FrancophonIA/ELRC3.0 huggingface dataset:
English: Abnormal liver function tests developing in patients participating in clinical trials were vigorously managed by requiring treatment interruption and permitting re-treatment only after return of liver function tests to the patient's baseline (see section 4.2).
Croatian: Povišenje vrijednosti testova jetrene funkcije u bolesnika koji su sudjelovali u kliničkim ispitivanjima rješavalo se odlučno prekidanjem liječenja, a ponovno uvođenje lijeka dozvoljeno je tek nakon što su se vrijednosti testova jetrene funkcije vratile na one koje je bolesnik imao prije početka ispitivanja (vidjeti dio 4.2).
English: Radiographic Progression-free Survival (rPFS) Progression or death Median rPFS in months (95% CI)
Croatian: Preživljenje bez radiografske progresije (rPFS) progresija ili smrt medijan rPFS u mjesecima (95% CI)
English: The number of patients treated with ZYTIGA by racial group was Caucasian 832 (69.4%), Asian 246 (20.5%), Black or African American 25 (2.1%), other 80 (6.7%), unknown/not reported 13 (1.1%), and American Indian or Alaska Native 3 (0.3%).
Croatian: Raspodjela bolesnika liječenih lijekom ZYTIGA prema rasnoj pripadnosti bila je sljedeća: 832 bijelca (69,4%), 246 azijata (20,5%), 25 crne rase ili afroamerikanaca (2,1%) i 80 ostalih (6,7%), nepoznato/neprijavljeno 13 (1,1%) i 3 američka indijanca ili domoroca s Aljaske (0,3%).
English: Swallow the tablets whole with water.
Croatian: Tablete progutajte cijele s vodom.
English: In the Phase 3 clinical studies, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values.
Croatian: U kliničkim ispitivanjima faze 3 bilo je vjerojatnije da će se porast vrijednosti testova jetrene funkcije javiti u bolesnika koji su imali povišeni ALT ili AST na početku ispitivanja nego u onih čije su početne vrijednosti bile normalne.
English: ZYTIGA is not for use in women.
Croatian: ZYTIGA nije namijenjena za primjenu u žena.
English: 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.
Croatian: U deset bolesnika koji su uzimali lijek ZYTIGA lijek je ukinut iz terapije radi hepatotoksičnosti; dvoje ih je imalo hepatotoksičnost stupnja 2, šest ih je imalo hepatotoksičnost stupnja 3, a dvoje ih je imalo hepatotoksičnost stupnja 4. Niti jedan bolesnik nije umro radi hepatotoksičnosti u ispitivanju 3011.
English: Alanine aminotransferase increased and/or aspartate aminotransferase increased includes ALT increased, AST increased, and hepatic function abnormal.
Croatian: Povišena razina alanin aminotransferaze i/ili povišena razina aspartat aminotransferaze uključuje povišen ALT, povišen AST i poremećaj funkcije jetre.
English: 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.
Croatian: Nakon primjene abirateronacetata, farmakokinetika abiraterona i abirateronacetata ispitana je u zdravih dobrovoljaca, bolesnika s metastatskim uznapredovalim karcinomom prostate te u osoba s oštećenjem jetre ili bubrega koje ne boluju od karcinoma.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir u bolesnika koji su na režimu prehrane s kontroliranim unosom natrija.
English: p-value* Hazard ratio** (95% CI)
Croatian: p-vrijednost* omjer hazarda** (95% CI)
English: How much to take The recommended dose is 1,000 mg (two tablets) once a day.
Croatian: Koliko lijeka uzeti Preporučena doza je 1000 mg (dvije tablete) jednom na dan.
English: Each 30 day carton contains 60 film-coated tablets in 5 cardboard wallets of 12 film-coated tablets each.
Croatian: Svaka kutija za 30 dana sadrži 60 filmom obloženih tableta u 5 kartonskih omota s po 12 filmom obloženih tableta.
