FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin in individuals receiving rivaroxaban.
Danish: Der er begrænset erfaring med tranexamsyre og ingen erfaringer med aminocapronsyre og aprotinin hos personer, der får rivaroxaban.
English: B: observed in treatment of DVT, PE and prevention of recurrence as very common in women < 55 years
Danish: B Iagttaget ved behandling af DVT, PE og forebyggelse af recidiv som meget almindelig hos kvinder < 55 år.
English: 1,197 patients continued treatment and prevention of recurrent venous thromboembolism
Danish: 1.197 patienter i fortsat behandling og forebyggelse af recidiverende venøs tromboemboli
English: If traumatic puncture occurs the administration of rivaroxaban is to be delayed for 24 hours.
Danish: Hvis traumatisk punktur forekommer, skal indtagelse af rivaroxaban udskydes i 24 timer.
English: Relative to placebo, Xarelto significantly reduced the primary composite endpoint of CV death, MI or stroke.
Danish: I forhold til placebo reducerede Xarelto signifikant det primære sammensatte endepunkt af CV-død, MI eller apopleksi.
English: Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.
Danish: Lægen vil beslutte, om du skal behandles med dette lægemiddel, og om du skal holdes under nøje observation.
English: • If the first and second characters are BX, the manufacturer is Bayer AG
Danish: Hvis det første og andet tegn er BX, er fremstilleren Bayer AG
English: - Bleeding leading to hospitalisation (non-fatal, not in critical organ, not requiring reoperation)
Danish: - Blødning, som fører til indlæggelse (ikke-dødelig, ikke i kritisk organ, kræver ikke gentagen operation)
English: Enoxaparin did not affect the pharmacokinetics of rivaroxaban.
Danish: Enoxaparin påvirkede ikke rivaroxabans farmakokinetik.
English: Prevention of VTE in medically ill patients
Danish: Forebyggelse af VTE hos medicinsk syge patienter
English: Figure 2: Time to first occurrence of primary efficacy outcome (stroke, myocardial infarction, cardiovascular death) in COMPASS
Danish: Figur 2: Tid til første forekomst af primære effektendepunkt (apopleksi, myokardieinfarkt, kardiovaskulær død) i COMPASS
English: For patients with moderate or severe renal impairment where the decision has been taken for 15 mg once daily from Day 22 onwards, other pack sizes only containing 15 mg film-coated tablets are available (see dosing instructions in section “Special populations” below).
Danish: For patienter med moderat eller alvorligt nedsat nyrefunktion, hvor der er truffet beslutning om at give 15 mg én gang dagligt fra dag 22 og frem, er andre pakningsstørrelser der kun indeholder 15 mg filmovertrukne tabletter, tilgængelige (se doseringsinstruktionerne i punktet ”Særlige populationer” nedenfor).
English: This is more marked in fasting state than in fed state.
Danish: Dette er tydeligere i fastende tilstand end efter indtagelse af føde.
English: In the pre- and postnatal study in rats, reduced viability of the offspring was observed at doses that were toxic to the dams.
Danish: I et præog postnatalt studie i rotter blev der set nedsat levedygtighed hos afkommet ved doser, der var toksiske for moderdyrene.
English: If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.
Danish: Hvis du bliver gravid, mens du tager dette lægemiddel, skal du fortælle det til lægen med det samme.
English: ♦ To ensure optimal protection, Xarelto - 2.5 mg can be taken with or without food - 10 mg can be taken with or without food - 15 mg must be taken with food - 20 mg must be taken with food
Danish: - kan 2,5 mg tages med eller uden et måltid - kan 10 mg tages med eller uden et måltid - skal 15 mg tages i forbindelse med et måltid - skal 20 mg tages i forbindelse med et måltid.
English: This was followed by 20 mg rivaroxaban once daily.
Danish: Der fortsattes derefter med 20 mg rivaroxaban én gang dagligt.
English: Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-factor Xa assay may be useful in exceptional situations where knowledge of rivaroxaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery (see sections 5.1 and 5.2).
Danish: Selvom behandling med rivaroxaban ikke kræver rutinemæssig monitorering af eksponeringen, kan bestemmelse af rivaroxaban-niveauerne med en kalibreret kvantitativ test for anti-faktor Xa være anvendelig i specielle situationer, hvor kendskab til eksponeringen for rivaroxaban kan være en støtte for kliniske beslutninger, f.eks. ved overdosering og akut kirurgi (se pkt.
