natgillin/translations-raw huggingface dataset:
In clinical trials, Xtandi was administered without regard to food. 
U kliničkim ispitivanjima, Xtandi se primjenjivao bez obzira na hranu.
Enzalutamide is not for use in women. 
Enzalutamid nije namijenjen primjeni u žena.
Dose appears to be an important predictor of the risk of seizure, as reflected by preclinical data, and data from a dose-escalation study. 
Čini se da je doza važan prediktor rizika od pojave napadaja, kako to pokazuju pretklinički podaci i podaci dobiveni ispitivanjem povećanja doze.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake kategorije učestalosti, nuspojave su navedene od ozbiljnijih prema manje ozbiljnima.
‡ Includes all preferred terms with the word ‘fracture' in bones. 
‡** Uključuje sve preporučene pojmove koji se odnose na kosti i uključuju riječ ‘prijelom'.
If you take more soft capsules than prescribed, stop taking Xtandi and contact your doctor. 
Ako uzmete više mekih kapsula nego što je propisano, prestanite uzimati Xtandi i obratite se svom liječniku.
Consistent MFS results were also observed in all pre-specified patient subgroups including PSADT (< 6 months or ≥ 6 months), demographic region (North America, Europe, rest of world), age (< 75 or ≥ 75), use of a prior bone-targeting agent (yes or no). 
Dosljedni rezultati za MFS opaženi su i u svim unaprijed određenim podskupinama bolesnika, uključujući podskupine prema PSADT-u (< 6 mjeseci ili ≥ 6 mjeseci), demografskoj regiji (Sjeverna Amerika, Europa, ostatak svijeta), dobi (< 75 ili ≥ 75) i prethodnoj primjeni lijekova koji ciljano djeluju na kosti (da ili ne).
Enzyme induction 
Indukcija enzima
Most patients (approximately 71%) in the study were Caucasian; 16% were Asian and 2% were Black. 
Većina bolesnika (približno 71%) u ispitivanju bili su bijelci, 16% činili su azijati, a 2% crnci.
This medicine contains less than 1 mmol sodium (less than 23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol natrija (manje od 23 mg) po jednoj filmom obloženoj tableti, tj. sadrži zanemarive količine natrija
The film-coated tablets should not be cut, crushed or chewed but should be swallowed whole with water, and can be taken with or without food. 
Filmom obložene tablete ne se smiju rezati, drobiti ni žvakati te ih treba progutati cijele s vodom, a mogu se uzimati s hranom ili bez nje.
Daily dosing of rats for two years with enzalutamide at 10-100 mg/kg/day produced an increased incidence of several, mostly benign, tumour types. 
U štakora je svakodnevna primjena enzalutamida u dozi od 10 - 100 mg/kg na dan tijekom dvije godine povećala incidenciju nekoliko vrsta tumora, uglavnom dobroćudnih.
The pharmacokinetics of enzalutamide have been evaluated in prostate cancer patients and in healthy male subjects. 
Farmakokinetika enzalutamida procijenjena je u bolesnika s rakom prostate i u zdravih muških ispitanika.
In vitro data indicate that enzalutamide and its major metabolites do not inhibit the following transporters at clinically relevant concentrations: OATP1B1, OATP1B3, OCT2, or OAT1. 
In vitro podaci pokazuju da enzalutamid i njegovi glavni metaboliti ne inhibiraju sljedeće transportere u klinički važnim koncentracijama: OATP1B1, OATP1B3, OCT2 ili OAT1.
If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time. 
Ako bolesnik propusti uzeti Xtandi u uobičajeno vrijeme, propisanu dozu treba uzeti čim bliže uobičajenom vremenu.
• the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). 
• liječenje odraslih muškaraca s metastatskim CRPC-om koji su asimptomatski ili s blagim simptomima nakon neuspješnog liječenja androgenom deprivacijom, a u kojih kemoterapija još nije klinički indicirana (vidjeti dio 5.1).
The AUC and Cmax of caffeine decreased by 11% and 4% respectively. 
AUC i Cmax kofeina snizili su se za 11 odnosno 4 %.
