FrancophonIA/ELRC3.0 huggingface dataset:
English: Bleeding can occur at any site and may be severe and even fatal (see section 4.4).
Danish: Blødninger kan forekomme alle steder og kan være svære og endda dødelige (se pkt.
English: In deciding whether a procedure should be delayed until 24 hours after the last dose of Roteas, the increased risk of bleeding should be weighed against the urgency of the intervention.
Danish: Når det skal besluttes, om et indgreb skal udskydes til 24 timer efter den sidste dosis Roteas, skal den forhøjede blødningsrisiko afvejes mod, hvor akut der behøves et indgreb.
English: The programme is also aimed at ensuring that the healthcare professionals who intend to prescribe Roteas are aware of the Patient alert card and that the card is to be given to and reviewed with all patients treated with Roteas.
Danish: Programmets mål er også at sikre, at læger og sundhedspersonale, der planlægger at ordinere Roteas, er bekendt med patientkortet, og at kortet udleveres til og gennemgås sammen med alle patienter, der behandles med Roteas.
English: Edoxaban is absorbed with peak plasma concentrations within 1 - 2 hours.
Danish: Edoxaban absorberes med maksimale plasmakoncentrationer i løbet af 1 - 2 timer.
English: • Roteas is an oral anticoagulant factor Xa inhibitor.
Danish: • Roteas er en oral antikoagulant faktor Xa-hæmmer.
English: Any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site.
Danish: Ethvert fald i hæmoglobin eller blodtryk bør medføre søgning efter blødningskilde.
English: 85276 Pfaffenhofen, Bayern Germany
Danish: 85276 Pfaffenhofen, Bayern Tyskland
English: Subjects with ESRD undergoing peritoneal dialysis had 93% higher total exposure compared with healthy subjects.
Danish: Personer med ESRD, der gennemgik peritonealdialyse, havde en 93 % højere total eksponering sammenlignet med raske personer.
English: There is a linear correlation between edoxaban plasma concentration and anti-FXa activity regardless of renal function.
Danish: Der er en lineær korrelation mellem plasmakoncentrationen af edoxaban og anti-FXa-aktivitet uanset nyrefunktion.
English: For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Roteas as prescribed.
Danish: For alle patienter, der gennemgår kardiovertering: Før kardiovertering skal patienten bekræfte, at Roteas er taget som ordineret.
English: apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open - if you have a liver disease which leads to an increased risk of bleeding - if you have uncontrolled high blood pressure - if you are pregnant or breast feeding
Danish: apixaban eller heparin), bortset fra når du skifter antikoagulerende behandling, eller hvis du får heparin gennem et vene- eller arteriekateter for at holde det åbent - hvis du har en leversygdom, som medfører øget risiko for blødning - hvis du har ukontrolleret højt blodtryk - hvis du er gravid eller ammer
English: • Prescriber Guide for healthcare professionals
Danish: • Ordinationsguide til læger og sundhedspersonale
English: Should a bleeding complication arise in a patient receiving edoxaban, the next edoxaban administration should be delayed or treatment should be discontinued as appropriate.
Danish: Såfremt der optræder blødningskomplikationer hos en patient, der får edoxaban, skal næste edoxabanadministration udsættes eller behandlingen seponeres, efter hvad der er hensigtsmæssigt.
English: c The two-sided p-value is based on the non-inferiority margin of 1.38.
Danish: c Den tosidede p-værdi er baseret på non-inferioritetsmarginen på 1,38.
English: This recommendation is based on standard treatment of drug overdose and data available with similar compounds, as the use of activated charcoal to reduce absorption of edoxaban has not been specifically studied in the edoxaban clinical programme.
Danish: Denne anbefaling er baseret på standardbehandlingen af en lægemiddeloverdosering, og tilgængelige data med lignende stoffer, såsom anvendelsen af aktivt kul for at reducere absorption af edoxaban, er ikke blevet specifikt undersøgt i det kliniske program for edoxaban.