English: - Take ZYTIGA at least two hours after eating and do not eat anything for at least one hour after taking ZYTIGA (see section 2, “ZYTIGA with food”).
Croatian: - Lijek ZYTIGA uzmite najmanje dva sata nakon jela i nemojte ništa jesti najmanje jedan sat nakon uzimanja lijeka ZYTIGA (pogledajte dio 2: “ZYTIGA s hranom”).
English: This medicinal product does not require special storage conditions.
Croatian: Lijek ne zahtijeva posebne uvjete čuvanja.
English: AA-P= subjects who received abiraterone acetate and prednisone p value is from log-rank test stratified by ECOG PS score (0/1 or 2) and visceral lesion (absent or present).
Croatian: AA-P= ispitanici koji su primili abirateronacetat i prednizon p vrijednost je iz log-rang testa stratificiranog prema ECOG funkcionalnom stanju (0/1 ili 2) i visceralnim lezijama (odsutne ili prisutne).
English: Time to Event (months) Median (95% CI)
Croatian: Vrijeme do događaja (mjeseci) Medijan (95% CI)
English: Re-treatment may take place only after return of liver function tests to the patient's baseline and at a reduced dose level (see section 4.2).
Croatian: Liječenje se može ponovno započeti tek kada se vrijednosti jetrenih enzima vrate na početne, i to sa smanjenom dozom (vidjeti dio 4.2).
English: Each 28 day carton contains 56 film-coated tablets in 4 cardboard wallets of 14 film-coated tablets each.
Croatian: Svaka kutija za 28 dana sadrži 56 filmom obloženih tableta u 4 kartonska omota s po 14 filmom obloženih tableta.
English: The mean half-life of abiraterone is prolonged to approximately 18 hours in subjects with mild hepatic impairment and to approximately 19 hours in subjects with moderate hepatic impairment.
Croatian: Srednje poluvrijeme raspada abiraterona produljeno je na oko 18 sati u ispitanika s blagim oštećenjem jetre, odnosno na oko 19 sati u ispitanika s umjerenim oštećenjem jetre.
English: Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS).
Croatian: Koprimarne mjere ishoda djelotvornosti bili su ukupno preživljenje i preživljenje bez radiografske progresije (rPFS, od engl. radiographic progression-free survival).
English: What ZYTIGA contains - The active substance is abiraterone acetate.
Croatian: Što ZYTIGA sadrži - Djelatna tvar je abirateronacetat.
English: CTCAE (version 4.0) Grade 3 hypertriglyceridaemia and angina pectoris occurred in < 1% of patients.
Croatian: Hipertrigliceridemija i angina pektoris stupnja 3 prema CTCAE (verzija 4.0) javile su se u < 1% bolesnika.
English: In Phase 3 studies, anticipated mineralocorticoid adverse reactions were seen more commonly in patients treated with abiraterone acetate than in patients treated with placebo: hypokalaemia 18% vs.8%, hypertension 22% vs. 16% and fluid retention (peripheral oedema) 23% vs. 17%, respectively.
Croatian: U ispitivanjima faze 3 očekivane mineralokortikoidne nuspojave zabilježene su češće u bolesnika liječenih abirateronacetatom nego u bolesnika koji su primali placebo: hipokalemija (18% naspram 8%), hipertenzija (22% naspram 16%) i retencija tekućine (periferni edem) (23% naspram 17%).
English: In addition to the co-primary endpoint measures, benefit was also assessed using time to opiate use for cancer pain, time to initiation of cytotoxic chemotherapy, time to deterioration in ECOG performance score by ≥ 1 point and time to PSA progression based on Prostate Cancer Working Group-2 (PCWG2) criteria.
Croatian: Dodatno uz koprimarne mjere ishoda, korist liječenja je također procijenjena prema vremenu potrebnom za primjenu opioidnih lijekova za bol karcinomskog porijekla, te prema vremenu do početka citotoksične kemoterapije, prema vremenu do pogoršanja ECOG izvedbenog statusa do točke ≥ 1, te prema vremenu do progresije PSA utemeljene na kriterijima Radne skupine za karcinom prostate-2 (PCWG2, od engl.
