FrancophonIA/ELRC3.0 huggingface dataset:
English: CRPC2 (AFFIRM) study (patients with metastatic CRPC who previously received chemotherapy)
Croatian: Ispitivanje CRPC2 (AFFIRM) (bolesnici s metastatskim CRPC-om koji su prethodno primali kemoterapiju)
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 27% while Cmax was again unchanged.
Croatian: Za ukupnu količinu nevezanog enzalutamida i nevezanog djelatnog metabolita, AUC se povećao za 27%, dok je Cmax opet ostao nepromijenjen.
English: The PROSPER study enrolled 1401 patients with asymptomatic, high-risk non-metastatic CRPC who continued on androgen deprivation therapy (ADT; defined as LHRH analogue or prior bilateral orchiectomy).
Croatian: U ispitivanje PROSPER bio je uključen 1401 bolesnik s asimptomatskim, visokorizičnim nemetastatskim CRPC-om koji je nastavio primati liječenje androgenom deprivacijom (koje se definiralo kao analog LHRH-a ili prethodna bilateralna orhidektomija).
English: In vivo studies have shown that enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19.
Croatian: Ispitivanja in vivo su pokazala da je enzalutamid jaki induktor CYP3A4 i umjereni induktor CYP2C9 i CYP2C19.
English: Consistent PFS benefit was observed across all pre-specified patient subgroups.
Croatian: Dosljedna korist u smislu PFS-a opažena je u svim unaprijed određenim podskupinama bolesnika.
English: The demographic and baseline characteristics were well-balanced between the two treatment arms.
Croatian: Demografske i početne značajke bile su ujednačene između dviju liječenih skupina.
English: In a single arm trial (9785-CL-0410) of patients previously treated with at least 24 weeks of abiraterone (plus prednisone), 22.4% had a ≥ 50% decrease from baseline in PSA levels.
Croatian: U ispitivanju s jednom skupinom (9785-CL-0410) bolesnika prethodno liječenih abirateronom (i prednizonom) u trajanju od najmanje 24 tjedna, 22,4% ispitanika je imalo ≥ 50% sniženje razina PSA u odnosu na početnu vrijednost.
English: Titanium dioxide (E171) Purified water
Croatian: titanijev dioksid (E171) i pročišćena voda.
English: An increased half-life of enzalutamide has been observed in patients with severe hepatic impairment, possibly related to increased tissue distribution.
Croatian: Produljeni poluvijek enzalutamida koji je bio zabilježen kod bolesnika s teškim oštećenjem funkcije jetre, može biti povezan s povećanom distribucijom u tkiva.
English: Studies in pregnant rats have shown that enzalutamide and/or its metabolites are transferred to fetuses.
Croatian: Ispitivanja u gravidnih ženki štakora su pokazala da enzalutamid i/ili njegovi metaboliti prelaze u fetuse.
English: Astellas Pharmaceuticals AEBE
Croatian: Astellas Pharmaceuticals AEBE Ελλάδα
English: Consistent rPFS benefit was observed across all pre-specified patient subgroups (e.g. age, baseline ECOG performance, baseline PSA and LDH, Gleason score at diagnosis, and visceral disease at screening).
Croatian: Dosljedna korist u smislu rPFS-a primijećena je u svim unaprijed određenim podskupinama bolesnika (npr. dob, početni ECOG status, početna vrijednost PSA i LDH, Gleason zbroj u trenutku postavljanja dijagnoze i visceralne metastaze kod probira).
English: • Cardiac glycosides (e.g. digoxin)
Croatian: • srčane glikozide (npr. digoksin)
English: HR is based on a Cox regression model (with treatment as the only covariate) stratified by PSA doubling time and prior or concurrent use of a bone targeting agent.
Croatian: 2. HR se temelji na Coxovom regresijskom modelu (uz liječenje kao jedinu kovarijantu) stratificiranom prema vremenu do udvostručenja vrijednosti PSA i prethodnoj ili istodobnoj primjeni lijekova koji ciljano djeluju na kosti.
English: Caution is advised in patients with severe renal impairment or end-stage renal disease (see section 4.4).
Croatian: Savjetuje se oprez u bolesnika s teškim oštećenjem funkcije bubrega ili završnom fazom bolesti bubrega (vidjeti dio 4.4).
English: Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Xtandi with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).