English: Cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.
Danish: Kartoner med 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 filmovertrukne tabletter.
English: All subjects with symptomatic recurrent VTEc, n (%)
Danish: Alle personer med symptomatisk recidiverende VTEc, n (%)
English: However, a calibrated anti-Factor Xa assay may help inform clinical decisions.
Danish: En kalibreret anti-faktor Xa-analyse kan imidlertid hjælpe med at informere ved kliniske beslutninger.
English: - if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6) - if you are actively bleeding - if you have a disease or condition that increases the risk of serious bleeding
Danish: - hvis du er allergisk over for edoxaban eller et af de øvrige indholdsstoffer i Roteas (angivet i punkt 6) - hvis du har en aktiv blødning - hvis du har en sygdom eller tilstand, som øger risikoen for alvorlig blødning
English: In healthy subjects, the total clearance is estimated as 22 (± 3) L/hour; 50% is renally cleared (11 L/hour).
Danish: Hos raske personer er den totale clearance estimeret til 22 (± 3) l/time, 50 % udskilles via nyrerne (11 l/time).
English: You have been prescribed Roteas, an anticoagulant medicine, which thins your blood and helps prevent you from suffering blood clots.
Danish: Du har fået ordineret Roteas, et antikoagulerende lægemiddel, som fortynder blodet og hjælper med til at forhindre, at du får blodpropper.
English: • Recommendations for dose adjustment in at risk populations, including patients with renal or hepatic impairment, low body weight and concomitant use of some P-gp inhibitors
Danish: • Anbefalinger til dosisjustering i risikopopulationer, herunder patienter med nedsat nyre- og leverfunktion, lav legemsvægt og samtidig anvendelse af visse P-gp-hæmmere
English: ICH fatal
Danish: ICH dødelig
English: Once a stable INR of ≥ 2.0 is achieved, the parenteral anticoagulant should be discontinued and the VKA continued.
Danish: Når der er opnået en stabil INR på ≥ 2,0, bør den parenterale antikoagulation seponeres, og behandling med VKA bør fortsætte.
English: If any of the above apply to you, tell your doctor before taking Roteas, because the effect of Roteas may be reduced.
Danish: Hvis noget af det ovenstående gælder for dig, skal du fortælle det til lægen, før du tager Roteas, da Roteass virkning kan blive nedsat.
English: Intravenous unfractionated heparin (UFH): Discontinue the infusion and start Roteas 4 hours later.
Danish: Intravenøst, ufraktioneret heparin (UFH): Seponer infusionen, og start behandling med Roteas 4 timer senere.
English: Once an INR ≥ 2.0 is achieved, Roteas should be discontinued.
Danish: Når INR ≥ 2,0 er opnået, skal Roteas seponeres.
English: Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AF03
Danish: Farmakoterapeutisk klassifikation: Andre antitrombotika, ATC-kode: B01AF03
English: Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
Danish: En kort behandlingsvarighed (mindst 3 måneder) bør baseres på forbigående risikofaktorer (f.eks. nylig operation, traume, immobilisering) og længere varighed bør baseres på permanente risikofaktorer eller idiopatisk DVT eller LE.
English: > 110 to ≤ 130 497 20
Danish: > 110 til ≤ 130 497 20
English: Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen på hvert blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: It was 1.07 in centres with the best control of warfarin therapy (4th quartile with > 73.9% of INR values in the therapeutic range).
Danish: Den var 1,07 i centre med den bedste kontrol over warfarinbehandlingen (4. kvartil med > 73,9 % af INR-værdier i det terapeutiske område).
English: HR (97.5% CI) p-value for non-inferiorityc
Danish: HR (97,5 % CI) p-værdi for non-inferioritetc
English: Tell your doctor before taking Roteas, because these medicines may increase the effects of Roteas and the chance of unwanted bleeding.
