natgillin/translations-raw huggingface dataset:
Baseret på et massebalancestudie hos mennesker vurderes den orale absorption af enzalutamid at være mindst 84,2 %.
Based on a mass balance study in humans, oral absorption of enzalutamide is estimated to be at least 84.2%.
De maksimale plasmakoncentrationer (Cmax) af enzalutamid hos patienter observeres 1 til 2 timer efter administration.
Maximum plasma concentrations (Cmax) of enzalutamide in patients are observed 1 to 2 hours after administration.
De fleste patienter i de kontrollerede kliniske studier (>74 %) var kaukasiere.
Most patients in the controlled clinical trials (> 74%) were Caucasian.
Disse former for medicin kan påvirke virkningen af Xtandi, eller Xtandi kan påvirke virkningen af disse former for medicin.
These medicines may influence the effect of Xtandi, or Xtandi may influence the effect of these medicines.
Der forventes interaktioner med visse lægemidler, der elimineres ved metabolisering eller ved aktiv transport.
Interactions with certain medicinal products that are eliminated through metabolism or active transport are expected.
Samtidig administration af warfarin og coumarinlignende antikoagulantia bør undgås.
Co-administration with warfarin and coumarin-like anticoagulants should be avoided.
Selv om der hos nogle patienter var et begrænset respons fra behandling med enzalutamid efter abirateron, er årsagen til dette fund på nuværende tidspunkt ukendt.
Although there was a limited response in some patients from treatment with enzalutamide after abiraterone, the reason for this finding is currently unknown.
P-gp-substrater
P-gp substrates
Den aktive metabolit bindes 95 % til plasmaproteiner.
The active metabolite is 95% bound to plasma proteins.
Xtandi er et lægemiddel, som virker ved at blokere aktiviteten af de hormoner, som kaldes androgener (såsom testosteron).
Xtandi is a medicine that works by blocking the activity of hormones called androgens (such as testosterone).
Patienter med serumkreatinin >177 μmol/l (2 mg/dl) blev udelukket fra kliniske studier.
Patients with serum creatinine > 177 μmol/L (2 mg/dL) were excluded from clinical trials.
Xtandi er indiceret til:
Xtandi is indicated for:
Radioaktiviteten i fosteret faldt til 0,08 gange maksimumkoncentrationen 72 timer efter administration.
The radioactivity in the fetus decreased to 0.08 times the maximum concentration at 72 hours after administration.
* Spontane indberetninger efter markedsføring
* Spontaneous reports from post-marketing experience
Der var ingen andre væsentlige ændringer i den kliniske patologi eller histopatologi for noget andet organsystem, herunder leveren, hos nogen af arterne.
There were no other important changes in clinical pathology or histopathology in any other organ system, including the liver, in either species.
Distributionsvolumenet for enzalutamid er større end kroppens totale vandvolumen, hvilket indikerer omfattende ekstravaskulær distribution.
The volume of distribution of enzalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Ændringer i de reproduktive organer hos begge arter var i overensstemmelse med den farmakologiske aktivitet af enzalutamid og var reverseret eller delvist forsvundet efter en 8-ugers restitutionsperiode.
Changes in the reproductive organs in both species were consistent with the pharmacological activity of enzalutamide and reversed or partially resolved after an 8-week recovery period.
Patienter bør advares om den potentielle risiko for at opleve en psykiatrisk eller neurologisk hændelse når de fører motorkøretøj eller betjener maskiner.
Patients should be advised of the potential risk of experiencing a psychiatric or neurological event while driving or operating machines.
hvis du er gravid eller i den fødedygtige alder (se "Graviditet, amning og frugtbarhed")
- If you are pregnant or may become pregnant (see ‘Pregnancy, breast-feeding and fertility')
Studiedesignet kunne hverken identificere hvilke patienter, behandlingen sandsynligvis vil gavne, eller den rækkefølge, hvori enzalutamid og abirateron optimalt bør administreres.
The study design could neither identify the patients who are likely to benefit, nor the order in which enzalutamide and abiraterone should be optimally sequenced.
Ved indtrædelse i studiet havde 41 % af de randomiserede patienter kun PSA-progression, mens 59 % af patienterne havde radiografisk progression.
At study entry, 41% of randomised patients had PSA progression only, whereas 59% of patients had radiographic progression.
Enzalutamid bindes 97 % til 98 % til plasmaproteiner, primært albumin.
