FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: ROg temelji na Coxovem regresijskem modelu (z zdravljenjem kot edino sospremenljivko) s stratifikacijo po času podvojitve PSA in predhodno ali sočasno uporabo sredstev, usmerjenih na kosti.
English: Xtandi contains sorbitol
Slovenian: Zdravilo Xtandi vsebuje sorbitol
English: 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.
Slovenian: Enzalutamid kompetitivno zavre vezavo androgenov na androgenske receptorje, in posledično zavre jedrno translokacijo aktiviranih receptorjev in zavre povezavo aktiviranih androgenskih receptorjev z DNA tudi v okoliščinah čezmerne ekspresije androgenskih receptorjev in v celicah raka prostate, odpornih proti androgenom.
English: Enzalutamide was not phototoxic in vitro.
Slovenian: Enzalutamid in vitro ni bil fototoksičen.
English: - If you forget to take Xtandi at the usual time, take your usual dose as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo Xtandi ob običajnem času, vzemite svoj običajni odmerek, čim se spomnite.
English: • the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
Slovenian: • zdravljenje odraslih moških z nemetastatskim, proti kastraciji odpornim rakom prostate (KORP) z velikim tveganjem (glejte poglavje 5.1),
English: Patients were required to have a PSA doubling time ≤ 10 months, PSA ≥ 2 ng/mL, and confirmation of non-metastatic disease by blinded independent central review (BICR).
Slovenian: Bolniki so morali imeti čas podvojitve PSA ≤ 10 mesecev, PSA ≥ 2 ng/ml in nemetastatsko bolezen, potrjeno s slepim neodvisnim centralnim pregledom (BICR - blinded independent central review).
English: CYP3A4 plays a minor role in the metabolism of enzalutamide.
Slovenian: CYP3A4 ima pri presnovi enzalutamida le majhno vlogo.
English: 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.
Slovenian: Med drugimi spremembami reproduktivnih tkiv so bile hipertrofija/hiperplazija hipofize in atrofija seminalnih vezikul pri podganah ter testikularna hipospermija in degeneracija semenskih tubulov pri psih.
English: The median age was 71 years (range 42 - 93) and the racial distribution was 77% Caucasian, 10% Asian, 2% Black and 11% other or unknown races.
Slovenian: Mediana starost je bila 71 let (razpon od 42 do 93) in porazdelitev glede na raso je bila 77 % belcev, 10 % azijcev, 2 % črncev in 11 % druge ali neznane rase.
English: 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.
Slovenian: Vsakodnevna 2-letna uporaba od 10 do 100 mg enzalutamida/kg/dan je pri podganah povečala pojavnost več vrst (večinoma benignih) tumorjev.
English: Do not take any soft capsule that is leaking, damaged, or shows signs of tampering.
Slovenian: Ne jemljite mehkih kapsul, ki puščajo, so poškodovane ali če opazite znake odpiranja.
English: 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.
Slovenian: Peroralno absorpcijo filmsko obloženih tablet enzalutamida so ocenili pri zdravih moških prostovoljcih po enkratnem 160-mg odmerku zdravila Xtandi v filmsko obloženih tabletah in za napoved farmakokinetičnega profila v stanju dinamičnega ravnovesja sta bila uporabljena farmakokinetično modeliranje in simulacija.
English: The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers.
Slovenian: Tveganje za poškodbe jeter po jemanju paracetamola je lahko večje pri bolnikih, ki se sočasno zdravijo z induktorji encimov.
English: Other medicines and Xtandi
Slovenian: Druga zdravila in zdravilo Xtandi
English: Elderly No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
Slovenian: Starejši bolniki Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavji 5.1 in 5.2).
English: The concomitant use of strong CYP2C8 inhibitors should be avoided if possible.
Slovenian: Sočasni uporabi močnih zaviralcev CYP2C8 se je treba izogniti, če je mogoče.
English: There is no relevant use of enzalutamide in the paediatric population in the indication of treatment of adult men with CRPC.
Slovenian: Enzalutamid ni primeren za uporabo pri pediatrični populaciji za indikacijo zdravljenje odraslih moških s KORP.
English: The study design could neither identify the patients who are likely to benefit, nor the order in which enzalutamide and abiraterone should be optimally sequenced.
Slovenian: Glede na načrt raziskave ni možno prepoznati bolnikov, ki bi imeli največje koristi od zdravljenja, niti ni možno prepoznati v kašnem zaporedju naj se uporabljata enzalutamid in abirateron, da bi bilo to najbolj optimalno.
