FrancophonIA/ELRC3.0 huggingface dataset:
English: The median rPFS was 19.7 months in the enzalutamide group and 5.4 months in the placebo group.
Danish: Den mediane rPFS var 19,7 måneder i enzalutamidgruppen og 5,4 måneder i placebogruppen.
English: Enzalutamide (160 mg once daily) did not cause a clinically relevant change in the AUC or Cmax of caffeine (CYP1A2 substrate) or pioglitazone (CYP2C8 substrate).
Danish: Enzalutamid (160 mg én gang dagligt) bevirkede ikke en klinisk relevant ændring i AUC eller Cmax for koffein (CYP1A2-substrat) eller pioglitazon (CYP2C8-substrat).
English: In vivo studies have shown that enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19.
Danish: In vivo-studier har vist, at enzalutamid er en kraftig induktor af CYP3A4 og en moderat induktor af CYP2C9 og CYP2C19.
English: Consistent benefit of enzalutamide over bicalutamide on PFS was observed in all pre-specified patient subgroups.
Danish: Der blev observeret en konsistent fordel af enzalutamid over bicalutamid på PFS i alle forhåndsspecificerede patientundergrupper.
English: Study results also have shown that enzalutamide and/or its metabolites are transferred to infant rat tissues via milk and subsequently eliminated.
Danish: Studieresultater har også vist, at enzalutamid og/eller dets metabolitter overføres til væv hos nyfødte rotter via mælk og efterfølgende elimineres.
English: The median age was 69 years (range 41 - 92) and the racial distribution was 93% Caucasian, 4% Black, 1% Asian, and 2% Other.
Danish: Medianalderen var 69 år (interval 41-92), og racefordelingen var 93 % kaukasiere, 4 % sorte, 1 % asiater og 2 % andre.
English: Additional changes to reproductive tissues included hypertrophy/hyperplasia of the pituitary gland and atrophy in seminal vesicles in rats and testicular hypospermia and seminiferous tubule degeneration in dogs.
Danish: Yderligere ændringer af reproduktivt væv omfattede hypertrofi/hyperplasi af hypofysen og atrofi i sædblærer hos rotter og testikelhypospermi og degeneration af sædkanaler hos hunde.
English: The European Medicines Agency has waived the obligation to submit the results of studies with enzalutamide in all subsets of the paediatric population in prostate carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med enzalutamid i alle undergrupper af den pædiatriske population ved prostatakarcinom (se pkt.
English: If the patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 3 months after treatment.
Danish: Hvis patienten har samleje med en kvinde i den fødedygtige alder, skal der anvendes kondom og anden form for prævention under og i 3 måneder efter behandling.
English: BATCH NUMBER
Danish: BATCHNUMMER Lot
English: Approximately 45% of patients had measurable soft tissue disease at study entry, and 12% of patients had visceral (lung and/or liver) metastases.
Danish: Ca. 45 % af patienterne havde målbar bløddelssygdom ved inklusion i studiet, og 12 % af patienterne havde viscerale metastaser (i lunge og/eller lever).
English: Patients with a previous history of seizure or a condition that might predispose to seizure and patients with moderate or severe pain from prostate cancer were excluded.
Danish: Patienter med en anamnese med krampeanfald eller en tilstand, der kan prædisponere for krampeanfald, og patienter med moderate eller kraftige smerter fra prostatacancer blev udelukket.
English: • Antipsychotics (e.g. haloperidol)
Danish: • Antipsykotika (f.eks. haloperidol)
English: Animal studies showed that enzalutamide affected the reproductive system in male rats and dogs (see section 5.3).
Danish: Dyrestudier har påvist, at enzalutamid påvirker det reproduktive system hos hanrotter og -hunde (se pkt.
English: In the 9785-CL-0403 (UPWARD) single-arm trial to assess incidence of seizure in patients with predisposing factors for seizure (whereof 1.6% had a history of seizures), 8 of 366 (2.2%) patients treated with enzalutamide experienced a seizure.
