natgillin/translations-raw huggingface dataset:
What ZYTIGA is and what it is used for
Kaj je zdravilo ZYTIGA in za kaj ga uporabljamo
It is not known whether abiraterone or its metabolites are present in semen.
Ni znano, ali so abirateron oziroma njegovi presnovki prisotni v spermi.
ZYTIGA must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.
Zdravila ZYTIGA se ne sme dajati v kombinaciji z Ra-223 zaradi možnega povečanja tveganja za zlome kosti ali smrti.
Therefore, in all studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Zato so v vseh študijah priporočali, da bolnik prejema študijsko zdravljenje, dokler ne izpolni za vsako študijo v nadaljevanju opisanih prekinitvenih kriterijev.
The active substance, abiraterone, shows an environmental risk for the aquatic environment, especially to fish.
Učinkovina abirateron predstavlja tveganje za vodno okolje, posebej za ribe.
There are no clinical data available to confirm transporter based interaction.
Kliničnih podatkov, ki bi potrdili medsebojno delovanje na osnovi prenašalca, ni.
Changes in PSA serum concentration independently do not always predict clinical benefit.
Spremembe koncentracije PSA v serumu vsaka zase ne napovedujejo vedno kliničnih koristi za bolnika.
Use with Spironolactone
Sočasna uporaba s spironolaktonom
In two instances marked increases in liver function tests occurred (see section 4.4).
V dveh primerih je prišlo do izrazitega zvišanja vrednosti testov jetrne funkcije (glejte poglavje 4.4).
This may lead to side effects or to ZYTIGA not working as well as it should.
To lahko vodi v pojav neželenih učinkov ali pa zdravilo ZYTIGA ne deluje tako učinkovito kot bi moralo.
- Women who are or may potentially be pregnant (see section 4.6).
- Ženske, ki so noseče oziroma bi lahko bile noseče (glejte poglavje 4.6).
Driving and using machines This medicine is not likely to affect your being able to drive and use any tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bo zdravilo vplivalo na vašo sposobnost vožnje in uporabe orodij in strojev.
What you need to know before you take ZYTIGA
Kaj morate vedeti, preden boste vzeli zdravilo ZYTIGA
No patient died of hepatotoxicity in Study 3011.
Noben bolnik pa v študiji 3011 ni umrl zaradi hepatotoksičnosti.
- Do not throw away any medicines via wastewater or household waste.
- Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
A planned interim analysis (IA) for OS was conducted after 333 deaths were observed.
Načrtovana vmesna analiza (IA) celokupnega preživetja (OS-overall survival) je bila izvedena po smrti 333 bolnikov.
Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take.
Zdravnik vam bo povedal, če boste morali spremeniti odmerek prednizona ali prednizolona.
Do not break the tablets.
Tablet ne smete zdrobiti.
If hepatotoxicity recurs at the reduced dose of 500 mg daily, treatment should be discontinued.
Če se hepatotoksičnost ponovno pojavi pri jemanju zmanjšanega odmerka 500 mg na dan, je treba zdravljenje prekiniti.
- Do not break the tablets.
- Tablet ne smete zdrobiti.
In all animal toxicity studies, circulating testosterone levels were significantly reduced.
V vseh študijah toksičnosti na živalih so opažali bistveno znižanje koncentracij testosterona v obtoku.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Aside from reproductive organ changes seen in all animal toxicology studies, non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Razen sprememb, ki so jih v vseh raziskavah toksičnosti na živalih opažali na reproduktivnih organih, neklinični podatki na podlagi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
The use of ZYTIGA in combination with a glucocorticoid could increase this effect.
Jemanje zdravila ZYTIGA v kombinaciji z glukokortikoidi lahko ta učinek poveča.
Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death.
Redko lahko pride do odpovedi delovanja jeter (imenujemo jo akutna odpoved jeter), ki lahko povzroči smrt.
ZYTIGA has no or negligible influence on the ability to drive and use machines.
Zdravilo ZYTIGA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The primary efficacy endpoint was overall survival.
Primarni cilj opazovanja je bilo celokupno preživetje.
Abiraterone acetate was not carcinogenic in female rats.
Abirateronacetat ni bil karcinogen pri podganjih samicah.
The changes in the reproductive organs and androgen-sensitive organs are consistent with the pharmacology of abiraterone.
Spremembe reproduktivnih in za androgene občutljivih organov so v skladu s farmakologijo abiraterona.
See leaflet for further information.
Za dodatne informacije glejte priloženo navodilo.
Excipients with known effect Each tablet contains 189 mg of lactose and 6.8 mg of sodium.
Pomožne snovi z znanim učinkom Ena tableta vsebuje 189 mg laktoze in 6,8 mg natrija.
ZYTIGA with food - This medicine must not be taken with food (see section 3, “Taking this medicine”).
Zdravilo ZYTIGA skupaj s hrano - Zdravila ne smete jemati skupaj s hrano (glejte poglavje 3, “Jemanje zdravila”).
The tablets should be swallowed whole with water (see section 4.2).
Tablete je treba pogoltniti cele z vodo (glejte poglavje 4.2).
Caution is advised in these patients (see section 4.4).
Pri teh bolnikih svetujemo previdnost (glejte poglavje 4.4).
Adverse reaction and frequency
Neželeni učinki in pogostnosti
Decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.
Pojavi se lahko zmanjšano število rdečih krvnih celic, zmanjšana spolna sla (libido), mišična šibkost in/ali bolečine v mišicah.
Study 3011 (patients with newly diagnosed high risk mHSPC) In Study 3011, (n=1199) the median age of enrolled patients was 67 years.
Študija 3011 (bolniki z na novo diagnosticiranim mHSPC z visokim tveganjem) V študiji 3011 (n=1.199) je bila mediana starost vključenih bolnikov 67 let.
The treatment effect of AA-P on rPFS and OS across the pre-specified subgroups was favorable and consistent with the overall study population, except for the subgroup of ECOG score of 2 where no trend towards benefit was observed, however the small sample size (n=40) limits drawing any meaningful conclusion.
Učinek zdravljenja AA-P na rPFS in OS v predhodno določenih podskupinah je bil ugoden in skladen s celokupno študijsko populacijo, razen v podskupini z oceno ECOG 2, kjer trenda izboljšanja niso opazili, majhen vzorec (n=40) pa omejuje kakršne koli pomembne zaključke.
The use of glucocorticoids could increase hyperglycaemia, therefore blood sugar should be measured frequently in patients with diabetes.
Uporaba glukokortikoidov lahko poslabša hiperglikemijo, zato je potrebno pri sladkornih bolnikih redno meriti koncentracijo glukoze v krvi.
Round white HDPE bottles fitted with a polypropylene child-resistant closure containing 120 tablets.
Okrogle bele HDPE plastenke z za otroke varno zaporko iz polipropilena, ki vsebujejo 120 tablet.
Patients with visceral metastases were excluded.
Bolniki z visceralnimi metastazami niso bili vključeni.
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.