FrancophonIA/ELRC3.0 huggingface dataset:
English: Long-term animal studies have not been conducted to evaluate the carcinogenic potential of apalutamide.
Croatian: Nisu provedena dugotrajna ispitivanja na životinjama kojima bi se ocijenio kancerogeni potencijal apalutamida.
English: The effect of apalutamide on CYP2B6 substrates has not been evaluated in vivo and the net effect is presently unknown.
Croatian: Učinak apalutamida na supstrate CYP2B6 nije se procjenjivao in vivo pa neto učinak trenutno nije poznat.
English: • under-active thyroid which can make you feel more tired and have difficulty getting started in the morning, and blood tests may also show an under-active thyroid
Croatian: • smanjena aktivnost štitnjače, zbog čega se možete osjećati umornije i imati poteškoća s razbuđivanjem ujutro, a koja također može biti vidljiva u nalazima krvnih pretraga
English: For patients having sex with female partners of reproductive potential, a condom should be used along with another highly effective contraceptive method during treatment and for 3 months after the last dose of Erleada.
Croatian: Ako bolesnici i njihove partnerice reproduktivne dobi imaju spolne odnose trebaju koristiti prezervativ u kombinaciji s još jednom visoko učinkovitom metodom kontracepcije tijekom liječenja i još 3 mjeseca nakon posljednje doze lijeka Erleada.
English: Metabolism is the main route of elimination of apalutamide.
Croatian: Metabolizam je glavni put eliminacije apalutamida.
English: Administration of apalutamide to healthy subjects under fasting conditions and with a high-fat meal resulted in no clinically relevant changes in Cmax and AUC.
Croatian: Primjena apalutamida zdravim ispitanicima natašte i uz obrok s visokim udjelom masti nije dovela do klinički značajnih promjena vrijednosti Cmax i AUC-a.
English: Skin rash associated with Erleada was most commonly described as macular or maculo-papular.
Croatian: Kožni osip povezan s primjenom lijeka Erleada najčešće se opisivao kao makularni ili makulo-papularni.
English: Adverse reactions in the event of an overdose has not yet been observed, it is expected that such reactions would resemble the adverse reactions listed in section 4.8.
Croatian: Još nisu opažene nuspojave u slučaju predoziranja, ali očekuje se da bi bile slične nuspojavama navedenima u dijelu 4.8.
English: The tablets are supplied in a plastic bottle with a child-resistant closure.
Croatian: Tablete dolaze u plastičnoj boci sa zatvaračem sigurnim za djecu.
English: Based on population pharmacokinetic analysis, there were no clinically relevant differences in apalutamide pharmacokinetics between White (Caucasian or Hispanic or Latino; N=761), Black (of African heritage or African American; N=71), Asian (non-Japanese; N=58) and Japanese (N=58).
Croatian: Prema populacijskoj farmakokinetičkoj analizi, nije bilo klinički značajnih razlika u farmakokinetici apalutamida između bijelaca (europeidi, Hispanoamerikanci ili Latinoamerikanci; N=761), crnaca (crnci afričkog porijekla ili Afroamerikanci; N=71), Azijaca (izuzevši Japanace; N=58) i Japanaca (N=58).
English: Tell your doctor if you are taking medicines that:
Croatian: Obavijestite svog liječnika ako uzimate lijekove za:
English: Women who are or may become pregnant (see section 4.6).
Croatian: Trudnice ili žene koje bi mogle zatrudnjeti (vidjeti dio 4.6).
English: Clinical and pharmacokinetic data are not available for patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Nisu dostupni klinički ni farmakokinetički podaci za bolesnike s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
English: Based on animal studies, Erleada may decrease fertility in males of reproductive potential (see section 5.3).
Croatian: S obzirom na ispitivanja na životinjama, Erleada može smanjiti plodnost u muškaraca reproduktivne dobi (vidjeti dio 5.3).
English: • no longer responds to medical or surgical treatment that lowers testosterone (also called castration-resistant prostate cancer).