English: In patients, baseline factor Xa and PT were influenced by the surgery resulting in a difference in the concentration-PT slope between the day postsurgery and steady state.
Danish: Hos patienter var baseline faktor Xa og -PT påvirket af det kirurgiske indgreb, hvilket resulterede i en ændring i koncentrationPT-hældningen mellem dagen efter det kirurgiske indgreb og steady-state.
English: If you have missed a dose, take it as soon as you remember.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det.
English: No clinically relevant prolongation of bleeding time was observed after concomitant administration of rivaroxaban (15 mg) and 500 mg naproxen.
Danish: Der blev ikke observeret en klinisk relevant forlængelse af blødningstiden efter samtidig indtagelse af rivaroxaban (15 mg) og 500 mg naproxen.
English: If a patient is to undergo elective surgery and anti-platelet effect is not desired, platelet aggregation inhibitors should be discontinued as directed by the manufacturer's prescribing information.
Danish: Hvis en patient skal gennemgå elektiv kirurgi og der ikke ønskes en antitrombotisk virkning, bør trombocytaggregationshæmmere seponeres efter retninglinjerne fra fremstillerens ordinationsinformation.
English: Your doctor has prescribed you Xarelto 10 mg once a day.
Danish: Din læge har ordineret Xarelto 10 mg én gang dagligt til dig.
English: Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis.
Danish: Før neuraksial intervention skal lægen afveje de mulige fordele med risikoen hos patienter, der får antikoagulantia, og hos patienter, der skal have antikoagulantia til tromboprofylakse.
English: Direct acting Oral Anticoagulants (DOACs) including rivaroxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Danish: Direkte virkende orale antikoagulantia (DOAK), herunder rivaroxaban, anbefales ikke til patienter med tidligere trombose, som er diagnosticerede med antifosfolipidsyndrom.
English: ** In the COMPASS study, there is a low anaemia incidence as a selective approach to adverse event collection was applied
Danish: ** I COMPASS-studiet er der en lav forekomst af anæmi, da der blev benyttet en selektiv metode for indsamlingen af uønskede hændelser.
English: Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
Danish: Fertile kvinder bør undgå at blive gravide under behandling med rivaroxaban.
English: These active substances are strong inhibitors of both CYP3A4 and P-gp (see section 4.4).
Danish: Disse aktive stoffer er stærke hæmmere af både CYP3A4 og P-gp (se pkt.
English: In all three phase III studies (see table 4), rivaroxaban significantly reduced the rate of total VTE (any venographically detected or symptomatic DVT, non-fatal PE and death) and major VTE (proximal DVT, non-fatal PE and VTE-related death), the pre-specified primary and major secondary efficacy endpoints.
Danish: I alle tre fase III-studier (se tabel 4) medførte indtagelsen af rivaroxaban en signifikant reduktion i den samlede forekomst af VTE (alle former for venografisk detekteret eller symptomatisk DVT, ikke-letal PE og dødsfald) og alvorlig VTE (proksimal DVT, ikke-letal PE og VTE-relateret dødsfald), som var de på forhånd specificerede primære og væsentligste sekundære effektendepunkter.
English: Risk: Cumulative incidence risk (Kaplan-Meier estimates) at 30 months; ISTH: International Society on Thrombosis and Haemostasis; od:
Danish: KI: konfidensinterval, kumulativ risiko: Kumulativ incidensrisiko (Kaplan-Meier-estimater) efter 30 måneder, ISTH: International Society on Thrombosis and Haemostasis
English: Patients were randomly assigned in a 1:1:1 fashion for an overall 12-month-therapy.
Danish: Patienterne blev randomiseret i forholdet 1:1:1 til 12 måneders behandling i alt.
English: 3,396 patients continued prevention of recurrent venous thromboembolism
Danish: 3.396 patienter fortsatte forebyggelse af recidiverende venøs tromboemboli
English: There are no data in patients with severe hepatic impairment.
Danish: Der foreligger ikke data om patienter med svært nedsat leverfunktion.
English: Very rare
Danish: Ikke almindelig Sjælden
English: Rivaroxaban is rapidly absorbed with maximum concentrations (Cmax) appearing 2 - 4 hours after tablet intake.
Danish: Rivaroxaban absorberes hurtigt, og den maksimale koncentration (Cmax) opnås 2 - 4 timer efter indtagelsen af tabletten.
