FrancophonIA/ELRC3.0 huggingface dataset:
English: • The active substance is apalutamide.
Slovenian: • Učinkovina je apalutamid.
English: The effects of renal impairment, hepatic impairment, age, race, and other extrinsic factors on the pharmacokinetics of apalutamide are summarised below.
Slovenian: Spodaj so opisani vplivi, ki jih imajo okvara ledvic, okvara jeter, starost, rasa in drugi ekstrinzični dejavniki na farmakokinetiko apalutamida.
English: If you forget to take Erleada
Slovenian: Če ste pozabili vzeti zdravilo Erleada
English: Apalutamide, mainly in the form of metabolites, is eliminated primarily via urine.
Slovenian: Apalutamid se izloča predvsem z urinom, večinoma v obliki presnovkov.
English: Erleada may harm your unborn baby.
Slovenian: Zdravilo Erleada lahko škoduje nerojenemu otroku.
English: The mean effective half-life for apalutamide in patients is about 3 days at steady-state.
Slovenian: Povprečni efektivni razpolovni čas apalutamida pri bolnikih je v stanju dinamičnega ravnovesja približno 3 dni.
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.
Slovenian: Zdravljenje z odtegnitvijo androgenov lahko podaljša interval QT Pri bolnikih z anamnezo podaljšanja intervala QT ali s prisotnimi dejavniki tveganja za podaljšanje intervala QT in pri bolnikih, ki sočasno prejemajo zdravila, ki lahko podaljšajo interval QT (glejte poglavje 4.5), mora zdravnik pred začetkom zdravljenja z zdravilom Erleada oceniti razmerje med koristjo in tveganjem, vključno z možnostjo razvoja Torsade de pointes.
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.
Slovenian: Klinični podatki kažejo, da je apalutamid šibek induktor P-glikoproteina (P-gp), proteina odpornosti pri raku dojke (BCRP - breast cancer resistance protein) in polipeptidnega prenašalca organskih anionov 1B1 (OATP1B1 - organic anion transporting polypeptide 1B1).
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.
Slovenian: • Druge sestavine jedra tablete so brezvodni koloidni silicijev dioksid, premreženi natrijev karmelozat, hipromeloza acetat sukcinat, magnezijev stearat, mikrokristalna celuloza in silicificirana mikrokristalna celuloza.
English: Skin rash associated with Erleada was most commonly described as macular or maculo-papular.
Slovenian: Kožni izpuščaj, povezan z jemanjem zdravila Erleada, so najpogosteje opredelili kot makulozni ali makulopapulozni izpuščaj.
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).
Slovenian: Po enkratnem peroralnem odmerku radioaktivno označenega apalutamida so 89% radioaktivnosti prestregli do 70. dne po odmerjanju: 65% so prestregli v urinu (1,2% odmerka v obliki nespremenjenega apalutamida in 2,7% v obliki N-desmetil apalutamida), 24% radioaktivnosti pa so prestregli v blatu (1,5% odmerka v obliki nespremenjenega apalutamida in 2% v obliki N-desmetil apalutamida).
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.
Slovenian: Apalutamid se veže na beljakovine v plazmi v 96%, N-desmetil apalutamid pa v 95%, in sicer sta večinoma vezana na albumine v plazmi neodvisno od koncentracije.
English: Erleada should not be used during breast-feeding.
Slovenian: Zdravila Erleada se ne sme uporabljati med dojenjem.
English: Women who are or may become pregnant (see section 4.6).
Slovenian: Nosečnice in ženske, ki bi lahko zanosile (glejte poglavje 4.6).
English: • Obligation to conduct post-authorisation measures
Slovenian: Obveznosti izvedbe ukrepov po pridobitvi dovoljenja za promet
English: Androgens can cause the cancer to grow.
Slovenian: Androgeni lahko povzročijo rast rakavih celic.
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.
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih pri samcih podgan in psov so opazili atrofijo, aspermijo/hipospermijo ter degeneracijo in/ali hiperplazijo oziroma hipertrofijo reproduktivnega sistema pri uporabi odmerkov, ki so glede na AUC ustrezali približno tolikšni izpostavljenosti, kot jo dosegamo pri ljudeh.
