FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of apalutamide 240 mg once daily on the QTc interval was assessed in an open-label, uncontrolled, multi-center, single-arm dedicated QT study in 45 patients with CRPC.
Croatian: Učinak apalutamida u dozi od 240 mg jedanput na dan na QTc interval ocjenjivao se u otvorenom, nekontroliranom, multicentričnom,ispitivanju s jednom skupinom, u kojem se posebno ispitivao učinak na QT interval, a provedeno je u 45 bolesnika s CRPC-om.
English: Do not use this medicine after the expiry date which is stated on the container (blister foils, inner wallet, outer wallet, bottle, and carton) after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na spremniku (foliji blistera, unutarnjem ovitku, vanjskom ovitku, boci i kutiji) iza oznake ‘Rok valjanosti' ili ‘EXP'.
English: • treat HIV infection (e.g. ritonavir, efavirenz, darunavir)
Croatian: • liječenje HIV infekcije (npr. ritonavir, efavirenz, darunavir)
English: Following a single oral administration of radiolabeled apalutamide, 89% of the radioactivity was recovered up to 70 days post-dose: 65% was recovered in urine (1.2% of dose as unchanged apalutamide and 2.7% as N-desmethyl apalutamide) and 24% was recovered in feces (1.5% of dose as unchanged apalutamide and 2% as N-desmethyl apalutamide).
Croatian: Nakon jednokratne peroralne primjene radioaktivno označenog apalutamida, 89% radioaktivnosti pronađeno je do 70 dana nakon primjene: 65% pronađeno je u mokraći (1,2% doze u obliku neizmijenjenog apalutamida i 2,7% u obliku N-dezmetil apalutamida), dok je 24% pronađeno u fecesu (1,5% doze u obliku neizmijenjenog apalutamida i 2% u obliku N-dezmetil apalutamida).
English: Patients with clinically significant cardiovascular disease in the past 6 months including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias were excluded from the clinical studies.
Croatian: U klinička ispitivanja nisu bili uključeni bolesnici s klinički značajnom kardiovaskularnom bolešću u prethodnih 6 mjeseci, uključujući tešku/nestabilnu anginu, infarkt miokarda, simptomatsko kongestivno zatajenje srca, arterijske ili venske tromboembolijske događaje (npr. plućnu emboliju, cerebrovaskularni incident, uključujući tranzitornu ishemijsku ataku) ili klinički značajne ventrikularne aritmije.
English: • treat serious mental illnesses (e.g. haloperidol)
Croatian: • liječenje ozbiljnih psihičkih bolesti (npr. haloperidol)
English: Treatment with Erleada significantly improved MFS.
Croatian: Liječenje lijekom Erleada značajno je produljilo MFS.
English: There is no clinical experience in re-administering Erleada to patients who experienced a seizure.
Croatian: Nema kliničkog iskustva s ponovnom primjenom lijeka Erleada u bolesnika koji su doživjeli napadaj.
English: In vitro data indicate that apalutamide and its N-desmethyl metabolite are not substrates for BCRP, OATP1B1 or OATP1B3.
Croatian: In vitro podaci ukazuju na to da apalutamid i njegov N-dezmetil metabolit nisu supstrati prijenosnika BCRP, OATP1B1 ni OATP1B3.
English: Falls were reported for 15.6% of patients treated with Erleada versus 9.0% of patients treated with placebo (see section 4.4).
Croatian: Padovi su prijavljeni u 15,6% bolesnika liječenih lijekom Erleada naspram 9,0% onih koji su primali placebo (vidjeti dio 4.4).
English: If Erleada is prescribed, patients with clinically significant cardiovascular disease should be monitored for risk factors such as hypercholesterolaemia, hypertriglyceridaemia, or other cardio-metabolic disorders (see section 4.8).
Croatian: Ako se Erleada propiše, bolesnike s klinički značajnom kardiovaskularnom bolešću, potrebno je nadzirati na moguće faktore rizika kao što su hiperkolesterolemija, hipertrigliceridemija ili drugi kardiometabolički poremećaji (vidjeti dio 4.8).
English: Also, some other medicines can affect the way Erleada works.
Croatian: Isto tako, neki drugi lijekovi mogu utjecati na način djelovanja lijeka Erleada.
