FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Delež bolnikov, zdravljenih z enzalutamidom, z merljivo boleznijo ob izhodišču, ki so imeli objektivni odziv mehkega tkiva, je bil 58,8 % (95 % IZ: 53,8, 63,7) v primerjavi s 5,0 % (95 % IZ: 3,0, 7,7) bolnikov, ki so dobivali placebo.
English: For the non-metastatic subgroup (N = 139) a total of 19 out of 70 (27.1%) patients treated with enzalutamide and 49 out of 69 (71.0%) patients treated with bicalutamide had PFS events (68 total events).
Slovenian: V podskupini brez metastaz (N = 139) je imelo dogodke PFS skupaj 19 od 70 (27,1 %) bolnikov, ki so prejemali enzalutamid, in 49 od 69 (71,0 %) bolnikov, ki so prejemali bikalutamid; skupno število dogodkov je bilo 68.
English: Deaths (%) Median survival (months) (95% CI)
Slovenian: Smrti (%) Mediano preživetje (meseci) (95 % IZ)
English: Baseline pain assessment was 0 - 1 (asymptomatic) in 67% of patients and 2 - 3 (mildly symptomatic) in 32% of patients as defined by the Brief Pain Inventory Short Form (worst pain over past 24 hours on a scale of 0 to 10).
Slovenian: Ocena bolečine ob izhodišču je bila 0-1 (asimptomatsko) pri 67 % bolnikov in 23 (blago simptomatsko) pri 32 % bolnikov, opredeljeno po skrajšanem vprašalniku BPI-SF (najhujša bolečina v zadnjih 24 urah na lestvici od 0 do 10).
English: 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.
Slovenian: Farmakokinetiko enzalutamida so raziskali pri preiskovancih z izhodiščno blago (Child-Pugh A; n = 6), zmerno (Child-Pugh B; n = 8) ali hudo (Child-Pugh C; n = 8) okvaro jeter in 22 usklajenih primerjalnih preiskovancih z normalnim delovanjem jeter.
English: - If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method, during treatment and for 3 months after treatment with this medicine.
Slovenian: Če imate spolne odnose z žensko, ki bi lahko zanosila, morate med zdravljenjem s tem zdravilom in še 3 mesece po zdravljenju pri spolnih odnosih uporabljati kondom in še eno učinkovito kontracepcijsko sredstvo.
English: • Cardiac glycosides (e.g. digoxin)
Slovenian: • srčni glikozidi (npr. digoksin)
English: Some urothelium papilloma and carcinoma of urinary bladder is expected in rats based on the horizontal structure of the rat urinary bladder, which can encounter concentrated urine and prolonged irritation from calculi.
Slovenian: Papilom urotelija in karcinom sečnega mehurja sta pričakovana pri podganah zaradi horizontalne strukture podganjega sečnega mehurja, kar lahko povzroči podaljšano lokalno draženje s koncentriranim urinom in kamni v urinu.
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.
Slovenian: Bolniki, randomizirani v en ali drug krak, so nadaljevali zdravljenje do napredovanja bolezni (ki je bilo opredeljeno kot radiografsko potrjeno napredovanje bolezni ali pojav z okostjem povezanega dogodka) oziroma do uvedbe novega sistemskega antineoplastičnega zdravljenja, nesprejemljivih toksičnih učinkov ali umika.
English: PSA Response was 22.1% (95% CI: 15.6, 29.7).
Slovenian: Odziv PSA je bil 22,1 % (95 % IZ: 15,6, 29,7).
English: Astellas Pharmaceuticals AEBE
Slovenian: Astellas Pharmaceuticals AEBE Ελλάδα
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Each carton contains 4 wallets (112 soft capsules).
Slovenian: Vsaka škatla vsebuje 4 pretisne zgibanke (112 mehkih kapsul).
English: Astellas Pharma B.V.Branch Belgique/Belgien Tél/Tel: + 32 (0)2 5580710
Slovenian: Luxembourg/Luxemburg Astellas Pharma B.V.Branch Belgique/Belgien Tél/Tel: + 32 (0)2 5580710
English: Post-authorisation efficacy study (PAES): In order to investigate the long-term effects of enzalutamide on Overall Survival and relevant secondary endpoints in adult men with high-risk non-metastatic castration-resistant prostate cancer, the MAH should submit the results of the MDV3100-14 (PROSPER) efficacy study:
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za oceno dolgoročnega učinka enzalutamida na preživetje in relevantne sekundarne opazovane dogodke pri odraslih moških z nemetastatskim, proti kastraciji odpornim rakom prostate z velikim tveganjem, mora imetnik dovoljenja za promet z zdravilom predložiti naslednje rezultate študije MDV3100-14 (PROSPER): - vmesna analiza preživetja; predložiti do: - končno poročilo o klinični študiji; predložiti do:
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).
