FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately 25% of patients had primary endocrine resistance (progression on endocrine therapy within the first 2 years of adjuvant endocrine therapy or within the first 6 months of first line endocrine therapy for metastatic breast cancer) and for the majority, endocrine resistance developed later.
Danish: Cirka 25 % af patienterne havde primær endokrin resistens (progression på endokrin behandling i løbet af de første 2 år med adjuverende endokrin behandling eller i løbet af de første 6 måneder med endokrin førstelinjebehandling for metastatisk brystcancer), og størstedelen udviklede endokrin resistens senere.
English: Abemaciclib blocks the effects of proteins called cyclin-dependent kinase 4 and 6.
Danish: Abemaciclib blokerer virkningerne af nogle proteiner, der kaldes for cyklinafhængig kinase 4 og 6.
English: The primary biotransformation is hydroxylation to a metabolite that circulates with an AUC that is 77% of parent drug.
Danish: Den primære biotransformationen sker via hydroxylering til en metabolit, der cirkulerer med et AUC, der er 77 % af moderstoffet.
English: Adverse reactions reported in phase 3 studies of abemaciclib in combination with endocrine therapy (N=768)
Danish: Bivirkninger indberettet i fase 3-studier med abemaciclib i kombination med endokrin behandling (N=768)
English: These circulating metabolites are active with similar potency to abemaciclib.
Danish: Disse cirkulerende metabolitter er aktive og har samme potens som abemaciclib.
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Danish: Brug ikke dette lægemiddel, hvis du bemærker, at pakningen er i stykker eller viser tegn på, at nogen har forsøgt at åbne den.
English: Patients receiving abemaciclib should not breast-feed.
Danish: Patienter, der får abemaciclib, bør ikke amme.
English: Elevation in AST and/or ALT >3 x ULN WITH total bilirubin >2 x ULN, in the absence of cholestasis
Danish: Stigning i ASAT og/eller ALAT >3 x ULN MED total bilirubin >2 x ULN, ved fravær af kolestase
English: If you vomit after taking the dose or forget a dose, take your next dose at your usual time.
Danish: Hvis du kaster op, efter du har taget en dosis, eller hvis du glemmer en dosis, skal du tage den næste dosis på det sædvanlige tidspunkt.
English: Abemaciclib was teratogenic and caused decreased foetal weight at maternal exposures similar to the recommended human dose.
Danish: Abemaciclib var teratogent og forårsagede reduceret fostervægt ved maternelle eksponeringer, der svarede til den anbefalede humane dosis.
English: Overall survival was not mature at the final PFS analysis (93 events observed across the two arms).
Danish: Den samlede overlevelse var ikke moden ved endelig analyse af PFS (93 observerede hændelser på tværs af de to arme).
English: Concentrations of abemaciclib and its active metabolites in cerebrospinal fluid are comparable to unbound plasma concentrations.
Danish: Koncentrationerne af abemaciclib og dets aktive metabolitter i cerebrospinalvæsken er sammenlignelige med de ubundne plasmakoncentrationer.
English: The safety and efficacy of abemaciclib in children and adolescents aged less than 18 years has not been established.
Danish: Abemaciclibs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Patients should be advised to be cautious when driving or using machines in case they experience fatigue or dizziness during treatment with Verzenios (see section 4.8).
Danish: Patienterne bør rådes til at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, hvis de oplever træthed eller svimmelhed under behandlingen med Verzenios (se pkt.
English: This was found to be due to reduced renal secretion with unaffected glomerular filtration.
Danish: Dette skyldtes nedsat renal sekretion uden påvirkning af den glomerulære filtration.
English: Abemaciclib is highly bound to plasma proteins in humans (mean bound fraction approximately 96% to 98%).
Danish: Abemaciclib bindes i høj grad til plasmaproteiner hos mennesker (gennemsnitlig bindingsgrad på 96 % til 98 %).
English: It is unknown whether abemaciclib is excreted in human milk.
