natgillin/translations-raw huggingface dataset:
EU/1/11/714/002 (56 film-coated tablets) EU/1/11/714/003 (60 film-coated tablets) 
EU/1/11/714/002 - (56 filmsko obloženi tablet) EU/1/11/714/003 - (60 filmsko obloženi tablet)
Abiraterone affected fertility in male and female rats, but these effects were fully reversible (see section 5.3). 
Abirateron vpliva na plodnost pri samicah in samcih podgan, vendar so njegovi učinki reverzibilni (glejte poglavje 5.3).
In Study 3011, grade 3 or 4 hepatotoxicity was observed in 8.4% of patients treated with ZYTIGA. 
V študiji 3011 so hepatotoksičnost 3. ali 4. stopnje opažali pri 8,4% bolnikov, ki so se zdravili z zdravilom ZYTIGA.
Injury, poisoning and procedural complications common: fractures** 
Poškodbe in zastrupitve in zapleti pri posegih pogosti: zlomi**
Figure 7: Overall survival by subgroup: hazard ratio and 95% confidence interval 
Celokupno preživetje po podskupinah: razmerje tveganja in 95-odstotni interval zaupanja
- If you are having sex with a pregnant woman, use a condom to protect the unborn child. 
Če imate spolne odnose z nosečnico, uporabljajte kondom, da zaščitite nerojenega otroka.
In these fertility and developmental toxicity studies performed in the rat, all effects were related to the pharmacological activity of abiraterone. 
V teh študijah plodnosti in razvojnih študijah toksičnega delovanja, ki so bile izvedene pri podganah, so bili vsi učinki povezani s farmakološkim delovanjem abiraterona.
Stop taking ZYTIGA and see a doctor immediately if you notice any of the following: - Muscle weakness, muscle twitches or a pounding heart beat (palpitations). 
Takoj prenehajte jemati zdravilo ZYTIGA in pojdite k zdravniku, če opazite katerega od teh neželenih učinkov: - mišična šibkost, trzanje mišic ali razbijanje srca (palpitacije).
This medicinal product may pose a risk to the aquatic environment (see section 5.3). 
To zdravilo lahko predstavlja tveganje za vodno okolje (glejte poglavje 5.3).
Efficacy was established in three randomised placebo-controlled multicentre Phase 3 clinical studies (studies 3011, 302 and 301) of patients with mHSPC and mCRPC. 
Učinkovitost so ugotavljali v treh randomiziranih, s placebom nadzorovanih, multicentričnih kliničnih študijah faze 3 (študijah 3011, 302 in 301) pri bolnikih z mHSPC in mCRPC.
Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data). 
Kategorije pogostnosti so opredeljene z naslednjim dogovorom: 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) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
EU/1/11/714/002 - 56 film-coated tablets (4 wallet packs of 14) EU/1/11/714/003 - 60 film-coated tablets (5 wallet packs of 12) 
EU/1/11/714/002 - 56 filmsko obloženih tablet (4 zloženke po 14 tablet) EU/1/11/714/003 - 60 filmsko obloženih tablet (5 zloženk po 12 tablet)
The safety and efficacy of concomitant use of ZYTIGA with cytotoxic chemotherapy has not been established (see section 5.1). 
Varnost in učinkovitost sočasne uporabe zdravila ZYTIGA in citotoksične kemoterapije ni bila ugotovljena (glejte poglavje 5.1).
Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels. 
Spironolakton se veže na androgene receptorje in lahko zveča koncentracije za prostato specifičnega antigena (PSA).
Although these results indicate that no clinically meaningful increases in exposure are expected when ZYTIGA is combined with medicinal products that are predominantly eliminated by CYP2C8, patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly. 
Čeprav ti rezultati kažejo, da ni pričakovati klinično pomembne zvečane izpostavljenosti ob sočasnem jemanju zdravila ZYTIGA z zdravili, ki se izločajo predvsem s CYP2C8, je treba bolnike spremljati glede znakov toksičnosti, povezanih s sočasno uporabo substratov CYP2C8 z ozkim terapevtskim oknom.