Additional changes to reproductive tissues included hypertrophy/hyperplasia of the pituitary gland and atrophy in seminal vesicles in rats and testicular hypospermia and seminiferous tubule degeneration in dogs. 
Dodatne promjene u reproduktivnim tkivima uključivale su hipertrofiju/hiperplaziju pituitarne žlijezde i atrofiju sjemenih mjehurića u štakora i testikularnu hipospermiju i degeneraciju sjemenovoda u pasa.
Fifty-one percent (51%) of patients were on bisphosphonates at baseline. 
Na početku je 51% bolesnika bilo na bisfosfonatima.
Figure 8: Overall survival by subgroup in the AFFIRM study - Hazard ratio and 95% confidence interval 
Slika 8: Ukupno preživljenje prema podskupinama u ispitivanju AFFIRM - omjer hazarda i interval pouzdanosti od 95%
In studies in mice (4 weeks), rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), changes in the reproductive organs associated with enzalutamide were decreases in organ weight with atrophy of the prostate and epididymis. 
U ispitivanjima na miševima (4 tjedna), štakorima (4 i 26 tjedana) i psima (4, 13 i 39 tjedana), promjene u reproduktivnim organima povezane s enzalutamidom sastojale su se od smanjenja težine organa s atrofijom prostate i pasjemenika.
Hepatic impairment did not have a pronounced effect on the total exposure to enzalutamide or its active metabolite. 
Oštećenje funkcije jetre nije imalo izražen učinak na ukupnu izloženost enzalutamidu ili njegovim aktivnim metabolitima.
In vitro data indicate that enzalutamide may be an inhibitor of the efflux transporter P-gp. 
In vitro podaci pokazuju da enzalutamid može inhibirati efluksni transporter P-gp.
Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression. 
Liječenje enzalutamidom smanjuje rast stanica raka prostate i može inducirati smrt stanica raka te povlačenje tumora.
The European Medicines Agency has waived the obligation to submit the results of studies with enzalutamide in all subsets of the paediatric population in prostate carcinoma (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka enzalutamida u svim podskupinama pedijatrijske populacije u karcinomu prostate (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Concomitant use of enzalutamide with medicinal products that are sensitive substrates of many metabolising enzymes or transporters (see section 4.5) should generally be avoided if their therapeutic effect is of large importance to the patient, and if dose adjustments cannot easily be performed based on monitoring of efficacy or plasma concentrations. 
Istovremenu primjenu enzalutamida s lijekovima koji su osjetljivi supstrati mnogih metabolizirajućih enzima ili transportera (vidjeti dio 4.5) potrebno je izbjegavati ukoliko je njihov terapijski učinak od velike važnosti za bolesnika, a prilagodba doze nije jednostavna jer se temelji na praćenju djelotvornosti ili koncentracija u plazmi.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Ako Vam je liječnik rekao da ne podnosite neke vrste šećera, obratite se liječniku prije nego što uzmete ovaj lijek.
• the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). 
• liječenje odraslih muškaraca s visokorizičnim nemetastatskim rakom prostate rezistentnim na kastraciju (engl. castration-resistant prostate cancer, CRPC) (vidjeti dio 5.1).
Uncommon (may affect up to 1 in 100 people) Hallucinations, difficulty thinking clearly, low white blood cell count 
Manje često (mogu se javiti u do 1 na 100 osoba) Halucinacije, otežano prosuđivanje, nizak broj bijelih krvnih stanica
Seizures were reported in 4 in every 1,000 people taking Xtandi, and in fewer than one in every 1,000 people taking placebo. 
Napadaji su zabilježeni u 4 na svakih 1000 osoba koje su uzimale Xtandi i kod manje od jedne na svakih 1000 osoba koje su uzimale placebo.
Gender differences were noted in rat mammary glands (male atrophy and female lobular hyperplasia). 
Razlike s obzirom na spol bile su zabilježene u mliječnim žlijezdama štakora (atrofija kod mužjaka i lobularna hiperplazija kod ženki).
Injury, poisoning and procedural complications 
Ozljede, trovanja i proceduralne komplikacije često: padovi
Strong inhibitors (e.g. gemfibrozil) of CYP2C8 are to be avoided or used with caution during enzalutamide treatment. 
