natgillin/translations-raw huggingface dataset:
There were no other important changes in clinical pathology or histopathology in any other organ system, including the liver, in either species.
Nije bilo drugih važnih promjena u kliničkoj patologiji ili patohistologiji drugih organskih sustava, uključujući jetru, niti u jedne od ove dvije životinjske vrste.
If any of the above applies to you or you are not sure, talk to your doctor before taking this medicine.
Ako se nešto od gore navedenog odnosi na Vas ili niste sigurni, obratite se svom liječniku prije nego uzmete ovaj lijek.
Therefore, in the three studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Stoga je u svim trima ispitivanjima bilo preporučeno da bolesnici nastave uzimati ispitivani lijek sve dok se ne zadovolje kriteriji za prekid liječenja, kako je specificirano u nastavku za svako ispitivanje.
See results below (Table 2).
Vidjeti rezultate u nastavku (Tablica 2).
- Do not take a double dose to make up for the dose you forgot.
- Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
Patients should be advised of the potential risk of experiencing a psychiatric or neurological event while driving or operating machines.
Bolesnike je potrebno obavijestiti o mogućem riziku od nastupa psihijatrijskog ili neurološkog događaja tijekom upravljanja vozilima ili rada sa strojevima.
Concomitant use with other medicinal products
Istovremena primjena s drugim lijekovima
If you take more Xtandi than you should
Ako uzmete više lijeka Xtandi nego što trebate
In addition to the co-primary efficacy endpoints, statistically significant improvements were also demonstrated in the following prospectively defined endpoints.
Osim mjera koprimarnih ishoda djelotvornosti, statistički značajna poboljšanja također su pokazana u sljedećim prospektivno definiranim mjerama ishoda.
In the event of an overdose, treatment with enzalutamide should be stopped and general supportive measures initiated taking into consideration the half-life of 5.8 days.
U slučaju predoziranja liječenje enzalutamidom treba prekinuti i započeti s općim potpornim mjerama, uzimajući u obzir poluvijek od 5,8 dana.
Changes in the reproductive organs in both species were consistent with the pharmacological activity of enzalutamide and reversed or partially resolved after an 8-week recovery period.
Promjene u reproduktivnim organima u obje životinjske vrste bile su sukladne farmakološkom djelovanju enzalutamida i povukle su se potpuno ili djelomično nakon 8-tjednog razdoblja oporavka.
If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take Xtandi.
Ako ste alergični na enzalutamid ili neki drugi sastojak ovog lijeka, nemojte uzeti Xtandi.
The film-coated tablets should not be cut or crushed.
Filmom obložene tablete ne smiju se rezati ni drobiti.
It is not known whether enzalutamide or its metabolites are present in semen.
Nije poznato jesu li enzalutamid ili njegovi metaboliti prisutni u sjemenu.
P-value1
P-vrijednost1
Based on Kaplan-Meier estimates.
4. Na temelju procjena prema Kaplan-Meieru.
Maximum plasma concentrations (Cmax) of enzalutamide in patients are observed 1 to 2 hours after administration.
Maksimalne koncentracije enzalutamida u plazmi (Cmax) bolesnika opažene su 1 do 2 sata nakon primjene.
This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant.
Ovaj lijek može štetiti nerođenom djetetu ili uzrokovati potencijalni gubitak ploda ako ga uzimaju trudnice.
The soft capsules should not be dissolved or opened.
Meke kapsule ne smiju se otapati ni otvarati.
Based on a mass balance study in humans, oral absorption of enzalutamide is estimated to be at least 84.2%.
Na temelju ispitivanja masene bilance u ljudi, procijenjena apsorpcija enzalutamida nakon peroralne primjene iznosi najmanje 84,2%.
Pharmacotherapeutic group: hormone antagonists and related agents, anti-androgens, ATC code: L02BB04.
Farmakoterapijska skupina: antagonisti hormona i srodni lijekovi, anti-androgeni, ATK oznaka: L02BB04.
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.
Ukoliko je njihov terapijski učinak od velike važnosti za bolesnika, i prilagodba doze nije jednostavna jer se temelji na praćenju djelotvornosti ili koncentracija u plazmi, ove lijekove treba izbjegavati ili ih primjenjivati s oprezom.
clopidogrel) - If you use chemotherapy like docetaxel - If you have problems with your liver - If you have problems with your kidneys
klopidogrel) - ako ste podvrgnuti kemoterapiji poput docetaksela - ako imate tegobe s jetrom - ako imate tegobe s bubrezima
There is also a risk of increased formation of active metabolites.