ZYTIGA contains lactose and sodium - ZYTIGA contains lactose (a type of sugar). 
Zdravilo ZYTIGA vsebuje laktozo in natrij - Zdravilo ZYTIGA vsebuje laktozo (vrsto sladkorja).
- Do not use this medicine after the expiry date which is stated on the carton and the bottle label. 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki plastenke.
The planned final analysis for OS was conducted after 741 deaths were observed (median follow up of 49 months). 
Načrtovana končna analiza celokupnega preživetja je bila izvedena po smrti 741 bolnikov (mediani čas spremljanja bolnikov 49 mesecev).
Endocrine disorders uncommon: adrenal insufficiency 
Bolezni endokrinega sistema občasni: adrenalna insuficienca
If clinical symptoms or signs suggestive of hepatotoxicity develop, serum transaminases should be measured immediately. 
Če se razvijejo klinični znaki ali simptomi, ki kažejo na hepatotoksičnost, je treba takoj izmeriti koncentracijo aminotransferaz v serumu.
The majority of exploratory endpoints favored treatment with abiraterone acetate and prednisone (AA-P) over Placebo. 
Večina raziskovanih ciljev je bila v prid zdravljenju z abirateronacetatom in prednizonom (AA-P) v primerjavi s placebom.
The AUC24 for dextrorphan, the active metabolite of dextromethorphan, increased approximately 33%. 
AUC24 dekstrorfana, aktivnega presnovka dekstrometorfana, se je povečala za približno 33%.
AA-P= subjects who received abiraterone acetate and prednisone. 
AA-P= preiskovanci, ki so prejemali abirateronacetat in prednizon.
High-risk prognosis was defined as having at least 2 of the following 3 risk factors: (1) Gleason score of ≥8; (2) presence of 3 or more lesions on bone scan; (3) presence of measurable visceral (excluding lymph node disease) metastasis. 
Visoki prognostični dejavniki tveganja so bili izpolnitev najmanj 2 od naslednjih 3 faktorjev tveganja; (1) ocena po Gleasonu ≥8;(2) prisotnost 3 ali več lezij posnetku okostja; (3) prisotnost merljivih visceralnih metastaz (brez prisotnosti bolezni v bezgavkah).
Based on a cumulative review of the data in relation to latency of rhabdomyolysis/myopathy cases, almost half of these cases occurred between 1 to 6 months after initiation of therapy with abiraterone acetate (AA). 
Na osnovi kumulativnega pregleda podatkov v povezavi z latenco primerov rabdomiolize/miopatije, je do skoraj polovice teh primerov prišlo med 1. in 6. mesecem po uvedbi zdravljenja z abirateronacetatom (AA).
Effect of food on abiraterone acetate 
Vpliv hrane na abirateronacetat
Human experience of overdose with ZYTIGA is limited. 
Izkušnje s prevelikim odmerjanjem zdravila ZYTIGA pri ljudeh so omejene.
Subjects randomised Event 
Randomizirani preiskovanci Dogodek
Skeletal muscle effects 
Učinki na mišično-skeletni sistem
Excipients with known effect Each film-coated tablet contains 253.2 mg of lactose and 13.5 mg of sodium. 
Pomožne snovi z znanim učinkom Ena filmsko obložena tableta vsebuje 253,2 mg laktoze in 13,5 mg natrija.
Table 1: Adverse reactions identified in clinical studies and post-marketing System Organ Class 
Preglednica 1: Neželeni učinki, poročani v kliničnih študijah in v obdobju trženja zdravila Organski sistem
Fifty percent of patients had only bone metastases, an additional 31% of patients had bone and soft tissue or lymph node metastases and 19% of patients had only soft tissue or lymph node metastases. 