Danish: I enkeltarmet studiet 9785-CL-0403 (UPWARD) til at vurdere forekomsten af krampeanfald hos patienter med prædisponerende faktorer for krampeanfald (hvoraf 1,6% havde en anamnese med krampeanfald), oplevede 8 ud af 366 (2,2%) patienter, behandlet med enzalutamid, et krampeanfald.
English: Astellas Pharmaceuticals AEBE
Danish: Astellas Pharmaceuticals AEBE Eλλάδα
English: Enzalutamide (N = 800)
Danish: Enzalutamid (N = 800)
English: - If you forget to take Xtandi at the usual time, take your usual dose as soon as you remember.
Danish: Hvis du har glemt at tage Xtandi på det sædvanlige tidspunkt, skal du tage din sædvanlige dosis, så snart du kommer i tanke om det.
English: Gender differences were noted in rat mammary glands (male atrophy and female lobular hyperplasia).
Danish: Der blev observeret kønsforskelle i brystkirtler hos rotter (atrofi hos hanner og lobulær hyperplasi hos hunner).
English: Based on in vitro data, inhibition of BCRP and MRP2 (in the intestine), as well as organic anion transporter 3 (OAT3) and organic cation transporter 1 (OCT1) (systemically) cannot be excluded.
Danish: Ud fra in vitro-data kan hæmning af BCRP og MRP2 (i tarmen), samt organisk aniontransportør 3 (OAT3) og organisk kationtransportør 1 (OCT1) (systemisk) ikke udelukkes.
English: The median age was 71 years (range 42 - 93) and the racial distribution was 77% Caucasian, 10% Asian, 2% Black and 11% other or unknown races.
Danish: Medianalderen var 71 år (interval 42-93), og racefordelingen var 77 % kaukasiere, 10 % asiater, 2 % sorte og 11 % andre eller ukendt.
English: Contains sorbitol (E420).
Danish: Indeholder sorbitol (E 420).
English: In vitro data indicate that enzalutamide may be an inhibitor of the efflux transporter P-gp.
Danish: In vitro-data indikerer, at enzalutamid kan være hæmmer af effluxtransportøren P-gp.
English: The Interim Analysis report of OS should be submitted by:
Danish: Interimanalyse rapporten for Samlet Overlevelse skal indsendes:
English: If co-administration of the strong CYP2C8 inhibitor is discontinued, the enzalutamide dose should be returned to the dose used prior to initiation of the strong CYP2C8 inhibitor (see section 4.5).
Danish: Hvis samtidig administration af den kraftige CYP2C8-hæmmer stoppes, bør dosis af enzalutamid ændres tilbage til den dosis, der blev anvendt inden initiering af den kraftige CYP2C8hæmmer (se pkt.
English: Efficacy of enzalutamide was established in three randomised placebo-controlled multicentre phase 3 clinical studies [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] of patients with progressive prostate cancer who had failed androgen deprivation therapy [LHRH analogue or after bilateral orchiectomy].
Danish: Virkningen af enzalutamid er fastlagt i tre randomiserede placebokontrollerede kliniske fase 3multicenterstudie [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] hos patienter med progressiv prostatacancer, som ikke responderede på androgen deprivationsbehandling [LHRH-analog eller efter bilateral orkiektomi].
English: The absolute difference in objective soft tissue response between enzalutamide and placebo arms was [53.9% (95% CI: 48.5, 59.1), p < 0.0001].
Danish: Den absolutte forskel i objektiv bløddelsrespons mellem enzalutamid- og placebogruppen var [53,9 % (95 % KI: 48,5, 59,1), p < 0,0001].
English: • Corticosteroids (e.g. dexamethasone, prednisolone)
Danish: • Kortikosteroider (f.eks. dexamethason, prednisolon)
English: Potential for other medicinal products to affect enzalutamide exposures
Danish: Andre lægemidlers potentiale til at påvirke enzalutamideksponeringer
English: Treatment with enzalutamide decreased the risk of FACT-P degradation by 37.5% compared with placebo (p < 0.0001).
Danish: Behandling med enzalutamid reducerede risikoen for forringelse af FACT-P med 37,5 % sammenlignet med placebo (p < 0,0001).
English: Most (91%) patients had metastases in bone and 23% had visceral lung and/or liver involvement.
