FrancophonIA/ELRC3.0 huggingface dataset:
English: The analysis involved 216 deaths without documented progression and 645 documented progression events, of which 303 (47%) were due to soft tissue progression, 268 (42%) were due to bone lesion progression and 74 (11%) were due to both soft tissue and bone lesions.
Danish: Analysen omfattede 216 dødsfald uden dokumenteret progression og 645 dokumenterede progressionshændelser, hvoraf 303 (47 %) skyldtes bløddelsprogression, 268 (42 %) skyldtes knoglelæsionsprogression og 74 (11 %) skyldtes både bløddels- og knoglelæsioner.
English: No clinically relevant effect of age on enzalutamide pharmacokinetics was seen in the elderly population pharmacokinetic analysis.
Danish: Der blev ikke observeret nogen klinisk relevant virkning af alder på enzalutamids farmakokinetik i den farmakokinetiske analyse af den ældre population.
English: White to off-white oblong soft capsules (approximately 20 mm x 9 mm) imprinted with “ENZ” in black ink on one side.
Danish: Hvide til offwhite, aflange, bløde kapsler (ca. 20 mm x 9 mm) præget med "ENZ" med sort tryk på den ene side.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET WITHOUT BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE TEGNEBOG UDEN BLUE BOX
English: Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.
Danish: Hjerte- eller karsygdomme, inklusive problemer med hjerterytmen (arytmi), eller er i behandling med lægemidler for disse lidelser.
English: PFS was the primary endpoint defined as the time from randomisation to the earliest objective evidence of radiographic progression, PSA progression, or death on study.
Danish: Det primære endepunkt var PFS, defineret som tiden fra randomisering til det tidligste objektive bevis på radiografisk progression, PSA-progression eller død under studiet.
English: Elimination The mean apparent clearance (CL/F) of enzalutamide in patients ranges from 0.520 and 0.564 L/h.
Danish: Den gennemsnitlige tilsyneladende clearance (CL/F) af enzalutamid hos patienter er fra 0,520 til 0,564 l/h.
English: This medicine has moderate effect on your ability to drive or use any tools or machines as the side effects of Xtandi include psychiatric and neurological events including seizure.
Danish: Dette lægemiddel påvirker i moderat grad din evne til at føre motorkøretøj eller betjene værktøj eller maskiner, da bivirkningerne for Xtandi omfatter psykiatriske og neurologiske hændelser, inklusiv krampeanfald.
English: Tablet coating Hypromellose Talc
Danish: Filmovertræk Hypromellose Talkum
English: In addition to the co-primary endpoints, benefit was also assessed using time to initiation of cytotoxic chemotherapy, best overall soft tissue response, time to first skeletal-related event, PSA response (≥ 50% decrease from baseline), time to PSA progression, and time to FACT-P total score degradation.
Danish: Foruden de co-primære endepunkter blev den gavnlige effekt af behandlingen vurderet ved anvendelse af tiden til initiering af cytotoksisk kemoterapi, bedste samlede bløddelsrespons, tiden til første skeletrelaterede hændelse, PSA-respons (≥50 % fald fra baseline), tiden til PSA-progression og tiden til forringelse af FACT-P total score.
English: Sorbitol sorbitan solution Glycerol
Danish: Sorbitol-sorbitan-opløsning Glycerol
English: Common: dry skin, pruritus Not known*: rash
Danish: Almindelig: Tør hud, pruritus Ikke kendt*: Udslæt
English: Post-authorisation efficacy study (PAES): In order to investigate the long-term effects of enzalutamide on Overall Survival and relevant secondary endpoints in adult men with high-risk non-metastatic castration-resistant prostate cancer, the MAH should submit the results of the MDV3100-14 (PROSPER) efficacy study:
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For at undersøge langtidseffekterne af enzalutamid på Samlet Overlevelse og relevante sekundære endepunkter hos voksne mænd med højrisiko, ikke-metastatisk kastrationsresistent prostatacancer, skal indehaveren af markedsføringstilladelsen indsende resultaterne af MDV3100-14 (PROSPER) effektstudie:
English: In studies in mice (4 weeks), rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), changes in the reproductive organs associated with enzalutamide were decreases in organ weight with atrophy of the prostate and epididymis.
