FrancophonIA/ELRC3.0 huggingface dataset:
English: Other major metabolic pathways involved hydroxylation, carbamate hydrolysis, indirect glucuronidation and glucose conjugate formation.
Croatian: Drugi bitni metabolički putevi uključuju hidroksilaciju, hidrolizu karbamata, indirektnu glukuronidaciju i stvaranje konjugata glukoze.
English: Most events were Grade 1 or 2 (14.6%) and 3.3% were Grade 3-4 events.
Croatian: Većina događaja bili su stupnja 1 ili 2 (14,6%), a 3,3% su bili stupnja 3-4.
English: Usually, these skin changes (see also section 2) are confined to a small area and can be removed with surgery and treatment with Braftovi (and binimetinib) can continue without interruption.
Croatian: Obično su ove promjene kože (vidjeti također dio 2.) ograničene na malu površinu i mogu se ukloniti kirurškim zahvatom, a liječenje lijekom Braftovi (i binimetinibom) može se nastaviti bez prekida.
English: Encorafenib was not genotoxic.
Croatian: Enkorafenib nije pokazao genotoksičnost.
English: Encorafenib was found to be a substrate of the P-glycoprotein (P-gp) transporters.
Croatian: Utvrđeno je da je enkorafenib supstrat transportera P-glikoproteina (P-gp).
English: Braftovi targets proteins made from this changed BRAF gene.
Croatian: Lijek Braftovi cilja proteine nastale od ovog izmijenjenog BRAF gena.
English: Patients were permitted to receive prior adjuvant therapy and one prior line of immunotherapy for unresectable locally advanced or metastatic disease.
Croatian: Bolesnicima je bilo dozvoljeno prethodno primiti adjuvantnu kemoterapiju i jednu liniju imunoterapije za neoperabilnu lokalno uznapredovalu ili metastatsku bolest.
English: Uveitis including iritis and iridocyclitis
Croatian: Uveitis, uključujući i iritis i iridociklitis
English: Model based predictions indicate that the effect of posaconazole after repeated administrations could be similar for AUC (3-fold increase) and slightly greater for Cmax (2.7-fold increase).
Croatian: Predviđanja temeljena na modelu ukazuju da učinak posakonazola poslije ponovljenih davanja može biti sličan za AUC (3 puta veći) i blago povećan za Cmax (2,7 puta veći).
English: Polyamide/aluminum/PVC/aluminum blister containing 6 capsules.
Croatian: Poliamid/aluminij/PVC/aluminij blister koji sadrži 6 kapsula.
English: What Braftovi looks like and contents of the pack
Croatian: Kako lijek Braftovi izgleda i sadržaj pakiranja
English: Avoid driving or using machines if you have any problems with your vision, or have any other side effects that can affect your ability to drive or use machines (see section 4), while taking Braftovi.
Croatian: Izbjegavajte vožnju ili upotrebu strojeva ako imate problema s vidom ili druge nuspojave koje mogu utjecati na vašu sposobnost upravljanja vozilima i strojevima (pogledajte dio 4.) dok uzimate lijek Braftovi.
English: Other medicines and Braftovi
Croatian: Drugi lijekovi i lijek Braftovi
English: Inhibition of P-gp is unlikely to result in a clinically important increase in encorafenib concentrations as encorafenib exhibits high intrinsic permeability.
Croatian: Malo je vjerojatno da inhibicija P-gp-a dovodi do klinički značajnog povećanja koncentracija enkorafeniba, budući da enkorafenib pokazuje visoku intrinzičnu permeabilnost.
English: The highest administered dose occurred as a dosing error in one patient who took encorafenib at a dose of 600 mg twice daily for 1 day (total dose 1200 mg).
Croatian: Najveća primijenjena doza dogodila se uslijed greške pri doziranju u jednog bolesnika koji je tijekom jednog dana uzeo enkorafenib u dozi od 600 mg dvaput dnevno (ukupna doza 1200 mg).
English: If symptoms of new or worsening visual disturbances including diminished central vision, blurred vision or loss of vision are identified, a prompt ophthalmologic examination is recommended.
Croatian: Ako se utvrde novi simptomi ili pogoršanje poremećaja vida, uključujući i oštećenje centralnog vida, zamućenje vida ili gubitak vida, preporučuje se hitan oftalmološki pregled.
