FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: Primjenu snažnih induktora CYP3A4 tijekom liječenja treba izbjegavati, osim ako ne postoji terapijska alternativa, obzirom na rizik smanjenja izloženosti abirateronu (vidjeti dio 4.5).
English: The use of glucocorticoids could increase hyperglycaemia, therefore blood sugar should be measured frequently in patients with diabetes.
Croatian: Primjena glukokortikoida može pojačati hiperglikemiju, stoga bolesnicima s dijabetesom treba redovito mjeriti šećer u krvi.
English: 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.
Croatian: Ako dijete ili adolescent slučajno progutaju lijek ZYTIGA, odmah se javite u bolnicu i ponesite ovu uputu o lijeku sa sobom kako bi ju pokazali liječniku u hitnoj službi.
English: A condom is required if the patient is engaged in sexual activity with a pregnant woman.
Croatian: Potrebno je koristiti kondom ako bolesnik ima spolni odnos s trudnicom.
English: Lung irritation (also called allergic alveolitis).
Croatian: Iritacija pluća (još se naziva alergijski alveolitis).
English: If clinical symptoms or signs suggestive of hepatotoxicity develop, serum transaminases should be measured immediately.
Croatian: Ako se razviju klinički simptomi ili znakovi koji ukazuju na hepatotoksičnost, odmah je potrebno izmjeriti razine serumskih transaminaza.
English: What you need to know before you take ZYTIGA
Croatian: Što morate znati prije nego počnete uzimati lijek ZYTIGA
English: Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels.
Croatian: Spironolakton se veže na androgene receptore i može povisiti razine prostatičnog specifičnog antigena (PSA).
English: This results from the selective inhibition of the CYP17 enzyme required for androgen biosynthesis.
Croatian: To je rezultat selektivne inhibicije enzima CYP17, potrebnog za biosintezu androgena.
English: Given the normal variation in the content and composition of meals, taking ZYTIGA with meals has the potential to result in highly variable exposures.
Croatian: S obzirom na uobičajene razlike u sadržaju i sastavu obroka, uzimanje lijeka ZYTIGA s hranom može rezultirati vrlo različitim razinama izloženosti lijeku.
English: Subjects randomised Event
Croatian: Randomizirani ispitanici Događaj
English: ZYTIGA must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.
Croatian: ZYTIGA se ne smije primjenjivati u kombinaciji s Ra-223 radi mogućeg porasta rizika od loma kostiju ili smrti.
English: Patients with visceral metastases were excluded.
Croatian: Bolesnici s visceralnim metastazama bili su isključeni.
English: However, there is no clinical experience in patients with prostate cancer and severe renal impairment.
Croatian: Međutim, nema kliničkog iskustva u bolesnika s karcinomom prostate i teškim oštećenjem bubrega.
English: 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.
Croatian: Prognoza visokog rizika bila je definirana s najmanje 2 od sljedeća 3 faktora rizika: (1) Gleasonov zbroj ≥8; (2) prisutnost 3 ili više lezija na snimki kostiju; (3) prisutnost mjerljivih visceralnih (isključujući bolest limfnih čvorova) metastaza.
English: Radiographic progression-free survival was defined as the time from randomization to the occurrence of radiographic progression or death from any cause.
Croatian: Preživljenje bez radiografske progresije bilo je definirano kao vrijeme od randomizacije do pojave radiografske progresije ili smrti radi bilo kojeg uzroka.
English: Abiraterone acetate was not carcinogenic in female rats.
Croatian: Abirateronacetat nije bio kancerogen u ženki štakora.
English: Androgen deprivation treatment may increase the risk of heart rhythm problems.
Croatian: Liječenje androgenom deprivacijom može povisiti rizik od razvoja problema sa srčanim ritmom.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Paediatric population There is no relevant use of ZYTIGA in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene lijeka ZYTIGA u pedijatrijskoj populaciji.
English: Contains lactose and sodium.
Croatian: Sadrži laktozu i natrij.
English: 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.
