FrancophonIA/ELRC3.0 huggingface dataset:
English: At all evaluation time points after the initial few months of treatment, a higher proportion of patients treated with ZYTIGA remained alive, compared with the proportion of patients treated with placebo (see Figure 6).
Danish: Ved samtlige tidspunkter i evalueringen efter de første få måneders behandling var en højere andel af de patienter, der fik ZYTIGA, fortsat i live sammenlignet med andelen af patienter, der fik placebo (se figur 6).
English: Of 15 detectable metabolites, 2 main metabolites, abiraterone sulphate and N-oxide abiraterone sulphate, each represents approximately 43% of total radioactivity.
Danish: Ud af 15 påviselige metabolitter tegner 2 hovedmetabolitter, abirateronsulfat og N-oxid-abirateronsulfat, sig hver for ca. 43 % af den totale radioaktivitet.
English: If ZYTIGA is accidentally ingested by a child or adolescent, go to the hospital immediately and take the package leaflet with you to show to the emergency doctor.
Danish: Hvis et barn eller en ung person ved et uheld kommer til at tage ZYTIGA, skal I straks tage på hospitalet og medbringe indlægssedlen, så I kan vise den til lægen på skadestuen.
English: ZYTIGA is not for use in women and is contraindicated in women who are or may potentially be pregnant (see section 4.3 and 5.3).
Danish: ZYTIGA er ikke beregnet til kvinder og er kontraindiceret hos kvinder, som er eller kan være gravide (se pkt.
English: Patients with prior ketoconazole treatment for prostate cancer were excluded from this study.
Danish: Patienter, der tidligere havde fået ketoconazol for prostatacancer, blev ekskluderet fra dette studie.
English: Tell your doctor if you have yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems.
Danish: Fortæl det til lægen, hvis du får gulfarvning af huden eller øjnene, mørk urin eller svær kvalme eller opkastning, eftersom dette kan være tegn eller symptomer på leverproblemer.
English: Each bottle contains
Danish: Hver beholder indeholder
English: The study was unblinded based on the magnitude of clinical benefit observed and patients in the placebo group were offered treatment with ZYTIGA.
Danish: Studiet var ublindet baseret på størrelsesordenen af observeret klinisk nytte, og patienterne i placebogruppen blev tilbudt behandling med ZYTIGA.
English: Lower rates of response might be expected in patients previously treated with ketoconazole for prostate cancer.
Danish: Der kan måske forventes lavere responsrater hos patienter, der tidligere er blevet behandlet med ketoconazol for prostatacancer.
English: The following study endpoints demonstrated a statistically significant advantage in favour of ZYTIGA treatment:
Danish: Følgende studieendepunkter demonstrerede en statistisk signifikant fordel ved ZYTIGA-behandling:
English: Censored
Danish: Censureret
English: The treatment effect of AA-P on rPFS and OS across the pre-specified subgroups was favorable and consistent with the overall study population, except for the subgroup of ECOG score of 2 where no trend towards benefit was observed, however the small sample size (n=40) limits drawing any meaningful conclusion.
Danish: Behandlingseffekten af AA-P på rPFS og OS i alle på forhånd specificerede subgrupper var gunstig og svarede til den samlede studiepopulation, bortset fra subgruppen med en ECOG-score på 2, hvor der ikke sås en tendens til en behandlingsfordel; men det lille antal patienter (n=40) begrænser muligheden for en relevant konklusion.
English: Ten patients who received ZYTIGA were discontinued because of hepatotoxicity; two had Grade 2 hepatotoxicity, six had Grade 3 hepatotoxicity, and two had Grade 4 hepatotoxicity.
Danish: Hos ti af de patienter, der fik ZYTIGA, blev behandlingen seponeret på grund af hepatotoksicitet, to havde hepatotoksicitet af grad 2, seks havde hepatotoksicitet af grad 3, og to havde hepatotoksicitet af grad 4.
English: For patients who develop Grade ≥ 3 toxicities including hypertension, hypokalaemia, oedema and other non-mineralocorticoid toxicities, treatment should be withheld and appropriate medical management should be instituted.
Danish: Hos patienter, der udvikler grad ≥ 3 toksiciteter, herunder hypertension, hypokaliæmi, ødemer og andre, non-mineralokortikoide toksiciteter, bør behandlingen seponeres og hensigtsmæssig behandling institueres.
English: The majority of exploratory endpoints favored treatment with abiraterone acetate and prednisone (AA-P) over Placebo.
Danish: Størstedelen af de eksplorative endepunkter indikerede en fordel ved behandling med abirateronacetat og prednison (AA-P) i forhold til placebo.
