred at 6 hours post-dose on Cycle 2 Day 1. 
Analiza centralne tendence je pokazala, da je bila največja povprečna sprememba vrednosti QTcF glede na izhodišče 12,3 ms (povprečje najmanjših kvadratov [LS - least squares] iz analize varianc [ANOVA]), do katere je prišlo 6 ur po odmerku 1. dan 2. cikla.
• Second dose reduction: XALKORI 250 mg taken orally once daily 
• Drugo zmanjšanje odmerka: zdravilo XALKORI 250 mg peroralno enkrat na dan.
One hundred seventy-three (173) patients were randomised to crizotinib and 174 patients were randomised to chemotherapy (either pemetrexed or docetaxel). 
V skupino s krizotinibom so naključno razporedili 173 bolnikov, v skupino s kemoterapijo pa 174 bolnikov (pemetreksed ali docetaksel).
Crizotinib dose adjustment according to Child-Pugh classification has not been studied in patients with hepatic impairment. 
Pri bolnikih z okvaro jeter prilagajanja odmerka krizotiniba na podlagi klasifikacije Child-Pugh niso preučevali.
Discontinue during evaluation of severe vision loss a. NCI Common Terminology Criteria for Adverse Events b. XALKORI must be permanently discontinued in case of further Grade ≥3 recurrence. 
Terminology Criteria for Adverse Events) b. Če pride do še ene ponovitve bolezni stopnje ≥ 3, morate zdravljenje z zdravilom XALKORI trajno prekiniti.
Withhold until recovery to Grade ≤1 or to heart rate 60 or above 
Prekinite zdravljenje, dokler ne pride do izboljšanja na stopnjo ≤ 1 ali na srčni utrip 60 ali več.
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). 
Krizotinib je treba uporabljati previdno pri bolnikih s tveganjem za nastanek perforacije v prebavilih (npr. pri bolnikih z anamnezo divertikulitisa ali metastazami, ki se širijo v prebavila, ter pri sočasni uporabi zdravil, za katera je znano, da lahko povzročijo perforacijo v prebavilih).
MARKETING AUTHORISATION NUMBER(S) XALKORI 200 mg hard capsules EU/1/12/793/001 
XALKORI 200 mg trde kapsule EU/1/12/793/001
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005, and 1007, age has no effect on crizotinib pharmacokinetics (see sections 4.2 and 5.1). 
Na podlagi populacijske farmakokinetične analize podatkov iz študij 1001, 1005 in 1007 starost nima vpliva na farmakokinetiko krizotiniba (glejte poglavji 4.2 in 5.1).
Crizotinib showed a significantly greater improvement from baseline compared to chemotherapy in alopecia (Cycles 2 to 15; p-value <0.05), cough (Cycles 2 to 20; p-value <0.0001), dyspnoea (Cycles 2 to 20; p-value <0.0001), haemoptysis (Cycles 2 to 20; p-value <0.05), pain in arm or shoulder (Cycles 2 to 20; p-value <0.0001), pain in chest (Cycles 2 to 20; p-value <0.0001), and pain in other parts (Cycles 2 to 20; p-value <0.05). 
Krizotinib je povzročil znatno večje izboljšanje od začetka študije pri alopeciji (cikli od 2 do 15; vrednost p < 0,05), kašlju (cikli od 2 do 20; vrednost p < 0,0001), dispneji (cikli od 2 do 20; vrednost p < 0,0001), hemoptizi (cikli od 2 do 20; vrednost p < 0,05), bolečini v roki ali rami (cikli od 2 do 20; vrednost p < 0,0001), bolečini v prsnem košu (cikli od 2 do 20; vrednost p < 0,0001) ter bolečini v drugih delih telesa (cikli od 2 do 20; vrednost p < 0,05) v primerjavi s kemoterapijo.
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. 
Učinkovitost in varnost krizotiniba pri zdravljenju bolnikov z ALK-pozitivnim metastatskim NSCLC, ki so predhodno prejeli sistematsko zdravljenje napredovale bolezni, so dokazali v globalni, randomizirani, odprti Študiji 1007.
OS is based on the data cutoff date of 31 August 2015. a. The median PFS times were 4.2 months (95% CI: 2.8, 5.7) for pemetrexed (HR=0.59; p-value=0.0004 for crizotinib compared with pemetrexed) and 2.6 months (95% CI: 1.6, 4.0) for docetaxel 
2012; OS so določili na dan zaključka zajema podatkov 31. avgusta 2015. a. Mediani čas PFS je bil 4,2 meseca (95 % IZ: 2,8; 5,7) pri pemetreksedu (HR = 0,59, vrednost p = 0,0004 za zdravilo XALKORI v primerjavi s pemetreksedom) in 2,6 meseca (95 % IZ: 1,6; 4,0) pri docetakselu
Dose modification is not required in cases of asymptomatic bradycardia. 