Danish: De fleste patienter (91 %) havde knoglemetastaser, og 23 % havde viscerale lunge- og/eller levermetastaser.
English: Following oral administration of 14C-enzalutamide, 84.6% of the radioactivity is recovered by 77 days post dose: 71.0% is recovered in urine (primarily as the inactive metabolite, with trace amounts of enzalutamide and the active metabolite), and 13.6% is recovered in faeces (0.39% of dose as unchanged enzalutamide).
Danish: Efter oral administration af 14C-enzalutamid genfindes 84,6 % af radioaktiviteten 77 dage efter dosering: Der genfindes 71,0 % i urinen (primært som den inaktive metabolit, med spormængder af enzalutamid og den aktive metabolit), og 13,6 % genfindes i fæces (0,39 % af dosis som uændret enzalutamid).
English: Metastasis-free survival (MFS) was the primary endpoint defined as the time from randomisation to radiographic progression or death within 112 days of treatment discontinuation without evidence of radiographic progression, whichever occurred first.
Danish: Det primære endepunkt var metastasefri overlevelse (MFS), defineret som tiden fra randomisering til radiografisk progression eller død, indenfor 112 dage efter afsluttet behandling uden tegn på radiografisk progression, uafhængigt af hvad der indtraf først.
English: Study treatment continued until disease progression (evidence of radiographic progression, a skeletalrelated event, or clinical progression) and the initiation of either a cytotoxic chemotherapy or an investigational agent, or until unacceptable toxicity.
Danish: Studiebehandlingen fortsatte indtil sygdomsprogression (evidens for radiografisk progression, en skeletrelateret hændelse eller klinisk progression) og initiering af cytotoksisk kemoterapi eller et forsøgsmiddel eller indtil uacceptabel toksicitet.
English: Seizures were reported in 4 in every 1,000 people taking Xtandi, and fewer than one in every 1,000 people taking placebo (see ‘Other medicines and Xtandi' below and section 4 ‘Possible side effects').
Danish: Der er rapporteret krampeanfald hos 4 ud af hver 1.000 personer, der har fået Xtandi, og hos færre end én ud af hver 1.000 personer, der har fået placebo (inaktivt middel) (se "Brug af anden medicin sammen med Xtandi" i det følgende og punkt 4, "Bivirkninger").
English: Strong inhibitors (e.g. gemfibrozil) of CYP2C8 are to be avoided or used with caution during enzalutamide treatment.
Danish: Kraftige hæmmere (f.eks. gemfibrozil) af CYP2C8 skal undgås eller anvendes med forsigtighed under behandling med enzalutamid.
English: Hazard Ratio (95% CI)2 P-value3
Danish: Hazard ratio (95 % KI)2 P-værdi3
English: The full induction potential of enzalutamide may not occur until approximately 1 month after the start of treatment, when steady-state plasma concentrations of enzalutamide are reached, although some induction effects may be apparent earlier.
Danish: Enzalutamid opnår måske ikke sit fulde induktionspotentiale før ca. 1 måned efter behandlingsstart, når steady-state for plasmakoncentrationen af enzalutamid er nået.
English: - If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method, during treatment and for 3 months after treatment with this medicine.
Danish: Hvis du har samleje med en kvinde i den fødedygtige alder, skal du benytte kondom og en anden effektiv præventionsform under behandlingen og i 3 måneder efter behandling med dette lægemiddel.
English: • Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil)
Danish: • Calciumkanalblokkere (f.eks. diltiazem, felodipin, nicardipin, nifedipin, verapamil)
English: Enzalutamide (N = 872)
Danish: Enzalutamid (N = 872)
English: 9785-CL-0410 study (enzalutamide post abiraterone in patients with metastatic CRPC)
Danish: 9785-CL-0410 studie (enzalutamid post abirateron hos patienter med metastatisk CRPC)
English: Hazard ratio < 1 favours enzalutamide.
Danish: En Hazard ratio <1 favoriserer enzalutamid
English: Complete responses were reported in 19.7% of enzalutamide-treated patients compared with 1.0% of placebo-treated patients, and partial responses were reported in 39.1% of enzalutamide-treated patients versus 3.9% of placebo-treated patients.