Croatian: Obzirom da liječenje androgenom deprivacijom može produljiti QT interval, potrebno je pažljivo procijeniti istovremenu primjenu lijeka Xtandi sa lijekovima za koje je poznato da mogu produljiti QT interval ili lijekovima koji mogu inducirati Torsade de pointes kao što su antiaritmici klase IA (npr. kinidin, dizopiramid) ili klase III (npr. amiodaron, sotalol, dofetilid, ibutilid), metadon, moksifloksacin, antipsihotici, itd. (vidjeti dio 4.4).
English: Figure 5: Updated overall survival analysis by subgroup: Hazard ratio and 95% confidence interval in the PREVAIL study (intent-to-treat analysis)
Croatian: Slika 5: Analiza ažuriranih podataka o ukupnom preživljenju prema podskupinama: omjer hazarda i interval pouzdanosti od 95% u ispitivanju PREVAIL (analiza podataka prikupljenih u bolesnika predviđenih za liječenje)
English: Xtandi might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other medicines (e.g. methadone, used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Croatian: Xtandi može interferirati sa određenim lijekovima za liječenje poremećaja srčanog ritma (npr. kinidin, prokainamid, amiodaron i sotalol) ili može povisiti rizik za poremećaj srčanog ritma kada se primjenjuje istovremeno s nekim drugim lijekovima (npr. metadon, koji se koristi za smanjenje bolova i kao dio detoksikacije ovisnika), moksifloksacin (antibiotik), antipsihotici koji se koriste za liječenje ozbiljnih mentalnih bolesti).
English: Hazard Ratio is derived from a stratified proportional hazards model.
Croatian: 2. Omjer hazarda dobiven je pomoću stratificiranog modela proporcionalnih hazarda.
English: - The ingredients of the ink are iron oxide black (E172) and polyvinyl acetate phthalate.
Croatian: - Sastojci tinte su crni željezov oksid (E172) i poli(vinilacetat) ftalat.
English: P-value is based on a stratified log-rank test by PSA doubling time (< 6 months, ≥ 6 months) and prior or concurrent use of a bone targeting agent (yes, no).
Croatian: P-vrijednost temelji se na log-rang testu stratificiranom prema vremenu do udvostručenja vrijednosti PSA (< 6 mjeseci, ≥ 6 mjeseci) i prethodnoj ili istodobnoj primjeni lijekova koji ciljano djeluju na kosti (da, ne).
English: If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily.
Croatian: Ako se bolesnicima mora istovremeno davati jaki inhibitor CYP2C8, doza enzalutamida mora biti smanjena na 80 mg jedanput na dan.
English: No dose adjustment is necessary when Xtandi is co-administered with inhibitors of CYP3A4.
Croatian: Nije potrebna prilagodba doze kad se Xtandi primjenjuje istovremeno s inhibitorima CYP3A4.
English: The hazard ratio was 0.24 (95% CI: 0.14, 0.42) and the median time to a PFS event was not reached in the enzalutamide group versus 8.6 months in the bicalutamide group.
Croatian: Omjer hazarda (engl. hazard ratio, HR) iznosio je 0,24 (95% CI: 0,14; 0,42), a medijan vremena do nastupa događaja PFS-a nije dostignut u skupini liječenoj enzalutamidom, dok je u skupini liječenoj bikalutamidom iznosio 8,6 mjeseci.
English: Potential for enzalutamide to affect exposures to other medicinal products
Croatian: Mogućnost utjecaja enzalutamida na izloženost drugim lijekovima
English: Xtandi contains sorbitol (E420).
Croatian: Xtandi sadrži sorbitol (E420).
English: • Antithrombotics (e.g. acenocoumarol, warfarin, clopidogrel)
Croatian: • antitrombotike (npr. acenokumarol, varfarin, klopidogrel)
English: Progression-free survival was defined as objective evidence of radiographic disease progression by independent central review, skeletal-related events, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.
Croatian: Preživljenje bez progresije bolesti određivalo se na temelju objektivnog dokaza radiografske progresije prema neovisnoj središnjoj ocjeni, koštanih događaja, uvođenja nove antineoplastične terapije ili smrti zbog bilo kojeg uzroka, što god je nastupilo prvo.
English: At steady state, the mean Cmax values for enzalutamide and its active metabolite are 16.6 μg/mL (23% coefficient of variation [CV]) and 12.7 μg/mL (30% CV), respectively.