English: Infections and infestations very common: urinary tract infection common: sepsis
Croatian: Infekcije i infestacije vrlo često: infekcija mokraćnih puteva često: sepsa
English: Hepatobiliary disorders very common: alanine aminotransferase increased and/or aspartate aminotransferase increased rare: hepatitis fulminant, acute hepatic failure
Croatian: Poremećaji jetre i žuči vrlo često: povišena razina alanin aminotransferaze i/ili povišena razina aspartat aminotransferaze rijetko: fulminantni hepatitis, akutno zatajenje jetre
English: The pharmacokinetics of abiraterone acetate was examined in subjects with pre-existing mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) and in healthy control subjects.
Croatian: Farmakokinetika abirateronacetata ispitana je u ispitanika s postojećim blagim ili umjerenim oštećenjem jetre (Child-Pugh stadij A, odnosno B) i u zdravih ispitanika u kontrolnoj skupini.
English: Belgium
Croatian: Belgija
English: Patients receiving ZYTIGA demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 38% vs. 10%, p < 0.0001.
Croatian: Bolesnici koji su primali lijek ZYTIGA imali su značajno veći odgovor na liječenje mjeren vrijednošću PSA (definiran kao smanjenje ≥ 50% u odnosu na početne vrijednosti), u usporedbi s bolesnicima koji su primali placebo, 38% naspram 10%, p < 0,0001.
English: Treatment with abiraterone acetate decreased the risk of radiographic progression or death by 47% compared with placebo (HR = 0.530; 95% CI: [0.451; 0.623], p < 0.0001).
Croatian: Liječenje abirateronacetatom smanjilo je rizik za radiografsku progresiju ili smrt za 47% u usporedbi s placebom (HR=0,530; 95% CI: [0,451; 0,623], p < 0,0001).
English: This medicinal product also contains more than 1.18 mmol (or 27 mg) sodium per dose of two tablets.
Croatian: Ovaj lijek sadržava i više od 1,18 mmol (odnosno 27 mg) natrija po dozi od dvije tablete.
English: No dose adjustment is necessary for patients with pre-existing mild hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s postojećim blagim oštećenjem jetre.
English: Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
Croatian: Graaf Engelbertlaan 75 NL-4837 DS BREDA Tel: +31 76 711 1111
English: The European Medicines Agency has waived the obligation to submit the results of studies with ZYTIGA in all subsets of the paediatric population in advanced prostate cancer.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka ZYTIGA u svim podskupinama pedijatrijske populacije u uznapredovalom karcinomu prostate.Vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: QT prolongation has been observed in patients experiencing hypokalaemia in association with ZYTIGA treatment.
Croatian: Produljenje QT intervala zabilježeno je u bolesnika s hipokalemijom vezanom uz liječenje lijekom ZYTIGA.
English: In addition to the observed improvements in overall survival and rPFS, benefit was demonstrated for ZYTIGA vs. placebo treatment in all prospectively-defined secondary endpoint measures as follows:
Croatian: Dodatno na zabilježena poboljšanja ukupnog preživljenja i rPFS-a, korist je dokazana za lijek ZYTIGA naspram liječenja placebom u svim prospektivno definiranim sekundarnim mjerama ishoda kako slijedi:
English: 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).
Croatian: Hipokalemija je bila zabilježena u 20,4% bolesnika u hormon osjetljivoj populaciji (ispitivanje 3011) u usporedbi s 19,2% i 14,9% u ispitivanjima 301, odnosno 302).
English: Potential to affect exposures to other medicinal products Abiraterone is an inhibitor of the hepatic drug-metabolising enzymes CYP2D6 and CYP2C8.
Croatian: Abirateron je inhibitor jetrenih enzima koji sudjeluju u biotransformaciji lijekova, CYP2D6 i CYP2C8.