English: The mean terminal half-life (t1/2) for enzalutamide in patients after a single oral dose is 5.8 days (range 2.8 to 10.2 days), and steady state is achieved in approximately one month.
Slovenian: Povprečni terminalni razpolovni čas (t1/2) enzalutamida je pri bolnikih po posameznem peroralnem odmerku 5,8 dneva (razpon: od 2,8 do 10,2 dneva), stanje dinamičnega ravnovesja pa je doseženo v približno enem mesecu.
English: - If you have any further questions, ask your doctor.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: 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.
Slovenian: Sočasni uporabi enzalutamida z zdravili, ki so občutljivi substrati mnogih presnovnih encimov ali prenašalcev (glejte poglavje 4.5) se je v večini potrebno izogniti, če imajo ta zdravila velik terapevtski učinek na bolnika in prilagoditev odmerka ni mogoče enostavno izvesti na osnovi spremljanja učinkovitosti ali koncentracij v plazmi.
English: If their therapeutic effect is of large importance to the patient, and dose adjustments are not easily performed based on monitoring of efficacy or plasma concentrations, these medicinal products are to be avoided or used with caution.
Slovenian: Če je njihov terapevtski učinek na bolnika velik in prilagajanje njihovega odmerka na osnovi spremljanja učinkovitosti ali koncentracij v plazmi ni enostavno, se je sočasni uporabi teh zdravil potrebno izogniti ali pa jih uporabljati previdno.
English: If you forget to take Xtandi
Slovenian: Če ste pozabili vzeti zdravilo Xtandi
English: In addition to the co-primary endpoints, benefit was also assessed using time to initiation of cytotoxic chemotherapy, best overall soft tissue response, time to first skeletal-related event, PSA response (≥ 50% decrease from baseline), time to PSA progression, and time to FACT-P total score degradation.
Slovenian: Poleg sočasnih primarnih opazovanih dogodkov so korist ocenili tudi s pomočjo časa do uvedbe citotoksične kemoterapije, najboljšega celokupnega odziva mehkega tkiva, časa do pojava prvega z okostjem povezanega dogodka, odziva PSA (zmanjšanje za ≥ 50 % od izhodišča), časa do napredovanja PSA in časa do upada skupne ocene FACT-P.
English: White to off-white oblong soft capsules (approximately 20 mm x 9 mm) imprinted with “ENZ” in black ink on one side.
Slovenian: Bele do skoraj bele, podolgovate mehke kapsule (velike približno 20 mm x 9 mm), ki imajo na eni strani s črnim črnilom natisnjeno oznako "ENZ".
English: A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Slovenian: Diagnozo potrdimo s slikanjem možganov, najbolje z magnetno resonanco (MR).
English: 35.3 (32.2, NR) 31.3 (28.8, 34.2)
Slovenian: 35,3 (32,2, ND) 31,3 (28,8, 34,2)
English: What Xtandi is and what it is used for What you need to know before you take Xtandi How to take Xtandi
Slovenian: Kaj je zdravilo Xtandi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xtandi Kako jemati zdravilo Xtandi Možni neželeni učinki
English: • 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).
Slovenian: • zdravljenje odraslih moških z metastatskim KORP, ki so asimptomatski ali blago simptomatski po nedelovanju zdravljenja z odtegnitvijo androgena, pri katerih kemoterapija še ni klinično indicirana (glejte poglavje 5.1),
English: Risk of seizure
Slovenian: Tveganje za konvulzije
English: The soft capsules should not be dissolved or opened.
Slovenian: Mehkih kapsul se ne sme raztopiti ali odpirati.
English: The volume of distribution of enzalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Slovenian: Volumen porazdelitve enzalutamida je večji od volumna celotne telesne vode.
English: Based on these predictions, as well as other supportive data, the median time to reach maximum plasma enzalutamide concentrations (Cmax) is 2 hours (range 0.5 to 6 hours), and the steady-state pharmacokinetic profiles of enzalutamide and its active metabolite are similar for the film-coated tablets and the Xtandi soft capsules formulation.
Slovenian: Na podlagi teh napovedi in drugih podpornih podatkov je mediani čas do dosežene največje koncentracije (Cmax) enzalutamida v plazmi 2 uri (razpon: od 0,5 do 6 ur) in farmakokinetični profil enzalutamida in njegovih aktivnih presnovkov je v stanju dinamičnega ravnovesja med uporabo filmsko obloženih tablet podoben kot med uporabo mehkih kapsul zdravila Xtandi.