Croatian: U stanju dinamičke ravnoteže, srednja vrijednost Cmax enzalutamida je 16,6 μg/ml (23% koeficijent varijacije [CV]), a njegovog djelatnog metabolita 12,7 μg/ml (30% CV).
English: 36.6 (33.1, NR)
Croatian: 36,6 (33,1; ND)
English: Potential for other medicinal products to affect enzalutamide exposures
Croatian: Mogućnost utjecaja drugih lijekova na izloženost enzalutamidu
English: Hazard ratio (95% CI)2 Updated survival analysis Number of deaths (%) Median survival, months (95% CI)
Croatian: Omjer hazarda (95% CI)2 Ažurirana analiza preživljenja Broj smrti (%) Medijan preživljenja, mjeseci (95% CI)
English: Patients randomised to either arm were to continue treatment until disease progression (defined as confirmed radiographic progression or the occurrence of a skeletal-related event) and initiation of new systemic antineoplastic treatment, unacceptable toxicity, or withdrawal.
Croatian: Bolesnici randomizirani u te skupine trebali su nastaviti s liječenjem sve do progresije bolesti (definirane kao potvrđena radiografska progresija ili pojava koštanog događaja) ili početka novog sistemskog antineoplastičkog liječenja, neprihvatljive toksičnosti ili povlačenja iz ispitivanja.
English: Study treatment continued until disease progression (evidence of radiographic progression, a skeletalrelated event, or clinical progression) and the initiation of either a cytotoxic chemotherapy or an investigational agent, or until unacceptable toxicity.
Croatian: Uzimanje ispitivanog lijeka nastavilo se sve do pojave progresije bolesti (dokaz radiografske progresije, pojava koštanog događaja ili klinička progresija) i započinjanja ili citotoksične kemoterapije ili nekog ispitivanog lijeka, ili do pojave znakova neprihvatljive toksičnosti.
English: Each carton contains 56 film-coated tablets (4 wallets).
Croatian: Svaka kutija sadrži 56 filmom obloženih tableta (4 omota).
English: Caprylocaproyl macrogol-8 glycerides Butylhydroxyanisole (E320) Butylhydroxytoluene (E321)
Croatian: Sadržaj kapsule kaprilokaproil makrogol-8 gliceridi butilhidroksianizol (E320) butilhidroksitoluen (E321)
English: Risk of seizure
Croatian: Rizik od napadaja
English: The median age at randomisation was 74 years in the enzalutamide arm and 73 years in the placebo arm.
Croatian: Medijan dobi prilikom randomizacije iznosio je 74 godine u skupini koja je primala enzalutamid i 73 godine u skupini koja je primala placebo.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Astellas Pharma B.V.Branch Belgique/Belgien Tél/Tel: + 32 (0)2 5580710
Croatian: Luxembourg/Luxemburg Astellas Pharma B.V.Branch Belgique/Belgien Tél/Tel: + 32 (0)2 5580710
English: The AUC of docetaxel decreased by 12% [geometric mean ratio (GMR) = 0.882 (90% CI: 0.767, 1.02)] while Cmax decreased by 4% [GMR = 0.963 (90% CI:
Croatian: AUC docetaksela smanjio se za 12% [omjer geometrijskih srednjih vrijednosti (eng. geometric mean ratio - GMR) =0,882 (90% CI: 0,767, 1,02)] dok se je Cmax smanjio za 4% [GMR = 0,963 (90% CI: 0,834, 1,11)].
English: The analysis involved 448 skeletal-related events, of which 277 events (62%) were radiation to bone, 95 events (21%) were spinal cord compression, 47 events (10%) were pathologic bone fracture, 36 events (8%) were change in antineoplastic therapy to treat bone pain, and 7 events (2%) were surgery to bone.
Croatian: Analiza je uključila 448 koštanih događaja, od kojih je 277 događaja (62%) bilo zračenje kosti, 95 događaja (21%) bili su kompresija leđne moždine, 47 događaja (10%) bili su patološki prijelomi kosti, 36 događaja (8%) bili su promjena antineoplastičke terapije za liječenje koštane boli i 7 događaja (2%) bili su kirurški zahvati na kosti.
