natgillin/translations-raw huggingface dataset:
How much to take The recommended dose is 1,000 mg (two tablets) once a day. 
Kako velik odmerek zdravila jemati Priporočeni odmerek je 1.000 mg (dve tableti) enkrat na dan.
Summary of the safety profile 
Povzetek varnosti zdravila
How much to take The recommended dose is 1,000 mg (four tablets) once a day. 
Kako velik odmerek zdravila jemati Priporočeni odmerek je 1.000 mg (štiri tablete) enkrat na dan.
In patients with pre-existing hypokalaemia or those that develop hypokalaemia whilst being treated with ZYTIGA, consider maintaining the patient's potassium level at ≥ 4.0 mM. 
Pri bolnikih z obstoječo hipokaliemijo ali pri tistih, pri katerih je do hipokaliemije prišlo med zdravljenjem z zdravilom ZYTIGA, je treba razmisliti o vzdrževanju koncentracije kalija ≥ 4,0 mmol/l.
Objective response: Objective response was defined as the proportion of subjects with measurable disease achieving a complete or partial response according to RECIST criteria (baseline lymph node size was required to be ≥ 2 cm to be considered a target lesion). 
Objektivni odgovor na zdravljenje: Objektivni odgovor na zdravljenje je bil definiran kot delež preiskovancev z znanimi boleznimi, ki so dosegli popolni ali delni odgovor na podlagi meril RECIST (izhodiščna mejna velikost bezgavke ≥ 2 cm).
Pain progression was defined as an increase from baseline of ≥ 30% in the BPI-SF worst pain intensity score over the previous 24 hours without a decrease in analgesic usage score observed at two consecutive visits, or an increase of ≥ 30% in analgesic usage score observed at two consecutive visits. 
Napredovanje bolečine je bilo opredeljeno kot zvečanje za ≥ 30% od izhodiščne vrednosti ocene najhujše bolečine v zadnjih 24 urah po vprašalniku BPI-SF in brez znižanja ocene porabe analgetikov, kar so ocenjevali na dveh zaporednih obiskih, ali pa kot zvišanje za ≥ 30% ocene porabe analgetikov med dvema zaporednima obiskoma.
Hazard ratio <1 favors AA-P. 
Razmerje tveganja  1 kaže prednost AA-P.
The proportion of patients with pain palliation was statistically significantly higher in the ZYTIGA group than in the placebo group (44% vs. 27%, p = 0.0002). 
Delež bolnikov, ki so jim paliativno lajšali bolečino, je bil statistično značilno večji v skupini z zdravilom ZYTIGA kot v skupini s placebom (44% v primerjavi s 27%, p = 0,0002).
Blood monitoring 
Krvni testi
The median time to progression was 26.7 months in the ZYTIGA group and 18.4 months in the placebo group. 
Mediani čas do napredovanja je bil 26,7 meseca v skupini, ki je prejemala zdravilo ZYTIGA in 18,4 meseca v skupini, ki je prejemala placebo.
This medicinal product also contains more than 1.18 mmol (or 27 mg) sodium per dose of two tablets. 
Zdravilo vsebuje tudi več kot 1,18 mmol (oziroma 27 mg) natrija na odmerek (v dveh tabletah).
The incidence of cardiovascular adverse reactions in the Phase 3 studies in patients taking abiraterone acetate versus patients taking placebo were as follows: atrial fibrillation 2.6% vs. 2.0%, tachycardia 1.9% vs. 1.0%, angina pectoris 1.7% vs. 0.8%, cardiac failure 0.7% vs. 0.2%, and arrhythmia 0.7% vs. 0.5%. 
Incidenca kardiovaskularnih neželenih učinkov v študijah faze 3 pri bolnikih, ki so jemali abirateronacetat, v primerjavi z bolniki, ki so prejemali placebo, je takšna: atrijska fibrilacija 2,6% proti 2,0%, tahikardija 1,9% proti 1,0%, angina pektoris 1,7% proti 0,8%, srčno popuščanje 0,7% proti 0,2% in aritmija 0,7% proti 0,5%.
Cardiovascular reactions 
Kardiovaskularni učinki
The number of patients treated with ZYTIGA by racial group was Caucasian 832 (69.4%), Asian 246 (20.5%), Black or African American 25 (2.1%), other 80 (6.7%), unknown/not reported 13 (1.1%), and American Indian or Alaska Native 3 (0.3%). 
