natgillin/translations-raw huggingface dataset:
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.
Radiographic progression free survival (rPFS) was assessed with the use of sequential imaging studies as defined by PCWG2 criteria (for bone lesions) and modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for soft tissue lesions).
Radiološko potrjeno preživetje brez napredovanja bolezni (rPFS- Radiographic Progression Free Survival) so ocenili z zaporednimi slikovnimi preiskavami po kriterijih PCWG2 (pri kostnih lezijah) in prilagojenih kriteriji za vrednotenje odziva pri solidnih tumorjih (RECIST - Response Evaluation Criteria In Solid Tumors) pri lezijah mehkega tkiva.
- Severe hepatic impairment [Child-Pugh Class C (see sections 4.2, 4.4 and 5.2)].
- Huda okvara jeter [Child-Pugh razreda C (glejte poglavja 4.2, 4.4 in 5.2)].
A skeletal-related event was defined as a pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
Z okostjem povezan dogodek je bil opredeljen kot patološki zlom, kompresija hrbtenjače, paliativno obsevanje kosti ali kirurški poseg na kosteh.
The major compounds present in faeces are unchanged abiraterone acetate and abiraterone (approximately 55% and 22% of the administered dose, respectively).
V blatu je mogoče najti predvsem nespremenjen abirateronacetat in abirateron (približno 55% oziroma 22% vnešenega odmerka).
For patients who develop hepatotoxicity during treatment (alanine aminotransferase [ALT] increases or aspartate aminotransferase [AST] increases above 5 times the upper limit of normal [ULN]), treatment should be withheld immediately (see section 4.4).
Če med zdravljenjem pride do hepatotoksičnosti (povečanje koncentracije alaninaminotransferaze [ALT] ali aspartat aminotransferaze [AST] za več kot 5-kratnik zgornje normalne vrednosti) je treba zdravljenje takoj prekiniti (glejte poglavje 4.4).
The incidence and severity of adverse events was higher in the subgroup of patients with baseline ECOG2 performance status grade and also in elderly patients (≥75 years ).
Incidenca in resnost neželenih učinkov je bila večja v podskupini bolnikov z začetnim splošnim stanjem zmogljivosti ECOG2 in pri starejših bolnikih (≥75let).
See section 4.2 for information on paediatric use.
Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
If you take more ZYTIGA than you should If you take more than you should, talk to your doctor or go to a hospital immediately.
Če ste vzeli večji odmerek zdravila ZYTIGA, kot bi smeli Če ste vzeli več tablet zdravila ZYTIGA, kot bi smeli, takoj pokličite zdravnika ali pojdite v bolnišnico.
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT(I) UPORABE
- The tablets are provided in a plastic bottle with a child-resistant closure.
- Tablete so na voljo v plastenki z za otroke varno zaporko.
At all evaluation time points after the initial few months of treatment, a higher proportion of patients treated with ZYTIGA remained alive, compared with the proportion of patients treated with placebo (see Figure 6).
V vseh primerih opazovanja po prvih nekaj mesecih zdravljenja je bil delež preživelih med bolniki, ki so prejemali zdravilo ZYTIGA, večji kot med bolniki, ki so prejemali placebo (glejte Sliko 6).
C-abiraterone acetate as capsules, abiraterone acetate is hydrolysed to abiraterone, which then undergoes metabolism including sulphation, hydroxylation and oxidation primarily in the liver.
C-abirateronacetata v obliki kapsul se abirateronacetat hidrolizira v abirateron, ta pa se nato večinoma v jetrih presnavlja naprej, med drugim s sulfacijo, hidroksilacijo in z oksidacijo.
AA = ZYTIGA
AA= zdravilo ZYTIGA
Eleven percent of patients enrolled had an ECOG performance score of 2; 70% had radiographic evidence of disease progression with or without PSA progression; 70% had received one prior cytotoxic chemotherapy and 30% received two.
Enajst odstotkov vključenih bolnikov je na lestvici ocenjevanja stanja zmogljivosti ECOG doseglo oceno 2; pri 70% je bilo napredovanje bolezni radiološko potrjeno skupaj z zviševanjem vrednosti PSA ali brez njega; 70% bolnikov je predhodno prejelo po eno citotoksično kemoterapijo, 30% pa po dve.
