FrancophonIA/ELRC3.0 huggingface dataset:
English: Radiographic progression included progression by bone scan (according to modified PCWG2) or progression of soft tissue lesions by CT or MRI (according to RECIST 1.1).
Slovenian: Radiološko napredovanje je vključevalo napredovanje glede na posnetek okostja (po prilagojenih kriterijih PCWG2) ali napredovanje lezij mehkih tkiv ocenjenih z računalniško tomografijo (CT-Computer Tomography) ali magnetno resonanco (MRI-Magnetic Resonance Imaging) (po merilih RECIST 1.1)
English: A responder for pain palliation was defined as a patient who experienced at least a 30% reduction from baseline in the BPI-SF worst pain intensity score over the last 24 hours without any increase in analgesic usage score observed at two consecutive evaluations four weeks apart.
Slovenian: Bolnik z odzivom na paliativno lajšanje bolečine je bil opredeljen kot bolnik z najmanj 30-odstotnim znižanjem ocene bolečine v zadnjih 24 urah (po skrajšanem vprašalniku Brief Pain Inventory - Short Form, BPISF) v primerjavi z izhodiščno oceno in brez zvišanja ocene porabe analgetikov, kar so ocenjevali na dveh zaporednih obiskih v razmiku 4 tednov.
English: When elevations of either ALT or AST > 5 x ULN, or elevations in bilirubin > 3 x ULN were observed, abiraterone acetate was withheld or discontinued.
Slovenian: Ko je pri bolnikih prišlo do zvišanja koncentracije bodisi ALT bodisi AST na > 5-kratnik zgornje meje normalnih vrednosti ali do zvišanja koncentracije bilirubina na > 3-kratnik zgornje meje normalnih vrednosti, so zdravljenje z abirateronacetatom začasno ali dokončno prekinili.
English: - This medicinal product does not require any special storage conditions.
Slovenian: - Za shranjevanje zdravila niso potrebna posebna navodila.
English: All treatment-related hormonal changes reversed or were shown to be resolving after a 4-week recovery period.
Slovenian: Po 4-tedenskem obdobju brez zdravila so se vse z zdravljenjem povezane hormonske spremembe zmanjšale oziroma so izzvenele.
English: There are no human data on the use of ZYTIGA in pregnancy and this medicinal product is not for use in women of childbearing potential.
Slovenian: Podatkov o uporabi zdravila ZYTIGA med nosečnostjo pri ljudeh ni.
English: The number of patients treated with ZYTIGA by racial group was Caucasian 520 (95.4%), Black 15 (2.8%), Asian 4 (0.7%) and other 6 (1.1%).
Slovenian: Glede na raso je bilo v zdravljenje z zdravilom Zytiga vključenih 520 (95,4%) belcev, 15 (2,8%) črncev, 4 (0,7%) Azijcev in 6 (1,1%) bolnikov drugih ras.
English: Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30
Slovenian: Imetnik dovoljenja za promet z zdravilom Janssen-Cilag International NV Turnhoutseweg 30
English: A lower proportion of patients in the ZYTIGA group had skeletal-related events compared with the placebo group at 6 months (18% vs. 28%), 12 months (30% vs. 40%), and 18 months (35% vs. 40%).
Slovenian: V skupini z zdravilom ZYTIGA je prišlo do z okostjem povezanih dogodkov pri manjšem deležu bolnikov kot v skupini s placebom, in sicer po 6 mesecih (pri 18% v primerjavi z 28%), po 12 mesecih (pri 30% v primerjavi s 40%) in po 18 mesecih (pri 35% v primerjavi s 40%).
English: A statistically significant improvement in median overall survival was seen in patients treated with ZYTIGA (see Table 7).
Slovenian: Pri bolnikih, ki so prejemali zdravilo ZYTIGA, je bilo mogoče opaziti statistično značilno izboljšanje medianega celotnega preživetja (glejte Preglednico 7).
English: ZYTIGA is not for use in women.
Slovenian: Zdravilo ZYTIGA ni namenjeno uporabi pri ženskah.
English: The mean half-life of abiraterone in plasma is approximately 15 hours based on data from healthy subjects.
Slovenian: Po podatkih zdravih oseb je povprečni razpolovni čas abiraterona v plazmi približno 15 ur.