Število bolnikov, zdravljenih z zdravilom ZYTIGA glede na raso je bilo: 832 (69,4%) belcev, 246 (20,5%) Azijcev, 25 (2,1%) črncev ali afroameričanov, 80 (6,7%) bolnikov drugih ras, 13 (1,1%) neznanih/ni bilo poročano in 3 (0,3%) severnoameriški indijanci ali staroselci z Aljaske.
There are no data on the clinical safety and efficacy of multiple doses of abiraterone acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). 
Podatkov o klinični varnosti in učinkovitosti večkratnih odmerkov abirateronacetata pri bolnikih z zmerno do hudo okvaro jeter (Child-Pugh razreda B ali C) ni.
Each 30 day carton contains 60 film-coated tablets in 5 cardboard wallets of 12 film-coated tablets each. 
Eno 30 dnevno pakiranje vsebuje 60 filmsko obloženih tablet v 5 zloženkah po 12 filmsko obloženih tablet.
Taking this medicine - Take this medicine by mouth. 
Jemanje zdravila - Zdravilo morate zaužiti.
Only patients with a baseline pain score of ≥ 4 and at least one post-baseline pain score were analysed (N = 512) for pain palliation. 
Analizirali so samo podatke bolnikov z izhodiščno oceno bolečine ≥ 4, pri čemer so v analizo poleg izhodiščne vključili še najmanj eno poznejšo oceno bolečine (n=512) za presojo paliativnega zdravljenja.
Six hundred and seven (607) subjects had radiographic progression or died: 271 (50%) in the abiraterone acetate group and 336 (62%) in the placebo group. 
Šeststosedem (607) preiskovancev je imelo radiološko potrjeno napredovanje bolezni ali umrlo: od tega jih je bilo 271 (50%) v skupini, ki je prejemala abirateronacetat in 336 (62%) v skupini, ki je prejemala placebo.
Each 28 day carton contains 56 film-coated tablets in 4 cardboard wallets of 14 film-coated tablets each. 
Eno 28 dnevno pakiranje vsebuje 56 filmsko obloženih tablet v 4 zloženkah po 14 filmsko obloženih tablet.
For patients who develop hepatotoxicity during treatment, suspension of treatment and dose adjustment may be required (see sections 4.2 and 4.4). 
Bolnikom, pri katerih pride med zdravljenjem do hepatotoksičnosti, je treba začasno prekiniti zdravljenje in prilagoditi odmerjanje (glejte poglavji 4.2 in 4.4).
Hypertension was reported in 36.7% of patients in the hormone sensitive population (study 3011) compared to 11.8% and 20.2% in studies 301 and 302, respectively. 
V populaciji hormonsko občutljivih bolnikov (študija 3011) so o hipertenziji poročali pri 36,7% bolnikov v primerjavi z 11,8% bolnikov v študiji 301 in 20,2% bolnikov v študiji 302.
Caution is required in treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalaemia (e.g., those on cardiac glycosides), or fluid retention (e.g., those with heart failure, severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia and those with severe renal impairment). 
Previdnost je potrebna pri zdravljenju bolnikov, pri katerih lahko osnovno bolezen poslabšajo zvišan krvni tlak, hipokaliemija (na primer bolniki, ki jemljejo kardiotonične glikozide) ali zastajanje tekočin (na primer bolniki s srčnim popuščanjem, hudo ali nestabilno angino pektoris, nedavnim miokardnim infarktom ali ventrikularno aritmijo in bolniki s hudo ledvično okvaro).
In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone was increased by 46% and the AUCs for M-III and M-IV, the active metabolites of pioglitazone, each decreased by 10% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate. 
V študiji medsebojnega delovanja zdravil s CYP2C8 pri zdravih osebah se je AUC pioglitazona zvečala za 46% in AUC vsakega od aktivnih presnovkov pioglitazona, M-III in M-IV, pri jemanju skupaj z enkratnim 1.000 mg odmerkom abirateronacetata zmanjšala za 10%.
The pharmacokinetics of abiraterone acetate was compared in patients with end-stage renal disease on a stable haemodialysis schedule versus matched control subjects with normal renal function. 