Enzalutamide is 97% to 98% bound to plasma proteins, primarily albumin.
Xtandi er til oral anvendelse.
Xtandi is for oral use.
Den finale kliniske studierapport skal indsendes:
The final clinical study report should be submitted by.
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
- Do not take a double dose to make up for the dose you forgot.
Analysen af rPFS benyttede centralt bedømte radiografiske vurderinger af progression.
Analysis of rPFS utilised centrally-reviewed radiographic assessment of progression.
Når de samtidig tages med Xtandi, kan disse former for medicin øge risikoen for et krampeanfald:
When taken at the same time as Xtandi, these medicines may increase the risk of a seizure:
ECOG: Eastern Cooperative Oncology Group, BPI-SF: Brief Pain Inventory-Short Form, PSA: Prostataspecifikt antigen
ECOG: Eastern Cooperative Oncology Group; BPI-SF: Brief Pain Inventory-Short Form; PSA: Prostate Specific Antigen
Synk tabletterne hele med vand.
- Swallow the tablets whole with water.
Almindelig: Angst Ikke almindelig: Visuelle hallucinationer
Common: anxiety Uncommon: visual hallucination
Benigne Leydigs celle-tumorer er forventet baseret på de farmakologiske egenskaber af dette antiandrogene lægemiddel, og anses ikke som relevant for mennesker.
Benign Leydig cell tumours are expected based on the pharmacological properties of this antiandrogen drug and not considered relevant to humans.
Sandsynligheden for krampeanfald øges, hvis du tager mere end den anbefalede dosis af dette lægemiddel, hvis du tager visse andre lægemidler, eller hvis din risiko for krampeanfald er større end den sædvanlige risiko.
Seizures are more likely if you take more than the recommended dose of this medicine, if you take certain other medicines, or if you are at higher than usual risk of seizure.
Der findes ingen antidot til enzalutamid.
There is no antidote for enzalutamide.
Lægen kan beslutte, at du skal stoppe med at tage Xtandi.
Your doctor may decide that you should stop taking Xtandi.
Hvis du får krampeanfald, hovedpine, der bliver værre, forvirring, blindhed eller andre synsproblemer, skal du hurtigst muligt kontakte din læge.
If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible.
51 % af patienterne var på bisphosphonater ved baseline.
Fifty-one percent (51%) of patients were on bisphosphonates at baseline.
Dette lægemiddel indeholder 57,8 mg sorbitol (en form for sukker) pr. bløde kapsel.
This medicine contains 57.8 mg sorbitol (a type of sugar) per soft capsule.
Dette lægemiddel kan muligvis påvirke mænds frugtbarhed.
- This medicine could possibly have an effect on male fertility.
Synk de bløde kapsler hele med vand.
- Swallow the soft capsules whole with water.
Din læge kan også ordinere anden medicin samtidig med, at du tager Xtandi.
Your doctor may also prescribe other medicines while you are taking Xtandi.
Alle patienter fortsatte med en LHRH-analog eller havde tidligere fået foretaget bilateral orkiektomi.
All patients continued on a LHRH analogue or had prior bilateral orchiectomy.
Hvis en patient glemmer en dosis en hel dag, skal behandlingen genoptages den følgende dag med den sædvanlige daglige dosis.
If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose.
Der var utilstrækkelige data til at evaluere potentielle forskelle i enzalutamids farmakokinetik hos andre racer.
There are insufficient data to evaluate potential differences in the pharmacokinetics of enzalutamide in other races.
Yderligere sekundære endepunkter inkluderede tid til første brug af cytotoksisk kemoterapi og kemoterapifri overlevelse.
Additional secondary endpoints included time to first use of cytotoxic chemotherapy and chemotherapy-free survival.
Leydigcellehypertrofi og/eller -hyperplasi blev observeret hos mus (4 uger) og hunde (39 uger).
Leydig cell hypertrophy and/or hyperplasia were observed in mice (4 weeks) and dogs (39 weeks).
På trods af lave eller endda upåviselige niveauer af serumandrogen fremmer androgenreceptorsignalering fortsat sygdomsprogression.
Despite low or even undetectable levels of serum androgen, androgen receptor signalling continues to promote disease progression.
P-værdien er afledt fra en ikke-stratificeret log-rank-test
P-value is derived from an unstratified log-rank test.