Croatian: U bolesnika na prednizonu ili prednizolonu koji su izloženi nesvakidašnjem stresu, može biti indicirana primjena povišenih doza kortikosteroida prije, za vrijeme i nakon stresne situacije.
English: 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.
Croatian: Stoga je u svim ispitivanjima preporučeno da bolesnici nastave s liječenjem u ispitivanju dok se ne ustanove kriteriji za prekid primjene, prema specifičnim zahtjevima za pojedino ispitivanje, navedenim niže.
English: The use of ZYTIGA in combination with a glucocorticoid could increase this effect.
Croatian: Primjena lijeka ZYTIGA u kombinaciji s glukokortikoidom može pojačati taj učinak.
English: Most cases developed within the first 6 months of treatment and recovered after ZYTIGA withdrawal.
Croatian: Većina se tih slučajeva razvila tijekom prvih 6 mjeseci liječenja uz oporavak nakon prekida uzimanja lijeka ZYTIGA.
English: Excipients with known effect Each tablet contains 189 mg of lactose and 6.8 mg of sodium.
Croatian: Pomoćne tvari s poznatim učinkom Svaka tableta sadrži 189 mg laktoze i 6,8 mg natrija.
English: This improvement was demonstrated even though 44% of patients in the placebo arm received ZYTIGA as subsequent therapy.
Croatian: Ovo poboljšanje je pokazano unatoč tome što je 44% bolesnika u placebo skupni primilo lijek ZYTIGA kao nastavno liječenje.
English: If you plan to take Ra-223 following treatment with ZYTIGA and prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223.
Croatian: Ako planirate uzeti Ra-223 nakon liječenja s lijekom ZYTIGA i prednizonom/prednizolonom, morate pričekati 5 dana prije započinjanja liječenja s Ra-223.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika traži se da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: The mean half-life of abiraterone in plasma is approximately 15 hours based on data from healthy subjects.
Croatian: Srednji poluvijek abiraterona u plazmi iznosi oko 15 sati, na temelju podataka prikupljenih u zdravih ispitanika.
English: The following study endpoints demonstrated a statistically significant advantage in favour of ZYTIGA treatment:
Croatian: Slijedeći ishodi ispitivanja pokazali su statistički značajnu prednost u korist liječenja lijekom ZYTIGA:
English: - Do not take ZYTIGA with food.
Croatian: - Nemojte uzimati lijek ZYTIGA s hranom.
English: Pharmacotherapeutic group: endocrine therapy, other hormone antagonists and related agents, ATC code: L02BX03
Croatian: Farmakoterapijska skupina: endokrina terapija, ostali antagonisti hormona i srodni lijekovi, ATK oznaka: L02BX03
English: The mechanism for hepatotoxicity is not understood.
Croatian: Mehanizam nastanka hepatotoksičnosti nije razjašnjen.
English: 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).
Croatian: Međutim, bolesnike koji imaju značajan rizik kongestivnog zatajenja srca potrebno je kontrolirati svaka 2 tjedna tijekom prva tri mjeseca liječenja, a nakon toga jednom mjesečno (vidjeti dio 4.4).
English: Caution is advised in these patients (see section 4.4).
Croatian: U tih se bolesnika savjetuje oprez (vidjeti dio 4.4).
English: 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.
Croatian: Ako uzmete više lijeka nego što ste trebali, odmah porazgovarajte s liječnikom ili otiđite u bolnicu.
English: Liver metastasis was present in 11% of patients treated with ZYTIGA.
Croatian: Metastaze u jetri bile su prisutne u 11% bolesnika liječenih lijekom ZYTIGA.
English: 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).
Croatian: Prestanite uzimati lijek ZYTIGA i odmah se javite liječniku ako primijetite neki od sljedećih simptoma: - slabost u mišićima, trzaje mišića ili lupanje srca (palpitacije).
English: The major compounds present in faeces are unchanged abiraterone acetate and abiraterone (approximately 55% and 22% of the administered dose, respectively).
Croatian: Glavni spojevi prisutni u stolici su nepromijenjeni abirateronacetat i abirateron (približno 55%, odnosno 22% primijenjene doze).
