FrancophonIA/ELRC3.0 huggingface dataset:
English: A gradual dose reduction of the concomitant medicinal product may be necessary when stopping enzalutamide treatment.
Danish: En gradvis dosisreduktion af samtidige lægemidler kan være nødvendig, når behandlingen med enzalutamid afbrydes.
English: Keep a list of them with you to show to your doctor when you are prescribed a new medicine.
Danish: Medbring en liste over den medicin, du tager, og vis den til lægen, når du får udskrevet ny medicin.
English: Median OS was not reached.
Danish: Median samlet overlevelse (OS) blev ikke nået.
English: CYP3A4 plays a minor role in the metabolism of enzalutamide.
Danish: CYP3A4 spiller en mindre rolle i metabolismen af enzalutamid.
English: Table 2: Summary of efficacy results in the PROSPER study (intent-to-treat analysis) Enzalutamide N = 933
Danish: Tabel 2: Resumé af effektresultater i PROSPER-studiet (intent-to-treat-analyse) Enzalutamid N = 933
English: Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
Danish: Behandling med enzalutamid skal initieres og overvåges af speciallæger med erfaring i medicinsk behandling af prostatacancer.
English: Enzalutamide was negative for genotoxicity in a standard battery of in vitro and in vivo tests.
Danish: Enzalutamid var negativ for genotoksicitet i et standardbatteri af in vitro- og in vivo-tests.
English: Uncommon (may affect up to 1 in 100 people) Hallucinations, difficulty thinking clearly, low white blood cell count
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) Hallucinationer, besvær med at tænke klart, lavt antal hvide blodlegemer
English: Patients were required to have a PSA doubling time ≤ 10 months, PSA ≥ 2 ng/mL, and confirmation of non-metastatic disease by blinded independent central review (BICR).
Danish: Patienterne skulle have en PSA-fordoblingstid på ≤ 10 måneder, PSA ≥ 2 ng / mL og bekræftelse af ikke-metastatisk sygdom ved blindet uafhængig central evaluering (Blinded Independent Central Review, BICR).
English: The risk of heart rhythm problems may be increased when using Xtandi.
Danish: Risikoen for problemer med hjerterytmen kan blive større, hvis du tager Xtandi.
English: This medicine is not for use in children and adolescents.
Danish: Børn og unge Denne medicin er ikke beregnet til brug af børn og unge.
English: Very common (may affect more than 1 in 10 people) Tiredness, broken bones, hot flushes, high blood pressure
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Træthed, knoglebrud, hedestigninger, højt blodtryk
English: Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression.
Danish: Enzalutamidbehandling nedsætter væksten af prostatacancerceller og kan inducere cancercelledød og tumorregression.
English: Xtandi is used to treat adult men with prostate cancer that no longer responds to androgen deprivation therapy.
Danish: Xtandi anvendes til behandling af voksne mænd med prostatakræft, som ikke længere responderer på androgen deprivationsbehandling.
English: Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.
Danish: Medicinsk kastration med en luteiniserende hormonfrigivende hormon (LHRH)-analog bør fortsættes ved behandling af patienter, som ikke har undergået kirurgisk kastration.
English: Enzalutamide treatment of pregnant mice resulted in an increased incidence of embryo-fetal deaths and external and skeletal changes.
Danish: Enzalutamidbehandling af drægtige mus resulterede i en øget forekomst af enbryoføtal død og ydre og skeletale forandringer.
English: The mean apparent volume of distribution (V/F) of enzalutamide in patients after a single oral dose is 110 L (29% CV).
Danish: Det gennemsnitlige tilsyneladende distributionsvolumen (V/F) for enzalutamid hos patienter efter en oral enkeltdosis er 110 l (29 % CV).
English: In the controlled clinical studies, patients with prior seizure or risk factors for seizure were excluded.
Danish: I de kontrollerede kliniske studier blev patienter med tidligere krampeanfald eller risikofaktorer for krampeanfald udelukket.
English: Food has no clinically significant effect on the extent of absorption.
Danish: Mad har ingen klinisk signifikant virkning på graden af absorption.
English: Clearance of enzalutamide is primarily via hepatic metabolism, producing an active metabolite that is equally as active as enzalutamide and circulates at approximately the same plasma concentration as enzalutamide.
Danish: Clearance af enzalutamid sker primært via hepatisk metabolisme, hvorved der produceres en aktiv metabolit, der er lige så aktiv som enzalutamid og cirkulerer i ca. samme plasmakoncentration som enzalutamid.
English: Daily dosing of rats for two years with enzalutamide at 10-100 mg/kg/day produced an increased incidence of several, mostly benign, tumour types.