Aminotransferase elevations resolved in all but 3 patients (2 with new multiple liver metastases and 1 with AST elevation approximately 3 weeks after the last dose of abiraterone acetate).
Zvišanje koncentracij aminotransferaze je izzvenelo pri vseh, razen pri 3 bolnikih (pri 2 bolnikih s številnimi novimi metastazami na jetrih in pri 1 bolniku z zvišanjem koncentracije AST približno 3 tedne po zadnjem odmerku zdravila ZYTIGA).
The majority of circulating radioactivity (approximately 92%) is found in the form of metabolites of abiraterone.
Večji del radioaktivnosti v obtoku (približno 92%) prispevajo presnovki abiraterona.
Abiraterone acetate is rapidly converted in vivo to abiraterone, an androgen biosynthesis inhibitor (see section 5.1).
Abirateronacetat se in vivo hitro pretvori v abirateron, ki je zaviralec biosinteze androgenov (glejte poglavje 5.1).
Mineralocorticoid reactions generally were able to be successfully managed medically.
Mineralokortikoidne neželene učinke so večinoma lahko odpravili z medicinskimi ukrepi.
Hazard ratio is derived from a stratified proportional hazards model.
Razmerje tveganja je izračunano s pomočjo stratificiranega proporcionalnega modela tveganj.
Ten patients who received ZYTIGA were discontinued because of hepatotoxicity; two had Grade 2 hepatotoxicity, six had Grade 3 hepatotoxicity, and two had Grade 4 hepatotoxicity.
Zaradi hepatotoksičnosti je zdravljenje z zdravilom ZYTIGA prekinilo 10 bolnikov; pri dveh bolnikih se je pojavila hepatotoksičnost 2. stopnje, pri šestih bolnikih hepatotoksičnost 3. stopnje in pri dveh bolnikih hepatotoksičnost 4. stopnje.
In all studies spironolactone use was not allowed as spironolactone binds to the androgen receptor and may increase PSA levels.
Spironolakton v nobeni od študij ni bil dovoljen, ker se veže na androgene receptorje in zato lahko zveča koncentracije PSA.
Moreover, sections 4.3 and 4.4 of the SmPC should be amended to reflect the contraindication of the use of Xofigo (Radium-223) in combination with abiraterone acetate and prednisone/prednisolone and the increased risk for fractures and mortality in patients treated with Radium-223 in combination with abiraterone.
Poleg tega je treba poglavji 4.3 in 4.4 povzetka glavnih značilnosti zdravila posodobiti s podatki o kontraindicirani uporabi zdravila Xofigo (radij-223) v kombinaciji z abirateronacetatom in prednizonom/prednizolonom in s podatki o povečanem tveganju za zlome in umrljivost pri bolnikih, zdravljenih z radijem-223 v kombinaciji z abirateronom.
- If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method.
- Če imate spolne odnose z žensko, ki lahko zanosi, uporabljajte kondom in še eno učinkovito kontracepcijsko metodo.
This improvement was demonstrated even though 44% of patients in the placebo arm received ZYTIGA as subsequent therapy.
Podaljšanje preživetja je bilo dokazano kljub temu, da je 44% bolnikov iz kontrolne skupine (placebo) v nadaljevanju zdravljenja prejemalo zdravilo ZYTIGA.
Potential for other medicinal products to affect abiraterone exposures In a clinical pharmacokinetic interaction study of healthy subjects pretreated with a strong CYP3A4 inducer rifampicin, 600 mg daily for 6 days followed by a single dose of abiraterone acetate 1,000 mg, the mean plasma AUC∞ of abiraterone was decreased by 55%.
Možnost vpliva drugih zdravil na izpostavljenost abirateronu V kliničnih farmakokinetičnih študijah medsebojnega delovanja pri zdravih osebah, že zdravljenih z močnim induktorjem CYP3A4 rifampicinom v odmerku 600 mg na dan, 6 dni, ki mu je sledil enkratni 1.000 mg odmerek abirateronacetata, se je povprečna vrednost AUC abiraterona v plazmi zmanjšala za 55%.
