FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Delne odzive so opazili pri 20 od 45 bolnikov z NSCLC, ki ni adenokarcinom, kar je predstavljalo 44 % ORR, in 9 od 22 bolnikov z NSCLC SCC, kar je predstavljalo 41 % ORR, to pa je bilo manj od ORR, o katerem so za vse bolnike poročali v Študiji 1005 (54 %).
English: Of note, the effectiveness of concomitant administration of oral contraceptives may be reduced.
Slovenian: Treba je biti pozoren na to, da se učinkovitost sočasno uporabljanih peroralnih kontraceptivov lahko zmanjša.
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.
Slovenian: Večina razpoložljivih podatkov se nanaša na bolnike s posebnim histološkim tipom ALK-pozitivnega nedrobnoceličnega raka pljuč (adenokarcinoma), za druge histološke tipe pa so na voljo le omejeni podatki.
English: • Clarithromycin, telithromycin, erythromycin, antibiotics used to treat bacterial infections.
Slovenian: • klaritromicin, telitromicin, eritromicin, antibiotiki, ki se uporabljajo za zdravljenje bakterijskih okužb,
English: These medicines should be avoided during your treatment with XALKORI.
Slovenian: Uporabi teh zdravil se je med zdravljenjem z zdravilom XALKORI treba izogibati.
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).
Slovenian: c. ocenjeno z uporabo Kaplan-Meierjeve metode d. V analizo varnosti so vključili podatke za PFS iz Študije 1005 pri 807 bolnikih, ki so jih identificirali s preiskavo FISH (na dan zaključka zajema podatkov 15. februarja 2012).
English: It is available in blister packs of 60 hard capsules and in plastic bottles of 60 hard capsules.
Slovenian: Na voljo je v pretisnih omotih s 60 trdimi kapsulami in plastenkah s 60 trdimi kapsulami.
English: Crizotinib can be administered with or without food (see section 4.2).
Slovenian: Krizotinib se lahko jemlje skupaj s hrano ali brez nje (glejte poglavje 4.2).
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.
Slovenian: Krizotinib je pokazal tudi izrazito protitumorsko aktivnost v študijah na miših s heterolognimi presadki, v katerih so tumorje ustvarili s pomočjo nabora celičnih linij NIH-3T3, proizvedenih za izražanje ključnih fuzij ROS1, odkritih v človeških tumorjih.
English: Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Slovenian: Izključiti je treba druge morebitne vzroke ILD/pnevmonitisa (glejte poglavji 4.2 in 4.4).
English: Warnings and precautions Talk to your doctor before taking XALKORI:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila XALKORI se posvetujte z zdravnikom:
English: Efficacy data from Study 1007 are summarised in Table 5, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
Slovenian: Podatki o učinkovitosti iz Študije 1007 so povzeti v preglednici 5, Kaplan-Meierjevi krivulji za PFS in OS pa sta prikazani na slikah 3 oziroma 4.
English: Hypersensitivity to crizotinib or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na krizotinib ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: • Abnormalities in liver blood tests.
Slovenian: • nenormalni izvidi krvnih preiskav delovanja jeter
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.
Slovenian: Geometrična srednja vrednost volumna porazdelitve (Vss) krizotiniba je po intravenskem dajanju 50 mg odmerka znašala 1.772 l, kar nakazuje obsežno porazdelitev v tkiva iz plazme.
English: The antitumour efficacy of crizotinib was dose-dependent and correlated to pharmacodynamic inhibition of phosphorylation of ALK fusion proteins (including EML4-ALK and NPM-ALK) in tumours in vivo.
Slovenian: Protitumorska učinkovitost krizotiniba je bila odvisna od odmerka in je bila povezana s farmakodinamskim zavrtjem fosforilacije ALK fuzijskih beljakovin (vključno z EML4-ALK in NPM-ALK) v tumorjih in vivo.
English: • Antipsychotics, used to treat mental illness.
Slovenian: • antipsihotiki, ki se uporabljajo za zdravljenje duševnih bolezni,
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.
Slovenian: Treba je omeniti, da v Študijo 1007 v skupino s krizotinibom ni bil vključen noben bolnik s histologijo SCC, v študijo 1014 pa noben bolnik s SCC, saj se je za primerjavo uporabljal režim na podlagi pemetrekseda.
English: Crizotinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay.
Slovenian: Krizotinib ni deloval mutageno in vitro pri preskusu bakterijske reverzne mutacije (Amesov preskus).
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).