English: - You need to take prednisone or prednisolone every day while you are taking ZYTIGA.
Slovenian: - V času jemanja zdravila ZYTIGA morate vsak dan jemati prednizon ali prednizolon.
English: In study 302, Grade 3 or 4 ALT or AST elevations were observed in 35 (6.5%) patients treated with abiraterone acetate.
Slovenian: V študiji 302 so pri 35 (6,5%) bolnikih, ki so prejemali abirateronacetat opazili 3. ali 4. stopnjo zvišanja koncentracij ALT ali AST.
English: ZYTIGA is not for use in women and is contraindicated in women who are or may potentially be pregnant (see section 4.3 and 5.3).
Slovenian: Kontraindicirano je pri ženskah, ki so noseče oziroma bi lahko bile noseče (glejte poglavji 4.3 in 5.3).
English: The efficacy and safety when given with food have not been established therefore this medicinal product must not be taken with food (see sections 4.2 and 5.2).
Slovenian: Zato se tega zdravila ne sme jemati skupaj s hrano (glejte poglavji 4.2 in 5.2).
English: Alanine aminotransferase increased and/or aspartate aminotransferase increased includes ALT increased, AST increased, and hepatic function abnormal.
Slovenian: Zvišane koncentracije alanin-aminotransferaze in/ali aspartat-aminotransferaze vključuje zvečanje koncentracije ALT, AST in motnje v delovanju jeter.
English: During treatment, blood pressure, serum potassium, fluid retention (weight gain, peripheral oedema), and other signs and symptoms of congestive heart failure should be monitored every 2 weeks for 3 months, then monthly thereafter and abnormalities corrected.
Slovenian: V prvih treh mesecih zdravljenja je treba na vsaka dva tedna, nato pa enkrat na mesec, spremljati krvni tlak, koncentracijo kalija v serumu, zastajanje tekočin (pridobivanje telesne mase, periferni edem) ter druge znake in simptome kongestivnega srčnega popuščanja in odpravljati nepravilnosti.
English: Cases of myopathy and rhabdomyolysis have been reported in patients treated with ZYTIGA.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom ZYTIGA so poročali o primerih miopatije in rabdomiolize.
English: The proportion of subjects with a confirmed PSA response was greater in the ZYTIGA group than in the placebo group (62% vs. 24%; p < 0.0001).
Slovenian: Razmerje preiskovancev s potrjenim odzivom PSA je bilo večje pri skupini, ki je prejemala zdravilo ZYTIGA kot pri skupini, ki je prejemala placebo (62% proti 24%; p < 0,0001).
English: Start date:
Slovenian: Začetek:
English: In addition to the co-primary endpoint measures, benefit was also assessed using time to skeletal-related event (SRE), time to subsequent therapy for prostate cancer, time to initiation of chemotherapy, time to pain progression, and time to PSA progression.
Slovenian: Poleg sočasnih primarnih meril so za oceno koristi zdravljenja uporabili tudi čas do z okostjem povezanih dogodkov (SRE-Skeletal related Events), čas do naslednjega zdravljenja raka prostate, čas do uvedbe kemoterapije, čas do napredovanja bolečine in čas do napredovanja koncentracij PSA. Z zdravljenjem so nadaljevali do napredovanja bolezni, odpovedjo privolitve sodelovanja, pojava nesprejemljive toksičnosti ali smrti.
English: Adrenal gland problems (related to salt and water problems), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): težave z nadledvično žlezo (povezane s težavami s soljo in vodo), motnje srčnega ritma (aritmije) mišična šibkost in/ali bolečine v mišicah.
English: Figure 2: Kaplan-Meier Plot of Overall Survival; Intent-to-treat Population (Study PCR3011)
Slovenian: Slika 2: Kaplan-Meierjevi krivulji celokupnega preživetja bolnikov; populacija bolnikov z namenom zdravljenja (študija PCR3011)
English: Marked increases in liver enzymes leading to treatment discontinuation or dose modification occurred in controlled clinical studies (see section 4.8).
Slovenian: V nadzorovanih kliničnih študijah je prihajalo do izrazitih zvišanj koncentracij jetrnih encimov, zaradi katerih je bilo treba prekiniti zdravljenje ali spremeniti odmerjanje zdravila (glejte poglavje 4.8).
