natgillin/translations-raw huggingface dataset:
9785-CL-0410 studie (enzalutamid post abirateron hos patienter med metastatisk CRPC)
9785-CL-0410 study (enzalutamide post abiraterone in patients with metastatic CRPC)
En Hazard ratio <1 favoriserer enzalutamid
Hazard ratio < 1 favours enzalutamide.
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.
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.
Kapsel, blød.
Soft capsule.
Dosisjustering er ikke indiceret, når et CYP1A2- eller CYP2C8-substrat administreres samtidig med Xtandi.
No dose adjustment is indicated when a CYP1A2 or CYP2C8 substrate is co-administered with Xtandi.
• Antiepileptika (f.eks. carbamazepin, clonazepam, phenytoin, primidon, valproinsyre)
• Antiepileptics (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON MED BLUE BOX
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON WITH BLUE BOX
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.
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.
Prostatacancer vides at være androgenfølsom og responderer på hæmning af androgenreceptorsignalering.
Prostate cancer is known to be androgen sensitive and responds to inhibition of androgen receptor signalling.
Lægemidler, der anvendes samtidigt bør derfor vurderes, når enzalutamidbehandling indledes.
A review of concomitant medicinal products should therefore be conducted when initiating enzalutamide treatment.
Figur 5: Opdateret analyse af samlet overlevelse baseret på undergruppe: Hazard ratio og 95 % konfidensinterval i PREVAIL-studiet (intent-to-treat-analyse)
Figure 5: Updated overall survival analysis by subgroup: Hazard ratio and 95% confidence interval in the PREVAIL study (intent-to-treat analysis)
Den sædvanlige dosis er 160 mg (fire bløde kapsler), som tages på samme tidspunkt én gang dagligt.
The usual dose is 160 mg (four soft capsules), taken at the same time once a day.
Enogfirs procent (81 %) af patienterne havde en ECOG- funktionsscore på 0, og 19 % patienter havde en ECOG- funktionsscore på 1.
Eighty-one percent (81%) of patients had an ECOG performance status score of 0 and 19% patients had an ECOG performance status of 1.
Caprylocaproyl macrogol-8-glycerider Butylhydroxyanisol (E 320) Butylhydroxytoluen (E 321)
Caprylocaproyl macrogol-8 glycerides Butylhydroxyanisole (E320) Butylhydroxytoluene (E321)
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.
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.
• Analgetika (f.eks. fentanyl, tramadol)
• Analgesics (e.g. fentanyl, tramadol)
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.
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).
Bivirkninger observeret under kliniske studier er anført nedenfor baseret på frekvenskategori.
Tabulated list of adverse reactions Adverse reactions observed during clinical studies are listed below by frequency category.
Patienterne blev stratificeret efter Prostata Specifik Antigen (PSA) fordoblingstid (PSADT) (< 6 måneder eller ≥ 6 måneder) og brug af middel mod knogleskørhed (ja eller nej).
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).
CYP1A2- og CYP2C8-substrater
CYP1A2 and CYP2C8 substrates
Samtidig anvendelse af kraftige CYP2C8-hæmmere Samtidig anvendelse af kraftige CYP2C8-hæmmere bør om muligt undgås.
The concomitant use of strong CYP2C8 inhibitors should be avoided if possible.
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].
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].
• Anticancermidler (f.eks. cabazitaxel)
• Anticancer agents (e.g. cabazitaxel)
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
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:
Hvis du har højere risiko for krampeanfald, bør du kontakte lægen.
If you are at higher risk of seizures, talk to your doctor.
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.
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.
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).
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).
PSA respons var 22,1 % (95 % KI: 15,6, 29,7).
PSA Response was 22.1% (95% CI: 15.6, 29.7).
For summen af ubundet enzalutamid plus den ubundne aktive metabolit blev AUC forøget med 27 %, mens Cmax igen var uændret.
For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 27% while Cmax was again unchanged.
Der er ikke gennemført et formelt studie af nedsat nyrefunktion for enzalutamid.
No formal renal impairment study for enzalutamide has been completed.
Studier med drægtige rotter har vist, at enzalutamid og/eller dets metabolitter overføres til fostre.
Studies in pregnant rats have shown that enzalutamide and/or its metabolites are transferred to fetuses.
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.
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.
Hazard ratio (95 % KI)2
Hazard ratio (95% CI)2
Hypromellose acetat succinat Mikrokrystalinsk cellulose Kolloid, vandfri silica Croscarmellosenatrium Magnesiumstearat
Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate
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).
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).
Enzalutamid er en potent hæmmer af androgenreceptorsignalering, der blokerer flere trin i androgenreceptorsignaleringssystemet.
Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway.
Hver karton indeholder 112 tabletter i 4 blistertegnebøger a 28 tabletter hver.