Croatian: • koji više ne odgovara na farmakološko (primjenom lijekova) ili kirurško liječenje koje snizuje razine testosterona (naziva se još i rakom prostate rezistentnim na kastraciju)
English: If a ≥ Grade 3 toxicity or an intolerable adverse reaction is experienced by the patient, dosing should be held rather than permanently discontinuing treatment until symptoms improve to ≤ Grade 1 or original grade, then should be resumed at the same dose or a reduced dose (180 mg or 120 mg), if warranted.
Croatian: Ako se u bolesnika pojavi toksičnost ≥ 3. stupnja ili nepodnošljiva nuspojava, umjesto trajne obustave liječenja potrebno je odgoditi doziranje lijeka dok se simptomi ne poboljšaju do ≤ 1. stupnja ili početne težine, a zatim je potrebno nastaviti liječenje istom ili smanjenom dozom (180 mg ili 120 mg), ako je to opravdano.
English: Time to symptomatic progression was defined as time from randomization to development of a skeletal related event, pain/symptoms requiring initiation of a new systemic anti-cancer therapy, or loco-regional tumor progression requiring radiation/surgery.
Croatian: Vrijeme do simptomatske progresije definiralo se kao vrijeme od randomizacije do razvoja koštanog događaja, pojave boli/simptoma koji zahtijevaju uvođenje nove sistemske protutumorske terapije ili lokoregionalne progresije tumora koja iziskuje zračenje/kirurški zahvat.
English: Cardiac disorders not known: QT prolongation (see sections 4.4 and 4.5)
Croatian: Srčani poremećaji nepoznato: produljenje QT intervala (vidjeti dijelove 4.4 i 4.5.)
English: The median MFS for Erleada was 41 months and was 16 months for placebo (see Figure 1.
Croatian: Medijan MFS-a uz lijek Erleada iznosio je 41 mjesec, a uz placebo 16 mjeseci (vidjeti Sliku 1.
English: Erleada may reduce male fertility.
Croatian: Erleada može smanjiti plodnost muškaraca.
English: Your healthcare provider may monitor you more closely if you are at risk for fractures.
Croatian: Liječnik će Vas možda pažljivije nadzirati ako kod Vas postoji rizik od prijeloma.
English: The most common adverse reactions are fatigue (30%), skin rash (24% of any grade and 5% Grade 3 or 4), weight decreased (16%), arthralgia (16%), and fall (16%).
Croatian: Najčešće su nuspojave umor (30%), kožni osip (24% za osip bilo kojeg stupnja i 5% za osip 3. ili 4. stupnja), smanjenje tjelesne težine (16%), artralgija (16%) i pad (16%).
English: Extra tablets should not be taken to make up the missed dose.
Croatian: Bolesnik ne smije uzeti dodatne tablete da bi nadoknadio propuštenu dozu.
English: Fifteen percent (15%) of subjects had < 2 cm pelvic lymph nodes at study entry.
Croatian: Petnaest posto (15%) ispitanika imalo je zdjelične limfne čvorove veličine < 2 cm pri uključivanju u ispitivanje.
English: Endocrine disorders common: hypothyroidism*
Croatian: Endokrini poremećaji često: hipotireoza*
English: There is no relevant use of apalutamide in the paediatric population in the treatment of non-metastatic castration-resistant prostate cancer.
Croatian: Nema relevantne primjene apalutamida u pedijatrijskoj populaciji za liječenje nemetastatskog raka prostate rezistentnog na kastraciju.
English: The mean effective half-life for apalutamide in patients is about 3 days at steady-state.
Croatian: Srednja vrijednost efektivnog poluvijeka apalutamida u bolesnika iznosi približno 3 dana u stanju dinamičke ravnoteže.
English: In the event of an overdose, Erleada should be stopped and general supportive measures should be undertaken until clinical toxicity has been diminished or resolved.
Croatian: U slučaju predoziranja potrebno je prekinuti primjenu lijeka Erleada te uvesti opće potporne mjere dok se klinička toksičnost ne smanji ili povuče.
English: Erleada is indicated in adult men for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC) who are at high risk of developing metastatic disease (see section 5.1).