Prisutan je također i rizik od povećanog stvaranja djelatnih metabolita.
The clinical relevance of this observation remains unknown.
Klinički značaj ovog nalaza za sada je nepoznat.
• the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
• liječenje odraslih muškaraca s metastatskim CRPC-om u kojih je bolest progredirala tijekom ili nakon terapije docetakselom.
Xtandi contains sorbitol
Xtandi sadrži sorbitol
UGT1A1 may have been induced as well.
Postoji mogućnost da je bila inducirana i UGT1A1.
Talk to your doctor before taking Xtandi - If you are taking any medicines to prevent blood clots (e.g. warfarin, acenocoumarol,
Razgovarajte sa svojim liječnikom prije uzimanja Xtandija - ako uzimate neke lijekove za sprječavanje zgrušavanja krvi (npr. varfarin, acenokumarol,
Very common (may affect more than 1 in 10 people) Tiredness, broken bones, hot flushes, high blood pressure
Vrlo često (mogu se javiti u više od 1 na 10 osoba) Umor, prijelomi kostiju, navale vrućine, visoki krvni tlak
Do not take any soft capsule that is leaking, damaged, or shows signs of tampering.
Nemojte uzeti meke kapsule koje propuštaju, koje su oštećene ili pokazuju znakove nestručnog rukovanja.
White to off-white oblong soft capsules (approximately 20 mm x 9 mm) imprinted with “ENZ” in black ink on one side.
Bijele do gotovo bijele duguljaste meke kapsule (približno 20 mm x 9 mm) s otisnutom oznakom “ENZ” crnom tintom na jednoj strani.
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.
S obzirom na dugi poluvijek enzalutamida (5,8 dana, vidjeti dio 5.2), učinci na enzime mogu trajati još mjesec dana ili dulje nakon prestanka primjene enzalutamida.
Daily fluctuations in plasma concentrations are low (peak-to-trough ratio of 1.25).
Svakodnevne promjene koncentracije u plazmi su male (omjer najviše i najniže vrijednosti je 1,25).
The AUC of pioglitazone increased by 20% while Cmax decreased by 18%.
AUC pioglitazona povećao se za 20%, dok se Cmax snizio za 18%.
CYP3A4 plays a minor role in the metabolism of enzalutamide.
CYP3A4 igra manju ulogu u metabolizmu enzalutamida.
This medicine contains 57.8 mg sorbitol (a type of sugar) per soft capsule.
Ovaj lijek sadrži 57,8 mg sorbitola (vrstu šećera) po mekoj kapsuli.
Despite low or even undetectable levels of serum androgen, androgen receptor signalling continues to promote disease progression.
Usprkos niskim ili čak nemjerljivim razinama androgena u serumu, signalizacija putem androgenih receptora i dalje potiče progresiju bolesti.
Soft capsule.
Meka kapsula.
Patients may be at increased risk of seizures following an overdose.
Bolesnici mogu imati povećan rizik od napadaja nakon predoziranja.
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.
Puni indukcijski potencijal enzalutamida ne mora nastupiti do približno 1 mjesec nakon početka liječenja, kad se postigne stanje dinamičke ravnoteže koncentracije enzalutamida u plazmi, iako se neki učinci indukcije mogu pojaviti i ranije.
18.4 (17.3, NR)
18,4 (17,3; ND)
Xtandi is used to treat adult men with prostate cancer that no longer responds to androgen deprivation therapy.
Xtandi se primjenjuje za liječenje odraslih muškaraca s rakom prostate koji više ne odgovara na liječenje androgenom deprivacijom.
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 potentan induktor enzima i može dovesti do gubitka djelotvornosti mnogih često primjenjivanih lijekova (vidjeti primjere u dijelu 4.5).
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 potentan induktor enzima i povećava sintezu mnogih enzima i transportera, stoga je interakcija s mnogim često primjenjivanim lijekovima, koji su supstrati enzima ili transportera, očekivana.
• Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)
• statine koje metabolizira CYP3A4 (npr. atorvastatin, simvastatin)
Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
Liječenje enzalutamidom treba započeti i nadzirati liječnik specijalist koji ima iskustva u medikamentoznom liječenju raka prostate.
The risk of heart rhythm problems may be increased when using Xtandi.
Rizik od poremećaja srčanog ritma može biti povišen prilikom uzimanja lijeka Xtandi.