Danish: Daglig dosering med enzalutamid på 10-100 mg/kg/dag hos rotter i 2 år førte til øget forekomst af flere, hovedsagelig benigne, tumortyper.
English: • Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)
Danish: • Statiner, som metaboliseres af CYP3A4 (f.eks. atorvastatin, simvastatin)
English: Potential for enzalutamide to affect exposures to other medicinal products
Danish: Enzalutamids potentiale til at påvirke eksponeringerne for andre lægemidler
English: It is unlikely that enzalutamide will be significantly removed by intermittent haemodialysis or continuous ambulatory peritoneal dialysis.
Danish: Det er usandsynligt, at enzalutamid vil blive fjernet i væsentlig grad ved intermitterende hæmodialyse eller kontinuerlig ambulatorisk peritonealdialyse.
English: In vitro, N-desmethyl enzalutamide is metabolised to the carboxylic acid metabolite by carboxylesterase 1, which also plays a minor role in the metabolism of enzalutamide to the carboxylic acid metabolite.
Danish: In vitro metaboliseres N-desmethyl-enzalutamid til carboxylsyremetabolitten af carboxylesterase 1, som også spiller en mindre rolle i metaboliseringen af enzalutamid til carboxylsyremetabolitten.
English: Patients were allowed but not required to take prednisone (maximum daily dose allowed was 10 mg prednisone or equivalent).
Danish: Det var tilladt, men ikke påkrævet for patienterne at tage prednison (den maksimalt tilladte daglige dosis var 10 mg prednison eller ækvivalent).
English: Key secondary endpoints assessed in the study were time to PSA progression, time to first use of new antineoplastic therapy (TTA), overall survival (OS).
Danish: De vigtigste sekundære endepunkter vurderet i studiet var tid til PSA progression, tid til første brug af ny antineoplastisk behandling (TTA), samlet overlevelse (OS).
English: - If you forget to take Xtandi for more than one day, talk to your doctor immediately.
Danish: Hvis du har glemt at tage Xtandi i mere end en dag, skal du straks kontakte lægen.
English: BCRP, MRP2, OAT3 and OCT1 substrates
Danish: BCRP-, MRP2-, OAT3- og OCT1-substrater
English: Patients may be at increased risk of seizures following an overdose.
Danish: Patienterne kan have en øget risiko for at få krampeanfald efter overdosering.
English: Concomitant use with other medicinal products
Danish: Samtidig anvendelse af andre lægemidler
English: The dose of Xtandi or any other medicines that you are taking may need to be changed.
Danish: Det kan være nødvendigt at ændre dosis af Xtandi eller anden medicin, du tager.
English: At the updated analysis 52% of enzalutamide-treated and 81% of placebo-treated patients had received subsequent therapies for metastatic CRPC that may prolong overall survival.
Danish: Ved den opdaterede analyse havde 52 % af patienterne i enzalutamidgruppen og 81 % i placebogruppen fået efterfølgende behandling for metastatisk CRPC, der kan forlænge den samlede overlevelse.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Danish: 4.1 Terapeutiske indikationer
English: Very common: hot flush, hypertension
Danish: Meget almindelig: Hedestigning, hypertension
English: Stimulation of tumour cell growth via the androgen receptor requires nuclear localization and DNA binding.
Danish: Stimulering af tumorcellevækst via androgenreceptoren kræver kernelokalisering og DNA-binding.
English: Discontinuation of Xtandi in patients who develop PRES is recommended.
Danish: Det anbefales at seponere behandling med Xtandi til patienter, som udvikler PRES.
English: Enzalutamide was not phototoxic in vitro.
Danish: Enzalutamid var ikke fototoksisk in vitro.
English: Dose appears to be an important predictor of the risk of seizure, as reflected by preclinical data, and data from a dose-escalation study.
Danish: Dosis synes at være en væsentlig indikator for risikoen for krampeanfald, som afspejlet i prækliniske data og data fra et dosistitreringsstudie.
English: If Xtandi 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).
Danish: Hvis Xtandi administreres samtidig med en antikoagulans, som metaboliseres af CYP2C9 (såsom warfarin eller acenocoumarol), bør der foretages supplerende International Normaliseret Ratio (INR)-monitorering (se pkt.
English: However, no obvious mechanistic rationale to explain specifically this malignancy can be established, and taking into account that exposure levels, based on AUC, achieved in the study, for enzalutamide plus its metabolites, were less than or similar to those in prostate cancer patients at the recommended dose of 160 mg/day, urinary bladder carcinogenicity potential of enzalutamide in humans cannot be excluded.