English: Polyamide/aluminum/PVC/aluminum blister containing 4 capsules.
Croatian: Poliamid/aluminij/PVC/aluminij blister koji sadrži 4 kapsule.
English: Therefore, concomitant administration of encorafenib with strong CYP3A4 inhibitors should be avoided (due to increased encorafenib exposure and potential increase in toxicity, see section 5.2).
Croatian: Stoga treba izbjegavati istodobnu primjenu enkorafeniba sa snažnim inhibitorima CYP3A4 (zbog povećane izloženosti enkorafenibu i potencijalnog povećanja toksičnosti, vidjeti dio 5.2).
English: Uveitis and visual impairment were generally reversible.
Croatian: Uveitis i oštećenje vida uglavnom su bili reverzibilni.
English: The NOAEL for the 13-week study was at 14- to 32-times human therapeutic exposures.
Croatian: NOAEL za 13-tjedno ispitivanje iznosio je 14 do 32 puta više od terapijskih izloženosti u ljudi.
English: If encorafenib is used during pregnancy or if the patient becomes pregnant while taking encorafenib, the patient should be informed of the potential hazard to the foetus.
Croatian: Ako se enkorafenib primjenjuje tijekom trudnoće ili bolesnica zatrudni tijekom liječenja enkorafenibom, bolesnicu se mora obavijestiti o mogućem riziku za plod.
English: Symptomatic treatment and supportive care should be provided as needed.
Croatian: Po potrebi treba uvesti simptomatsko liječenje i potpornu njegu.
English: Encorafenib is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Enkorafenib se ne preporučuje u trudnica i u žena u reproduktivnoj dobi koje ne koriste kontraceptivnu zaštitu.
English: 1st dose reduction 300 mg once daily 2nd dose reduction 200 mg once daily Subsequent modification
Croatian: Prvo smanjenje doze 300 mg jednom dnevno Drugo smanjenje doze 200 mg jednom dnevno
English: Encorafenib may decrease the efficacy of hormonal contraceptives (see section 4.5).
Croatian: Enkorafenib može smanjiti djelotvornost hormonskih kontraceptiva (vidjeti dio 4.5).
English: However if the missed dose is more than 12 hours late, skip that dose and take your next dose at the usual time.
Croatian: Ali, ako kasnite s propuštenom dozom više od 12 sati, preskočite tu dozu i uzmite sljedeću dozu u uobičajeno vrijeme.
English: • Recurrent or intolerable Grade 2 adverse reactions
Croatian: • Ponovni nastup ili nepodnošljive nuspojave stupnja 2
English: Other contributing factors included diabetes and hypertension.
Croatian: Drugi doprinoseći čimbenici su dijabetes i hipertenzija.
English: Renal failure was generally reversible with dose interruption, rehydration and other general supportive measures.
Croatian: Općenito je zatajenje bubrega bilo reverzibilno s privremenim prekidom liječenja, rehidracijom i drugim općim potpornim mjerama.
English: Cut-off date: 19 May 2016
Croatian: Krajnji rok: 19. svibnja 2016.
English: Side effects of Braftovi such as nausea, vomiting, dehydration and blurred vision may appear or worsen.
Croatian: Nuspojave lijeka Braftovi kao što su mučnina, povraćanje, dehidracija i zamućenje vida mogu se pojaviti ili pogoršati.
English: Braftovi is not recommended during pregnancy.
Croatian: Lijek Braftovi se ne preporučuje tijekom trudnoće.
English: It is not known if Braftovi passes into breast milk.
Croatian: Nije poznato prelazi li lijek Braftovi u majčino mlijeko.
English: In vitro, encorafenib inhibited the hepatic transporter OCT1, but is unlikely to be an effective inhibitor clinically.
Croatian: In vitro enkorafenib inhibira jetreni transporter OCT1, ali nije vjerojatno da će biti klinički učinkovit inhibitor.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake Rok valjanosti ili EXP.
English: Your doctor will run blood tests to check your liver before and during treatment.
Croatian: Vaš će liječnik provesti krvne pretrage kako bi provjerio Vašu jetru prije i tijekom liječenja.