Samo kostne metastaze je imelo 50% bolnikov, 31% bolnikov je imelo kostne metastaze, metastaze v mehkih tkivih ali v bezgavkah, 19% bolnikov pa je imelo metastaze samo v mehkih tkivih ali samo v bezgavkah.
Taking the tablets with food increases systemic exposure to abiraterone (see sections 4.5 and 5.2). 
Jemanje tablet s hrano poveča sistemsko izpostavljenost abirateronu (glejte poglavji 4.5 in 5.2).
Discard unused contents appropriately in accordance with local requirements. 
Neuporabljeno vsebino zavrzite v skladu z lokalnimi predpisi.
Tell your doctor if you are taking any of the medicines listed above. 
Zdravnika obvestite, če jemljete katero od navedenih zdravil.
For patients who develop Grade ≥ 3 toxicities including hypertension, hypokalaemia, oedema and other non-mineralocorticoid toxicities, treatment should be withheld and appropriate medical management should be instituted. 
Pri bolnikih s stopnjo toksičnosti ≥ 3, vključno s hipertenzijo, hipokaliemijo, edemom in drugimi nemineralokortikoidnimi toksičnostmi, je treba zdravljenje prekiniti in uvesti primerno zdravljenje.
Contains lactose and sodium. 
Vsebuje laktozo in natrij.
This is important because ZYTIGA may increase the effects of a number of medicines including heart medicines, tranquilisers, herbal medicines (e.g., St John's wort) and others. 
To je pomembno, ker lahko zdravilo ZYTIGA poveča učinek številnih zdravil, tudi zdravil za zdravljenje srčnih bolezni, pomirjeval, zdravil rastlinskega izvora (npr. šentjanževka) in drugih zdravil.
If you forget to take ZYTIGA - If you forget to take ZYTIGA or prednisone or prednisolone, take your usual dose the following day. 
Če ste pozabili vzeti zdravilo ZYTIGA - Če ste pozabili vzeti zdravilo ZYTIGA ali prednizon oziroma prednizolon, naslednji dan vzemite običajni odmerek.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied. 
Odbor CHMP zato priporoča spremembo pogojev dovoljenj(-a) za promet z zdravilom.
Potential to affect exposures to other medicinal products Abiraterone is an inhibitor of the hepatic drug-metabolising enzymes CYP2D6 and CYP2C8. 
Možnost vpliva abiraterona na izpostavljenost drugim zdravilom Abirateron je zaviralec jetrnih encimov za presnovo zdravil CYP2D6 in CYP2C8.
This results from the selective inhibition of the CYP17 enzyme required for androgen biosynthesis. 
To omogoča selektivno zaviranje encima CYP17, ki je potreben za biosintezo androgenov.
- Taking ZYTIGA with food may cause side effects. 
- Jemanje zdravila ZYTIGA skupaj s hrano lahko povzroča neželene učinke.
If at any time the ALT or AST rises above 5 times the ULN, treatment should be interrupted immediately and liver function closely monitored. 
Če kadarkoli pride do zvišanja koncentracij ALT ali AST nad 5-kratno ULN, je treba zdravljenje takoj prekiniti in skrbno spremljati delovanje jeter.
What ZYTIGA is and what it is used for What you need to know before you take ZYTIGA How to take ZYTIGA 
Kaj je zdravilo ZYTIGA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ZYTIGA Kako jemati zdravilo ZYTIGA Možni neželeni učinki
• the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. 
• za zdravljenje mCRPC pri odraslih bolnikih, pri katerih je bolezen napredovala med ali po zdravljenju s kemoterapijo z docetakselom.
Hepatotoxicity and hepatic impairment 
Hepatotoksičnost in okvara jeter
In the event of a missed daily dose of either ZYTIGA, prednisone or prednisolone, treatment should be resumed the following day with the usual daily dose. 
V primeru izpuščenega dnevnega odmerka zdravila ZYTIGA ali prednizona oziroma prednizolona je treba zdravljenje naslednji dan nadaljevati z običajnimi odmerki.