English: Co-administration of enzalutamide (160 mg once daily) with single oral doses of sensitive CYP substrates in prostate cancer patients resulted in an 86% decrease in the AUC of midazolam (CYP3A4 substrate), a 56% decrease in the AUC of S-warfarin (CYP2C9 substrate), and a 70% decrease in the AUC of omeprazole (CYP2C19 substrate).
Croatian: Istovremena primjena enzalutamida (160 mg jedanput na dan) uz jednokratne peroralne doze osjetljivih supstrata CYP-a u bolesnika s rakom prostate dovela je do smanjenja AUC midazolama (supstrata CYP3A4) za 86%, smanjenje AUC S-varfarina (supstrata CYP2C9) za 56% i smanjenja AUC omeprazola (supstrata CYP2C19) za 70%.
English: Enzalutamide is contraindicated in women who are or may become pregnant (see sections 4.3, 5.3, and 6.6).
Croatian: Enzalutamid je kontraindiciran u trudnica ili žena koje mogu zatrudnjeti (vidjeti dijelove 4.3, 5.3 i 6.6).
English: • Betablockers (e.g. bisoprolol, propranolol)
Croatian: • beta-blokatore (npr. bisoprolol, propranolol)
English: Key Secondary Efficacy Endpoints Time to PSA progression
Croatian: Ključne mjere sekundarnih ishoda za djelotvornost Vrijeme do progresije prema vrijednosti PSA Broj događaja (%)
English: • HIV antivirals (e.g. indinavir, ritonavir)
Croatian: • antivirusne lijekove protiv HIV-a (npr. indinavir, ritonavir)
English: Eighty-one percent (81%) of patients had an ECOG performance status score of 0 and 19% patients had an ECOG performance status of 1.
Croatian: Osamdesetjedan posto (81 %) bolesnika imalo je ECOG fumkcionalni status 0, a 19 % bolesnika je ECOG funkcionalni statusom 1.
English: - Each carton contains 112 soft capsules in 4 blister wallets of 28 soft capsules each.
Croatian: - Jedna kutija sadrži 112 mekih kapsula u 4 omota po 28 mekih kapsula u svakom omotu.
English: The proportion of enzalutamide-treated patients with measurable disease at baseline who had an objective soft tissue response was 58.8% (95% CI: 53.8, 63.7) compared with 5.0% (95% CI: 3.0, 7.7) of patients receiving placebo.
Croatian: Udio bolesnika liječenih enzalutamidom s mjerljivom bolešću na početku ispitivanja, koji su imali objektivan odgovor mekog tkiva na liječenje bio je 58,8% (95% CI: 53,8; 63,7) u odnosu na 5,0% (95% CI: 3,0; 7,7) bolesnika koji su primali placebo.
English: Following oral administration of 14C-enzalutamide, 84.6% of the radioactivity is recovered by 77 days post dose: 71.0% is recovered in urine (primarily as the inactive metabolite, with trace amounts of enzalutamide and the active metabolite), and 13.6% is recovered in faeces (0.39% of dose as unchanged enzalutamide).
Croatian: Nakon peroralne primjene 14C-enzalutamida, 84,6% radioaktivnosti bude otkriveno do 77 dana nakon primjene doze: 71,0% otkrije se u mokraći (prvenstveno u obliku nedjelatnog metabolita, s time da su enzalutamid i djelatni metabolit prisutni u tragovima), a 13,6% otkrije se u stolici (0,39% doze u obliku neizmijenjenog enzalutamida).
English: Sixty-eight percent (68%) of patients had an ECOG performance status score of 0 and 32% patients had an ECOG performance status of 1.
Croatian: Opće stanje šezdeset i osam posto (68%) bolesnika prema ECOG-skali ocijenjeno je statusom 0, a 32% bolesnika imalo je ECOG funkcionalni status 1.
English: - Xtandi soft capsules are white to off-white, oblong soft capsules (approximately 20 mm by
Croatian: Kako Xtandi izgleda i sadržaj pakiranja - Xtandi meke kapsule su bijele do gotovo bijele, duguljaste meke kapsule (približno 20 mm puta
English: Posterior reversible encephalopathy syndrome (PRES) There have been rare reports of PRES, a rare, reversible condition involving the brain, in patients treated with Xtandi.
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES) Kod bolesnika liječenih lijekom Xtandi prijavljeni su rijetki slučajevi PRES-a, rijetkog, reverzibilnog stanja koje uključuje mozak.
