FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies showed that apalutamide and N-desmethyl apalutamide are moderate to strong CYP3A4 and CYP2B6 inducers, are moderate inhibitors of CYP2B6 and CYP2C8, and weak inhibitors of CYP2C9, CYP2C19, and CYP3A4.
Croatian: Ispitivanja in vitro pokazala su da su apalutamid i N-dezmetil apalutamid umjereni do snažni induktori CYP3A4 i CYP2B6, umjereni inhibitori CYP2B6 i CYP2C8 te slabi inhibitori CYP2C9, CYP2C19 i CYP3A4.
English: At steady-state, the maximum mean QTcF change from baseline was 12.4 ms (2-sided 90% upper CI: 16.0 ms).
Croatian: U stanju dinamičke ravnoteže, najveća srednja vrijednost promjene QTcF intervala u odnosu na početnu vrijednost iznosila je 12,4 ms (2-strani gornji 90%-tni CI: 16,0 ms).
English: Erleada is a cancer medicine that contains the active substance apalutamide.
Croatian: Erleada je lijek namijenjen za liječenje raka, a sadrži djelatnu tvar apalutamid.
English: For the active moieties (sum of apalutamide plus the potency adjusted active metabolite), Cmax decreased by 22% while AUC was again similar.
Croatian: Cmax aktivnih komponenata (apalutamid plus aktivni metabolit prilagođen za potentnost) smanjio se za 22%, dok je AUC ponovno bio podjednak.
English: The mean apparent volume of distribution at steady-state of apalutamide is about 276 L. The volume of distribution of apalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Croatian: Volumen distribucije apalutamida veći je od volumena ukupne količine vode u tijelu, što ukazuje na opsežnu ekstravaskularnu distribuciju.
English: In humans, Erleada is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9.
Croatian: Erleada je u ljudi snažan induktor CYP3A4 i CYP2C19 te slab induktor CYP2C9.
English: The median survival for the apalutamide arm was not reached compared to 39.03 months with a 95% CI of (39.03, NE) for the placebo arm. Statistical significance was not reached in overall survival at the pre-specified interim analysis.
Croatian: U usporedbi s 39,03 mjeseci s 95% CI od (39,03, NE) za placebo skupinu za apalutamid skupinu nije dostignut medijan preživljenja.
English: Following a single oral 240 mg dose of apalutamide, the geometric mean ratio (GMR) for AUC and Cmax for apalutamide in subjects with mild impairment was 95% and 102%, respectively, and the GMR for AUC and Cmax of apalutamide in subjects with moderate impairment was 113% and 104%, respectively, compared to healthy control subjects.
Croatian: Nakon primjene jedne peroralne doze apalutamida od 240 mg, geometrijska srednja vrijednost omjera (engl. geometric mean ratio, GMR) za AUC i Cmax apalutamida u ispitanika s blagim oštećenjem iznosila je 95% odnosno 102%, dok je u ispitanika s umjerenim oštećenjem iznosila 113% odnosno 104% u odnosu na zdrave kontrolne ispitanike.
English: Concomitant administration of Erleada with medicinal products that are substrates of UGT (e.g., levothyroxine, valproic acid) can result in lower exposure to these medicinal products.
Croatian: Istodobna primjena lijeka Erleada i lijekova koji su supstrati UGT-a (npr. levotiroksin, valproatna kiselina) može smanjiti izloženost tim lijekovima.
English: Medicinal products which prolong the QT interval Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g., quinidine, disopyramide) or class III (e.g., amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics (e.g. haloperidol), etc. should be carefully evaluated (see section 4.4).
Croatian: Budući da terapija androgenom deprivacijom može produljiti QT interval, potrebno je pažljivo ocijeniti istodobnu primjenu lijeka Erleada s lijekovima za koje se zna da produljuju QT interval ili lijekovima koji mogu inducirati torsades de pointes, kao što su antiaritmici skupine IA (npr. kinidin, dizopiramid) ili skupine III (npr. amiodaron, sotalol, dofetilid, ibutilid), metadon, moksifloksacin, antipsihotici (npr. haloperidol) itd. (vidjeti dio 4.4).
