FrancophonIA/ELRC3.0 huggingface dataset:
English: 9785-CL-0222 (TERRAIN) study (chemotherapy-naïve patients with metastatic CRPC)
Danish: 9785-CL-0222 (TERRAIN)-studiet (kemoterapi-naive patienter med metastatisk CRPC)
English: • Thyroid agents (e.g. levothyroxine)
Danish: • Thyroideamidler (f.eks. levothyroxin)
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: The following patient demographics and baseline disease characteristics were balanced between the treatment arms.
Danish: Følgende patientdemografi og sygdomskarakteristika ved baseline var afbalanceret mellem behandlingsarmene.
English: 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).
Danish: 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
English: 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.
Danish: 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.
English: Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver blød kapsel indeholder 57,8 mg sorbitol.
English: • Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate.
Danish: Tabletkerne: Hypromellose acetat succinat, mikrokrystalinsk cellulose, kolloid, vandfri silica, croscarmellosenatrium, magnesiumstearat.
English: For the 69 patients who previously received chemotherapy, median rPFS was 7.9 months (95% CI: 5.5, 10.8).
Danish: For de 69 patienter, der tidligere modtog kemoterapi, var median rPFS 7,9 måneder (95 % KI: 5,5, 10,8).
English: 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).
Danish: 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).
English: Other medicines and Xtandi
Danish: Brug af anden medicin sammen med Xtandi
English: Ischemic Heart Disease
Danish: Iskæmisk hjertesygdom
English: Astellas Pharma B.V.Branch Belgique/Belgien Tél/Tel: + 32 (0)2 5580710
Danish: Luxembourg/Luxemburg Astellas Pharma B.V.Branch Belgique/Belgien Tél/Tel: + 32 (0)2 5580710
English: Seizure occurred in 0.4% of enzalutamide-treated patients, 0.1% of placebo-treated patients and 0.3% in bicalutamide-treated patients.
Danish: 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.
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 77% while Cmax decreased by 19%.
Danish: For summen af ubundet enzalutamid plus den ubundne aktive metabolit blev AUC forøget med 77 %, mens Cmax faldt med 19 %.
English: There have been rare reports of posterior reversible encephalopathy syndrome (PRES) in patients receiving Xtandi (see section 4.8).
Danish: Der har været sjældne rapporter om posteriort reversibelt encefalopati-syndrom (PRES) hos patienter, der får Xtandi (se pkt.
English: Each carton contains 56 film-coated tablets (4 wallets).
Danish: Hver æske indeholder 56 filmovertrukne tabletter (4 tegnebøger).
English: Enzalutamide and/or its metabolites are secreted in rat milk (see section 5.3).
Danish: Enzalutamid og/eller dets metabolitter udskilles i mælken hos rotter (se pkt.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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).
Danish: 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.
English: 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).
Danish: 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).
English: Table 4: Overall survival of patients treated with either enzalutamide or placebo in the AFFIRM study (intent-to-treat analysis)
Danish: Tabel 4: Samlet overlevelse for patienter behandlet med enten enzalutamid eller placebo i AFFIRM-studiet (intent-to-treat-analyse)
English: For the 145 patients who had no previous chemotherapy, median rPFS was 8.1 months (95% CI: 5.7, 8.3).
Danish: For de 145 patienter, der ikke tidligere havde modtaget kemoterapi, var median rPFS 8,1 måneder (95 % KI: 5,7, 8,3).
English: - 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).
Danish: 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).
English: - Each carton contains 112 soft capsules in 4 blister wallets of 28 soft capsules each.
Danish: Hver karton indeholder 112 bløde kapsler i 4 blistertegnebøger a 28 bløde kapsler hver.
English: Rare cases of posterior reversible encephalopathy syndrome have been reported in enzalutamidetreated patients (see section 4.4).
Danish: Der er rapporteret om sjældne tilfælde af posteriort reversibelt encefalopati-syndrom hos enzalutamidbehandlede patienter (se pkt.
English: Astellas Pharma Kft. Tel.: + 36 1 577 8200
Danish: Magyarország Astellas Pharma Kft. Tel.: +36 1 577 8200
English: • Immunosuppressant (e.g. tacrolimus)
Danish: • Immunsuppressiva (f.eks. tacrolimus)
English: - If you have any further questions, ask your doctor.