English: Drug metabolising enzymes
Croatian: Enzimi koji metaboliziraju lijekove
English: Mean absolute oral bioavailability is approximately 100%, indicating that apalutamide is completely absorbed after oral administration.
Croatian: Srednja vrijednost apsolutne bioraspoloživosti nakon peroralne primjene iznosi približno 100%, što ukazuje na potpunu apsorpciju apalutamida nakon peroralne primjene.
English: Mean (CV%) AUC metabolite/parent drug ratio for N-desmethyl apalutamide following repeat-dose administration was about 1.3 (21%).
Croatian: Srednja vrijednost (CV%) omjera AUC-a metabolita i ishodišnog spoja za N-dezmetil apalutamid nakon ponovljene primjene iznosila je približno 1,3 (21%).
English: Apalutamide was shown to be a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically.
Croatian: Pokazalo se da je u kliničkim uvjetima apalutamid slab induktor P-glikoproteina (P-gp), proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP) i polipeptidnog prijenosnika organskih aniona 1B1 (engl. organic anion transporting polypeptide 1B1, OATP1B1).
English: White opaque high-density polyethylene (HDPE) bottle with a polypropylene (PP) child-resistant closure.
Croatian: Bijela, neprozirna boca od polietilena visoke gustoće (HDPE) s polipropilenskim (PP) zatvaračem sigurnim za djecu.
English: Caution is required in patients with severe renal impairment as apalutamide has not been studied in this patient population (see section 5.2).
Croatian: Potreban je oprez u bolesnika s teškim oštećenjem bubrežne funkcije jer se apalutamid nije ispitivao u toj populaciji bolesnika (vidjeti dio 5.2).
English: Janssen Cilag SpA Via C. Janssen Borgo San Michele Latina 04100, Italy
Croatian: Janssen Borgo San Michele Latina 04100, Italija
English: The contribution of CYP2C8 and CYP3A4 in the metabolism of apalutamide is estimated to be 58% and 13% following single dose but the level of contribution is expected to change at steady-state due to induction of CYP3A4 by apalutamide after repeat dose.
Croatian: Procjenjuje se da doprinos CYP2C8 i CYP3A4 metabolizmu apalutamida nakon primjene jedne doze iznosi 58% odnosno 13%, no očekuje se da će se razina tog doprinosa promijeniti u stanju dinamičke ravnoteže zbog indukcije CYP3A4 apalutamidom nakon višekratne primjene.
English: • The other ingredients of the tablet core are colloidal anhydrous silica, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose.
Croatian: • Drugi sastojci jezgre tablete su bezvodni koloidni silicijev dioksid, umrežena karmelozanatrij, hipromelozaacetatsukcinat, magnezijev stearat, mikrokristalična celuloza i silicificirana mikrokristalična celuloza.
English: This is because Erleada can affect the way some other medicines work.
Croatian: Naime, Erleada može utjecati na način djelovanja nekih drugih lijekova.
English: Subjects treated with Erleada and ADT showed significant improvement over those treated with ADT alone for the following secondary endpoints of time to metastasis (HR = 0.28; 95% CI: 0.23, 0.34; p < 0.0001), progression-free survival (PFS) (HR = 0.30; 95% CI: 0.25, 0.36; p < 0.0001); time to symptomatic progression (HR = 0.45; 95% CI: 0.32, 0.63; p < 0.0001); and a trend for overall survival (OS) (HR = 0.70; 95% CI: 0.47 1.04; p = 0.0742).
Croatian: U usporedbi s ispitanicima koji su primali samo ADT, ispitanici liječeni lijekom Erleada i ADT-om pokazali su značajno poboljšanje sljedećih sekundarnih mjera ishoda: vremena do pojave metastaze (HR = 0,28; 95% CI: 0,23; 0,34; p < 0,0001), preživljenja bez progresije bolesti (engl. progression-free survival, PFS) (HR = 0,30; 95% CI: 0,25; 0,36; p < 0,0001); vremena do simptomatske progresije (HR = 0,45; 95% CI: 0,32; 0,63; p < 0,0001) i trenda ukupnog preživljenja (engl. overall survival, OS) (HR = 0,70; 95% CI: 0,47; 1,04; p = 0,0742).