English: • blood test showing high level of cholesterol in the blood
Croatian: • visoke razine kolesterola u krvi, vidljive u nalazima krvnih pretraga
English: • treat fungal infections (e.g. itraconazole, ketoconazole)
Croatian: • liječenje gljivičnih infekcija (npr. itrakonazol, ketokonazol)
English: • fit or seizure - this is uncommon (may affect up to 1 in 100 people).
Croatian: • napadaj - javlja se manje često (može se javiti u do 1 na 100 osoba).
English: Mild or moderate inhibitors of CYP3A4 are not expected to affect the exposure of apalutamide.
Croatian: Ne očekuje se da će blagi ili umjereni inhibitori CYP3A4 utjecati na izloženost apalutamidu.
English: The CL/F of apalutamide is 1.3 L/h after single dosing and increases to 2.0 L/h at steady-state after once-daily dosing.
Croatian: Vrijednost CL/F apalutamida iznosi 1,3 l/h nakon primjene jedne doze te se povećava do 2,0 l/h u stanju dinamičke ravnoteže uz primjenu jedanput na dan.
English: • treat bacterial infections (e.g. moxifloxacin, clarithromycin)
Croatian: • liječenje bakterijskih infekcija (npr. moksifloksacin, klaritromicin)
English: Patients should be evaluated for fractures and fall risk before starting Erleada and should continue to be monitored and managed for fractures according to established treatment guidelines and use of bone-targeted agents should be considered.
Croatian: Prije početka liječenja lijekom Erleada bolesnike je potrebno procijeniti vezano uz rizik prijeloma i padova, a zatim ih je potrebno nastaviti pratiti i liječiti prijelome u skladu s utvrđenim smjernicama za liječenje te je potrebno razmotriti primjenu lijekova koji ciljano djeluju na kosti.
English: Erleada may be harmful to a developing foetus.
Croatian: Erleada može naškoditi plodu u razvoju.
English: humerus fracture, thoracic vertebral fracture, upper limb fracture, fractured sacrum, hand fracture, pubis fracture, acetabulum fracture, ankle fracture, compression fracture, costal cartilage fracture, facial bones fracture, lower limb fracture, osteoporotic fracture, wrist fracture, avulsion fracture, fibula fracture, fractured coccyx, pelvic fracture, radius fracture, sternal fracture, stress fracture, traumatic fracture, cervical vertebral fracture, femoral neck fracture, tibia fracture.
Croatian: Uključuje prijelom rebra, prijelom lumbalnog kralješka, kompresijski prijelom kralježnice, prijelom kralježnice, prijelom stopala, prijelom kuka, prijelom ramene kosti, prijelom torakalnog kralješka, prijelom gornjeg ekstremiteta, prijelom križne kosti, prijelom šake, prijelom preponske kosti, prijelom acetabula, prijelom gležnja, kompresijski prijelom, prijelom rebrene hrskavice, prijelom ličnih kostiju, prijelom donjeg ekstremiteta, osteoporotski prijelom, prijelom zapešća, avulzijski prijelom, prijelom lisne kosti, prijelom trtične kosti, prijelom zdjelice, prijelom palčane kosti, prijelom prsne kosti, stresni prijelom, traumatski prijelom, prijelom vratnog kralješka, prijelom vrata bedrene kosti, prijelom goljenične kosti.
English: Your healthcare provider will stop Erleada if you have a seizure during treatment.
Croatian: Liječnik će prekinuti liječenje lijekom Erleada ako doživite napadaj tijekom liječenja.
English: Iron oxide black (E172) Iron oxide yellow (E172) Macrogol
Croatian: Film ovojnica željezov oksid, crni (E172) željezov oksid, žuti (E172) makrogol poli(vinilni alkohol) (djelomično hidroliziran) talk titanijev dioksid (E171)
English: If given with warfarin, INR should be monitored during Erleada treatment.
Croatian: Ako se Erleada primjenjuje istodobno s varfarinom, potrebno je pratiti INR tijekom liječenja.
English: Each film-coated tablet contains 60 mg of apalutamide.