Danish: I studier med mus (4 uger), rotter (4 og 26 uger) og hunde (4, 13 og 39 uger) var ændringer i de reproduktive organer associeret med enzalutamid fald i organvægt med atrofi af prostata og epididymis.
English: A prolonged time to reach steady state concentrations is however anticipated, and the time to maximum pharmacological effect as well as time for onset and decline of enzyme induction (see section 4.5) may be increased.
Danish: Det forventes imidlertid, at der går længere tid, inden steady state-koncentrationer nås, og tiden til den maksimale farmakologiske effekt samt tiden for start og fald i enzyminduktion (se pkt.
English: Of the 3179 patients in the controlled clinical trials who received enzalutamide, 2518 patients (79%) were 65 years and over and 1162 patients (37%) were 75 years and over.
Danish: Af de 3179 patienter i de klinisk kontrollerede studier, der fik enzalutamid, var 2518 patienter (79 %) 65 år og derover, og 1162 patienter (37 %) var 75 år og derover.
English: Enzalutamide is a potent enzyme inducer and may lead to loss of efficacy of many commonly used medicinal products (see examples in section 4.5).
Danish: Enzalutamid er en stærk enzyminduktor og kan medføre, at mange almindeligt anvendte lægemidler mister deres effekt (se eksemplerne i pkt.
English: • the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
Danish: • behandling af voksne mænd med højrisiko, ikke-metastatisk kastrationsresistent prostatacancer (CRPC) (se pkt.
English: The soft capsules should not be chewed, dissolved or opened but should be swallowed whole with water, and can be taken with or without food.
Danish: De bløde kapsler må ikke tygges, opløses eller åbnes, men bør synkes hele med vand og kan tages med eller uden mad.
English: If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time.
Danish: Hvis en patient glemmer at tage Xtandi på det sædvanlige tidspunkt, skal den ordinerede dosis tages så tæt som muligt på det sædvanlige tidspunkt.
English: Medicinal products with a narrow therapeutic range that are substrates for P-gp (e.g. colchicine, dabigatran etexilate, digoxin) should be used with caution when administered concomitantly with Xtandi and may require dose adjustment to maintain optimal plasma concentrations.
Danish: Lægemidler med et snævert terapeutisk interval, som er substrater for P-gp (f.eks. colchicin, dabigatran-etexilat, digoxin), bør anvendes med forsigtighed ved administration samtidig med Xtandi og kan nødvendiggøre dosisjustering for at opretholde optimale plasmakoncentrationer.
English: If you have a seizure during treatment: See your doctor as soon as possible.
Danish: Hvis du får et krampeanfald under behandlingen: Kontakt lægen hurtigst muligt.
English: Figure 8: Overall survival by subgroup in the AFFIRM study - Hazard ratio and 95% confidence interval
Danish: Figur 8: Samlet overlevelse baseret på undergruppe i AFFIRM-studiet - Hazard ratio og 95 % konfidensinterval
English: Not known*: nausea, vomiting, diarrhoea
Danish: Ikke kendt*: Kvalme, opkastning, diarré
English: No dose adjustment is necessary for patients with mild, moderate or severe hepatic impairment (ChildPugh Class A, B or C, respectively).
Danish: Dosisjustering er ikke nødvendig for patienter med let, moderat eller svært nedsat leverfunktion (henholdsvis Child-Pugh klasse A, B eller C).
English: By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing.
Danish: Ved at blokere androgener standser enzalutamid prostatakræftcellers vækst og deling.
English: The median time to degradation in FACT-P was 11.3 months in the enzalutamide group and 5.6 months in the placebo group.
Danish: Mediantiden til forringelse af FACT-P var 11,3 måneder i enzalutamidgruppen og 5,6 måneder i placebogruppen.
English: - Xtandi is not for use in women.
Danish: Xtandi er ikke beregnet til anvendelse hos kvinder.