Danish: Det er ukendt, om abemaciclib udskilles i human mælk.
English: Verzenios is not recommended during pregnancy and in women of child-bearing potential not using contraception.
Danish: Det frarådes at anvende Verzenios under graviditeten og til kvinder i den fertile alder, som ikke anvender kontraception.
English: After a single oral dose of [14C] -abemaciclib, approximately 81% of the dose was excreted in faeces and 3.4% excreted in urine.
Danish: Efter en enkelt oral dosis [14C]-abemaciclib blev cirka 81 % af dosen udskilt i fæces og 3,4 % i urinen.
English: PCTFE/PE/PVC blisters sealed with an aluminium foil in a calendar blister card, in packs of 14, 28, 42, 56, 70 or 168 film-coated tablets.
Danish: PCTFE/PE/PVC-blister forseglet med aluminiumsfolie i et kalenderblisterkort, i pakninger med 14, 28, 42, 56, 70 eller 168 filmovertrukne tabletter.
English: Management recommendations for diarrhoea
Danish: Anbefalinger vedrørende håndtering af diarré
English: Very common Decreased appetite
Danish: Meget almindelig Nedsat appetit
English: Patients should be monitored for signs and symptoms of infection and treated as medically appropriate.
Danish: Patienterne skal monitoreres for tegn og symptomer på infektion og have passende medicinsk behandling.
English: Persistent or recurrent Grade 2 toxicity that does not resolve with maximal supportive measures to baseline or Grade 1 within 7 days
Danish: Vedvarende eller tilbagevendende toksicitet af grad 2, som ikke bedres til baseline eller grad 1 i løbet af 7 dage med maksimale understøttende tiltag
English: Steady state was achieved within 5 days following repeated twice daily dosing, and abemaciclib accumulated with a geometric mean accumulation ratio of 3.7 (58% CV) and 5.8 (65% CV) based on Cmax and AUC, respectively.
Danish: Steady state blev nået i løbet af 5 dage efter gentagen dosering to gange dagligt, og abemaciclib blev akkumuleret med en geometrisk middelværdi for akkumulationsratioen på 3,7 (58 % CV) og 5,8 (65 % CV) baseret på hhv. Cmax og AUC.
English: Approximately 39% of patients had received chemotherapy and 44% had received antihormonal therapy in the (neo)adjuvant setting.
Danish: Cirka 39 % af patienterne havde fået kemoterapi, og 44 % havde fået antihormonel behandling i (neo)adjuverende regi.
English: The half-life of abemaciclib increased from 24 to 55 hours (see section 4.2).
Danish: Abemaciclibs halveringstid steg fra 24 til 55 timer (se pkt.
English: Patients with prior (neo)adjuvant endocrine therapy must have completed this therapy at least 12 months before study randomisation.
Danish: Patienter, der havde fået forudgående (neo)adjuverende endokrin behandling, skulle have afsluttet denne behandling mindst 12 måneder inden randomiseringen i studiet.
English: The majority of the dose eliminated in faeces was metabolites.
Danish: Størstedelen af den udskilte dosis i fæces var metabolitter.
English: Although not an adverse reaction, abemaciclib has been shown to increase serum creatinine in 98.3% of patients (based on laboratory findings), 1.9% Grade 3 or 4 (based on laboratory findings).
Danish: Selvom det ikke er en bivirkning, har abemaciclib vist sig at øge serumkreatinin hos 98,3 af patienterne (baseret på laboratoriefund); 1,9 % grad 3 eller 4 (baseret på laboratoriefund).
English: Mild and moderate renal impairment had no effect on the exposure of abemaciclib.
Danish: Let og moderat nyreinsufficiens havde ingen indvirkning på eksponeringen for abemaciclib.
English: Verzenios film-coated tablets come in different strengths:
Danish: Verzenios filmovertrukne tabletter fås i forskellige styrker:
English: Grade 4 (>20.0 x ULN)
Danish: Grad 4 (>20,0 x ULN)
English: Pregnancy You should not use Verzenios if you are pregnant.