In the event of an overdose, administration should be withheld and general supportive measures undertaken, including monitoring for arrhythmias, hypokalaemia and for signs and symptoms of fluid retention. 
Če pride do prevelikega odmerjanja, je treba jemanje prekiniti in uvesti splošne podporne ukrepe, vključno s spremljanjem bolnika glede pojavljanja aritmij, hipokaliemije in znakov in simptomov zastajanja tekočin.
Study treatments were discontinued at the time of unequivocal clinical progression. 
Študijsko zdravljenje so prekinili, ko je bilo nedvomno ugotovljeno klinično poslabšanje.
Androgen-sensitive prostatic carcinoma responds to treatment that decreases androgen levels. 
Karcinom prostate, občutljiv za androgene, se odziva na zdravljenje, ki znižuje ravni androgenov.
Effects on the external genitalia were observed though abiraterone acetate was not teratogenic. 
Opazili so učinke na zunanjih spolovilih, vendar abirateronacetat ni bil tetatogen.
Treatments could also be discontinued at the time of confirmed radiographic progression at the discretion of the investigator. 
Zdravljenje so lahko prekinili tudi v primeru radiološko potrjenega napredovanja bolezni.
The median baseline pain score, as measured by the Brief Pain Inventory Short Form (BPI-SF) was 2.0 in both the treatment and Placebo groups. 
Mediana izhodiščna ocena bolečine po skrajšanem vprašalniku za opis bolečine Brief Pain Inventory-Short Form (BPI-SF) je bila 2,0 tako v skupini z zdravilom kot s placebom.
However, there is no clinical experience in patients with prostate cancer and severe renal impairment. 
Ni kliničnih izkušenj o zdravljenju bolnikov z rakom prostate in hudo okvaro ledvic.
To be taken into consideration by patients on a controlled sodium diet. 
To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija.
Tell your doctor if you have yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. 
Zdravniku povejte, če se vam koža ali očesne beločnice rumeno obarvajo, imate temen urin, vas močno sili na bruhanje ali bruhate, ker so to lahko znaki ali simptomi jetrnih obolenj.
Other medicines and ZYTIGA Ask your doctor or pharmacist for advice before taking any medicine. 
Druga zdravila in zdravilo ZYTIGA Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katero koli zdravilo.
The study was unblinded based on the magnitude of clinical benefit observed and patients in the placebo group were offered treatment with ZYTIGA. 
Podatke o študiji so razkrili na podlagi razsežnosti opaženih kliničnih koristi, bolnikom v skupini, ki je prejemala placebo, pa ponudili zdravljenje z zdravilom ZYTIGA.
Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for abiraterone the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing abiraterone is unchanged subject to the proposed changes to the product information 
Podlaga za priporočilo spremembe pogojev dovoljenj(-a) za promet z zdravilom Na podlagi znanstvenih zaključkov za abirateron odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo abirateron ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
However, patients with a significant risk for congestive heart failure should be monitored every 2 weeks for the first three months of treatment and monthly thereafter (see section 4.4). 
Bolnike s pomembnim tveganjem za kongestivno srčno pupuščanje je treba spremljati v prvih treh mesecih zdravljenja na vsaka dva tedna, nato pa enkrat na mesec (glejte poglavje 4.4).
Prior use of ketoconazole 
Predhodna uporaba ketokonazola
In a separate clinical pharmacokinetic interaction study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone. 
V posameznih kliničnih farmakokinetičnih študijah medsebojnega delovanja pri zdravih osebah, sočasno dajanje ketokonazola, močnega zaviralca CYP3A4, ni klinično pomembno vplivalo na farmakokinetiko abiraterona.
In subjects with measurable soft tissue disease, significantly increased numbers of complete and partial tumor responses were seen with ZYTIGA treatment. 
Pri preiskovancih z znaki bolezni mehkih tkiv, ki so prejemali zdravilo ZYTIGA, so opazili pomembno povečanje v številu popolnih in delnih odgovorov na tumor.