English: The pharmacokinetics of enzalutamide were examined in subjects with baseline mild (N = 6), moderate (N = 8) or severe (N = 8) hepatic impairment (Child-Pugh Class A, B or C, respectively) and in 22 matched control subjects with normal hepatic function.
Danish: Enzalutamids farmakokinetik blev undersøgt hos personer, der ved baseline havde let (N = 6), moderat (N = 8) eller svært (N=8) nedsat leverfunktion (henholdsvis Child-Pugh-klasse A, B eller C), og hos 22 matchede kontrolpersoner med normal leverfunktion.
English: Seizures were reported in 4 in every 1,000 people taking Xtandi, and in fewer than one in every 1,000 people taking placebo.
Danish: Der er rapporteret krampeanfald hos 4 ud af hver 1.000 personer, der har fået Xtandi, og hos færre end én ud af hver 1.000 personer, der har fået placebo.
English: Do not use this medicine after the expiry date which is stated on the cardboard wallet and outer carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på paptegnebog og den ydre karton af pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Hazard Ratio is derived from an unstratified proportional hazards model.
Danish: Hazard ratio er afledt fra en ikke-stratificeret, proportional hazards-model.
English: The ECOG performance score was 0 - 1 in 91.5% of patients and 2 in 8.5% of patients; 28% had a mean Brief Pain Inventory score of ≥ 4 (mean of patient's reported worst pain over the previous 24 hours calculated for seven days prior to randomisation).
Danish: ECOG-funktionsscoren var 0-1 for 91,5 % af patienterne og 2 for 8,5 % af patienterne; 28 % havde en gennemsnitlig Brief Pain Inventory-score på ≥4 (gennemsnit af patientens rapporterede værste smerter inden for de forudgående 24 timer beregnet for syv dage forud for randomisering).
English: In vitro data indicate that enzalutamide and its major metabolites do not inhibit the following transporters at clinically relevant concentrations: OATP1B1, OATP1B3, OCT2, or OAT1.
Danish: In vitro-data indikerer, at enzalutamid og dets væsentlige metabolitter ikke hæmmer følgende transportører ved klinisk relevante koncentrationer: OATP1B1, OATP1B3, OCT2 eller OAT1.
English: Enzalutamide is extensively metabolised.
Danish: Enzalutamid metaboliseres i stor udstrækning.
English: Enzalutamide is not a substrate of the efflux transporters P-gp or BCRP.
Danish: Enzalutamid er ikke substrat for effluxtransportørerne P-gp eller BCRP.
English: The PREVAIL study enrolled metastatic CRPC chemotherapy-naïve patients; whereas the AFFIRM study enrolled metastatic CRPC patients who had received prior docetaxel; and the PROSPER study enrolled patients with non-metastatic CRPC.
Danish: PREVAIL-studiet inkluderede kemoterapi-naive patienter med metastatisk CRPC, mens AFFIRM-studiet inkluderede patienter med metastatisk CRPC, der tidligere havde fået docetaxel, og PROSPER-studiet inkluderede patienter med ikke-metastatisk CRPC.
English: The protocol pre-specified interim analysis after 520 deaths showed a statistically significant superiority in overall survival in patients treated with enzalutamide compared to placebo (Table 4 and Figures 7 and 8).
Danish: Den i protokollen forudspecificerede interimanalyse efter 520 dødsfald påviste en statistisk signifikant superioritet i samlet overlevelse for patienter behandlet med enzalutamid sammenlignet med placebo (tabel 4 og figur 7 og 8).
English: Reproductive toxicology studies were not conducted with enzalutamide, but in studies in rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), atrophy, aspermia/hypospermia, and hypertrophy/hyperplasia in the reproductive system were noted, consistent with the pharmacological activity of enzalutamide.
Danish: Der er ikke udført reproduktionstoksikologiske studier for enzalutamid, men i studier med rotter (4 og 26 uger) og hunde (4, 13 og 39 uger) blev der observeret atrofi, aspermi/hypospermi og hypertrofi/hyperplasi i det reproduktive system, hvilket er i overensstemmelse med den farmakologiske aktivitet af enzalutamid.