English: Number of events (progressive disease) (%)
Croatian: Broj događaja (progresivna bolest)
English: In the small group of patients aged ≥75 years (n=15), patients were more likely to experience serious adverse events and adverse events leading to discontinuation of treatment.
Croatian: ≥ 75 godina (n = 15), bolesnici su imali veću šansu doživjeti ozbiljne nuspojave i nuspojave koje dovode do trajne obustave liječenja.
English: Patients should be instructed to immediately inform their physicians if new skin lesions develop.
Croatian: Bolesnike je potrebno savjetovati da svog liječnika odmah obavijeste o svakoj novoj promjeni na koži.
English: It is unknown whether encorafenib or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se enkorafenib ili njegovi metaboliti u majčino mlijeko.
English: It should be considered to permanently discontinue encorafenib in patients who develop RAS mutation-positive non-cutaneous malignancies.
Croatian: Treba razmotriti trajno obustavljanje enkorafeniba u bolesnika koji razviju zloćudne bolesti koje nisu na koži s pozitivnom RAS mutacijom.
English: Treatment should continue until the patient no longer derives benefit or the development of unacceptable toxicity.
Croatian: Liječenje se treba provoditi sve dok bolesnik od njega ima koristi ili dok ne razvije neprihvatljivu toksičnost.
English: • QTcF > 500 ms and change ≤ 60 ms from pre-treatment value
Croatian: • Produljenje QTcF na > 500 ms i promjena za ≤ 60 ms u odnosu na vrijednosti prije liječenja
English: Besides the serious side effects mentioned above, people taking Braftovi may also get other side effects.
Croatian: Osim gore spomenutih ozbiljnih nuspojava, osobe koje uzimaju lijek Braftovi mogu iskusiti i druge nuspojave.
English: All the PPES adverse reactions were either Grade 1 (3.3%) or Grade 2 (2.9%).
Croatian: Sve nuspojave u vidu PPES-a bile su ili stupnja 1 (3,3%) ili stupnja 2 (2,9%).
English: What Braftovi is and what it is used for
Croatian: Što je lijek Braftovi i za što se koristi
English: When Braftovi was used on its own in clinical trials
Croatian: Kada je lijek Braftovi bio korišten kao monoterapija u kliničkim ispitivanjima
English: Braftovi can affect your ability to drive or use machines.
Croatian: Lijek Braftovi može utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: 42 hard capsules 168 hard capsules
Croatian: 42 tvrde kapsule 168 tvrde kapsule
English: Contact your doctor straightaway if you become pregnant while taking Braftovi.
Croatian: Odmah se obratite svom liječniku ako zatrudnite dok uzimate lijek Braftovi.
English: There are no data on the effects of encorafenib on fertility in humans.
Croatian: Nema podataka o učincima enkorafeniba na plodnost kod ljudi.
English: Since encorafenib is moderately bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with encorafenib.
Croatian: S obzirom da se enkorafenib umjereno vezuje za proteine plazme, hemodijaliza će vjerojatno biti neučinkovita u liječenju predoziranja enkorafenibom.
English: For new primary cutaneous malignancies: No dose modifications are required for encorafenib.
Croatian: Za nove primarne kožne zloćudne bolesti: Nije potrebna prilagodba doze za enkorafenib.
English: The Functional Assessment of Cancer Therapy-Melanoma (FACT-M), the European Organisation for Research and Treatment of Cancer's core quality of life questionnaire (EORTC QLQ-C30) and the EuroQoL-5 Dimension-5 Level examination (EQ-5D-5L) were used to explore patient-reported outcomes (PRO) measures of health-related Quality of Life, functioning, melanoma symptoms, and treatment-related adverse reactions.
Croatian: European Organization for Research and Treatment of Cancer's core quality of life questionnaire, EORTC QLQ-C30) i EuroQoL-5 dimenzija-5 razina ispitivanje (EQ-5D-5L) korišteni su za ispitivanje ishoda koje bilježe bolesnici mjerenja kvalitete života povezane sa zdravljem, funkcioniranjem, simptomima melanoma i nuspojavama uzrokovanim liječenjem.
English: Facial paresis
Croatian: Facijalna pareza
English: The inter-subject variability (CV%) of AUC is ranged from 12.3% to 68.9%.
Croatian: Varijabilnost AUC-a među bolesnicima (CV %) bila je u rasponu od 12,3% do 68,9%.
