FrancophonIA/ELRC3.0 huggingface dataset:
English: Induction of CYP3A4 by apalutamide suggests that UDP-glucuronosyl transferase (UGT) may also be induced via activation of the nuclear pregnane X receptor (PXR).
Danish: Apalutamids CYP3A4-induktion tyder på, at UDP-glucuronosyltransferase (UGT) også kan være induceret via aktivering af den nukleare pregnane X receptor (PXR).
English: Apalutamide treatment decreases tumor cell proliferation and increases apoptosis leading to potent antitumor activity.
Danish: Apalutamidbehandling reducerer tumorcelleproliferation og øger apoptose og deraf følgende potent antitumoraktivitet.
English: Injury, poisoning and procedural complications very common: fall
Danish: Traumer, forgiftninger og behandlingskomplikationer meget almindelig: fald
English: • If you forget to take Erleada for the whole day - take your usual dose the following day.
Danish: • Hvis du glemmer at tage Erleada hele dagen, skal du tage den sædvanlige dosis næste dag.
English: The recommended dose is 240 mg (four 60 mg tablets) as an oral single daily dose.
Danish: Den anbefalede dosis er 240 mg (fire 60 mg tabletter) som en enkelt oral daglig dosis.
English: An increase in apparent clearance (CL/F) was observed with repeat dosing, likely due to induction of apalutamide's own metabolism.
Danish: Der blev set en stigning i tilsyneladende clearance (CL/F) ved gentagen dosering, sandsynligvis på grund af induktion af apalutamids egen metabolisme.
English: Fifteen percent (15%) of subjects had < 2 cm pelvic lymph nodes at study entry.
Danish: Femten procent (15 %) af forsøgsdeltagerne havde lymfeknuder i bækkenet < 2 cm, da de indgik i studiet.
English: This medicine contains less than 1 mmol sodium (23 mg) per 240 mg dose (4 tablets), that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis på 240 mg (4 tabletter), dvs. det er i det væsentlige natriumfrit.
English: Бизнес Парк София, сграда 4 София 1766
Danish: Бизнес Парк София, сграда 4
English: Tell your healthcare provider right away if you notice any of the serious side effects above.
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du bemærker en af ovenstående alvorlige bivirkninger.
English: • lower cholesterol levels (e.g. ‘statins' such as rosuvastatin, simvastatin)
Danish: • sænkning af kolesterol (f.eks. ”statiner” såsom rosuvastatin, simvastatin)
English: • falls or fractures (broken bones) - these are very common (may affect more than 1 in
Danish: • fald eller brud (brækkede knogler) - disse bivirkninger er meget almindelige (kan forekomme hos flere end 1 ud af 10 personer).
English: Patients should be evaluated for fractures and fall risk before starting Erleada and should continue to be monitored and managed for fractures according to established treatment guidelines and use of bone-targeted agents should be considered.
Danish: Patienterne skal have vurderet deres risiko for frakturer og fald inden opstart af Erleada, og skal løbende monitoreres og behandles for frakturer i henhold til gældende behandlingsretningslinjer, og det bør overvejes at anvende knoglespecifikke midler.
English: Apalutamide prevents AR nuclear translocation, inhibits DNA binding, impedes AR-mediated transcription, and lacks androgen receptor agonist activity.
Danish: Apalutamid forhindrer AR-nuklear translokation, hæmmer DNA-binding, hæmmer AR-medieret transskription og er uden androgenreceptoragonistaktivitet.
English: Grade 3 skin rashes (defined as covering > 30% body surface area [BSA]) were reported with Erleada treatment in 5.2% of patients.
Danish: Hududslæt af grad 3 (defineret som dækkende > 30 % af legemsoverfladearealet [BSA]) blev indberettet hos 5,2 % af patienterne i behandling med Erleada.
English: Eighty-one percent of patients had resolution of rash with a median of 60 days to resolution.