Farmakokinetične lastnosti abirateronacetata so primerjali med bolniki s končno odpovedjo ledvic, zdravljenih s stabilno dializno shemo, in med skladnimi kontrolnimi osebami z normalnim delovanjem ledvic.
Pain: Treatment with ZYTIGA significantly reduced the risk of average pain intensity progression by 18% compared with placebo (p = 0.0490). 
Bolečina: Zdravljenje z zdravilom ZYTIGA pomembno zmanjša tveganje za napredovanje jakosti povprečne bolečine za 18% v skupini, ki je prejemala zdravilo ZYTIGA v primerjavi s placebom (p=0,0490).
Metabolism and nutrition disorders very common: hypokalaemia common: hypertriglyceridaemia 
Presnovne in prehranske motnje zelo pogosti: hipokaliemija pogosti: hipertrigliceridemija
- Swallow the tablets whole with water. 
- Tablete pogoltnite cele z vodo.
- This medicine may cause harm to the unborn child if it is taken by women who are pregnant. 
- Če nosečnica jemlje zdravilo, lahko to škodi nerojenemu otroku .
ZYTIGA may cause hypertension, hypokalaemia and fluid retention as a pharmacodynamic consequence of its mechanism of action. 
Hipertenzija, hipokaliemija in zastajanje tekočin, ki jih lahko povzroča zdravilo ZYTIGA, so farmakodinamične posledice mehanizma delovanja tega zdravila.
ZYTIGA decreases serum testosterone and other androgens to levels lower than those achieved by the use of LHRH analogues alone or by orchiectomy. 
Zdravilo ZYTIGA znižuje koncentracije testosterona in drugih androgenov v serumu na vrednosti, ki so nižje kot pri samostojni uporabi analogov LHRH oziroma pri orhidektomiji.
The time to PSA progression was approximately doubled with ZYTIGA treatment (HR = 0.488). 
Čas do zviševanja koncentracij PSA se je pri zdravljenju z zdravilom ZYTIGA približno podvojil (razmerje tveganja=0,488).
The recommended dose is 1,000 mg (four 250 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below). 
Priporočeni odmerek je 1.000 mg (štiri 250 mg tablete) v enem odmerku na dan, ki ga bolnik ne sme zaužiti skupaj s hrano (glejte “Način uporabe” v nadaljevanju).
- Take ZYTIGA at least two hours after eating and do not eat anything for at least one hour after taking ZYTIGA (see section 2, “ZYTIGA with food”). 
- Zdravilo ZYTIGA jemljite najmanj dve uri po jedi, po zaužitju zdravila ZYTIGA pa najmanj eno uro ne uživajte nobene hrane (glejte poglavje 2 “Zdravilo ZYTIGA skupaj s hrano”).
Abnormal liver function tests developing in patients participating in clinical trials were vigorously managed by requiring treatment interruption and permitting re-treatment only after return of liver function tests to the patient's baseline (see section 4.2). 
Na patološke vrednosti testov jetrne funkcije pri bolnikih v kliničnih študijah so se takoj odzvali s predpisano prekinitvijo zdravljenja, ponovna uvedba zdravila pa je bila dovoljena šele po znižanju testov jetrne funkcije na bolnikove izhodiščne vrednosti (glejte poglavje 4.2).
= confidence interval; ECOG = Eastern Cooperative Oncology Group performance score; HR = hazard ratio; NE = not evaluable 
AA = zdravilo ZYTIGA; BPI (Brief Pain Inventory) = bolečinska lestvica; IZ = interval zaupanja; ECOG (Eastern Cooperative Oncology Group) = lestvica ocenjevanja stanja zmogljivosti; HR = razmerje tveganja (hazard ratio); NM = nemerljivo
Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele I-04100 Latina, Italy 
Via C. Janssen Borgo San Michele I-04100 Latina, Italija
The recommended dose is 1,000 mg (two 500 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below). 
Priporočeni odmerek je 1.000 mg (dve 500 mg tablete) v enem odmerku na dan, ki ga bolnik ne sme zaužiti skupaj s hrano (glejte “Način uporabe” v nadaljevanju).