Croatian: Erleada je indicirana za liječenje nemetastatskog raka prostate rezistentnog na kastraciju (engl. non-metastatic castration-resistant prostate cancer, NM-CRPC) u odraslih muškaraca u kojih postoji visok rizik od razvoja metastatske bolesti (vidjeti dio 5.1).
English: Half of the patients experienced a fall within 7 days before the fracture event in both treatment groups.
Croatian: U obje je liječene skupine polovica bolesnika doživjela pad unutar 7 dana prije događaja prijeloma.
English: Treatment with apalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
Croatian: Liječenje apalutamidom treba započeti i nadzirati liječnik spacijalist s iskustvom u liječenju raka prostate.
English: 28-day carton
Croatian: 28-dnevno pakiranje
English: If you take more than you should, stop taking Erleada and contact your doctor.
Croatian: Ako uzmete više tableta nego što ste trebali, prestanite uzimati lijek Erleada i obratite se svom liječniku.
English: For the most common adverse reactions, see section 4.8.
Croatian: Za najčešće nuspojave vidjeti dio 4.8.
English: Talk to your doctor or pharmacist before taking this medicine if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek:
English: There is no known specific antidote for apalutamide overdose.
Croatian: Nema poznatog specifičnog protulijeka za predoziranje apalutamidom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Erleada in all subsets of the paediatric population in advanced prostate cancer.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Erleada u svim podskupinama pedijatrijske populacije za indikaciju uznapredovalog raka prostate.
English: Apalutamide is a potent enzyme inducer and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected.
Croatian: Apalutamid je snažan induktor enzima koji pojačava sintezu brojnih enzima i prijenosnika; stoga se očekuje interakcija s mnogim često korištenim lijekovima koji su supstrati enzima ili prijenosnika.
English: Danmark Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
Croatian: Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
English: Following repeat once-daily dosing, apalutamide exposure (Cmax and area under the concentration curve [AUC]) increased in a dose-proportional manner across the dose range of 30 to 480 mg.
Croatian: Nakon ponovljene prim jene jedanput na dan, izloženost apalutamidu (Cmax i područje ispod krivulje koncentracije [engl. area under the concentration curve, AUC]) povećala se proporcionalno dozi u rasponu doza od 30 do 480 mg.
English: 30-day carton
Croatian: 30-dnevno pakiranje
English: Potential for other medicinal products to affect apalutamide exposures
Croatian: Potencijal drugih lijekova da utječu na izloženost apalutamidu
English: The tablets may be supplied either in a bottle or in a wallet pack.
Croatian: Tablete mogu dolaziti zapakirane u bocu ili ovitak.
English: • Erleada must not be taken by women who are pregnant, may become pregnant, or who are breast-feeding.
Croatian: • Lijek Erleada ne smiju uzimati trudnice, žene koje bi mogle zatrudnjeti ni dojilje.
English: Apalutamide is a potent enzyme inducer and may lead to loss of efficacy of many commonly used medicinal products (see section 4.5).
Croatian: Budući da je apalutamid snažan induktor enzima, može dovesti do gubitka djelotvornosti mnogih lijekova koji se često koriste (vidjeti dio 4.5).
English: • falls or fractures (broken bones) - these are very common (may affect more than 1 in
Croatian: • padovi ili prijelomi kostiju - oni su vrlo česti (može se javiti u više od 1 na 10 osoba).
English: Subjects enrolled had a Prostate Specific Antigen (PSA) Doubling Time (PSADT) ≤ 10 months, considered to be at high risk of imminent metastatic disease and prostate cancer-specific death.
Croatian: Uključeni ispitanici imali su vrijeme do udvostručenja vrijednosti prostata specifičnog antigena (PSA) ≤ 10 mjeseci, te se smatralo da imaju visok rizik za neminovan razvoj metastatske bolesti i smrt zbog raka prostate.
English: Apalutamide, mainly in the form of metabolites, is eliminated primarily via urine.
Croatian: Apalutamid, prvenstveno u obliku metabolita, prvenstveno se izlučuje kroz mokraću.
