FrancophonIA/ELRC3.0 huggingface dataset:
English: Verzenios is used to treat women with certain types of breast cancer (hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)) which have spread beyond the original tumour and/or to other organs.
Danish: Verzenios anvendes til behandling af kvinder med visse typer brystkræft (hormonreceptor-positiv (HR+), human epidermal vækstfaktorreceptor 2-negativ (HER2-)), der har spredt sig ud over den oprindelige kræftknude og/eller til andre organer.
English: Effects of other medicinal products on the pharmacokinetics of abemaciclib
Danish: Andre lægemidlers indvirkning på abemaciclibs farmakokinetik
English: No dose adjustments are necessary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let (Child Pugh A) eller moderat (Child Pugh B) leverinsufficiens.
English: The recommended dose of abemaciclib is 150 mg twice daily when used in combination with endocrine therapy.
Danish: Den anbefalede dosis er 150 mg abemaciclib to gange dagligt, når lægemidlet anvendes i kombination med endokrin behandling.
English: • Watering eyes
Danish: • Rindende øjne
English: Abemaciclib prevents retinoblastoma protein (Rb) phosphorylation, blocking cell cycle progression from the G1 to the S-phase of cell division, leading to suppression of tumour growth.
Danish: Abemaciclib forhindrer fosforylering af retinoblastom-protein (Rb), hvilket blokerer cellecyklusprogression fra celledelingens G1- til S-fase, hvilket resulterer i hæmning af tumorvæksten.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, dvs. det er i det væsentlige natrium-frit.
English: Median [months] (95% CI) Hazard ratio (95% CI) and p-value
Danish: Median [måneder] (95 % CI) Hazard ratio (95 % CI) og p-værdi
English: Excipients: lactose.
Danish: Hjælpestof: lactose.
English: Venous thromboembolic events were reported in 5.3% of patients treated with abemaciclib plus fulvestrant or aromatase inhibitors, compared to 0.8% of patients treated with placebo plus fulvestrant or aromatase inhibitors.
Danish: Der blev rapporteret om venøse tromboemboliske hændelser hos 5,3 % af de patienter, der fik behandling med abemaciclib plus fulvestrant eller aromatasehæmmere, sammenlignet med 0,8 % hos de patienter, der fik behandling med placebo plus fulvestrant eller aromatasehæmmere.
English: These results correspond to a clinically meaningful reduction in the risk of disease progression or death of 46% for patients treated with abemaciclib plus an aromatase inhibitor.
Danish: Disse resultater svarer til en klinisk betydningsfuld reduktion på 46 % i risikoen for sygdomsprogression eller død hos patienter i behandling med abemaciclib plus en aromatasehæmmer.
English: The HR was 0.854 (95% CI: 0.598, 1.221), p=0.3886.
Danish: HR var 0,854 (95 % CI: 0,598; 1,221), p=0,3886.
English: Elderly No dose adjustment is required based on age (see section 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis på baggrund af alder (se pkt.
English: In a clinical drug interaction study with metformin (substrate of OCT2, MATE1 and 2) co-administered with 400 mg abemaciclib, a small but not clinically relevant increase (37%) in metformin plasma exposure was observed.
Danish: I et klinisk interaktionsstudie med samtidig administration af metformin (substrat for OCT2, MATE1 og 2) og 400 mg abemaciclib blev der set en lille stigning uden klinisk relevans (37%) i plasmaeksponeringen for metformin.
English: Common Muscular weakness
Danish: Almindelig Muskelsvaghed
English: Patients should start treatment with antidiarrhoeal agents such as loperamide at the first sign of loose stools, increase oral fluids and notify their healthcare provider.
Danish: Patienterne bør påbegynde behandling med lægemidler mod diarré, såsom loperamid, ved det første tegn på løs afføring, øge deres orale væskeindtag og kontakte deres læge.
English: Patient requires administration of blood cell growth factors
Danish: Patienten skal have blodlegemevækstfaktorer (G-CSF)
English: Patients were randomised in a 2:1 ratio to receive Verzenios 150 mg twice daily plus fulvestrant 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose, versus placebo plus fulvestrant according to the same schedule.
Danish: Patienterne blev randomiseret i forholdet 2:1 til Verzenios 150 mg to gange dagligt plus fulvestrant 500 mg med en måneds mellemrum og en yderligere dosis på 500 mg to uger efter den første dosis eller til placebo plus fulvestrant i henhold til samme plan.