Skeletal-related events
Z okostjem povezani dogodki
Study 3011 enrolled patients who were newly diagnosed (within 3 months of randomization) mHSPC who had high-risk prognostic factors.
V študijo 3011 so vključili na novo diagnosticirane (največ 3 mesece pred randomizacijo) bolnike z mHSPC z visokimi prognostičnimi dejavniki tveganja.
Androgen deprivation treatment may increase the risk of heart rhythm problems.
Zdravljenje, ki znižuje raven androgenov, lahko poveča možnost za pojav motenj srčnega ritma.
WALLET 500 mg (30 days)
ZLOŽENKA 500 mg (30 dni)
Following administration of abiraterone acetate, the pharmacokinetics of abiraterone and abiraterone acetate have been studied in healthy subjects, patients with metastatic advanced prostate cancer and subjects without cancer with hepatic or renal impairment.
Farmakokinetične lastnosti abiraterona in abirateronacetata po vnosu abirateronacetata so preučevali pri zdravih osebah, pri bolnikih z napredovalim metastatskim rakom prostate in pri osebah brez raka, a z okvaro jeter ali ledvic.
In a developmental toxicity study in the rat, abiraterone acetate affected pregnancy including reduced foetal weight and survival.
V razvojnih študijah toksičnega delovanja pri podganah je abirateronacetat vplival na nosečnost, zmanjšanje telesne mase ploda in preživetje.
Radiographic progression-free survival was defined as the time from randomization to the occurrence of radiographic progression or death from any cause.
Radiološko potrjeno preživetje brez bolezni so ocenili s časom od randomizacije do pojava radiološko napredovanja bolezni ali smrti zaradi katerega koli vzroka.
The radiographic progression and death are considered in defining the rPFS event.
Za določanje rPFS se uporablja radiološko napredovanje in smrt.
56 film-coated tablets 60 film-coated tablets
56 filmsko obloženih tablet 60 filmsko obloženih tablet
In study 302, (n = 1,088) the median age of enrolled patients was 71 years for patients treated with ZYTIGA plus prednisone or prednisolone and 70 years for patients treated with placebo plus prednisone or prednisolone.
V študiji 302 (n=1.088) je bila mediana starost bolnikov, ki so se zdravili z zdravilom ZYTIGA in prednizonom ali prednizolonom, 71 let, pri bolnikih, ki so se zdravili s placebom in prednizonom ali prednizolonom, pa 70 let.
All patients enrolled (both active and placebo-treated patients) were concomitantly treated with androgen deprivation therapy, predominantly with the use of LHRH analogues, which has been associated with diabetes, myocardial infarction, cerebrovascular accident and sudden cardiac death.
Vsi vključeni bolniki (tako tisti, ki so prejemali zdravilo, kot tisti, ki so prejemali placebo) so bili sočasno zdravljeni z androgeno deprivacijo, večinoma z uporabo analogov gonadorelina, kar je bilo povezano s sladkorno boleznijo, z miokardnim infarktom, s cerebrovaskularnimi zapleti in z nenadno srčno smrtjo.
WALLET 500 mg (28 days)
ZLOŽENKA 500 mg (28 dni)
Respiratory, thoracic and mediastinal disorders rare: allergic alveolitis
Bolezni dihal, prsnega koša in mediastinalnega prostora redki: alergijski alveolitis
Administration of abiraterone acetate with food, compared with administration in a fasted state, results in up to a 10-fold (AUC) and up to a 17-fold (Cmax) increase in mean systemic exposure of abiraterone, depending on the fat content of the meal.
Vnos abirateronacetata skupaj s hrano povzroči do 10-krat [AUC] in do 17-krat [Cmax] večjo povprečno sistemsko izpostavljenost abirateronu v primerjavi z vnosom na tešče, odvisno od vsebnosti maščob v obroku.
Intolerance to excipients
Intoleranca za pomožne snovi
Taking into account the PRAC Assessment Report on the PSUR(s) for abiraterone, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za abirateron, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Treba je presoditi o zmanjšanju odmerka zdravila z majhno terapevtsko širino, ki ga presnavlja CYP2D6.