English: ibutilide)
Croatian: ibutilid)
English: Adverse reactions observed during clinical studies are listed below by frequency category.
Croatian: Nuspojave opažene tijekom kliničkih ispitivanja navedene su u nastavku prema kategoriji učestalosti.
English: Consistent improvement in MFS with Erleada was observed for all prespecified subgroups, including age, race, region of the world, nodal status, prior number of hormonal therapies, baseline PSA, PSA doubling time, baseline ECOG status and use of bone-sparing agents.
Croatian: Dosljedno poboljšanje MFS uz lijek Erleada bio je zapažen za sve unaprijed određene podskupine, uključujući dob, rasu, regiju svijeta, nodalni status, prethodni broj hormonskih terapija, početni PSA, vrijeme udvostručavanja PSA, početni ECOG status i upotrebu lijekova koji štede kosti (engl. bone sparing agents).
English: Metastasis-free survival (MFS) was the primary endpoint, defined as the time from randomisation to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first.
Croatian: Preživljenje bez metastaza (engl. metastasis-free survival, MFS) bilo je primarna mjera ishoda, koja se definirala kao vrijeme od randomizacije do prvog dokaza udaljene metastaze u koštanom ili mekom tkivu potvrđene slijepom centralnom ocjenom snimaka ili do smrti, što god je nastupilo prije.
English: Potential for apalutamide to affect exposures to other medicinal products
Croatian: Potencijal apalutamida da utječe na izloženost drugim lijekovima
English: Erleada is contraindicated in women who are or may become pregnant (see section 4.3).
Croatian: Erleada je kontraindicirana u trudnica ili žena koje bi mogle zatrudnjeti (vidjeti dio 4.3).
English: • treat heart conditions or lower blood pressure (e.g. digoxin, felodipine)
Croatian: • liječenje srčanih bolesti ili snižavanje krvnog tlaka (npr. digoksin, felodipin)
English: Daily fluctuations in apalutamide plasma concentrations were low, with mean peak-to-trough ratio of 1.63.
Croatian: Dnevne fluktuacije plazmatskih koncentracija apalutamida bile su niske, uz srednju vrijednost omjera vršnih i najnižih koncentracija od 1,63.
English: Based on its mechanism of action, Erleada may cause foetal harm when administered during pregnancy.
Croatian: S obzirom na mehanizam djelovanja, Erleada može naškoditi plodu ako se primjenjuje tijekom trudnoće.
English: Grade 3 skin rashes (defined as covering > 30% body surface area [BSA]) were reported with Erleada treatment in 5.2% of patients.
Croatian: Kožni osipi 3. stupnja (definirani kao osipi koji su zahvatili > 30% tjelesne površine) prijavljeni su u 5,2% bolesnika liječenih lijekom Erleada.
English: What you need to know before you take Erleada
Croatian: Što morate znati prije nego počnete uzimati lijek Erleada
English: Because apalutamide is completely absorbed after oral administration, P-gp does not limit the absorption of apalutamide and therefore, inhibition or induction of P-gp is not expected to affect the bioavailability of apalutamide.
Croatian: Budući da se apalutamid potpuno apsorbira nakon peroralne primjene, P-gp ne ograničava apsorpciju apalutamida pa se ne očekuje da će inhibicija ili indukcija P-gp-a utjecati na bioraspoloživost apalutamida.
English: Erleada is not recommended in patients with a history of seizures or other predisposing factors including, but not limited to, underlying brain injury, recent stroke (within one year), primary brain tumours or brain metastases.
Croatian: Erleada se ne preporučuje u bolesnika koji u anamnezi imaju napadaje ili druge predisponirajuće faktore, uključujući (između ostaloga) podležeću ozljedu mozga, nedavni moždani udar (unutar prethodnih godinu dana), primarne tumore na mozgu ili moždane metastaze.
English: In repeat-dose toxicity studies in male rats and dogs, atrophy, aspermia/hypospermia, degeneration and/or hyperplasia or hypertrophy in the reproductive system were observed at doses corresponding to exposures approximately equal to the human exposure based on AUC.