Danish: Ingen indlysende mekanistisk begrundelse, til specifikt at forklare denne malignitet, kan etableres, og under hensyntagen til at eksponeringsniveauerne opnået i studiet, baseret på AUC, for enzalutamid plus dets metabolitter var mindre end eller tilsvarende niveauerne hos patienter med prostatacancer ved den anbefalede dosis på 160 mg/dag, kan enzalutamids potentiale for urinblærecarcinogenicitet hos mennesker imidlertid ikke udelukkes.
English: Xtandi should not be handled by persons other than the patient and his caregivers, and especially not by women who are or may become pregnant.
Danish: Xtandi bør ikke håndteres af andre personer end patienten og hans omsorgspersoner, og især ikke af kvinder, der er eller kan blive gravid.
English: Based on a population pharmacokinetic analysis, no dose adjustment is necessary for patients with calculated creatinine clearance (CrCL) values ≥ 30 mL/min (estimated by the Cockcroft and Gault formula).
Danish: Baseret på en populationsfarmakokinetisk analyse er dosisjustering ikke nødvendig for patienter med beregnede kreatininclearance (CrCL)-værdier ≥30 ml/min (beregnet ved hjælp af Cockcroft-Gault-formlen).
English: The transport protein P-gp may also be induced, and probably other transporters as well, e.g. multidrug resistance-associated protein 2 (MRP2), breast cancer resistance protein (BCRP) and the organic anion transporting polypeptide 1B1 (OATP1B1).
Danish: Transportproteinet P-gp kan også være induceret og sandsynligvis også andre transportører, f.eks. multimedicinsk resistens-associeret protein 2 (MRP2), brystcancerresistent protein (BCRP) og det organiske aniontransporterende polypeptid 1B1 (OATP1B1).
English: The mechanism by which enzalutamide may lower the seizure threshold is not known, but could be related to data from in vitro studies showing that enzalutamide and its active metabolite bind to and can inhibit the activity of the GABA-gated chloride channel.
Danish: Mekanismen, hvormed enzalutamid kan sænke krampetærsklen, kendes ikke, men der er måske en forbindelse til de data fra in vitro-studier, der viser, at enzalutamid og dets aktive metabolit bindes til og kan hæmme aktiviteten af den GABA-styrede chloridkanal.
English: CYP2C8 plays an important role in the elimination of enzalutamide and in the formation of its active metabolite.
Danish: CYP2C8 spiller en væsentlig rolle i eliminationen af enzalutamid og i dannelsen af den aktive metabolit deraf.
English: This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant.
Danish: Dette lægemiddel kan forårsage skade på det ufødte barn eller muligvis abort, hvis det tages af gravide kvinder.
English: The mean terminal half-life (t1/2) for enzalutamide in patients after a single oral dose is 5.8 days (range 2.8 to 10.2 days), and steady state is achieved in approximately one month.
Danish: Den gennemsnitlige terminale halveringstid (t1/2) for enzalutamid hos patienter efter en oral enkeltdosis er 5,8 dage (interval 2,8 til 10,2 dage), og steady-state opnås inden for ca. en måned.
English: There is no relevant use of enzalutamide in the paediatric population in the indication of treatment of adult men with CRPC.
Danish: Der er ingen relevante indikationer for enzalutamid i den pædiatriske population, idet indikationen er behandling af voksne mænd med CRPC.
English: The solubility of enzalutamide is increased by caprylocaproyl macrogolglycerides as emulsifier/surfactant.
Danish: Opløseligheden af enzalutamid øges af caprylocapryolmacrogolglycerider som emulgator/overfladeaktivt stof.
English: In the active treatment arm, Xtandi was administered orally at a dose of 160 mg daily.
Danish: I den aktive behandlingsarm blev Xtandi administreret oralt med en dosis på 160 mg dagligt.
English: Please tell your doctor if you have any of the following:
Danish: Fortæl din læge, hvis du har noget af det følgende:
English: Based on these predictions, as well as other supportive data, the median time to reach maximum plasma enzalutamide concentrations (Cmax) is 2 hours (range 0.5 to 6 hours), and the steady-state pharmacokinetic profiles of enzalutamide and its active metabolite are similar for the film-coated tablets and the Xtandi soft capsules formulation.
Danish: Baseret på disse forudsigelser samt andre understøttende data er mediantiden for at opnå maksimal plasmakoncentration af enzalutamid (Cmax) 2 timer (i intervallet 0,5 til 6 timer), og de farmakokinetiske profiler for enxalutamid og dens aktive metabolit ved steady-state er ens for de filmovertrukne tabletter og Xtandi bløde kapsler.