English: Postauthorisation efficacy study (PAES): In order to further evaluate the efficacy of Erleada, the MAH should submit the final clinical study report, including overall survival results, from study ARN-509-003 (SPARTAN) comparing the efficacy and safety of Apalutamide vs. placebo in subjects with high risk NonMetastatic (M0) Castration-Resistant Prostate Cancer.
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): U svrhu daljnje ocjene djelotvornosti lijek Erleada, nositelj odobrenja dužan je podnijeti završno izvješće kliničkog ispitivanja, uključujuči rezultate ukupnog preživljenja iz ispitivanja ARN-509-003 (SPARTAN) u kojem se uspoređuje djelotvornost i sigurnost apalutamida naspram placeba u ispitanika s visokim rizikom za nemetastatski (M0) rak prostate rezistentan na kastraciju.
English: A major metabolite, N-desmethyl apalutamide, exhibited one-third the in vitro activity of apalutamide.
Croatian: Aktivnost glavnog metabolita, N-dezmetil apalutamida, iznosila je trećinu aktivnosti apalutamida in vitro.
English: Erleada is not recommended in patients with severe hepatic impairment as there are no data in this patient population and apalutamide is primarily hepatically eliminated (see section 5.2).
Croatian: Erleada se ne preporučuje za primjenu u bolesnika s teškim oštećenjem jetrene funkcije jer nema podataka o primjeni u toj populaciji bolesnika, a apalutamid se prvenstveno eliminira kroz jetru (vidjeti dio 5.2).
English: If treatment is started, patients should be monitored for the adverse reactions listed in section 4.8 and dose reduce as per section 4.2 Posology and method of administration.
Croatian: Ako se liječenje uvede, potrebno je nadzirati bolesnike zbog moguće pojave nuspojava navedenih u dijelu 4.8 i pridržavati se smjernica za smanjivanje doze navedenih u dijelu 4.2 „Doziranje i način primjene”.
English: In a fertility study in male rats, a decrease in sperm concentration and motility, copulation and fertility rates (upon pairing with untreated females) along with reduced weights of the secondary sex glands and epididymis were observed following 4 weeks of dosing at doses corresponding to exposures approximately equal to the human exposure based on AUC.
Croatian: U ispitivanju plodnosti provedenom na mužjacima štakora opaženo je smanjenje koncentracije i pokretljivosti spermija te stopa kopulacije i plodnosti (nakon parenja sa ženkama kojima nije primijenjen lijek), kao i smanjena težina sekundarnih spolnih žlijezda i epididimisa, nakon 4 tjedna primjene doza kojima su postignute razine izloženosti približno jednake onima koje se postižu u ljudi na temelju AUC-a.
English: Do not swallow or discard the desiccant.
Croatian: Nemojte progutati niti baciti sredstvo za sušenje.
English: Post-progression survival (PFS-2, defined as the time to disease progression after first subsequent therapy or death) was longer for subjects treated with Erleada compared to those treated with placebo (HR = 0.489; 95%CI: 0.361, 0.662; p < 0.0001).
Croatian: Preživljenje nakon progresije bolesti (PFS-2, definirano kao vrijeme do progresije bolesti nakon prve sljedeće terapije ili do smrti) bilo je dulje u ispitanika liječenih lijekom Erleada nego u onih koji su primali placebo (HR = 0,489; 95% CI: 0,361; 0,662; p < 0,0001).
English: Based on the population pharmacokinetic analysis using data from clinical studies in subjects with castration-resistant prostate cancer (CRPC) and healthy subjects, no significant difference in systemic exposure was observed in subjects with pre-existing mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] between 30 to 89 mL/min/1.73 m2; N=585) compared to subjects with baseline normal renal function (eGFR ≥ 90 mL/min/1.73 m2; N=372).
Croatian: Prema populacijskoj farmakokinetičkoj analizi utemeljenoj na podacima iz kliničkih ispitivanja provedenih u ispitanika s rakom prostate rezistentnim na kastraciju (CRPC) i zdravih ispitanika, nije opažena značajna razlika u sistemskoj izloženosti između ispitanika s otprije postojećim blagim do umjerenim oštećenjem bubrežne funkcije (procijenjena brzina glomerularne filtracije [engl. estimated glomerular filtration rate, eGFR] između 30 i 89 ml/min/1,73 m2; N=585) i onih koji su na početku ispitivanja imali normalnu bubrežnu funkciju (eGFR ≥ 90 ml/min/1,73 m2; N=372).