What ZYTIGA looks like and contents of the pack - ZYTIGA tablets are white to off-white, oval shaped (15.9 mm long x 9.5 mm wide), with 
Izgled zdravila ZYTIGA in vsebina pakiranja - Tablete ZYTIGA so bele do sivo bele barve in ovalne oblike (dolge 15,9 mm in široke 9,5 mm),
Across Phase 3 clinical studies, hepatotoxicity grades 3 and 4 (e.g., ALT or AST increases of > 5 x ULN or bilirubin increases > 1.5 x ULN) were reported in approximately 6% of patients who received abiraterone acetate, typically during the first 3 months after starting treatment. 
Skupaj so v kliničnih študijah faze 3 o hepatotoksičnosti 3. in 4. stopnje (npr. zvišanje koncentracije ALT ali AST na > 5-kratnik zgornje meje normalnih vrednosti ali zvišanje koncentracije bilirubina na > 1,5-kratnik zgornje meje normalnih vrednosti) poročali pri približno 6% bolnikov, ki so prejemali abirateronacetat, večinoma v prvih 3 mesecih po začetku zdravljenja.
Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS). 
Sočasni primarni cilji učinkovitosti so bili celokupno preživetje (OS-Overall Survival) in radiološko potrjeno preživetje brez napredovanja bolezni (rPFSradiographic Progression-Free Survival).
Patients were maintained on study treatments until there was PSA progression (confirmed 25% increase over the patient's baseline/nadir) together with protocol-defined radiographic progression and symptomatic or clinical progression. 
Bolniki so prejemali študijsko zdravljenje dokler se je koncentracija PSA zviševala (potrjeno zvišanje za 25% od izhodiščne/najnižje vrednosti pri bolniku), pri tem pa je šlo hkrati za radiološko potrjeno in simptomatsko ali klinično napredovanje bolezni.
In the Phase 3 clinical studies, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values. 
V kliničnih študijah faze 3 je bila verjetnost za zvišanje vrednosti testov jetrne funkcije večja pri bolnikih, katerih vrednosti ALT ali AST so bile zvišane že v izhodišču, kakor pri tistih bolnikih, ki so imeli v izhodišču normalne vrednosti.
Cardiac disorders common: cardiac failure*, angina pectoris, atrial fibrillation, tachycardia uncommon: other arrhythmias not known: myocardial infarction, QT prolongation (see sections 4.4 and 4.5) 
Srčne bolezni pogosti: srčno popuščanje,* angina pektoris, atrijska fibrilacija, tahikardija občasni: druge aritmije neznana: miokardni infarkt, podaljšanje intervala QT (glejte poglavji 4.4. in 4.5)
Musculoskeletal and connective tissue disorders uncommon: myopathy, rhabdomyolysis 
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni: miopatija, rabdomioliza
ZYTIGA in combination with prednisone or prednisolone may increase bone loss. 
Jemanje zdravila ZYTIGA skupaj s prednizonom ali prednizolonom lahko zmanjšanje kostne gostote poveča.
Other side effects include: 
Drugi možni neželeni učinki:
What ZYTIGA looks like and contents of the pack - ZYTIGA tablets are purple, oval-shaped, film-coated (20 mm long by 10 mm wide) with “AA” written on one side and “500” on the other side. 
Izgled zdravila ZYTIGA in vsebina pakiranja - Tablete ZYTIGA so vijolične, ovalne oblike, filmsko obložene tablete (dolge 20 mm in široke 10 mm), “AA” na eni strani in oznako “500” na drugi strani.
This medicinal product also contains more than 1 mmol (or 27.2 mg) sodium per dose of four tablets. 
Zdravilo vsebuje tudi več kot 1 mmol (oziroma 27,2 mg) natrija na odmerek (v štirih tabletah).
CYP17 catalyses the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively, by 17α-hydroxylation and cleavage of the C17,20 bond. 
CYP17 katalizira pretvorbo pregnenolona in progesterona v dehidroepiandrosteron (DHEA) oziroma androstenedion, ki sta predstopnji testosterona, in sicer s hidroksilacijo na mestu 17α in s cepitvijo vezi na mestih C17,20.
Swallow the tablets whole with water. 
Tablete pogoltnite cele z vodo.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. 
Če niste prepričani, ali katera od teh navedb velja za vas, se pred uporabo zdravila posvetujte z zdravnikom ali farmacevtom.
Purple, oval-shaped, film-coated tablets (20 mm long by 10 mm wide), debossed with “AA” on one side and “500” on the other side. 
Vijolične, ovalne filmsko obložene tablete (dolge 20 mm in široke 10 mm), z vtisnjeno oznako “AA” na eni strani in “500” na drugi strani.