Slovenian: Vrednost p temelji na stratificiranem log-rang testu glede na čas podvojitve PSA (< 6 mesecev, ≥ 6 mesecev) in predhodno ali sočasno uporabo sredstev, usmerjenih na kosti (da, ne).
English: Ischemic Heart Disease
Slovenian: Ishemična srčna bolezen
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.
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (PRES) Pri bolnikih, ki so jemali zdravilo Xtandi so redko poročali o PRES, redkem, reverzibilnem stanju, ki vključuje možgane.
English: Xtandi is for oral use.
Slovenian: Zdravilo Xtandi je namenjeno za peroralno uporabo.
English: Tell your doctor if you are taking the following medicines.
Slovenian: Svojemu zdravniku morate povedati, če jemljete naslednja zdravila.
English: The median was not reached in either treatment group and neither analysis showed a statistically significant difference between treatment arms.
Slovenian: V vmesni analizi niso ugotovili statistično značilnih razlik med skupinama.
English: Enzalutamide is contraindicated in women who are or may become pregnant (see sections 4.3, 5.3, and 6.6).
Slovenian: Enzalutamid je kontraindiciran pri nosečih ženskah in ženskah, ki bi lahko zanosile (glejte poglavja 4.3, 5.3 in 6.6).
English: 36.6 (33.1, NR)
Slovenian: 36,6 (33,1, ND)
English: • HIV antivirals (e.g. indinavir, ritonavir)
Slovenian: • protivirusna zdravila proti HIV (npr. indinavir, ritonavir)
English: - Medicines used to treat certain psychiatric disorders such as depression and schizophrenia (e.g. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
Slovenian: Zdravila za zdravljenje nekaterih psihiatričnih motenj, npr. depresije ali shizofrenije (npr. klozapin, olanzapin, risperidon, ziprazidon, bupropion, litij, klorpromazin, mesoridazin, tioridazin, amitriptilin, dezipramin, doksepin, imipramin, maprotilin, mirtazapin).
English: Seizure occurred in 0.4% of enzalutamide-treated patients, 0.1% of placebo-treated patients and 0.3% in bicalutamide-treated patients.
Slovenian: Konvulzije so se pojavile pri 0,4 % bolnikov, zdravljenih z enzalutamidom, pri 0,1 % bolnikov, zdravljenih s placebom in pri 0,3 % bolnikov, zdravljenih z bikalutamidom.
English: Enzalutamide is poorly water soluble.
Slovenian: Enzalutamid je slabo topen v vodi.
English: If co-administration of the strong CYP2C8 inhibitor is discontinued, the enzalutamide dose should be returned to the dose used prior to initiation of the strong CYP2C8 inhibitor (see section 4.5).
Slovenian: Če se sočasna uporaba močnega zaviralca CYP2C8 prekine, je treba odmerek enzalutamida povečati na odmerek, uporabljan pred uvedbo močnega zaviralca CYP2C8 (glejte poglavje 4.5).
English: Astellas Pharma Kft. Tel.: + 36 1 577 8200
Slovenian: Magyarország Astellas Pharma Kft. Tel.: +36 1 577 8200
English: PSA Response was 23.2% (95% CI: 13.9, 34.9).
Slovenian: Odziv PSA je bil 23,2 % (95 % IZ: 13,9, 34,9).
English: PFS was the primary endpoint defined as the time from randomisation to the earliest objective evidence of radiographic progression, PSA progression, or death on study.
Slovenian: Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS), opredeljeno kot čas od randomizacije do najzgodnejšega objektivnega dokaza radiografskega napredovanja bolezni, napredovanja PSA ali smrti med študijo.
English: 9785-CL-0222 (TERRAIN) study (chemotherapy-naïve patients with metastatic CRPC)
Slovenian: Študija 9785-CL-0222 (TERRAIN) (bolniki z metastatskim KORP, predhodno še nezdravljeni s kemoterapijo)
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).
Slovenian: Sočasna uporaba enzalutamida (160 mg enkrat na dan) s posameznimi peroralnimi odmerki občutljivih substratov CYP je pri bolnikih z rakom prostate povzročila 86 % zmanjšanje AUC midazolama (substrat CYP3A4), 56 % zmanjšanje AUC S-varfarina (substrat CYP2C9) in 70 % zmanjšanje AUC omeprazola (substrat CYP2C19).