English: 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
Croatian: Na temelju znanstvenih zaključaka za abirateron, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) abirateron nepromijenjen, uz predložene izmjene informacija o lijeku.
English: If patients develop severe hepatotoxicity (ALT or AST 20 times the ULN) anytime while on therapy, treatment should be discontinued and patients should not be re-treated.
Croatian: Ako se u bolesnika bilo kada tijekom terapije razvije teška hepatotoksičnost (ALT ili AST 20 puta GGN), liječenje treba prekinuti i ne smije se ponovno započinjati.
English: Treatment with ZYTIGA decreases serum testosterone to undetectable levels (using commercial assays) when given with LHRH analogues (or orchiectomy).
Croatian: Liječenje lijekom ZYTIGA snižava koncentracije testosterona u serumu ispod razine detekcije (komercijalno dostupnim testovima) kad se primjenjuje zajedno s analozima LHRH (ili orhidektomijom).
English: Survival continued to be followed after this IA.
Croatian: Nastavlja se praćenje preživljenja nakon ove privremene analize.
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.
Croatian: Kad je uočen porast ALT-a ili AST-a > 5 x GGN, ili povišenje vrijednosti bilirubina > 3 x GGN, liječenje abirateronacetatom je privremeno ili trajno prekinuto.
English: No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrega (vidjeti dio 5.2).
English: Table 2:
Croatian: Slika 2:
English: If you forget to take ZYTIGA - If you forget to take ZYTIGA or prednisone or prednisolone, take your usual dose the following day.
Croatian: - Ako zaboravite uzeti lijek ZYTIGA ili prednizon ili prednizolon, uzmite uobičajenu dozu sljedećeg dana.
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).
Croatian: Udio ispitanika s potvrđenim PSA odgovorom bio je veći u skupini s lijekom ZYTIGA nego u placebo skupini (62% napram 24%; p < 0,0001).
English: If you stop taking ZYTIGA Do not stop taking ZYTIGA or prednisone or prednisolone unless your doctor tells you to.
Croatian: Nemojte prestati uzimati lijek ZYTIGA, niti prednizon ili prednizolon ako Vam to ne kaže liječnik.
English: Safety in patients with left ventricular ejection fraction (LVEF) < 50% or NYHA Class III or IV heart failure (in study 301) or NYHA Class II to IV heart failure (in studies 3011 and 302) was not established (see sections 4.8 and 5.1).
Croatian: Nije bila ustanovljena sigurnost primjene u bolesnika s ejekcijskom frakcijom lijeve klijetke (LVEF) < 50% niti u bolesnika sa zatajivanjem srca NYHA stupnja III ili IV (u ispitivanju 301), niti sa zatajivanjem srca NYHA stupnja II do IV (u ispitivanjima 3011 i 302), (vidjeti dijelove 4.8 i 5.1).
English: The incidence of cardiovascular adverse reactions in the Phase 3 studies in patients taking abiraterone acetate versus patients taking placebo were as follows: atrial fibrillation 2.6% vs. 2.0%, tachycardia 1.9% vs. 1.0%, angina pectoris 1.7% vs. 0.8%, cardiac failure 0.7% vs. 0.2%, and arrhythmia 0.7% vs. 0.5%.
Croatian: Incidencije kardiovaskularnih nuspojava u ispitivanjima faze 3 u bolesnika koji uzimaju abirateronacetat u odnosu na bolesnike koji uzimaju placebo bile su slijedeće: atrijska fibrilacija 2,6% naspram 2,0%, tahikardija 1,9% naspram 1,0%, angina pektoris 1,7% naspram 0,8%, zatajenje srca 0,7% naspram 0,2% i aritmija 0,7% naspram
English: ZYTIGA 250 mg tablets
Croatian: ZYTIGA 250 mg tablete
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.
Croatian: U ispitivanju 302, bolesnici s metastazama u jetri nisu bili prikladni, a bolesnici s početnim vrijednostima ALT-a i AST-a ≥ 2,5 x GGN, bili su isključeni.
