natgillin/translations-raw huggingface dataset:
This medicine is not for use in children and adolescents.
Otroci in mladostniki Zdravilo ni namenjeno za uporabo pri otrocih in mladostnikih.
The risk of heart rhythm problems may be increased when using Xtandi.
Tveganje za težave srčnega ritma je lahko povečano, ko uporabljate zdravilo Xtandi.
This should be taken into account if Xtandi is prescribed in these patients.
Omenjeno je potrebno upoštevati pri predpisovanju zdravila Xtandi tem bolnikom.
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).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z enzalutamidom za vse podskupine pediatrične populacije pri karcinomu prostate (glejte poglavje 4.2 za informacije pri pediatrični populaciji).
Enzalutamide is 97% to 98% bound to plasma proteins, primarily albumin.
Enzalutamid je 97- do 98-odstotno vezan na beljakovine v plazmi, predvsem na albumin.
Results from this analysis were consistent with those from the interim analysis (Table 3, Figure 4).
Rezultati analize so bili skladni z rezultati vmesnih analiz (preglednica 3, slika 4).
EU/1/13/846/002 (film-coated tablet 40 mg) EU/1/13/846/003 (film-coated tablet 80 mg)
EU/1/13/846/002 (filmsko obložene tablete 40 mg) EU/1/13/846/003 (filmsko obložene tablete 80 mg)
Analysis of rPFS utilised centrally-reviewed radiographic assessment of progression.
Pri analizi rPFS so uporabili centralno pregledane radiografske ocene napredovanja bolezni.
P-value is derived from an unstratified log-rank test.
Vrednost p je dobljena na podlagi nestratificiranega log-rang testa.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Daily fluctuations in plasma concentrations are low (peak-to-trough ratio of 1.25).
Dnevna nihanja koncentracije v plazmi so majhna (razmerje med največjo in najmanjšo 1,25).
Use with chemotherapy
Uporaba s kemoterapijo
Your doctor may decide that you should stop taking Xtandi.
Zdravnik se bo morda odločil, da morate prenehati jemati zdravilo Xtandi.
In the controlled clinical studies, patients with prior seizure or risk factors for seizure were excluded.
V vseh kontroliranih kliničnih študijah so bili bolniki s predhodnimi konvulzijami ali dejavniki tveganja izključeni.
Based on pharmacokinetic data from studies in Japanese and Chinese patients with prostate cancer, there were no clinically relevant differences in exposure among the populations.
Farmakokinetični podatki, zbrani v študijah pri japonskih in kitajskih bolnikih z rakom prostate, ne kažejo klinično pomembnih razlik v izpostavljenosti med populacijami.
Benign Leydig cell tumours are expected based on the pharmacological properties of this antiandrogen drug and not considered relevant to humans.
Benigni tumorji Leydigovih celic so pričakovani glede na farmakološke lastnosti tega antiandrogenskega zdravila in jih ne ocenjujejo kot pomembne za človeka.
Caution is required in patients with severe renal impairment as enzalutamide has not been studied in this patient population.
Pri bolnikih s hudo okvaro ledvic je potrebna previdnost, kajti enzalutamid v tej populaciji bolnikov ni raziskan.
Stimulation of tumour cell growth via the androgen receptor requires nuclear localization and DNA binding.
Stimulacija rasti tumorskih celic prek androgenskih receptorjev zahteva jedrno lokalizacijo in vezavo DNA.
CYP2C8 plays an important role in the elimination of enzalutamide and in the formation of its active metabolite.
CYP2C8 ima pomembno vlogo pri odstranjevanju enzalutamida in tvorbi njegovega aktivnega presnovka.
All patients continued on a LHRH analogue or had prior bilateral orchiectomy.
Vsi bolniki so nadaljevali zdravljenje z analogom LHRH ali so imeli predhodno obojestransko orhidektomijo.
This medicine contains less than 1 mmol sodium (less than 23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (manj kot 23 mg) v eni filmsko obloženi tableti, kar v bistvu pomeni "brez natrija".
If you are allergic to enzalutamide, this may result in a rash or swelling of the face, tongue, lip or throat.
Če ste alergični na enzalutamid, se vam lahko pojavi izpuščaj ali otekanje obraza, jezika, ustnic ali žrela.
There is also a risk of increased formation of active metabolites.
Obstaja tudi tveganje za povečan nastanek aktivnih presnovkov.
In consideration of the long half-life of enzalutamide (5.8 days, see section 5.2), effects on enzymes may persist for one month or longer after stopping enzalutamide.