Danish: Hos 81 % af patienterne forsvandt udslættet med en mediantid til resolution på 60 dage.
English: Based on animal studies, Erleada may decrease fertility in males of reproductive potential (see section 5.3).
Danish: Baseret på dyreforsøg kan Erleada reducere fertiliteten hos mænd med reproduktionspotentiale (se pkt.
English: Apalutamide and N-desmethyl apalutamide are 96% and 95% bound to plasma proteins, respectively, and mainly bind to serum albumin with no concentration dependency.
Danish: Apalutamid og N-desmethylapalutamid har en plasmaproteinbindingsgrad på henholdsvis 96 % og 95 % og bindes primært til serumalbumin uafhængigt af koncentrationen.
English: Subjects randomised to either arm were to continue treatment until disease progression defined by blinded central imaging review (BICR), initiation of new treatment, unacceptable toxicity or withdrawal.
Danish: De randomiserede patienter i begge arme skulle fortsætte behandlingen indtil sygdomsprogression påvist ved en blindet, central billedgennemgang (BICR), iværksættelse af ny behandling, uacceptabel toksicitet eller seponering.
English: Metabolism and nutrition disorders common: hypercholesterolaemia common: hypertriglyceridaemia
Danish: Metabolisme og ernæring almindelig: hyperkolesterolæmi almindelig: hypertriglyceridæmi
English: Clinical and pharmacokinetic data are not available for patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Der foreligger ingen kliniske og farmakokinetiske data for patienter med svært nedsat leverfunktion (Child-Pugh-klasse C).
English: There is no relevant use of apalutamide in the paediatric population in the treatment of non-metastatic castration-resistant prostate cancer.
Danish: Det er ikke relevant at anvende apalutamid i den pædiatriske population til behandling af ikke-metastatisk kastrationsresistent prostatacancer.
English: Apalutamide is a potent enzyme inducer and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected.
Danish: Apalutamid er en potent enzyminduktor og øger syntesen af mange enzymer og transportører; der forventes derfor interaktion med mange almindelige lægemidler, som er substrater for enzymer eller transportører.
English: The effect of apalutamide 240 mg once daily on the QTc interval was assessed in an open-label, uncontrolled, multi-center, single-arm dedicated QT study in 45 patients with CRPC.
Danish: Virkningen af apalutamid 240 mg en gang dagligt på QTc-intervallet blev vurderet i et åbent, ukontrolleret, QT-dedikeret multicenterstudie med en enkelt arm hos 45 patienter med CRPC.
English: Metastasis-free survival (MFS) was the primary endpoint, defined as the time from randomisation to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first.
Danish: Det primære endepunkt var metastasefri overlevelse (MFS), hvilket var defineret som tiden fra randomisering til første BICR-bekræftede fjernmetastase i knogler eller bløddele eller død af enhver årsag, alt efter hvad der indtrådte først.
English: Seizure occurred in 0.2% of patients receiving Erleada in clinical studies.
Danish: Krampeanfald forekom hos 0,2 % af de patienter, der fik Erleada i kliniske studier.
English: Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated.
Danish: Medicinsk kastration med gonadotropinfrigivende hormonanaloger (GnRHa) bør fortsættes under behandling af patienter, der ikke er kirurgisk kastreret.
English: The most common adverse reactions are fatigue (30%), skin rash (24% of any grade and 5% Grade 3 or 4), weight decreased (16%), arthralgia (16%), and fall (16%).
Danish: De mest almindelige bivirkninger er træthed (30 %), hududslæt (alle grader: 24 %; grad 3 eller 4: 5 %), vægttab (16 %), artralgi (16 %) og fald (16 %).
English: Erleada is a cancer medicine that contains the active substance apalutamide.
Danish: Erleada er et lægemiddel mod kræft, som indeholder det aktive stof apalutamid.
English: Animal reproductive studies have not been conducted with Erleada.