English: • Periodic Safety Update Report
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: If you plan to take Ra-223 following treatment with ZYTIGA and prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223.
Danish: Hvis du planlægger at tage Ra-223 efter behandling med ZYTIGA og prednison/prednisolon, skal du vente 5 dage, før du starter behandling med Ra-223.
English: Caution is advised when administering with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Danish: Forsigtighed tilrådes ved administration sammen med lægemidler, der aktiveres eller metaboliseres af CYP2D6 - især lægemidler med et snævert terapeutisk indeks.
English: ZYTIGA may cause hypertension, hypokalaemia and fluid retention as a pharmacodynamic consequence of its mechanism of action.
Danish: ZYTIGA kan medføre hypertension, hypokaliæmi og væskeretention som en farmakodynamisk konsekvens af produktets virkningsmekanisme.
English: Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in incidence and severity of these adverse reactions.
Danish: Samtidig indgift af et kortikosteroid hæmmer virkningen af det adrenokortikotrope hormon (ACTH), hvilket fører til en reduktion af forekomsten og sværhedsgraden af disse bivirkninger.
English: In addition to the observed improvement in overall survival, all secondary study endpoints favoured ZYTIGA and were statistically significant after adjusting for multiple testing as follows:
Danish: Ud over den observerede forbedring i samlet overlevelse faldt alle sekundære endepunkter i studiet ud til fordel for ZYTIGA og var statistisk signifikante efter justering for multiple testing på følgende måde:
English: Objective response: Objective response was defined as the proportion of subjects with measurable disease achieving a complete or partial response according to RECIST criteria (baseline lymph node size was required to be ≥ 2 cm to be considered a target lesion).
Danish: Objektivt respons: Objektivt respons var defineret som den andel af forsøgspersoner med registrerbare sygdomme, der opnåede et fuldstændigt eller delvist respons ifølge RECIST-kriterier (baselinelymfeknudestørrelse skulle være over ≥ 2 cm for at blive anset for en target-læsion).
English: Aminotransferase elevations resolved in all but 3 patients (2 with new multiple liver metastases and 1 with AST elevation approximately 3 weeks after the last dose of abiraterone acetate).
Danish: Aminotransferaseforhøjelserne forsvandt hos alle undtagen 3 patienter (2 med multiple levermetastaser og 1 med ASAT-forhøjelse cirka 3 uger efter sidste abirateronacetat-dosis).
English: Radiographic progression free survival (rPFS) was assessed with the use of sequential imaging studies as defined by PCWG2 criteria (for bone lesions) and modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for soft tissue lesions).
Danish: Radiografisk progressionsfri overlevelse (rPFS) blev evalueret vha. brug af sekventielle billedstudier som defineret af PCWG2-kriterier (for knoglelæsioner) og modificerede Response Evaluation Criteria In Solid Tumors (RECIS-) kriterier (for bløddelslæsioner).
English: Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated.
Danish: Medicinsk kastration med luteiniserende hormon-releasing hormon- (LHRH-) analog bør fortsætte under behandling af patienter, der ikke er kastreret kirurgisk.
English: Figure 7: Overall survival by subgroup: hazard ratio and 95% confidence interval
Danish: Figur 7: Samlet overlevelse fordelt på subgrupper: hazard ratio og 95 % konfidensinterval
English: A score of 0-1 on Brief Pain Inventory-Short Form (BPI-SF) worst pain in last 24 hours was considered asymptomatic, and a score of 2-3 was considered mildly symptomatic.
Danish: En score på 0-1 på Brief Pain Inventory-Short Form (BPI-SF) for værste smerte i løbet af de seneste 24 timer ansås som asymptomatisk, mens en score på 2-3 ansås som lettere symptomatisk.
English: Abiraterone affected fertility in male and female rats, but these effects were fully reversible (see section 5.3).
Danish: Abirateron påvirkede fertiliteten hos han- og hunrotter, men disse virkninger var fuldt reversible (se pkt.
English: 120 tablets
Danish: 120 tabletter
English: In patients with pre-existing hypokalaemia or those that develop hypokalaemia whilst being treated with ZYTIGA, consider maintaining the patient's potassium level at ≥ 4.0 mM.
Danish: Hos patienter med præ-eksisterende hypokaliæmi og patienter, der udvikler hypokaliæmi under behandling med ZYTIGA, skal det overvejes at holde patientens kaliumniveau ≥ 4,0 mM.
English: This is important because ZYTIGA may increase the effects of a number of medicines including heart medicines, tranquilisers, herbal medicines (e.g., St John's wort) and others.