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Erleada.
Croatian: Ako se bilo što od gore navedenoga odnosi na Vas (ili niste sigurni), razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete lijek Erleada.
English: Erleada contains sodium
Croatian: Erleada sadrži natrij
English: Medicinal products that induce CYP3A4 or CYP2C8
Croatian: Lijekovi koji induciraju CYP3A4 ili CYP2C8
English: Seizure occurred in 0.2% of patients receiving Erleada in clinical studies.
Croatian: Napadaji su se javili u 0,2% bolesnika koji su primali lijek Erleada u kliničkim ispitivanjima.
English: This medicine is not likely to affect you being able to drive and use any tools or machines.
Croatian: Nije vjerojatno da će ovaj lijek utjecati na sposobnost upravljanja vozilima i rada sa strojevima ili alatima.
English: • treat heart rhythm problems (e.g. quinidine, disopyramide, amiodarone, sotalol, dofetilide,
Croatian: • liječenje problema sa srčanim ritmom (npr. kinidin, dizopiramid, amiodaron, sotalol, dofetilid,
English: If a seizure develops during treatment with Erleada, treatment should be discontinued permanently.
Croatian: Ako se tijekom liječenja lijekom Erleada doživi napadaj, liječenje treba trajno obustaviti.
English: PVC-PCTFE foil blister with an aluminum push-through foil sealed inside a wallet pack.
Croatian: Blister od PVC-PCTFE folije prekriven protisnom aluminijskom folijom i zatvoren u ovitak.
English: No in vitro inhibition of organic anion transporter 1 (OAT1) was observed.
Croatian: Nije opažena inhibicija prijenosnika organskih aniona 1 (engl. organic anion transporter 1, OAT1) in vitro.
English: CYP2C8 plays a role in the elimination of apalutamide and in the formation of its active metabolite.
Croatian: CYP2C8 igra ulogu u eliminaciji apalutamida i nastanku njegova aktivnog metabolita.
English: CYP3A4 plays a role in the elimination of apalutamide and in the formation of its active metabolite.
Croatian: CYP3A4 igra ulogu u eliminaciji apalutamida i nastanku njegova aktivnog metabolita.
English: No clinically meaningful changes in their overall exposure is expected as a result of drug interaction with inhibitors or inducers of CYP2C8 or CYP3A4.
Croatian: Ne očekuju se klinički značajne promjene ukupne izloženosti tim spojevima zbog interakcija s inhibitorima ili induktorima enzima CYP2C8 ili CYP3A4.
English: Erleada should not be used during breast-feeding.
Croatian: Erleada se ne smije primjenjivati tijekom dojenja.
English: The recommended dose is 240 mg (four tablets) once a day.
Croatian: Koliko lijeka uzeti Preporučena doza je 240 mg (četiri tablete) jedanput na dan.
English: N-desmethyl apalutamide is characterised by a flat concentration-time profile at steady-state with a mean peak-to-trough ratio of 1.27.
Croatian: N-dezmetil apalutamid karakterizira stabilan profil koncentracije kroz vrijeme u stanju dinamičke ravnoteže, uz srednju vrijednost omjera vršnih i najnižih koncentracija od 1,27.
English: An exposure-QT analysis suggested a concentration-dependent increase in QTcF for apalutamide and its active metabolite.
Croatian: Analiza odnosa između izloženosti lijeku i QT intervala ukazala je na produljenje QTcF intervala ovisno o koncentraciji apalutamida i njegova aktivnog metabolita.
English: Apalutamide and N-desmethyl apalutamide are further metabolised to form the inactive carboxylic acid metabolite by carboxylesterase.
Croatian: Apalutamid i N-dezmetil apalutamid dodatno se metaboliziraju djelovanjem karboksilesteraze do neaktivnog metabolita - derivata karboksilne kiseline.
English: Based on in vitro data, inhibition of organic cation transporter 2 (OCT2), organic anion transporter 3 (OAT3) and multidrug and toxin extrusions (MATEs) by apalutamide and its N-desmethyl metabolite cannot be excluded.