Each carton contains 112 tablets in 4 blister wallets of 28 tablets each.
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.
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.
Enzyminduktion
Enzyme induction
PSA respons var 23,2 % (95 % KI: 13,9, 34,9).
PSA Response was 23.2% (95% CI: 13.9, 34.9).
• Hypnotika (f.eks. diazepam, midazolam, zolpidem)
• Hypnotics (e.g. diazepam, midazolam, zolpidem)
De demografiske kendetegn, samt kendetegnene ved baseline, var velafbalanceret mellem de to behandlingsarme.
The demographic and baseline characteristics were well-balanced between the two treatment arms.
DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Xtandi findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
MDV3100-14 (PROSPER)-studiet (patienter med ikke-metastatisk CRPC)
MDV3100-14 (PROSPER) study (patients with non-metastatic CRPC)
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.
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.
Hvis patienterne samtidig skal have administreret en kraftig CYP2C8-hæmmer, bør dosis af enzalutamid reduceres til 80 mg én gang dagligt.
If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily.
N-desmethyl-enzalutamid (aktivt) og et carboxylsyrederivat (inaktivt).
There are two major metabolites in human plasma: N-desmethyl enzalutamide (active) and a carboxylic acid derivative (inactive).
9785-CL-0222 (TERRAIN)-studiet (kemoterapi-naive patienter med metastatisk CRPC)
9785-CL-0222 (TERRAIN) study (chemotherapy-naïve patients with metastatic CRPC)
• Thyroideamidler (f.eks. levothyroxin)
• Thyroid agents (e.g. levothyroxine)
P-værdien er baseret på en stratificeret log-rank test ved PSA-fordoblingstid (< 6 måneder, ≥ 6 måneder) og tidligere eller samtidig brug af et middel mod knogleskørhed (ja, nej).
P-value is based on a stratified log-rank test by PSA doubling time (< 6 months, ≥ 6 months) and prior or concurrent use of a bone targeting agent (yes, no).
Patienter med visceral sygdom, patienter med let til moderat hjerteinsufficiens i anamnesen (NYHA-klasse I eller II), og patienter, der tog lægemidler, der er forbundet med sænkning af krampetærsklen, blev inkluderet.
Patients with visceral disease, patients with a history of mild to moderate heart failure (NYHA Class I or II), and patients taking medicinal products associated with lowering the seizure threshold were allowed.
Følgende patientdemografi og sygdomskarakteristika ved baseline var afbalanceret mellem behandlingsarmene.
The following patient demographics and baseline disease characteristics were balanced between the treatment arms.
I et klinisk studie med patienter med metastatisk CRPC havde Xtandi (160 mg én gang dagligt) ingen klinisk relevant effekt på farmakokinetikken af intravenøst administreret docetaxel
In a clinical study in patients with metastatic CRPC, Xtandi (160 mg once daily) had no clinically relevant effect on the pharmacokinetics of intravenously administered docetaxel (75 mg/m2 by infusion every 3 weeks).
Hazard ratio var 0,24 (95 % KI: 0,14, 0,42) og mediantiden til en PFS-hændelse blev ikke nået i enzalutamidgruppen, mod 8,6 måneder i bicalutamidgruppen.
The hazard ratio was 0.24 (95% CI: 0.14, 0.42) and the median time to a PFS event was not reached in the enzalutamide group versus 8.6 months in the bicalutamide group.
Hjælpestof, som behandleren skal være opmærksom på Hver blød kapsel indeholder 57,8 mg sorbitol.
Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol.
Tabletkerne: Hypromellose acetat succinat, mikrokrystalinsk cellulose, kolloid, vandfri silica, croscarmellosenatrium, magnesiumstearat.
• Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate.
For de 69 patienter, der tidligere modtog kemoterapi, var median rPFS 7,9 måneder (95 % KI: 5,5, 10,8).
For the 69 patients who previously received chemotherapy, median rPFS was 7.9 months (95% CI: 5.5, 10.8).
Samtidig administration af enzalutamid (160 mg én gang dagligt) og orale enkeltdoser af følsomme CYP-substrater hos prostatacancerpatienter resulterede i en 86 % mindskning af AUC for midazolam (CYP3A4-substrat), en 56 % mindskning af AUC for S-warfarin (CYP2C9substrat) og en 70 % mindskning af AUC for omeprazol (CYP2C19-substrat).
Co-administration of enzalutamide (160 mg once daily) with single oral doses of sensitive CYP substrates in prostate cancer patients resulted in an 86% decrease in the AUC of midazolam (CYP3A4 substrate), a 56% decrease in the AUC of S-warfarin (CYP2C9 substrate), and a 70% decrease in the AUC of omeprazole (CYP2C19 substrate).