Danish: Fortæl det altid lægen, før du tager Roteas, da disse lægemidler kan øge virkningen af Roteas og risikoen for uønsket blødning.
English: The educational programme is aimed at mitigating the risk of serious bleeds or haemorrhage in patients treated with Roteas by ensuring prescriber awareness and providing guidance on appropriate patient selection, correct dosing as well as management of the risk.
Danish: Uddannelsesprogrammets mål er at reducere risikoen for alvorlige blødninger eller hæmoragi hos patienter, der behandles med Roteas, ved at sikre, at den person, der skal ordinere medicinen, er bekendt med denne risiko, og give vejledning i passende patientudvælgelse, korrekt dosering samt håndtering af risikoen.
English: Do not take a double dose on the same day to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis på den samme dag som erstatning for den glemte dosis.
English: Edoxaban has three active metabolites, the predominant metabolite (M-4), formed by hydrolysis, is active and reaches less than 10% of the exposure of the parent compound in healthy subjects.
Danish: Edoxaban har tre aktive metabolitter, den primære metabolit (M-4), der dannes ved hydrolyse, er aktiv og når op på under 10 % af eksponeringen fra udgangsstoffet hos raske personer.
English: • Bleeding following an injury (puncture)
Danish: • Blødning efter en skade (punktur)
English: • a problem with the blood vessels in the back of your eyes (retinopathy)
Danish: • et problem med blodårerne bagest i øjnene (retinopati)
English: If possible, Roteas should be stopped at least 24 hours before an operation.
Danish: Hvis det er muligt, skal behandlingen med Roteas stoppes mindst 24 timer før en operation.
English: Patients with mild or moderate hepatic impairment exhibited comparable pharmacokinetics and pharmacodynamics to their matched healthy control group.
Danish: Patienter med let eller moderat nedsat leverfunktion udviste en farmakokinetik og farmakodynamik, der var sammenlignelig med deres matchede raske kontrolgruppe.
English: These agents should not be administered simultaneously.
Danish: Disse midler bør ikke administreres samtidigt.
English: Edoxaban has a half-life of approximately 10 to 14 hours (see section 5.2).
Danish: Edoxaban har en halveringstid på ca. 10 til 14 timer (se pkt.
English: There was a statistically significant interaction between the effect of edoxaban versus warfarin on the main study outcome (stroke/SEE) and renal function (p-value 0.0042; mITT, overall study period).
Danish: Der var en statistisk signifikant interaktion mellem virkningen af edoxaban versus warfarin på udfaldet af det primære studie (apopleksianfald/SEE) og nyrefunktion (p-værdi 0,0042; mITT, samlet studieperiode).
English: • Blood in the spit when coughing
Danish: • Blod i spyttet, når du hoster
English: Signature of physician:
Danish: Lægens underskrift:
English: Edoxaban is a substrate for the efflux transporter P-gp.
Danish: Edoxaban er et substrat for effluks-transportproteinet P-gp.
English: • Please read the Patient Information Leaflet found inside each pack of Roteas.
Danish: • Læs indlægssedlen, der findes i alle pakninger med Roteas.
English: The effect on prothrombin time (PT) and other coagulation biomarkers (e.g. anti-FXa, aPTT) was measured.
Danish: Virkningen på protrombintid (PT) og andre koagulationsbiomarkører (f.eks. anti-FXa og aPTT) blev målt.
English: Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that edoxaban passes the placenta, Roteas is contraindicated during pregnancy (see section 4.3).
Danish: På grund af den mulige reproduktionstoksicitet, den intrinsiske blødningsrisiko og beviset for, at edoxaban krydser placenta, er Roteas kontraindiceret under graviditeten (se pkt.
English: What you need to know before you take Roteas 3.
Danish: Det skal du vide, før du begynder at tage Roteas 3.
English: Data from animals indicate that edoxaban is secreted into breast milk.