CYP2C8 plays an important role in the elimination of enzalutamide and in the formation of its active metabolite.
CYP2C8 igra važnu ulogu u eliminaciji enzalutamida i u stvaranju njegovog djelatnog metabolita.
Benign Leydig cell tumours are expected based on the pharmacological properties of this antiandrogen drug and not considered relevant to humans.
Dobroćudni tumori Leydigovih stanica očekivani su s obzirom na farmakološka svojstava ovog antiandrogenog lijeka i ne smatraju se značajnima za ljude.
There is no relevant use of enzalutamide in the paediatric population in the indication of treatment of adult men with CRPC.
Nema relevantne primjene enzalutamida u pedijatrijskoj populaciji za indikaciju liječenja odraslih muškaraca s CRPC-om.
- If you forget to take Xtandi for more than one day, talk to your doctor immediately.
- Ako zaboravite uzeti Xtandi dulje od jednog dana, odmah se obratite liječniku.
No studies to evaluate the effects of enzalutamide on the ability to drive and use machines have been conducted.
Nisu provedena ispitivanja kako bi se ocijenili učinci enzalutamida na sposobnost upravljanja vozilima i rada sa strojevima.
You may have an increased risk of seizure or other side effects.
Možete imati povećan rizik od napadaja ili drugih nuspojava.
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.
In vitro se N-dezmetil enzalutamid metabolizira do metabolita karboksilatne kiseline pomoću karboksilesteraze 1, koja također ima manju ulogu u metabolizmu enzalutamida do metabolita karboksilatne kiseline.
- Do not cut, crush or chew the tablets before swallowing.
- Nemojte rezati, drobiti ni žvakati tablete prije gutanja.
The mean apparent volume of distribution (V/F) of enzalutamide in patients after a single oral dose is 110 L (29% CV).
Prosječni prividni volumen distribucije (V/F) enzalutamida u bolesnika nakon jednokratne peroralne doze iznosi 110 l (29% CV).
Leydig cell hypertrophy and/or hyperplasia were observed in mice (4 weeks) and dogs (39 weeks).
Hipertrofija i/ili hiperplazija Leydigovih stanica primijećene su u miševa (4 tjedna) i pasa (39 tjedana).
Co-administration with warfarin and coumarin-like anticoagulants should be avoided.
Potrebno je izbjegavati istovremenu primjenu s varfarinom i antikoagulansima sličnima kumarinu.
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.
Poluvijek enzalutamida je bio udvostručen kod bolesnika s teškim oštećenjem jetre u usporedbi sa zdravim kontrolnim ispitanicima (10,4 dana u usporedbi sa 4,7 dana), što može biti povezano s povećanom distribucijom u tkiva.
Enzalutamide is extensively metabolised.
Enzalutamid se opsežno metabolizira.
All patients continued on a LHRH analogue or had prior bilateral orchiectomy.
Svi bolesnici nastavili su primati analog LHRH ili su prethodno bili podvrgnuti bilateralnoj orhidektomiji.
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 temelju analize populacijske farmakokinetike, nije potrebna prilagodba doze u bolesnika s vrijednostima izračunatog klirensa kreatinina (CrCL) ≥ 30 ml/min (procjena pomoću Cockcroft-Gaultove formule).
If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose.
Ako bolesnik propusti uzeti dozu cijeli jedan dan, liječenje treba nastaviti sljedećeg dana uobičajenom dnevnom dozom.
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.
Klirens enzalutamida prvenstveno se odvija putem jetrenog metabolizma, stvaranjem djelatnog metabolita koji je jednako aktivan kao enzalutamid i cirkulira u približno istoj koncentraciji u plazmi kao i enzalutamid.
Enzalutamide was negative for genotoxicity in a standard battery of in vitro and in vivo tests.
Enzalutamid je bio negativan na genotoksičnost u standardnom nizu testova in vitro i in vivo.
Elderly No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
Nije potrebna prilagodba doze u starijih bolesnika (vidjeti dijelove 5.1 i 5.2).
Caution is required in patients with severe renal impairment as enzalutamide has not been studied in this patient population.
Potreban je oprez u bolesnika s teškim oštećenjem funkcije bubrega, jer enzalutamid nije ispitivan u ovoj populaciji bolesnika.
At study entry, 41% of randomised patients had PSA progression only, whereas 59% of patients had radiographic progression.
Pri uključenju u ispitivanje, 41% randomiziranih bolesnika imalo je progresiju bolesti samo po PSA, dok je 59% bolesnika imalo radiološke znakove progresije bolesti.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at the same or a reduced dose (120 mg or 80 mg) if warranted.