Other important adverse reactions include, cardiac disorders, hepatotoxicity, fractures, and allergic alveolitis. 
Drugi pomembni neželeni učinki zdravila vključujejo srčne bolezni, hepatotoksičnost, zlome in alergijski alveolitis.
Use with products known to prolong QT interval 
Sočasna uporaba z zdravili, ki podaljšajo interval QT
In a 24-month carcinogenicity study in the rat, abiraterone acetate increased the incidence of interstitial cell neoplasms in the testes. 
V 24-mesečni študiji karcinogenosti pri podganah je abirateronacetat zvečal pojavljanje novotvorb intersticijskih celic v testisih.
As a result, reduction in organ weights and morphological and/or histopathological changes in the reproductive organs, and the adrenal, pituitary and mammary glands were observed. 
Zato so opažali tudi zmanjšano maso ter morfološke in/ali histopatološke spremembe reproduktivnih organov in adrenalnih in mlečnih žlez ter hipofize.
ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer. 
Zdravilo Zytiga preprečuje nastajanje testosterona v telesu in s tem upočasnjuje rast raka prostate.
Patients were using an LHRH analogue or were previously treated with orchiectomy. 
Bolniki so prejemali katerega od analogov LHRH ali pa so jih predhodno zdravili z orhidektomijo.
Interactions with other medicinal products 
Medsebojno delovanje z drugimi zdravili
ROMÂNIA Tel: +40 21 207 18 00 
ROMANIA Tel: +40 21 207 18 00
In fertility studies in both male and female rats, abiraterone acetate reduced fertility, which was completely reversible in 4 to 16 weeks after abiraterone acetate was stopped. 
V študijah plodnosti pri samicah in samcih podgan je abirateronacetat zmanjšal plodnost, kar pa je po 4 do 16 tednih po ukinitvi izzvenelo.
Patients were not required to show disease progression on docetaxel, as toxicity from this chemotherapy may have led to discontinuation. 
Bolniki med zdravljenjem z docetakselom niso nujno kazali vidnih znakov napredovanja bolezni, ker je lahko že sama toksičnost te kemoterapije vodila v prekinitev zdravljenja.
Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency category. 
Neželeni učinki o katerih so poročali v kliničnih študijah in v obdobju trženja zdravila, so navedeni po kategorijah pogostnosti.
The following study endpoints demonstrated a statistically significant advantage in favour of ZYTIGA treatment: 
Naslednji cilji opazovanja so pokazali statistično značilno prednost uporabe zdravila ZYTIGA:
It is recommended that subsequent treatment with Ra-223 is not initiated for at least 5 days after the last administration of ZYTIGA in combination with prednisone/prednisolone. 
Priporočljivo je, da se zdravljenja z Ra-223 ne uvede še najmanj 5 dni po zadnjem odmerjanju zdravila ZYTIGA v kombinaciji s prednizonom/prednizolonom.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Before treatment with ZYTIGA, cardiac failure should be treated and cardiac function optimised. 
Pred začetkom zdravljenja z zdravilom ZYTIGA je treba zdraviti srčno popuščanje in optimalizirati srčno funkcijo.
Patients with prior ketoconazole treatment for prostate cancer were excluded from this study. 
Bolnikov, pri katerih so pred tem rak prostate zdravili s ketokonazolom, niso vključili v študijo.
Studies in animals have shown reproductive toxicity (see section 5.3). 
V študijah pri živalih so ugotovili toksične učinke na sposobnost razmnoževanja (glejte poglavje 5.3).
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S) 
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
A significant difference in rPFS between treatment groups was observed (see Table 2 and Figure 1). 
Med zdravljenimi skupinami so opažali so pomembno razliko v rPFS (glejte Preglednico 2 in Sliko 1)
Treatment with ZYTIGA should not be reinitiated until symptoms of the toxicity have resolved to Grade 1 or baseline. 