The median time to SRE has not been reached for the ZYTIGA or placebo study arm.
Mediani čas do SRE v skupinah, ki sta prejemali zdravilo ZYTIGA ali placebo, ni bil dosežen.
Hypokalemia was observed in 20.4% of patients in the hormone sensitive population (study 3011) compared to 19.2% and 14.9% in 301 and 302, respectively).
Hipokaliemijo so opažali pri 20,4% populacije hormonsko občutljivih bolnikov (študija 3011) v primerjavi z 19,2% bolnikov v študiji 301 in 14,9% bolnikov v študiji 302.
A significant difference in rPFS between treatment groups was observed (see Table 4 and Figure 3).
Med skupinami so opažali pomembne razlike v rPFS (glejte Preglednico 4 in Sliko 3).
Subgroup survival analyses showed a consistent survival benefit for treatment with ZYTIGA (see Figure 7).
Rezultati analize preživetja po podskupinah dosledno kažejo boljše preživetje pri zdravljenju z zdravilom ZYTIGA (glejte Sliko 7).
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Med zdravljenjem se uporabi močnih induktorjev CYP3A4 (npr. fenitoin, karbamazepin, rifampicin, rifabutin, fenobarbital, šentjanževka [Hypericum perforatum]) izogibajte, razen v primerih, ko ni druge možnosti zdravljenja.
When ZYTIGA is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy).
Če vam zdravilo ZYTIGA predpišejo za zdravljenje zgodnjega stadija bolezni, ko se še odziva na hormonsko zdravljenje, se ga uporablja skupaj zdravilom, ki zmanjšuje raven testosterona (zdravljenje z deprivacijo androgenov).
In clinical trials, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline hepatitis or significant abnormalities of liver function tests.
V kliničnih študijah je bilo tveganje za hepatotoksičnost manjše, saj v študije niso vključili bolnikov z že obstoječim hepatitisom ali izrazito patološkimi izvidi jetrne funkcije.
Tablet White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed with AA250 on one side.
Bele do sivo bele ovalne tablete (dolge 15,9 mm in široke 9,5 mm), z vtisnjeno oznako AA250 na eni strani.
ZYTIGA may affect your liver, and you may not have any symptoms.
Zdravilo ZYTIGA lahko škoduje jetrom, ne da bi imeli kakršne koli simptome.
Pharmacotherapeutic group: endocrine therapy, other hormone antagonists and related agents, ATC code: L02BX03
Drugi hormonski antagonisti in sorodne učinkovine, oznaka ATC: L02BX03
In a planned analysis conducted after 552 deaths were observed, 42% (333 of 797) of patients treated with ZYTIGA compared with 55% (219 of 398) of patients treated with placebo, had died.
Po rezultatih načrtovane analize, ki so jo izvedli po tem, ko je umrlo 552 bolnikov, je med tistimi, ki so prejemali zdravilo ZYTIGA, umrlo 42% bolnikov (333 od 797) v primerjavi s 55% bolnikov, ki so prejemali placebo (219 od 398).
Patients that were treated with prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer were excluded with the exception of up to 3 months of ADT or 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease.
Bolniki, ki so bili predhodno zdravljeni s farmakoterapijo, radioterapijo ali so imeli operativni poseg zaradi metastatskega raka prostate so bili izključeni, z izjemo bolnikov, ki so bili zdravljeni z ADT največ 3 mesece ali tistih z 1 paliativnim radiacijskim zdravljenjem ali kirurškim zdravljenjem simptomov zaradi metastaz.
In another trial, the pharmacokinetics of abiraterone were examined in subjects with pre-existing severe (n = 8) hepatic impairment (Child-Pugh Class C) and in 8 healthy control subjects with normal hepatic function.
V drugem preskušanju so farmakokinetiko abiraterona raziskovali pri bolnikih z obstoječo hudo okvaro jeter (n=8) (Child-Pugh razreda C) in pri 8 kontrolnih zdravih preiskovancih z normalnim delovanjem jeter.