Brug af anden medicin sammen med Xtandi
Other medicines and Xtandi
Iskæmisk hjertesygdom
Ischemic Heart Disease
Der forekom krampeanfald hos 0,4 % af de enzalutamidbehandlede patienter, hos 0,1 % af patienterne i placebogruppen og hos 0,3 % af de bicalutamidbehandlede patienter.
Seizure occurred in 0.4% of enzalutamide-treated patients, 0.1% of placebo-treated patients and 0.3% in bicalutamide-treated patients.
For summen af ubundet enzalutamid plus den ubundne aktive metabolit blev AUC forøget med 77 %, mens Cmax faldt med 19 %.
For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 77% while Cmax decreased by 19%.
Der har været sjældne rapporter om posteriort reversibelt encefalopati-syndrom (PRES) hos patienter, der får Xtandi (se pkt.
There have been rare reports of posterior reversible encephalopathy syndrome (PRES) in patients receiving Xtandi (see section 4.8).
Hver æske indeholder 56 filmovertrukne tabletter (4 tegnebøger).
Each carton contains 56 film-coated tablets (4 wallets).
Enzalutamid og/eller dets metabolitter udskilles i mælken hos rotter (se pkt.
Enzalutamide and/or its metabolites are secreted in rat milk (see section 5.3).
Efter en oral enkeltdosis på 160 mg enzalutamid steg AUC og Cmax for enzalutamid hos forsøgspersoner med let nedsat leverfunktion med henholdsvis 5 % og 24 %, AUC for enzalutamid hos forsøgspersoner med moderat nedsat leverfunktion steg med 29 % og Cmax faldt med 11 %, og AUC og Cmax for enzalutamid hos forsøgspersoner med svært nedsat leverfunktion henholdsvis øgedes med 5 % og faldt med 41 %, sammenlignet med raske forsøgspersoner.
Following a single oral 160 mg dose of enzalutamide, the AUC and Cmax for enzalutamide in subjects with mild impairment increased by 5% and 24%, respectively, the AUC and Cmax of enzalutamide in subjects with moderate impairment increased by 29% and decreased by 11%, respectively, and the AUC and Cmax of enzalutamide in subjects with severe impairment increased by 5% and decreased by 41%, respectively, compared to healthy control subjects.
I den ikke-metastatiske undergruppe (N = 139) havde i alt 19 ud af 70 (27,1 %) patienter behandlet med enzalutamid og 49 ud af 69 (71 %) patienter behandlet med bicalutamid, PFS-hændelser (til sammen 68 hændelser).
For the non-metastatic subgroup (N = 139) a total of 19 out of 70 (27.1%) patients treated with enzalutamide and 49 out of 69 (71.0%) patients treated with bicalutamide had PFS events (68 total events).
Patienter med krampeanfald i anamnesen, en sygdom som kan prædisponere dem for krampeanfald eller visse tidligere behandlinger for prostatacancer (dvs. kemoterapi, ketoconazol, abirateronacetat, aminoglutetimid og/eller enzalutamid) blev ekskluderet.
Patients were excluded with a previous history of seizure, a condition that might predispose them to seizure, or certain prior treatments for prostate cancer (i.e., chemotherapy, ketoconazole, abiraterone acetate, aminoglutethimide and/or enzalutamide).
STRIVE-studiet inkluderede 396 ikke-metastatiske eller metastatiske CRPC patienter som havde serologisk eller radiografisk sygdomsprogression til trods for primær androgen deprivationsbehandling, som blev randomiseret til at modtage enten enzalutamid i en dosis på 160 mg én gang dagligt (N = 198) eller bicalutamid i en dosis på 50 mg én gang dagligt (N = 198).
The STRIVE study enrolled 396 non-metastatic or metastatic CRPC patients who had serologic or radiographic disease progression despite primary androgen deprivation therapy who were randomised to receive either enzalutamide at a dose of 160 mg once daily (N = 198) or bicalutamide at a dose of 50 mg once daily (N = 198).
Tabel 4: Samlet overlevelse for patienter behandlet med enten enzalutamid eller placebo i AFFIRM-studiet (intent-to-treat-analyse)
Table 4: Overall survival of patients treated with either enzalutamide or placebo in the AFFIRM study (intent-to-treat analysis)
For de 145 patienter, der ikke tidligere havde modtaget kemoterapi, var median rPFS 8,1 måneder (95 % KI: 5,7, 8,3).
For the 145 patients who had no previous chemotherapy, median rPFS was 8.1 months (95% CI: 5.7, 8.3).
medicin, som anvendes til behandling af visse psykiatriske lidelser, som f.eks. depression og skizofreni (f.eks. clozapin, olanzapin, risperidon, ziprasidon, bupropion, lithium, chlorpromazin, mesoridazin, thioridazin, amitriptylin, desipramin, doxepin, imipramin, maprotilin, mirtazapin).