English: Investigator assessment, number of events
Danish: Investigators vurdering, antal hændelser (%)
English: The median time to onset of the first diarrhoea event was approximately 6 to 8 days across studies, and the median duration of diarrhoea was 9 to 12 days (Grade 2) and 6 to 8 days (Grade 3) across studies.
Danish: Mediantiden til indtræden af den første diarréhændelse var cirka 6 til 8 dage på tværs af studierne, og medianvarigheden af diarré var 9 til 12 dage (grad 2) og 6 til 8 dage (grad 3) på tværs af studierne.
English: In patients with severe (Child Pugh C) hepatic impairment, a decrease in dosing frequency to once daily is recommended (see section 5.2).
Danish: Hos patienter med svær (Child Pugh C) leverinsufficiens anbefales det at reducere doseringshyppigheden til én gang dagligt (se pkt.
English: How long to take Verzenios
Danish: Hvor længe skal du tage Verzenios
English: Persistent or Recurrent Grade 2, or Grade 3 (>5.0-20.0 x ULN)
Danish: Vedvarende eller tilbagevendende grad 2; eller grad 3 (>5,0-20,0 x ULN)
English: In an exposure-response analysis in healthy subjects at exposures comparable to a 200 mg twice-daily dose, abemaciclib did not prolong the QTcF interval to any clinically relevant extent.
Danish: I en analyse af eksponering-respons hos raske forsøgsdeltagere med eksponeringer, der var sammenlignelige med en dosis på 200 mg to gange dagligt, forårsagede abemaciclib ingen klinisk relevant forlængelse af QTcF-intervallet.
English: Patients were randomised in a 2:1 ratio to receive Verzenios 150 mg twice daily plus a non-steroidal aromatase inhibitor given daily at the recommended dose versus placebo plus a non-steroidal aromatase inhibitor according to the same schedule.
Danish: Patienterne blev randomiseret i forholdet 2:1 til Verzenios 150 mg to gange dagligt plus en non-steroid aromatasehæmmer dagligt i den anbefalede dosis versus placebo plus en non-steroid aromatasehæmmer i henhold til samme plan.
English: If a patient vomits or misses a dose of Verzenios, the patient should be instructed to take the next dose at its scheduled time; an additional dose should not be taken.
Danish: Hvis patienten kaster op eller glemmer en dosis Verzenios, bør patienten instrueres i at tage den næste dosis på det sædvanlige tidspunkt.
English: Patients should be monitored for signs and symptoms of deep vein thrombosis and pulmonary embolism and treated as medically appropriate.
Danish: Patienterne skal monitoreres for tegn og symptomer på dyb venetrombose og lungeemboli og have passende medicinsk behandling.
English: • medicines that may reduce the effectiveness of Verzenios: o Carbamazepine (anti-epileptic used to treat seizures or fits) o Rifampicin, used to treat tuberculosis (TB) o Phenytoin (used to treat seizures) o St. John's wort (a herbal product used to treat mild depression and anxiety)
Danish: • Lægemidler, der kan nedsætte virkningen af Verzenios: o Carbamazepin (et anti-epileptisk lægemiddel, som bruges til behandling af anfald eller kramper) o Rifampicin, som anvendes til behandling af tuberkulose (TB) o Phenytoin (anvendes til behandling af krampeanfald) o Perikon (et naturlægemiddel, der anvendes til behandling af mild depression og angst)
English: [%] (95% CI) a Measurable disease defined per RECIST version 1.1 b Complete response + partial response c Complete response + partial response + stable disease for ≥ 6 months N=number of patients; CI=confidence interval; NR=not reached.
Danish: Clinical benefit ratec (målbar sygdom) [%] (95% CI) a Målbar sygdom er defineret i henhold til RECIST version 1.1 b Komplet respons + delvist respons c Komplet respons + delvist respons + stabil sygdom i ≥ 6 måneder N=antal patienter; CI=konfidensinterval; NR=ikke nået.
English: In cancer patients, abemaciclib inhibits CDK4 and CDK6 as indicated by inhibition of phosphorylation of Rb and topoisomerase II alpha, which results in cell cycle inhibition upstream of the G1 restriction point.
Danish: Hos cancerpatienter hæmmer abemaciclib CDK4 og CDK6, hvilket giver sig udtryk i hæmmet fosforylering af Rb og topoisomerase II-alfa, hvilket resulterer i cellecyklushæmning opstrøms for G1-restriktionspunktet.
English: In patients who have had their dose reduced to 50 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose may be continued with close monitoring of signs of toxicity.
Danish: Hos patienter, som har fået deres dosis reduceret til 50 mg abemaciclib to gange dagligt, og hos hvem samtidig administration af en stærk CYP3A4-hæmmer ikke kan undgås, kan abemaciclibdosis fortsættes under tæt monitorering for tegn på toksicitet.