Zdravljenje z zdravilom ZYTIGA lahko ponovno uvedemo, ko se simptomi toksičnosti povrnejo na stopnjo 1 ali na izhodiščno vrednost.
Administration with food significantly increases the absorption of abiraterone acetate. 
Jemanje zdravila skupaj s hrano bistveno poveča absorpcijo abirateronacetata.
Subgroup analyses consistently favor treatment with ZYTIGA. 
Rezultati analize podskupin dosledno kažejo v prid zdravljenja z zdravilom ZYTIGA.
PVdC/PE/PVC/aluminum blister of 12 film-coated tablets in a cardboard wallet. 
PVdC/PE/PVC/aluminijev pretisni omot z 12 filmsko obloženimi tabletami v zloženki iz lepenke.
If ZYTIGA is continued after corticosteroids are withdrawn, patients should be monitored for symptoms of mineralocorticoid excess (see information above). 
Če bolnik po ukinitvi kortikosteroidov še jemlje zdravilo ZYTIGA, ga je treba opazovati glede simptomov, ki jih povzroča presežek mineralokortikoidov (glejte zgoraj).
• Periodic Safety Update Report 
● Redno posodobljena poročila o varnosti zdravila (PSUR)
PVdC/PE/PVC/aluminum blister of 14 film-coated tablets in a cardboard wallet. 
PVdC/PE/PVC/aluminijev pretisni omot s 14 filmsko obloženimi tabletami v zloženki iz lepenke.
Concomitant use of a corticosteroid reduces the incidence and severity of these adverse reactions (see section 4.4). 
Sočasna uporaba kortikosteroida zmanjša pogostnost in izraženost navedenih neželenih učinkov (glejte poglavje 4.4).
In a study to determine the effects of abiraterone acetate (plus prednisone) on a single dose of the CYP2D6 substrate dextromethorphan, the systemic exposure (AUC) of dextromethorphan was increased approximately 2.9 fold. 
V študiji učinkov abirateronacetata (skupaj s prednizonom) na enkraten odmerek dekstrometorfana (substrat CYP2D6) se je sistemska izpostavljenost (AUC) dekstrometorfanu povečala za približno 2,9-krat.
• the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) 
• za zdravljenje proti kastraciji odpornega metastatskega raka prostate (mCRPC- Metastatic Castration Resistant Prostate Cancer) pri odraslih bolnikih, ki nimajo simptomov ali imajo blage simptome po neuspešnem zdravljenju z deprivacijo androgenov in pri katerih kemoterapija še ni klinično indicirana (glejte poglavje 5.1).
In patients on prednisone or prednisolone who are subjected to unusual stress, an increased dose of corticosteroids may be indicated before, during and after the stressful situation. 
Pri bolnikih, ki prejemajo prednizon ali prednizolon in so v stresni situaciji, je lahko pred in med stresno situacijo ter po njej indiciran zvečan odmerek kortikosteroidov.
CYP17 inhibition also results in increased mineralocorticoid production by the adrenals (see section 4.4). 
Zaviranje CYP17 povzroča tudi povečano tvorbo mineralokortikoidov v nadledvičnih žlezah (glejte poglavje 4.4).
Upon discontinuation of treatment, both patients had normalisation of their liver function tests and one patient was re-treated without recurrence of the elevations. 
Po prekinitvi uporabe zdravila ZYTIGA so se vrednosti testov jetrne funkcije pri obeh bolnikih normalizirale in eden od obeh bolnikov se je spet začel zdraviti brez ponovnega zvišanja vrednosti navedenih parametrov.
th percentile in the ZYTIGA group was twice that of the control group at 9.9 months versus 4.9 months. 
Vrednost 25. percentile časa do prvega z okostjem povezanega dogodka je bila v skupini z zdravilom ZYTIGA dvakrat višja kot v kontrolni skupini, in sicer 9,9 meseca v primerjavi s 4,9 meseca.