English: Enzalutamide has not been evaluated in patients with severe renal impairment (CrCL < 30 mL/min) or end-stage renal disease, and caution is advised when treating these patients.
Danish: Enzalutamid er ikke evalueret hos patienter med svært nedsat nyrefunktion (CrCL <30 ml/min) eller nyresygdom i slutstadiet, og der tilrådes forsigtighed ved behandling af disse patienter.
English: Patients taking medicinal products that are substrates of CYP2B6, CYP3A4, CYP2C9, CYP2C19 or UGT1A1 should be evaluated for possible loss of pharmacological effects (or increase in effects in cases where active metabolites are formed) during the first month of enzalutamide treatment and dose adjustment should be considered as appropriate.
Danish: Patienter, som tager lægemidler, der er substrater for CYP2B6, CYP3A4, CYP2C9, CYP2C19 eller UGT1A1, bør evalueres for muligt tab af farmakologiske virkninger (eller øgede virkninger i de tilfælde, hvor der dannes aktive metabolitter) i den første måned med enzalutamid-behandling, og dosisjustering bør overvejes efter behov.
English: The half-life of enzalutamide was however doubled in patients with severe hepatic impairment compared with healthy controls (10.4 days compared to 4.7 days), possibly related to an increased tissue distribution.
Danish: Halveringstiden for enzalutamid blev imidlertid fordoblet hos patienter med svært nedsat leverfunktion i sammenligning med raske forsøgspersoner (10,4 dage sammenlignet med 4,7 dage), hvilket muligvis har sammenhæng med en øget vævsdistribution.
English: If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take Xtandi.
Danish: Hvis du er allergisk over for enzalutamid eller nogle af indholdsstofferne, må du ikke tage Xtandi.
English: Some urothelium papilloma and carcinoma of urinary bladder is expected in rats based on the horizontal structure of the rat urinary bladder, which can encounter concentrated urine and prolonged irritation from calculi.
Danish: Nogle uroteliale papillomer og karcinomer i urinblæren er forventet i rotter baseret på den horisontale struktur af rottens urinblære, som kan være udsat for koncentreret urin og langvarig irritation fra blæresten.
English: In addition to the observed improvement in overall survival, key secondary endpoints (PSA progression, radiographic progression-free survival, and time to first skeletal-related event) favoured enzalutamide and were statistically significant after adjusting for multiple testing.
Danish: Ud over den observerede forbedring i samlet overlevelse favoriserede centrale sekundære endepunkter (PSA-progression, radiografisk progressionsfri overlevelse og tid indtil første skeletrelaterede hændelse) enzalutamid, og de var desuden statistisk signifikante efter justering for multipel testning.
English: If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at the same or a reduced dose (120 mg or 80 mg) if warranted.
Danish: Hvis en patient oplever en toksicitet af grad 3 eller derover eller en uacceptabel bivirkning, skal doseringen pauseres i en uge, eller indtil symptomerne er mildnet til grad 2 eller derunder, og derpå genoptages med samme eller reduceret dosis (120 mg eller 80 mg), hvis det er berettiget.
English: Pharmacotherapeutic group: hormone antagonists and related agents, anti-androgens, ATC code: L02BB04.
Danish: Farmakoterapeutisk klassifikation: Hormon-antagonister og lignende stoffer, antiandrogener, ATCkode: L02BB04.
English: Median rPFS (radiologic progression free survival, the study´s primary endpoint) was 8.1 months (95% CI: 6.1, 8.3).
Danish: Median rPFS (radiologisk progressionsfri overlevelse, studiets primære endepunkt) var 8,1 måneder (95 % KI: 6,1, 8,3).
English: HR is based on a Cox regression model (with treatment as the only covariate) stratified by PSA doubling time and prior or concurrent use of a bone targeting agent.
Danish: HR er baseret på en Cox-regressjonsmodel (med behandling som eneste kovariat) stratificeret ved PSAfordoblingstid og tidligere eller samtidig brug af et middel mod knogleskørhed.
English: EU/1/13/846/001 112 soft capsules
Danish: EU/1/13/846/001 112 bløde kapsler
English: Hazard Ratio is derived from a stratified proportional hazards model.
Danish: Hazard ratio er baseret på en stratificeret proportional hazards-model.
English: Enzalutamide competitively inhibits androgen binding to androgen receptors, and consequently; inhibits nuclear translocation of activated receptors and inhibits the association of the activated androgen receptor with DNA even in the setting of androgen receptor overexpression and in prostate cancer cells resistant to anti-androgens.