English: Compartment syndrome secondary to a bleeding
Danish: Kompartmentsyndrom sekundært til blødning
English: Embryo-foetal toxicity (post-implantation loss, retarded/progressed ossification, hepatic multiple light coloured spots) and an increased incidence of common malformations as well as placental changes were observed at clinically relevant plasma concentrations.
Danish: Embryo-føtal-toksicitet (post-implantationstab, forsinket/progressiv knogledannelse, hepatiske multiple svagt farvede pletter) og et øget antal tilfælde af almindelige misdannelser samt ændringer i placenta blev set ved klinisk relevante plasmakoncentrationer.
English: Patients with non-valvular atrial fibrillation who undergo PCI (percutaneous coronary intervention) with stent placement
Danish: Patienter med ikke-valvulær atrieflimren, som gennemgår PCI (perkutan koronar intervention) med indsat stent
English: Duration of treatment should be determined for each individual patient based on regular evaluations and should consider the risk for thrombotic events versus the bleeding risks.
Danish: Behandlingsvarigheden skal bestemmes for hver enkelt patient baseret på regelmæssige evalueringer, og risikoen for trombotiske hændelser versus blødningsrisikoen skal overvejes.
English: Therefore, administration of rivaroxaban distal to the stomach should be avoided since this can result in reduced absorption and related rivaroxaban exposure.
Danish: Derfor bør administration af rivaroxaban distalt til maven undgås, da dette kan medføre reduceret absorption og relateret rivaroxabaneksponering.
English: Do not use this medicine after the expiry date which is stated on the carton and on each wallet after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter "EXP" og på det enkelte omslag efter "EXP".
English: See section 2 “Xarelto contains lactose and sodium”.
Danish: Se punkt 2 ”Xarelto indeholder lactose og natrium”.
English: The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used (see section 4.5).
Danish: INR er ikke et pålideligt mål for Xareltos antikoagulerende aktivitet og bør derfor ikke benyttes (se pkt.
English: Allergic reaction, dermatitis allergic, Angioedema and allergic oedema
Danish: Allergisk reaktion, allergisk dermatitis, angioødem og allergisk ødem
English: Due to the pharmacological mode of action, the use of Xarelto may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia.
Danish: På grund af Xareltos farmakologiske virkningsmekanisme kan brugen af Xarelto være forbundet med en øget risiko for okkult eller synlig blødning fra alle væv eller organer, hvilket kan medføre posthæmoragisk anæmi.
English: In Table 5 the efficacy results of patients undergoing percutaneous coronary intervention (PCI) are presented.
Danish: Tabel 5 er en oversigt over virkningsresultaterne hos de patienter, der gennemgik en perkutan koronar intervention (PCI).
English: Exclusion criteria included the need for dual antiplatelet or other non-ASA antiplatelet or oral anticoagulant therapy and patients with high bleeding risk, or heart failure with ejection fraction < 30% or New York Heart Association class III or IV, or any ischaemic, non-lacunar stroke within 1 month or any history of haemorrhagic or lacunar stroke.
Danish: Eksklusionskriterierne omfattede behovet for dobbelt antitrombocytbehandling eller anden ikke-ASA antitrombocytbehandling eller behandling med orale antikoagulantia og patienter med høj blødningsrisiko, eller hjerteinsufficiens med uddrivningsfraktion < 30 % eller New York Heart Association klasse III eller IV, eller alle iskæmiske, ikke-lakunære apopleksier inden for én måned eller tidligere hæmoragisk eller lakunær apopleksi.
English: Based on in vitro investigations rivaroxaban is a substrate of the transporter proteins P-gp (P-glycoprotein) and Bcrp (breast cancer resistance protein).
Danish: In vitro-undersøgelser har vist, at rivaroxaban er et substrat for transportproteinerne P-gp (P-glycoprotein) og Bcrp (brystcancer-resistensprotein).
English: Possible side effects which may be a sign of bleeding
Danish: Bivirkninger, der kan være tegn på blødning
English: If it is desired to test the pharmacodynamic effects of warfarin during the conversion period, INR measurement can be used at the Ctrough of rivaroxaban (24 hours after the previous intake of rivaroxaban) as this test is minimally affected by rivaroxaban at this time point.
Danish: Såfremt den farmakodynamiske virkning af warfarin ønskes undersøgt i skifteperioden, kan INRmåling benyttes ved rivaroxabans Cdal (24 timer efter seneste indtagelse af rivaroxaban), idet denne test på dette tidspunkt påvirkes minimalt af rivaroxaban.