English: • you are allergic to apalutamide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Erleada: - če ste alergični na apalutamid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • Periodic safety update reports
Slovenian: ● Redno posodobljena poročila o varnosti zdravila (PSUR)
English: Erleada did not cause clinically meaningful changes in exposure to the CYP2C8 substrate.
Slovenian: Zdravilo Erleada ni povzročilo klinično pomembnih sprememb izpostavljenosti substratom CYP2C8.
English: The film-coating contains iron oxide black (E172), iron oxide yellow (E172), macrogol, polyvinyl alcohol (partially hydrolysed), talc, and titanium dioxide (E171).
Slovenian: Filmska obloga tablete vsebuje črni železov oksid (E172), rumeni železov oksid (E172), makrogol, delno hidrolizirani polivinilalkohol, smukec in titanov dioksid (E171).
English: There is no relevant use of apalutamide in the paediatric population in the treatment of non-metastatic castration-resistant prostate cancer.
Slovenian: Apalutamid ni namenjen za uporabo pri pediatrični populaciji za zdravljenje nemetastatskega, na kastracijo odpornega raka prostate.
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.
Slovenian: Pri vključenih preiskovancih je bil čas podvojitve za prostato specifičnega antigena (PSA - Prostate Specific Antigen, PSADT - PSA Doubling Time) ≤ 10 mesecev, kar pomeni veliko tveganje za prihodnji razsoj raka (razvoj metastatske bolezni) in za smrt, do katere pride specifično zaradi raka prostate.
English: Daily fluctuations in apalutamide plasma concentrations were low, with mean peak-to-trough ratio of 1.63.
Slovenian: Dnevno nihanje koncentracije apalutamida v plazmi je bilo majhno, povprečna vrednost razmerja med najvišjo in najnižjo koncentracijo apalutamida v plazmi je bila 1,63.
English: Caution is required in patients with severe renal impairment as apalutamide has not been studied in this patient population (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic je potrebna previdnost, saj uporabe apalutamida pri tej skupini bolnikov niso preučevali (glejte poglavje 5.2).
English: The effect of apalutamide on CYP2B6 substrates has not been evaluated in vivo and the net effect is presently unknown.
Slovenian: Vpliva apalutamida na substrate CYP2B6 niso ocenjevali v raziskavah in vivo in trenutno ni znan.
English: In the apalutamide arm, 62 (7.7%) subjects died compared to 42 (10.5%) subjects in the placebo arm.
Slovenian: V skupini z apalutamidom je umrlo 62 preskovancev (7,7%), v skupini s placebom pa 42 preiskovancev (10,5%).
English: The following patient demographics and baseline disease characteristics were balanced between the treatment arms.
Slovenian: Demografske značilnosti bolnikov in izhodiščne značilnosti njihove bolezni, ki so navedene v nadaljevanju, so bile uravnotežene med obema študijskima skupinama.
English: Erleada is contraindicated in women who are or may become pregnant (see section 4.3).
Slovenian: Zdravilo Erleada je kontraindicirano pri ženskah, ki so noseče ali bi lahko zanosile (glejte poglavje 4.3).
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.
Slovenian: Pri vseh vključenih preiskovancih je bila odsotnost metastaz ob vstopu v študijo potrjena s centralnim slepim pregledom posnetkov slikovnih preiskav, njihova ocena statusa zmogljivosti po ECOG (Eastern Cooperative Oncology Group) pa je bila ob vstopu v študijo 0 ali 1.
English: In vitro data indicate that apalutamide and its N-desmethyl metabolite are not substrates for BCRP, OATP1B1 or OATP1B3.
Slovenian: Po podatkih raziskav in vitro apalutamid in njegov N-desmetil presnovek nista substrata prenašalcev BCRP, OATP1B1 ali OATP1B3.
English: Other medicines and Erleada
Slovenian: Druga zdravila in zdravilo Erleada
English: Medicinal products that inhibit CYP3A4
Slovenian: Zdravila, ki zavirajo CYP3A4
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.