Ako bolesnik razvije toksičnost stupnja ≥ 3 ili nepodnošljivu nuspojavu, uzimanje lijeka treba obustaviti na tjedan dana ili dok se simptomi ne poboljšaju do stupnja ≤ 2, a zatim nastaviti istom ili sniženom dozom (120 mg ili 80 mg) ako je to opravdano.
Enzalutamide treatment of pregnant mice resulted in an increased incidence of embryo-fetal deaths and external and skeletal changes.
Liječenje skotnih ženki miševa enzalutamidom rezultiralo je povećanom incidencijom embrio-fetalnih smrti, te vanjskim i skeletnim promjenama.
BCRP, MRP2, OAT3 and OCT1 substrates
Supstrati BCRP, MRP2, OAT3 i OCT1
28 soft capsules
28 mekih kapsula
Ischemic Heart Disease
Ishemijska bolest srca
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 metabolizira CYP2C8 i u manjoj mjeri CYP3A4/5 (vidjeti dio 4.5), od kojih oba igraju ulogu u stvaranju djelatnog metabolita.
The dose of Xtandi or any other medicines that you are taking may need to be changed.
Možda će Vam trebati promijeniti dozu lijeka Xtandi ili nekog drugog lijeka koji uzimate.
Animal studies showed that enzalutamide affected the reproductive system in male rats and dogs (see section 5.3).
Ispitivanja na životinjama pokazala su da je enzalutamid utjecao na reproduktivni sustav mužjaka štakora i pasa (vidjeti dio 5.3).
Enzalutamide and/or its metabolites are secreted in rat milk (see section 5.3).
Enzalutamid i/ili njegovi metaboliti se izlučuju u mlijeko štakora (vidjeti dio 5.3).
NR = Not Reached.
ND = Nije dostignut.
Other important adverse reactions include fall, cognitive disorder, and neutropenia.
Ostale važne nuspojave uključuju padove, kognitivni poremećaj i neutropeniju.
- Do not chew, dissolve or open the soft capsules before swallowing.
- Nemojte žvakati, otapati niti otvarati meke kapsule prije gutanja.
If you stop taking Xtandi
Ako prestanete uzimati Xtandi
Hazard ratio (95% CI)2
Omjer hazarda (95% CI)2
With daily oral administration, enzalutamide accumulates approximately 8.3-fold relative to a single dose.
Kod svakodnevne peroralne primjene, enzalutamid se nakuplja približno 8,3 puta više nego kod primjene jednokratne doze.
Patients taking medicinal products that are substrates of CYP2B6, CYP3A4, CYP2C9, CYP2C19 or UGT1A1 should be evaluated for possible loss of pharmacological effects (or increase in effects in cases where active metabolites are formed) during the first month of enzalutamide treatment and dose adjustment should be considered as appropriate.
U bolesnika koji uzimaju lijekove koji su supstrati CYP2B6, CYP3A4, CYP2C9, CYP2C19 ili UGT1A1 treba procijeniti mogući gubitak farmakoloških učinaka (ili pojačanja učinaka u slučajevima u kojima se stvaraju aktivni metaboliti) tijekom prvog mjeseca liječenja enzalutamidom i po potrebi razmotriti prilagodbu doze.
- If you forget to take Xtandi at the usual time, take your usual dose as soon as you remember.
- Ako zaboravite uzeti Xtandi u uobičajeno vrijeme, uzmite svoju uobičajenu dozu čim se sjetite.
Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.
Bilo kakav poremećaj srca ili krvnih žila, uključujući poremećaje srčanog ritma (aritmija), ili uzimate lijekove za navedene poremećaje.
Patients were allowed but not required to take prednisone (maximum daily dose allowed was 10 mg prednisone or equivalent).
Bolesnici su smjeli, ali nisu morali uzimati prednizon (maksimalna dopuštena dnevna doza bila je 10 mg prednizona ili ekvivalent).
If you forget to take Xtandi
Ako ste zaboravili uzeti Xtandi
A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Za potvrdu dijagnoze PRES-a potrebno je oslikavanje mozga, po mogućnosti magnetska rezonancija (MR).
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.