English: Radiographic Progression-free Survival (rPFS) Progression or death Median rPFS in months (95% CI)
Slovenian: Število napredovanj ali smrti Mediano rPFS v mesecih (95% IZ)
English: Tell your doctor if you have been told you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.
Slovenian: Težave s srcem ali žilami, vključno z motnjami srčnega ritma (aritmijami) ali jemljete zdravila za ta stanja.
English: Take ZYTIGA at least two hours after eating and do not eat anything for at least one hour after taking ZYTIGA.
Slovenian: Zdravilo ZYTIGA jemljite najmanj dve uri po jedi, po zaužitju zdravila ZYTIGA pa najmanj eno uro ne uživajte nobene hrane.
English: - If you have any further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: p value is from a log-rank test stratified by ECOG PS score (0/1 or 2) and visceral lesion (absent or present).
Slovenian: Vrednost p je izračunana na osnovi log-rank testa, stratificiranega glede na rezultat ocene zmogljivosti po lestvici ECOG PS (0-1 ali 2) in glede na visceralne lezije (prisotne ali odsotne).
English: Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated.
Slovenian: Med zdravljenjem je treba pri bolnikih, ki niso bili kirurško kastrirani, nadaljevati medikamentozno kastracijo z analogi gonadorelina (luteinizirajoči hormon sproščujočega hormona, LHRH).
English: Figure 1: Kaplan-Meier Plot of Radiographic Progression-free Survival; Intent-to-treat Population (Study PCR3011)
Slovenian: Slika 1: Kaplan-Meierjevi krivulji radiološko potrjenega preživetja brez napredovanja bolezni; populacija bolnikov z namenom zdravljenja (študija PCR3011).
English: At the planned rPFS analysis there were 401 events, 150 (28%) of patients treated with ZYTIGA and 251 (46%) of patients treated with placebo had radiographic evidence of progression or had died.
Slovenian: V načrtovani analizi radiološko potrjenega preživetja brez napredovanja bolezni je prišlo do 401 dogodka radiološko potrjenega napredovanja bolezni ali smrti pri 150 (28%) bolnikih, ki so prejemali zdravilo ZYTIGA, in pri 251 (46%) bolnikih, ki so prejemali placebo.
English: Anaemia and sexual dysfunction may occur in men with metastatic prostate cancer including those undergoing treatment with ZYTIGA.
Slovenian: Pri bolnikih z metastatskim rakom prostate in pri bolnikih, ki se zdravijo z zdravilom ZYTIGA, se lahko pojavita anemija in spolna disfunkcija.
English: ZYTIGA is indicated with prednisone or prednisolone for:
Slovenian: Zdravilo ZYTIGA je indicirano za uporabo skupaj s prednizonom ali prednizolonom:
English: * Cardiac failure also includes congestive heart failure, left ventricular dysfunction and ejection fraction decreased ** Fractures includes osteoporosis and all fractures with the exception of pathological fractures Spontaneous reports from post-marketing experience
Slovenian: ** Zlomi vključujejo osteoporozo in vse vrste zlomov, razen patoloških zlomov.
English: Dosage of prednisone or prednisolone For mHSPC, ZYTIGA is used with 5 mg prednisone or prednisolone daily.
Slovenian: Odmerek prednizona ali prednizolona mHSPC: zdravilo ZYTIGA se jemlje skupaj s 5 mg prednizona ali prednizolona na dan.
English: In the 302 trial, patients with liver metastases were not eligible and patients with baseline ALT and AST ≥ 2.5 x ULN were excluded.
Slovenian: Za vključitev v študijo 302 niso bili primerni bolniki s prisotnimi metastazami na jetrih; izključili so bolnike z izhodiščnimi koncentracijami ALT in AST na ≥ 2,5-kratniku zgornje meje normalnih vrednosti.
English: ZYTIGA 500 mg film-coated tablets abiraterone acetate
Slovenian: ZYTIGA 500 mg filmsko obložene tablete abirateronacetat
English: In the 301 trial, patients with baseline ALT and AST ≥ 2.5 x ULN in the absence of liver metastases and > 5 x ULN in the presence of liver metastases were excluded.