Croatian: Sudeći prema podacima prikupljenima in vitro, ne može se isključiti inhibicija prijenosnika organskih kationa 2 (engl. organic cation transporter 2, OCT2), prijenosnika organskih aniona 3 (engl. organic anion transporter 3, OAT3) i prijenosnika za izlučivanje više lijekova i toksina (engl. multidrug and toxin extrusion, MATE) uslijed djelovanja apalutamida i njegova N-dezmetil metabolita.
English: Based on the drug-drug interaction study results with strong CYP3A4 inhibitor or strong CYP2C8 inhibitor, CYP3A4 or CYP2C8 inducers are not expected to have clinically relevant effects on the pharmacokinetics of apalutamide and the active moieties therefore no dose adjustment is necessary when Erleada is co-administered with inducers of CYP3A4 or CYP2C8.
Croatian: S obzirom na rezultate ispitivanja interakcija između lijekova provedenih sa snažnim inhibitorom CYP3A4 ili snažnim inhibitorom CYP2C8, ne očekuje se da će induktori CYP3A4 ili CYP2C8 imati klinički značajan učinak na farmakokinetiku apalutamida i aktivnih komponenata, pa nije potrebno prilagođavati dozu kad se Erleada primjenjuje istodobno s induktorima CYP3A4 ili CYP2C8.
English: Concomitant use of Erleada with medicinal products that are primarily metabolised by CYP3A4 (e.g., darunavir, felodipine, midazolam, simvastatin), CYP2C19 (e.g., diazepam, omeprazole), or CYP2C9 (e.g., warfarin, phenytoin) can result in lower exposure to these medicinal products.
Croatian: Istodobna primjena lijeka Erleada s lijekovima koji se prvenstveno metaboliziraju putem CYP3A4 (npr. darunavir, felodipin, midazolam, simvastatin), CYP2C19 (npr. diazepam, omeprazol) ili CYP2C9 (npr. varfarin, fenitoin) može smanjiti izloženost tim lijekovima.
English: In vitro, apalutamide and its N-desmethyl metabolite are substrates for P-gp.
Croatian: In vitro su apalutamid i njegov N-dezmetil metabolit supstrati P-gp-a.
English: Apalutamide is an orally administered, selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.
Croatian: Apalutamid je selektivan inhibitor androgenih receptora za peroralnu primjenu, koji se vezuje izravno za domenu androgenog receptora koja vezuje ligand.
English: Skin and subcutaneous tissue disorders very common: skin rash** common: pruritus
Croatian: Poremećaji kože i potkožnog tkiva vrlo često: kožni osip** često: pruritus
English: Androgen deprivation therapy may prolong the QT interval In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5), physicians should assess the benefit-risk ratio including the potential for Torsade de pointes prior to initiating Erleada.
Croatian: Terapija androgenom deprivacijom može produljiti QT interval U bolesnika koji u anamnezi imaju produljenje QT intervala ili faktore rizika za produljenje QT intervala te bolesnika koji istodobno primaju lijekove koji bi mogli produljiti QT interval (vidjeti dio 4.5) liječnici moraju prije uvođenja lijeka Erleada ocijeniti omjer koristi i rizika, uključujući mogućnost pojave torsades de pointes.
English: Apalutamide is not ionizable under relevant physiological pH condition, therefore acid lowering agents (e.g., proton pump inhibitor, H2-receptor antagonist, antacid) are not expected to affect the solubility and bioavailability of apalutamide.
Croatian: Budući da se apalutamid ne ionizira pri relevantnim fiziološkim pH vrijednostima, ne očekuje se da će lijekovi koji smanjuju količinu kiseline (npr. inhibitori protonske pumpe, antagonisti H2-receptora, antacidi) utjecati na topljivost i bioraspoloživost apalutamida.
English: At steady-state, mean (CV%) Cmax and AUC values for apalutamide were 6 µg/mL (28%) and 100 µg.h/mL (32%), respectively.
Croatian: Srednja vrijednost (CV%) Cmax i AUC-a apalutamida u stanju dinamičke ravnoteže iznosila je 6 µg/ml (28%) odnosno 100 µg.h/ml (32%).