Croatian: Jedna filmom obložena tableta sadrži 60 mg apalutamida.
English: Each bottle contains 120 tablets and a total of 6 g of desiccant.
Croatian: Jedna boca sadrži 120 tableta i ukupno 6 g sredstva za sušenje.
English: Falls and fractures
Croatian: Padovi i prijelomi
English: Patients should be treated, if appropriate, after initiating Erleada for these conditions according to established treatment guidelines.
Croatian: Ako je to prikladno, u bolesnika treba provoditi liječenje ovih stanja nakon uvođenja lijeka Erleada, u skladu s utvrđenim smjernicama za liječenje.
English: A drug-drug interaction study using a cocktail approach showed that co-administration of Erleada with single oral doses of sensitive transporter substrates resulted in a 30% decrease in the AUC of fexofenadine (P-gp substrate) and 41% decrease in the AUC of rosuvastatin (BCRP/OATP1B1 substrate) but had no impact on Cmax.
Croatian: Ispitivanje interakcija u kojem se primjenjivao koktel lijekova pokazalo je da je istodobna primjena lijeka Erleada s jednokratnim peroralnim dozama osjetljivih supstrata prijenosnika smanjila AUC feksofenadina (supstrata P-gp-a) za 30%, a AUC rosuvastatina (supstrata BCRP-a/OATP1B1) za 41%, dok na Cmax nije utjecala.
English: No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP2C8 (e.g., gemfibrozil, clopidogrel) however, a reduction of the Erleada dose based on tolerability should be considered (see section 4.2).
Croatian: Nije potrebna prilagodba početne doze kada se Erleada primjenjuje istodobno sa snažnim inhibitorom CYP2C8 (npr. gemfibrozilom, klopidogrelom), ali potrebno je razmotriti smanjenje doze lijeka Erleada s obzirom na podnošljivost (vidjeti dio 4.2).
English: In the apalutamide arm, 62 (7.7%) subjects died compared to 42 (10.5%) subjects in the placebo arm.
Croatian: U usporedbi s 42 (10,5%) ispitanika u placebo skupini u skupini s apalutamidom umrlo je 62 (7,7%) ispitanika.
English: If Erleada is co-administered with an anticoagulant metabolised by CYP2C9 (such as warfarin or acenocoumarol), additional International Normalised Ratio (INR) monitoring should be conducted (see section 4.5).
Croatian: Ako se Erleada primjenjuje istodobno s antikoagulansom koji se metabolizira putem CYP2C9 (poput varfarina ili acenokumarola), treba dodatno pratiti međunarodni normalizirani omjer (engl.
English: Mild or moderate inhibitors of CYP2C8 are not expected to affect the exposure of apalutamide.
Croatian: Ne očekuje se da će blagi ili umjereni inhibitori CYP2C8 utjecati na izloženost apalutamidu.
English: Musculoskeletal and connective tissue disorders very common: fracture+ very common: arthralgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često: prijelom vrlo često: artralgija
English: Skin rash led to Erleada treatment discontinuation in 9% of patients who experienced skin rash.
Croatian: Kožni osip je doveo do trajne obustave liječenja lijekom Erleada u 9% bolesnika s kožnim osipom.
English: Slightly yellowish to greyish green, oblong-shaped, film-coated tablets (16.7 mm long x 8.7 mm wide), debossed with “AR 60” on one side.
Croatian: Blijedo žućkaste do sivkastozelene ovalne filmom obložene tablete (duljine 16,7 mm i širine 8,7 mm), s utisnutom oznakom „AR 60” na jednoj strani.
English: • prevent blood clots (e.g. warfarin, clopidogrel, dabigatran etexilate)
Croatian: • sprječavanje nastanka krvnih ugrušaka (npr. varfarin, klopidogrel, dabigatran eteksilat)
English: In patients not receiving thyroid replacement therapy, hypothyroidism occurred in 5.7% of patients treated with Erleada and in 0.8% of patients treated with placebo.
