natgillin/translations-raw huggingface dataset:
No clinically relevant effect of age on enzalutamide pharmacokinetics was seen in the elderly population pharmacokinetic analysis. 
Nije opažen klinički važan učinak dobi na farmakokinetiku enzalutamida u analizi populacijske farmakokinetike.
If you are at higher risk of seizures, talk to your doctor. 
Ako imate povećan rizik za napadaje, trebate se obratiti liječniku.
Enzalutamide (160 mg once daily) did not cause a clinically relevant change in the AUC or Cmax of caffeine (CYP1A2 substrate) or pioglitazone (CYP2C8 substrate). 
Enzalutamid (160 mg jedanput na dan) nije prouzročio klinički važne promjene u AUC ili Cmax kofeina (supstrat CYP1A2) ili pioglitazona (supstrat CYP2C8).
Key secondary endpoints assessed in the study were time to PSA progression, time to first use of new antineoplastic therapy (TTA), overall survival (OS). 
Ključne mjere sekundarnih ishoda koje su se ocjenjivale u ispitivanju bile su vrijeme do progresije PSA, vrijeme do prve primjene nove antineoplastične terapije, ukupno preživljenje (engl. overall survival, OS).
Groups of medicinal products that can be affected include, but are not limited to: 
Skupine lijekova kod kojih može doći do interakcija uključuju, između ostalih, i sljedeće:
- Swallow the soft capsules whole with water. 
Uzimanje lijeka Xtandi - Meke kapsule progutajte cijele s vodom.
- If you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6). 
Nemojte uzimati Xtandi: - ako ste alergični na enzalutamid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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]. 
Djelotvornost enzalutamida utvrđena je u trima randomiziranim, placebom kontroliranim multicentričnim kliničkim ispitivanjima faze III [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] na bolesnicima s progresivnim rakom prostate kod kojih je liječenje androgenom deprivacijom bilo neuspješno [analog LHRH ili nakon bilateralne orhidektomije].
Contains sorbitol (E420). 
Sadrži sorbitol (E420).
Studies in rodents indicate that enzalutamide and its active metabolite can cross the blood brain barrier. 
Ispitivanja u glodavaca pokazuju da enzalutamid i njegov djelatni metabolit mogu prijeći krvno-moždanu barijeru.
The median age was 69 years (range 41 - 92) and the racial distribution was 93% Caucasian, 4% Black, 1% Asian, and 2% Other. 
Medijan dobi iznosio je 69 godina (raspon 41 - 92), a rasna raspodjela bila je 93% bijelaca, 4% crnaca, 1% azijata i 2% drugih rasa.
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. 
Medijan dobi iznosio je 71 godinu (u rasponu 42 - 93), a distribucija prema rasi bila je 77% bijele rase, 10% azijati, 2% crne i 11% druge ili nepoznate rase.
Xtandi is for oral use. 
Xtandi je namijenjen za peroralnu primjenu.
• Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil) 
• blokatore kalcijevih kanala (npr. diltiazem, felodipin, nikardipin, nifedipin, verapamil)
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: 
Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Radi ispitivanja dugoročnog učinka enzalutamida na ukupno preživljenje i važne mjere sekundarnih ishoda kod odraslih muškaraca s visokorizičnim nemetastatskim rakom prostate rezistentnim na kastraciju, nositelj odobrenja treba predati rezultate ispitivanja djelotvornosti MDV310014 (PROSPER).
The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers. 
Smatra se da je rizik od jetrenog oštećenja nakon primjene paracetamola veći u bolesnika koji istovremeno uzimaju induktore enzima.
The ECOG performance score was 0 - 1 in 91.5% of patients and 2 in 8.5% of patients; 28% had a mean Brief Pain Inventory score of ≥ 4 (mean of patient's reported worst pain over the previous 24 hours calculated for seven days prior to randomisation). 
Ocjena općeg stanja prema ECOG-u iznosila je 0 - 1 u 91,5% bolesnika i 2 u 8,5% bolesnika; 28% bolesnika imalo je prosječnu ocjenu na Kratkom upitniku o boli ≥ 4 (prosječno najjača bol koju je bolesnik prijavio u prethodna 24 sata izračunata iz sedam dana prije randomizacije).