Glede na dolgi razpolovni čas enzalutamida (5,8 dneva, glejte poglavje 5.2) lahko vplivi na encime trajajo še en mesec ali več po prenehanju uporabe enzalutamida.
No studies to evaluate the effects of enzalutamide on the ability to drive and use machines have been conducted.
Študij za ovrednotenje vplivov enzalutamida na sposobnost vožnje in upravljanja s stroji niso izvedli.
An updated survival analysis was conducted when 784 deaths were observed.
Ko je bilo opaženih 784 primerov smrti, je bila narejena posodobljena analiza preživetja.
Other important adverse reactions include fall, cognitive disorder, and neutropenia.
Drugi pomembni neželeni učinki vključujejo padce, kognitivne motnje in nevtropenijo.
Pharmacotherapeutic group: hormone antagonists and related agents, anti-androgens, ATC code: L02BB04.
Farmakoterapevtska skupina: hormonski antagonisti in sorodne učinkovine, antiandrogeni, oznaka ATC: L02BB04.
Patients should be advised of the potential risk of experiencing a psychiatric or neurological event while driving or operating machines.
Bolnike je treba seznaniti z možnim tveganjem za pojav psihiatričnih ali nevroloških učinkov med upravljanjem vozil in strojev.
The safety and efficacy of concomitant use of Xtandi with cytotoxic chemotherapy has not been established.
Varnost in učinkovitost sočasne uporabe zdravila Xtandi s citotoksično kemoterapijo ni bila dokazana.
If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible.
Če imate napade krčev, poslabšanje glavobola, zmedenost, izgubo vida ali druge težave z vidom, se čim prej posvetujte s svojim zdravnikom.
Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
Zdravljenje z enzalutamidom mora začeti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem raka prostate.
The AUC of pioglitazone increased by 20% while Cmax decreased by 18%.
AUC pioglitazona se je povečala za 20 %, Cmax pa se je zmanjšala za 18 %.
- Xtandi can be taken with or without food.
Zdravilo Xtandi lahko vzamete s hrano ali brez nje.
If you are taking a medicine that can cause seizures or that can increase the susceptibility for having seizures (see ‘Other medicines and Xtandi' below)
Če jemljete zdravila, ki lahko povzročijo napade krčev ali ki lahko povečajo dovzetnost za napade krčev (glejte "Druga zdravila in zdravilo Xtandi", spodaj).
Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.
Kakršnakoli srčno-žilna stanja, vključno s težavami srčnega ritma (aritmije), ali se zdravite z zdravili zaradi teh stanj.
Food has no clinically significant effect on the extent of absorption.
Hrana nima klinično pomembnega vpliva na obseg absorpcije.
Xtandi is a medicine that works by blocking the activity of hormones called androgens (such as testosterone).
Zdravilo Xtandi deluje tako, da prepreči delovanje hormonov imenovanih androgeni (kot je testosteron).
The half-life of enzalutamide was however doubled in patients with severe hepatic impairment compared with healthy controls (10.4 days compared to 4.7 days), possibly related to an increased tissue distribution.
Vseeno je bil razpolovni čas enzalutamida pri bolnikih s hudo okvaro jeter v primerjavi z zdravo kontrolo podvojen (10,4 dni v primerjavi z 4,7 dni), kar je lahko povezano s povečano porazdelitvijo v tkivih.
Based on a mass balance study in humans, oral absorption of enzalutamide is estimated to be at least 84.2%.
Na podlagi študije masne bilance pri ljudeh je bila peroralna absorpcija enzalutamida ocenjena na vsaj 84,2 %.
Enzalutamide is not for use in women.
Enzalutamid ni namenjen za uporabo pri ženskah.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželene reakcije navedene po padajoči resnosti.
In addition to the co-primary efficacy endpoints, statistically significant improvements were also demonstrated in the following prospectively defined endpoints.
Poleg sočasnih primarnih opazovanih dogodkov so bila statistično značilna izboljšanja dokazana tudi za naslednje prospektivno določene opazovane dogodke.
Use of enzalutamide has been associated with seizure (see section 4.8).
Uporaba enzalutamida je bila povezana s konvulzijami (glejte poglavje 4.8).
The active metabolite is 95% bound to plasma proteins.
Aktivni presnovek je 95-odstotno vezan na beljakovine v plazmi.
- If you forget to take Xtandi for more than one day, talk to your doctor immediately.
Če ste zdravilo Xtandi pozabili vzeti več kot en dan, se takoj posvetujte z zdravnikom.
There is no antidote for enzalutamide.
Antidota za enzalutamid ni.
• Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)
• statini, ki se presnavljajo s CYP3A4 (npr. atorvastatin, simvastatin)
Interactions with certain medicinal products that are eliminated through metabolism or active transport are expected.
Medsebojno delovanje z določenimi zdravili, ki se izločajo preko presnove ali z aktivnim prenosom je pričakovano.
Most patients (approximately 71%) in the study were Caucasian; 16% were Asian and 2% were Black.
Večina bolnikov (približno 71 %) v študiji je bilo belcev, 16 % je bilo azijcev in 2 % je bilo črncev.
Approximately 45% of patients had measurable soft tissue disease at study entry, and 12% of patients had visceral (lung and/or liver) metastases.
Približno 45 % bolnikov je imelo ob vstopu v študijo izmerljivo bolezen mehkega tkiva in 12 % bolnikov je imelo visceralne (pljuča in/ali jetra) metastaze.
28 soft capsules
28 mehkih kapsul
Median OS was not reached.
Mediano skupno preživetje ni bilo doseženo.
When taken at the same time as Xtandi, these medicines may increase the risk of a seizure:
Jemanje teh zdravil hkrati z zdravilom Xtandi lahko poveča tveganje za napade krčev:
Leydig cell hypertrophy and/or hyperplasia were observed in mice (4 weeks) and dogs (39 weeks).
Hipertrofijo in/ali hiperplazijo Leydigovih celic so opazili pri miših (4 tedni) in psih (39 tednov).
Very common (may affect more than 1 in 10 people) Tiredness, broken bones, hot flushes, high blood pressure
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) utrujenost, zlomi kosti, vročinski oblivi, visok krvni tlak
Based on a population pharmacokinetic analysis, no dose adjustment is necessary for patients with calculated creatinine clearance (CrCL) values ≥ 30 mL/min (estimated by the Cockcroft and Gault formula).
Na podlagi populacijske farmakokinetične analize odmerka ni treba prilagoditi bolnikom z izračunano vrednostjo očistka kreatinina (CrCL) ≥ 30 ml/min (ocenjeno s formulo po Cockcroftu in Gaultu).
There were no other important changes in clinical pathology or histopathology in any other organ system, including the liver, in either species.
Drugih pomembnih sprememb v klinični patologiji ali histopatologiji katerega koli drugega organskega sistema (vključno z jetri) ni bilo ne pri eni ne pri drugi vrsti.
Enzalutamide is a potent enzyme inducer and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected.
Enzalutamid je močan induktor encimov, ki poveča sintezo mnogih encimov in prenašalcev, zato je možna tudi interakcija s pogostimi zdravili, ki so substrati ali prenašalci encimov.
There are two major metabolites in human plasma: N-desmethyl enzalutamide (active) and a carboxylic acid derivative (inactive).
V človeški plazmi sta dva glavna presnovka: N-desmetil-enzalutamid (aktiven) in karboksilnokislinski derivat (neaktiven).
A gradual dose reduction of the concomitant medicinal product may be necessary when stopping enzalutamide treatment.
Postopno zmanjševanje odmerka sočasno uporabljanih zdravil bo morda potrebno po prekinitvi zdravljenja z enzalutamidom.
Co-administration with warfarin and coumarin-like anticoagulants should be avoided.
Sočasni uporabi z varfarinom ali kumarinskimi antikoagulanti se je treba izogniti.
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).
Primerljive rezultate MFS so opažali tudi v vseh vnaprej opredeljenih podskupinah bolnikov, vključno s PSADT (< 6 mesecev ali ≥ 6 mesecev), demografsko regijo (Severna Amerika, Evropa, preostali svet), starostjo (< 75 ali ≥ 75 let) in predhodno uporabo sredstev, usmerjenih na kosti (da ali ne).
Maximum plasma concentrations (Cmax) of enzalutamide in patients are observed 1 to 2 hours after administration.
Največja koncentracija enzalutamida v plazmi (Cmax) se pri bolnikih pojavi od 1 do 2 uri po uporabi zdravila.
• the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
• zdravljenje odraslih moških z metastatskim KORP, pri katerih je bolezen med zdravljenjem ali po zdravljenju z docetakselom napredovala.
Enzyme induction
Indukcija encimov
The full induction potential of enzalutamide may not occur until approximately 1 month after the start of treatment, when steady-state plasma concentrations of enzalutamide are reached, although some induction effects may be apparent earlier.
Polni indukcijski potencial enzalutamida se lahko razvije šele po približno 1 mesecu od začetka zdravljenja, ko je dosežena plazemska koncentracija v stanju dinamičnega ravnovesja; nekateri indukcijski učinki pa so lahko opazni že prej.