Pri asimptomatski bradikardiji odmerka ni treba prilagoditi.
Number of deaths, n (%) Overall Survivalc [median (95% CI)] months 
Število smrti, n (%) Skupno preživetje c (mediana (95 % IZ)), meseci
In randomised Phase 3 Study 1007, increases to Grade 3 or 4 ALT or AST elevations were observed in 18% and 9% of patients receiving crizotinib and 5% and <1% of patients receiving chemotherapy. 
V randomizirani študiji 3. faze, Študiji 1007, so povečanja vrednosti ALT ali AST do stopnje 3 ali 4 opazili pri 18 % oziroma 9 % bolnikov, ki so prejemali krizotinib, in 5 % oziroma < 1 % bolnikov, ki so prejemali kemoterapijo.
Of 172 ALK-positive patients treated with crizotinib in randomised Phase 3 Study 1007, 27 (16%) were 65 years or older. 
Izmed 172 bolnikov z ALK-pozitivnim NSCLC, zdravljenih s krizotinibom v randomizirani študiji 3. faze, Študiji 1007, jih je bilo 27 (16 %) starih 65 let ali več.
In vitro, crizotinib is not an inhibitor of BSEP at clinically relevant concentrations. 
In vitro krizotinib v klinično pomembnih koncentracijah ni zaviralec BSEP.
The antitumour efficacy of crizotinib was dose-dependent and demonstrated a correlation with inhibition of ROS1 phosphorylation in vivo. 
Protitumorska učinkovitost krizotiniba je bila odvisna od odmerka in povezana z zavrtjem fosforilacije ROS1 in vivo.
Objective Response Rate (Based on IRR) Objective Response Rate % (95% CI) 
d % (95 % IZ) Delež objektivnega odziva (na podlagi IRR) Delež objektivnega odziva % (95 % IZ)
In Study 1014, the median duration of study treatment was 47 weeks for patients in the crizotinib arm (N=171); the median duration of treatment was 23 weeks for patients who crossed over from the chemotherapy arm to receive crizotinib treatment (N=109). 
V Študiji 1014 je bilo mediano trajanje preiskovanega zdravljenja pri bolnikih v skupini s krizotinibom (n = 171) 47 tednov, pri bolnikih, ki so prešli iz skupine s kemoterapijo v skupino, ki je prejemala krizotinib (n = 109), pa 23 tednov.
• Keep this medicine out of the sight and reach of children. 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Vision disordere (63%) 
Očesne bolezni motnje vida e (63 %)
The data described below reflect exposure to XALKORI in 1669 patients with ALK-positive advanced NSCLC who participated in 2 randomised Phase 3 studies (Studies 1007 and 1014) and in 2 single-arm studies (Studies 1001 and 1005), and in 53 patients with ROS1-positive advanced NSCLC who participated in single-arm Study 1001, for a total of 1722 patients (see section 5.1). 
Spodaj navedeni podatki odražajo izpostavljenost zdravilu XALKORI pri skupno 1.722 bolnikih, od tega pri 1.669 bolnikih z ALK-pozitivnim napredovalim NSCLC, ki so sodelovali v 2 randomiziranih študijah 3. faze (Študiji 1007 in 1014) ter dveh študijah z eno skupino bolnikov (Študiji 1001 in 1005), in pri 53 bolnikih z ROS1-pozitivnim napredovalim NSCLC, ki so sodelovali v Študiji 1001 z eno skupino bolnikov (glejte poglavje 5.1).
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. 
Vse zgornje meje 90-odstotnega intervala zaupanja spremembe povprečja najmanjših kvadratov vrednosti QTcF glede na izhodišče so bile < 20 ms v vseh časovnih točkah 1. dne 2. cikla.
Of the 53 ROS1-positive NSCLC patients in single arm Study 1001, 15 (28%) were 65 years or older. 
Izmed 53 bolnikov z ROS1-pozitivnim NSCLC v enoskupinski Študiji 1001 jih je bilo 15 (28 %) starih 65 let ali več.
• Metformin, used to treat diabetes. 
• metformin, ki se uporablja za zdravljenje sladkorne bolezni,
XALKORI may cause foetal harm when administered to a pregnant woman. 