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov iz študij 1001, 1005 in 1007 je bila predvidena vrednost površine pod krivuljo plazemske koncentracije v odvisnosti od časa (AUCss) v stanju dinamičnega ravnovesja (95 % IZ) za 23 %-37 % večja pri azijskih bolnikih (n = 523) kot pri bolnikih, ki niso bili azijskega porekla (n = 691).
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.
Slovenian: Zato bi jemanje krizotiniba skupaj z zdravili, ki so substrati P-gp (npr. digoksin, dabigatran, kolhicin, pravastatin) lahko okrepilo njihov terapevtski učinek in neželene učinke.
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.
Slovenian: Pri bolnikih z ALK-pozitivnim NSCLC je bila pogostnost neželenih učinkov na splošno podobna pri bolnikih < 65 let in bolnikih  65 let, z izjemo edema in zaprtosti, o katerih so v Študiji 1014 pogosteje ( 15 % razlika) poročali pri bolnikih  65 let, zdravljenih s krizotinibom.
English: Leukopenia was associated with a dose reduction for <0.5% of patients, and no patients permanently discontinued crizotinib treatment associated with leukopenia.
Slovenian: Levkopenija je bila povezana z zmanjšanjem odmerka pri < 0,5 % bolnikov, zaradi levkopenije pa zdravljenja s krizotinibom ni trajno prekinil noben bolnik.
English: • If your next dose is in less than 6 hours, skip the missed capsule.
Slovenian: • Če je do naslednjega odmerka, ki ga morate vzeti, manj kot 6 ur, pozabljeno kapsulo izpustite.
English: Based on nonclinical safety findings, male and female fertility may be compromised by treatment with XALKORI (see section 5.3).
Slovenian: Na osnovi predkliničnih izsledkov glede varnosti je lahko plodnost tako moških kot tudi žensk zaradi zdravljenja z zdravilom XALKORI zmanjšana (glejte poglavje 5.3).
English: A total of 259 (16%) of 1666 patients with at least 1 postbaseline vital sign assessment had a pulse rate <50 bpm.
Slovenian: Skupno 259 (16 %) od 1.666 bolnikov z vsaj 1 oceno življenjskih znakov po izhodišču je imelo srčni utrip < 50 utripov na minuto.
English: (HR=0.30; p-value <0.0001 for crizotinib compared with docetaxel).
Slovenian: (HR = 0,30, vrednost p < 0,0001 za krizotinib v primerjavi z docetakselom).
English: XALKORI may increase side effects associated with the following medicines:
Slovenian: Zdravilo XALKORI lahko okrepi neželene učinke, povezane z naslednjimi zdravili:
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%).
Slovenian: Neželeni učinki zaradi vseh vzrokov, povezani s trajno prekinitvijo zdravljenja, so se pojavili pri 302 (18 %) bolnikih, najpogostejša (≥ 1 %) med njimi pa sta bila intersticijska bolezen pljuč (1 %) in povečana vrednost transaminaz (1 %).
English: CTCAEa Grade
Slovenian: Stopnja CTCAE
English: • If you are currently treated with any of the medicines listed in section Other medicines and
Slovenian: • če trenutno jemljete katerokoli izmed zdravil, navedenih v poglavju Druga zdravila in zdravilo XALKORI.
English: Drug-induced ILD/pneumonitis should be considered in the differential diagnosis of patients with ILD-like conditions such as: pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonitis, pulmonary fibrosis, acute respiratory distress syndrome (ARDS), alveolitis, lung infiltration, pneumonia, pulmonary oedema, chronic obstructive pulmonary disease, pleural effusion, aspiration pneumonia, bronchitis, obliterative bronchiolitis, and bronchiectasis.
Slovenian: Na z zdravljenjem povezan ILD/pnevmonitis je treba pomisliti pri diferencialni diagnozi pri bolnikih s stanji, podobnimi ILD, kot so: pnevmonitis, radiacijski pnevmonitis, preobčutljivostni pnevmonitis, intersticijski pnevmonitis, pljučna fibroza, sindrom dihalne stiske pri odraslem (ARDS), alveolitis, pljučna infiltracija, pljučnica, pljučni edem, kronična obstruktivna pljučna bolezen, plevralni izliv, aspiracijska pljučnica, bronhitis, obliterativni bronhiolitis in bronhiektazija.
English: Following oral single dose administration in the fasted state, crizotinib is absorbed with median time to achieve peak concentrations of 4 to 6 hours.
Slovenian: Po peroralnem zaužitju enkratnega odmerka na tešče se krizotinib absorbira z medianim časom do dosega največjih koncentracij 4 do 6 ur.