Danish: Der er ikke udført reproduktionsstudier med Erleada hos dyr.
English: Subjects enrolled had a Prostate Specific Antigen (PSA) Doubling Time (PSADT) ≤ 10 months, considered to be at high risk of imminent metastatic disease and prostate cancer-specific death.
Danish: De inkluderede forsøgsdeltagere havde en PSA-fordoblingstid (PSADT) ≤ 10 måneder og blev vurderet at have en høj risiko for forestående metastatisk sygdom og prostatacancer-specifik død.
English: • take this package leaflet with you to show to the emergency doctor.
Danish: • Medbring denne indlægsseddel, og vis den til lægen.
English: In the apalutamide arm, 62 (7.7%) subjects died compared to 42 (10.5%) subjects in the placebo arm.
Danish: I apalutamid-armen døde 62 (7,7 %) forsøgsdeltagere sammenlignet med 42 (10,5 %) forsøgsdeltagere i placeboarmen.
English: An exposure-QT analysis suggested a concentration-dependent increase in QTcF for apalutamide and its active metabolite.
Danish: En eksponerings-QT-analyse tydede på en koncentrationsafhængig stigning i QTcF med apalutamid og dets aktive metabolit.
English: Talk to your doctor or pharmacist before taking this medicine if:
Danish: Kontakt lægen eller apotekspersonalet, før du tager dette lægemiddel, hvis:
English: Because apalutamide is completely absorbed after oral administration, P-gp does not limit the absorption of apalutamide and therefore, inhibition or induction of P-gp is not expected to affect the bioavailability of apalutamide.
Danish: Eftersom apalutamid absorberes fuldstændigt efter oral administration, begrænser P-gp ikke absorptionen af apalutamid, og derfor forventes P-gp-hæmning eller -induktion ikke at påvirke biotilgængeligheden af apalutamid.
English: Erleada may be harmful to a developing foetus.
Danish: Erleada kan være skadeligt for et foster.
English: Falls and fractures
Danish: Fald og frakturer
English: Erleada is not recommended in patients with a history of seizures or other predisposing factors including, but not limited to, underlying brain injury, recent stroke (within one year), primary brain tumours or brain metastases.
Danish: Erleada frarådes til patienter med krampeanfald i anamnesen eller andre prædisponerende faktorer, herunder men ikke begrænset til, underliggende hjerneskade, nylig apopleksi (inden for det seneste år), primære hjernetumorer eller hjernemetastaser.
English: Following a single oral administration of radiolabeled apalutamide, 89% of the radioactivity was recovered up to 70 days post-dose: 65% was recovered in urine (1.2% of dose as unchanged apalutamide and 2.7% as N-desmethyl apalutamide) and 24% was recovered in feces (1.5% of dose as unchanged apalutamide and 2% as N-desmethyl apalutamide).
Danish: Efter en enkelt oral administration af radiomærket apalutamid blev 89 % af radioaktiviteten genfundet op til 70 dage efter indgivelsen: 65 % blev genfundet i urinen (1,2 % af dosen som uomdannet apalutamid og 2,7 % som N-desmethylapalutamid), og 24 % blev genfundet i fæces (1,5 % af dosen som uomdannet apalutamid og 2 % som N-desmethylapalutamid).
English: Potential for apalutamide to affect exposures to other medicinal products
Danish: Apalutamids potentielle indvirkning på eksponeringen for andre lægemidler
English: If you forget to take Erleada
Danish: Hvis du har glemt at tage Erleada
English: It is not known whether apalutamide or its metabolites are present in semen.
Danish: Det er ukendt, om apalutamid eller dets metabolitter forekommer i sæd.
English: Erleada is contraindicated in women who are or may become pregnant (see section 4.3).
Danish: Erleada er kontraindiceret hos kvinder, der er eller kan blive gravide (se pkt.