Danish: Graviditet Du bør ikke bruge Verzenios, hvis du er gravid.
English: Approximately 56% patients had visceral metastases.
Danish: Cirka 56 % af patienterne havde viscerale metastaser.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: The geometric mean systemic volume of distribution is approximately 750 L (69% CV), indicating distribution of abemaciclib into tissues.
Danish: Den geometriske middelværdi for distributionsvoluminet er cirka 750 l (69 % CV), hvilket viser, at abemaciclib fordeles til vævene.
English: Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), and most active against Cyclin D1/CDK4 in enzymatic assays.
Danish: Abemaciclib er en potent og selektiv hæmmer af cyklinafhængig kinase 4 og 6 (CDK4 og CDK6) og mest aktiv over for cyklin D1/CDK4 i enzymanalyser.
English: Mon. Tue.
Danish: Man. Tirs.
English: Common Lacrimation increased
Danish: Almindelig Øget tåresekretion
English: The effect of abemaciclib on fertility in humans is unknown.
Danish: Abemaciclibs virkning på fertiliteten hos mennesker kendes ikke.
English: However, cytotoxic effects to the male reproductive tract in rats and dogs indicate that abemaciclib may impair fertility in males (see section 5.3).
Danish: Cytotoksiske virkninger på hannernes reproduktionsveje hos rotter og hunde tyder dog på, at abemaciclib kan nedsætte fertiliteten hos mænd (se pkt.
English: There are no data on the efficacy and safety of abemaciclib in patients with visceral crisis.
Danish: Der foreligger ingen data vedrørende abemaciclibs virkning og sikkerhed hos patienter med visceral krise.
English: These results correspond to a clinically meaningful reduction in the risk of disease progression or death of 44.7% and a 7.2 month improvement in median PFS for patients treated with Verzenios plus fulvestrant.
Danish: Disse resultater svarer til en klinisk betydningsfuld reduktion i risikoen for sygdomsprogression eller død på 44,7 % og en forbedring på 7,2 måneder i median-PFS for de patienter, der blev behandlet med Verzenios plus fulvestrant.
English: Take Verzenios continuously for as long as your doctor tells you to.
Danish: Bliv ved med at tage Verzenios, så længe lægen anviser det.
English: Grade 3 or 4 or requires hospitalisation a NCI CTCAE
Danish: Grad 3 eller 4 eller hospitaliseringskrævende a NCI CTCAE
English: It should not be taken with grapefruit or grapefruit juice (see section 4.5).
Danish: Den bør ikke tages sammen med grapefrugt eller grapefrugtjuice (se pkt.
English: Overall survival was not mature at the final PFS analysis (133 events observed across the two arms).
Danish: Den samlede overlevelse var umoden ved den endelige analyse af PFS (133 observerede hændelser på tværs af de to arme).
English: How to take Verzenios Recommended dose
Danish: Sådan skal du tage Verzenios Anbefalet dosis
English: Examples of strong CYP3A4 inhibitors include, but not limited to: clarithromycin, itraconazole, ketoconazole, lopinavir/ritonavir, posaconazole or voriconazole.
Danish: Eksempler på stærke CYP3A4-hæmmere inkluderer, men er ikke begrænset til: Clarithromycin, itraconazol ketoconazol, lopinavir/ritonavir, posaconazol og voriconazol.
English: A high-fat meal increased combined AUC of abemaciclib and its active metabolites by 9% and increased Cmax by 26%.
Danish: Et måltid med højt fedtindhold øgede det samlede AUC for abemaciclib og dets aktive metabolitter med 9 % og øgede Cmax med 26 %.
English: In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Danish: I et klinisk studie med patienter med brystcancer var der ingen klinisk relevante farmakokinetiske interaktioner mellem abemaciclib og anastrozol, fulvestrant, exemestan, letrozol eller tamoxifen.