English: Tablet core croscarmellose sodium lactose monohydrate microcrystalline cellulose colloidal hydrated silica sodium stearyl fumarate
Danish: Croscarmellosenatrium Lactosemonohydrat mikrokrystallinsk cellulose kolloid silica natriumstearylfumarat
English: The primary endpoint was investigator-assessed PFS evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Danish: Det primære endepunkt var investigators vurdering af PFS i henhold til RECIST 1.1; de vigtigste sekundære effektendepunkter omfattede objektiv responsrate (ORR), clinical benefit rate (CBR) og samlet overlevelse (OS).
English: Verzenios is available in calendar blister packs of 14, 28, 42, 56, 70 and 168 film-coated tablets and perforated unit dose blisters of 28 x 1 film-coated tablets.
Danish: Verzenios fås i kalenderblisterpakninger med 14, 28, 42, 56, 70 og 168 filmovertrukne tabletter og i perforerede enkeltdosisblistere med 28 x 1 filmovertrukne tabletter.
English: Grade 1 or 2.
Danish: Grad 1 eller 2.
English: Complete blood counts 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: Der bør gennemføres komplette blodtællinger 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: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Infections were reported in patients receiving abemaciclib plus endocrine therapy at a higher rate than in patients treated with placebo plus endocrine therapy.
Danish: Der blev rapporteret om højere forekomst af infektioner hos de patienter, som fik abemaciclib sammen med endokrin behandling end hos de patienter, som blev behandlet med placebo og endokrin behandling.
English: Across clinical studies, median time to onset of the first diarrhoea event was approximately 6 to 8 days, and median duration of diarrhoea was 9 to 12 days (Grade 2) and 6 to 8 days (Grade 3).
Danish: På tværs af de kliniske studier var mediantiden til indtræden af den første diarréhændelse cirka 6 til 8 dage, og medianvarigheden af diarré var 9 til 12 dage (grad 2) og 6 til 8 dage (grad 3).
English: 14 film-coated tablets 168 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets 56 film-coated tablets 42 film-coated tablets 70 film-coated tablets
Danish: 14 filmovertrukne tabletter 168 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 42 filmovertrukne tabletter 70 filmovertrukne tabletter
English: Based on the level of ALT or AST elevation, abemaciclib may require dose modification (see section 4.2).
Danish: Afhængigt af omfanget af ALAT- eller ASAT-stigningerne kan det være nødvendigt at ændre abemaciclibdosen (se pkt.
English: Placebo plus aromatase inhibitor
Danish: Placebo plus aromatasehæmmer
English: Very common Dysgeusia Dizziness
Danish: Meget almindelig Dysgeusi Svimmelhed
English: The primary endpoint was investigator-assessed progression-free survival (PFS) evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Danish: Det primære endepunkt var investigators vurdering af progressionsfri overlevelse (PFS) i henhold til RECIST 1.1; de vigtigste sekundære effektendepunkter omfattede objektiv responsrate (ORR), clinical benefit rate (CBR) og samlet overlevelse (OS).
English: • Abnormalities in liver blood tests
Danish: • Uregelmæssige resultater af blodprøver vedrørende leverfunktionen
English: Verzenios contains sodium
Danish: Verzenios indeholder natrium
English: Abemaciclib should be administered with caution in patients with severe renal impairment, with close monitoring for signs of toxicity.
Danish: Hos patienter med svær nyreinsufficiens bør abemaciclib administreres med forsigtighed og under tæt monitorering for tegn på toksicitet.
English: Venous thromboembolic events include DVT, pulmonary embolism, cerebral venous sinus thrombosis, subclavian, axillary vein thrombosis,DVT inferior vena cava and pelvic venous thrombosis
Danish: c Venøse tromboemboliske hændelser omfatter DVT, lungeemboli, cerebral venøs sinustrombose, trombose i vena subclavia, vena axillaris, DVT i vena cava inferior og venetrombose i bækkenet.
English: Very common Fatigue
Danish: Meget almindelig Træthed
English: Management recommendations for haematologic toxicities
Danish: Anbefalinger vedrørende håndtering af hæmatologisk toksicitet
English: In healthy subjects, co-administration of abemaciclib and the P-glycoprotein (P-gp) substrate loperamide resulted in an increase in loperamide plasma exposure of 9% based on AUC0-∞ and 35% based on Cmax.