English: 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.
Croatian: Učinak AA-P liječenja na rPFS i OS kroz unaprijed definirane podskupine bio je pozitivan i konzistentan u cjelokupnoj ispitivanoj populaciji, osim za podskupinu ECOG rezultata 2 gdje nije zabilježen trend prema koristi, međutim mala veličina uzorka (n=40) ograničava donošenje značajnog zaključka.
English: In two instances marked increases in liver function tests occurred (see section 4.4).
Croatian: U dva slučaja nastupilo je izraženo povišenje vrijednosti testova jetrene funkcije (vidjeti dio 4.4).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for abiraterone, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za abirateron, znanstveni zaključci CHMP-a su sljedeći:
English: Other important adverse reactions include, cardiac disorders, hepatotoxicity, fractures, and allergic alveolitis.
Croatian: Druge važne nuspojave uključuju srčane poremećaje, hepatotoksičnost, frakture i alergijski alveolitis.
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).
Croatian: Djelotvornost i sigurnost kada se uzima s hranom nisu ustanovljene, stoga se ovaj lijek ne smije uzimati s hranom (vidjeti dijelove 4.2 i
English: Not reached (NE; NE)
Croatian: nije dostignuto (NP; NP)
English: ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer.
Croatian: ZYTIGA zaustavlja stvaranje testosterona u organizmu, što može usporiti rast karcinoma prostate.
English: - If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method.
Croatian: - Ako imate spolni odnos sa ženom koja može zatrudnjeti, koristite kondom i još jednu učinkovitu metodu kontrole začeća.
English: - Do not break the tablets.
Croatian: - Tablete nemojte lomiti.
English: Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in incidence and severity of these adverse reactions.
Croatian: Istodobna primjena kortikosteroida suprimira djelovanje adrenokortikotropnog hormona (ACTH), što dovodi do smanjene incidencije i težine ovih nuspojava.
English: The AUC24 for dextrorphan, the active metabolite of dextromethorphan, increased approximately 33%.
Croatian: AUC24 dekstrorfana, aktivnog metabolita dekstrometorfana, povećala se za približno 33%.
English: Of 15 detectable metabolites, 2 main metabolites, abiraterone sulphate and N-oxide abiraterone sulphate, each represents approximately 43% of total radioactivity.
Croatian: Od 15 metabolita koji se mogu pronaći, svaki od 2 glavna metabolita, abirateronsulfat i N-oksid abirateronsulfat, predstavlja približno 43% ukupne radioaktivnosti.
English: The majority of exploratory endpoints favored treatment with abiraterone acetate and prednisone (AA-P) over Placebo.
Croatian: Većina eksplorativnih mjera ishoda bilo je u korist liječenju abirateronacetatom i prednizonom (AA-P) u odnosu na placebo.
English: Endocrine disorders uncommon: adrenal insufficiency
Croatian: Endokrini poremećaji manje često: adrenalna insuficijencija
English: 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.
Croatian: Pedeset posto bolesnika imalo je metastaze samo u kostima, dodatnih 31% bolesnika imalo je metastaze u kostima i mekim tkivima ili metastaze u limfnim čvorovima, a 19% bolesnika imalo je metastaze jedino u mekim tkivima ili limfnim čvorovima.
English: Abiraterone acetate was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse.
Croatian: Abirateronacetat nije bio kancerogen u 6-mjesečnom ispitivanju u transgeničnih (Tg.rasH2) miševa.
English: ZYTIGA may affect your liver, and you may not have any symptoms.
Croatian: ZYTIGA može djelovati na jetru, a da ne izazove nikakve simptome.
English: Driving and using machines This medicine is not likely to affect your being able to drive and use any tools or machines.
Croatian: Nije vjerojatno će ovaj lijek utjecati na Vašu sposobnost vožnje i korištenja alata i strojeva.
English: If ZYTIGA is continued after corticosteroids are withdrawn, patients should be monitored for symptoms of mineralocorticoid excess (see information above).