English: You should avoid becoming pregnant while taking Verzenios.
Danish: Du bør undgå at blive gravid, mens du tager Verzenios.
English: Verzenios in combination with endocrine therapy
Danish: Verzenios i kombination med endokrin behandling
English: The European Medicines Agency has waived the obligation to submit the results of studies with Verzenios in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Verzenios i alle undergrupper af den pædiatriske population med brystcancer (se pkt.
English: In addition, Ndesethyl and N-desethylhydroxy metabolites circulate at AUCs that are 39% and 15% of parent drug.
Danish: Der cirkulerer desuden Ndesethyl- og N-desethylhydroxymetabolitter med AUC'er, der er 39 % og 15 % af moderstoffet.
English: Approximately 22% of patients had bone-only disease, and 53% patients had visceral metastases.
Danish: Cirka 22 % af patienterne havde kun sygdom i knoglerne, og 53 % havde viscerale metastaser.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinases inhibitors, ATC code: L01XE50
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE50
English: The geometric mean hepatic clearance (CL) of abemaciclib was 21.8 L/h (39.8% CV), and the mean plasma elimination half-life for abemaciclib in patients was 24.8 hours (52.1% CV).
Danish: Den geometriske middelværdi for hepatisk clearance (CL) af abemaciclib var 21,8 l/t (39,8 % CV), og den gennemsnitlige halveringstid for abemaciclib i plasma var 24,8 timer (52,1 % CV).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Aluminium/aluminium perforated unit dose blisters of 28 x 1 film-coated tablets.
Danish: Aluminium/aluminium perforeret enkeltdosisblister med 28 x 1 filmovertrukne tabletter.
English: - Diarrhoea (which may affect more than 1 in 10 people).
Danish: - Diarré (som kan forekomme hos flere end 1 ud af 10 behandlede).
English: 17% of patients were pre/perimenopausal on ovarian suppression with a GnRH agonist.
Danish: 17 % af patienterne var præ-/perimenopausale kvinder i ovariehæmmende behandling med en GnRH-agonist.
English: Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Tables 1-5.
Danish: Det kan være nødvendigt at afbryde og/eller reducere doseringen, som angivet i tabel 1-5, for at håndtere visse bivirkninger.
English: Hazard ratio (95% CI) and p-value
Danish: Hazard ratio (95 % CI) og p-værdi
English: Renal clearance of abemaciclib and its metabolites is minor.
Danish: Den renale clearance af abemaciclib og dets metabolitter er beskeden.
English: Diarrhoea is the most common adverse reaction.
Danish: Diarré er den mest almindelige bivirkning.
English: The median age of patients enrolled was 63 years (range 32-88).
Danish: Forsøgsdeltagernes gennemsnitsalder var 63 år (interval 32-88).
English: 59% of patients had most recent endocrine therapy in the (neo)adjuvant setting, and 38% in metastatic setting.
Danish: 59 % af patienterne havde fået deres seneste endokrine behandling i (neo)adjuverende regi og 38 % i metastatisk regi.
English: If the CYP3A4 inhibitor is discontinued, the abemaciclib dose should be increased to the dose used prior to the initiation of the CYP3A4 inhibitor (after 3 to 5 half-lives of the CYP3A4 inhibitor).
Danish: Hvis CYP3A4-hæmmeren bliver seponeret, bør abemaciclibdosis øges til den dosis, der blev anvendt inden opstart af CYP3A4-hæmmeren (efter 3 til 5 halveringstider for CYP3A4-hæmmeren.
English: Age, gender, and body weight had no effect on the exposure of abemaciclib in a population pharmacokinetic analysis in patients with cancer (135 males and 859 females; age range 24-91 years; and body weight range 36-175 kg).
Danish: Alder, køn og legemsvægt havde ingen indvirkning på eksponeringen for abemaciclib i en populationsfarmakokinetisk analyse hos patienter med cancer (135 mænd og 859 kvinder; aldersinterval 24-91 år og legemsvægtsinterval 36-175 kg).