Croatian: U ispitivanjima toksičnosti ponovljenih doza provedenima na mužjacima štakora i pasa opažene su atrofija, aspermija/hipospermija, degeneracija i/ili hiperplazija ili hipertrofija u reproduktivnom sustavu pri dozama kojima su postignute razine izloženosti približno jednake onima koje se postižu u ljudi na temelju AUC-a.
English: Subjects randomised to either arm were to continue treatment until disease progression defined by blinded central imaging review (BICR), initiation of new treatment, unacceptable toxicity or withdrawal.
Croatian: Ispitanici randomizirani u bilo koju od navedenih skupina trebali su nastaviti liječenje do progresije bolesti definirane slijepom centralnom ocjenom snimaka (engl. blinded central imaging review, BICR), uvođenja nove terapije, pojave neprihvatljive toksičnosti ili povlačenja iz ispitivanja.
English: Apalutamide treatment decreases tumor cell proliferation and increases apoptosis leading to potent antitumor activity.
Croatian: Liječenje apalutamidom smanjuje proliferaciju tumorskih stanica i pojačava apoptozu te tako ostvaruje snažno protutumorsko djelovanje.
English: An increase in apparent clearance (CL/F) was observed with repeat dosing, likely due to induction of apalutamide's own metabolism.
Croatian: Kod ponovljene primjene opaženo je povećanje prividnog klirensa (CL/F), vjerojatno zbog indukcije metabolizma samog apalutamida.
English: After oral administration, median time to achieve peak plasma concentration (tmax) was 2 hours (range: 1 to 5 hours).
Croatian: Medijan vremena do postizanja vršnih plazmatskih koncentracija (tmax) nakon peroralne primjene iznosio je 2 sata (raspon: 1 - 5 sati).
English: • If you are having sex with a woman who can become pregnant - use a condom and another highly effective method of contraception.
Croatian: • Ako imate spolni odnos sa ženom koja može zatrudnjeti - Vi i vaša partnerica trebate koristiti prezervativ i još jednu visokoučinkovitu metodu kontracepcije.
English: • If you forget to take Erleada for the whole day - take your usual dose the following day.
Croatian: • Ako ste zaboravili uzeti lijek Erleada cijeli taj dan - preskočite propuštenu dozu i uzmite uobičajenu dozu sljedeći dan.
English: In Study ARN-509-003, fracture was reported for 11.7% of patients treated with Erleada and 6.5% of patients treated with placebo.
Croatian: U ispitivanju ARN-509-003 prijelom je prijavljen u 11,7% bolesnika liječenih lijekom Erleada i 6,5% onih koji su primali placebo.
English: There are no data available from the use of Erleada in pregnant women.
Croatian: Nema dostupnih podataka o primjeni lijeka Erleada u trudnica.
English: Following administration of 240 mg once daily, apalutamide steady state was achieved after 4 weeks and the mean accumulation ratio was approximately 5-fold relative to a single dose.
Croatian: Nakon primjene doze od 240 mg jedanput na dan, stanje dinamičke ravnoteže apalutamida postignuto je nakon 4 tjedna, uz srednju vrijednost omjera akumulacije koja je bila približno 5 puta veća nego kod primjene samo jedne doze.
English: You may have an increased risk of side effects.
Croatian: Možete imati povećan rizik od nuspojava.
English: Erleada did not cause clinically meaningful changes in exposure to the CYP2C8 substrate.
Croatian: Erleada nije uzrokovala klinički značajne promjene izloženosti supstratu CYP2C8.
English: Apalutamide was negative for genotoxicity in a standard battery of in vitro and in vivo tests.
Croatian: Apalutamid se nije pokazao genotoksičnim u standardnom nizu testova in vitro i in vivo.
English: The film-coating contains iron oxide black (E172), iron oxide yellow (E172), macrogol, polyvinyl alcohol (partially hydrolysed), talc, and titanium dioxide (E171).