English: bid: twice daily; CI: confidence interval; KM %: Kaplan-Meier estimates of cumulative incidence risk calculated at 900 days; CV: cardiovascular; MI: myocardial infarction; od: once daily
Danish: CI: konfidensinterval, KM %: Kaplan-Meier-estimater for den kumulative risiko for forekomst beregnet efter 900 dage, CV: kardiovaskulær, MI: myokardieinfarkt
English: - The active substance is rivaroxaban.
Danish: - Aktivt stof: rivaroxaban.
English: Re-dosing of recombinant factor VIIa shall be considered and titrated depending on improvement of bleeding.
Danish: Det bør overvejes at redosere og titrere rekombinant faktor VIIa afhængigt af bedringen i blødningen.
English: Bioavailability (AUC and Cmax) was comparable for 20 mg rivaroxaban administered orally as a crushed tablet mixed in apple puree, or suspended in water and administered via a gastric tube followed by a liquid meal, compared to a whole tablet.
Danish: Biotilgængeligheden (AUC og Cmax) var sammenlignelig for 20 mg rivaroxaban administreret oralt som en knust tablet blandet i æblemos, eller suspenderet i vand og administreret via en mavesonde, efterfulgt af et flydende måltid, sammenlignet med en hel tablet.
English: Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors, ATC code: B01AF01 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antitrombosemidler, direkte faktor Xa-hæmmere, ATC-kode: B01AF01
English: Xarelto contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents.
Danish: Xarelto indeholder det aktive stof rivaroxaban, og det tilhører en gruppe medicin, der kaldes antitrombotika.
English: Rivaroxaban has a half-life of approximately 5 to 13 hours (see section 5.2).
Danish: Rivaroxaban har en halveringstid på ca. 5 - 13 timer (se pkt.
English: The MAH shall provide an educational pack prior to launch, targeting all physicians who are expected to prescribe/use Xarelto.
Danish: Indehaveren af markedsføringstilladelsen skal inden lanceringen af lægemidlet fremstille uddannelsesmateriale rettet mod de læger, som forventes at ordinere/anvende Xarelto.
English: On the following day you should carry on taking one 15 mg tablet twice a day.
Danish: Næste dag skal du fortsætte med at tage én 15 mg-tablet to gange dagligt.
English: • other gastrointestinal disease without active ulceration that can potentially lead to bleeding complications (e.g. inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease)
Danish: • anden gastrointestinal sygdom uden aktiv ulcerativ, der potentielt kan medføre blødningskomplikationer (f.eks. inflammatorisk tarmsygdom, øsofagitis, gastritis og gastroøsofageal refluks)
English: The duration of therapy and dose selection should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Danish: Behandlingens varighed og valg af dosis skal fastsættes individuelt efter omhyggelig afvejning af fordelen ved behandling mod risikoen for blødning (se pkt.
English: There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine.
Danish: Der er ikke behov for overvågning af koagulationsparametrene under behandling med rivaroxaban som klinisk rutine.
English: After at least 6 months blood clot treatment your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.
Danish: Efter mindst 6 måneders behandling mod blodpropper kan din læge beslutte at fortsætte behandlingen med enten én 10 mg-tablet én gang dagligt eller én 20 mg-tablet én gang dagligt.
English: Patients are to be frequently monitored for signs and symptoms of neurological impairment (e.g. numbness or weakness of the legs, bowel or bladder dysfunction).
Danish: Patienten skal overvåges hyppigt for symptomer på neurologisk svækkelse (f.eks. følelsesløshed eller svaghed i benene og afførings- eller vandladningsforstyrrelser).
English: 5 mg co-administered with ASA or 10 mg alone
Danish: 5 mg administreret sammen med ASA eller 10 mg alene
English: Following removal of the catheter, at least 6 hours should elapse before the next rivaroxaban dose is administered.
Danish: Efter fjernelse af katetret skal der gå mindst 6 timer, før den næste rivaroxaban-dosis administreres.
English: Should a bleeding complication arise in a patient receiving rivaroxaban, the next rivaroxaban administration should be delayed or treatment should be discontinued as appropriate.
Danish: Såfremt der optræder blødningskomplikationer hos en patient, der får rivaroxaban, skal næste rivaroxaban-administration udsættes eller behandlingen seponeres efter lægens vurdering.