English: Hepatic impairment did not have a pronounced effect on the total exposure to enzalutamide or its active metabolite.
Slovenian: Okvara jeter ni imela izrazitega vpliva na celokupno izpostavljenost enzalutamidu ali njegovim aktivnim presnovkom.
English: Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C9, CYP2C19, and uridine 5'-diphospho-glucuronosyltransferase (UGTs - glucuronide conjugating enzymes).
Slovenian: Možni inducirani encimi lahko vključujejo CYP3A v jetrih in črevesju, CYP2B6, CYP2C9, CYP2C19 in uridin 5'-difosfat-glukuronil-transferazo (UGT - glukuronidni konjugacijski encimi).
English: In vitro, N-desmethyl enzalutamide is metabolised to the carboxylic acid metabolite by carboxylesterase 1, which also plays a minor role in the metabolism of enzalutamide to the carboxylic acid metabolite.
Slovenian: N-desmetil enzalutamid se in vitro presnovi v presnovek karboksilne kisline s karboksilesterazo 1, ki ima tudi manjšo vlogo pri presnovi enzalutamida v presnovek karboksilne kisline.
English: 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.
Slovenian: Od 3179 bolnikov v kontroliranih kliničnih preskušanjih, ki so prejemali enzalutamid, jih je bilo 2518 (79 %) starih 65 let ali več in 1162 (37 %) starih 75 let ali več.
English: Enzalutamide treatment of pregnant mice resulted in an increased incidence of embryo-fetal deaths and external and skeletal changes.
Slovenian: Dajanje enzalutamida brejim mišim je povzročilo večjo incidenco embrio-fetalnih smrti in zunanjih sprememb ter sprememb okostja.
English: In clinical trials, Xtandi was administered without regard to food.
Slovenian: V kliničnih preskušanjih so zdravilo Xtandi uporabljali ne glede na hrano.
English: If you have a seizure, see your doctor as soon as possible.
Slovenian: Če se vam pojavi napad krčev, čim prej obiščite svojega zdravnika.
English: No major deviations from dose proportionality are observed over the dose range 40 to 160 mg.
Slovenian: V razponu odmerkov od 40 do 160 mg niso opazili večjih odklonov od sorazmernosti odmerku.
English: 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.
Slovenian: Sočasno dajanje enzalutamida nima klinično pomembnega učinka na farmakokinetiko intravensko uporabljenega docetaksela (glejte poglavje 4.5), vendar pa povečanja pojavnosti nevtropenije zaradi docetaksela ni mogoče izključiti.
English: The mean apparent volume of distribution (V/F) of enzalutamide in patients after a single oral dose is 110 L (29% CV).
Slovenian: Povprečni navidezni volumen porazdelitve (V/F) enzalutamida je pri bolnikih po posameznem peroralnem odmerku 110 l (KV 29 %).
English: The dose of Xtandi or any other medicines that you are taking may need to be changed.
Slovenian: Morda vam bo moral spremeniti odmerek zdravila Xtandi ali kakšnih drugih zdravil, ki jih jemljete.
English: • Antipsychotics (e.g. haloperidol)
Slovenian: • antipsihotiki (npr. haloperidol)
English: You may have an increased risk of seizure or other side effects.
Slovenian: Poveča se vam lahko tveganje za napade krčev (konvulzije) ali druge neželene učinke.
English: Enzalutamide and/or its metabolites are secreted in rat milk (see section 5.3).
Slovenian: Enzalutamid in/ali njegovi presnovki se pri podganah izločajo v mleko (glejte poglavje 5.3).
English: 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.
Slovenian: Podatki in vitro kažejo, da enzalutamid in njegovi glavni presnovki v klinično pomembnih koncentracijah ne zavirajo naslednjih prenašalcev: OATP1B1, OATP1B3, OCT2 ali OAT1.
English: The HR is relative to placebo with < 1 favouring enzalutamide.
Slovenian: ROg je glede na placebo; vrednost < 1 je v korist enzalutamida.
English: Potential for enzalutamide to affect exposures to other medicinal products
Slovenian: Možnost vpliva enzalutamida na izpostavljenost drugim zdravilom
English: Enzalutamide (N = 800)
Slovenian: Enzalutamid (N = 800)
English: Gender differences were noted in rat mammary glands (male atrophy and female lobular hyperplasia).
Slovenian: Razlike med spoloma so opazili v mlečnih žlezah podgan (atrofija pri samcih in lobularna hiperplazija pri samicah).