Danish: Det er vigtigt, fordi ZYTIGA kan forstærke virkningen af en række lægemidler, herunder blandt andet hjertemedicin, beroligende midler, naturlægemidler (f.eks. perikon) og anden medicin.
English: Hazard ratio is from stratified proportional hazards model.
Danish: Hazard ratio er fra en stratificeret proportional hazards-model.
English: A condom is required if the patient is engaged in sexual activity with a pregnant woman.
Danish: Der bør anvendes kondom, hvis patienten dyrker sex med en gravid kvinde.
English: - Women who are or may potentially be pregnant (see section 4.6).
Danish: - Kvinder, som er eller kan være gravide (se pkt.
English: Human experience of overdose with ZYTIGA is limited.
Danish: Der er begrænset erfaring med overdosering med ZYTIGA hos mennesker.
English: A statistically significant improvement in median overall survival was seen in patients treated with ZYTIGA (see Table 7).
Danish: Der sås en statistisk signifikant forbedring i den mediane samlede overlevelse hos patienter, der blev behandlet med ZYTIGA (se tabel 7).
English: Hazard ratio <1 favors AA-P.
Danish: Hazard ratio < 1 indikerer en fordel for AA-P
English: Six hundred and seven (607) subjects had radiographic progression or died: 271 (50%) in the abiraterone acetate group and 336 (62%) in the placebo group.
Danish: 607 forsøgspersoner havde radiografisk progression eller døde: 271 (50 %) i abirateronacetatgruppen og 336 (62 %) i placebogruppen.
English: Androgen deprivation therapies, such as treatment with LHRH analogues or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumour.
Danish: Androgen deprivationsbehandling såsom behandling med LHRH-analog eller orkiektomi, nedsætter produktion af androgen i testiklerne, men påvirker ikke androgenproduktion i binyrerne eller i tumoren.
English: Efficacy was established in three randomised placebo-controlled multicentre Phase 3 clinical studies (studies 3011, 302 and 301) of patients with mHSPC and mCRPC.
Danish: ZYTIGAs virkning blev klarlagt i tre randomiserede, placebokontrollerede, kliniske fase 3-multicenterstudier (studie 3011, 302 og 301) med patienter med mHSPC og mCRPC.
English: In a study to determine the effects of abiraterone acetate (plus prednisone) on a single dose of the CYP2D6 substrate dextromethorphan, the systemic exposure (AUC) of dextromethorphan was increased approximately 2.9 fold.
Danish: I et studie til bestemmelse af virkningerne af abirateronacetat (plus prednison) efter en enkelt dosis af CYP2D6-substratet dextromethorphan steg den systemiske eksponering (AUC) for dextromethorphan ca. med faktor 2,9.
English: Polyvinyl alcohol Talc
Danish: Polyvinylalkohol Talkum
English: Hazard ratio is derived from a stratified proportional hazards model.
Danish: Hazard ratio er beregnet ud fra en stratificeret proportional hazards model.
English: Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death.
Danish: I sjældne tilfælde kan leveren holde op med at fungere (dette kaldes akut leversvigt), hvilket kan være dødeligt.
English: Administration of abiraterone acetate with food, compared with administration in a fasted state, results in up to a 10-fold (AUC) and up to a 17-fold (Cmax) increase in mean systemic exposure of abiraterone, depending on the fat content of the meal.
Danish: Administration af abirateronacetat i forbindelse med et måltid sammenlignet med administration i fastende tilstand resulterede i en stigning på op til en faktor 10 [AUC] og op til en faktor 17 [Cmax] i gennemsnitlig systemisk eksponering for abirateron, afhængigt af måltidets fedtindhold.
English: - ZYTIGA with prednisone or prednisolone is contraindicated in combination with Ra-223.
Danish: - ZYTIGA med prednison eller prednisolon er kontraindiceret i kombination med Ra-223.
English: If ZYTIGA is continued after corticosteroids are withdrawn, patients should be monitored for symptoms of mineralocorticoid excess (see information above).
Danish: Hvis ZYTIGA fortsættes efter kortikosteroidbehandlingen er stoppet, bør patienterne overvåges for symptomer på en forhøjet mængde mineralokortikoider (se ovenfor).
English: The mean half-life of abiraterone in plasma is approximately 15 hours based on data from healthy subjects.
Danish: Abiraterons gennemsnitlige halveringstid er ca. 15 timer baseret på data fra raske forsøgspersoner.
English: What you need to know before you take ZYTIGA
Danish: Det skal du vide, før du begynder at tage ZYTIGA
English: This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues.