Zdravilo XALKORI lahko škoduje plodu, če ga jemljejo nosečnice.
In Study 1005, the adjusted geometric mean Ctrough, ss of crizotinib in mild (N=191) and moderate (N=65) renal impairment groups were 9.1% and 15% higher, respectively, than those in patients with normal renal function. 
V Študiji 1005 je bilo prilagojeno geometrično povprečje Ctrough, ss krizotiniba pri bolnikih z blago (n = 191) in zmerno (n = 65) okvaro ledvic 9,1 % in 15 % večje kot pri bolnikih z normalnim delovanjem ledvic.
If dose reduction is necessary for patients treated with crizotinib 250 mg orally twice daily, then the dose of crizotinib should be reduced as below. 
Če je potrebno zmanjšanje odmerka pri bolnikih, ki se zdravijo s krizotinibom 250 mg peroralno dvakrat na dan, je treba odmerek krizotiniba zmanjšati, kot je navedeno spodaj.
Abbreviations: CI=confidence interval; HR=hazard ratio; IRR=independent radiology review; N/n=number of patients; PFS=progression-free survival; OS=overall survival. 
Kratice: IZ = interval zaupanja, HR = razmerje ogroženosti, IRR = neodvisni radiološki pregled, n = število bolnikov, PFS = preživetje brez napredovanja bolezni, OS = skupno preživetje.
Most events were mild in severity. 
Resnost večine teh dogodkov je bila blaga.
In randomised Phase 3 Study 1014, increases to Grade 3 or 4 ALT or AST elevations were observed in 15% and 8% of patients receiving crizotinib versus 2% and 1% of patients receiving chemotherapy. 
V randomizirani študiji 3. faze, Študiji 1014, so povečanja vrednosti ALT ali AST do stopnje 3 ali 4 opazili pri 15 % oziroma 8 % bolnikov, ki so prejemali krizotinib, in 2 % oziroma 1 % bolnikov, ki so prejemali kemoterapijo.
An ECG substudy using blinded manual ECG measurements was conducted in 52 ALK-positive NSCLC patients who received crizotinib 250 mg twice daily. 
Izvedena je bila podštudija EKG z zaslepljenimi ročnimi meritvami EKG pri 52 ALK-pozitivnih bolnikih z nedrobnoceličnim pljučnim rakom, ki so dvakrat dnevno prejeli 250 mg krizotiniba.
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. 
Pri bolnikih z obstoječo bradikardijo, podaljšanjem intervala QTc v anamnezi ali predispozicijo zanj, bolnikih, ki jemljejo antiaritmike ali druga zdravila, ki podaljšujejo interval QT, ter bolnikih s pomembno obstoječo srčno boleznijo in/ali motnjami elektrolitov je treba pred začetkom zdravljenja razmisliti o koristih in morebitnih tveganjih krizotiniba.
The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, presence of brain metastases and prior EGFR TKI therapy. 
Koristni učinek krizotiniba na PFS je bil konsistenten v vseh podskupinah bolnikov glede na izhodiščne značilnosti, kot so starost, spol, rasa, status kajenja, čas od diagnoze, stanje zmogljivosti po ECOG, prisotnost možganskih metastaz in predhodno zdravljenje z zaviralci tirozinske kinaze EGFR.
Neuropathyd (25%) Dysgeusia (21%) 
Bolezni živčevja nevropatija d (25 %) disgevzija (21 %)
No safety and efficacy data are available on re-treatment with crizotinib of patients who received crizotinib in previous lines of therapy. 
Podatki o varnosti in učinkovitosti ponovnega zdravljenja s krizotinibom pri bolnikih, ki so prejemali krizotinib pri prejšnjih izbirah zdravljenja, niso na voljo.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving XALKORI. 
Ženskam v rodni dobi je treba svetovati, da se med jemanjem zdravila XALKORI izogibajo zanositvi.
Do not breast-feed during treatment with XALKORI. 
Med zdravljenjem z zdravilom XALKORI ne smete dojiti.
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. 
Kratice: IZ = interval zaupanja, HR = razmerje ogroženosti, IRR = neodvisni radiološki pregled, n = število bolnikov, NR = ni bila dosežena, PFS = preživetje brez napredovanja bolezni, OS = skupno preživetje.
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. 
Učinkovitost in varnost krizotiniba pri zdravljenju bolnikov z ALK-pozitivnim metastatskim NSCLC, ki še niso prejeli sistemskega zdravljenja zaradi napredovale bolezni, so dokazali v globalni randomizirani odprti Študiji 1014.