English: Hazard ratio (95% CI)2 Updated survival analysis Number of deaths (%) Median survival, months (95% CI)
Danish: Hazard ratio (95 % KI)2 Opdateret overlevelsesanalyse Antal dødsfald (%) Median overlevelse, måneder (95 % KI)
English: Titanium dioxide (E171) Purified water
Danish: Titandioxid (E 171) Renset vand
English: At steady state, the mean Cmax values for enzalutamide and its active metabolite are 16.6 μg/mL (23% coefficient of variation [CV]) and 12.7 μg/mL (30% CV), respectively.
Danish: Ved steady-state er de gennemsnitlige Cmax-værdier for enzalutamid og dens aktive metabolit henholdsvis 16,6 μg/ml (23 % variationskoefficient [CV]) og 12,7 μg/ml (30 % CV).
English: Daily fluctuations in plasma concentrations are low (peak-to-trough ratio of 1.25).
Danish: De daglige udsving i plasmakoncentrationerne er små (variationerne mellem laveste og højeste koncentration (peak/trough-ratio) er 1,25).
English: Common: ischemic heart disease† Not known*: QT-prolongation (see sections 4.4 and 4.5)
Danish: Almindelig: Iskæmisk hjertesygdom† Ikke kendt*: QT-forlængelse (se pkt.
English: CRPC2 (AFFIRM) study (patients with metastatic CRPC who previously received chemotherapy)
Danish: CRPC2 (AFFIRM)-studiet (patienter med metastatisk CRPC, der tidligere havde fået kemoterapi)
English: ¥ As evaluated by narrow SMQs of ‘Convulsions' including convulsion, grand mal convulsion, complex partial seizures, partial seizures, and status epilepticus.
Danish: ¥ Som vurderet ved afgrænsede SMQs (Standardised MedDRA Queries) af ”Konvulsioner” herunder krampe, grand mal krampe, komplekse partielle anfald, partielle anfald og status epilepticus.
English: If you forget to take Xtandi
Danish: Hvis du har glemt at tage Xtandi
English: The pharmacokinetics of enzalutamide have been evaluated in prostate cancer patients and in healthy male subjects.
Danish: Enzalutamids farmakokinetik er evalueret hos prostatacancerpatienter og hos raske mandlige forsøgspersoner.
English: According to prior chemotherapy history, the results proportion of patients with a ≥ 50% decrease in PSA levels were 22.1% and 23.2%, for the no prior chemotherapy and prior chemotherapy patient groups, respectively.
Danish: Ifølge tidligere kemoterapianamnese var andelen af patienter med ≥ 50 % reduktion i PSA-niveauerne 22,1 % og 23,2 % for henholdsvis de ikke tidligere kemoterapi- og tidligere kemoterapipatientgrupper.
English: Other tumours, which are also potentially related to the primary pharmacology include fibroadenoma of mammary glands and benign thymoma of thymus in males, benign granulosa cell tumours of ovaries in females, and adenoma of pituitary pars distalis in both sexes.
Danish: Andre tumorer, som også potentielt er relateret til den primære farmakologi, omfatter fibroadenom i brystkirtlerne og benignt tymom i thymus hos hankøn, benigne granulosacelletumorer i ovarierne hos hunkøn, og adenom i pars distalis i hypofysen hos begge køn.
English: The film-coated tablets should not be cut, crushed or chewed but should be swallowed whole with water, and can be taken with or without food.
Danish: De filmovertrukne tabletter må ikke deles, knuses eller tygges, men bør synkes hele med vand og kan tages med eller uden mad.
English: Consistent MFS results were also observed in all pre-specified patient subgroups including PSADT (< 6 months or ≥ 6 months), demographic region (North America, Europe, rest of world), age (< 75 or ≥ 75), use of a prior bone-targeting agent (yes or no).
Danish: Konsistente MFS resultater blev også observeret i alle forhåndsspecificerede patientundergrupper, inklusive PSADT (< 6 måneder eller ≥ 6 måneder), demografisk område (Nordamerika, Europa, resten af verden), alder (< 75 måneder eller ≥ 75),
English: • the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
Danish: • behandling af voksne mænd med metastatisk CRPC, som er asymptomatiske eller har lette symptomer efter svigt af androgen deprivationsbehandling, og hvor kemoterapi endnu ikke er klinisk indiceret (se pkt.