Danish: Komplet respons blev rapporteret hos 19,7 % af de enzalutamidbehandlede patienter sammenlignet med 1,0 % af patienterne i placebogruppen, og partiel respons blev rapporteret hos 39,1 % af de enzalutamidbehandlede patienter i forhold til 3,9 % af patienterne i placebogruppen.
English: Soft capsule.
Danish: Kapsel, blød.
English: No dose adjustment is indicated when a CYP1A2 or CYP2C8 substrate is co-administered with Xtandi.
Danish: Dosisjustering er ikke indiceret, når et CYP1A2- eller CYP2C8-substrat administreres samtidig med Xtandi.
English: • Antiepileptics (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid)
Danish: • Antiepileptika (f.eks. carbamazepin, clonazepam, phenytoin, primidon, valproinsyre)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON WITH BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON MED BLUE BOX
English: In randomized placebo-controlled clinical studies, ischemic heart disease occurred in 2.5% of patients treated with enzalutamide plus ADT compared to 1.3 % patients treated with placebo plus ADT.
Danish: I randomiserede placebokontrollerede kliniske studier forekom iskæmisk hjertesygdom hos 2,5 % af patienterne behandlet med enzalutamid plus ADT sammenlignet med 1,3 % af patienterne behandlet med placebo plus ADT.
English: Prostate cancer is known to be androgen sensitive and responds to inhibition of androgen receptor signalling.
Danish: Prostatacancer vides at være androgenfølsom og responderer på hæmning af androgenreceptorsignalering.
English: A review of concomitant medicinal products should therefore be conducted when initiating enzalutamide treatment.
Danish: Lægemidler, der anvendes samtidigt bør derfor vurderes, når enzalutamidbehandling indledes.
English: Figure 5: Updated overall survival analysis by subgroup: Hazard ratio and 95% confidence interval in the PREVAIL study (intent-to-treat analysis)
Danish: Figur 5: Opdateret analyse af samlet overlevelse baseret på undergruppe: Hazard ratio og 95 % konfidensinterval i PREVAIL-studiet (intent-to-treat-analyse)
English: The usual dose is 160 mg (four soft capsules), taken at the same time once a day.
Danish: Den sædvanlige dosis er 160 mg (fire bløde kapsler), som tages på samme tidspunkt én gang dagligt.
English: Eighty-one percent (81%) of patients had an ECOG performance status score of 0 and 19% patients had an ECOG performance status of 1.
Danish: Enogfirs procent (81 %) af patienterne havde en ECOG- funktionsscore på 0, og 19 % patienter havde en ECOG- funktionsscore på 1.
English: Caprylocaproyl macrogol-8 glycerides Butylhydroxyanisole (E320) Butylhydroxytoluene (E321)
Danish: Caprylocaproyl macrogol-8-glycerider Butylhydroxyanisol (E 320) Butylhydroxytoluen (E 321)
English: Patients randomised to either arm were to continue treatment until disease progression (defined as confirmed radiographic progression or the occurrence of a skeletal-related event) and initiation of new systemic antineoplastic treatment, unacceptable toxicity, or withdrawal.
Danish: Efter randomisering skulle patienterne i begge behandlingsarme fortsætte med behandlingen indtil sygdomsprogression (defineret som bekræftet radiografisk progression eller forekomst af en skeletrelateret hændelse) og initiering af ny systemisk antineoplastisk behandling, uacceptabel toksicitet eller udtrædelse.
English: • Analgesics (e.g. fentanyl, tramadol)
Danish: • Analgetika (f.eks. fentanyl, tramadol)
English: Under conditions of clinical use, enzalutamide is a strong inducer of CYP3A4, a moderate inducer of CYP2C9 and CYP2C19, and has no clinically relevant effect on CYP2C8 (see section 4.5).
Danish: Under betingelser svarende til klinisk brug er enzalutamid en potent CYP3A4-induktor, en moderat induktor af CYP2C9 og CYP2C19, og stoffet har ingen klinisk relevant virkning på CYP2C8 (se pkt.
English: Tabulated list of adverse reactions Adverse reactions observed during clinical studies are listed below by frequency category.