Slovenian: V študijo 301 niso vključili bolnikov z izhodiščnimi koncentracijami ALT in AST na ≥ 2,5-kratniku zgornje meje normalnih vrednosti pri bolnikih brez jetrnih metastaz oziroma na > 5-kratniku zgornje meje normalnih vrednosti pri bolnikih s prisotnimi metastazami na jetrih.
English: Liver metastasis was present in 11% of patients treated with ZYTIGA.
Slovenian: Med bolniki, ki so prejemali zdravilo ZYTIGA, jih je imelo 11% jetrne metastaze.
English: Abiraterone acetate was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse.
Slovenian: V 6mesečni študiji pri transgenskih (Tg.rasH2) miših abirateronacetat ni bil karcinogen.
English: Heart attack, changes in ECG - electrocardiogram (QT prolongation).
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov) srčni infarkt, spremembe elektrokardiograma - EKG (podaljšanje intervala QT)
English: Tell your doctor if you are receiving medicine - used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol); - known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].
Slovenian: - za katera je znano, da povečajo tveganje za pojav srčnih motenj [na primer metadon (uporablja se za lajšanje bolečin in odvajanje od prepovedanih drog), moksifloksacin (antibiotik), antipsihotike (uporablja se za zdravljenje duševnih bolezni)].
English: The following CTCAE (version 4.0) Grade 3 adverse reactions occurred in patients treated with abiraterone acetate: hypokalaemia 5%; urinary tract infection 2%; alanine aminotransferase increased and/or aspartate aminotransferase increased 4%; hypertension 6%; fractures 2%; peripheral oedema, cardiac failure, and atrial fibrillation 1% each.
Slovenian: Pri bolnikih, ki so prejemali abirateronacetat, so se pojavili naslednji neželeni učinki 3. stopnje po CTCAE (verzija 4.0): hipokaliemija pri 5%; okužba sečil pri 2%, zvišanje koncentracije alaninaminotransferaze in/ali aspartat-aminotransferaze pri 4%, hipertenzija pri 6%, zlomi pri 2%, periferni edemi, srčno popuščanje in atrijska fibrilacija pri 1%.
English: Interim survival analysis Deaths (%) Median survival (months) (95% CI)
Slovenian: Vmesna analiza preživetja Število smrti (%) Mediana preživetja (meseci) (95% IZ)
English: * p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1) ** Hazard ratio < 1 favours ZYTIGA
Slovenian: * vrednost p je izračunana na osnovi log-rank testa, stratificiranega glede na začetno vrednost po lestvici ECOG (0 ali 1) ** razmerje tveganja < 1 kaže prednost zdravila ZYTIGA
English: The three Phase 3 studies excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA Class III or IV heart failure (study 301) or Class II to IV heart failure (studies 3011 and 302) or cardiac ejection fraction measurement of < 50%.
Slovenian: V tri študije faze 3 niso vključili bolnikov z neurejeno hipertenzijo ali s klinično pomembno srčno boleznijo, kot je miokardni infarkt ali arterijski trombotični dogodki v zadnjih 6 mesecih, s hudo ali z nestabilno angino pektoris ali s srčnim popuščanjem razreda III ali IV po klasifikaciji NYHA (študija 301) oziroma s srčnim popuščanjem razreda II do IV (študiji 3011 in 302) in bolnikov z iztisnim deležem < 50%.
English: It should be taken at least two hours after eating and no food should be eaten for at least one hour after taking ZYTIGA.
Slovenian: Zdravilo je treba vzeti najmanj dve uri po jedi, po zaužitju zdravila ZYTIGA pa bolnik najmanj eno uro ne sme zaužiti nobene hrane.
English: Pain
Slovenian: Bolečina
English: For mCRPC, ZYTIGA is used with 10 mg prednisone or prednisolone daily.
Slovenian: mCRPC: zdravilo ZYTIGA se jemlje skupaj z 10 mg prednizona ali prednizolona na dan.
English: p-value is derived from a log-rank test stratified by ECOG performance status score (0-1 vs. 2), pain score (absent vs. present), number of prior chemotherapy regimens (1 vs. 2), and type of disease progression (PSA only vs. radiographic).