Danish: Er du i tvivl, så spørg lægen.
English: 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).
Danish: 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.
English: It must not be taken by women who are pregnant, may become pregnant, or who are breast-feeding.
Danish: Det må ikke tages af gravide, kvinder i den fødedygtige alder eller kvinder, der ammer.
English: Sixty-eight percent (68%) of patients had an ECOG performance status score of 0 and 32% patients had an ECOG performance status of 1.
Danish: 68 % af patienterne havde en ECOG-funktionsscore på 0, og 32 % af patienterne havde en ECOG-funktionsscore på 1.
English: Busuttil Ltd. Tel: +356 21 447184
Danish: E.J. Busuttil Ltd. Tel: + 356 21 447184
English: Astellas Pharma a/s Tlf: + 45 43 430355
Danish: Danmark Astellas Pharma a/s Tlf.: + 45 4343 0355
English: 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).
Danish: 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).
English: • Antithrombotics (e.g. acenocoumarol, warfarin, clopidogrel)
Danish: • Tromboseforebyggende midler (f.eks. acenocoumarol, warfarin, clopidogrel)
English: 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.
Danish: 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.
English: CYP2C8 and CYP3A4 inducers
Danish: CYP2C8- og CYP3A4-induktorer
English: Each carton contains 4 wallets (112 soft capsules).
Danish: Hver æske indeholder 4 tegnebøger (112 bløde kapsler).
English: Table 3: Overall survival of patients treated with either enzalutamide or placebo in the PREVAIL study (intent-to-treat analysis)
Danish: Tabel 3: Samlet overlevelse hos patienter behandlet med enten enzalutamid eller placebo i PREVAIL-studiet (intent-to-treat-analyse)
English: Xtandi - 40 mg soft capsules
Danish: Xtandi - 40 mg bløde kapsler
English: • Tablet coating: Hypromellose, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172).
Danish: Filmovertræk: Hypromellose, talkum, macrogol 8000, titandioxid (E 171), gul jernoxid (E 172).
English: Risk of seizure
Danish: Risiko for krampeanfald
English: - The ingredients of the ink are iron oxide black (E172) and polyvinyl acetate phthalate.
Danish: Indholdsstoffer i blækket er jernoxidsort (E 172) og polyvinylacetatphthalat.
English: Patients were randomised 2:1 to receive either enzalutamide at a dose of 160 mg once daily (N = 933) or placebo (N = 468).
Danish: Patienterne blev randomiseret 2:1 til at modtage enten enzalutamid i en dosis på 160 mg én gang dagligt (N = 933) eller placebo (N = 468).
English: In a 6month study in transgenic rasH2 mice, enzalutamide did not show carcinogenic potential (absence of neoplastic findings) at doses up to 20 mg/kg per day (AUC24h ~317 µg•h/mL), which resulted in plasma exposure levels similar to the clinical exposure (AUC24h 322 µg•h/mL) in mCRPC patients receiving 160 mg, daily.
Danish: I et 6måneders studie på transgene rasH2-mus viste enzalutamid ikke karsinogent potentiale (fravær af neoplastiske fund) ved doser op til 20 mg/kg/dag (AUC24t ~ 317 µg·t/ml, hvilket resulterede i eksponeringsniveauer i plasma svarende til den kliniske eksponering (AUC24t ~ 322 µg·t/ml) hos mCRPC-patienter, der fik 160 mg daglig.
English: The effect of enzalutamide on P-gp substrates has not been evaluated in vivo; however, under conditions of clinical use, enzalutamide may be an inducer of P-gp via activation of the nuclear pregnane receptor (PXR).
Danish: Under kliniske anvendelsesbetingelser kan enzalutamid imidlertid være induktor af P-gp via aktivering af den nukleære pregnanreceptor (PXR).
English: Posterior reversible encephalopathy syndrome (PRES) There have been rare reports of PRES, a rare, reversible condition involving the brain, in patients treated with Xtandi.
Danish: Posteriort reversibelt encefalopati-syndrom (PRES) Der har været sjældne rapporter om patienter i behandling med Xtandi, som har fået PRES, en sjælden, reversibel sygdom, der rammer hjernen.