English: XALKORI is an anticancer medicine containing the active substance crizotinib used to treat adults with a type of lung cancer called non-small cell lung cancer, that presents with a specific rearrangement or defect in either a gene called anaplastic lymphoma kinase (ALK) or a gene called ROS1.
Slovenian: XALKORI je zdravilo za zdravljenje rakavih bolezni, ki vsebuje učinkovino krizotinib, uporablja pa se za zdravljenje odraslih z vrsto pljučnega raka, imenovanega nedrobnocelični pljučni rak, pri katerem prihaja do specifične preureditve ali okvare na genu, imenovanem anaplastična limfom kinaza (ALK), ali na genu, imenovanem ROS1.
English: Withhold until recovery to Grade ≤2, then resume at the same dose schedule
Slovenian: Prekinite zdravljenje, dokler ne pride do izboljšanja na stopnjo ≤ 2, nato z zdravljenjem nadaljujte ob enakem načinu odmerjanja.
English: Intracranial Disease Control Rate (IC-DCR) at 12 weeks was 65% and 46% for crizotinib and chemotherapy-treated patients, respectively.
Slovenian: Intracranial Disease Control Rate) po 12 tednih je bil 65 % v skupini s krizotinibom in 46 % v skupini s kemoterapijo.
English: • Methadone, used to treat pain and for the treatment of opioid dependence.
Slovenian: • metadon, ki se uporablja za blaženje bolečin in za zdravljenje odvisnosti od opioidov,
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).
Slovenian: In vitro študije na humanih hepatocitih so pokazale, da krizotinib lahko inducira encime, ki jih uravnavata pregnan X receptor (PXR) in konstitutivni androstanski receptor (CAR) (npr. CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
English: The onset of vision disorders generally started within the first week of drug administration.
Slovenian: Motnje vida so se običajno pojavile v prvem tednu dajanja zdravila.
English: In vitro studies suggest that crizotinib is a substrate for P-glycoprotein (P-gp).
Slovenian: In vitro študije kažejo, da je krizotinib substrat za P-glikoprotein (P-gp).
English: • The recommended dose is one capsule of 250 mg taken orally twice daily (total amount
Slovenian: • Priporočeni odmerek je ena 250 mg kapsula, ki jo vzamete peroralno dvakrat na dan (skupna količina 500 mg).
English: Following single doses of crizotinib, the apparent plasma terminal half-life of crizotinib was 42 hours in patients.
Slovenian: Po enkratnih odmerkih krizotiniba je navidezni končni razpolovni čas izločanja krizotiniba iz plazme pri bolnikih znašal 42 ur.
English: • Phenytoin, carbamazepine or phenobarbital, anti-epileptics used to treat seizures or fits.
Slovenian: • fenitoin, karbamazepin ali fenobarbital, antiepileptiki, ki se uporabljajo za zdravljenje epileptičnih napadov ali krčev,
English: A monitoring of the QT interval should be made in case of combinations of such medicinal products (see sections 4.2 and 4.4).
Slovenian: V primeru sočasne uporabe takih zdravil je potreben nadzor intervala QT (glejte poglavji 4.2 in 4.4).
English: • Increased blood levels of creatinine (may indicate that kidneys are not functioning properly).
Slovenian: • povišane ravni kreatinina v krvi (lahko kažejo na nepravilno delovanje ledvic)
English: Other potential causes of ILD/pneumonitis should be excluded, and crizotinib should be permanently discontinued in patients diagnosed with treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Slovenian: Izključiti je treba druge morebitne vzroke ILD/pnevmonitisa, pri bolnikih, pri katerih je diagnosticiran z zdravljenjem povezan ILD/pnevmonitis, pa trajno prekiniti zdravljenje s krizotinibom (glejte poglavji 4.2 in 4.8).
English: • Ergot alkaloids (e.g., ergotamine, dihydroergotamine), used to treat migraine.
Slovenian: • ergot alkaloidi (npr. ergotamin, dihidroergotamin), ki se uporabljajo za zdravljenje migrene,
English: 2013; OS is based on the last patient last visit date of 30 November 2016, and is based on a median follow up of approximately 46 months.
Slovenian: * PFS, delež objektivnega odziva in trajanje odziva so določili na dan zaključka zajema podatkov 30. novembra 2013; OS so določili na datum zadnjega obiska zadnjega bolnika 30. novembra 2016 in temelji na medianem času spremljanja približno 46 mesecev.