Slovenian: Vrednost p je izračunana na osnovi log-rank testa, stratiticiranega glede na rezultat ocene stanja zmogljivosti po lestvici ECOG (ECOG - Eastern Cooperative Oncology Group) (0-1 ali 2), oceno bolečine (prisotna ali odsotna), število predhodnih vrst zdravljenja (1 ali 2) in tipa napredovanja bolezni (samo PSA ali radiološki).
English: Fluid in your legs or feet, low blood potassium, liver function test increases, high blood pressure, urinary tract infection, diarrhoea.
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): zastajanje tekočine v nogah ali stopalih, nizka raven kalija v krvi, povišane vrednosti testov jetrne funkcije, visok krvni tlak, okužba sečil, driska.
English: Most cases developed within the first 6 months of treatment and recovered after ZYTIGA withdrawal.
Slovenian: Do večine teh primerov je prišlo v prvih 6 mesecih zdravljenja.
English: - Women who are pregnant or who may be pregnant should wear gloves if they need to touch or handle ZYTIGA.
Slovenian: - Ženske, ki so ali bi lahko bile noseče, morajo v primeru stika ali rokovanja z zdravilom
English: CTCAE (version 4.0) Grade 3 hypertriglyceridaemia and angina pectoris occurred in < 1% of patients.
Slovenian: Pri manj kot 1% bolnikov je prišlo do hipertrigliceridemije in angine pektoris 3. stopnje po CTCAE (verzija 4.0).
English: This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues.
Slovenian: Ta encim nastaja v tkivu mod, nadledvičnih žlezah in tumorskem tkivu prostate, kjer je njegova prisotnost potrebna za biosintezo androgenov.
English: Time to deterioration in ECOG performance score by ≥ 1 point: The median time to deterioration in ECOG performance score by ≥ 1 point was 12.3 months for patients receiving ZYTIGA and 10.9 months for patients receiving placebo (HR = 0.821; 95% CI: [0.714; 0.943], p = 0.0053).
Slovenian: Čas do poslabšanja stanja zmogljivosti do ≥ 1 po lestvici ECOG: mediani čas do poslabšanja stanja zmogljivosti do ≥ 1 po lestvici ECOG je bil pri bolnikih, ki so prejemali zdravilo ZYTIGA 12,3 meseca in pri bolnikih, ki so prejemali placebo 10,9 meseca (razmerje tveganja=0,821; 95% IZ: [0,714; 0,943], p=0,0053).
English: ZYTIGA should not be used in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Slovenian: Zdravila ZYTIGA ne smemo uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavja 4.2, 4.3 in 5.2).
English: Blood pressure, serum potassium and fluid retention should be monitored monthly.
Slovenian: Krvni tlak, koncentracijo kalija v serumu in zastajanje tekočine je treba spremljati enkrat na mesec (glejte poglavje 4.4).
English: Gastrointestinal disorders very common: diarrhoea common: dyspepsia
Slovenian: Bolezni prebavil zelo pogosti: driska pogosti: dispepsija
English: Survival continued to be followed after this IA.
Slovenian: Po vmesni analizi so še naprej spremljali preživetje.
English: In addition to the observed improvements in overall survival and rPFS, benefit was demonstrated for ZYTIGA vs. placebo treatment in all secondary endpoint measures as follows:
Slovenian: Poleg opaženega izboljšanja celokupnega preživetja in rPFS so vse primerjave sekundarnih ciljev govorile v korist uporabe zdravila ZYTIGA v primerjavi s placebom in sicer:
English: These should be swallowed whole with water.
Slovenian: Tablete je treba pogoltniti cele z vodo.
English: Based on its mechanism of action, this medicinal product may harm a developing foetus; therefore, women who are pregnant or may be pregnant should not handle it without protection, e.g., gloves.
Slovenian: Zato ženske, ki so noseče ali bi lahko bile noseče, ne smejo rokovati z zdravilom brez ustrezne zaščite, na primer rokavic.
English: Each carton contains (56 film-coated tablets) 4 wallets.
Slovenian: Eno pakiranje vsebuje 4 zloženke (56 filmsko obloženih tablet).
English: Breast-feeding ZYTIGA is not for use in women.
Slovenian: Dojenje Zdravilo ZYTIGA ni namenjeno uporabi pri ženskah.