Danish: Data fra dyreforsøg indikerer, at edoxaban udskilles i modermælk.
English: Edoxaban showed vaginal haemorrhage at higher doses in rats and rabbits but had no effects in the reproductive performance of parent rats.
Danish: Edoxaban viste vaginal blødning ved højere doser hos rotter og kaniner, men det havde ingen virkning på reproduktionsevnen hos hunrotterne.
English: Thus, medicines or disease conditions that increase gastric emptying and gut motility have the possibility of reducing edoxaban dissolution and absorption.
Danish: Derfor har lægemidler og sygdomstilstande, der øger mavetømningen og tarmmotiliteten, mulighed for at reducere opløsningen og absorptionen af edoxaban.
English: This exploratory study showed low rates of major and CRNM bleeding and thromboembolism in the two treatment groups in the setting of cardioversion.
Danish: Dette eksplorative studie viste lave hyppigheder af svær og CRNM-blødning og tromboembolisme i de to behandlingsgrupper i forbindelse med kardiovertering.
English: The main analysis of efficacy was aimed to show the non-inferiority of edoxaban versus warfarin on first stroke or SEE that occurred during treatment or within 3 days from the last dose taken in the modified intention-to-treat (mITT) population.
Danish: Den primære analyse af virkning havde det formål at vise non-inferioritet for edoxaban versus warfarin på første apopleksianfald eller SEE, der forekom under behandling eller inden for 3 dage fra den sidste dosis, der blevet taget i den modificerede intention-to-treat (mITT)-population.
English: Table 3: List of adverse reactions for NVAF and VTE System Organ Class
Danish: Tabel 3: Liste over bivirkninger for NVAF og VTE Systemorganklasse
English: Table 10: Efficacy Results from the Hokusai-VTE Study - mITT population, overall study period Primary endpointa
Danish: Tabel 10: Virkningsresultater fra Hokusai-VTE-studiet - mITT-population, samlet studieperiode Primære endepunkta
English: • Bleeding from the skin or under the skin
Danish: • Blødning fra huden eller under huden
English: Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant.
Danish: Fortsat tilstrækkelig antikoagulation bør sikres ved alle overgange til anden antikoagulation.
English: Edoxaban displays approximately dose-proportional pharmacokinetics for doses of 15 mg to 60 mg in healthy subjects.
Danish: Edoxaban udviser omtrent dosisproportional farmakokinetik for doser på 15 mg til 60 mg hos raske personer.
English: • Unexplained tiredness
Danish: • Uforklarlig træthed
English: If oral medicinal products cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant and then switch to oral once daily Roteas (see section 4.2).
Danish: Hvis der ikke kan indtages orale lægemidler i løbet af eller efter det kirurgiske indgreb, bør det overvejes at administrere parenteral antikoagulation og derefter skifte til oral behandling med Roteas en gang dagligt (se pkt.
English: Edoxaban vs Warfarin HR (95% CI)b p-valuec
Danish: Edoxaban vs. warfarin HR (95% CI)b p-værdic
English: Edoxaban is a substrate for the efflux transporter P-glycoprotein (P-gp), but not a substrate for uptake transporters such as organic anion transporter polypeptide OATP1B1, organic anion transporters OAT1 or OAT3 or organic cation transporter OCT2.
Danish: Edoxaban er et substrat for efflux-transporterproteinet P-glykoprotein (P-gp), men det er ikke et substrat for optagelsestransportproteiner, såsom organisk aniontransportprotein-polypeptid OATP1B1, organisk aniontransportprotein OAT1 eller OAT3 eller organisk kationtransportprotein OCT2.
English: Discontinuation for surgery and other interventions If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, Roteas should be stopped as soon as possible and preferably at least 24 hours before the procedure.
Danish: Seponering med henblik på kirurgi og andre indgreb Hvis antikoagulation skal seponeres for at nedsætte blødningsrisikoen ved kirurgiske indgreb eller andre procedurer, bør Roteas stoppes så snart som muligt, og helst mindst 24 timer før indgrebet.