Danish: Dette enzym eksprimeres under og er nødvendigt for androgen biosyntese i tumorvæv i testikler, binyrer og prostata.
English: Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Danish: Det bør overvejes at reducere doseringen af lægemidler med snævert terapeutisk indeks, der metaboliseres af CYP2D6.
English: Do not break the tablets.
Danish: Tabletterne må ikke knuses.
English: The incidence and severity of adverse events was higher in the subgroup of patients with baseline ECOG2 performance status grade and also in elderly patients (≥75 years).
Danish: Forekomsten og sværhedsgraden af bivirkningerne var højere i subgrupperne af patienter med ECOG2 i performancestatusgrad ved baseline såvel som hos ældre patienter (≥ 75 år).
English: In all studies spironolactone use was not allowed as spironolactone binds to the androgen receptor and may increase PSA levels.
Danish: I ingen af de tre studier var anvendelse af spironolacton tilladt, eftersom spironolacton binder til androgenreceptoren og kan øge PSA-koncentrationen.
English: Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels.
Danish: Spironolacton binder til androgenreceptoren og kan øge koncentrationen af prostataspecifikt antigen (PSA).
English: In the event of a missed daily dose of either ZYTIGA, prednisone or prednisolone, treatment should be resumed the following day with the usual daily dose.
Danish: Hvis en daglig dosis af enten ZYTIGA, prednison eller prednisolon springes over, skal behandlingen fortsætte næste dag med den sædvanlige daglige dosis.
English: In Study 3011, grade 3 or 4 hepatotoxicity was observed in 8.4% of patients treated with ZYTIGA.
Danish: I studie 3011 sås hepatotoksicitet af grad 3 eller 4 hos 8,4 % af de patienter, der blev behandlet med ZYTIGA.
English: In subjects with measurable soft tissue disease, significantly increased numbers of complete and partial tumor responses were seen with ZYTIGA treatment.
Danish: Blandt forsøgspersoner med registrerbar bløddelssygdom blev der set signifikant flere tilfælde af fuldstændigt eller delvist tumorrespons med ZYTIGA-behandling.
English: ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer.
Danish: ZYTIGA hindrer kroppen i at fremstille testosteron og kan derved nedsætte væksten af prostatacancer.
English: In a 24-month carcinogenicity study in the rat, abiraterone acetate increased the incidence of interstitial cell neoplasms in the testes.
Danish: I et 24måneders karcinogenicitetsstudie hos rotter øgede abirateronacetat incidensen af interstitialcelletumorer i testiklerne.
English: Study 3011 (patients with newly diagnosed high risk mHSPC) In Study 3011, (n=1199) the median age of enrolled patients was 67 years.
Danish: Studie 3011 (patienter med nydiagnosticeret mHSPC med høj risiko) I studie 3011 (n=1199) var medianalderen for de deltagende patienter 67 år.
English: Other important adverse reactions include, cardiac disorders, hepatotoxicity, fractures, and allergic alveolitis.
Danish: Andre vigtige bivirkninger omfatter hjertelidelser, levertoksicitet, frakturer og allergisk alveolitis.
English: Based on a cumulative review of the data in relation to latency of rhabdomyolysis/myopathy cases, almost half of these cases occurred between 1 to 6 months after initiation of therapy with abiraterone acetate (AA).
Danish: Baseret på en kumulativ gennemgang af data i forbindelse med latenstiden for tilfældene af rabdomyolyse/myopati forekom næsten halvdelen af disse tilfælde mellem 1 og 6 måneder efter indledning af behandling med abirateronacetat (AA).
English: For patients who develop hepatotoxicity during treatment (alanine aminotransferase [ALT] increases or aspartate aminotransferase [AST] increases above 5 times the upper limit of normal [ULN]), treatment should be withheld immediately (see section 4.4).
Danish: Hos patienter, som får levertoksicitet under behandlingen (alanin-aminotransferase [ALAT] eller aspartat-aminotransferase [ASAT] stiger til > 5 x øvre normalgrænse [ULN]), bør behandlingen omgående indstilles (se pkt.
English: In clinical trials, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline hepatitis or significant abnormalities of liver function tests.
Danish: I kliniske studier begrænsedes risikoen for hepatotoksicitet ved at udelukke patienter med baseline hepatitis eller signifikante unormale leverfunktionstest.
English: Excipients with known effect Each tablet contains 189 mg of lactose and 6.8 mg of sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 189 mg lactose og 6,8 mg natrium.
English: AA-P= subjects who received abiraterone acetate and prednisone.