English: Apalutamide and N-desmethyl apalutamide are 96% and 95% bound to plasma proteins, respectively, and mainly bind to serum albumin with no concentration dependency.
Croatian: Neovisno o koncentraciji, 96% apalutamida i 95% N-dezmetil apalutamida vezuje se za proteine u plazmi, i to uglavnom za serumski albumin.
English: • The active substance is apalutamide.
Croatian: • Djelatna tvar je apalutamid.
English: • treat anxiety (e.g. midazolam, diazepam)
Croatian: • liječenje tjeskobe (npr. midazolam, diazepam)
English: In the apalutamide arm 64 (7.9%) subjects developed symptomatic progression compared with 63 (16%) in the placebo arm, with a hazard ratio of 0.447 (95% CI: 0.315, 0.634), which met the pre-specified O'Brien Fleming type efficacy boundary for significance, p < 0.00008.
Croatian: Simptomatska progresija nastupila je u 64 (7,9%) ispitanika liječena apalutamidom u odnosu na 63 (16%) bolesnika koja su primala placebo, uz omjer hazarda od 0,447 (95% CI: 0,315; 0,634), koji je ispunjavao unaprijed specificiranu graničnu vrijednost za značajnost prema O'Brien Flemingovoj metodi, p < 0,00008.
English: These studies excluded patients with a history of seizure or predisposing factors for seizure.
Croatian: U tim ispitivanjima nisu mogli sudjelovati bolesnici koji su u anamnezi imali napadaje ili predisponirajuće faktore za napadaje.
English: The recommended dose is 240 mg (four 60 mg tablets) as an oral single daily dose.
Croatian: Preporučena doza je 240 mg (četiri tablete od 60 mg), a uzima se peroralno u jednoj dnevnoj dozi.
English: At steady-state, the mean (CV%) Cmax and AUC values for the major active metabolite, N-desmethyl apalutamide, were 5.9 µg/mL (18%) and 124 µg.h/mL (19%), respectively.
Croatian: Srednja vrijednost (CV%) Cmax i AUC-a glavnog aktivnog metabolita, N-dezmetil apalutamida, u stanju dinamičke ravnoteže iznosila je 5,9 µg/ml (18%) odnosno 124 µg.h/ml (19%).
English: Apalutamide prevents AR nuclear translocation, inhibits DNA binding, impedes AR-mediated transcription, and lacks androgen receptor agonist activity.
Croatian: Apalutamid sprječava translokaciju androgenih receptora u jezgru, inhibira vezivanje DNK, ometa transkripciju posredovanu androgenim receptorima, a ne djeluje kao agonist androgenih receptora.
English: 4.7 Effects on ability to drive and use machines Erleada has no or negligible influence on the ability to drive and use machines.
Croatian: Erleada ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • blood test showing high level of a type of fat called “triglycerides” in the blood
Croatian: • visoke razine jedne vrste masnoća (zovu se trigliceridi) u krvi, vidljive u nalazima krvnih pretraga
English: Nervous system disorders uncommon: seizure (see section 4.4)
Croatian: Poremećaji živčanog sustava manje često: napadaj (vidjeti dio 4.4)
English: • treat cancer (e.g. lapatinib, methotrexate)
Croatian: • liječenje raka (npr. lapatinib, metotreksat)
English: INFORMATION IN BRAILLE Erleada 60 mg
Croatian: Erleada 60 mg
English: Apalutamide is an inducer of enzymes and transporters and may lead to an increase in elimination of many commonly used medicinal products.
Croatian: Budući da je apalutamid induktor enzima i prijenosnika, može povećati eliminaciju mnogih lijekova koji se često koriste.
English: For the active moieties (sum of apalutamide plus the potency adjusted active metabolite), Cmax decreased by 21% while AUC increased by 45%.
Croatian: Cmax aktivnih komponenata (apalutamid plus aktivni metabolit prilagođen za potentnost) smanjio se za 21%, dok se AUC povećao za 45%.
English: The effects of CYP3A4 or CYP2C8 inducers on the pharmacokinetics of apalutamide have not been evaluated in vivo.
Croatian: Učinci induktora CYP3A4 ili CYP2C8 na farmakokinetiku apalutamida nisu se ispitivali in vivo.