Administration in patients with renal impairment, including severe renal impairment, does not require dose reduction (see section 4.2). 
Pri uporabi pri bolnikih z okvaro ledvic, tudi pri tistih s hudo okvaro ledvic, ni treba zniževati odmerkov (glejte poglavje 4.2).
Use with chemotherapy 
Sočasna uporaba kemoterapije
Treatment with abiraterone acetate decreased the risk of radiographic progression or death by 47% compared with placebo (HR = 0.530; 95% CI: [0.451; 0.623], p < 0.0001). 
Zdravljenje z abirateronacetatom je v primerjavi s placebom zmanjšalo tveganje za radiološko potrjeno napredovanje bolezni ali smrt za 47% (HR=0,530; 95% IZ: [0,451; 0,623], p < 0,0001).
If patients develop severe hepatotoxicity (ALT or AST 20 times the ULN) anytime while on therapy, treatment should be discontinued and patients should not be re-treated. 
Če kadarkoli med zdravljenjem pride do pojava hude hepatotoksičnosti (koncentracija ALT ali AST 20-krat večja od ULN), moramo zdravljenje prekiniti in ga ne smemo ponovno uvesti.
Vascular disorders very common: hypertension 
Žilne bolezni zelo pogosti: hipertenzija
Caution is advised when administering with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index. 
Pri sočasni uporabi z zdravili, ki jih aktivira ali presnavlja CYP2D6, zlasti tistimi z majhno terapevtsko širino, je potrebna previdnost.
Corticosteroid withdrawal and coverage of stress situations Caution is advised and monitoring for adrenocortical insufficiency should occur if patients are withdrawn from prednisone or prednisolone. 
Prekinitev zdravljenja s kortikosteroidi in ukrepanje v stresnih situacijah Pri ukinitvi prednizona oziroma prednizolona je potrebna previdnost, bolnika pa je treba opazovati glede razvoja adrenokortikalne insuficience.
In Phase 3 studies, anticipated mineralocorticoid adverse reactions were seen more commonly in patients treated with abiraterone acetate than in patients treated with placebo: hypokalaemia 18% vs.8%, hypertension 22% vs. 16% and fluid retention (peripheral oedema) 23% vs. 17%, respectively. 
V študijah faze 3 so pričakovane mineralokortikoidne neželene učinke opažali pogosteje pri bolnikih, ki so prejemali abirateronacetat, kot pri bolnikih, ki so prejemali placebo: hipokaliemijo pri 18% v primerjavi z 8%, hipertenzijo pri 22% v primerjavi s 16% in zastajanje tekočin (periferne edeme) pri 23% v primerjavi s 17%.
Hypertension, hypokalaemia and fluid retention should be corrected and controlled. 
Urediti in spremljati je treba hipertenzijo, hipokaliemijo in zastajanje tekočin.
The pharmacokinetics of abiraterone acetate was examined in subjects with pre-existing mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) and in healthy control subjects. 
Farmakokinetične lastnosti abirateronacetata so preiskovali pri osebah z že prisotno blago ali zmerno okvaro jeter (Child-Pugh razreda A oziroma B) in pri zdravih kontrolnih osebah.
Before treating patients with a significant risk for congestive heart failure (e.g.a history of cardiac failure, uncontrolled hypertension, or cardiac events such as ischaemic heart disease), consider obtaining an assessment of cardiac function (e.g. echocardiogram). 
Pri bolnikih s pomembnim tveganjem za kongestivno srčno popuščanje (npr. anamneza srčnega popuščanja, nenadzorovane hipertenzije ali srčni dogodki kot je ishemična bolezen srca) je potrebno pred začetkom zdravljenja oceniti srčno funkcijo (ehokardiogram).
- if you have an irregular or rapid heart rate - if you have shortness of breath - if you have gained weight rapidly - if you have swelling in the feet, ankles, or legs - if you have taken a medicine known as ketoconazole in the past for prostate cancer - about the need to take this medicine with prednisone or prednisolone - about possible effects on your bones - if you have high blood sugar. 