English: Based on systemic exposure, relative potency, and pharmacokinetic properties, N-desmethyl apalutamide likely contributed to the clinical activity of apalutamide.
Danish: Baseret på systemisk eksponering, relativ potens og farmakokinetiske egenskaber bidrager N-desmethylapalutamid sandsynligvis til apalutamids kliniske virkning.
English: Skin rash associated with Erleada was most commonly described as macular or maculo-papular.
Danish: Hududslæt i forbindelse med Erleada blev oftest beskrevet som makulært eller makulopapuløst.
English: Seventy-three percent (73%) of subjects received prior treatment with a first generation anti-androgen; 69% of subjects received bicalutamide and 10% of subjects received flutamide.
Danish: Treoghalvfjerds procent (73 %) af forsøgsdeltagerne fik forudgående behandling med et førstegenerations-anti-androgen; 69 % af forsøgsdeltagerne fik bicalutamid, og 10 % af forsøgsdeltagerne fik flutamid.
English: There is no clinical experience in re-administering Erleada to patients who experienced a seizure.
Danish: Der er ingen klinisk erfaring med at genoptage behandlingen med Erleada hos patienter, der har oplevet et krampeanfald.
English: Mention to your doctor that you are taking Erleada if the doctor wants to start you on any new medicine.
Danish: Fortæl lægen, at du tager Erleada, hvis lægen vil ordinere et nyt lægemiddel til dig.
English: • under-active thyroid which can make you feel more tired and have difficulty getting started in the morning, and blood tests may also show an under-active thyroid
Danish: • nedsat skjoldbruskkirtelfunktion, hvilket kan forårsage øget træthed og problemer med at komme i gang om morgenen, og blodprøver kan også vise nedsat skjoldbruskkirtelfunktion
English: • If you are having sex with a woman who can become pregnant - use a condom and another highly effective method of contraception.
Danish: • Hvis du dyrker sex med en kvinde, som kan blive gravid, skal du bruge kondom og en anden meget sikker præventionsmetode.
English: Erleada did not cause clinically meaningful changes in exposure to the CYP2C8 substrate.
Danish: Erleada forårsagede ikke klinisk betydningsfulde forandringer i eksponeringen for CYP2C8-substratet.
English: Apalutamide was negative for genotoxicity in a standard battery of in vitro and in vivo tests.
Danish: Apalutamid var negativ for genotoksicitet en i en række standardtest in vitro og in vivo.
English: Daily fluctuations in apalutamide plasma concentrations were low, with mean peak-to-trough ratio of 1.63.
Danish: De daglige udsving i plasmakoncentrationen af apalutamid var lave med en gennemsnitlig top/dal-ratio på 1,63.
English: N-desmethyl apalutamide is characterised by a flat concentration-time profile at steady-state with a mean peak-to-trough ratio of 1.27.
Danish: N-desmethylapalutamid er kendetegnet ved en flad koncentrations-/tidsprofil ved steady state med en gennemsnitlig top/dal-ratio på 1,27.
English: A review of concomitant medicinal products should therefore be conducted when apalutamide treatment is initiated.
Danish: Derfor bør der foretages en gennemgang af samtidig brug af andre lægemidler ved opstart af apalutamidbehandling.
English: The risk of seizure may be increased in patients receiving concomitant medicinal products that lower the seizure threshold.
Danish: Risikoen for krampeanfald kan være forøget hos patienter, der samtidig modtager behandling med lægemidler, der sænker krampetærsklen.
English: There is no known specific antidote for apalutamide overdose.
Danish: Der findes intet specifikt antidot mod overdosering af apalutamid.
English: Adverse reactions in the event of an overdose has not yet been observed, it is expected that such reactions would resemble the adverse reactions listed in section 4.8.
Danish: Der er endnu ikke observeret tilfælde af overdosering med bivirkninger, men sådanne reaktioner forventes at ligne de bivirkninger, der er nævnt i pkt.
English: Apalutamide is an orally administered, selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.
Danish: Apalutamid er en oralt administreret, selektiv androgenreceptor-hæmmer (AR-hæmmer), som bindes direkte til det ligandbindende domæne på AR.
English: • If you are having sex with a pregnant woman - use a condom to protect the unborn baby.
Danish: • Hvis du dyrker sex med en gravid kvinde, skal du bruge kondom for at beskytte fostret.
English: A total of 1207 subjects with NM-CRPC were randomised 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with androgen deprivation therapy (ADT) (medical castration or prior surgical castration) or placebo with ADT in a multicenter, double-blind, clinical study (Study ARN-509-003).
Danish: I alt 1207 forsøgsdeltagere med NM-CRPC blev randomiseret i forholdet 2:1 til at få enten oralt administreret apalutamid i en dosis på 240 mg én gang dagligt i kombination med androgen deprivationsbehandling (ADT) (medicinsk kastration eller forudgående kirurgisk kastration) eller placebo med ADT i et dobbeltblindet, klinisk multicenterstudie (studie ARN-509-003).
English: Extra tablets should not be taken to make up the missed dose.
Danish: Der må ikke tages ekstra tabletter som erstatning for den glemte dosis.
English: Apalutamide and N-desmethyl apalutamide do not affect CYP1A2 and CYP2D6 at therapeutically relevant concentrations.
Danish: Apalutamid og N-desmethylapalutamid påvirker ikke CYP1A2 og CYP2D6 ved terapeutisk relevante koncentrationer.
English: Apalutamide was shown to be a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically.
Danish: Det er påvist, at apalutamid er en svag induktor af P-glykoprotein (P-gp), brystcancerresistent protein (BCRP) og organisk anion-transportpolypeptid 1B1 (OATP1B1) klinisk.
English: • The other ingredients of the tablet core are colloidal anhydrous silica, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose.
Danish: • Øvrige indholdsstoffer i tabletkernen: kolloid vandfri silica, croscarmellosenatrium, hypromelloseacetatsuccinat, magnesiumstearat, mikrokrystallinsk cellulose og silicificeret mikrokrystallinsk cellulose.
English: Danmark Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
Danish: Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
English: Erleada is indicated in adult men for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC) who are at high risk of developing metastatic disease (see section 5.1).
Danish: Erleada er indiceret hos voksne mænd til behandling af ikke-metastatisk kastrationsresistent prostatacancer (NM-CRPC), som har høj risiko for at udvikle metastatisk sygdom (se pkt.
English: The tablets may be supplied either in a bottle or in a wallet pack.
Danish: Tabletterne kan enten udleveres i en beholder eller i et etui.
English: Following repeat once-daily dosing, apalutamide exposure (Cmax and area under the concentration curve [AUC]) increased in a dose-proportional manner across the dose range of 30 to 480 mg.
Danish: Efter gentagen dosering én gang dagligt steg eksponeringen for apalutamid (Cmax og arealet under koncentrationskurven [AUC]) dosisproportionelt i dosisområdet 30 til 480 mg.
English: If you take more than you should, stop taking Erleada and contact your doctor.
Danish: Hvis du har taget for meget Erleada, skal du stoppe med at tage det og kontakte lægen.
English: Apalutamide and N-desmethyl apalutamide are further metabolised to form the inactive carboxylic acid metabolite by carboxylesterase.
Danish: Apalutamid og N-desmethylapalutamid metaboliseres desuden til den inaktive carboxylsyremetabolit via carboxylesterase.
English: In vitro data indicate that apalutamide and its N-desmethyl metabolite are not substrates for BCRP, OATP1B1 or OATP1B3.
Danish: In vitro-data viser, at apalutamid og dets N-desmethylmetabolit ikke er substrater for BCRP, OATP1B1 eller OATP1B3.