English: Enzalutamide significantly decreased the risk of the first skeletal-related event by 28% [HR = 0.718 (95% CI: 0.61, 0.84), p < 0.0001].
Danish: Enzalutamid reducerede signifikant risikoen for første skeletrelaterede hændelse med 28 % [HR = 0,718 (95 % KI: 0,61, 0,84), p < 0,0001].
English: • HIV antivirals (e.g. indinavir, ritonavir)
Danish: • Antivirale midler mod HIV (f.eks. indinavir, ritonavir)
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig for patienter med let eller moderat nedsat nyrefunktion (se pkt.
English: No dose adjustment is necessary when Xtandi is coadministered with inducers of CYP2C8 or CYP3A4.
Danish: Det er ikke nødvendigt med dosisjustering, når Xtandi administreres samtidig med induktorer af CYP2C8 eller CYP3A4.
English: P-value is derived from a log rank test stratified by ECOG performance status score (0-1 vs. 2) and mean pain score
Danish: P-værdien er baseret på en log-rank-test stratificeret efter ECOG-funktionsscore (0-1 ift.
English: Vistor hf Sími: + 354 535 7000
Danish: Sími: + 354 535 7000
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det (de) aktive stof(fer) eller over for et eller flere af hjælpestofferne anført i pkt.
English: Xtandi has moderate influence on the ability to drive and use machines as psychiatric and neurologic events including seizure have been reported (see section 4.8).
Danish: Xtandi påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner, da der er indberettet psykiatriske og neurologiske hændelser, herunder krampeanfald (se pkt.
English: • Betablockers (e.g. bisoprolol, propranolol)
Danish: • Betablokkere (f.eks. bisoprolol, propranolol)
English: If you have a seizure, see your doctor as soon as possible.
Danish: Hvis du får et krampeanfald, skal du kontakte lægen hurtigst muligt.
English: Elderly No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig for ældre patienter (se pkt.
English: The usual dose is 160 mg (four 40 mg film-coated tablets or two 80 mg film-coated tablets), taken at the same time once a day.
Danish: Den sædvanlige dosis er 160 mg (fire 40 mg filmovertrukne tabletter eller to 80 mg filmovertrukne tabletter), som tages på samme tidspunkt én gang dagligt.
English: 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.
Danish: Patienter med let til moderat hjertesvigt (NYHA-klasse I eller II) i anamnesen, og patienter som tog lægemidler forbundet med sænkning af krampetærsklen blev inkluderet.
English: At the pre-specified interim analysis for overall survival when 540 deaths were observed, treatment with enzalutamide demonstrated a statistically significant improvement in overall survival compared to treatment with placebo with a 29.4% reduction in risk of death [HR = 0.706 (95% CI: 0.60; 0.84), p < 0.0001].
Danish: Ved den forudspecificerede interimanalyse for samlet overlevelse, da 540 dødsfald var observeret, viste behandling med enzalutamid en statistisk signifikant forbedring i samlet overlevelse sammenlignet med placebo med en 29,4 % reduktion i risiko for død [HR = 0,706 (95 % KI: 0,60, 0,84), p < 0,0001].
English: After oral administration of radiolabeled 14C-enzalutamide to rats on day 14 of pregnancy at a dose of 30 mg/kg (~ 1.9 times the maximum dose indicated in humans), the maximum radioactivity in the fetus was reached 4 hours after administration and was lower than that in the maternal plasma with tissue/plasma ratio of 0.27.
Danish: Efter oral administration af radioaktivt mærket 14C-enzalutamid til rotter på dag 14 af drægtigheden, i en dosis på 30 mg/kg (~ 1,9 gange den maksimale dosis rekommanderet til mennesker), blev den maksimale radioaktivitet i fosteret nået 4 timer efter administration og var lavere end i moderens plasma med et væv/plasma-forhold på 0,27.
English: Astellas Pharma GmbH Tel: + 49 (0)89 454401
Danish: Deutschland Astellas Pharma GmbH Tel: + 49 (0)89 454401
English: Common: fall
Danish: Almindelig: Gynækomasti
English: Caution is advised in patients with severe renal impairment or end-stage renal disease (see section 4.4).