9785-CL-0410 study (enzalutamide post abiraterone in patients with metastatic CRPC) 
Ispitivanje 9785-CL-0410 (enzalutamid nakon primjene abiraterona u bolesnika s metastatskim CRPC-om)
The HR is relative to placebo with < 1 favouring enzalutamide. 
HR je prikazan u odnosu na placebo, a vrijednost < 1 govori u prilog enzalutamidu.
No dose adjustment is necessary for patients with mild, moderate or severe hepatic impairment (ChildPugh Class A, B or C, respectively). 
Nije potrebna prilagodba doze u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije jetre (Child-Pugh stadij A, B, odnosno C).
Seizures were reported in 4 in every 1,000 people taking Xtandi, and fewer than one in every 1,000 people taking placebo (see ‘Other medicines and Xtandi' below and section 4 ‘Possible side effects'). 
Napadaji su zabilježeni u 4 na svakih 1000 osoba koje su uzimale Xtandi i kod manje od jedne na svakih 1000 osoba koje su uzimale placebo (vidjeti odlomak ‘Drugi lijekovi i Xtandi'i dio 4. ‘Moguće nuspojave').
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). 
Xtandi umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima, jer su zabilježeni psihijatrijski i neurološki učinci, uključujući napadaje (vidjeti dio 4.8).
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. 
Ispitivanje je uključivalo jednu skupinu od 214 bolesnika s progredirajućim metastatskim CRPC-om koji su liječeni enzalutamidom (160 mg jednom dnevno) nakon najmanje 24 tjedna liječenja abirateronacetatom i prednizonom.
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. 
Analiza je uključila 216 slučajeva smrti bez dokumentirane progresije bolesti i 645 dokumentiranih progresija bolesti, među kojima se 303 (47%) odnosilo na progresiju bolesti u mekim tkivima, 268 (42%) na progresiju koštanih lezija, a 74 (11%) i na meka tkiva i na koštane lezije.
Under conditions of clinical use, enzalutamide is a strong inducer of CYP3A4, a moderate inducer of CYP2C9 and CYP2C19, and has no clinically relevant effect on CYP2C8 (see section 4.5). 
U uvjetima kliničke primjene, enzalutamid je jaki induktor CYP3A4, umjereni induktor CYP2C9 i CYP2C19 i nema klinički važan učinak na CYP2C8 (vidjeti dio 4.5).
The Interim Analysis report of OS should be submitted by: 
Izvješće interim analize ukupnog preživljenja, mora biti predano do:
An increased half-life of enzalutamide has however been observed in patients with severe hepatic impairment (see sections 4.4 and 5.2). 
Produljeni poluvijek enzalutamida bio je zabilježen kod bolesnika s teškim oštećenjem jetre (vidjeti dijelove 4.4 i 5.2).
Metastasis-free survival (MFS) was the primary endpoint defined as the time from randomisation to radiographic progression or death within 112 days of treatment discontinuation without evidence of radiographic progression, whichever occurred first. 
Mjera primarnog ishoda bila je preživljenje bez metastaza (engl. metastasis-free survival, MFS), koje se definiralo kao vrijeme od randomizacije do radiografske progresije bolesti ili smrti unutar 112 dana od prekida liječenja bez dokaza radiografske progresije, što god je nastupilo prvo.
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). 
Protokolom planirana interim analiza nakon 520 smrti pokazala je statistički značajnu superiornost u ukupnom preživljenju bolesnika liječenih enzalutamidom u usporedbi s placebom (Tablica 4 i Slike 7 i
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). 
Ako se prekine istovremena primjena jakog inhibitora CYP2C8, dozu enzalutamida treba vratiti na razinu koja je primjenjivana prije početka primjene jakog inhibitora CYP2C8 (vidjeti dio 4.5).
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. 
Srednja vrijednost terminalnog poluvijeka (t1/2) enzalutamida u bolesnika nakon jednokratne peroralne doze iznosi 5,8 dana (raspon 2,8 do 10,2 dana), a stanje dinamičke ravnoteže postiže se za približno mjesec dana.
In preclinical studies, the absorption of enzalutamide was increased when dissolved in caprylocaproyl macrogolglycerides. 