English: Confirmed PSA decline of 50% or 90% were 54.0% and 24.8%, respectively, for patients treated with enzalutamide and 1.5% and 0.9%, respectively, for patients who received placebo (p < 0.0001).
Croatian: Potvrđeno sniženje PSA za 50% odnosno 90% bilo je prisutno u 54,0% odnosno 24,8% bolesnika liječenih enzalutamidom i u 1,5% odnosno 0,9% bolesnika koji su primali placebo (p < 0,0001).
English: PSA Response was 22.1% (95% CI: 15.6, 29.7).
Croatian: PSA odgovor je bio 22,1 % (95% CI: 15,6; 29,7).
English: Hazard ratio < 1 favours enzalutamide.
Croatian: Omjer hazarda < 1 govori u prilog enzalutamidu
English: Vistor hf Sími: + 354 535 7000
Croatian: Sími: + 354 535 7000
English: 112 film-coated tablets
Croatian: 112 filmom obloženih tableta
English: - Xtandi should not be handled by persons other than the patient and his caregivers, and especially not by women who are or may become pregnant.
Croatian: - Lijekom Xtandi ne smije rukovati nitko osim bolesnika i njegovih njegovatelja, a osobito ne trudnice ili žene koje mogu zatrudnjeti.
English: If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily (see section 4.2).
Croatian: Ako se bolesnicima mora istovremeno davati jaki inhibitor CYP2C8, dozu enzalutamida potrebno je smanjiti na 80 mg jedanput na dan (vidjeti dio 4.2).
English: Enzalutamide is poorly water soluble.
Croatian: Enzalutamid je loše topiv u vodi.
English: Consistent benefit of enzalutamide over bicalutamide on PFS was observed in all pre-specified patient subgroups.
Croatian: Dosljedna korist u smislu PFS-a uz enzalutamid u odnosu na bikalutamid opažena je u svim unaprijed određenim podskupinama bolesnika.
English: Enzalutamide significantly decreased the risk of the first skeletal-related event by 28% [HR = 0.718 (95% CI: 0.61, 0.84), p < 0.0001].
Croatian: Enzalutamid je značajno smanjio rizik za pojavu prvog koštanog događaja za 28% [HR = 0,718 (95% CI: 0,61; 0,84), p < 0,0001].
English: It is not known if enzalutamide is present in human milk.
Croatian: Nije poznato izlučuje li se enzalutamid u majčinom mlijeku.
English: After oral administration of radiolabeled 14C-enzalutamide to rats on day 14 of pregnancy at a dose of 30 mg/kg (~ 1.9 times the maximum dose indicated in humans), the maximum radioactivity in the fetus was reached 4 hours after administration and was lower than that in the maternal plasma with tissue/plasma ratio of 0.27.
Croatian: Nakon peroralne primjene radiooznačenog 14C-enzalutamida 14. dana graviditeta u ženki, u dozi od 30 mg/kg (~ 1,9 puta maksimalne doze indicirane kod ljudi), maksimalna radioaktivnost kod fetusa je postignuta 4 sata nakon primjene i bila je niža nego ona u plazmi majke s omjerom tkivo/plazma 0,27.
English: 9785-CL-0222 (TERRAIN) study (chemotherapy-naïve patients with metastatic CRPC)
Croatian: Ispitivanje 9785-CL-0222 (TERRAIN) (bolesnici s metastatskim CRPC-om koji prethodno nisu primali kemoterapiju)
English: Deaths (%) Median survival (months) (95% CI)
Croatian: Smrtni slučajevi (%) Medijan preživljenja (mjeseci) (95% CI)
English: The most common adverse reactions are asthenia/fatigue, hot flush, fractures, and hypertension.
Croatian: Najčešće nuspojave su astenija/umor, navale vrućine, prijelomi i hipertenzija.
English: The analysis included 587 skeletal-related events, of which 389 events (66.3%) were radiation to bone, 79 events (13.5%) were spinal cord compression, 70 events (11.9%) were pathologic bone fracture, 45 events (7.6%) were change in antineoplastic therapy to treat bone pain, and 22 events (3.7%) were surgery to bone.