Danish: Bivirkninger observeret under kliniske studier er anført nedenfor baseret på frekvenskategori.
English: Patients were stratified by Prostate Specific Antigen (PSA) Doubling Time (PSADT) (< 6 months or ≥ 6 months) and the use of bone-targeting agents (yes or no).
Danish: Patienterne blev stratificeret efter Prostata Specifik Antigen (PSA) fordoblingstid (PSADT) (< 6 måneder eller ≥ 6 måneder) og brug af middel mod knogleskørhed (ja eller nej).
English: CYP1A2 and CYP2C8 substrates
Danish: CYP1A2- og CYP2C8-substrater
English: The concomitant use of strong CYP2C8 inhibitors should be avoided if possible.
Danish: Samtidig anvendelse af kraftige CYP2C8-hæmmere Samtidig anvendelse af kraftige CYP2C8-hæmmere bør om muligt undgås.
English: Overall survival was evaluated at two prespecified interim analyses to date; the first at the time of final MFS (n = 165) [HR = 0.80 (95% CI: 0.58, 1.09), p = 0.1519], and the second interim analysis (n = 288) [HR = 0.83 (95% CI: 0.65, 1.06), p = 0.1344].
Danish: Samlet overlevelse blev evalueret ved 2 forudspecificerede interimanalyser til dato; den første på tidspunktet for den endelige MFS (n = 165) [HR = 0,80 (95 % KI: 0,58, 1,09), p = 0,1519], og den anden interimanalyse (n = 288) [HR = 0,83 (95 % KI: 0,65, 1,06), p = 0,1344].
English: • Anticancer agents (e.g. cabazitaxel)
Danish: • Anticancermidler (f.eks. cabazitaxel)
English: The AUC of docetaxel decreased by 12% [geometric mean ratio (GMR) = 0.882 (90% CI: 0.767, 1.02)] while Cmax decreased by 4% [GMR = 0.963 (90% CI:
Danish: AUC for docetaxel faldt med 12 % [geometrisk middelratio (GMR) =0,882 (90 % KI: 0,767-1,02)], mens Cmax faldt med 4 % [GMR = 0,963 (90 % KI: 0,834
English: If you are at higher risk of seizures, talk to your doctor.
Danish: Hvis du har højere risiko for krampeanfald, bør du kontakte lægen.
English: The analysis included 587 skeletal-related events, of which 389 events (66.3%) were radiation to bone, 79 events (13.5%) were spinal cord compression, 70 events (11.9%) were pathologic bone fracture, 45 events (7.6%) were change in antineoplastic therapy to treat bone pain, and 22 events (3.7%) were surgery to bone.
Danish: Analysen inkluderede 587 skeletrelaterede hændelser, hvoraf 389 hændelser (66,3 %) var strålebehandling af knogler, 79 hændelser (13,5 %) var rygmarvskompression, 70 hændelser (11,9 %) var patologisk knoglefraktur, 45 hændelser (7,6 %) var ændring af antineoplastisk behandling for at behandle knoglesmerter, og 22 hændelser (3,7 %) var knoglekirurgi.
English: Confirmed PSA decline of 50% or 90% were 54.0% and 24.8%, respectively, for patients treated with enzalutamide and 1.5% and 0.9%, respectively, for patients who received placebo (p < 0.0001).
Danish: Bekræftet PSA-fald på 50 % eller 90 % var henholdsvis 54,0 % og 24,8 % for patienter behandlet med enzalutamid og henholdsvis 1,5 % og 0,9 % for patienter, som modtog placebo (p <0,0001).
English: PSA Response was 22.1% (95% CI: 15.6, 29.7).
Danish: PSA respons var 22,1 % (95 % KI: 15,6, 29,7).
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 27% while Cmax was again unchanged.
Danish: For summen af ubundet enzalutamid plus den ubundne aktive metabolit blev AUC forøget med 27 %, mens Cmax igen var uændret.
English: No formal renal impairment study for enzalutamide has been completed.
Danish: Der er ikke gennemført et formelt studie af nedsat nyrefunktion for enzalutamid.