Danish: Der tilrådes forsigtighed hos patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (se pkt.
English: The TERRAIN study enrolled 375 chemo- and antiandrogen-therapy naïve patients with metastatic CRPC who were randomised to receive either enzalutamide at a dose of 160 mg once daily (N = 184) or bicalutamide at a dose of 50 mg once daily (N = 191).
Danish: TERRAIN studiet indrullerede 375 kemo- og antiandrogen-terapi-naive patienter med metastatisk CRPC, som blev randomiseret til at få enten 160 mg enzalutamid én gang dagligt (N = 184) eller bicalutamid 50 mg én gang dagligt (N = 191).
English: The recommended dose is 160 mg enzalutamide (four 40 mg film-coated tablets or two 80 mg film-coated tablets) as a single oral daily dose.
Danish: Den anbefalede dosering er 160 mg enzalutamid (fire 40 mg filmovertrukne tabletter eller to 80 mg filmovertrukne tabletter) som en daglig oral enkeltdosis.
English: Enzalutamide is contraindicated in women who are or may become pregnant (see sections 4.3, 5.3, and 6.6).
Danish: Enzalutamid er kontraindiceret hos kvinder, som er eller kan blive gravide (se pkt.
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 Xtandi.
Danish: Androgen deprivationsterapi kan forlænge QT-intervallet Hos patienter med anamnese med eller risikofaktorer for QT-forlængelse og hos patienter, der samtidig får lægemidler, der kan forlænge QT-intervallet (se pkt.
English: A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain.
Danish: En skeletrelateret hændelse blev defineret som strålebehandling af knogler eller knoglekirurgi som følge af prostatacancer, patologisk knoglefraktur, rygmarvskompression eller ændring af antineoplastisk behandling for at behandle knoglesmerter.
English: Astellas Pharma s.r.o., Tel: +421 2 4444 2157
Danish: Slovenská republika Astellas Pharma s.r.o., Tel: + 421 2 4444 2157
English: Studies in lactating rats have shown that enzalutamide and/or its metabolites are secreted in rat milk.
Danish: Studier med diegivende rotter har vist, at enzalutamid og/eller dets metabolitter udskilles i mælken hos rotter.
English: Figure 2: Kaplan-Meier curves of time to first use of new antineoplastic therapy in the PROSPER study (intent-to-treat analysis)
Danish: Figur 2: Kaplan-Meier-kurver for tid til første brug af ny antineoplastisk behandling i PROSPER-studiet (intent-to-treat-analyse)
English: The steady-state Cmin values of enzalutamide and the active metabolite in individual patients remained constant during more than one year of chronic therapy, demonstrating time-linear pharmacokinetics once steady-state is achieved.
Danish: Der er ikke observeret væsentlige afvigelser fra dosisproportionalitet over dosisintervallet 40 til 160 mg. Cmin-værdierne for enzalutamid og dets aktive metabolit hos individuelle patienter ved steadystate forblev konstante gennem mere end et års kronisk behandling, hvilket viser, at der er tidslineær farmakokinetik, når steady-state er opnået.
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 soft capsules.
Danish: Paptegnebog indeholdende en PVC/PCTFE/aluminium-blister med 28 bløde kapsler.
English: If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily (see section 4.2).
Danish: Hvis patienterne samtidig skal have administreret en kraftig CYP2C8-hæmmer, bør dosis af enzalutamid reduceres til 80 mg én gang dagligt (se pkt.
English: Macrogol (8000) Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Macrogol (8000) Titandioxid (E 171) Jernoxid gul (E 172)
English: A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change of antineoplastic therapy to treat bone pain.
Danish: En skeletrelateret hændelse blev defineret som strålebehandling af knogler eller knoglekirurgi, patologisk knoglefraktur, rygmarvskompression eller ændring af antineoplastisk behandling med henblik på behandling af knoglesmerter.
English: No dose adjustment is necessary when Xtandi is co-administered with inhibitors of CYP3A4.
Danish: Dosisjustering er ikke nødvendig, når Xtandi administreres samtidig med hæmmere af CYP3A4.