English: Grade 3 or 4 ALT or AST elevations (based on laboratory findings) were reported in 6.1% and 4.2% patients.
Danish: Der blev rapporteret om ALAT- eller ASAT-stigninger af grad 3 eller 4 (baseret på laboratoriefund) hos 6,1 % og 4,2 % af patienterne.
English: In breast cancer xenograft models, abemaciclib dosed daily without interruption at clinically relevant concentrations alone or in combination with anti-oestrogens resulted in reduction of tumour size.
Danish: I xenotransplantationsmodeller af brystcancer resulterede daglig dosering af abemaciclib uden afbrydelser i klinisk relevante koncentrationer alene eller i kombination med anti-østrogener, i reduceret tumorstørrelse.
English: o Itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections) o Lopinavir/ritonavir (used to treat HIV/AIDS) o Digoxin (used to treat heart disorders) o Dabigatran etexilate (used to reduce the risk of stroke and blood clots)
Danish: o Itraconazol, ketoconazol, posaconazol, voriconazol (anvendes til behandling af svampeinfektioner) o Lopinavir/ritonavir (anvendes til behandling af hiv/aids) o Digoxin (anvendes til behandling af hjertesygdomme) o Dabigatranetexilat (anvendes til at nedsætte risikoen for slagtilfælde og blodpropper)
English: Discontinue abemaciclib.
Danish: Seponer abemaciclib.
English: If you are able to have children, you should use adequate contraceptive methods (e.g., double -barrier contraception such as condom and diaphragm) during therapy and for at least 3 weeks after completing therapy.
Danish: Hvis du kan få børn, skal du anvende sikker prævention (f.eks. dobbelt barriereprævention såsom kondom og pessar) under behandlingen og i mindst 3 uger efter behandlingen.
English: Management recommendations for increased aminotransferases
Danish: Anbefalinger vedrørende håndtering af forhøjede aminotransferaser
English: In patients receiving an aromatase inhibitor or fulvestrant alone, 78.4% reported an increase in serum creatinine (all laboratory grades).
Danish: Hos de patienter, der fik en aromatasehæmmer eller fulvestrant alene, blev der rapporteret om øget serumkreatinin (alle laboratoriegrader) hos 78,4 % af patienterne.
English: Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters without affecting glomerular function (as measured by iohexol clearance) (see section 4.5).
Danish: Abemaciclib har vist sig at øge serumkreatinin som følge af hæmning af renale tubulære sekretionstransportører uden indvirkning på den glomerulære funktion (målt på iohexol-clearance) (se pkt.
English: If toxicity does not resolve within 24 hours to Grade 1 or less, suspend dose until resolution.
Danish: Hvis toksiciteten ikke bedres til grad 1 eller derunder i løbet af 24 timer, bør doseringen afbrydes, indtil der opnås bedring.
English: Management recommendations
Danish: Anbefalinger vedrørende håndtering
English: Abemaciclib plus endocrine therapya All Grades Toxicity
Danish: Abemaciclib plus endokrin behandlinga Toksicitet, alle grader (%)
English: Mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had no effect on the exposure of abemaciclib.
Danish: Let (Child Pugh A) og moderat (Child Pugh B) leverinsufficiens havde ingen indvirkning på eksponeringen for abemaciclib.
English: If strong CYP3A4 inhibitors cannot be avoided, the abemaciclib dose should be reduced to 100 mg twice daily.
Danish: Hvis stærke CYP3A4-hæmmere ikke kan undgås, bør abemaciclibdosis reduceres til 100 mg to gange dagligt.
English: If you stop taking Verzenios
Danish: Hvis du holder op med at tage Verzenios
English: Concomitant use of strong CYP3A4 inducers (including, but not limited to: carbamazepine, phenytoin, rifampicin and St. John's wort) should be avoided due to the risk of decreased efficacy of abemaciclib.