Slovenian: Pri preiskovancih, ki so bili randomizirani v katero koli od obeh skupin, so načrtovali zdravljenje do napredovanja bolezni, ki je opredeljeno na osnovi centralnega slepega pregleda posnetkov slikovnih preiskav (BICR - blinded central imaging review), ali do uvedbe novega zdravljenja, pojava nesprejemljive toksičnosti oziroma do prekinitve sodelovanja v študiji.
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).
Slovenian: Pri preiskovancih, ki so prejemali zdravilo Erleada in ADT, je prišlo do statistično značilno večjega izboljšanja kot pri tistih, ki so prejemali samo ADT, pri naslednjih sekundarnih ciljih študije: čas do metastaz (HR = 0,28; 95% IZ: 0,23; 0,34; p < 0,0001), preživetje brez napredovanja bolezni (PFSprogression-free survival) (HR = 0,30; 95% IZ: 0,25, 0,36; p < 0,0001), čas do simptomatskega napredovanja bolezni (HR = 0,45; 95% IZ: 0,32, 0,63; p < 0,0001) in trend celokupnega preživetja (OS - overall survival) (HR = 0,70; 95% IZ: 0,47, 1,04; p = 0,0742).
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.
Slovenian: V skupini z apalutamidom je pri 64 bolnikih (7,9%) prišlo do simptomatskega napredovanja v skupini s placebom pa pri 63 bolnikih (16%), z razmerjem ogroženosti 0,447 (95% IZ: 0,315; 0,634), kar je doseglo vnaprej določeno O'Brien Flemingovo mejo učinkovitosti za signifikanco, p < 0,00008.
English: This medicine is not likely to affect you being able to drive and use any tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo po vsej verjetnosti ne vpliva na sposobnost za vožnjo ali uporabo orodij in strojev.
English: Potential for apalutamide to affect exposures to other medicinal products
Slovenian: Možnost vpliva apalutamida na izpostavljenost drugim zdravilom
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.
Slovenian: Ker se apalutamid po peroralnem odmerjanju v celoti absorbira, P-glikoprotein ne omejuje absorpcije apalutamida in zato ni pričakovati, da bi indukcija P-glikoproteina lahko vplivala na biološko razpoložljivost apalutamida.
English: Falls were reported for 15.6% of patients treated with Erleada versus 9.0% of patients treated with placebo (see section 4.4).
Slovenian: O padcih so poročali pri 15,6% bolnikov, ki so prejemali zdravilo Erleada, v primerjavi z 9,0% pri bolnikih, ki so prejemali placebo (glejte poglavje 4.4).
English: Apalutamide prevents AR nuclear translocation, inhibits DNA binding, impedes AR-mediated transcription, and lacks androgen receptor agonist activity.
Slovenian: Apalutamid preprečuje prenos androgenskih receptorjev v jedro, zavira vezavo DNA, ovira z androgenskimi receptorji posredovano transkripcijo in nima agonistične aktivnosti na androgenske receptorje.
English: You need to list the names of the medicines you take and show the list to your doctor or pharmacist when you start a new medicine.
Slovenian: Seznam teh zdravil imejte vedno pri sebi in ga pokažite zdravniku ali farmacevtu, kadar vam predpišejo novo zdravilo.
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).
Slovenian: Na osnovi populacijske farmakokinetične analize z uporabo podatkov iz kliničnih študij pri bolnikih z na kastracijo odpornim rakom prostate in pri zdravih osebah niso opazili statistično značilnih razlik v sistemski izpostavljenosti zdravilu pri osebah z že prisotno blago do zmerno okvaro ledvic (z oceno hitrosti glomerulne filtracije [eGFR] med 30 in 89 ml/min/1,73 m2, N=585) v primerjavi z vrednostmi pri osebah z normalno ledvično funkcijo ob izhodišču (z oceno hitrosti glomerulne filtracije ≥ 90 ml/min/1,73 m2, N=372).
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.