English: Roteas has no or negligible influence on the ability to drive and use machines.
Danish: Roteas påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: In clinical studies, co-administration of NSAIDs resulted in increased clinically relevant bleeding.
Danish: I kliniske studier førte samtidig administration af NSAID'er til flere klinisk relevante blødninger.
English: (aPTT) are not a useful measure of the effect of Roteas.
Danish: er ikke anvendelige til at måle virkningen af Roteas.
English: There is very limited experience on the use of edoxaban with dual antiplatelet therapy or fibrinolytic agents.
Danish: Der er meget begrænset erfaring med anvendelse af edoxaban med dobbelt antitrombolytisk behandling eller fibronolytiske midler.
English: • Bleeding from the mouth and/or throat
Danish: • Blødning fra munden og/eller halsen
English: Do not take Roteas if you are pregnant or breast-feeding.
Danish: Tag ikke Roteas hvis du er gravid eller ammer.
English: The majority of edoxaban treated patients were Caucasians (69.6%) and Asians (21.0%), 3.8% were Black, 5.3% were categorised as Other race.
Danish: Hovedparten af patienter behandlet med edoxaban var af kaukasisk herkomst (69,6 %) og af asiatisk herkomst (21,0 %), 3,8 % var sorte, 5,3 % blev kategoriseret som anden race.
English: There is neither scientific rationale for benefit nor experience with the use of systemic haemostatics (desmopressin, aprotinin) in individuals receiving edoxaban.
Danish: Der er hverken videnskabelig rationale for fordele eller erfaring med anvendelse af systemiske hæmostatika (desmopressin, aprotinin) hos personer, der får edoxaban.
English: Clinically Relevant Bleeding (Major and CRNM)b, n (%) n
Danish: Klinisk relevante blødninger (Svær og CRNM),b n (%) n
English: • Uncontrolled severe hypertension.
Danish: • Svær hypertension, som ikke er under kontrol.
English: • Other types of bleeding
Danish: • Andre typer blødninger
English: Continued anticoagulant therapy is important in patients with NVAF and VTE.
Danish: Fortsat behandling med antikoagulantia er vigtig for patienter med NVAF og VTE.
English: There is no clinically relevant accumulation of edoxaban (accumulation ratio 1.14) with once daily dosing.
Danish: Der er ingen klinisk relevant akkumulation af edoxaban (akkumulationsforhold 1/14) med dosering en gang dagligt.
English: • When an invasive procedure is required, Roteas should be stopped at least 24 hours beforehand,
Danish: • Når det er nødvendigt med et invasivt indgreb, skal Roteas stoppes mindst 24 timer i forvejen, og der skal tages passende hensyn.
English: Your doctor will determine when to restart Roteas.
Danish: Din læge vil bestemme, hvornår Roteas skal genstartes.
English: When the effects of edoxaban on digoxin PK were also examined, the Cmax of digoxin increased by approximately 28% and AUC by 7%.
Danish: Da virkningerne af edoxaban på farmakokinetikken for digoxin også blev undersøgt, var Cmax for digoxin forhøjet med ca. 28 % og AUC med 7 %.
English: Co-administration of low dose ASA (≤ 100 mg) did not affect the peak or total exposure of edoxaban either after single dose or at steady-state.
Danish: Administration af ASA i lav dosis (≤ 100 mg) påvirkede ikke den maksimale eller totale eksponering for edoxaban hverken efter en enkelt dosis eller ved steady-state.
English: Woman of childbearing potential Women of childbearing potential should avoid becoming pregnant during treatment with edoxaban.
Danish: Kvinder i den fertile alder Kvinder i den fertile alder skal undgå at blive gravide under behandling med edoxaban.
English: Oral anticoagulants other than VKA
Danish: Andre orale antikoagulantia end VKA
English: Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, the serine protease located in the final common pathway of the coagulation cascade.