Jake inhibitore (npr. gemfibrozil) CYP2C8 treba izbjegavati ili primjenjivati s oprezom tijekom liječenja enzalutamidom.
Study results also have shown that enzalutamide and/or its metabolites are transferred to infant rat tissues via milk and subsequently eliminated. 
Rezultati ispitivanja su također pokazali da se enzalutamid i/ili njegovi metaboliti prenose putem mlijeka u tkivo novookoćene mladunčadi te se naknadno eliminiraju.
Enzalutamide competitively inhibits androgen binding to androgen receptors, and consequently; inhibits nuclear translocation of activated receptors and inhibits the association of the activated androgen receptor with DNA even in the setting of androgen receptor overexpression and in prostate cancer cells resistant to anti-androgens. 
Enzalutamid kompetitivno inhibira vezanje androgena na androgene receptore te posljedično inhibira translokaciju aktiviranih receptora u jezgru i inhibira povezivanje aktiviranog androgenog receptora s DNK čak i kod pretjerane izraženosti androgenih receptora i u stanicama raka prostate rezistentnima na anti-androgene.
If you take more tablets than prescribed, stop taking Xtandi and contact your doctor. 
Ako uzmete više tableta nego što je propisano, prestanite uzimati Xtandi i obratite se svom liječniku.
- If you forget to take Xtandi for the whole day, take your usual dose the following day. 
- Ako zaboravite uzeti Xtandi cijeli dan, uzmite uobičajenu dozu sljedećeg dana.
The mechanism by which enzalutamide may lower the seizure threshold is not known, but could be related to data from in vitro studies showing that enzalutamide and its active metabolite bind to and can inhibit the activity of the GABA-gated chloride channel. 
Mehanizam kojim enzalutamid može sniziti prag napadaja nije poznat, ali može biti povezan s podacima iz ispitivanja in vitro koji su pokazali da se enzalutamid i njegov djelatni metabolit vežu za kloridni kanal GABA receptora i mogu inhibirati njegovu aktivnost.
Use of enzalutamide has been associated with seizure (see section 4.8). 
Primjena enzalutamida povezana je s napadajima (vidjeti dio 4.8).
Approximately 45% of patients had measurable soft tissue disease at study entry, and 12% of patients had visceral (lung and/or liver) metastases. 
Oko 45% bolesnika u trenutku uključivanja u ispitivanje imalo je mjerljivu bolest mekog tkiva, a 12% bolesnika imalo je visceralne metastaze (pluća i/ili jetra).
In the active treatment arm, Xtandi was administered orally at a dose of 160 mg daily. 
U skupini s aktivnim liječenjem, Xtandi je primjenjivan peroralno u dozi od 160 mg na dan.
A prolonged time to reach steady state concentrations is however anticipated, and the time to maximum pharmacological effect as well as time for onset and decline of enzyme induction (see section 4.5) may be increased. 
Ipak, predviđeno je produljeno vrijeme do postizanja koncentracije u stanju dinamičke ravnoteže, a vrijeme do maksimalnog farmakološkog učinka kao i vrijeme za početak i prekid indukcije enzima (vidjeti dio 4.5) može biti produljeno.
There are no human data on the use of Xtandi in pregnancy and this medicinal product is not for use in women of childbearing potential. 
Nema podataka o primjeni lijeka Xtandi tijekom trudnoće u ljudi jer ovaj lijek nije namijenjen za primjenu u žena reproduktivne dobi.
It is unlikely that enzalutamide will be significantly removed by intermittent haemodialysis or continuous ambulatory peritoneal dialysis. 
Enzalutamid se najvjerojatnije neće ukloniti u značajnoj količini povremenom hemodijalizom ili kontinuiranom ambulantnom peritonejskom dijalizom.
At the updated analysis 52% of enzalutamide-treated and 81% of placebo-treated patients had received subsequent therapies for metastatic CRPC that may prolong overall survival. 