Danish: Enzalutamid hæmmer kompetitivt androgen binding til androgenreceptorer og hæmmer dermed også kernetranslokation af aktiverede receptorer og associering af den aktiverede androgenreceptor med DNA - selv i tilfælde af overekspression af androgenreceptor og i prostatacancerceller, som er resistente over for anti-androgener.
English: Studies in rodents indicate that enzalutamide and its active metabolite can cross the blood brain barrier.
Danish: Studier hos gnavere indikerer, at enzalutamid og den aktive metabolit deraf kan krydse blod-hjerne-barrieren.
English: If you are taking a medicine that can cause seizures or that can increase the susceptibility for having seizures (see ‘Other medicines and Xtandi' below)
Danish: Hvis du tager medicin, som kan forårsage krampeanfald eller som kan øge tilbøjeligheden til at få krampeanfald (se "Brug af anden medicin sammen med Xtandi" nedenfor)
English: (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Frekvenskategorierne er defineret som følger: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Enzalutamide is not for use in women.
Danish: Enzalutamid er ikke beregnet til anvendelse hos kvinder.
English: You may have an increased risk of seizure or other side effects.
Danish: Du kan have øget risiko for krampeanfald eller andre bivirkninger.
English: Radiographic progression was assessed with the use of sequential imaging studies as defined by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (for bone lesions) and/or Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria (for soft tissue lesions).
Danish: Radiografisk progression blev vurderet ved anvendelse af sekventielle billeddiagnostiske undersøgelser ifølge PCWG2 (Prostate Cancer Clinical Trials Working Group 2)-kriterier (for knoglelæsioner) og/eller RECIST v 1.1 (Response Evaluation Criteria in Solid Tumors)-kriterier (for bløddelslæsioner).
English: The efficacy and safety of enzalutamide in patients with metastatic CRPC who had received docetaxel and were using a LHRH analogue or had undergone orchiectomy were assessed in a randomised, placebo-controlled, multicentre phase 3 clinical trial.
Danish: Virkningen og sikkerheden af enzalutamid hos patienter med metastatisk CRPC, som havde fået docetaxel, og som blev behandlet med en LHRH-analog eller havde fået foretaget orkiektomi, blev vurderet i et randomiseret, placebokontrolleret, klinisk fase 3-multicenterstudie.
English: Consistent PFS benefit was observed across all pre-specified patient subgroups.
Danish: Konsistent PFS-fordel blev observeret på tværs af alle forhåndsspecificerede patientundergrupper.
English: It is not known whether enzalutamide or its metabolites are present in semen.
Danish: Det vides ikke, om enzalutamid eller metabolitter deraf er til stede i sæd.
English: Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C9, CYP2C19, and uridine 5'-diphospho-glucuronosyltransferase (UGTs - glucuronide conjugating enzymes).
Danish: Enzymer, der kan være induceret, omfatter CYP3A i lever og tarm, CYP2B6, CYP2C9, CYP2C19 og uridin 5'-diphospho-glucuronosyltransferase (UGT'er - glucuronidkonjugerende enzymer).
English: Common: headache, memory impairment, amnesia, disturbance in attention, restless legs syndrome Uncommon: cognitive disorder, seizure¥ Not known*: posterior reversible encephalopathy syndrome
Danish: Almindelig: Hovedpine, hukommelsessvækkelse, amnesi, opmærksomhedsforstyrrelse, restless legs-syndrom Ikke almindelig: Kognitiv forstyrrelse, krampeanfald¥ Ikke kendt*: Posteriort reversibelt encefalopati-syndrom
English: Hepatic impairment did not have a pronounced effect on the total exposure to enzalutamide or its active metabolite.
Danish: Nedsat leverfunktion havde ikke nogen udtalt effekt på den samlede eksponering for enzalutamid eller dets aktive metabolit.
English: Xtandi contains the active substance enzalutamide.
Danish: Xtandi indeholder det aktive stof enzalutamid.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERFOLIE
English: Oral absorption of film-coated enzalutamide tablets was evaluated in healthy male volunteers after a single 160 mg dose of Xtandi film-coated tablets, and pharmacokinetic modelling and simulation were used to predict the pharmacokinetic profile at steady state.
Danish: Oral absorption af enzalutamid filmovertrukne tabletter blev vurderet hos raske mandlige forsøgspersoner efter en enkelt 160 mg dosis Xtandi - filmovertrukne tabletter, og farmakokinetisk modellering og simulering blev anvendt til at forudsige den farmakokinetiske profil ved steady state.
English: - Certain medicines for the treatment of pain (e.g. pethidine).
Danish: visse former for medicin til behandling af smerter (f.eks. pethidin).