English: Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%, apart from on the day of surgery and the following day when variability in exposure is high (70%).
Danish: Variabiliteten i rivaroxabans farmakokinetik er moderat med en inter-individuel variabilitet (CV%), der ligger mellem 30 % og 40 %, bortset fra på operationsdagen og dagen efter, hvor variabiliteten i eksponering er høj (70 %).
English: Rates of major bleeding, recurrent VTE and all-cause mortality for rivaroxaban were 0.7%, 1.4% and 0.5%, respectively.
Danish: Forekomsten af alvorlige blødninger, recidiverende VTE og død uanset årsag for rivaroxaban var henholdsvis 0,7 %, 1,4 % og 0,5 %.
English: 5,142 patients with acute DVT were enrolled to investigate the long-term safety of rivaroxaban compared with standard-of-care anticoagulation therapy in clinical practice.
Danish: 5.142 patienter med akut DVT blev inkluderet med henblik på at undersøge sikkerheden ved langtidsbehandling med rivaroxaban sammenlignet med standard antikoagulationsbehandling efter klinisk praksis.
English: Longer duration of therapy should be considered in patients with provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or a history of recurrent DVT or PE.
Danish: Længere behandlingsvarighed bør overvejes hos patienter med provokeret DVT eller PE, som ikke er forbundet med større midlertidige risikofaktorer, idiopatisk DVT eller PE, eller en anamnese med recidiverende DVT eller PE.
English: Contents of the pack and other information What Xarelto contains
Danish: Pakningsstørrelser og yderligere oplysninger Xarelto indeholder:
English: Therapy with Xarelto should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding (see section 4.4).
Danish: Behandling med Xarelto bør fortsættes langsigtet, forudsat fordelen ved forebyggelse af apopleksi og systemisk emboli overstiger risikoen ved blødning (se pkt.
English: HR (95% CI) p-value, test for superiority
Danish: HR (95 % KI) p-værdi, test for superioritet
English: Rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR).
Danish: Rivaroxaban bør ikke anvendes til tromboseprofylakse hos patienter, der for nyligt har gennemgået transkateterbaseret hjerteklapudskiftning (transcatheter aortic valve replacement, TAVR).
English: Your doctor will tell you how much of these to take (usually between 75 to 100 mg acetylsalicylic acid daily or a daily dose of 75 to 100 mg acetylsalicylic acid plus a daily dose of either 75 mg clopidogrel or a standard daily dose of ticlopidine).
Danish: Din læge vil fortælle dig, hvor meget du skal tage af disse (normalt mellem 75 og 100 mg acetylsalicylsyre dagligt eller en daglig dosis på 75 til 100 mg acetylsalicylsyre plus en daglig dosis af enten 75 mg clopidogrel eller en daglig standarddosis af ticlopidin).
English: Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily.
Danish: Rivaroxabans farmakokinetik er tilnærmelsesvis lineær op til omkring 15 mg én gang dagligt.
English: Treatment Initiation Pack rivaroxaban This medicine is subject to additional monitoring.
Danish: Startpakning rivaroxaban Dette lægemiddel er underlagt supplerende overvågning.
English: Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea and unexplained shock.
Danish: Blødningskomplikationer kan optræde som svaghed, bleghed, svimmelhed, hovedpine eller uforklarlig hævelse, dyspnø og uforklarligt shock.
English: Furthermore, in all three studies the rate of symptomatic VTE (symptomatic DVT, nonfatal PE, VTE-related death) was lower in rivaroxaban treated patients compared to patients treated with enoxaparin.
Danish: Desuden var forekomsten af symptomatisk VTE (symptomatisk DVT, ikke-letal PE og VTE-relateret dødsfald) i alle tre studier lavere hos patienter, der blev behandlet med rivaroxaban, end hos patienter, der blev behandlet med enoxaparin.
English: Exposure is further reduced when rivaroxaban is released in the distal small intestine, or ascending colon.
Danish: Eksponeringen reduceres ydeligere, når rivaroxaban frigøres i den distale tyndtarm, eller ascenderende kolon.
English: 3,449 patients with symptomatic acute deep vein thrombosis
Danish: 3.449 patienter med symtomatisk akut dyb ventrombose
English: There were no clinically relevant differences in pharmacokinetics and pharmacodynamics between male and female patients.
Danish: Der var ingen klinisk relevante forskelle mellem mænd og kvinder, hvad angår farmakokinetik og farmakodynamik.