Slovenian: Uporaba zdravila Erleada ni priporočljiva pri bolnikih z anamnezo konvulzij ali drugimi predispozicijskimi dejavniki, med drugim tudi pri bolnikih s poškodbo možganov, nedavno kapjo (v zadnjem letu), pri bolnikih s primarnimi možganskimi tumorji ali metastazami v možganih.
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).
Slovenian: Glede na to, da je apalutamid induktor CYP3A4, bi lahko induciral tudi UDP-glukuronil transferazo (UGT) prek aktivacije jedrnega pregnanskega X receptorja (PXR - pregnane X receptor).
English: Metabolism and nutrition disorders common: hypercholesterolaemia common: hypertriglyceridaemia
Slovenian: Presnovne in prehranske motnje pogosti: hiperholesterolemija pogosti: hipertrigliceridemija
English: The tablets may be supplied either in a bottle or in a wallet pack.
Slovenian: Tablete so na voljo v plastenki ali v pakiranju v obliki zloženke.
English: Median time to reach tmax was delayed about 2 hours with food (see section 4.2).
Slovenian: Pri uporabi skupaj s hrano je bil mediani čas do najvišje koncentracije (tmax) daljši za približno 2 uri (glejte poglavje 4.2).
English: 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UK
Slovenian: 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Tel: +44 1 494 567 444
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).
Slovenian: Uporaba zdravila Erleada ni priporočljiva pri bolnikih s hudo okvaro jeter, ker pri tej populaciji bolnikov ni podatkov in ker se apalutamid primarno izloča preko jeter (glejte poglavje 5.2)
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.
Slovenian: Apalutamid v fiziološko pomembnih pH pogojih ne ionizira, zato ni pričakovati, da bi zdravila, ki zmanjšujejo kislost želodčne vsebine, (npr. zaviralci protonske črpalke, antagonisti histaminskih receptorjev H2 in antacidi) vplivala na topnost in biološko razpoložljivost apalutamida.
English: General disorders and administration site conditions very common: fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti: utrujenost
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.
Slovenian: V klinične študije niso vključevali bolnikov, ki so imeli v predhodnih 6 mesecih katero od klinično pomembnih bolezni srca in ožilja, vključno s hudo/nestabilno angino pektoris, miokardnim infarktom, simptomatskim kongestivnim popuščanjem srca, arterijskimi ali venskimi trombemboličnimi dogodki (npr. pljučno embolijo ali možganskožilne zaplete, vključno s tranzitorno ishemično atako) ali katero od klinično pomembnih ventrikularnih aritmij.
English: Medicinal products that induce CYP3A4 or CYP2C8
Slovenian: Zdravila, ki inducirajo CYP3A4 ali CYP2C8
English: Medicinal products that inhibit CYP2C8
Slovenian: Zdravila, ki zavirajo CYP2C8
English: The recommended dose is 240 mg (four 60 mg tablets) as an oral single daily dose.
Slovenian: Priporočeni odmerek je 240 mg (štiri 60-miligramske tablete) v enkratnem peroralnem odmerku na dan.
English: At steady-state, the maximum mean QTcF change from baseline was 12.4 ms (2-sided 90% upper CI: 16.0 ms).
Slovenian: V stanju dinamičnega ravnovesja je bila maksimalna povprečna sprememba QTcF od izhodiščne vrednosti 12,4 ms (2-stranski 90% zgornji IZ: 16,0 ms).
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).
Slovenian: Preživetje po napredovanju bolezni (PFS-2 - post-progression survival, opredeljeno kot čas do napredovanja bolezni po prehodu na prvo naslednje zdravljenje ali do smrti) je bilo pri preiskovancih, ki so prejemali zdravilo Erleada, daljše kot pri tistih, ki so prejemali placebo (HR = 0,489; 95% IZ: 0,361, 0,662; p < 0,0001).
English: A majority of subjects had a Gleason score of 7 or higher (81%).
Slovenian: Pri večini preiskovancev (81%) je bila ocena po Gleasonu 7 ali več.