U ažuriranoj analizi 52% bolesnika liječenih enzalutamidom i 81% bolesnika liječenih placebom primilo je naknadne terapije za metastatski karcinom prostate rezistentan na kastraciju, koje mogu produljiti ukupno preživljenje.
The concomitant use of strong CYP2C8 inhibitors should be avoided if possible. 
Potrebno je izbjegavati istovremenu primjenu jakih inhibitora CYP2C8, ukoliko je to moguće.
If you have a seizure, see your doctor as soon as possible. 
Ako doživite napadaj, čim prije posjetite liječnika.
The soft capsules should not be chewed, dissolved or opened but should be swallowed whole with water, and can be taken with or without food. 
Meke kapsule se ne smiju žvakati, otapati ni otvarati te ih treba progutati cijele s vodom, a mogu se uzimati s hranom ili bez nje.
Enzalutamide is not a substrate of the efflux transporters P-gp or BCRP. 
Enzalutamid nije supstrat efluksnih prijenosnika P-gp ili BCRP.
• Hypnotics (e.g. diazepam, midazolam, zolpidem) 
• hipnotike (npr. diazepam, midazolam, zolpidem)
PRES is a rare, reversible, neurological disorder which can present with rapidly evolving symptoms including seizure, headache, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. 
PRES je rijetki, reverzibilni, neurološki poremećaj koji se može manifestirati simptomima koji se brzo razvijaju a koji uključuju napadaje, glavobolju, smetenost, sljepoću i druge poremećaje vida te neurološke poremećaje, sa ili bez povezane hipertenzije.
There are two major metabolites in human plasma: N-desmethyl enzalutamide (active) and a carboxylic acid derivative (inactive). 
Postoje dva glavna metabolita u ljudskoj plazmi: N-dezmetil enzalutamid (djelatni) i derivat karboksilne kiseline (nedjelatan).
The solubility of enzalutamide is increased by caprylocaproyl macrogolglycerides as emulsifier/surfactant. 
Topivost enzalutamida je poboljšana kaprilokaproil makrogolgliceridima koji djeluju kao emulgator/surfaktant.
Stimulation of tumour cell growth via the androgen receptor requires nuclear localization and DNA binding. 
Za stimulaciju rasta tumorskih stanica putem androgenih receptora potrebna je lokalizacija u jezgri i vezanje za DNK.
There was no protein binding displacement between enzalutamide and other highly bound medicinal products (warfarin, ibuprofen and salicylic acid) in vitro. 
In vitro nije primijećeno međusobno istiskivanje s proteina između enzalutamida i drugih lijekova s visokim afinitetom vezivanja (varfarin, ibuprofen i salicilatna kiselina).
Of the 3179 patients in the controlled clinical trials who received enzalutamide, 2518 patients (79%) were 65 years and over and 1162 patients (37%) were 75 years and over. 
Od 3179 bolesnika koji su u kontroliranim kliničkim ispitivanjima primali enzalutamid, 2518 bolesnika (79%) je bilo u dobi od 65 ili više godina, a 1162 bolesnika (37%) u dobi od 75 ili više godina.
Food has no clinically significant effect on the extent of absorption. 
Hrana nema klinički značajnog učinka na opseg apsorpcije.
How Xtandi works 
Kako Xtandi djeluje
The pharmacokinetics of enzalutamide were examined in subjects with baseline mild (N = 6), moderate (N = 8) or severe (N = 8) hepatic impairment (Child-Pugh Class A, B or C, respectively) and in 22 matched control subjects with normal hepatic function. 
Farmakokinetika enzalutamida bila je provjerena u ispitanika s početnim blagim (N = 6), umjerenim (N = 8), ili teškim (N = 8) oštećenjem funkcije jetre (Child-Pugh stadij A, B, odnosno C) i u 22 usklađena kontrolna ispitanika s normalnom funkcijom jetre.
Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol. 
Pomoćna tvar s poznatim učinkom: Jedna meka kapsula sadrži 57,8 mg sorbitola.
Enzalutamide has not been evaluated in patients with severe renal impairment (CrCL < 30 mL/min) or end-stage renal disease, and caution is advised when treating these patients. 