English: Grade 4 Bradycardiad,e,f Life-threatening consequences, urgent intervention indicated
Slovenian: d,e,f smrtno nevarne posledice; indicirana nujna intervencija
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.
Slovenian: V kliničnih študijah so pri bolnikih, zdravljenih s krizotinibom (glejte poglavji 4.8 in 5.2), opazili podaljšanje intervala QTc, kar lahko povzroči povečano tveganje za ventrikularne tahiaritmije (npr. Torsade de Pointes) ali nenadno smrt.
English: • Pimozide, used to treat mental illness.
Slovenian: • pimozid, ki se uporablja za zdravljenje duševnih bolezni,
English: The results of an in vitro phototoxicity study demonstrated that crizotinib may have phototoxic potential.
Slovenian: Rezultati in vitro študije fototoksičnosti so pokazali, da bi krizotinib lahko deloval fototoksično.
English: The full analysis population included 347 patients with ALK-positive advanced NSCLC as identified by FISH prior to randomisation.
Slovenian: V analizo celotne populacije so vključili 347 bolnikov z ALK-pozitivnim napredovalim NSCLC, ki so ga pred randomizacijo določili s testom FISH.
English: Patient brochure including a Patient Alert Card (text as agreed by the CHMP).
Slovenian: povzetek glavnih značilnosti in navodilo za uporabo vodnik za bolnike, vključno z opozorilno kartico za bolnika (besedilo v dogovoru s CHMP)
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.
Slovenian: metastatska bolezen pri 98 % bolnikov, 92 % tumorjev bolnikov, histološko razvrščenih med adenokarcinome, in 27 % bolnikov z možganskimi metastazami.
English: • Closed pouches of fluid within the kidneys (kidney cysts).
Slovenian: • zaprti mešički tekočine v ledvicah (ledvične ciste)
English: • Ciclosporin, sirolimus and tacrolimus used in transplant patients.
Slovenian: • ciklosporin, sirolimus in takrolimus, ki se uporabljajo pri bolnikih s presajenimi organi,
English: Crizotinib was not shown to be teratogenic in pregnant rats or rabbits.
Slovenian: Krizotinib ni bil teratogen pri brejih podganah oziroma kuncih.
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.
Slovenian: Čas do poslabšanja (TTD - Time to Deterioration) so vnaprej opredelili kot prvi pojav povečanja rezultata simptomov bolečine v prsnem košu, kašlja ali dispneje za ≥ 10 točk od izhodišča, kar so ocenili z vprašalnikom EURTC QLQ-LC13.
English: Patients with or without pre-existing cardiac disorders, receiving crizotinib, should be monitored for signs and symptoms of heart failure (dyspnoea, oedema, rapid weight gain from fluid retention).
Slovenian: Bolnike z obstoječimi srčnimi boleznimi ali brez njih, ki prejemajo krizotinib, je treba spremljati glede pojava znakov in simptomov srčnega popuščanja (dispneja, edem, hitro povečanje telesne mase zaradi zastajanja tekočine v telesu).
English: There are no data in pregnant women using crizotinib.
Slovenian: Na voljo ni nobenih podatkov, ki bi se nanašali na nosečnice, ki so uporabljale krizotinib.
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.
Slovenian: Nosečnice oziroma bolnice, ki med zdravljenjem s krizotinibom zanosijo, in zdravljene moške partnerje nosečnic je treba seznaniti z možno nevarnostjo za plod.
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.
Slovenian: Pri uporabi krizotiniba je treba preiskavi EKG in elektrolitov (npr. kalcija, magnezija, kalija) opraviti čimbližje uporabi prvega odmerka, potem pa se priporoča redno spremljanje EKG in elektrolitov, predvsem na začetku zdravljenja, če pride do bruhanja, driske, dehidracije ali poslabšanega delovanja ledvic.
English: • Moxifloxacine, used to treat bacterial infections.
Slovenian: • moksifloksacin, ki se uporablja za zdravljenje bakterijskih okužb,
English: Crizotinib demonstrated potent and selective growth inhibitory activity and induced apoptosis in tumour cell lines exhibiting ALK fusion events (including echinoderm microtubule-associated protein-like 4 [EML4]-ALK and nucleophosmin [NPM]-ALK), ROS1 fusion events, or exhibiting amplification of the ALK or MET gene locus.
Slovenian: Krizotinib je pokazal močno in selektivno aktivnost pri zaviranju rasti in je sprožil apoptozo pri linijah tumorskih celic, pri katerih je prihajalo do s fuzijo ALK povezanih dogodkov, (ki vključujejo z mikrotubuli povezano beljakovino 4 [EML4]-ALK iglokožcev in nukleofozminom [NPM]-ALK), s fuzijo ROS1 povezanih dogodkov ali pa je okrepil mesta ALK ali MET genov.