What Xtandi is and what it is used for
Kaj je zdravilo Xtandi in za kaj ga uporabljamo
Contains sorbitol (E420).
Vsebuje sorbitol (E420).
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.
Mehanizem, po katerem lahko enzalutamid zniža prag za konvulzije, ni znan, lahko pa bi bil povezan s podatki iz študij in vitro, ki so pokazale, da se enzalutamid in njegov aktivni presnovek vežeta na GABA kloridne kanalčke in lahko zavreta njihovo aktivnost.
The pharmacokinetics of enzalutamide have been evaluated in prostate cancer patients and in healthy male subjects.
Farmakokinetiko enzalutamida so ocenili pri bolnikih z rakom prostate in pri zdravih moških preiskovancih.
The transport protein P-gp may also be induced, and probably other transporters as well, e.g. multidrug resistance-associated protein 2 (MRP2), breast cancer resistance protein (BCRP) and the organic anion transporting polypeptide 1B1 (OATP1B1).
Induciran je lahko tudi transportni protein P-gp in prav tako ostali prenašalci, npr. protein za multiplo odpornost na zdravila 2 (MRP2 - multidrug resistance-associated protein 2), protein odpornosti za raka dojke (BCRP - breast cancer resistance protein) in polipeptidni prenašalec organskih anionov 1B1 (OATP1B1 - organic anion transporting polypeptide 1B1).
Enzalutamide is a potent enzyme inducer and may lead to loss of efficacy of many commonly used medicinal products (see examples in section 4.5).
Enzalutamid je močan induktor encimov, kar lahko vodi do zmanjšanja učinkovitosti mnogih pogosto uporabljanih zdravil (glejte primere v poglavju 4.5).
Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression.
Zdravljenje z enzalutamidom zmanjša rast celic raka prostate in lahko inducira odmrtje rakavih celic in regresijo tumorja.
Key secondary endpoints assessed in the study were time to PSA progression, time to first use of new antineoplastic therapy (TTA), overall survival (OS).
Ključni sekundarni opazovani dogodki, ocenjeni v študiji, so bili čas do napredovanja PSA, čas do prve uporabe novega antineoplastičnega zdravljenja (TTA) in celokupno preživetje (OS).
If any of the above applies to you or you are not sure, talk to your doctor before taking this medicine.
Če kaj od naštetega velja za vas, ali če niste prepričani, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
Common: ischemic heart disease† Not known*: QT-prolongation (see sections 4.4 and 4.5)
Srčne bolezni pogosti: ishemična srčna bolezen† neznana*: podaljšanje intervala QT (glejte poglavji 4.4 in 4.5)
BCRP, MRP2, OAT3 and OCT1 substrates
Substrati BCRP, MRP2, OAT3 in OCT1
In preclinical studies, the absorption of enzalutamide was increased when dissolved in caprylocaproyl macrogolglycerides.
V predkliničnih študijah je bila absorpcija enzalutamida povečana, če je le-ta bil raztopljen v kaprilat kaprinat makrogolglicerolu.
- Do not take a double dose to make up for the dose you forgot.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
- Swallow the tablets whole with water.
Tablete pogoltnite cele in z vodo.
- Swallow the soft capsules whole with water.
Mehke kapsule pogoltnite cele in z vodo.
(≥ 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 pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Radiographic progression was assessed with the use of sequential imaging studies as defined by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (for bone lesions) and/or Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria (for soft tissue lesions).
Radiografsko napredovanje bolezni je bilo ocenjeno s pomočjo študij sekvenčnega slikanja po kriterijih PCWG2 (Prostate Cancer Clinical Trials Working Group 2) (za kostne lezije) in/ali kriterijih RECIST različica 1.1 (Response Evaluation Criteria in Solid Tumors) (za lezije v mehkem tkivu).
You should not start or stop taking any medicine before you talk with the doctor that prescribed Xtandi.
Nobenega zdravila ne začnite in ne nehajte jemati, dokler se ne posvetujete z zdravnikom, ki vam je predpisal zdravilo Xtandi.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
The efficacy and safety of enzalutamide in patients with metastatic CRPC who had received docetaxel and were using a LHRH analogue or had undergone orchiectomy were assessed in a randomised, placebo-controlled, multicentre phase 3 clinical trial.
Učinkovitost in varnost enzalutamida pri bolnikih z metastatskim KORP, ki so prejemali docetaksel in so uporabljali analog LHRH ali so opravili orhidektomijo, so ocenili v randomiziranem, s placebom kontroliranem multicentričnem kliničnem preskušanju 3. faze.