112 bløde kapsler
112 soft capsules
Der skal anvendes kondom under og i 3 måneder efter behandling med enzalutamid, hvis patienten er seksuelt aktiv med en gravid kvinde.
A condom is required during and for 3 months after treatment with enzalutamide if the patient is engaged in sexual activity with a pregnant woman.
Der var ingen proteinbindingsfortrængning mellem enzalutamid og andre stærkt bundne lægemidler (warfarin, ibuprofen og salicylsyre) in vitro.
There was no protein binding displacement between enzalutamide and other highly bound medicinal products (warfarin, ibuprofen and salicylic acid) in vitro.
EU/1/13/846/002 (filmovertrukken tablet 40 mg) EU/1/13/846/003 (filmovertrukken tablet 80 mg)
EU/1/13/846/002 (film-coated tablet 40 mg) EU/1/13/846/003 (film-coated tablet 80 mg)
HR står i forhold til placebo med < 1 favoriserende enzalutamid.
The HR is relative to placebo with < 1 favouring enzalutamide.
Farmakokinetiske data fra studier med japanske og kinesiske patienter med prostatacancer viste ingen klinisk relevante forskelle i eksponering mellem populationerne.
Based on pharmacokinetic data from studies in Japanese and Chinese patients with prostate cancer, there were no clinically relevant differences in exposure among the populations.
Du bør ikke begynde på eller holde op med at tage anden medicin, før du har talt med lægen, der udskrev Xtandi til dig.
You should not start or stop taking any medicine before you talk with the doctor that prescribed Xtandi.
Øvrige indholdsstoffer i de filmovertrukne tabletterer:
The other ingredients of the film-coated tablets are:
AUC og Cmax for koffein blev reduceret med henholdsvis 11 % og 4 %.
The AUC and Cmax of caffeine decreased by 11% and 4% respectively.
Nylig kardiovaskulær sygdom
Recent cardiovascular disease
De fleste patienter (ca. 71 %) i studiet var kaukasiere; 16 % var asiatiske og 2 % var sorte.
Most patients (approximately 71%) in the study were Caucasian; 16% were Asian and 2% were Black.
Tag ikke eventuelt bløde kapsler, som er utætte, beskadigede eller viser tegn på manipulation.
Do not take any soft capsule that is leaking, damaged, or shows signs of tampering.
Ved daglig oral administration akkumuleres enzalutamid med en faktor ca. 8,3 i forhold til en enkeltdosis.
With daily oral administration, enzalutamide accumulates approximately 8.3-fold relative to a single dose.
Denne medicin indeholder mindre end 1 mmol natrium (mindre end 23 mg) pr. filmovertrukne tablet, dvs. den er i det væsentlige natriumfri.
This medicine contains less than 1 mmol sodium (less than 23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
De bløde kapsler bør ikke opløses eller åbnes.
The soft capsules should not be dissolved or opened.
Hvis du er allergisk over for enzalutamid, kan det medføre udslæt eller hævelse af ansigtet, tungen, læberne eller svælget.
If you are allergic to enzalutamide, this may result in a rash or swelling of the face, tongue, lip or throat.
Ændring i PSA-serumkoncentrationen alene er ikke altid en indikator for en klinisk gavnlig effekt.
Changes in PSA serum concentration independently do not always predict clinical benefit.
Hvis den terapeutiske virkning har stor betydning for patienten og der ikke nemt kan foretages dosisjusteringer på baggrund af monitorering af effekt eller plasmakoncentrationer, skal den type lægemidler undgås eller anvendes med forsigtighed.
If their therapeutic effect is of large importance to the patient, and dose adjustments are not easily performed based on monitoring of efficacy or plasma concentrations, these medicinal products are to be avoided or used with caution.
• behandling af voksne mænd med metastatisk CRPC, hvis sygdom er progredieret under eller efter docetaxelbehandling.
• the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Andre vigtige bivirkninger inkluderer fald, kognitiv forstyrrelse og neutropeni.
Other important adverse reactions include fall, cognitive disorder, and neutropenia.
Posteriort reversibelt encefalopati-syndrom
Posterior reversible encephalopathy syndrome
I kliniske studier blev Xtandi administreret uden hensyntagen til mad.
In clinical trials, Xtandi was administered without regard to food.
Beslutningen om at fortsætte behandlingen af patienter, der udvikler krampeanfald, skal tages fra sag til sag.
The decision to continue treatment in patients who develop seizure should be taken case by case.