- če imate visok krvni tlak, popuščanje srca ali nizko koncentracijo kalija v krvi (nizka koncentracija kalija v krvi lahko poveča verjetnost pojava motenj srčnega ritma), - če ste kdaj imeli druge težave s srcem ali s krvnimi žilami, - če imate nepravilen ali hiter srčni utrip, - če ste zadihani, - če ste hitro pridobili telesno maso, - če imate otekla stopala, gležnje ali noge, - če ste kdaj v preteklosti za zdravljenje raka prostate jemali zdravilo, ki ga imenujemo ketokonazol, - o potrebnosti jemanja zdravila skupaj s prednizonom ali prednizolonom, - o možnih učinkih zdravila na kosti, - če imate visoke koncentracije sladkorja v krvi.
General disorders and administration site conditions very common: oedema peripheral 
Splošne težave in spremembe na mestu aplikacije zelo pogosti: periferni edemi
- If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, talk to your doctor without delay. 
- Če več kot en dan niste vzeli zdravila ZYTIGA ali prednizona oziroma prednizolona, se takoj posvetujte z zdravnikom.
In a Phase 3 clinical study of patients who failed prior chemotherapy with taxanes, 38% of patients treated with abiraterone acetate, versus 10% of patients treated with placebo, had at least a 50% decline from baseline in PSA levels. 
V študiji faze 3 je pri bolnikih, pri katerih predhodna kemoterapija s taksani ni bila uspešna, prišlo do znižanja ravni PSA za najmanj 50% pri 38% bolnikov, ki so prejemali abirateronacetat, v primerjavi z 10% bolnikov, ki so prejemali placebo.
Strong inducers of CYP3A4 during treatment are to be avoided unless there is no therapeutic alternative, due to risk of decreased exposure to abiraterone (see section 4.5). 
Zaradi tveganja za manjšo izpostavljenost abirateronu se med zdravljenjem izogibajte uporabi močnih induktorjev CYP3A4, razen v primerih, ko ni druge možnosti zdravljenja (glejte poglavje 4.5).
If ZYTIGA is accidentally ingested by a child or adolescent, go to the hospital immediately and take the package leaflet with you to show to the emergency doctor. 
Če zdravilo ZYTIGA nenamerno zaužije otrok ali mladostnik, ga takoj odpeljite v bolnišnico.
Infections and infestations very common: urinary tract infection common: sepsis 
Infekcijske in parazitske bolezni zelo pogosti: okužba sečil pogosti: sepsa
A score of 0-1 on Brief Pain Inventory-Short Form (BPI-SF) worst pain in last 24 hours was considered asymptomatic, and a score of 2-3 was considered mildly symptomatic. 
Rezultat 0-1 najhujša bolečina v zadnjih 24 urah po skrajšanem vprašalniku za opis bolečine Brief Pain Inventory-Short Form (BPI-SF) je bil ocenjen kot brez simptomov in rezultat 2-3 kot z blagimi simptomi.
Time to skeletal-related event (SRE): There was a 30% reduction in the risk of skeletal-related events (HR = 0.703; 95% CI: [0.539, 0.916], p = 0.0086). 
Čas do pojava z okostjem povezanih dogodkov (SRE-Skeletal Related Event): Opazili so 30% zmanjšanje tveganja za z okostjem povezane dogodke (razmerje tveganja = 0,703; 95% IZ: [0,539; 0,916], p = 0,0086).
Paediatric population There is no relevant use of ZYTIGA in the paediatric population. 
Pediatrična populacija Uporaba zdravila ZYTIGA pri otrocih ni smiselna.
Use with products known to prolong QT interval Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. 
Sočasna uporaba z zdravili, ki podaljšajo interval QT Zdravljenje z deprivacijo androgenov lahko podaljša interval QT, zato je pri uporabi zdravila ZYTIGA skupaj z zdravili, ki podaljšajo interval QT, ali zdravili, ki lahko sprožijo torsade de pointes razreda IA (na primer kinidin, dizopramid) ali razreda III (na primer amiodaron, sotalol, dofetilid, ibutilid), antiaritmiki, metadonom, moksifloksacinom, antipsihotiki, itd. potrebna previdnost.
Study 302 (chemotherapy naïve patients) 
Študija 301 (bolniki, ki so že prejeli kemoterapijo)
What ZYTIGA contains - The active substance is abiraterone acetate. 
Kaj vsebuje zdravilo ZYTIGA - Učinkovina je abirateronacetat.
ZYTIGA 500 mg film-coated tablets 
ZYTIGA 500 mg filmsko obložene tablete