English: - Each carton contains 112 soft capsules in 4 blister wallets of 28 soft capsules each.
Slovenian: eno pakiranje vsebuje 112 mehkih kapsul v 4 pretisnih zgibankah po 28 mehkih kapsul.
English: • Antithrombotics (e.g. acenocoumarol, warfarin, clopidogrel)
Slovenian: • antitrombotiki (npr. acenokumarol, varfarin, klopidogrel)
English: The usual dose is 160 mg (four soft capsules), taken at the same time once a day.
Slovenian: Priporočeni odmerek je 160 mg (štiri mehke kapsule), uporabljen enkrat na dan, vedno ob istem času.
English: Do not use this medicine after the expiry date which is stated on the cardboard wallet and outer carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski pretisni zgibanki in zunanji ovojnini poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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).
Slovenian: Če mora bolnik sočasno dobivati močan zaviralec CYP2C8, je treba odmerek enzalutamida zmanjšati na 80 mg enkrat na dan (glejte poglavje 4.2).
English: In randomized placebo-controlled clinical studies, ischemic heart disease occurred in 2.5% of patients treated with enzalutamide plus ADT compared to 1.3 % patients treated with placebo plus ADT.
Slovenian: V randomiziranih, s placebom kontroliranih kliničnih študijah se je ishemična srčna bolezen pojavila pri 2,5 % bolnikov, ki so prejemali enzalutamid in ADT, in pri 1,3 % bolnikov, ki so prejemali placebo in ADT.
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).
Slovenian: Zdravilo Xtandi lahko vpliva na delovanje nekaterih zdravil za zdravljenje težav srčnega ritma (npr. kinidin, prokainamid, amiodaron in sotalol) ali lahko pri sočasni uporabi z nekaterimi zdravili (npr. metadon (uporablja se za lajšanje bolečine in je del zdravljenja odvisnosti od drog), moksifloksacin (antibiotik), antipsihotiki, ki se uporabljajo za resne duševne bolezni) poveča tveganje za težave srčnega ritma.
English: Strong inhibitors (e.g. gemfibrozil) of CYP2C8 are to be avoided or used with caution during enzalutamide treatment.
Slovenian: Med zdravljenjem z enzalutamidom se je treba močnim zaviralcem (npr. gemfibrozilu) CYP2C8 izogniti, ali pa jih je treba uporabljati previdno.
English: Hazard ratio (95% CI)2
Slovenian: Razmerje ogroženosti (95 % IZ)2
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.
Slovenian: Zdravljenje v okviru študije se je nadaljevalo do napredovanja bolezni (radiografsko potrjeno napredovanje bolezni, pojav z okostjem povezanega dogodka ali klinično napredovanje) in uvedbe citotoksične kemoterapije ali preučevanega zdravila, ali do nesprejemljivih toksičnih učinkov.
English: For the 69 patients who previously received chemotherapy, median rPFS was 7.9 months (95% CI: 5.5, 10.8).
Slovenian: Za 69 bolnikov, ki so bili predhodno zdravljeni s kemoterapijo, je bil mediani rPFS 7,9 meseca (95 % IZ: 5,5, 10,8).
English: This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant.
Slovenian: Če nosečnica vzame to zdravilo, lahko to škoduje nerojenemu otroku ali privede do morebitne prekinitve nosečnosti.
English: Xtandi - 40 mg soft capsules
Slovenian: Xtandi - 40 mg mehke kapsule
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.
Slovenian: Študija PREVAIL je zajela bolnike z metastatskim KORP, ki predhodno še niso prejemali kemoterapije, študija AFFIRM je zajela bolnike z metastatskim KORP, ki so prejemali docetaksel, študija PROSPER pa je zajela bolnike z nemetastatskim KORP.
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.
Slovenian: Po peroralnem dajanju radioaktivno označenega 14C-enzalutamida podganam v laktaciji v odmerku 30 mg/kg (~1,9 kratnik največjega človeškega odmerka), je najvišja vrednost radioaktivnosti v mleku dosežena 4 ure po dajanju in je bila do 3,54-krat višja od koncentracije v plazmi samice.
English: Hazard ratio (95% CI)2 Updated survival analysis Number of deaths (%) Median survival, months (95% CI)
Slovenian: Razmerje ogroženosti (95 % IZ)2 Posodobljena analiza preživetja Število smrti (%) Mediana preživetja, v mesecih (95 % IZ)
English: 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.