Croatian: Među bolesnicima koji nisu primali nadomjesnu terapiju hormonima štitnjače, hipotireoza se javila u 5,7% bolesnika liječenih lijekom Erleada i 0,8% onih koji su primali placebo.
English: The potential effect of severe renal impairment or end stage renal disease (eGFR ≤29 mL/min/1.73 m2) have not been established due to insufficient data.
Croatian: Mogući učinci teškog oštećenja bubrežne funkcije ili bubrežne bolesti u terminalnoj fazi (eGFR ≤ 29 ml/min/1,73
English: In a drug-drug interaction study, the Cmax of apalutamide decreased by 21% while AUC increased by 68% following co-administration of apalutamide 240 mg single dose with gemfibrozil (strong CYP2C8 inhibitor).
Croatian: U jednom ispitivanju interakcija između lijekova, Cmax apalutamida smanjio se za 21%, dok se AUC povećao za 68% nakon istodobne primjene jednokratne doze apalutamida od 240 mg i gemfibrozila (snažnog inhibitora CYP2C8).
English: A dedicated hepatic impairment study compared the systemic exposure of apalutamide and N- desmethyl apalutamide in subjects with baseline mild hepatic impairment (N=8, Child-Pugh Class A, mean score = 5.3) or moderate hepatic impairment (N=8, Child-Pugh Class B, mean score = 7.6)
Croatian: U posebnom ispitivanju učinaka oštećenja jetrene funkcije uspoređivala se sistemska izloženost apalutamidu i N-dezmetil apalutamidu u ispitanika koji su na početku ispitivanja imali blago (N=8, Child-Pugh stadij A, srednja vrijednost rezultata = 5,3) ili umjereno oštećenje jetrene funkcije (N=8, Child-Pugh stadij B, srednja vrijednost rezultata = 7,6) u odnosu na zdrave kontrolne ispitanike s normalnom jetrenom funkcijom (N=8).
English: It is metabolised primarily by CYP2C8 and CYP3A4 to form N-desmethyl apalutamide.
Croatian: Metabolizira se prvenstveno djelovanjem CYP2C8 i CYP3A4 do N-dezmetil apalutamida.
English: It is unknown whether apalutamide/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se apalutamid/njegovi metaboliti u majčino mlijeko.
English: Injury, poisoning and procedural complications very common: fall
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često: umor Pretrage vrlo često: smanjenje tjelesne težine Ozljede, trovanja i proceduralne komplikacije vrlo često: pad
English: P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Croatian: Kada se supstrati P-gp-a, BCRP-a ili OATP1B1 primjenjuju istodobno s lijekom Erleada, potrebno je provoditi procjene kako bi se provjerilo postojanje gubitka djelotvornosti supstrata, a možda će biti potrebno prilagoditi dozu supstrata radi održavanja optimalnih plazmatskih koncentracija.
English: Mention to your doctor that you are taking Erleada if the doctor wants to start you on any new medicine.
Croatian: Napomenite svom liječniku da uzimate lijek Erleada ako Vam želi uvesti bilo koji novi lijek.
English: Eighty-one percent of patients had resolution of rash with a median of 60 days to resolution.
Croatian: Osip se povukao u 81% bolesnika, a medijan vremena do povlačenja iznosio je 60 dana.
English: Erleada 60 mg film-coated tablets apalutamide
Croatian: Erleada 60 mg filmom obložene tablete apalutamid
English: • treat opioid addiction or pain (e.g. methadone)
Croatian: • liječenje ovisnosti o opioidima ili liječenje boli (npr. metadon)
English: Animal reproductive studies have not been conducted with Erleada.
Croatian: Nisu provedena ispitivanja učinaka lijeka Erleada na reprodukciju u životinja.
English: In a drug-drug interaction study, the Cmax of apalutamide decreased by 22% while AUC was similar following co-administration of Erleada as a 240 mg single dose with itraconazole (strong CYP3A4 inhibitor).
Croatian: U jednom ispitivanju interakcija između lijekova, Cmax apalutamida smanjio se za 22%, dok je AUC ostao podjednak nakon istodobne primjene jednokratne doze lijeka Erleada od 240 mg i itrakonazola (snažnog inhibitora CYP3A4).