English: How to take ZYTIGA
Croatian: Kako uzimati lijek ZYTIGA
English: - This medicinal product does not require any special storage conditions.
Croatian: - Lijek ne zahtijeva posebne uvjete čuvanja.
English: Hypertension was reported in 36.7% of patients in the hormone sensitive population (study 3011) compared to 11.8% and 20.2% in studies 301 and 302, respectively.
Croatian: Hipertenzija je bila prijavljena u 36,7% bolesnika u hormon osjetljivoj populaciji (ispitivanje 3011) u usporedbi s 11,8% i 20,2% u ispitivanjima 301 odnosno 302.
English: The number of patients treated with ZYTIGA by racial group was Caucasian 737 (93.2%), Black 28 (3.5%), Asian 11 (1.4%) and other 14 (1.8%).
Croatian: Raspodjela bolesnika liječenih lijekom ZYTIGA prema rasnoj pripadnosti bila je sljedeća: 737 bijelaca (93,2%), 28 crnaca (3,5%), 11 azijata (1,4%) i 14 ostalih (1,8%).
English: Film-coated tablet
Croatian: Filmom obložena tableta
English: How to store ZYTIGA
Croatian: Kako čuvati lijek ZYTIGA
English: Iron oxide black (E172) Iron oxide red (E172) Macrogol 3350
Croatian: Film-ovojnica željezov oksid, crni (E172) željezov oksid, crveni (E172) makrogol 3350 poli(vinilni alkohol) talk titanijev dioksid
English: 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%.
Croatian: U kliničkom ispitivanju farmakokinetičkih interakcija, u zdravih ispitanika koji su prethodno primali jaki CYP3A4 induktor rifampicin, 600 mg dnevno tijekom 6 dana, zatim jednokratnu dozu abirateronacetata 1000 mg, prosječna izloženost AUC∞ abiraterona u plazmi je smanjena za 55%.
English: Musculoskeletal and connective tissue disorders uncommon: myopathy, rhabdomyolysis
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često: miopatija, rabdomioliza
English: For patients being re-treated, serum transaminases should be monitored at a minimum of every two weeks for three months and monthly thereafter.
Croatian: U bolesnika u kojih se ponovno započinje liječenje, razine transaminaza u serumu treba kontrolirati najmanje svaka dva tjedna u prva tri mjeseca, a nakon toga jednom mjesečno.
English: Time to degradation in the FACT-P (Total Score): Treatment with ZYTIGA decreased the risk of FACT-P (Total Score) degradation by 22% compared with placebo (p = 0.0028).
Croatian: Functional Assessment of Cancer Therapy-Prostate) (ukupni rezultat): Liječenje lijekom ZYTIGA je smanjilo rizik za degradaciju FACT-P (ukupni rezultat) za 22% u usporedbi s placebom (p=0,0028).
English: Purple, oval-shaped, film-coated tablets (20 mm long by 10 mm wide), debossed with “AA” on one side and “500” on the other side.
Croatian: Ljubičaste filmom obložene tablete ovalnog oblika (20 mm dužine sa 10 mm širine), s utisnutom oznakom “AA” na jednoj strani i “500” na drugoj strani.
English: Overall survival was longer for ZYTIGA than placebo with a 25% reduction in risk of death (HR = 0.752; 95% CI: [0.606; 0.934], p = 0.0097), but OS was not mature and interim results did not meet the pre-specified stopping boundary for statistical significance (see Table 4).
Croatian: Ukupno preživljenje bilo je dulje uz lijek ZYTIGA nego uz placebo sa smanjenjem rizika od smrti od 25% (HR=0,752; 95% CI: [0,606; 0,934], p=0,0097), ali podaci za ukupno preživljenje nisu bili zreli i rezultati interim analize nisu dostigli unaprijed definiranu granicu prekida za statističku značajnost (vidjeti Tablicu 6).
English: The proportion of patients with pain palliation was statistically significantly higher in the ZYTIGA group than in the placebo group (44% vs. 27%, p = 0.0002).