English: An increased half-life of enzalutamide has been observed in patients with severe hepatic impairment, possibly related to increased tissue distribution.
Danish: Der er observeret en længere halveringstid for enzalutamid hos patienter med svært nedsat leverfunktion, som muligvis har sammenhæng med øget vævsdistribution.
English: - Certain medicines used to treat asthma and other respiratory diseases (e.g. aminophylline, theophylline).
Danish: visse former for medicin, som anvendes til behandling af astma og andre luftvejssygdomme (f.eks. aminophyllin, theophyllin).
English: The phase 3 studies excluded patients with recent myocardial infarction (in the past 6 months) or unstable angina (in the past 3 months), New York Heart Association Class (NYHA) III or IV heart failure except if Left Ventricular Ejection Fraction (LVEF) ≥ 45%, bradycardia or uncontrolled hypertension.
Danish: Fase 3-studierne udelukkede patienter med nylig myokardieinfarkt (inden for de seneste 6 måneder) eller ustabil angina (inden for de seneste 3 måneder), hjertesvigt af NYHA (New York Heart Association) klasse III eller IV, medmindre venstre ventrikels uddrivningsfraktion (LVEF) ≥ 45 %, bradykardi eller ukontrolleret hypertension.
English: One hundred and eighteen (14%) enzalutamide-treated patients and 321 (40%) of placebo-treated patients had an event.
Danish: 118 (14 %) af de enzalutamidbehandlede patienter og 321 (40 %) af patienterne i placebogruppen oplevede en hændelse.
English: The median age at randomisation was 74 years in the enzalutamide arm and 73 years in the placebo arm.
Danish: Medianalderen ved randomisering var 74 år i enzalutamidarmen og 73 år i placeboarmen.
English: Table 1: Adverse reactions identified in controlled clinical trials and post-marketing MedDRA System organ class Adverse reaction and frequency
Danish: Tabel 1: Bivirkninger identificeret i kontrollerede kliniske studier og efter markedsføring MedDRAsystemorganklasse
English: In a single arm trial (9785-CL-0410) of patients previously treated with at least 24 weeks of abiraterone (plus prednisone), 22.4% had a ≥ 50% decrease from baseline in PSA levels.
Danish: I et enkeltarmet studie (9785-CL-0410) med patienter, tidligere behandlet i mindst 24 uger med abirateron (plus prednison), havde 22,4 % en reduktion på ≥ 50 % i PSA-niveauerne fra baseline.
English: In the three clinical trials, patients received placebo in the control arm and patients were allowed, but not required, to take prednisone (maximum daily dose allowed was 10 mg prednisone or equivalent).
Danish: I de tre kliniske studier fik patienter i kontrolarmen placebo, og det var tilladt, men ikke påkrævet, at patienterne fik prednison (maksimal daglig tilladte dosis var 10 mg prednison eller ækvivalent).
English: In the study, calculi and crystals were observed in rat urinary bladders.
Danish: I studiet blev der observeret sten og krystaller i rotte urinblærer.
English: † As evaluated by narrow SMQs of ‘Myocardial Infarction' and ‘Other Ischemic Heart Disease' including the following preferred terms observed in at least two patients in randomized placebo-controlled phase 3 studies: angina pectoris, coronary artery disease, myocardial infarctions, acute myocardial infarction, acute coronary syndrome, angina unstable, myocardial ischaemia, and arteriosclerosis coronary artery.
Danish: † Som vurderet ved afgrænsede SMQs af ”Myokardieinfarkt” og ”Andre Iskæmiske Hjertesygdomme” inklusive følgende foretrukne termer observeret i mindst 2 patienter i randomiserede placebokontrollerede fase 3 studier: Angina pectoris, koronararteriesygdom, myokardieinfarkt, akut myokardieinfarkt, akut koronarsyndrom, ustabil angina, myokardie iskæmi og åreforkalkning af koronararterie.