English: Adverse reactions of skin rash were reported for 24% of patients treated with Erleada.
Croatian: Kožni je osip kao nuspojava prijavljen u 24% bolesnika liječenih lijekom Erleada.
English: Fill in your weekdays Start date:
Croatian: Datum početka uzimanja:
English: Erleada decreased the relative risk of distant metastasis or death by 70% compared to placebo (HR = 0.30;
Croatian: Erleada je smanjila relativan rizik od udaljenih metastaza ili smrti za 70% u odnosu na placebo (HR = 0,30; 95% CI: 0,24; 0,36; p < 0,0001).
English: What Erleada looks like and contents of the pack Erleada film-coated tablets are slightly yellowish to greyish green, oblong-shaped, film-coated tablets (16.7 mm long x 8.7 mm wide), with “AR 60” written on one side.
Croatian: Erleada filmom obložene tablete su blijedo žućkaste do sivkastozelene ovalne filmom obložene tablete (duljine 16,7 mm i širine 8,7 mm) s oznakom ‘AR 60' na jednoj strani.
English: Renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
English: Do not stop taking Erleada without checking with your doctor first.
Croatian: Ako prestanete uzimati lijek Erleada Nemojte prestati uzimati lijek Erleada bez prethodnog razgovora sa svojim liječnikom.
English: When substrates of CYP2B6 (e.g., efavirenz) are administered with Erleada, monitoring for an adverse reaction and evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Croatian: Kada se supstrati CYP2B6 (npr. efavirenz) primjenjuju istodobno s lijekom Erleada, potrebno je pratiti bolesnike zbog mogućih nuspojava i provoditi procjene zbog mogućeg gubitka djelotvornosti supstrata, a možda će biti potrebno prilagoditi dozu supstrata radi održavanja optimalnih plazmatskih koncentracija.
English: Concomitant use of Erleada with medicinal products that are substrates of P-gp (e.g., colchicine, dabigatran etexilate, digoxin), BCRP or OATP1B1 (e.g., lapatinib, methotrexate, rosuvastatin, repaglinide) can result in lower exposure of these medicinal products.
Croatian: Istodobna primjena lijeka Erleada s lijekovima koji su supstrati P-gp-a (npr. kolhicin, dabigatran eteksilat, digoksin), BCRP-a ili OATP1B1 (npr. lapatinib, metotreksat, rosuvastatin,
English: Your doctor may also prescribe other medicines while you are taking Erleada.
Croatian: Liječnik će Vam tijekom liječenja lijekom Erleada možda propisati i neke druge lijekove.
English: C-labeled apalutamide 240 mg, apalutamide, the active metabolite, N-desmethyl apalutamide, and an inactive carboxylic acid metabolite accounted for the majority of the 14C-radioactivity in plasma, representing 45%, 44%, and 3%, respectively, of the total 14C-AUC.
Croatian: N-dezmetil apalutamid i neaktivni metabolit (derivat karboksilne kiseline), koji su predstavljali 45%, 44% odnosno 3% ukupnog C-AUC-a.
English: In a drug-drug interaction study using a cocktail approach, co-administration of Erleada with single oral doses of sensitive CYP substrates resulted in a 92% decrease in the AUC of midazolam (CYP3A4 substrate), 85% decrease in the AUC of omeprazole (CYP2C19 substrate), and 46% decrease in the AUC of S-warfarin (CYP2C9 substrate).
Croatian: U ispitivanju interakcija u kojem se primjenjivao koktel lijekova, istodobna primjena lijeka Erleada s jednokratnim dozama osjetljivih supstrata CYP enzima smanjila je AUC midazolama (supstrata CYP3A4) za 92%, AUC omeprazola (supstrata CYP2C19) za 85% i AUC S-varfarina (supstrata CYP2C9) za 46%.
English: No dose adjustment is necessary for patients with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively).
Croatian: Nije potrebno prilagođavati dozu u bolesnika koji na početku liječenja imaju blago ili umjereno oštećenje jetrene funkcije (Child-Pugh stadij A odnosno B).