U prekliničkim je ispitivanjima apsorpcija enzalutamida bila povećana kada se otopio u kaprilokaproil makrogolgliceridima.
Very common: hot flush, hypertension 
Krvožilni poremećaji vrlo često: navale vrućine, hipertenzija
• Antipsychotics (e.g. haloperidol) 
• antipsihotike (npr. haloperidol)
- Swallow the tablets whole with water. 
Uzimanje lijeka Xtandi - Tablete progutajte cijele s vodom.
Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated. 
Farmakološku kastraciju analogom hormona koji oslobađa luteinizirajući hormon (engl. luteinising hormone-releasing hormone, LHRH) potrebno je nastaviti tijekom čitavog trajanja liječenja u bolesnika kod kojih nije izvršena kirurška kastracija.
PSA Response (defined as ≥ 50% decrease from baseline) was 22.4% (95% CI: 17.0, 28.6). 
PSA odgovor (definiran kao smanjenje ≥ 50% od početne vrijednosti) iznosio je 22,4% (95% CI: 17,0; 28,6).
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. 
Terapija androgenom deprivacijom može produljiti QT interval Kod bolesnika sa rizičnim faktorima za produljenje QT intervala u anamnezi i kod bolesnika koji istovremeno uzimaju lijekove koji mogu produljiti QT interval (vidjeti dio 4.5) liječnik treba procijeniti omjer rizika i koristi uključujući potencijal za Torsade de pointes prije propisivanja lijeka Xtandi.
N-desmethyl enzalutamide was not metabolised by CYPs in vitro. 
N-dezmetil enzalutamid nije bio metaboliziran enzimima CYP in vitro.
Headache, fall, feeling anxious, dry skin, itching, difficulty remembering, blockage of the arteries in the heart (ischemic heart disease), breast enlargement in men (gynaecomastia), symptom of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg), reduced concentration, forgetfulness 
Glavobolja, padovi, osjećaj tjeskobe, suha koža, svrbež, otežano pamćenje, začepljenje arterija u srcu (ishemijska bolest srca), povećanje dojki u muškaraca (ginekomastija), simptomi sindroma nemirnih nogu (potreba pokretanja dijelova tijela, obično nogu, koja se ne može kontrolirati), smanjena koncentracija, zaboravljivost
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). 
U podskupini nemetastatskih bolesnika (N = 139) kod ukupno 19 od 70 (27,1%) bolesnika liječenih enzalutamidom te 49 od 69 (71,0%) bolesnika liječenih bikalutamidom zabilježeni su događaji PFS-a (ukupno 68 događaja).
¥ As evaluated by narrow SMQs of ‘Convulsions' including convulsion, grand mal convulsion, complex partial seizures, partial seizures, and status epilepticus. 
Ocijenjeno na temelju uskog standardiziranog MedDRA upita (engl. standardised MedDRA query, SMQ) za pojam ‘konvulzije', koji uključuje konvulzije, grand mal konvulzije, kompleksne parcijalne napadaje, parcijalne napadaje i epileptični status.
In the 9785-CL-0403 (UPWARD) single-arm trial to assess incidence of seizure in patients with predisposing factors for seizure (whereof 1.6% had a history of seizures), 8 of 366 (2.2%) patients treated with enzalutamide experienced a seizure. 
U ispitivanju 9785-CL-0403 (UPWARD) s jednom skupinom bolesnika u kojem je cilj bio ocijeniti incidenciju napadaja u bolesnika s predisponirajućim čimbenicima za napadaje (gdje je 1,6 % bolesnika imalo napadaje u anamnezi), kod 8 od 366 (2,2 %) bolesnika liječenih enzalutamidom su se razvili napadaji.
By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing. 
Blokiranjem androgena, enzalutamid zaustavlja rast i diobu stanica raka prostate.
Median rPFS (radiologic progression free survival, the study´s primary endpoint) was 8.1 months (95% CI: 6.1, 8.3). 
Medijan rPFS (preživljenje bez radiološke progresije, koje je mjera primarnog ishoda) bio je 8,1 mjeseci (95% CI: 6,1; 8,3).
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. 