Danish: AA-P=forsøgspersoner, der fik abirateronacetat og prednison.
English: C-abiraterone acetate as capsules, abiraterone acetate is hydrolysed to abiraterone, which then undergoes metabolism including sulphation, hydroxylation and oxidation primarily in the liver.
Danish: C-mærket abirateronacetat som kapsler hydrolyseres abirateronacetat til abirateron, som dernæst gennemgår metabolisme inklusiv omdannelse til sulfat, hydroxylering og oxidation primært i leveren.
English: CYP17 catalyses the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively, by 17α-hydroxylation and cleavage of the C17,20 bond.
Danish: CYP17 katalyserer konverteringen af henholdsvis pregnenolon og progesteron til testosteron-forstadierne DHEA og androstenedion ved hjælp af 17α-hydroxylering og spaltning af C17,20-bindingen.
English: Administration with food significantly increases the absorption of abiraterone acetate.
Danish: Administration sammen med føde medfører en signifikant øget absorption af abirateronacetat.
English: • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Danish: • behandling af (mCRPC) hos voksne mænd med progression af sygdommen under eller efter kemoterapi baseret på docetaxel.
English: ZYTIGA is for use in male patients only.
Danish: ZYTIGA er udelukkende beregnet til brug hos mandlige patienter.
English: - Do not take ZYTIGA with food.
Danish: - ZYTIGA må ikke tages sammen med mad.
English: During treatment, blood pressure, serum potassium, fluid retention (weight gain, peripheral oedema), and other signs and symptoms of congestive heart failure should be monitored every 2 weeks for 3 months, then monthly thereafter and abnormalities corrected.
Danish: Under behandlingen bør blodtryk, serumkalium, væskeretention (vægtstigning, perifere ødemer) og andre symptomer på kongestiv hjerteinsufficiens kontrolleres hver anden uge i tre måneder og derefter månedligt, og uregelmæssigheder skal korrigeres.
English: Patients that were treated with prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer were excluded with the exception of up to 3 months of ADT or 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease.
Danish: Patienter, der var blevet behandlet med tidligere farmakoterapi, stråleterapi eller operation af metastaserende prostatacancer blev ekskluderet med undtagelse af ADT i op til 3 måneder eller 1 forløb med palliativ stråling eller kirurgisk behandling af symptomer som følge af metastaserende sygdom.
English: Following administration of abiraterone acetate, the pharmacokinetics of abiraterone and abiraterone acetate have been studied in healthy subjects, patients with metastatic advanced prostate cancer and subjects without cancer with hepatic or renal impairment.
Danish: Efter administration af abirateronacetat blev farmakokinetikken af abirateron og abirateronacetat undersøgt hos raske forsøgspersoner, patienter med metastaserende avanceret prostatacancer og forsøgspersoner uden cancer med nedsat lever- eller nyrefunktion.
English: Administration in patients with renal impairment, including severe renal impairment, does not require dose reduction (see section 4.2).
Danish: Administration til patienter med nedsat nyrefunktion inklusiv alvorligt nedsat nyrefunktion kræver ikke dosisreduktion (se pkt.
English: In a separate clinical pharmacokinetic interaction study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.
Danish: I et separat klinisk farmakokinetisk interaktionsstudie med raske forsøgspersoner havde samtidig administration af ketoconazol, en potent CYP3A4-hæmmer, ingen klinisk relevant indvirkning på abiraterons farmakokinetik.
English: CTCAE (version 4.0) Grade 3 hypertriglyceridaemia and angina pectoris occurred in < 1% of patients.
Danish: CTCAE (version 4.0) grad 3-hypertriglyceridæmi og angina pectoris forekom hos < 1 % af patienterne.
English: A significant difference in rPFS between treatment groups was observed (see Table 2 and Figure 1).
Danish: Der blev observeret en signifikant forskel i rPFS mellem de 2 behandlingsgrupper (se tabel 2 og figur 1).
English: Anaemia and sexual dysfunction may occur in men with metastatic prostate cancer including those undergoing treatment with ZYTIGA.
Danish: Der kan opstå anæmi og seksuel dysfunktion hos mænd med metastaserende prostatacancer - også hos mænd i behandling med ZYTIGA.
English: Corticosteroid withdrawal and coverage of stress situations Caution is advised and monitoring for adrenocortical insufficiency should occur if patients are withdrawn from prednisone or prednisolone.
Danish: Seponering af kortikosteroider og håndtering af stressende situationer Forsigtighed tilrådes, og patienterne bør overvåges for adrenokortikal insufficiens, hvis de får stoppet behandling med prednison eller prednisolon.