English: Each bottle contains 120 film-coated tablets and a total of 6 g of silica gel desiccant.
Croatian: Jedna boca sadrži 120 filmom obloženih tableta i ukupno 6 g silika gela kao sredstva za sušenje.
English: • treat epilepsy (e.g. phenytoin, valproic acid)
Croatian: • liječenje epilepsije (npr. fenitoin, valproatnu kiselinu)
English: Τηλ: +357 22 207 700
Croatian: CY-2234 Λευκωσία Τηλ: +357 22 207 700
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 60 mg (12 count) (Blister sealed in inner wallet)
Croatian: BLISTER 60 mg (12 tableta) (blister zatvoren u unutarnji ovitak)
English: PHARMACEUTICAL FORM AND CONTENTS 120 tablets
Croatian: 120 tableta
English: • lower blood glucose (e.g. repaglinide)
Croatian: • snižavanje razine glukoze u krvi (npr. repaglinid)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 60 mg (16 count) (Blister sealed in inner wallet)
Croatian: BLISTER 60 mg (16 tableta) (blister zatvoren u unutarnji ovitak)
English: A total of 1207 subjects with NM-CRPC were randomised 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with androgen deprivation therapy (ADT) (medical castration or prior surgical castration) or placebo with ADT in a multicenter, double-blind, clinical study (Study ARN-509-003).
Croatian: (engl. androgen deprivation therapy, ADT) (farmakološka kastracija ili prethodna kirurška kastracija) ili placeba u kombinaciji s ADT-om u multicentričnom, dvostruko slijepom kliničkom ispitivanju (ispitivanje ARN-509-003).
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets
Croatian: 112 filmom obloženih tableta
English: There were no statistically significant differences observed in the change from baseline analysis of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) for the total score or any of the subscales between subjects on Erleada added to ADT versus placebo with ADT.
Croatian: Nisu opažene statistički značajne razlike s obzirom na promjenu ukupnog rezultata i bilo kojeg od podrezultata upitnika za funkcionalnu ocjenu terapije za rak prostate (engl.
English: Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted (see section 4.5).
Croatian: Kada je to klinički indicirano, treba uvesti nadomjesnu terapiju hormonima štitnjače ili prilagoditi njihovu dozu (vidjeti dio 4.5).
English: • you are taking any medicines to prevent blood clots (e.g., warfarin, acenocoumarol) • you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia)
Croatian: • ako imate bilo kakvu bolest srca ili krvnih žila, uključujući probleme sa srčanim ritmom (aritmiju)
English: When substrates of UGT are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Croatian: Kada se supstrati UGT-a primjenjuju istodobno s lijekom Erleada, potrebno je provoditi procjene kako bi se provjerilo postojanje gubitka djelotvornosti supstrata, a možda će biti potrebno prilagoditi dozu supstrata radi održavanja optimalnih plazmatskih koncentracija.
English: Skin rash included rash, rash maculo-papular, rash generalised, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, and rash vesicular.
Croatian: Kožni osip uključivao je osip, makulopapularni osip, generalizirani osip, urtikariju, pruritički osip, makularni osip, konjunktivitis, multiformni eritem, papularni osip, ljuštenje kože, genitalni osip, eritemski osip, stomatitis, izbijanje kožnih promjena uzrokovano lijekom, ulceraciju u ustima, pustularni osip, mjehure na koži, papule, pemfigoid, eroziju kože i vezikularni osip.
English: Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated.
Croatian: U bolesnika koji nisu podvrgnuti kirurškoj kastraciji potrebno je tijekom liječenja nastaviti farmakološku kastraciju analogom hormona koji oslobađa gonadotropin (engl. gonadotropin releasing hormone analogue, GnRHa).
English: Hypothyroidism occurred in 28% of patients already receiving thyroid replacement therapy in the Erleada arm and in 5.9% of patients in the placebo arm.
Croatian: Među bolesnicima koji su već primali nadomjesnu terapiju hormonima štitnjače, hipotireoza se javila u 28% bolesnika u skupini liječenoj lijekom Erleada i 5,9% onih u skupini koja je primala placebo.