Potpuni odgovor zabilježen je u 19,7% bolesnika liječenih enzalutamidom u usporedbi s 1,0% bolesnika liječenih placebom, a parcijalni odgovor zabilježen je u 39,1% bolesnika liječenih enzalutamidom u odnosu na 3,9% bolesnika liječenih placebom.
Prostate cancer is known to be androgen sensitive and responds to inhibition of androgen receptor signalling. 
Poznato je da je rak prostate osjetljiv na androgene i odgovara na inhibiciju signalizacije putem androgenih receptora.
Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS). 
Mjere koprimarnih ishoda djelotvornosti bile su ukupno preživljenje i preživljenje bez radiografske progresije bolesti (rPFS prema engl. radiographic progression-free survival).
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). 
multidrug resistance-associated protein 2), BCRP (eng. breast cancer resistance protein) te OATP1B1 (eng. organic anion transporting polypeptide 1B1).
Most (91%) patients had metastases in bone and 23% had visceral lung and/or liver involvement. 
Većina (91%) bolesnika imala je metastaze u kostima, dok su pluća i/ili jetra bili zahvaćeni u njih 23%.
This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant (see sections 4.3, 5.3, and 6.6). 
Ovaj lijek može štetiti nerođenom djetetu ili uzrokovati potencijalni gubitak ploda kod trudnica koje uzimaju lijek (vidjeti dijelove 4.3, 5.3 i 6.6).
† 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. 
† Ocijenjeno na temelju uskog SMQ-a za pojmove ‘infarkt miokarda' i ‘druge ishemijske bolesti srca', koji uključuju sljedeće preporučene pojmove opažene u najmanje dva bolesnika u randomiziranim, placebom kontroliranim ispitivanjima faze 3: anginu pektoris, bolest koronarnih arterija, infarkt miokarda, akutni infarkt miokarda, akutni koronarni sindrom, nestabilnu anginu, ishemiju miokarda i arteriosklerozu koronarne arterije.
Treatment with enzalutamide decreased the risk of FACT-P degradation by 37.5% compared with placebo (p < 0.0001). 
Liječenje enzalutamidom snizilo je rizik za smanjenje rezultata FACT-P za 37,5% u usporedbi s placebom (p < 0,0001).
• Analgesics (e.g. fentanyl, tramadol) 
• analgetike (npr. fentanil, tramadol)
• Tablet coating: Hypromellose, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172). 
• Ovojnica tablete: hipromeloza, talk, makrogol 8000, titanijev dioksid (E171), žuti željezov oksid (E172)
The median time to degradation in FACT-P was 11.3 months in the enzalutamide group and 5.6 months in the placebo group. 
Medijan vremena do smanjenja rezultata FACT-P iznosio je 11,3 mjeseca u skupini liječenoj enzalutamidom i 5,6 mjeseci u skupini liječenoj placebom.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
The final clinical study report should be submitted by. 
Konačno kliničko izvješće mora biti predano do:
In a clinical study in patients with metastatic CRPC, Xtandi (160 mg once daily) had no clinically relevant effect on the pharmacokinetics of intravenously administered docetaxel (75 mg/m2 by infusion every 3 weeks). 
U kliničkom ispitivanju na bolesnicima s metastatskim rakom prostate rezistentnim na kastraciju, Xtandi (160 mg jedanput na dan) nije imao klinički značajan učinak na farmakokinetiku intravenski primijenjenog docetaksela (75 mg/m2 u infuziji svaka 3 tjedna).
For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 77% while Cmax decreased by 19%. 
Za ukupnu količinu nevezanog enzalutamida i nevezanog aktivnog metabolita, AUC se povećao za 77%, dok se Cmax smanjio za 19%.
Overall survival was evaluated at two prespecified interim analyses to date; the first at the time of final MFS (n = 165) [HR = 0.80 (95% CI: 0.58, 1.09), p = 0.1519], and the second interim analysis (n = 288) [HR = 0.83 (95% CI: 0.65, 1.06), p = 0.1344]. 
Ukupno preživljenje je do danas procijenjeno u dvije unaprijed planirane interim analize, prva u vrijeme konačnog MFS-a (n=165) [HR = 0.80 (95% CI: 0.58, 1.09), p = 0.1519], a druga interim analiza (n=288) [HR = 0.83 (95% CI: 0.65, 1.06), p = 0.1344].