Enzalutamid nije ispitivan u bolesnika s teškim oštećenjem funkcije bubrega (CrCL < 30 ml/min) ili završnom fazom zatajenja bubrega i savjetuje se oprez kad se liječe ti bolesnici.
Do not use this medicine after the expiry date which is stated on the cardboard wallet and outer carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskom omotu i kutiji iza oznake 'Rok valjanosti' ili 'EXP'.
The safety and efficacy of concomitant use of Xtandi with cytotoxic chemotherapy has not been established. 
Sigurnost i djelotvornost istovremene primjene lijeka Xtandi i citotoksične kemoterapije nije ustanovljena.
Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C9, CYP2C19, and uridine 5'-diphospho-glucuronosyltransferase (UGTs - glucuronide conjugating enzymes). 
Enzimi koji mogu biti inducirani uključuju CYP3A u jetri i crijevima CYP2B6, CYP2C9, CYP2C19, te uridin 5'-difosfo-glukuronoziltransferazu (UGT-glukuronid konjugacijski enzimi).
Reproductive toxicology studies were not conducted with enzalutamide, but in studies in rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), atrophy, aspermia/hypospermia, and hypertrophy/hyperplasia in the reproductive system were noted, consistent with the pharmacological activity of enzalutamide. 
Nisu provedena ispitivanja reproduktivne toksičnosti enzalutamida, ali u ispitivanjima na štakorima (4 i 26 tjedana) i psima (4, 13 i 39 tjedana) zabilježeni su atrofija, aspermija/hipospermija i hipertrofija/hiperplazija reproduktivnog sustava, što je sukladno farmakološkom djelovanju enzalutamida.
Posterior reversible encephalopathy syndrome 
Sindrom posteriorne reverzibilne encefalopatije
The decision to continue treatment in patients who develop seizure should be taken case by case. 
Odluku o nastavku liječenja u bolesnika kod kojih se pojave napadaji, potrebno je donijeti od slučaja do slučaja.
In the three clinical trials, patients received placebo in the control arm and patients were allowed, but not required, to take prednisone (maximum daily dose allowed was 10 mg prednisone or equivalent). 
U svim trima kliničkim ispitivanjima bolesnici u kontrolnoj skupini primali su placebo, te je bolesnicima bilo dopušteno, ali se to nije zahtijevalo, da uzimaju prednizon (dopuštena maksimalna dnevna doza bila je 10 mg prednizona ili odgovarajućeg ekvivalenta).
The steady-state Cmin values of enzalutamide and the active metabolite in individual patients remained constant during more than one year of chronic therapy, demonstrating time-linear pharmacokinetics once steady-state is achieved. 
Vrijednosti Cmin enzalutamida i njegovog djelatnog metabolita u stanju dinamičke ravnoteže kod pojedinih bolesnika ostale su konstantne tijekom više od godinu dana kronične terapije, što ukazuje na vremenski linearnu farmakokinetiku nakon postizanja stanja dinamičke ravnoteže.
39.6 (37.7, NR) 
39,6 (37,7; ND)
Medicinal products with a narrow therapeutic range that are substrates for P-gp (e.g. colchicine, dabigatran etexilate, digoxin) should be used with caution when administered concomitantly with Xtandi and may require dose adjustment to maintain optimal plasma concentrations. 
Lijekove s uskim terapijskim rasponom koji su supstrati P-gp (npr. kolhicin, dabigatran eteksilat, digoksin) potrebno je davati s oprezom kad se primjenjuju istovremeno s lijekom Xtandi i možda im bude potrebno prilagoditi dozu da bi se održale optimalne koncentracije u plazmi.
Additional secondary endpoints included time to first use of cytotoxic chemotherapy and chemotherapy-free survival. 
Dodatne mjere sekundarnih ishoda uključivale su vrijeme do prve primjene citotoksične kemoterapije i preživljenje bez kemoterapije.
In addition to the observed improvement in overall survival, key secondary endpoints (PSA progression, radiographic progression-free survival, and time to first skeletal-related event) favoured enzalutamide and were statistically significant after adjusting for multiple testing. 