English: 32.4 (30.1, NR) 30.2 (28.0, NR)
Slovenian: 32,4 (30,1, ND) 30,2 (28,0, ND)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
English: The analysis involved 216 deaths without documented progression and 645 documented progression events, of which 303 (47%) were due to soft tissue progression, 268 (42%) were due to bone lesion progression and 74 (11%) were due to both soft tissue and bone lesions.
Slovenian: Analiza je zajela 216 smrti brez dokumentiranega napredovanje in 645 dokumentiranih dogodkov napredovanja; od tega jih je bilo 303 (47 %) posledica napredovanja v mehkih tkivih, 268 (42 %) napredovanja kostnih lezij in 74 (11 %) napredovanja tako v mehkih tkivih kot kostnih lezij.
English: In vivo studies have shown that enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19.
Slovenian: In vivo študije so pokazale, da je enzalutamid močan induktor CYP3A4 in zmeren induktor CYP2C9 in CYP2C19.
English: 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.
Slovenian: V študijah na miših (4 tedni), podganah (4 in 26 tednov) in psih (4, 13 in 39 tednov) so bile z enzalutamidom povezane spremembe reproduktivnih organov zmanjšanje mase organov z atrofijo prostate in epididimisa.
English: There was no protein binding displacement between enzalutamide and other highly bound medicinal products (warfarin, ibuprofen and salicylic acid) in vitro.
Slovenian: In vitro ni prišlo do izpodrivanja pri vezavi na beljakovine med enzalutamidom in drugimi zdravili, ki se močno vežejo (varfarin, ibuprofen in salicilna kislina).
English: Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol.
Slovenian: Pomožna snov z znanim učinkom Ena mehka kapsula vsebuje 57,8 mg sorbitola.
English: The median age at randomisation was 74 years in the enzalutamide arm and 73 years in the placebo arm.
Slovenian: Mediana starost ob randomizaciji je bila v skupini z enzalutamidom 74 let in v skupini s placebom 73 let.
English: • Hypnotics (e.g. diazepam, midazolam, zolpidem)
Slovenian: • hipnotiki (npr. diazepam, midazolam, zolpidem)
English: † As evaluated by narrow SMQs of ‘Myocardial Infarction' and ‘Other Ischemic Heart Disease' including the following preferred terms observed in at least two patients in randomized placebo-controlled phase 3 studies: angina pectoris, coronary artery disease, myocardial infarctions, acute myocardial infarction, acute coronary syndrome, angina unstable, myocardial ischaemia, and arteriosclerosis coronary artery.
Slovenian: † Ovrednoteno s SMQ "miokardni infarkt" in "druga ishemična srčna bolezen", vključno z naslednjimi prednostnimi izrazi, zabeleženimi pri vsaj dveh bolnikih v randomiziranih, s placebom kontroliranih študijah 3. faze: angina pektoris, bolezni koronarnih arterij, miokardni infarkti, akutni miokardni infarkt, akutni koronarni sindrom, nestabilna angina pektoris, ishemija miokarda in arterioskleroza koronarnih arterij.
English: Xtandi has moderate influence on the ability to drive and use machines as psychiatric and neurologic events including seizure have been reported (see section 4.8).
Slovenian: Zdravilo Xtandi ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji; opisani so bili namreč psihiatrični in nevrološki dogodki, vključno s konvulzijami (glejte poglavje 4.8).
English: • Antibiotics (e.g. clarithromycin, doxycycline)
Slovenian: • antibiotiki (npr. klaritromicin, doksiciklin)
English: Patients were stratified by Prostate Specific Antigen (PSA) Doubling Time (PSADT) (< 6 months or ≥ 6 months) and the use of bone-targeting agents (yes or no).
Slovenian: Bolnike so stratificirali glede na čas podvojitve (PSADT) prostatičnega specifičnega antigena (PSA) (< 6 mesecev ali ≥ 6 mesecev) in uporabo sredstev, usmerjenih na kosti (da ali ne).
English: Food has no clinically significant effect on the extent of exposure to enzalutamide.
Slovenian: Hrana nima klinično pomembnega vpliva na obseg izpostavljenosti enzalutamidu.
English: The median time to degradation in FACT-P was 11.3 months in the enzalutamide group and 5.6 months in the placebo group.
Slovenian: Mediani čas do upada skupne ocene FACT-P je bil 11,3 meseca v skupini z enzalutamidom in 5,6 meseca v skupini s placebom.
English: By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing.
Slovenian: S preprečitvijo delovanja androgenov enzalutamid ustavi rast in delitev celic raka prostate.