English: The most common adverse reactions are asthenia/fatigue, hot flush, fractures, and hypertension.
Danish: De hyppigste bivirkninger er asteni/træthed, hedestigninger, frakturer og hypertension.
English: The most prominent of these were benign Leydig cell tumours, urothelium papilloma, and carcinoma of urinary bladder.
Danish: De mest fremtrædende af disse var benigne Leydigs celletumorer, urotelialt papillom og karcinom i urinblæren.
English: • Antibiotics (e.g. clarithromycin, doxycycline)
Danish: • Antibiotika (f.eks. clarithromycin, doxycyclin)
English: In preclinical studies enzalutamide lacks androgen receptor agonist activity.
Danish: I prækliniske studier har enzalutamid ikke androgenreceptor-agonistaktivitet.
English: N-desmethyl enzalutamide was not metabolised by CYPs in vitro.
Danish: N-desmethyl-enzalutamid blev ikke metaboliseret af CYP-isoenzymer in vitro.
English: In vitro data indicate that enzalutamide is not a substrate for OATP1B1, OATP1B3, or OCT1; and N-desmethyl enzalutamide is not a substrate for P-gp or BCRP.
Danish: In vitro-data indikerer, at enzalutamid ikke er substrat for OATP1B1, OATP1B3 eller OCT1, og Ndesmethyl-enzalutamid er ikke substrat for P-gp eller BCRP.
English: - If you forget to take Xtandi for the whole day, take your usual dose the following day.
Danish: Hvis du har glemt at tage Xtandi en hel dag, skal du tage din sædvanlige dosis den følgende dag.
English: The PROSPER study enrolled 1401 patients with asymptomatic, high-risk non-metastatic CRPC who continued on androgen deprivation therapy (ADT; defined as LHRH analogue or prior bilateral orchiectomy).
Danish: PROSPER-studiet inkluderede 1401 patienter med asymptomatisk, højrisiko, ikke-metastatisk CRPC, som fortsatte med androgen deprivationsbehandling (ADT, defineret som LHRH-analog eller tidligere bilateral orkiektomi).
English: If you take more tablets than prescribed, stop taking Xtandi and contact your doctor.
Danish: Hvis du har taget flere tabletter end foreskrevet, skal du holde op med at tage Xtandi og kontakte lægen.
English: Progression-free survival was defined as objective evidence of radiographic disease progression by independent central review, skeletal-related events, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.
Danish: Progressionsfri overlevelse blev defineret som objektiv evidens for radiografisk sygdomsprogression ved uafhængig central vurdering, skeletrelaterede hændelser, initiering af ny antineoplastisk behandling eller død uanset årsag, uafhængigt af hvad der indtraf først.
English: If you take more soft capsules than prescribed, stop taking Xtandi and contact your doctor.
Danish: Hvis du har taget flere bløde kapsler end foreskrevet, skal du holde op med at tage Xtandi og kontakte lægen.
English: The study was a single-arm study in 214 patients with progressing metastatic CRPC who received enzalutamide (160 mg once daily) after at least 24 weeks of treatment with abiraterone acetate plus prednisone.
Danish: Studiet var et enkeltarmet studie med 214 patienter med progressiv metastatisk CRPC, der fik enzalutamid (160 mg en gang daglig) efter mindst 24 ugers behandling med abirateronacetat plus prednison.
English: PSA Response (defined as ≥ 50% decrease from baseline) was 22.4% (95% CI: 17.0, 28.6).
Danish: PSA respons (defineret som ≥ 50 % reduktion fra baseline) var 22,4 % (95 % KI: 17,0, 28,6).
English: Consistent rPFS benefit was observed across all pre-specified patient subgroups (e.g. age, baseline ECOG performance, baseline PSA and LDH, Gleason score at diagnosis, and visceral disease at screening).
Danish: Der blev observeret en ensartet gavnlig effekt på rPFS i alle forudspecificerede patientundergrupper (f.eks. alder, ECOG-funktion ved baseline, PSA og LDH ved baseline, Gleasonscore ved diagnosticering og visceral sygdom ved screening).