Der er ikke udført studier til vurdering af virkningerne af enzalutamid på evnen til at føre motorkøretøj og betjene maskiner.
No studies to evaluate the effects of enzalutamide on the ability to drive and use machines have been conducted.
Sikkerheden og effekten af samtidig anvendelse af Xtandi og cytotoksisk kemoterapi er ikke fastslået.
The safety and efficacy of concomitant use of Xtandi with cytotoxic chemotherapy has not been established.
P-værdi1
P-value1
Der er mistanke om, at risikoen for leverskader efter administration af paracetamol er højere hos patienter, der samtidig behandles med enzyminduktorer.
The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers.
I prækliniske studier blev absorptionen af enzalutamid øget, når det blev opløst i caprylcaproylmacrogolglycerider.
In preclinical studies, the absorption of enzalutamide was increased when dissolved in caprylocaproyl macrogolglycerides.
AUC for pioglitazon blev forøget med 20 %, mens Cmax faldt med 18 %.
The AUC of pioglitazone increased by 20% while Cmax decreased by 18%.
PRES er en sjælden, reversibel, neurologisk lidelse, der kan vise sig med symptomer, der udvikler sig hurtigt, herunder krampeanfald, hovedpine, forvirring, blindhed og andre visuelle og neurologiske forstyrrelser, med eller uden ledsagende hypertension.
PRES is a rare, reversible, neurological disorder which can present with rapidly evolving symptoms including seizure, headache, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension.
En diagnose med PRES kræver bekræftelse ved scanning af hjernen, fortrinsvis magnetisk resonans (MR)-scanning.
A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Det vides ikke, om enzalutamid udskilles i human mælk.
It is not known if enzalutamide is present in human milk.
Forsigtighed er påkrævet hos patienter med svært nedsat nyrefunktion, da enzalutamid ikke er undersøgt i denne patientpopulation.
Caution is required in patients with severe renal impairment as enzalutamide has not been studied in this patient population.
Xtandi indeholder sorbitol
Xtandi contains sorbitol
Der er ingen humane data fra anvendelse af Xtandi under graviditet, og dette lægemiddel er ikke beregnet til kvinder i den fertile alder.
There are no human data on the use of Xtandi in pregnancy and this medicinal product is not for use in women of childbearing potential.
En gradvis dosisreduktion af samtidige lægemidler kan være nødvendig, når behandlingen med enzalutamid afbrydes.
A gradual dose reduction of the concomitant medicinal product may be necessary when stopping enzalutamide treatment.
Medbring en liste over den medicin, du tager, og vis den til lægen, når du får udskrevet ny medicin.
Keep a list of them with you to show to your doctor when you are prescribed a new medicine.
Median samlet overlevelse (OS) blev ikke nået.
Median OS was not reached.
CYP3A4 spiller en mindre rolle i metabolismen af enzalutamid.
CYP3A4 plays a minor role in the metabolism of enzalutamide.
Tabel 2: Resumé af effektresultater i PROSPER-studiet (intent-to-treat-analyse) Enzalutamid N = 933
Table 2: Summary of efficacy results in the PROSPER study (intent-to-treat analysis) Enzalutamide N = 933
Behandling med enzalutamid skal initieres og overvåges af speciallæger med erfaring i medicinsk behandling af prostatacancer.
Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
Enzalutamid var negativ for genotoksicitet i et standardbatteri af in vitro- og in vivo-tests.
Enzalutamide was negative for genotoxicity in a standard battery of in vitro and in vivo tests.
Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) Hallucinationer, besvær med at tænke klart, lavt antal hvide blodlegemer
Uncommon (may affect up to 1 in 100 people) Hallucinations, difficulty thinking clearly, low white blood cell count
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).
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).
Risikoen for problemer med hjerterytmen kan blive større, hvis du tager Xtandi.
The risk of heart rhythm problems may be increased when using Xtandi.
Børn og unge Denne medicin er ikke beregnet til brug af børn og unge.
This medicine is not for use in children and adolescents.
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Træthed, knoglebrud, hedestigninger, højt blodtryk
Very common (may affect more than 1 in 10 people) Tiredness, broken bones, hot flushes, high blood pressure
Enzalutamidbehandling nedsætter væksten af prostatacancerceller og kan inducere cancercelledød og tumorregression.
Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression.
Xtandi anvendes til behandling af voksne mænd med prostatakræft, som ikke længere responderer på androgen deprivationsbehandling.