English: The contribution of CYP2C8 and CYP3A4 in the metabolism of apalutamide is estimated to be 58% and 13% following single dose but the level of contribution is expected to change at steady-state due to induction of CYP3A4 by apalutamide after repeat dose.
Danish: CYP2C8's og CYP3A4's bidrag til metaboliseringen af apalutamid estimeres at være 58 % og 13 % efter enkeltdoser, men bidragets omfang forventes at ændres ved steady state, eftersom apalutamid inducerer CYP3A4 efter gentagne doser.
English: There were no statistically significant differences observed in the change from baseline analysis of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) for the total score or any of the subscales between subjects on Erleada added to ADT versus placebo with ADT.
Danish: Der blev ikke set nogen statistisk signifikante forskelle i ændringen i FACT-P (Functional Assessment of Cancer Therapy-Prostate) i forhold til baseline, hvad angik totalscoren og underskalaerne, mellem de forsøgsdeltagere, der fik Erleada i tillæg til ADT, og dem, der fik placebo med ADT.
English: Apalutamide is an inducer of enzymes and transporters and may lead to an increase in elimination of many commonly used medicinal products.
Danish: Apalutamid er en enzym- og transportør-induktor og kan medføre øget elimination af mange almindeligt anvendte lægemidler.
English: No in vitro inhibition of organic anion transporter 1 (OAT1) was observed.
Danish: Der blev ikke set nogen hæmning af organisk aniontransportør 1 (OAT1) in vitro.
English: Tell your doctor if you are taking medicines that:
Danish: Fortæl det til lægen, hvis du tager lægemidler til:
English: In vitro, apalutamide and its N-desmethyl metabolite are substrates for P-gp.
Danish: In vitro er apalutamid og dets N-desmethyl-metabolit substrater for P-gp.
English: • treat heart conditions or lower blood pressure (e.g. digoxin, felodipine)
Danish: • behandling af hjertesygdomme eller sænkning af blodtrykket (f.eks. digoxin, felodipin)
English: If given with warfarin, INR should be monitored during Erleada treatment.
Danish: Ved samtidig brug af warfarin skal INR monitoreres under behandlingen med Erleada.
English: In Study ARN-509-003, fracture was reported for 11.7% of patients treated with Erleada and 6.5% of patients treated with placebo.
Danish: I studie ARN-509-003 blev der rapporteret om fraktur hos 11,7 % af de patienter, der blev behandlet med Erleada, og hos 6,5 % af de patienter, der blev behandlet med placebo.
English: Apalutamide, mainly in the form of metabolites, is eliminated primarily via urine.
Danish: Apalutamid elimineres primært via urinen, hovedsageligt i form af metabolitter.
English: * Includes hypothyroidism, blood thyroid stimulating hormone increased, thyroxine decreased, autoimmune thyroiditis,
Danish: * Omfatter hypothyreoidisme, øget indhold af thyroideastimulerende hormon i blodet, reduceret thyroxin, autoimmun thyroiditis, reduceret frit thyroxin, reduceret triiodthyronin
English: Patients with clinically significant cardiovascular disease in the past 6 months including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias were excluded from the clinical studies.
Danish: Patienter med klinisk signifikant kardiovaskulær sygdom inden for de seneste 6 måneder, herunder svær/ustabil angina, myokardieinfarkt, symptomatisk kongestiv hjerteinsufficiens, arterielle eller venøse tromboemboliske hændelser (f.eks. lungeemboli, cerebrovaskulære hændelser, herunder transitorisk iskæmisk attak) eller klinisk signifikante ventrikulære arytmier, blev udelukket fra de kliniske studier.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne anført efter faldende alvorsgrad.
English: No dose adjustment is necessary for patients with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let eller moderat nedsat leverfunktion ved baseline (hhv. Child-Pugh-klasse A og B).
English: • The active substance is apalutamide.
Danish: • Aktivt stof: apalutamid.
English: ibutilide)
Danish: ibutilid)