- Medicines used to treat certain psychiatric disorders such as depression and schizophrenia (e.g. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
Hver karton indeholder 112 bløde kapsler i 4 blistertegnebøger a 28 bløde kapsler hver.
- Each carton contains 112 soft capsules in 4 blister wallets of 28 soft capsules each.
Der er rapporteret om sjældne tilfælde af posteriort reversibelt encefalopati-syndrom hos enzalutamidbehandlede patienter (se pkt.
Rare cases of posterior reversible encephalopathy syndrome have been reported in enzalutamidetreated patients (see section 4.4).
• Immunsuppressiva (f.eks. tacrolimus)
• Immunosuppressant (e.g. tacrolimus)
Er du i tvivl, så spørg lægen.
- If you have any further questions, ask your doctor.
Eftersom androgen deprivationsterapi kan forlænge QT-intervallet, skal brug af Xtandi sammen med lægemidler, som er kendt for at forlænge QT-intervallet, eller lægemidler, som kan inducere torsades de pointes, såsom antiarytmika af klasse IA (f.eks. kinidin, disopyramid) eller klasse III (f.eks. amiodaron, sotalol, dofetilid, ibutilid), methadon, moxifloxacin, antipsykotika osv. vurderes nøje (se pkt.
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Xtandi with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).
Det må ikke tages af gravide, kvinder i den fødedygtige alder eller kvinder, der ammer.
It must not be taken by women who are pregnant, may become pregnant, or who are breast-feeding.
68 % af patienterne havde en ECOG-funktionsscore på 0, og 32 % af patienterne havde en ECOG-funktionsscore på 1.
Sixty-eight percent (68%) of patients had an ECOG performance status score of 0 and 32% patients had an ECOG performance status of 1.
Danmark Astellas Pharma a/s Tlf.: + 45 4343 0355
Astellas Pharma a/s Tlf: + 45 43 430355
Eksponeringsniveauerne opnået i dette studie hos hanrotter i uge 26 ved 100 mg/kg/day for enzalutamid plus dets aktive metabolitter M1 og M2 (AUC24: enzalutamid ~ 457 µg·t/ml, M1 ~ 321 µg·t/ml, M2 ~ 35 µg·t/ml) var mindre end eller tilsvarende niveauerne hos patienter med prostatacancer ved den anbefalede dosis (160 mg/dag) af enzalutamid (AUC24: enzalutamid ~ 322 µg·t/ml, M1 ~ 193 µg·t/ml, M2 ~ 278 µg·t/ml).
The exposure levels achieved in this study in male rats at Week 26 at 100 mg/kg per day for enzalutamide plus its active metabolites M1 and M2 (AUC24: enzalutamide ~457 µg·h/mL, M1 ~321 µg·h/mL, M2 ~35 µg·h/mL) were less than or similar to those in prostate cancer patients at the recommended dose (160 mg/day) of enzalutamide (AUC24: enzalutamide ~322 µg·h/mL, M1 ~193 µg·h/mL, M2 ~278 µg·h/mL).
• Tromboseforebyggende midler (f.eks. acenocoumarol, warfarin, clopidogrel)
• Antithrombotics (e.g. acenocoumarol, warfarin, clopidogrel)
Efter oral administration af radioaktivt mærket 14C-enzalutamid til diegivende rotter, i en dosis på 30 mg/kg (~ 1,9 gange den maksimale dosis rekommanderet til mennesker), blev den maksimale radioaktivitet i mælken nået 4 timer efter administration og var op til 3,54 gange højere end i moderens plasma.
After oral administration of radiolabeled 14C-enzalutamide to lactating rats at a dose of 30 mg/kg (~ 1.9 times the maximum dose indicated in humans), the maximum radioactivity in the milk was reached 4 hours after administration and was up to 3.54-fold higher than that in the maternal plasma.
CYP2C8- og CYP3A4-induktorer
CYP2C8 and CYP3A4 inducers
Hver æske indeholder 4 tegnebøger (112 bløde kapsler).
Each carton contains 4 wallets (112 soft capsules).
Tabel 3: Samlet overlevelse hos patienter behandlet med enten enzalutamid eller placebo i PREVAIL-studiet (intent-to-treat-analyse)
Table 3: Overall survival of patients treated with either enzalutamide or placebo in the PREVAIL study (intent-to-treat analysis)
Xtandi - 40 mg bløde kapsler
Xtandi - 40 mg soft capsules
Filmovertræk: Hypromellose, talkum, macrogol 8000, titandioxid (E 171), gul jernoxid (E 172).
• Tablet coating: Hypromellose, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172).
Risiko for krampeanfald
Risk of seizure
Indholdsstoffer i blækket er jernoxidsort (E 172) og polyvinylacetatphthalat.
- The ingredients of the ink are iron oxide black (E172) and polyvinyl acetate phthalate.