Na temelju tih predviđanja, kao i drugih potpornih podataka, medijan vremena do postizanja maksimalnih plazmatskih koncentracija enzalutamida (Cmax) iznosi 2 sata (raspon: 0,5 - 6 sati), a farmakokinetički profili enzalutamida i njegovog djelatnog metabolita u stanju dinamičke ravnoteže slični su kod primjene filmom obloženih tableta i kod primjene Xtandi mekih kapsula.
- 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.
- Ako imate spolne odnose sa ženom koja može zatrudnjeti, koristite prezervativ i drugu učinkovitu metodu kontrole začeća tijekom liječenja i 3 mjeseca nakon liječenja ovim lijekom.
In clinical trials, Xtandi was administered without regard to food.
U kliničkim ispitivanjima, Xtandi se primjenjivao bez obzira na hranu.
Enzalutamide is not for use in women.
Enzalutamid nije namijenjen primjeni u žena.
Dose appears to be an important predictor of the risk of seizure, as reflected by preclinical data, and data from a dose-escalation study.
Čini se da je doza važan prediktor rizika od pojave napadaja, kako to pokazuju pretklinički podaci i podaci dobiveni ispitivanjem povećanja doze.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake kategorije učestalosti, nuspojave su navedene od ozbiljnijih prema manje ozbiljnima.
‡ Includes all preferred terms with the word ‘fracture' in bones.
‡** Uključuje sve preporučene pojmove koji se odnose na kosti i uključuju riječ ‘prijelom'.
If you take more soft capsules than prescribed, stop taking Xtandi and contact your doctor.
Ako uzmete više mekih kapsula nego što je propisano, prestanite uzimati Xtandi i obratite se svom liječniku.
Consistent MFS results were also observed in all pre-specified patient subgroups including PSADT (< 6 months or ≥ 6 months), demographic region (North America, Europe, rest of world), age (< 75 or ≥ 75), use of a prior bone-targeting agent (yes or no).
Dosljedni rezultati za MFS opaženi su i u svim unaprijed određenim podskupinama bolesnika, uključujući podskupine prema PSADT-u (< 6 mjeseci ili ≥ 6 mjeseci), demografskoj regiji (Sjeverna Amerika, Europa, ostatak svijeta), dobi (< 75 ili ≥ 75) i prethodnoj primjeni lijekova koji ciljano djeluju na kosti (da ili ne).
Enzyme induction
Indukcija enzima
Most patients (approximately 71%) in the study were Caucasian; 16% were Asian and 2% were Black.
Većina bolesnika (približno 71%) u ispitivanju bili su bijelci, 16% činili su azijati, a 2% crnci.
This medicine contains less than 1 mmol sodium (less than 23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol natrija (manje od 23 mg) po jednoj filmom obloženoj tableti, tj. sadrži zanemarive količine natrija
The film-coated tablets should not be cut, crushed or chewed but should be swallowed whole with water, and can be taken with or without food.
Filmom obložene tablete ne se smiju rezati, drobiti ni žvakati te ih treba progutati cijele s vodom, a mogu se uzimati s hranom ili bez nje.
Daily dosing of rats for two years with enzalutamide at 10-100 mg/kg/day produced an increased incidence of several, mostly benign, tumour types.
U štakora je svakodnevna primjena enzalutamida u dozi od 10 - 100 mg/kg na dan tijekom dvije godine povećala incidenciju nekoliko vrsta tumora, uglavnom dobroćudnih.
The pharmacokinetics of enzalutamide have been evaluated in prostate cancer patients and in healthy male subjects.
Farmakokinetika enzalutamida procijenjena je u bolesnika s rakom prostate i u zdravih muških ispitanika.
In vitro data indicate that enzalutamide and its major metabolites do not inhibit the following transporters at clinically relevant concentrations: OATP1B1, OATP1B3, OCT2, or OAT1.
In vitro podaci pokazuju da enzalutamid i njegovi glavni metaboliti ne inhibiraju sljedeće transportere u klinički važnim koncentracijama: OATP1B1, OATP1B3, OCT2 ili OAT1.
If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time.
Ako bolesnik propusti uzeti Xtandi u uobičajeno vrijeme, propisanu dozu treba uzeti čim bliže uobičajenom vremenu.
• the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
• liječenje odraslih muškaraca s metastatskim CRPC-om koji su asimptomatski ili s blagim simptomima nakon neuspješnog liječenja androgenom deprivacijom, a u kojih kemoterapija još nije klinički indicirana (vidjeti dio 5.1).
The AUC and Cmax of caffeine decreased by 11% and 4% respectively.
AUC i Cmax kofeina snizili su se za 11 odnosno 4 %.