Danish: Hos raske forsøgsdeltagere resulterede samtidig administration af abemaciclib og loperamid, som er et P-glycoprotein (P-gp)-substrat, i en stigning i plasmaeksponeringen for loperamid på 9 % baseret på AUC0-∞ og på 35 % baseret på Cmax.
English: In clinical studies, increases in serum creatinine occurred within the first month of abemaciclib dosing, remained elevated but stable through the treatment period, were reversible upon treatment discontinuation, and were not accompanied by changes in markers of renal function, such as blood urea nitrogen (BUN), cystatin C, or calculated glomerular filtration rate based on cystatin C.
Danish: Niveauerne var forhøjede, men stabile, i hele behandlingsperioden, var reversible ved seponering af behandlingen og var ikke ledsaget af ændringer i markørerne for nyrefunktionen, såsom blodureanitrogen (BUN), cystatin C eller beregnet glomerulær filtrationshastighed (kalkuleret GFR) baseret på cystatin C.
English: The HR was 1.057 (95% CI: 0.683, 1.633), p=0.8017.
Danish: HR var 1,057 (95 % CI: 0,683; 1,633), p=0,8017.
English: Effects of abemaciclib on the pharmacokinetics of other medicinal products
Danish: Abemaciclibs indvirkning på andre lægemidlers farmakokinetik
English: Investigator assessment, number of events Median [months] (95% CI)
Danish: Investigators vurdering, antal hændelser (%) Median [måneder] (95 % CI)
English: Co-administration of abemaciclib with CYP3A4 inhibitors can increase plasma concentrations of abemaciclib.
Danish: Samtidig administration af abemaciclib og CYP3A4-hæmmere kan øge plasmakoncentrationen af abemaciclib.
English: Abemaciclib is primarily metabolised by CYP3A4.
Danish: Abemaciclib metaboliseres primært via CYP3A4.
English: Concomitant use of CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib (see section 4.5).
Danish: Samtidig brug af CYP3A4-induktorer bør undgås på grund af risikoen for nedsat virkning af abemaciclib (se pkt.
English: In subjects with severe hepatic impairment (Child Pugh C), the AUC0-∞ of abemaciclib and potency adjusted unbound abemaciclib plus its active metabolites increased 2.1-fold and 2.4-fold, respectively.
Danish: Hos forsøgsdeltagere med svær leverinsufficiens (Child Pugh C) var AUC0-∞ for abemaciclib og potensjusteret ubundet abemaciclib plus dets aktive metabolitter forøget henholdsvis 2,1-foldigt og 2,4-foldigt.
English: Suspend dose until toxicity resolves to baseline or Grade 1.
Danish: Afbryd doseringen, indtil toksiciteten bedres til baseline eller grad 1.
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede)
English: Neutropenia was reported in patients receiving abemaciclib.
Danish: Der blev rapporteret om neutropeni hos patienter, der fik abemaciclib.
English: Treatment with antidiarrhoeal agents, such as loperamide, should be started at the first sign of loose stools.
Danish: Der bør iværksættes behandling med lægemidler mod diarré, såsom loperamid, ved det første tegn på løs afføring.
English: There are no data in patients with severe renal impairment, end stage renal disease or in patients on dialysis.
Danish: Der foreligger ingen data fra patienter med svær nyreinsufficiens, patienter med nyresygdom i slutstadiet eller dialysepatienter.
English: In patients with advanced and/or metastatic cancer, co-administration of the CYP3A4 inhibitor clarithromycin resulted in a 3.4-fold increase in the plasma exposure of abemaciclib and a 2.5-fold increase in the combined unbound potency adjusted plasma exposure of abemaciclib and its active metabolites.
Danish: Hos patienter med fremskreden og/eller metastatisk cancer resulterede samtidig administration af CYP3A4-hæmmeren clarithromycin i en 3,4-foldig stigning i plasmaeksponeringen for abemaciclib og i en 2,5-foldig stigning i den samlede ubundne potensjusterede plasmaeksponering for abemaciclib og dets aktive metabolitter.
English: In oestrogen receptor-positive breast cancer cell lines, sustained target inhibition with abemaciclib prevented rebound of Rb phosphorylation resulting in cell senescence and apoptosis.
Danish: I østrogenreceptor-positive brystcancercellelinjer forhindrede vedvarende targeteret hæmning med abemaciclib tilbagevenden af Rb-fosforylering, hvilket resulterede i cellesenescens og apoptose.
English: There are no data regarding abemaciclib administration in patients with severe renal impairment, end stage renal disease, or in patients on dialysis (see section 5.2).
Danish: Der foreligger ingen data vedrørende administration af abemaciclib hos patienter med svær nyreinsufficiens, patienter med nyresygdom i slutstadiet eller dialysepatienter (se pkt.
English: In the following tables, adverse reactions are listed in order of MedDRA body system organ class and frequency.
Danish: Bivirkningerne er angivet i nedenstående tabel efter systemorganklasse og hyppighed i henhold til MedDRA-konventionen.
English: • Tablet core: colloidal hydrated silica, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate.
Danish: • Tabletkerne: kolloid silica, croscarmellosenatrium, lactosemonohydrat, mikrokrystallinsk cellulose, natriumstearylfumarat.
English: Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Danish: Verzenios er indiceret til behandling af kvinder med lokalt fremskreden eller metastatisk hormonreceptor (HR)-positiv, human epidermal vækstfaktorreceptor 2 (HER2)-negativ brystcancer i kombination med en aromatasehæmmer eller fulvestrant som indledende endokrinbaseret behandling, eller hos kvinder, der har fået forudgående endokrin behandling.
English: Dose adjustment recommendations for adverse reactions Verzenios dose combination therapy
Danish: Anbefalede dosisjusteringer i tilfælde af bivirkninger Verzenios-dosis kombinationsbehandling
English: The efficacy and safety of Verzenios in combination with fulvestrant was evaluated in MONARCH 2, a randomised, double-blind, placebo-controlled phase 3 study in women with HR positive, HER2 negative locally advanced or metastatic breast cancer.
Danish: Virkningen og sikkerheden af Verzenios i kombination med fulvestrant blev evalueret i MONARCH 2, et randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie med kvinder med lokalt fremskreden eller metastatisk HR-positiv, HER2-negativ brystcancer.
English: In patients who have had their dose reduced to 100 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose should be further reduced to 50 mg twice daily.
Danish: Hos patienter, som har fået deres dosis reduceret til 100 mg abemaciclib to gange dagligt, og hos hvem samtidig administration af en stærk CYP3A4-hæmmer ikke kan undgås, bør abemaciclibdosis reduceres yderligere til 50 mg to gange dagligt.
English: Very common Neutropenia Leukopenia Anaemia Thrombocytopenia Common Lymphopenia Uncommon Febrile neutropenia
Danish: Thrombocytopeni Almindelig Lymfopeni Ikke almindelig Febril neutropeni
English: - The active substance is abemaciclib.
Danish: Aktivt stof: abemaciclib.
English: Randomised Phase 3 Study MONARCH 3: Verzenios in combination with aromatase inhibitors
Danish: MONARCH 3 - et randomiseret fase 3-studie: Verzenios i kombination med aromatasehæmmere
English: Co-administration of abemaciclib with the strong CYP3A4 inducer rifampicin decreased the plasma concentration of abemaciclib by 95% and unbound potency adjusted plasma concentration of abemaciclib plus its active metabolites by 77% based on AUC0-∞.
Danish: Samtidig administration af abemaciclib og den stærke CYP3A4-induktor rifampicin reducerede plasmakoncentrationen af abemaciclib med 95 % og den ubundne, potensjusterede plasmakoncentration af abemaciclib plus dets aktive metabolitter med 77 % baseret på AUC0-∞.
English: Genotoxicity
Danish: Genotoksicitet
English: Women of childbearing potential/Contraception in females Women of childbearing potential should use highly effective contraception methods (e.g. double-barrier contraception) during treatment and for at least 3 weeks after completing therapy (see section 4.5).
Danish: Kvinder i den fertile alder skal anvende sikker kontraception (f.eks. dobbelt barrierekontraception) under behandlingen og i mindst 3 uger efter behandlingen (se pkt.
English: Grade 1 or 2
Danish: Grad 1 eller 2
English: Do not stop taking Verzenios unless your doctor tells you to.
Danish: Hold ikke op med at tage Verzenios uden lægens anvisning.
English: You should not breast-feed while taking Verzenios.
Danish: Du bør ikke amme, mens du tager Verzenios.
English: Patients should be instructed to report any episode of fever to their healthcare provider.
Danish: Patienterne bør instrueres i, at de skal kontakte lægen i tilfælde af feber.
English: and a Grade 3 or 4 decrease in neutrophil counts (based on laboratory findings) was reported in 28.2% of patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant.
Danish: Neutropeni blev indberettet hyppigt (45,1 %), og fald i neutrofiltallet af grad 3 eller 4 (baseret på laboratoriefund) blev indberettet hos 28,2 % af de patienter, der fik abemaciclib i kombination med aromatasehæmmere eller fulvestrant.