Croatian: Ako se liječenje lijekom ZYTIGA nastavi nakon ukidanja kortikosteroida, bolesnike treba nadzirati kako bi se uočili simptomi prekomjerne razine mineralokortikoida (vidjeti gore u tekstu).
English: Before treatment with ZYTIGA, cardiac failure should be treated and cardiac function optimised.
Croatian: Prije liječenja lijekom ZYTIGA, potrebno je liječiti zatajenje srca, te optimizirati funkciju srca.
English: The primary efficacy endpoint was overall survival.
Croatian: Primarna mjera ishoda djelotvornosti ispitivanja bilo je ukupno preživljenje.
English: Caution is advised when administering with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Croatian: Preporučuje se oprez kad se primjenjuje s lijekovima koji se aktiviraju ili metaboliziraju putem CYP2D6, a osobito s lijekovima koji imaju uzak terapijski indeks.
English: Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17).
Croatian: Specifično, abirateron selektivno inhibira enzim 17α-hidroksilazu/C17,20-liazu (CYP17).
English: Human experience of overdose with ZYTIGA is limited.
Croatian: Iskustva u ljudi vezano uz predoziranje lijekom ZYTIGA su ograničena.
English: If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method.
Croatian: Ako bolesnik ima spolni odnos sa ženom reproduktivne dobi, potrebno je koristiti kondom zajedno s još nekom učinkovitom metodom kontracepcije.
English: 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.
Croatian: Iako ovi rezultati ukazuju da se ne očekuju klinički značajna povećanja izloženosti kada se lijek ZYTIGA kombinira s lijekovima koji se eliminiraju pretežno putem CYP2C8, kada se primjenjuju istodobno, bolesnike se mora pratiti na znakove toksičnosti povezane s CYP2C8 supstaratom s uskim terapijskim indeksom.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: AA-P= subjects who received abiraterone acetate and prednisone.
Croatian: AA-P= ispitanici koji su primili abirateronacetat i prednizon.
English: Women who are or may be pregnant should not handle ZYTIGA without gloves.
Croatian: Žene koje su trudne ili bi mogle biti trudne ne smiju rukovati lijekom ZYTIGA bez rukavica.
English: ZYTIGA in combination with prednisone or prednisolone may increase bone loss.
Croatian: ZYTIGA u kombinaciji s prednizonom ili prednizolonom može povećati gubitak koštane mase.
English: Take the prednisone or prednisolone exactly as your doctor has told you.
Croatian: Prednizon ili prednizolon uzmite točno onako kako Vam je rekao liječnik.
English: 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.
Croatian: U ispitivanjima plodnosti, i u mužjaka i u ženki štakora abirateronacetat je smanjio plodnost, što je u potpunosti bilo reverzibilno 4 do 16 tjedana nakon prestanka primjene abirateronacetata.
English: 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.
Croatian: Recite svom liječniku ako imate pojavu žute boje kože ili očiju, tamnog urina, ili teške mučnine ili povraćanja, budući da oni mogu biti znakovi ili simptomi problema s jetrom.
English: If at any time the ALT or AST rises above 5 times the ULN, treatment should be interrupted immediately and liver function closely monitored.
Croatian: Ako bilo kada tijekom liječenja ALT ili AST naraste više od 5 puta GGN, liječenje treba odmah prekinuti i pažljivo nadzirati funkciju jetre.
English: Use with ZYTIGA is not recommended (see section 5.1).
Croatian: Primjena s lijekom ZYTIGA se ne preporučuje (vidjeti dio 5.1).
English: In studies 3011 and 302, patients with atrial fibrillation, or other cardiac arrhythmia requiring medical therapy were excluded.
Croatian: Iz ispitivanja 3011 i 302, isključeni su bolesnici s atrijskom fibrilacijom ili drugim srčanim aritmijama, koji zahtijevaju medicinsko liječenje.
English: In a developmental toxicity study in the rat, abiraterone acetate affected pregnancy including reduced foetal weight and survival.
Croatian: U ispitivanju razvojne toksičnosti u štakora, abirateronacetat je utjecao na trudnoću uključujući smanjenje fetalne težine i preživljenje.