English: CRPC2 (AFFIRM) study (patients with metastatic CRPC who previously received chemotherapy)
Slovenian: Študija CRPC2 (AFFIRM) (bolniki z metastatskim KORP, ki so predhodno dobivali kemoterapijo)
English: Complete responses were reported in 19.7% of enzalutamide-treated patients compared with 1.0% of placebo-treated patients, and partial responses were reported in 39.1% of enzalutamide-treated patients versus 3.9% of placebo-treated patients.
Slovenian: O celovitih odzivih so poročali pri 19,7 % bolnikov, zdravljenih z enzalutamidom, v primerjavi z 1,0 % bolnikov, zdravljenih s placebom, in o delnih odzivih so poročali pri 39,1 % bolnikov, zdravljenih z enzalutamidom, v primerjavi s 3,9 % bolnikov, zdravljenih z placebom.
English: The study was a single-arm study in 214 patients with progressing metastatic CRPC who received enzalutamide (160 mg once daily) after at least 24 weeks of treatment with abiraterone acetate plus prednisone.
Slovenian: To je bila neprimerjalna raziskava z enim krakom pri 214 bolnikih z napredujočim mKORP, ki so prejemali enzalutamid (160 mg enkrat dnevno) po vsaj 24 tednih predhodnega zdravljenja z abirateron acetatom in prednizonom.
English: Based on in vitro data, inhibition of BCRP and MRP2 (in the intestine), as well as organic anion transporter 3 (OAT3) and organic cation transporter 1 (OCT1) (systemically) cannot be excluded.
Slovenian: Na podlagi podatkov in vitro ni mogoče izključiti inhibicije BCRP in MRP2 (v črevesju), kot tudi prenašalca organskih anionov 3 (OAT3 - organic anion transporter 3) in prenašalca organskih kationov 1 (OCT1organic cation transporter 1) (sistemski).
English: Efficacy of enzalutamide was established in three randomised placebo-controlled multicentre phase 3 clinical studies [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] of patients with progressive prostate cancer who had failed androgen deprivation therapy [LHRH analogue or after bilateral orchiectomy].
Slovenian: Učinkovitost enzalutamida so ugotavljali v treh randomiziranih, s placebom kontroliranih multicentričnih kliničnih študijah 3. faze [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] pri bolnikih s progresivnim rakom prostate, pri katerih zdravljenje z odtegnitvijo androgena ni bilo uspešno [analog LHRH ali po obojestranski orhidektomiji].
English: • Analgesics (e.g. fentanyl, tramadol)
Slovenian: • analgetiki (npr. fentanil, tramadol)
English: Not known (frequency cannot be estimated from the available data) Muscle pain, muscle spasms, muscular weakness, back pain, changes in ECG (QT prolongation), upset stomach including feeling sick (nausea), rash, being sick (vomiting), swelling of the face, lips, tongue and/or throat, reduction in blood platelets (which increases risk of bleeding or bruising), diarrhoea
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) bolečine v mišicah, mišični krči, mišična šibkost, bolečine v hrbtu, spremembe v EKG (podaljšanje QT intervala), razdražen želodec vključno s siljenjem na bruhanje (navzea), izpuščaj, bruhanje, otekanje obraza, ustnic, jezika in/ali žrela, zmanjšanje števila krvnih ploščic (kar poveča tveganje za krvavitve ali modrice), driska
English: Androgen deprivation therapy may prolong the QT interval In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Xtandi.
Slovenian: Zdravljenje z odtegnitvijo androgena lahko podaljša interval QT Pri bolnikih z anamnezo podaljšanja intervala QT ali dejavniki tveganja za podaljšanje QT in pri bolnikih, ki so sočasno prejemali zdravila, ki lahko podaljšajo interval QT (glejte poglavje 4.5) mora zdravnik pred začetkom zdravljenja z zdravilom Xtandi oceniti razmerje med koristjo in tveganjem vključno z možnostjo Torsade de pointes.
English: The protocol pre-specified interim analysis after 520 deaths showed a statistically significant superiority in overall survival in patients treated with enzalutamide compared to placebo (Table 4 and Figures 7 and 8).
Slovenian: V protokolu vnaprej določena vmesna analiza po 520 smrtih je pri bolnikih, ki so prejemali enzalutamid, pokazala statistično značilno superiornost glede celokupnega preživetja v primerjavi s placebom (preglednica 4 in sliki 7 in 8).
English: Enzalutamide (N = 872)
Slovenian: Enzalutamid (N = 872)