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.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za nadaljno oceno učinkovitosti zdravila Erleada mora imetnik dovoljenja za promet z zdravilom predložiti končno poročilo študije ARN-509-003 (SPARTAN), ki primerja učinkovitost in varnost apalutamida v primerjavi s placebom pri bolnikih z velikim tveganjem za nemetastatski, na kastracijo odporni rakom prostate.
English: The median MFS for Erleada was 41 months and was 16 months for placebo (see Figure 1.
Slovenian: Pri uporabi zdravila Erleada je bilo mediano preživetje brez pojava metastaz 41 mesecev, pri uporabi placeba pa 16 mesecev (glejte sliko 1.
English: Clinical and pharmacokinetic data are not available for patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Za bolnike s hudo okvaro jeter (Child-Pugh razreda C) ni na voljo kliničnih in farmakokinetičnih podatkov.
English: Erleada is a cancer medicine that contains the active substance apalutamide.
Slovenian: Zdravilo Erleada je zdravilo proti raku, ki vsebuje učinkovino apalutamid.
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).
Slovenian: Če se predpiše zdravilo Erleada, je treba pri bolnikih s klinično pomembnimi boleznimi srca in ožilja spremljati dejavnike tveganja kot so hiperholesterolemija, hipertrigliceridemija ali druge srčno presnovne bolezni (glejte poglavje 4.8).
English: * Includes hypothyroidism, blood thyroid stimulating hormone increased, thyroxine decreased, autoimmune thyroiditis,
Slovenian: * vključuje hipotiroidizem, povišano koncentracijo tirotropina (TSH) v krvi, znižano koncentracijo tiroksina,
English: Tell your doctor straight away if you notice any of the following serious side effects - your doctor may stop treatment:
Slovenian: Če opazite katerega koli od naslednjih resnih neželenih učinkov, takoj obvestite zdravnika, ki vam bo morda naročil, da prekinete zdravljenje:
English: CYP2C8 plays a role in the elimination of apalutamide and in the formation of its active metabolite.
Slovenian: CYP2C8 ima pomembno vlogo pri odstranjevanju apalutamida in tvorbi njegovega aktivnega presnovka.
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.
Slovenian: In vitro študije so pokazale, da sta apalutamid in N-desmetil apalutamid zmerna do močna induktorja CYP3A4 in CYP2B6, zmerna zaviralca CYP2B6 in CYP2C8 ter šibka zaviralca CYP2C9, CYP2C19 in CYP3A4.
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).
Slovenian: Če bolnik zdravilo Erleada uporablja sočasno z antikoagulansom, ki se presnavlja s CYP2C9, (npr. z varfarinom ali acenokumarolom), je treba dodatno spremljati internacionalno normalizirano razmerje (INRInternational Normalised Ratio) (glejte poglavje 4.5).
English: 28-day carton
Slovenian: Škatla z 28-dnevnim pakiranjem
English: Do not take this medicine if any of the above apply to you.
Slovenian: Če karkoli od zgoraj navedenega velja za vas, ne jemljite tega zdravila.
English: The recommended dose is 240 mg (four tablets) once a day.
Slovenian: Koliko zdravila je treba jemati Priporočeni odmerek je 240 mg (štiri tablete) enkrat na dan.
English: Musculoskeletal and connective tissue disorders very common: fracture+ very common: arthralgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti: zlom zelo pogosti: artralgija
English: Injury, poisoning and procedural complications very common: fall
Slovenian: Preiskave zelo pogosti: zmanjšanje telesne mase Poškodbe, zastrupitve in zapleti pri posegih zelo pogosti: padec
English: CYP3A4 plays a role in the elimination of apalutamide and in the formation of its active metabolite.
Slovenian: CYP3A4 ima pomembno vlogo pri odstranjevanju apalutamida in tvorbi njegovega aktivnega presnovka.
English: Janssen Cilag SpA Via C. Janssen Borgo San Michele Latina 04100, Italy
Slovenian: Janssen Cilag S.P.A Via C. Janssen, Borgo San Michele, Latina 04100, Italija