Xtandi is used to treat adult men with prostate cancer that no longer responds to androgen deprivation therapy.
Medicinsk kastration med en luteiniserende hormonfrigivende hormon (LHRH)-analog bør fortsættes ved behandling af patienter, som ikke har undergået kirurgisk kastration.
Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.
Enzalutamidbehandling af drægtige mus resulterede i en øget forekomst af enbryoføtal død og ydre og skeletale forandringer.
Enzalutamide treatment of pregnant mice resulted in an increased incidence of embryo-fetal deaths and external and skeletal changes.
Det gennemsnitlige tilsyneladende distributionsvolumen (V/F) for enzalutamid hos patienter efter en oral enkeltdosis er 110 l (29 % CV).
The mean apparent volume of distribution (V/F) of enzalutamide in patients after a single oral dose is 110 L (29% CV).
I de kontrollerede kliniske studier blev patienter med tidligere krampeanfald eller risikofaktorer for krampeanfald udelukket.
In the controlled clinical studies, patients with prior seizure or risk factors for seizure were excluded.
Mad har ingen klinisk signifikant virkning på graden af absorption.
Food has no clinically significant effect on the extent of absorption.
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.
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.
Daglig dosering med enzalutamid på 10-100 mg/kg/dag hos rotter i 2 år førte til øget forekomst af flere, hovedsagelig benigne, tumortyper.
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.
• Statiner, som metaboliseres af CYP3A4 (f.eks. atorvastatin, simvastatin)
• Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)
Enzalutamids potentiale til at påvirke eksponeringerne for andre lægemidler
Potential for enzalutamide to affect exposures to other medicinal products
Det er usandsynligt, at enzalutamid vil blive fjernet i væsentlig grad ved intermitterende hæmodialyse eller kontinuerlig ambulatorisk peritonealdialyse.
It is unlikely that enzalutamide will be significantly removed by intermittent haemodialysis or continuous ambulatory peritoneal dialysis.
In vitro metaboliseres N-desmethyl-enzalutamid til carboxylsyremetabolitten af carboxylesterase 1, som også spiller en mindre rolle i metaboliseringen af enzalutamid til carboxylsyremetabolitten.
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.
Det var tilladt, men ikke påkrævet for patienterne at tage prednison (den maksimalt tilladte daglige dosis var 10 mg prednison eller ækvivalent).
Patients were allowed but not required to take prednisone (maximum daily dose allowed was 10 mg prednisone or equivalent).
De vigtigste sekundære endepunkter vurderet i studiet var tid til PSA progression, tid til første brug af ny antineoplastisk behandling (TTA), samlet overlevelse (OS).
Key secondary endpoints assessed in the study were time to PSA progression, time to first use of new antineoplastic therapy (TTA), overall survival (OS).
Hvis du har glemt at tage Xtandi i mere end en dag, skal du straks kontakte lægen.
- If you forget to take Xtandi for more than one day, talk to your doctor immediately.
BCRP-, MRP2-, OAT3- og OCT1-substrater
BCRP, MRP2, OAT3 and OCT1 substrates
Patienterne kan have en øget risiko for at få krampeanfald efter overdosering.
Patients may be at increased risk of seizures following an overdose.
Samtidig anvendelse af andre lægemidler
Concomitant use with other medicinal products
Det kan være nødvendigt at ændre dosis af Xtandi eller anden medicin, du tager.
The dose of Xtandi or any other medicines that you are taking may need to be changed.
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.
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.
4.1 Terapeutiske indikationer
CLINICAL PARTICULARS 4.1 Therapeutic indications
Meget almindelig: Hedestigning, hypertension
Very common: hot flush, hypertension
Stimulering af tumorcellevækst via androgenreceptoren kræver kernelokalisering og DNA-binding.
Stimulation of tumour cell growth via the androgen receptor requires nuclear localization and DNA binding.
Det anbefales at seponere behandling med Xtandi til patienter, som udvikler PRES.
Discontinuation of Xtandi in patients who develop PRES is recommended.
Enzalutamid var ikke fototoksisk in vitro.
Enzalutamide was not phototoxic in vitro.
Dosis synes at være en væsentlig indikator for risikoen for krampeanfald, som afspejlet i prækliniske data og data fra et dosistitreringsstudie.
Dose appears to be an important predictor of the risk of seizure, as reflected by preclinical data, and data from a dose-escalation study.