Danish: Samtidig brug af stærke CYP3A4-induktorer ((inklusive, men ikke begrænset til: Carbamazepin, phenytoin, rifampicin og perikon) bør undgås på grund af risikoen for nedsat virkning af abemaciclib.
English: What you need to know before you take Verzenios Do not take Verzenios:
Danish: Det skal du vide, før du begynder at tage Verzenios Tag ikke Verzenios:
English: Abemaciclib is metabolised to several metabolites primarily by cytochrome P450 (CYP) 3A4.
Danish: Abemaciclib metaboliseres til flere metabolitter, primært via cytochrom P450 (CYP) 3A4.
English: However, based on the in vitro inhibition of P-gp and breast cancer resistance protein (BCRP) observed with abemaciclib, in vivo interactions of abemaciclib with narrow therapeutic index substrates of these transporters, such as digoxin or dabigatran etexilate, may occur.
Danish: Med udgangspunkt i den in vitro-hæmning af P-gp og brystcancerresistent protein (BCRP), der er set med abemaciclib, kan der imidlertid opstå in vivo-interaktioner mellem abemaciclib og substrater for disse transportører med snævert terapeutisk indeks, såsom digoxin eller dabigatranetexilat.
English: In patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant, ALT and AST elevations were reported frequently (15.1% and 14.2%, respectively).
Danish: Hos de patienter, der fik abemaciclib i kombination med aromatasehæmmere eller fulvestrant, blev der hyppigt rapporteret om ALAT- og ASAT-stigninger (hhv. 15,1 % og 14,2 %).
English: A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), disease site, disease setting (de novo metastatic vs recurrent metastatic vs locally advanced recurrent), presence of measurable disease, progesterone receptor status, and baseline ECOG performance status.
Danish: Der blev set konsekvente PFS-analyseresultater i en række præ-definerede- undergrupper af patienter, herunder alder (<65 eller ≥65 år), sygdomslokalisation, sygdomsregi (de novo metastatisk vs. recidiverende metastatisk vs. lokalt fremskredent recidiverende sygdom), tilstedeværelse af målbar sygdom, progesteronreceptorstatus og ECOG-performancestatus ved baseline.
English: The median age of patients enrolled was 60 years (range, 32-91 years).
Danish: Forsøgsdeltagernes gennemsnitsalder var 60 år (interval 32-91 år).
English: Grade 1 (>ULN-3.0 x ULN) Grade 2 (>3.0-5.0 x ULN)
Danish: Grad 1 (>ULN-3,0 x ULN) Grad 2 (>3,0-5,0 x ULN)
English: Randomised Phase 3 Study MONARCH 2: Verzenios in combination with fulvestrant
Danish: MONARCH 2 - et randomiseret fase 3-studie: Verzenios i kombination med fulvestrant
English: Abemaciclib was not mutagenic in a bacterial reverse mutation (Ames) assay, was not clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes, and was not clastogenic in an in vivo rat bone marrow micronucleus assay.
Danish: Abemaciclib var ikke mutagent i en bakteriel mutationsanalyse (Ames' test), var ikke klastogent i en in vitro-test for kromosomforandringer i humane perifere blodlymfocytter og var ikke klastogent i en in vivo-mikronukleusanalyse af knoglemarv fra rotter.
English: Alanine aminotransferase (ALT) and aspartate aminostransferase (AST) should be monitored prior to the start of Verzenios therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated.
Danish: Alanin-aminotransferase (ALAT) og aspartat-aminotransferase (ASAT) bør kontrolleres inden opstart af behandlingen med Verzenios, hver 2. uge i de første to måneder af behandlingen, en gang om måneden i de efterfølgende to måneder og efter klinisk behov.
English: • Inflamation of the mouth and lips, nausea (feeling sick), vomiting,
Danish: • Betændelse i mund og læber, kvalme, opkastning