Do not take XALKORI 
Ne jemljite zdravila XALKORI
The effect of renal function as measured by baseline CLcr on observed crizotinib steady-state trough concentrations (Ctrough, ss) was evaluated. 
Vpliv delovanja ledvic so ocenili z vrednostjo CLcr ob najmanjši koncentraciji krizotiniba v stanju dinamičnega ravnovesja (Ctrough, ss).
The median OS at the time of data cutoff was 51.4 months (95% CI: 29.3, NR). 
Mediano OS na dan zaključka zajema podatkov je bilo 51,4 meseca (95 % IZ: 29,3; NR).
Patients could continue treatment as assigned beyond the time of RECIST-defined disease progression at the discretion of the investigator if the patient was perceived to be experiencing clinical benefit. 
Bolniki so lahko zdravljenje nadaljevali po napredovanju bolezni, opredeljenem z merili RECIST, če je tako presodil raziskovalec in je bolnik še vedno imel klinično korist.
Thirty-four of 1619 patients (2.1%) with at least 1 postbaseline ECG assessment were found to have QTcF ≥500 msec, and 79 of 1585 patients (5.0%) with a baseline and at least 1 postbaseline ECG assessment had an increase from baseline QTcF ≥60 msec by automated machine-read evaluation of ECG (see section 4.4). 
Pri štiriintridesetih od 1.619 bolnikov (2,1 %) z vsaj 1 oceno EKG po izhodišču so ugotovili, da je QTcF ≥ 500 ms, pri 79 od 1.585 bolnikov (5,0 %) z oceno EKG ob izhodišču in vsaj 1 oceno EKG po izhodišču pa se je interval QTcF podaljšal za ≥ 60 ms glede na izhodiščno vrednost, ocenjeno z avtomatskim čitalcem EKG (glejte poglavje 4.4).
Dosing interruption, dose reduction, or discontinuation should be considered as appropriate if such symptoms are observed. 
Če se pojavijo takšni simptomi, je treba prekiniti odmerjanje, zmanjšati odmerek ali prekiniti zdravljenje.
Therefore, the concomitant use of crizotinib with medicinal products known to prolong QT interval or medicinal products able to induce Torsades de pointes (e.g., class IA [quinidine, disopyramide] or class III [e.g., amiodarone, sotalol, dofetilide, ibutilide], methadone, cisapride, moxifloxacine, antipsychotics, etc.) should be carefully considered. 
Zato je potreben skrben premislek, kadar se krizotinib uporablja sočasno z zdravili, za katera je znano, da podaljšujejo interval QT, ali z zdravili, ki lahko povzročijo Torsades de pointes (npr. antiaritmiki skupine IA [kinidin, disopiramid] ali skupine III [npr. amiodaron, sotalol, dofetilid, ibutilid], metadon, cisaprid, moksifloksacin, antipsihotiki, itn.).
Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are substrates of OCT1 or OCT2 (e.g., metformin, procainamide). 
Torej lahko zveča plazemske koncentracije sočasno uporabljenih zdravil, ki so substrati OCT1 in OCT2 (npr. metformin, prokainamid).
The median PFS at the time of data cutoff was 19.3 months (95% CI: 15.2, 39.1). 
Mediano PFS na dan zaključka zajema podatkov je bilo 19,3 meseca (95 % IZ: 15,2; 39,1).
Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are substrates of OCT1 or OCT2 (see section 4.5). 
Torej bi lahko povzročil povečanje plazemskih koncentracij sočasno uporabljenih zdravil, ki so substrati OCT1 ali OCT2 (glejte poglavje 4.5).
However, the systemic crizotinib exposure in patients with moderate hepatic impairment at the dose of 200 mg twice daily was comparable to that observed from patients with normal hepatic function at a dose of 250 mg twice daily, with geometric mean ratios for AUCdaily and Cmax of 114% and 109%, respectively. 
Vendar pa je bila sistemska izpostavljenost krizotinibu pri bolnikih z zmerno okvaro jeter pri odmerku 200 mg dvakrat na dan primerljiva izpostavljenosti, ki so jo opazili pri bolnikih z normalnim delovanjem jeter pri odmerku 250 mg dvakrat na dan, z razmerjem geometričnih sredin 114 % za AUCdaily in 109 % za Cmax.
• If your next dose is in 6 hours or more, take the missed capsule as soon as you remember. 
• Če je do naslednjega odmerka, ki ga morate vzeti, 6 ur ali več, kapsulo, ki ste jo pozabili vzeti,