English: Time to opiate use for cancer pain: The median time to opiate use for prostate cancer pain at the time of final analysis was 33.4 months for patients receiving ZYTIGA and was 23.4 months for patients receiving placebo (HR = 0.721; 95% CI: [0.614; 0.846], p < 0.0001).
Slovenian: Čas do uporabe opiatov za bolečino pri karcinomu: mediani čas do uporabe opioidov za bolečino pri raku prostate je bil pri bolnikih, ki so prejemali zdravilo ZYTIGA, 33,4 meseca, pri bolnikih, ki so prejemali placebo, pa 23,4 meseca (razmerje tveganja=0,721; 95% IZ: [0,614; 0,846], p < 0,0001).
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone (K29/K32), colloidal anhydrous silica, and sodium laurilsulfate (see section 2, “ZYTIGA contains lactose and sodium”).
Slovenian: - Pomožne snovi so silificirana mikrokristalna celuloza, premreženi natrijev karmelozat, hipromeloza 2910 (15 mPa.S), laktoza monohidrat, magnezijev stearat, brezvodni koloidni silicijev dioksid in natrijev lavrilsulfat (glejte poglavje 2, “Zdravilo ZYTIGA vsebuje laktozo in natrij”).
English: Do not stop taking prednisone or prednisolone unless your doctor tells you to.
Slovenian: Prednizon ali prednizolon lahko prenehate jemati le, če vam tako naroči zdravnik.
English: ZYTIGA should not be used in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Slovenian: Zdravila ZYTIGA ne smejo jemati bolniki s hudo okvaro jeter (glejte poglavja 4.3, 4.4 in 5.2).
English: Time to initiation of cytotoxic chemotherapy: The median time to initiation of cytotoxic chemotherapy was 25.2 months for patients receiving ZYTIGA and 16.8 months for patients receiving placebo (HR = 0.580; 95% CI: [0.487; 0.691], p < 0.0001).
Slovenian: Čas do uvedbe citotoksične kemoterapije: mediani čas do uvedbe citotoksične kemoterapije je bil pri bolnikih, ki so prejemali zdravilo ZYTIGA 25,2 meseca, pri bolnikih, ki so prejemali placebo, pa 16,8 meseca (razmerje tveganja = 0,580; 95% IZ: [0,487; 0,691], p < 0,0001).
English: Hazard ratio < 1 favours ZYTIGA
Slovenian: ** Razmerje tveganja < 1 kaže prednost zdravila ZYTIGA.
English: Systemic exposure to abiraterone after a single oral 1,000 mg dose did not increase in subjects with end-stage renal disease on dialysis.
Slovenian: Po enkratnem peroralnem odmerku 1.000 mg pri bolnikih, ki so imeli končno odpoved ledvic in so se zdravili z dializo, sistemska izpostavljenost abirateronu ni bila zvečana.
English: Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17).
Slovenian: Abirateronacetat (ZYTIGA) se in vivo pretvori v abirateron, ki je zaviralec biosinteze androgenov oziroma natančneje selektivno zavira encim 17α-hidroksilaza/C17,20-liaza (CYP17).
English: Each carton contains (60 film-coated tablets) 5 wallets.
Slovenian: Eno pakiranje vsebuje 5 zloženk (60 filmsko obloženih tablet).
English: Assess cardiac function as clinically indicated, institute appropriate management and consider discontinuation of this treatment if there is a clinically significant decrease in cardiac function (see section 4.2).
Slovenian: Če pride do klinično pomembnega zmanjšanja srčne funkcije (glejte poglavje 4.2) je treba srčno funkcijo oceniti, uvesti ustrezno zdravljenje in preučiti možnost prekinitve tega zdravljenja.
English: Lower rates of response might be expected in patients previously treated with ketoconazole for prostate cancer.
Slovenian: Pri bolnikih z rakom prostate, zdravljenih s ketokonazolom, lahko pričakujemo nižjo stopnjo odziva na zdravljenje.
English: The AUC to abiraterone increased by approximately 600% and the fraction of free drug increased by 80% in subjects with severe hepatic impairment compared to subjects with normal hepatic function.
Slovenian: Pri bolnikih s hudo okvaro jeter se je v primerjavi s preiskovanci z normalnim delovanjem jeter AUC abirateronu zvečala za približno 600%, delež nevezane učinkovine pa se je zvečal za 80%.