English: The median (range) encorafenib terminal half-life (T1/2) was 6.32 h (3.74 to 8.09 h).
Croatian: Medijan (raspon) terminalnog poluvijeka enkorafeniba (T1/2) bio je 6,32 sati (raspon od 3,74 do 8,09 sati).
English: Most patients had metastatic disease (95%) and were Stage IVM1c (64%); 27% of patients had elevated baseline serum lactate dehydrogenase (LDH), and 45% of patients had at least 3 organs with tumour involvement at baseline and 3.5% had brain metastases.
Croatian: Većina bolesnika imala je metastatsku bolest (95%) i bila je u stadiju IVM1c (64%); 27% bolesnika imalo je povišenu početnu vrijednost serumske laktat dehidrogenaze (LDH), 45% bolesnika je na početku imalo najmanje 3 organa zahvaćenih tumorom, a 3,5% je već imalo metastaze na mozgu.
English: Gastrointestinal disorders were typically managed with standard therapy.
Croatian: Poremećaji probavnog sustava bili su obično liječeni uobičajenom standardnom terapijom.
English: Elderly patients No dose adjustment is required for patients aged 65 years and older (see section 5.2).
Croatian: Za bolesnike u dobi 65 od godina ili starije nije potrebna prilagodba doze (vidjeti dio 5.2).
English: At doses of encorafenib between 600 to 800 mg once daily, renal dysfunction (Grade 3 hypercreatinaemia) was observed in 3 out of 14 patients.
Croatian: Pri primjeni enkorafeniba u dozama od 600 do 800 mg jednom dnevno, primijećen je poremećaj funkcije bubrega (hiperkreatinemija stupnja 3) u 3 od 14 bolesnika.
English: Visual disturbances have been reported in some patients treated with encorafenib during clinical studies.
Croatian: Poremećaji vida primijećeni su u nekih bolesnika liječenih enkorafenibom tijekom kliničkih ispitivanja.
English: Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor.
Croatian: Enkorafenib je potentan, visokoselektivan i kompetitivan ATP-u niskomolekularni inhibitor RAF kinaze.
English: Encorafenib suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K).
Croatian: Enkorafenib blokira RAF/MEK/ERK signalni put u tumorskim stanicama koje imaju izraženu ekspresiju nekoliko mutiranih oblika BRAF kinaze (V600E, D i K).
English: Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse reactions that may affect their ability to drive and use machines (see sections 4.4 and 4.8).
Croatian: Bolesnicima se mora napomenuti da ne upravljaju vozilom i ne rade sa strojevima ako primijete smetnje vida ili bilo kakve druge nuspojave koje mogu utjecati na njihovu sposobnost upravljanja vozilima ili rada sa strojevima (vidjeti dijelove 4.4 i 4.8).
English: Unstratified subgroup analyses demonstrated point estimates in favour of Combo 450, including LDH at baseline, ECOG performance status and AJCC stage.
Croatian: Nestratificirane analize podskupina pokazale su procjene točaka u korist kombinirane terapije 450, uključujući i početne vrijednosti LDH, funkcionalni status ECOG i stupanj AJCC.
English: If you continue Braftovi on its own while the other medicine (binimetinib) is temporarily stopped based on your doctor's decision, you may get some of the side effects given in the lists above, although the frequency may change (increase or decrease).
Croatian: Ako nastavite uzimati lijek Braftovi kao monoterapiju dok je drugi lijek (binimetinib) privremeno prekinut po preporuci Vašeg liječnika, možete dobiti neke od nuspojava nabrojanih u gore navedenoj listi, iako učestalost može varirati (povećati se ili smanjiti).
English: Your doctor will check your skin for any new skin cancers before treatment, every 2 months during treatment, and for up to 6 months after you stop taking Braftovi.
Croatian: Liječnik će provjeriti eventualnu pojavu bilo kakvog novog raka kože prije početka liječenja, potom svaka 2 mjeseca tijekom liječenja te do 6 mjeseci nakon što prestanete uzimati lijek Braftovi.
English: Patients should be assessed at each visit for symptoms of new or worsening visual disturbance.
Croatian: Pri svakoj kontroli treba provesti procjenu novih simptoma ili pogoršanja poremećaja vida u bolesnika.