English: The changes in the reproductive organs and androgen-sensitive organs are consistent with the pharmacology of abiraterone.
Croatian: Promjene na spolnim organima i organima osjetljivima na androgene u skladu su s farmakologijom abiraterona.
English: This medicinal product may pose a risk to the aquatic environment (see section 5.3).
Croatian: Ovaj lijek može predstavljati rizik za vodeni okoliš (vidjeti dio 5.3).
English: 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).
Croatian: U bolesnika u kojih se tijekom liječenja razvije hepatotoksičnost (porast razine alanin aminotransferaze [ALT] ili aspartat aminotransferaze [AST] više od 5 puta iznad gornje granice normale [GGN]), liječenje se mora odmah zaustaviti (vidjeti dio 4.4).
English: Excipients with known effect Each film-coated tablet contains 253.2 mg of lactose and 13.5 mg of sodium.
Croatian: Pomoćne tvari s poznatim učinkom Svaka filmom obložena tableta sadrži 253,2 mg laktoze i 13,5 mg natrija.
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.
Croatian: Recite svom liječniku ako Vam je rečeno da imate bilo koju bolest srca ili krvnih žila, uključujući probleme sa srčanim ritmom (aritmija), ili ako se liječite lijekovima za ova stanja.
English: The time to PSA progression was approximately doubled with ZYTIGA treatment (HR = 0.488).
Croatian: Vrijeme do progresije PSA bilo je približno udvostručeno uz liječenje lijekom ZYTIGA (HR=0,488).
English: Via C. Janssen IT-04100 Borgo San Michele Latina
Croatian: Janssen IT-04100 Borgo San Michele Latina
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.
Croatian: Nema podataka o primjeni lijeka ZYTIGA u trudnoći u ljudi, a lijek nije namijenjen za primjenu u žena reproduktivne dobi.
English: 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).
Croatian: Porast aminotransferaza povukao se kod svih osim kod 3 bolesnika (2 su imala nove višestruke metastaze u jetri, a 1 porast AST približno 3 tjedna nakon posljednje doze abirateronacetata).
English: The safety and efficacy of concomitant use of ZYTIGA with cytotoxic chemotherapy has not been established (see section 5.1).
Croatian: Sigurnost i djelotvornost istodobne primjene lijeka ZYTIGA sa citotoksičnom kemoterapijom nije ustanovljena (vidjeti dio 5.1).
English: Hazard ratio is from stratified proportional hazards model.
Croatian: Omjer hazarda je iz stratificiranog modela proporcionalnih hazarda.
English: In subjects with measurable soft tissue disease, significantly increased numbers of complete and partial tumor responses were seen with ZYTIGA treatment.
Croatian: U bolesnika s mjerljivim bolestima mekih tkiva, uz lijek ZYTIGA značajno je povećan broj potpunih i parcijalnih tumorskih odgovora na liječenje.
English: In a 24-month carcinogenicity study in the rat, abiraterone acetate increased the incidence of interstitial cell neoplasms in the testes.
Croatian: U 24-mjesečnom ispitivanju kancerogenosti u štakora, abirateronacetat je povećao incidenciju neoplazmi intersticijskih stanica u testisima.
English: In vitro, the major metabolites abiraterone sulphate and N-oxide abiraterone sulphate were shown to inhibit the hepatic uptake transporter OATP1B1 and as a consequence it may increase the concentrations of medicinal products eliminated by OATP1B1.
Croatian: In vitro je pokazano da glavni metaboliti abirateronsulfat i N-oksid abirateronsulfat inhibiraju OATP1B1 transporter unosa u jetru što posljedično može povisiti koncentracije lijekova koji se eliminiraju putem OATP1B1.
English: 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).
Croatian: Objektivni odgovor: Objektivni odgovor definiran je kao udio ispitanika s mjerljivom bolesti, koji postižu potpuni ili parcijalni odgovor prema kriteriju RECIST (da bi se limfni čvor promatrao kao ciljna lezija, njegova veličina na početku trebala je biti ≥ 2 cm).