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 redka, reverzibilna, nevrološka motnja, ki se lahko kaže s hitro razvijajočimi simptomi, vključno s konvulzijami, glavobolom, zmedenostjo, izgubo vida in drugimi vidnimi in nevrološkimi motnjami, ki so lahko ali pa niso povezani s povišanim krvnim tlakom.
Uncommon (may affect up to 1 in 100 people) Hallucinations, difficulty thinking clearly, low white blood cell count
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) halucinacije, težave z jasnim razmišljanjem, majhno število belih krvnih celic
Please tell your doctor if you have any of the following:
Povejte svojemu zdravniku, če imate karkoli od naštetega:
Animal studies showed that enzalutamide affected the reproductive system in male rats and dogs (see section 5.3).
Študije na živalih so pokazale, da enzalutamid vpliva na reproduktivni sistem samcev pri podganah in psih (glejte poglavje 5.3).
At study entry, 41% of randomised patients had PSA progression only, whereas 59% of patients had radiographic progression.
Ob vstopu v študijo je imelo samo napredovanje PSA 41 % randomiziranih bolnikov, radiografsko napredovanje bolezni pa je imelo 59 % bolnikov.
Enzalutamide is metabolised by CYP2C8 and to a lesser extent by CYP3A4/5 (see section 4.5), both of which play a role in the formation of the active metabolite.
Enzalutamid se presnovi s CYP2C8 in v manjši meri s CYP3A4/5 (glejte poglavje 4.5); oba igrata vlogo pri nastanku aktivnega presnovka.
Most (91%) patients had metastases in bone and 23% had visceral lung and/or liver involvement.
Večina (91 %) bolnikov je imela metastaze v kosteh, 23 % pa jih je imelo visceralno prizadetost pljuč in/ali jeter.
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.
Enzalutamida niso raziskali pri bolnikih s hudo okvaro ledvic (CrCL < 30 ml/min) ali končno odpovedjo ledvic; pri zdravljenju teh bolnikov je potrebna previdnost.
Figure 8: Overall survival by subgroup in the AFFIRM study - Hazard ratio and 95% confidence interval
Slika 8: Celokupno preživetje po podskupinah v študiji AFFIRM - razmerje ogroženosti in 95 % interval zaupanja
With daily oral administration, enzalutamide accumulates approximately 8.3-fold relative to a single dose.
Med vsakodnevno peroralno uporabo se enzalutamid kopiči približno 8,3-kratno v primerjavi s posameznim odmerkom.
If you have any further questions on the use of this medicine, ask your doctor.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom.
Elimination The mean apparent clearance (CL/F) of enzalutamide in patients ranges from 0.520 and 0.564 L/h.
Izločanje Povprečni navidezni očistek (CL/F) enzalutamida je pri bolnikih od 0,520 do 0,564 l/h.
The solubility of enzalutamide is increased by caprylocaproyl macrogolglycerides as emulsifier/surfactant.
Topnost enzalutamida je povečana s pomočjo kaprilat kaprinat makrogolglicerola kot emulgatorja/površinsko aktivno snovjo.
It is not known whether enzalutamide or its metabolites are present in semen.
Ni znano, ali se enzalutamid ali njegovi presnovki pojavijo v semenu.
If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time.
Če bolnik pozabi vzeti zdravilo Xtandi ob običajnem času, mora predpisani odmerek vzeti čim bližje običajnemu času.
Xtandi is used to treat adult men with prostate cancer that no longer responds to androgen deprivation therapy.
Zdravilo Xtandi uporabljamo za zdravljenje odraslih moških z rakom prostate, ki se ne odziva več na zdravljenje z odtegnitvijo androgena.
The film-coated tablets should not be cut or crushed.
Filmsko obloženih tablet se ne sme lomiti oziroma drobiti.
Additional secondary endpoints included time to first use of cytotoxic chemotherapy and chemotherapy-free survival.
Med dodatnimi sekundarnimi opazovanimi dogodki sta bila čas do prve uporabe citotoksične kemoterapije in preživetja brez kemoterapije.
This medicine has moderate effect on your ability to drive or use any tools or machines as the side effects of Xtandi include psychiatric and neurological events including seizure.
To zdravilo ima zmeren vpliv na vašo sposobnost upravljanja vozil in uporabo orodij ali strojev, ker neželeni učinki zdravila Xtandi vključujejo psihiatrične in nevrološke učinke, vključno z napadom krčev.