Slovenian: Ni podatkov glede uporabe zdravila Xtandi med nosečnostjo pri ljudeh.
English: Recent cardiovascular disease
Slovenian: Nedavne bolezni srca in ožilja
English: Hazard Ratio (95% CI)2 P-value3
Slovenian: Razmerje ogroženosti (95 % IZ)2 Vrednost p3
English: Clearance of enzalutamide is primarily via hepatic metabolism, producing an active metabolite that is equally as active as enzalutamide and circulates at approximately the same plasma concentration as enzalutamide.
Slovenian: Pri tem nastane aktiven presnovek, ki je enako aktiven kot enzalutamid in v plazmi kroži s približno enako koncentracijo kot enzalutamid.
English: Hazard ratio < 1 favours enzalutamide.
Slovenian: Razmerje ogroženosti < 1 je v korist enzalutamida.
English: • Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate.
Slovenian: • Jedro tablete: hipromeloza acetat sukcinat, mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, premreženi natrijev karmelozat, magnezijev stearat
English: Tell your doctor if you are taking any of the following medicines.
Slovenian: Svojemu zdravniku morate povedati, če jemljete katero od naslednjih zdravil.
English: It is unlikely that enzalutamide will be significantly removed by intermittent haemodialysis or continuous ambulatory peritoneal dialysis.
Slovenian: Ni verjetno, da bi intermitentna hemodializa ali kontinuirana ambulantna peritonealna dializa odstranili enzalutamid v pomembni meri.
English: • Tablet coating: Hypromellose, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172).
Slovenian: • Obloga tablete: hipromeloza, smukec, makrogol 8000, titanov dioksid (E171), rumeni železov oksid (E172)
English: Each carton contains 56 film-coated tablets (4 wallets).
Slovenian: Ena škatla vsebuje 56 filmsko obloženih tablet (4 ovojnice).
English: • Immunosuppressant (e.g. tacrolimus)
Slovenian: • imunosupresivi (npr. takrolimus)
English: Astellas Pharma GmbH Tel: + 49 (0)89 454401
Slovenian: Deutschland Astellas Pharma GmbH Tel: + 49 (0)89 454401
English: The exposure levels achieved in this study in male rats at Week 26 at 100 mg/kg per day for enzalutamide plus its active metabolites M1 and M2 (AUC24: enzalutamide ~457 µg·h/mL, M1 ~321 µg·h/mL, M2 ~35 µg·h/mL) were less than or similar to those in prostate cancer patients at the recommended dose (160 mg/day) of enzalutamide (AUC24: enzalutamide ~322 µg·h/mL, M1 ~193 µg·h/mL, M2 ~278 µg·h/mL).
Slovenian: Ravni izpostavljenosti, dosežene v tej študiji pri podganjih samcih 26. teden ob odmerku 100 mg/kg na dan, so bile za enzalutamid in njegova aktivna presnovka M1 in M2 (AUC24: enzalutamid ~457 µg.h/ml, M1 ~321 µg.h/ml, M2 ~35 µg.h/ml) manjše ali podobne izpostavljenosti pri bolnikih z rakom prostate med uporabo priporočenega odmerka enzalutamida 160 mg/dan (AUC24: enzalutamid ~322 µg.h/ml, M1 ~193 µg.h/ml, M2 ~278 µg.h/ml).
English: 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.
Slovenian: Mehkih kapsul se ne sme žvečiti, raztopiti ali odpirati, ampak jih je treba zaužiti cele z vodo.
English: Soft capsule.
Slovenian: kapsula, mehka
English: If you are at higher risk of seizures, talk to your doctor.
Slovenian: Če je pri vas večje tveganje za pojav napadov, se morate posvetovati s svojim zdravnikom.
English: If you take more soft capsules than prescribed, stop taking Xtandi and contact your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Xtandi, kot bi smeli Če ste vzeli več mehkih kapsul, kot je predpisano, nehajte jemati zdravilo Xtandi in se posvetujte s svojim zdravnikom.
English: For the 145 patients who had no previous chemotherapy, median rPFS was 8.1 months (95% CI: 5.7, 8.3).
Slovenian: Za 145 bolnikov, ki predhodno niso bili zdravljeni s kemoterapijo, je bil mediani rPFS 8,1 meseca (95 % IZ: 5,7, 8,3).
English: Vistor hf Sími: + 354 535 7000
Slovenian: Sími: + 354 535 7000
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.