Croatian: Film ovojnica sadrži crni željezov oksid (E172), žuti željezov oksid (E172), makrogol, poli(vinilni alkohol) (djelomično hidroliziran), talk i titanijev dioksid (E171).
English: Concomitant use of apalutamide with medicinal products that are sensitive substrates of many metabolising enzymes or transporters (see section 4.5) should generally be avoided if their therapeutic effect is of large importance to the patient, and if dose adjustments cannot easily be performed based on monitoring of efficacy or plasma concentrations.
Croatian: U načelu treba izbjegavati primjenu apalutamida istodobno s lijekovima koji su osjetljivi supstrati mnogih metabolizirajućih enzima ili prijenosnika (vidjeti dio 4.5) ako je terapijski učinak tih lijekova vrlo važan za bolesnika, a njihove se doze ne mogu jednostavno prilagoditi na temelju praćenja djelotvornosti ili koncentracija u plazmi.
English: Apalutamide and N-desmethyl apalutamide do not affect CYP1A2 and CYP2D6 at therapeutically relevant concentrations.
Croatian: Apalutamid i N-dezmetil apalutamid ne utječu na CYP1A2 i CYP2D6 pri terapijski značajnim koncentracijama.
English: If you forget to take Erleada
Croatian: Ako ste zaboravili uzeti lijek Erleada
English: Based on systemic exposure, relative potency, and pharmacokinetic properties, N-desmethyl apalutamide likely contributed to the clinical activity of apalutamide.
Croatian: S obzirom na sistemsku izloženost, relativnu potentnost i farmakokinetička svojstva, N-dezmetil apalutamid vjerojatno pridonosi kliničkoj aktivnosti apalutamida.
English: Skin rash recurred in approximately half of patients who were re-challenged.
Croatian: Kožni osip ponovno se pojavio u približno polovice bolesnika nakon ponovnog izlaganja lijeku.
English: By blocking the effect of androgens, apalutamide stops prostate cancer cells from growing and dividing.
Croatian: Blokiranjem učinaka androgena apalutamid zaustavlja rast i diobu stanica raka prostate.
English: All subjects enrolled were confirmed to be non-metastatic by blinded central imaging review and had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status score of 0 or 1 at study entry.
Croatian: Svi su uključeni ispitanici imali potvrđenu nemetastatsku bolest (potvrđeno slijepom centralnom ocjenom snimaka) te funkcionalni ECOG (Eastern Cooperative Oncology Group) status 0 ili 1 pri uključivanju u ispitivanje.
English: Induction of CYP3A4 by apalutamide suggests that UDP-glucuronosyl transferase (UGT) may also be induced via activation of the nuclear pregnane X receptor (PXR).
Croatian: Indukcija CYP3A4 djelovanjem apalutamida ukazuje na to da je moguća i indukcija UDP-glukuronozil transferaze (UGT) putem aktivacije jezgrenog receptora pregnana X (engl. pregnane X receptor, PXR).
English: * Includes hypothyroidism, blood thyroid stimulating hormone increased, thyroxine decreased, autoimmune thyroiditis,
Croatian: * Uključuje hipotireozu, povišene vrijednosti hormona koji stimulira štitnjaču u krvi, snižene vrijednosti tiroksina,
English: The effects of renal impairment, hepatic impairment, age, race, and other extrinsic factors on the pharmacokinetics of apalutamide are summarised below.
Croatian: Učinci oštećenja bubrežne funkcije, oštećenja jetrene funkcije, dobi, rase i drugih ekstrinzičnih faktora na farmakokinetiku apalutamida sažeto su opisani u nastavku.
English: • lower high fat levels in the blood (e.g. gemfibrozil)
Croatian: • snižavanje visokih razina masnoća u krvi (npr. gemfibrozil)
English: Metabolism and nutrition disorders common: hypercholesterolaemia common: hypertriglyceridaemia
Croatian: Poremećaji metabolizma i prehrane često: hiperkolesterolemija često: hipertrigliceridemija
English: This medicine contains less than 1 mmol sodium (23 mg) per 240 mg dose (4 tablets), that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 240 mg (4 tablete), tj. zanemarive količine natrija.