Croatian: Analiza je uključila 587 koštanih događaja, od kojih je 389 (66,3%) bilo zračenje kosti, 79 (13,5%) kompresija kralježnične moždine, 70 (11,9%) patološka fraktura kosti, 45 (7,6%) promjena antineoplastične terapije radi liječenja koštane boli i 22 (3,7%) kirurški zahvati na kostima.
English: Astellas Pharma s.r.o., Tel: +421 2 4444 2157
Croatian: Slovenská republika Astellas Pharma s.r.o., Tel: + 421 2 4444 2157
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC and Cmax in subjects with mild impairment increased by 14% and 19%, respectively, the AUC and Cmax in subjects with moderate impairment increased by 14% and decreased by 17%, respectively, and the AUC and Cmax in subjects with severe hepatic impairment increased by 34% and decreased by 27%, respectively, compared to healthy control subjects.
Croatian: Za ukupnu količinu nevezanog enzalutamida i nevezanog djelatnog metabolita, AUC i Cmax su se u ispitanika s blagim oštećenjem funkcije jetre povećali za 14% odnosno 19%, u ispitanika s umjerenim oštećenjem funkcije jetre AUC se povećao za 14% a Cmax smanjio za 17%, a u bolesnika s teškim oštećenjem funkcije jetre AUC se povećao za 34% a Cmax smanjio za 27%, u usporedbi sa zdravim kontrolnim ispitanicima.
English: Astellas Pharma GmbH Tel: + 49 (0)89 454401
Croatian: Deutschland Astellas Pharma GmbH Tel: + 49 (0)89 454401
English: • Proton pump inhibitor (e.g. omeprazole)
Croatian: • inhibitore protonske pumpe (npr. omeprazol)
English: Xtandi should not be handled by persons other than the patient and his caregivers, and especially not by women who are or may become pregnant.
Croatian: Lijekom Xtandi ne smije rukovati nitko osim bolesnika i njegovih njegovatelja, a osobito ne trudnice i žene koje mogu zatrudnjeti.
English: The PREVAIL study enrolled metastatic CRPC chemotherapy-naïve patients; whereas the AFFIRM study enrolled metastatic CRPC patients who had received prior docetaxel; and the PROSPER study enrolled patients with non-metastatic CRPC.
Croatian: Ispitivanje PREVAIL uključivalo je bolesnike s metastatskim CRPC-om koji ranije nisu primali kemoterapiju, dok je ispitivanje AFFIRM uključivalo bolesnike s metastatskim CRPC-om koji su ranije primali docetaksel, a ispitivanje PROSPER bolesnike s nemetastatskim CRPC-om.
English: After oral administration of radiolabeled 14C-enzalutamide to lactating rats at a dose of 30 mg/kg (~ 1.9 times the maximum dose indicated in humans), the maximum radioactivity in the milk was reached 4 hours after administration and was up to 3.54-fold higher than that in the maternal plasma.
Croatian: Nakon peroralne primjene radiooznačenog 14C-enzalutamida ženkama štakora u laktaciji, u dozi od 30 mg/kg (~ 1,9 puta maksimalne doze indicirane kod ljudi), maksimalna radioaktivnost u mlijeku je postignuta 4 sata nakon primjene i bila je do 3,54 puta viša u odnosu na plazmu ženke.
English: No dose adjustment is necessary when Xtandi is coadministered with inducers of CYP2C8 or CYP3A4.
Croatian: Nije potrebna prilagodba doze kad se Xtandi primjenjuje istovremeno s induktorima CYP2C8 ili CYP3A4.
English: Tell your doctor if you are taking any of the following medicines.
Croatian: Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova.
English: A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain.
Croatian: Koštani događaj definiran je kao terapija zračenjem ili kirurški zahvat na kosti zbog karcinoma prostate, patološke frakture kosti, kompresija kralježnične moždine ili promjena antineoplastične terapije radi liječenja koštane boli.
English: The median rPFS was not reached (95% CI: 13.8, not reached) in the enzalutamide-treated group and was 3.9 months (95% CI: 3.7, 5.4) in the placebotreated group (Figure 6).
Croatian: Medijan rPFS-a nije dostignut (95% CI: 13,8; nije dostignuto) u skupini liječenoj enzalutamidom i iznosio je 3,9 mjeseci (95% CI: 3,7; 5,4) u skupini liječenoj placebom (Slika 6).
English: • Immunosuppressant (e.g. tacrolimus)
Croatian: • imunosupresive (npr. takrolimus)