Slovenian: Analiza je zajela 587 z okostjem povezanih dogodkov, 389 (66,3 %) od teh dogodkov je bilo obsevanj kosti, 79 dogodkov (13,5 %) kompresija hrbtnega mozga, 70 dogodkov (11,9 %) patološki zlom kosti, 45 dogodkov (7,6 %) sprememba antineoplastičnega zdravljenja za zdravljenje kostnih bolečin in 22 dogodkov (3,7 %) operacija kosti.
English: Caprylocaproyl macrogol-8 glycerides Butylhydroxyanisole (E320) Butylhydroxytoluene (E321)
Slovenian: Vsebina kapsule: makrogol-8 glicerol kaprilat kaprinat butilhidroksianizol (E320) butilhidroksitoluen (E321)
English: Key Secondary Efficacy Endpoints Time to PSA progression
Slovenian: Ključni sekundarni opazovani dogodki učinkovitosti Čas do napredovanja PSA Število dogodkov (%)
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.
Slovenian: Z okostjem povezan dogodek je bil opredeljen kot obsevanje ali operacija kosti zaradi raka prostate, patološki zlom kosti, utesnitev hrbtenjače ali sprememba antineoplastičnega zdravljenja za zdravljenje kostnih bolečin.
English: If the patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 3 months after treatment.
Slovenian: Če ima bolnik spolne odnose z žensko v rodni dobi, morata med zdravljenjem in še 3 mesece po zdravljenju uporabljati kondome in še en drug način kontracepcije.
English: 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.
Slovenian: Cmin enzalutamida in aktivnega presnovka sta pri posameznih bolnikih v stanju dinamičnega ravnovesja ostali stalni med več kot eno leto trajajočim kroničnim zdravljenjem.
English: MDV3100-14 (PROSPER) study (patients with non-metastatic CRPC)
Slovenian: MDV3100-14 (študija PROSPER) (bolniki z nemetastatskim KORP)
English: In a 6month study in transgenic rasH2 mice, enzalutamide did not show carcinogenic potential (absence of neoplastic findings) at doses up to 20 mg/kg per day (AUC24h ~317 µg•h/mL), which resulted in plasma exposure levels similar to the clinical exposure (AUC24h 322 µg•h/mL) in mCRPC patients receiving 160 mg, daily.
Slovenian: Šestmesečna študija na transgenskih miših rasH2 ni pokazala kancerogenega potenciala enzalutamida (odsotnost neoplastičnih sprememb) v odmerkih do 20 mg/kg na dan (AUC24h ~317 µg.h/ml), s katerimi je bila v plazmi dosežena raven izpostavljenosti podobna klinični izpostavljenosti (AUC24h 322 µg.h/ml) pri bolnikih z mKORP, ki prejemajo 160 mg na dan.
English: In preclinical studies enzalutamide lacks androgen receptor agonist activity.
Slovenian: V predkliničnih študijah enzalutamid ni deloval agonistično na androgenskih receptorjih.
English: 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.
Slovenian: A v študijah na podganah (4 in 26 tednov) in psih (4, 13 in 39 tednov) so zabeležili atrofijo, aspermijo/hipospermijo in hipertrofijo/hiperplazijo reproduktivnega sistema.
English: Astellas Pharma s.r.o., Tel: +421 2 4444 2157
Slovenian: Slovenská republika Astellas Pharma s.r.o., Tel: + 421 2 4444 2157
English: Do not stop taking this medicine unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Xtandi Ne prenehajte jemati tega zdravila, če vam tega ne naroči vaš zdravnik.
English: Common: headache, memory impairment, amnesia, disturbance in attention, restless legs syndrome Uncommon: cognitive disorder, seizure¥ Not known*: posterior reversible encephalopathy syndrome
Slovenian: Bolezni živčevja pogosti: glavobol, okvara spomina, amnezija, motnje pozornosti, sindrom nemirnih nog občasni: kognitivna motnja, konvulzije¥ neznana*: sindrom posteriorne reverzibilne encefalopatije
English: It must not be taken by women who are pregnant, may become pregnant, or who are breast-feeding.
Slovenian: Tega zdravila ne smejo jemati noseče ženske, ženske, ki bi lahko zanosile, in ženske, ki dojijo.
English: If you take more tablets than prescribed, stop taking Xtandi and contact your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Xtandi, kot bi smeli Če ste vzeli več tablet, kot je predpisano, nehajte jemati zdravilo Xtandi in se posvetujte s svojim zdravnikom.