Croatian: Udio bolesnika s ublaženim simptoma boli bio je statistički značajno veći u skupini liječenoj lijekom ZYTIGA nego u skupini koja je primala placebo (44% naspram 27%, p=0,0002).
English: Only patients with a baseline pain score of ≥ 4 and at least one post-baseline pain score were analysed (N = 512) for pain palliation.
Croatian: Ublažavanje boli analizirano je samo u bolesnika s početnim intenzitetom boli ≥ 4 i najmanje jednim rezultatom procjene boli nakon početka liječenja (N=512).
English: Across Phase 3 clinical studies, hepatotoxicity grades 3 and 4 (e.g., ALT or AST increases of > 5 x ULN or bilirubin increases > 1.5 x ULN) were reported in approximately 6% of patients who received abiraterone acetate, typically during the first 3 months after starting treatment.
Croatian: Hepatotoksičnosti stupnja 3 i 4 (npr. ALT ili AST povišen > 5 x iznad gornje granice normale (GGN) ili bilirubin povišen > 1,5 x GGN) zabilježene su u približno 6% bolesnika koji su primali abirateronacetat ukupno u kliničkim ispitivanjima faze 3, a tipično bi se javljale u prva 3 mjeseca nakon započinjanja liječenja.
English: ROMÂNIA Tel: +40 21 207 1800
Croatian: Tel: +40 21 207 1800
English: Each carton contains (56 film-coated tablets) 4 wallets.
Croatian: Svaka kutija sadrži (56 filmom obloženih tableta) 4 omota.
English: Systemic exposure to abiraterone after a single oral 1,000 mg dose increased by approximately 11% and 260% in subjects with mild and moderate pre-existing hepatic impairment,
Croatian: Sustavna izloženost abirateronu nakon pojedinačne peroralne doze od 1000 mg povećala se za približno 11% u ispitanika s postojećim blagim te za približno 260% u ispitanika s postojećim umjerenim oštećenjem jetre.
English: 14 film-coated tablets
Croatian: 14 filmom obloženih tableta
English: Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele I-04100 Latina, Italy
Croatian: Janssen Borgo San Michele I-04100 Latina, Italija
English: Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Janssen-Cilag International NV Turnhoutseweg 30
English: Overall Survival (months) Median (95% CI)
Croatian: Ukupno preživljenje (mjeseci) Medijan (95% CI)
English: Skeletal muscle effects
Croatian: Učinci na poprečno prugaste mišiće
English: The median time to SRE has not been reached for the ZYTIGA or placebo study arm.
Croatian: Medijan vremena do pojave koštanog događaja nije postignut za ispitivanu skupinu s lijekom ZYTIGA ili placebom.
English: The tablets should be taken at least two hours after eating and no food should be eaten for at least one hour after taking the tablets.
Croatian: Tablete se moraju uzimati najmanje dva sata nakon jela i najmanje sat vremena nakon uzimanja tableta ne smije se uzeti nikakva hrana.
English: In a Phase 3 clinical study of patients who failed prior chemotherapy with taxanes, 38% of patients treated with abiraterone acetate, versus 10% of patients treated with placebo, had at least a 50% decline from baseline in PSA levels.
Croatian: U kliničkom ispitivanju faze 3 u bolesnika koji nisu odgovorili na prethodnu kemoterapiju taksanom, u 38% bolesnika liječenih abirateronacetatom te u 10% bolesnika koji su primali placebo zabilježeno je najmanje 50%-tno sniženje razine PSA u odnosu na početne vrijednosti.
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.
Croatian: Bolesnik koji je odgovorio na ublažavanje boli definiran je kao onaj bolesnik koji je tijekom prethodna 24 sata osjetio najmanje 30%-tno smanjenje najjače boli u odnosu na početni rezultat Kratkog upitnika o boli bez povećanja doze analgetika u dvije uzastopne posjete u razmaku od četiri tjedna.
English: Hyperglycaemia
Croatian: Hiperglikemija
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba):