FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall list of possible side effects:
Danish: Samlet liste med mulige bivirkninger:
English: Roteas can be initiated or continued in patients who may require cardioversion.
Danish: Roteas kan initieres eller fortsættes hos patienter, der kan have brug for kardiovertering.
English: Renal clearance accounts for approximately 35% of the administered dose.
Danish: Nyreclearance finder sted for ca. 35 % af den administrerede dosis.
English: Vaginal bleeds were reported commonly in women under the age of 50 years, while it was uncommon in women over the age of 50 years.
Danish: Vaginalblødninger blev rapporteret med almindelig hyppighed hos kvinder under 50 år, mens de ikke var almindelige hos kvinder over 50 år.
English: Unchanged edoxaban is the predominant form in plasma.
Danish: Uændret edoxaban er den primære form i plasma.
English: Present it to your healthcare professional, pharmacist, surgeon or dentist before any medical treatment or intervention.
Danish: Vis det til sundhedspersonalet, farmaceuten, kirurgen eller tandlægen, før nogen medicinsk behandling eller intervention.
English: PRESCRIBER INFORMATION For more information or in case of emergency, please contact: Physician's name:
Danish: ORDINATIONSINFORMATION For yderligere oplysninger eller i nødstilfælde bedes du kontakte: Lægens navn:
English: In vitro plasma protein binding is approximately 55%.
Danish: In-vitro plasma-proteinbindingsgraden er ca. 55 %.
English: PVC/Aluminium blisters.
Danish: PVC/aluminiumblisters.
English: Effect of edoxaban on other medicines
Danish: Virkningen af edoxaban på andre lægemidler
English: Do not take Roteas:
Danish: Tag ikke Roteas:
English: 30 mg once daily
Danish: 30 mg en gang dagligt
English: Concomitant administration of higher doses than 100 mg ASA should only be performed under medical supervision.
Danish: Samtidig administration af højere doser end 100 mg ASA bør kun udføres under medicinsk overvågning.
English: Date of birth:
Danish: Fødselsdato:
English: Roteas can be taken with or without food.
Danish: Roteas kan tages sammen med eller uden mad.
English: Disposition is biphasic.
Danish: Fordeling Dispositionen er bifasisk.
English: It is very important to take Roteas before and after the operation exactly at the times you have been told by your doctor.
Danish: Det er yderst vigtigt, at du tager Roteas før og efter operationen på præcist de tidspunkter, som lægen har angivet.
English: In case of clinically significant bleeding, stop treatment immediately.
Danish: I tilfælde af klinisk signifikant blødning skal behandlingen straks stoppes.
English: (mm/yy)
Danish: (mm/åå)
English: • Lesion or condition, if considered to be a significant risk for major bleeding.
Danish: • Læsion eller sygdom, hvis det anses for at være en signifikant risiko for svær blødning.
English: • Vomiting blood or material that looks like ground coffee
Danish: • Opkastning af blod eller materiale, der ligner kaffegrums
English: c 'Any Confirmed Bleeding' includes those that the adjudicator defined as clinically overt.
Danish: c 'Alle bekræftede blødninger' omfatter dem, som bedømmeren definerede som klinisk åbenlyse.
English: Renal function in NVAF
Danish: Nyrefunktion ved NVAF
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2017
Danish: Dato for første markedsføringstilladelse: 20. april 2017
English: • endstage kidney disease or if you are on dialysis
Danish: • nyresygdom i slutstadiet, eller hvis du er i dialyse
English: Its active metabolite is a substrate for OATP1B1.
Danish: Den aktive metabolit er et substrat for OATP1B1.
English: p-value < 0.0001 (non-inferiority)
Danish: p-værdi < 0,0001 (non-inferioritet)
English: Depending on local availability, a consultation with a coagulation expert should be considered in case of major bleedings.
Danish: Afhængig af lokal tilgængelighed bør det overvejes at konsultere en koagulationsekspert i tilfælde af større blødninger.
English: Periodic hepatic monitoring is recommended for patients on Roteas treatment beyond 1 year.
Danish: Der anbefales periodisk leverovervågning for patienter i behandling med Roteas længere end 1 år.
English: If you become pregnant while you are taking Roteas, immediately tell your doctor, who will decide how you should be treated.
Danish: Hvis du bliver gravid, mens du tager Roteas, skal du straks fortælle det til lægen, som vil bestemme, hvilken behandling, du skal have.
English: • Relevant information on the risk of bleeding
Danish: • Relevant information om risikoen for blødning
English: These medicinal products should not be administered simultaneously.
Danish: Disse lægemidler bør ikke administreres samtidigt.
English: There is a potential for inadequate anticoagulation during the transition from Roteas to VKA.
Danish: Der er mulighed for utilstrækkelig antikoagulation ved overgangen fra Roteas til VKA.
English: a On-Treatment: Time from first dose of study drug to last dose plus 3 days.
Danish: a Under behandling: Tid fra første dosis af studielægemiddel til den sidste dosis plus 3 dage.
English: If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Roteas.
Danish: Hvis der er en mulighed for, at du kan blive gravid, skal du anvende en pålidelig præventionsmetode, mens du tager Roteas.
English: • Do not start any other medications (including over the counter) without consulting your doctor.
Danish: • Start ikke andre lægemidler (herunder ikke-receptpligtige lægemidler) uden at kontakte lægen.
English: The volume of distribution is 107 (19.9) L mean (SD).
Danish: Fordelingsvoluminet er 107 (19,9) L-gennemsnit (SD).
English: Edoxaban and initial parenteral anticoagulant should not be administered simultaneously.
Danish: Edoxaban og indledende parenteral antikoagulation må ikke administreres samtidigt.
English: • Clinically significant active bleeding.
Danish: • Klinisk signifikant aktiv blødning.
English: • The signs or symptoms of bleeding and when to seek attention
Danish: • Tegn eller symptomer på blødning, og hvornår du skal søge hjælp
English: 1 Reporting rates are based on the female population in clinical trials.
Danish: Sjælden 1 Rapporteringshyppighederne er baseret på den kvindelige population i kliniske studier.
English: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
Danish: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Tyskland
English: This was not considered clinically significant.
Danish: Dette blev ikke anset for at være klinisk signifikant.
English: Safety in patients with VTE (DVT and PE) in Hokusai-VTE
Danish: Sikkerhed hos patienter med VTE (DVT og PE) i Hokusai-VTE
English: Decisions on initiation and duration of treatment should follow established guidelines for anticoagulant treatment in patients undergoing cardioversion.
Danish: Beslutninger vedrørende initiering og varighed af behandling skal følge fastlagte retningslinjer for antikoagulant behandling hos patienter, der gennemgår kardiovertering.
English: No dose modification is necessary when Roteas is administered with digoxin.
Danish: Ingen dosismodifikation er nødvendig, når Roteas administreres sammen med digoxin.
English: • recent bleeding in your brain (intracranial or intracerebral bleeding)
Danish: • nylig blødning i hjernen (intrakraniel eller intracerebral blødning)
English: This method is recommended when assessing patients' CrCL prior to and during Roteas treatment.
Danish: Denne metode anbefales, når patienternes CrCl vurderes før og under behandlingen med Roteas.
English: In patients with renal impairment the metabolite profile changes and a higher quantity of active metabolites are formed.
Danish: Hos patienter med nedsat nyrefunktion ændres den metaboliske profil, og der dannes en større mængde aktive metabolitter.
English: • Renal function should also be assessed when a change in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).
Danish: • Nyrefunktionen skal også vurderes, når der er mistanke om en ændring af nyrefunktionen under behandlingen (f.eks. hypovolæmi, dehydrering og i tilfælde af anvendelse sammen med visse lægemidler).
English: Roteas 15 mg is not indicated as monotherapy, as it may result in decreased efficacy.
Danish: Roteas 15 mg er ikke indiceret til monoterapi, da det kan føre til nedsat virkning.
English: • Guidance regarding surgery or invasive procedure, and temporary discontinuation
Danish: • Vejledning i relation til operation eller invasivt indgreb og midlertidig seponering
English: • Dizziness or sudden headache
Danish: • Svimmelhed eller pludselig hovedpine
English: • medicines to prevent organ rejection after transplantation (e.g. ciclosporin)
Danish: • lægemidler, der forhindrer organafstødning efter transplantation (f.eks. ciclosporin)
English: Edoxaban is poorly soluble at pH of 6.0 or higher.
Danish: Edoxaban er dårligt opløseligt ved pH på 6.0 eller derover.
English: Most patients (85%) should be able to achieve an INR ≥ 2.0 within 14 days of concomitant administration of Roteas and VKA.
Danish: Det bør være muligt for de fleste patienter (85 %) at opnå en INR ≥ 2,0 i løbet af 14 dage med administration af Roteas sammen med VKA.
English: The Patient alert card should contain the following key safety messages:
Danish: Patientkortet skal indeholder følgende sikkerhedsmæssige nøglemeddelelser:
English: You should take the tablet immediately and then continue the following day with the once daily tablet as usual.
Danish: Du bør straks tage tabletten og fortsætte den følgende dag med en tablet en gang dagligt som sædvanligt.
English: No specific studies with edoxaban in humans have been conducted to evaluate effects on fertility.
Danish: Der er ikke udført specifikke studier med edoxaban hos mennesker for at evaluere virkningerne på fertilitet.
English: Patients should not take a loading dose of VKA in order to promptly achieve a stable INR between 2 and 3.
Danish: Patienter må ikke tage en støddosis VKA for hurtigt at opnå en stabil INR mellem 2 og 3.
English: Subcutaneous anticoagulant (i.e.: LMWH, fondaparinux):
Danish: Subkutane antikoagulantia (dvs.: LMWH og fondaparinux):
English: Cardioversion should be performed no later than 12 hours after the dose of Roteas on the day of the procedure.
Danish: Kardiovertering skal udføres højst 12 timer efter dosen af Roteas på dagen for proceduren.
English: If you currently take 30 mg (dose reduced) Roteas:
Danish: Hvis du aktuelt tager 30 mg (dosisreduceret) Roteas:
English: Metabolism and biliary/intestinal excretion account for the remaining clearance.
Danish: Metabolisme og galde/tarmudskillelse udgør den resterende clearance.
English: • Do not stop taking Roteas without consulting your doctor as this can increase your risk of developing a blood clot.
Danish: • Hold ikke op med at tage Roteas uden at kontakte lægen, da det kan øge din risiko for at udvikle en blodprop.
English: However, there is limited clinical experience with the use of this product in individuals receiving edoxaban.
Danish: Der er imidlertid begrænset klinisk erfaring med anvendelsen af dette produkt hos personer, der får edoxaban.
English: Discontinue the VKA and start Roteas when the international normalised ratio (INR) is ≤ 2.5.
Danish: Seponer VKA og start behandling med Roteas, når international normalised ratio (INR) er ≤ 2,5.
English: • Reduced number of platelets in your blood (which can affect clotting)
Danish: • Nedsat antal blodplader i blodet (hvilket kan påvirke størkningen)
English: Patients with antiphospholipid syndrome
Danish: Patienter med antifosfolipidsyndrom
English: It is recommended to take into account the maintenance dose of VKA and if the patient was previously taking a VKA or to use valid INR driven VKA treatment algorithm, in accordance with local practice.
Danish: Det anbefales at tage hensyn til vedligeholdelsesdosen af VKA, og om patienten tidligere tog en VKA, eller at anvende en gyldig behandlingsalgoritme for VKA baseret på INR i henhold til lokal praksis.
English: • Guidance on switching from or to Roteas treatment
Danish: • Vejledning i skift fra eller til Roteas-behandling
English: • Roteas may increase the risk of bleeding.
Danish: • Roteas kan øge blødningsrisikoen.
English: The Prescriber Guide for healthcare professionals shall contain the following key elements:
Danish: Ordinationsguiden til læger og sundhedspersonale skal indeholde følgende nøgleelementer:
English: • If you miss a dose, take it immediately and then continue the following day as normal - do not take double the prescribed dose in a single day.
Danish: • Hvis du glemmer en dosis, skal du straks tage den, og derefter fortsætte den følgende dag som normalt - tag ikke det dobbelte af din ordinerede dosis på en enkelt dag.
English: Prior to launch of Roteas in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før lancering af Roteas i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen være enig med den relevante nationale myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: • Importance of treatment compliance
Danish: • Vigtigheden af at overholde behandlingen
English: Talk to your doctor or pharmacist before taking Roteas,
Danish: Kontakt lægen eller apotekspersonalet, før du tager Roteas,
English: Vitamin K Antagonist (VKA)
Danish: K-vitaminantagonist (VKA)
English: Within renal function subgroups, results for the secondary efficacy endpoints were consistent with those for the primary endpoint.
Danish: Inden for undergrupperne for nyrefunktionen var resultaterne for sekundære virkningsendepunkter i overensstemmelse med resultaterne for det primære endepunkt.
English: Prevention of stroke and systemic embolism
Danish: Forebyggelse af apopleksi og systemisk emboli
English: • That all patients should be provided with a Patient alert card and be counselled about: The signs or symptoms of bleeding and when to seek attention from a healthcare provider Importance of treatment compliance Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals that they are taking Roteas if they need to have any surgery or invasive procedure
Danish: • At alle patienter skal forsynes med et patientkort og rådgives om: Tegn og symptomer på blødning, og hvornår de skal søge hjælp hos en læge eller sundhedspersonale Vigtigheden af at overholde behandlingen Nødvendigheden af at have patientkortet på sig hele tiden Nødvendigheden af at informere læger eller sundhedspersonale om, at de tager Roteas, hvis de skal have foretaget en operation eller et invasivt indgreb
English: TEE-guided (within 3 days of initiation) or conventional cardioversion (at least 21 days of pre-treatment) was employed.
Danish: TEE-styret (inden for 3 dage efter initiering) eller traditionel kardiovertering (mindst 21 dage efter forbehandling) blev anvendt.
English: • Management of overdose situations and haemorrhage
Danish: • Håndtering af situationer med overdosering og hæmoragi
English: Intracranial haemorrhage (ICH)
Danish: Intrakraniel blødning (ICH)
English: The anticoagulant effect of edoxaban cannot be reliably monitored with standard laboratory testing.
Danish: Den antikoagulerende virkning af edoxaban kan ikke måles pålideligt med standard laboratorietests.
English: • Necessity to carry the Patient alert card with them at all times
Danish: • Nødvendigheden af at have patientkortet på sig hele tiden
English: It is important that you take your medication exactly as instructed by your doctor.
Danish: Det er vigtigt, at du tager dit lægemiddel nøjagtigt, som lægen har anvist det.
English: Assessment of renal function:
Danish: Vurdering af nyrefunktionen:
English: If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Roteas at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body.
Danish: Hvis der er brug for, at din unormale hjerterytme bringes tilbage til en normal rytme ved hjælp af en procedure, der kaldes kardiovertering, skal du tage Roteas på de tidspunkter, din læge fortæller dig, for at forebygge blodpropper i hjernen og andre blodkar i kroppen.
English: There may be situations that warrant a change in anticoagulation therapy (Table 2).
Danish: Der kan være situationer, der kræver en ændring i behandlingen med antikoagulantia (tabel 2).
English: Roteas is not recommended in children and adolescents under 18 years of age.
Danish: Roteas bør ikke anvendes til børn og unge under 18 år.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or phototoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet eller fototoksicitet.
English: c The p-value is for the pre-defined non-inferiority margin of 1.5.
Danish: c p-værdien er for den prædefinerede non-inferioritetsmargin på 1,5.
English: INFORMATION FOR HEALTHCARE PROFESSIONALS
Danish: INFORMATION TIL SUNDHEDSPERSONALE
English: These patients are to be carefully monitored for signs and symptoms of bleeding complications and anaemia after initiation of treatment (see section 4.8).
Danish: Disse patienter skal omhyggeligt overvåges for tegn og symptomer på blødningskomplikationer og anæmi efter indledning af behandlingen (se pkt.
English: ≥ 30 to ≤ 50 1,302 96
Danish: ≥ 30 til ≤ 50 1.302 96
English: • For creatinine in mg/dL:
Danish: • For kreatinin i mg/dl:
English: Early administration of activated charcoal may be considered in case of edoxaban overdose to reduce absorption.
Danish: Tidlig administration af aktivt kul kan overvejes i tilfælde af en overdosering med edoxaban for at reducere absorptionen.
English: • The need to inform Health Care Professionals that they are taking Roteas if they need to have any surgery or invasive procedure
Danish: • Nødvendigheden af at informere læger eller sundhedspersonale om, at de tager Roteas, hvis de skal have foretaget en operation eller et invasivt indgreb
English: Roteas contains the active substance edoxaban and belongs to a group of medicines called anticoagulants.
Danish: Roteas indeholder det aktive stof edoxaban og tilhører en gruppe lægemidler, som kaldes antikoagulantia.
English: After 14 days it is recommended that Roteas is discontinued and the VKA continued to be titrated to achieve an INR between 2 and 3.
Danish: Efter 14 dage anbefales det at seponere Roteas og fortsætte med at titrere VKA for at opnå en INR fra 2 til 3.
English: Subjects were maintained on treatment for 28 days post cardioversion.
Danish: Forsøgspersonerne blev opretholdt på behandlingen i 28 dage efter kardiovertering.
English: • Contraindications
Danish: • Kontraindikationer
English: In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study, peak and total exposure in Asian patients and non-Asian patients were comparable.
Danish: I en populationsfarmakokinetisk analyse af ENGAGE AF-TIMI 48-studiet var den maksimale og totale eksponering hos asiatiske patienter og ikke-asiatiske patienter sammenlignelige.
English: • For creatinine in µmol/L:
Danish: • For kreatinin i µmol/l:
English: WHEN TO SEEK MEDICAL ADVICE
Danish: HVORNÅR SKAL DU SØGE LÆGEHJÆLP?
English: • Nose bleeds or cuts that take a long time to stop bleeding
Danish: • Næseblod eller sår, hvor det tager lang tid at holde op med at bløde
English: Efficacy and safety of edoxaban in the treatment and/or prevention of VTE in patients with active cancer have not been established.
Danish: Edoxabans virkning og sikkerhed ved behandling og/eller forebyggelse af VTE hos patienter med aktiv cancer er ikke klarlagt.
English: Assessment of renal function: CrCL should be monitored at the beginning of the treatment in all patients and afterwards when clinically indicated (see section 4.2).
Danish: Vurdering af nyrefunktionen: CrCl bør overvåges ved begyndelsen af behandlingen for alle patienter og derefter ved klinisk indikation (se pkt.
English: If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.
Danish: Hvis du oplever blødningshændelser, der ikke stopper af sig selv, eller hvis du oplever tegn på for kraftig blødning (usædvanlig svaghed, træthed, bleghed, svimmelhed, hovedpine eller uforklarlig hævelse), skal du straks kontakte lægen.
English: Following the switch to edoxaban on Day 4 the PT was equivalent to Day 3 of rivaroxaban and apixaban.
Danish: Efter skiftet til edoxaban på dag 4 var PT ækvivalent med dag 3 for rivaroxaban og apixaban.
English: Edoxaban increases the risk of bleeding and can cause serious, potentially fatal bleeding.
Danish: Edoxaban øger blødningsrisikoen, og kan føre til alvorlige, muligvis dødelige blødninger.
English: - prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
Danish: - forebygge dannelsen af blodpropper i hjernen (apopleksi) og i andre blodårer i kroppen, hvis du har en form for uregelmæssig hjerterytme, der kaldes non-valvulær atrieflimren, og mindst én yderligere risikofaktor.
English: In ENGAGE AF-TIMI 48 study in NVAF, efficacy and safety results were similar for subjects with and without concomitant amiodarone use.
Danish: I ENGAGE AF-TIMI 48-studiet af NVAF var resultaterne for virkning og sikkerhed sammenlignelige for personer med og uden samtidig anvendelse af amiodaron.
English: A total of 2149 subjects were treated with either edoxaban (N = 1067) or enoxaparin/warfarin (N = 1082).
Danish: I alt 2149 forsøgspersoner blev behandlet med enten edoxaban (N = 1067) eller enoxaparin/warfarin (N = 1082).
English: ICH non-fatal CRNM Bleeding n
Danish: ICH ikke-dødelig CRNM-blødninger n
English: Several sub-groups of patients, as detailed below, are at increased risk of bleeding.
Danish: Flere patientgrupper har, som beskrevet nedenfor, øget risiko for blødning.
English: Therefore, use of edoxaban is not recommended in these patients.
Danish: Derfor bør edoxaban ikke anvendes til disse patienter.
English: Therefore, edoxaban should only be used in patients with NVAF and high creatinine clearance after a careful evaluation of the individual thromboembolic and bleeding risk.
Danish: Derfor bør edoxaban kun anvendes til patienter med NVAF og en høj kreatininclearance efter en nøje evaluering af den individuelle tromboemboliske risiko og blødningsrisiko.
English: Edoxaban can be co-administered with low dose ASA (≤ 100 mg/day).
Danish: Edoxaban kan administreres sammen med en lav dosis ASA (≤ 100 mg/dag).
English: Roteas has been prescribed at a once-daily dose of:
Danish: Roteas er blevet ordineret med en dosis én gang dagligt på:
English: Therapy with edoxaban in NVAF patients should be continued long term.
Danish: Behandling med edoxaban hos patienter med NVAF bør være langvarig.
English: Edoxaban was administered with or without food in the ENGAGE AF-TIMI 48 and the Hokusai-VTE studies.
Danish: Edoxaban blev administreret sammen med eller uden mad i ENGAGE AF-TIMI 48- og Hokusai-VTE-studierne.
English: The MAH shall ensure that in each Member State where Roteas is marketed, all healthcare professionals who are expected to use Roteas are provided with the following educational material:
Danish: Indehaveren af markedsføringstilladelsen skal i hver medlemsstat, hvor Roteas markedsføres, sikre, at alle læger og alt sundhedspersonale, der forventes at anvende Roteas, forsynes med følgende uddannelsesmateriale:
English: If you take more Roteas than recommended, you may have an increased risk of bleeding.
Danish: Hvis du tager mere Roteas end anbefalet, kan du have en øget blødningsrisiko.