English: Effects of other medicinal products on encorafenib Encorafenib is primarily metabolised by CYP3A4.
Croatian: Učinak drugih lijekova na enkorafenib Enkorafenib se pretežno metabolizira putem CYP3A4.
English: If you are breast-feeding, or planning to breast-feed, ask your doctor for advice before taking this medicine.
Croatian: Ako dojite ili planirate dojiti, pitajte svog liječnika za savjet prije nego uzmete ovaj lijek.
English: The median duration of treatment was longer for Combo 300 vs Enco 300, 52.1 weeks vs 31.5 weeks.
Croatian: Medijan trajanja liječenja je bio duži za kombiniranu terapiju 300 naspram enkorafeniba 300, 52,1 tjedan naspram 31,5 tjedana.
English: If treatment-related toxicities occur, then encorafenib and binimetinib should be simultaneously dose reduced, interrupted or discontinued.
Croatian: Ako se pojave toksičnosti povezane s liječenjem, potrebno je istodobno smanjiti dozu enkorafeniba i binimetiniba, privremeno je prekinuti ili trajno obustaviti.
English: No event required discontinuation, dose modification or interruption.
Croatian: Ni u jednom slučaju nije bio potreban privremeni prekid, prilagodba doze ili obustava liječenja.
English: The recommended dose of encorafenib is 450 mg (six 75 mg capsules) once daily, when used in combination with binimetinib.
Croatian: Preporučena doza enkorafeniba je 450 mg (šest kapsula od 75 mg), jednom dnevno, kad se primjenjuje u kombinaciji s binimetinibom.
English: If not improved within 6 weeks, ophthalmic monitoring should be repeated and encorafenib should be permanently discontinued.
Croatian: Ako nema poboljšanja unutar narednih 6 tjedana, treba ponoviti oftalmološko praćenje, a enkorafenib treba trajno obustaviti.
English: Results from a dedicated clinical study indicate a 25% higher total encorafenib exposures in patients with mild hepatic impairment (Child-Pugh Class A) compared with subjects with normal liver function.
Croatian: Rezultati iz posebnog kliničkog ispitivanja ukazuju na 25% veću ukupnu izloženost enkorafenibu u bolesnika s blagim oštećenjem jetrene funkcije (Child-Pugh stupanj A) u usporedbi s ispitanicima s normalnom jetrenom funkcijom.
English: New primary malignancies
Croatian: Nove primarne zloćudne bolesti
English: Encorafenib should be resumed at a reduced dose when QTcF ≤500 ms.
Croatian: Treba nastaviti sa smanjenom dozom enkorafeniba kada QTcF interval bude ≤ 500 ms.
English: The concomitant administration of encorafenib with grapefruit juice should be avoided (see sections 4.4 and 4.5)
Croatian: Mora se izbjegavati istodobna primjena enkorafeniba sa sokom od grejpa (vidjeti dijelove 4.4 i 4.5)
English: A definitive 10% deterioration in FACT-M and in EORTC QLQC30 was significantly delayed in patients treated with Combo 450 relative to other treatments.
Croatian: Jasno pogoršanje za 10% prema FACT-M skali i prema upitniku EORTC QLQ-C30 značajno je odloženo u bolesnika liječenih kombiniranom terapijom 450 u usporedbi s drugim vrstama liječenja.
English: If Grade 1 or 2 uveitis does not respond to specific (e.g. topical) ocular therapy or for Grade 3 uveitis, encorafenib should be withheld and ophthalmic monitoring should be repeated within 2 weeks.
Croatian: Ako uveitis stupnja 1 ili 2 ne reagira na specifičnu (npr. topikalnu) očnu terapiju ili u slučaju uveitisa stupnja 3, treba prekinuti enkorafenib i ponoviti oftalmološko praćenje unutar 2 tjedna.
English: 28 hard capsules 112 hard capsules
Croatian: 28 tvrdih kapsula 112 tvrdih kapsula
English: For co-administration with CYP3A4 and UGT1A1 substrates that undergo gut extraction, a minor to moderate interaction is expected.
Croatian: Kod istodobne primjene sa supstratima CYP3A4 i UGT1A1 koji se izlučuju putem crijeva očekuje se manja do umjerena interakcija.
English: A small decrease in CL/F (≤5%) was predicted for patients with mild and moderate renal impairment, which is unlikely to be clinically relevant.