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 
Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) Mišićna bol, grčevi mišića, mišićna slabost, bol u leđima, promjene u EKG-u (QT produljenje), nadražen želudac uključujući mučninu, osip, povraćanje, oticanje lica, usana, jezika i/ ili grla, smanjenje broja krvnih pločica (što može povećati rizik od krvarenja ili modrica na koži), proljev
Tell your doctor if you are taking any of the medicines listed above. 
Obavijestite liječnika ako uzimate neki od gore navedenih lijekova.
• Antiepileptics (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid) 
• antiepileptike (npr. karbamazepin, klonazepam, fenitoin, primidon, valproatna kiselina)
Food has no clinically significant effect on the extent of exposure to enzalutamide. 
Hrana nema klinički značajnog učinka na opseg izloženosti enzalutamidu.
PSA Response was 23.2% (95% CI: 13.9, 34.9). 
PSA odgovor je bio 23,2 % (95% CI: 13,9; 34,9).
If Xtandi is co-administered with an anticoagulant metabolised by CYP2C9 (such as warfarin or acenocoumarol), additional International Normalised Ratio (INR) monitoring should be conducted (see section 4.5). 
Ako se Xtandi primjenjuje istovremeno s antikoagulansom koji se metabolizira putem CYP2C9 (kao što je varfarin ili acenokumarol), potrebno je dodatno pratiti INR (eng.
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. 
Uz mjere koprimarnih ishoda, korist je ocjenjivana i pomoću vremena do započinjanja citotoksične kemoterapije, najboljeg sveukupnog odgovora mekog tkiva, vremena do pojave prvog koštanog događaja, odgovora PSA (smanjenje ≥ 50% u odnosu na početne vrijednosti), vremena do progresije PSA i vremena do smanjenja ukupnog FACT-P rezultata (od engl.
Each carton contains 4 wallets (112 soft capsules). 
Svaka kutija sadrži 4 omota (112 mekih kapsula).
In controlled clinical studies, 13 patients (0.4%) experienced a seizure out of 3179 patients treated with a daily dose of 160 mg enzalutamide, whereas one patient (0.1%) receiving placebo and one patient (0.3%) receiving bicalutamide, experienced a seizure. 
U kontroliranim kliničkim ispitivanjima, 13 bolesnika (0,4%) od 3179 liječenih dnevnom dozom od 160 mg enzalutamida imalo je napadaje, dok je napadaje imao jedan bolesnik (0,1%) koji je primao placebo i jedan bolesnik (0,3%) koji je primao bikalutamid.
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. 
Ako bolesnik ima spolne odnose sa ženom reproduktivne dobi, mora upotrebljavati prezervative i neki drugi oblik kontrole začeća za vrijeme i tijekom 3 mjeseca nakon liječenja.
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. 
Ovaj lijek umjereno utječe na Vašu sposobnost upravljanja vozilima i rukovanja alatima ili strojevima s obzirom na to da u nuspojave koje se mogu javiti kod primjene lijeka Xtandi spadaju psihijatrijski i neurološki događaji, uključujući napadaje.
EU/1/13/846/002 (film-coated tablet 40 mg) EU/1/13/846/003 (film-coated tablet 80 mg) 
EU/1/13/846/003 (filmom obložena tableta 80 mg)
Table 1: Adverse reactions identified in controlled clinical trials and post-marketing MedDRA System organ class Adverse reaction and frequency 
Tablica 1: Nuspojave identificirane u kontroliranim kliničkim ispitivanjima i nakon stavljanja lijeka u promet Klasifikacija organskih sustava prema MedDRA-i
35.3 (32.2, NR) 31.3 (28.8, 34.2) 
35.3 (32,2; ND) 31.3 (28,8; 34,2)
The usual dose is 160 mg (four soft capsules), taken at the same time once a day. 
Uobičajena doza je 160 mg (četiri meke kapsule) i uzima se jedanput na dan u isto vrijeme.
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. 
Pojedini urotelni papilom i karcinom mokraćnog mjehura su u štakora očekivani na temelju horizontalne strukturę mokraćnog mjehura štakora koji može doći u doticaj s koncentriranim urinom i produljiti iritaciju izazvanu kamencem.