Uz opaženo poboljšanje ukupnog preživljenja, ključne mjere sekundarnih ishoda (progresija bolesti prema PSA, preživljenje bez radiološke progresije bolesti i vrijeme do prvog koštanog događaja) davali su prednost enzalutamidu i bili statistički značajni nakon prilagodbe za višestruko testiranje.
(≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). 
Kategorije učestalosti definiraju se na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznata učestalost (ne može se procijeniti iz dostupnih podataka).
Common: ischemic heart disease† Not known*: QT-prolongation (see sections 4.4 and 4.5) 
Srčani poremećaji često: ishemijska bolest srca† nepoznata učestalost*: produljenje QT intervala (vidjeti dio 4.4 i 4.5)
In the controlled clinical studies, patients with prior seizure or risk factors for seizure were excluded. 
Iz kontroliranih kliničkih ispitivanja isključeni su bolesnici koji su ranije imali napadaje ili su imali faktore rizika za pojavu napadaja.
Co-administration of enzalutamide has no clinically relevant effect on the pharmacokinetics of intravenous docetaxel (see section 4.5); however, an increase in the occurrence of docetaxel-induced neutropenia cannot be excluded. 
Istovremena primjena enzalutamida nema klinički značajan učinak na farmakokinetiku intravenski primijenjenog docetaksela (vidjeti dio 4.5); ipak, porast učestalosti neutropenije inducirane docetakselom ne može se isključiti.
Elimination The mean apparent clearance (CL/F) of enzalutamide in patients ranges from 0.520 and 0.564 L/h. 
Eliminacija Prosječni prividni klirens (CL/F) enzalutamida u bolesnika kreće se u rasponu od 0,520 do 0,564 l/sat.
The median rPFS was 19.7 months in the enzalutamide group and 5.4 months in the placebo group. 
Medijan rPFS-a iznosio je 19,7 mjeseci u skupini liječenoj enzalutamidom i 5,4 mjeseci u placebo skupini.
Common: anxiety Uncommon: visual hallucination 
Psihijatrijski poremećaji često: anksioznost manje često: vidne halucinacije
The effect of enzalutamide on P-gp substrates has not been evaluated in vivo; however, under conditions of clinical use, enzalutamide may be an inducer of P-gp via activation of the nuclear pregnane receptor (PXR). 
P-gp nije procijenjen in vivo; međutim, u uvjetima kliničke primjene, enzalutamid može biti induktor P-gp putem aktivacije PXR (eng. nuclear pregnane receptor).
• Antibiotics (e.g. clarithromycin, doxycycline) 
• antibiotike (npr. klaritromicin, doksiciklin)
In vitro data indicate that enzalutamide is not a substrate for OATP1B1, OATP1B3, or OCT1; and N-desmethyl enzalutamide is not a substrate for P-gp or BCRP. 
In vitro podaci pokazuju da enzalutamid nije supstrat za OATP1B1, OATP1B3 ili OCT1; i N-dezmetil enzalutamid nije supstrat za P-gp ili BCRP.
Enzalutamide was not phototoxic in vitro. 
Enzalutamid nije bio fototoksičan in vitro.
Oral absorption of film-coated enzalutamide tablets was evaluated in healthy male volunteers after a single 160 mg dose of Xtandi film-coated tablets, and pharmacokinetic modelling and simulation were used to predict the pharmacokinetic profile at steady state. 
Apsorpcija enzalutamida nakon peroralne primjene filmom obloženih tableta ocjenjivala se u zdravih dobrovoljaca muškog spola nakon jedne doze Xtandi filmom obloženih tableta od 160 mg, a za predviđanje farmakokinetičkog profila u stanju dinamičke ravnoteže koristili su se farmakokinetičko modeliranje i simulacija.
- The ingredients of the soft capsule shell are gelatin, sorbitol sorbitan solution (see section 2), 
- Sastojci ovojnice meke kapsule su želatina, otopina sorbitol sorbitana (vidjeti dio 2.), glicerol,
* Spontaneous reports from post-marketing experience 
* Spontane prijave nakon stavljanja lijeka u promet
Effect of food on enzalutamide exposures 
Učinak hrane na izloženost enzalutamidu