Danish: Edoxaban er en højselektiv, direkte og reversibel hæmmer af faktor Xa, den serinprotease, der findes i den sidste fælles sti i koagulationskaskaden.
English: Edoxaban had no effect on the Cmax and AUC of quinidine.
Danish: Edoxaban havde ingen virkning på Cmax og AUC for quinidin.
English: Concomitant Roteas and VKA can increase the INR post Roteas dose by up to 46%.
Danish: Behandling med Roteas sammen med VKA kan øge INR efter Roteas-dosen med op til 46 %.
English: Due to the high plasma protein binding edoxaban is not expected to be dialysable.
Danish: På grund af edoxabans høje plasmaproteinbinding forventes det ikke, at lægemidlet kan dialyseres.
English: Hydroxypropylcellulose Magnesium stearate (E470b)
Danish: Hydroxypropylcellulose Magnesiumstearat (E470b)
English: For dabigatran higher aPTT activity was observed after edoxaban administration with prior dabigatran treatment compared to that after treatment with edoxaban alone.
Danish: For dabigatran blev en højere aPTT-aktivitet observeret efter administration af edoxaban sammen med tidligere dabigatranbehandling, når den blev sammenlignet med aktiviteten efter behandling med edoxaban alene.
English: Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of edoxaban.
Danish: Protaminsulfat og K-vitamin forventes ikke at påvirke edoxabans antikoagulerende aktivitet.
English: The majority of subjects in the edoxaban and warfarin groups had cardioversion performed (83.7% and 78.9%, respectively) or were auto-converted (6.6% and 8.6%, respectively).
Danish: Størstedelen af forsøgspersonerne i edoxabanog warfaringrupperne fik udført kardiovertering (henholdsvis 83,7 % og 78,9 %) eller blev autokonverteret (henholdsvis 6,6 % og 8,6 %).
English: • Blood in the urine
Danish: • Blod i urinen
English: Direct acting Oral Anticoagulants (DOACs) including edoxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Danish: Direkte virkende orale antikoagulantia (DOAK), herunder edoxaban, anbefales ikke til patienter med tidligere trombose, som er diagnosticerede med antifosfolipidsyndrom.
English: Edoxaban is metabolised via hydrolysis (mediated by carboxylesterase 1), conjugation or oxidation by CYP3A4/5 (< 10%).
Danish: Edoxaban metaboliseres via hydrolyse (medieret af carboxylesterase 1), konjugation eller oxidation med CYP3A4/5 (< 10 %).
English: Mannitol (E421) Pregelatinised starch Crospovidone
Danish: Mannitol (E421) Pregelatineret stivelse Crospovidon
English: Edoxaban produces rapid onset of pharmacodynamic effects within 1 - 2 hours, which corresponds with peak edoxaban exposure (Cmax).
Danish: Edoxaban fremkalder en hurtigt indsættende farmakokinetisk virkning inden for 1 - 2 timer, hvilket svarer til den maksimale edoxabaneksponering (Cmax).
English: Do not stop taking Roteas without talking to your doctor first, because Roteas treats and prevents serious conditions.
Danish: Du må ikke holde op med at tage Roteas uden først at kontakte lægen, da Roteas behandler og forebygger alvorlige sygdomme.
English: For life-threatening bleeding that cannot be controlled with the measures such as transfusion or haemostasis, the administration of a 4-factor prothrombin complex concentrate (PCC) at 50 IU/kg has been shown to reverse the effects of Roteas 30 minutes after completing the infusion.
Danish: For livstruende blødninger, der ikke kan kontrolleres ved behandling med transfusion eller hæmostase, har administrationen af 4-faktor protrombinkomplekskoncentrat (prothrombin complex concentrate, PCC) med 50 IE pr. kg vist sig at reversere virkningen af Roteas 30 minutter efter infusionen er gennemført.