Croatian: Malo smanjenje prividnog klirensa CL/F (≤ 5%) predviđeno je u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega, pa se ne smatra da je od kliničkog značaja.
English: The most common AEs reported with a higher incidence in patients aged ≥ 65 years compared to patients aged < 65 years included diarrhoea, pruritus, GGT and blood phosphatase alkaline elevation.
Croatian: Najčešće zabilježene nuspojave koje su imale veću učestalost u bolesnika dobi ≥ 65 godina u usporedbi s bolesnicima dobi < 65 godina uključivale su proljev, pruritus, porast GGT i alkalne fosfataze u krvi.
English: Do not take Braftovi if you are allergic to encorafenib or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na enkorafenib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: A drug interaction study in healthy subjects indicated the extent of encorafenib exposure was not altered in the presence of a gastric pH-altering agent (rabeprazole).
Croatian: Ispitivanje interakcije lijekova u zdravih ispitanika ukazuje na to da razina izloženosti enkorafenibu nije bila promijenjena u prisustvu lijeka za promjenu želučane pH (rabeprazol).
English: No formal clinical study has been conducted to evaluate the effect of renal impairment on the pharmacokinetics of encorafenib.
Croatian: Nije provedeno formalno kliničko ispitivanje za procjenu učinka oštećenja funkcije bubrega na farmakokinetiku enkorafeniba.
English: Encorafenib is an inhibitor of UGT1A1.
Croatian: Enkorafenib je inhibitor UGT1A1.
English: Visual impairment, including blurred vision and reduced visual acuity, occurred in 21.5% (59/274) of patients.
Croatian: Oštećenje vida, uključujući i zamućenje i smanjenu vidnu oštrinu, javili su se u 21,5% (59/274)
English: Ocular toxicities including uveitis, iritis and iridocyclitis can occur when encorafenib is administered.
Croatian: Očne toksičnosti, uključujući i uveitis, iritis i iridociklitis, mogu se pojaviti prilikom primjene enkorafeniba.
English: Patients receiving Combo 450 reported no change or a slight improvement in the mean change from baseline EQ-5D-5L index score at all visits, whilst patients receiving vemurafenib or encorafenib reported decreases at all visits (with statistical significant differences).
Croatian: Bolesnici koji su primali kombiniranu terapiju 450 nisu prijavili nikakve promjene ili su prijavili blago poboljšanje prosječne promjene u odnosu na početnu vrijednost rezultata indeksa EQ-5D-5L u svim posjetima, dok su bolesnici koji su liječeni vemurafenibom ili enkorafenibom prijavili smanjenje pri svim posjetima (sa statistički značajnim razlikama).
English: Model-based predictions for ketoconazole suggest an increase of approx. 5-fold for encorafenib AUC and 3 to 4-fold for encorafenib Cmax.
Croatian: Predviđanja temeljena na modelu za ketokonazol ukazuju na približno povećanje od 5 puta za AUC enkorafeniba i od 3 do 4 puta za Cmax enkorafeniba.
English: For new primary non-cutaneous RAS mutation-positive malignancies: it should be considered to discontinue encorafenib and binimetinib permanently.
Croatian: Za nove primarne zloćudne bolesti s pozitivnom RAS mutacijom koje nisu kožne: Mora se razmotriti trajno obustavljanje enkorafeniba i binimetiniba.
English: Ocular toxicities
Croatian: Očne toksičnosti
English: In a population pharmacokinetic analysis, no clear trend in encorafenib CL/F was observed in patients with mild (eGFR 60 to 90 mL/min/1.73 m2) or moderate (eGFR 30 to 59 mL/min/1.73 m2) renal impairment compared with subjects with normal renal function (eGFR ≥90 mL/min/1.73 m2).
Croatian: U populacijskoj farmakokinetičkoj analizi nije primijećen jasan utjecaj na prividni klirens enkorafeniba (CL/F) u bolesnika s blagim (eGFR od 60 do 90 ml/min/1,73 m2) ili umjerenim (eGFR od 30 do 59 ml/min/1,73 m2) oštećenjem bubrežne funkcije u odnosu na ispitanike s normalnom funkcijom bubrega (eGFR ≥ 90 ml/min/1,73 m2).