English: For most patients, ROS1-positive NSCLC was identified by FISH.
Slovenian: Pri večini bolnikov so ROS1-pozitivni napredovali NSCLC potrdili s preiskavo FISH.
English: • Pilocarpine, used to treat glaucoma (a severe eye disease).
Slovenian: • pilokarpin, ki se uporablja za zdravljenje glavkoma (huda bolezen oči),
English: The effect of a moderate inducer including but not limited to efavirenz or rifabutin is not clearly established therefore, their combination with crizotinib should be also avoided (see section 4.4).
Slovenian: Učinek zmernih induktorjev, med drugim tudi efavirenza ali rifabutina, še ni jasen, zato se je treba sočasni uporabi le-teh s krizotinibom izogibati (glejte poglavje 4.4).
English: PVC-foil blisters containing 10 hard capsules.
Slovenian: Pretisni omoti iz PVC-folije, ki vsebujejo 10 trdih kapsul.
English: Findings observed in the female reproductive tract included single-cell necrosis of ovarian follicles of a rat given 500 mg/kg/day for 3 days.
Slovenian: Ugotovitve, ki so jih opažali na rodilih pri samicah, so vključevale nekrozo posamičnih celic v foliklih jajčnikov podgan, ki so tri dni prejemale odmerek 500 mg/kg/dan.
English: d. See sections 4.4 and 4.8. e. Heart rate less than 60 beats per minute (bpm).
Slovenian: d. Glejte poglavji 4.4 in 4.8. e. srčni utrip je manjši od 60 utripov na minuto f. Pri ponovitvi zdravljenje trajno prekinite.
English: These patients received a starting oral dose of 250 mg taken twice daily continuously.
Slovenian: Ti bolniki so prejemali začetni peroralni 250 mg odmerek, ki so ga brez prekinitve jemali dvakrat na dan.
English: • Stomach upset, including vomiting, diarrhoea, nausea.
Slovenian: • težave z želodcem, vključno z bruhanjem, drisko, slabostjo s siljenjem na bruhanje
English: Grapefruit or grapefruit juice may also increase plasma concentrations of crizotinib and should be avoided (see sections 4.2 and 4.4).
Slovenian: Grenivke oziroma grenivkin sok prav tako lahko poveča(jo) plazemske koncentracije krizotiniba, zato se jim je treba izogibati (glejte poglavji 4.2 in 4.4).
English: No patients in the crizotinib arm of randomised Phase 3 Studies 1007 and 1014, and single arm Study 1005 were >85 years.
Slovenian: Noben bolnik v skupini s krizotinibom v randomiziranih študijah 3. faze, Študiji 1007 in 1014, ter enoskupinski Študiji 1005 ni bil star  85 let.
English: Limited information is available in patients with ALK-positive and ROS1-positive NSCLC with non-adenocarcinoma histology, including squamous cell carcinoma (SCC) (see section 5.1).
Slovenian: Na voljo so le omejeni podatki pri bolnikih z NSCLC, ki je ALK in ROS1 pozitiven in ima histološke značilnosti, ki ne nakazujejo adenokarcinoma, vključno s ploščatoceličnim karcinomom (SCCSquamous Cell Carcinoma) (glejte poglavje 5.1).
English: The NOAEL for aneugenicity was approximately 1.8-fold human clinical exposure based on AUC.
Slovenian: Raven NOAEL glede odsotnosti vpliva na dedne lastnosti je znašala približno 1,8-kratnik klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC.
English: In vitro studies indicated that crizotinib is an inhibitor of CYP2B6.
Slovenian: In vitro študije so pokazale, da je krizotinib inhibitor CYP2B6.
English: XALKORI dose modification - non-haematological toxicities CTCAEa Grade
Slovenian: Prilagajanje odmerkov zdravila XALKORI - nehematološka toksičnost Stopnja CTCAE
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.
Slovenian: Pri bolnikih z blago (60 ≤ očistek kreatinina [CLcr] < 90 mL/min) ali zmerno (30 ≤ CLcr < 60 mL/min) okvaro ledvic prilagajanje začetnega odmerka ni priporočeno, ker populacijska farmakokinetična analiza pri teh bolnikih ni pokazala klinično pomembnih sprememb v izpostavljenosti krizotinibu v stanju dinamičnega ravnovesja.