English: Studies in pregnant rats have shown that enzalutamide and/or its metabolites are transferred to fetuses.
Danish: Studier med drægtige rotter har vist, at enzalutamid og/eller dets metabolitter overføres til fostre.
English: The proportion of enzalutamide-treated patients with measurable disease at baseline who had an objective soft tissue response was 58.8% (95% CI: 53.8, 63.7) compared with 5.0% (95% CI: 3.0, 7.7) of patients receiving placebo.
Danish: Andelen af enzalutamidbehandlede patienter med registrerbar sygdom ved baseline, der havde en objektiv bløddelsrespons, var 58,8 % (95 % KI: 53,8, 63,7) sammenlignet med 5,0 % (95 % KI: 3,0, 7,7) af patienterne, der fik placebo.
English: Hazard ratio (95% CI)2
Danish: Hazard ratio (95 % KI)2
English: Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate
Danish: Hypromellose acetat succinat Mikrokrystalinsk cellulose Kolloid, vandfri silica Croscarmellosenatrium Magnesiumstearat
English: Xtandi might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other medicines (e.g. methadone, used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Danish: Xtandi kan påvirke nogle lægemidler, som bruges til at behandle hjerterytmeproblemer (f.eks. kinidin, procainamid, amiodaron og sotalol), og kan øge risikoen for hjerterytmeproblemer, når det bruges sammen med visse andre lægemidler (f.eks. methadon, som anvendes til smertelindring og ved narkotika-afvænning, moxifloxacin (et antibiotikum), antipsykotika, som anvendes til alvorlige psykiske lidelser).
English: Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway.
Danish: Enzalutamid er en potent hæmmer af androgenreceptorsignalering, der blokerer flere trin i androgenreceptorsignaleringssystemet.
English: Each carton contains 112 tablets in 4 blister wallets of 28 tablets each.
Danish: Hver karton indeholder 112 tabletter i 4 blistertegnebøger a 28 tabletter hver.
English: In controlled clinical studies, 13 patients (0.4%) experienced a seizure out of 3179 patients treated with a daily dose of 160 mg enzalutamide, whereas one patient (0.1%) receiving placebo and one patient (0.3%) receiving bicalutamide, experienced a seizure.
Danish: I de kontrollerede kliniske studier forekom der et krampeanfald hos 13 patienter (0,4 %) ud af 3179 patienter, som blev behandlet med en daglig dosis på 160 mg enzalutamid, hos én patient (0,1 %) i placebogruppen, og hos én patient (0,3 %), som blev behandlet med bicalutamid.
English: Enzyme induction
Danish: Enzyminduktion
English: PSA Response was 23.2% (95% CI: 13.9, 34.9).
Danish: PSA respons var 23,2 % (95 % KI: 13,9, 34,9).
English: • Hypnotics (e.g. diazepam, midazolam, zolpidem)
Danish: • Hypnotika (f.eks. diazepam, midazolam, zolpidem)
English: The demographic and baseline characteristics were well-balanced between the two treatment arms.
Danish: De demografiske kendetegn, samt kendetegnene ved baseline, var velafbalanceret mellem de to behandlingsarme.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Xtandi findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: MDV3100-14 (PROSPER) study (patients with non-metastatic CRPC)
Danish: MDV3100-14 (PROSPER)-studiet (patienter med ikke-metastatisk CRPC)
English: Xtandi 80 mg film-coated tablets are yellow oval film-coated tablets, debossed with E 80 Each carton contains 56 tablets in 4 blister wallets of 14 tablets each.
Danish: Xtandi 80 mg filmovertrukne tabletter er gule, ovale, filmovertrukne tabletter, præget med E 80 Hver karton indeholder 56 tabletter i 4 blistertegnebøger a 14 tabletter hver.
English: If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily.
Danish: Hvis patienterne samtidig skal have administreret en kraftig CYP2C8-hæmmer, bør dosis af enzalutamid reduceres til 80 mg én gang dagligt.
English: There are two major metabolites in human plasma: N-desmethyl enzalutamide (active) and a carboxylic acid derivative (inactive).
Danish: N-desmethyl-enzalutamid (aktivt) og et carboxylsyrederivat (inaktivt).