FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit-risk of the treatment should be individually assessed on a regular basis.
Danish: Benefit/risk-forholdet for behandlingen skal vurderes individuelt regelmæssigt.
English: This medicine can be taken with or without food.
Danish: Dette lægemiddel kan tages sammen med eller uden mad.
English: The overall combined treatment duration in all studies was up to 21 months.
Danish: Den samlede kombinerede behandlingsvarighed i alle studier var op til 21 måneder.
English: The treatment duration was for 3, 6 or 12 months depending on the clinical judgement of the investigator.
Danish: Behandlingsvarigheden var 3, 6 eller 12 måneder afhængigt af investigators kliniske vurdering.
English: After oral administration the elimination becomes absorption rate limited.
Danish: Efter oral administration begrænses eliminationen af absorptionshastigheden.
English: Nevertheless, there may be individuals with a more pronounced pharmacodynamic response.
Danish: Hos nogle patienter kan der dog opstå en mere udtalt farmakodynamisk respons.
English: Patients with an indication for continued therapeutic-dosed anticoagulation were excluded from the study.
Danish: Patienter med en indikation for fortsat antikoagulationsbehandling blev udelukket fra studiet.
English: Xarelto can be initiated or continued in patients who may require cardioversion.
Danish: Behandling med Xarelto kan initieres eller fortsættes hos patienter, der får behov for kardiovertering.
English: Therefore, concomitant administration of strong CYP3A4 inducers should be avoided unless the patient is closely observed for signs and symptoms of thrombosis.
Danish: Samtidig indtagelse af stærke CYP3A4-induktorer bør derfor undgås, medmindre patienten observeres nøje for tegn og symptomer på trombose.
English: Your doctor will decide how long you must continue treatment.
Danish: Lægen beslutter, hvor længe du skal fortsætte behandlingen.
English: Death due to bleeding*
Danish: Død som følge af blødning*
English: Rare cases of overdose up to 600 mg have been reported without bleeding complications or other adverse reactions.
Danish: Der er indberettet sjældne tilfælde af overdosering på op til 600 mg uden blødningskomplikationer eller andre bivirkninger.
English: Stroke, MI or CV death
Danish: Apopleksi, MI eller CV-død
English: Xarelto has minor influence on the ability to drive and use machines.
Danish: Xarelto påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Subjects without a continuous need for treatment with a proton pump inhibitor were randomized to pantoprazole or placebo.
Danish: Personer uden et vedvarende behov for behandling med en protonpumpehæmmer blev randomiseret til pantoprazol eller placebo.
English: If neurological compromise is noted, urgent diagnosis and treatment is necessary.
Danish: Hvis der bemærkes neurologisk svækkelse, skal der øjeblikkeligt stilles en diagnose og iværksættes behandling.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.
Danish: Det må besluttes enten at afbryde amningen eller at afbryde/undgå behandlingen.
English: It should be noted that Xarelto can contribute to an elevated INR.
Danish: Det skal bemærkes, at Xarelto kan medføre forhøjet INR.
English: Therefore, Xarelto is to be used with caution in these patients.
Danish: Xarelto skal derfor anvendes med forsigtighed hos disse patienter.
English: Extremes in body weight (< 50 kg or > 120 kg) had only a small influence on rivaroxaban plasma concentrations (less than 25%).
Danish: Ekstrem legemsvægt (< 50 kg eller > 120 kg) havde kun ringe indvirkning på rivaroxabans plasmakoncentrationer (under 25 %).
English: Other medicines / conditions:
Danish: Anden medicin/andre forhold:
English: If the procedure cannot be delayed the increased risk of bleeding should be assessed against the urgency of the intervention.
Danish: Såfremt indgrebet ikke kan udskydes, må den øgede blødningsrisiko afvejes mod behovet for hurtig intervention.
English: The manufacturer can be identified by the batch number printed on the side flap of the carton and on each blister or bottle:
Danish: Fremstilleren kan identificeres ved hjælp af batchnummeret, der er trykt på æskens sideflap og på hver blisterpakning eller plastbeholder:
English: Patients with elevated biomarkers (troponin or CK-MB) and without a prior stroke/TIA constituted 80% of the study population.
Danish: Patienter med forhøjede biomarkører (troponin eller CK-MB) og uden tidligere slagtilfælde/TIA udgjorde 80 % af studiepopulationen.
English: Einstein DVT, PE and Extension used the same pre-defined primary and secondary efficacy outcomes.
Danish: Einstein DVT, PE og Extension benyttede samme på forhånd fastsatte primære og sekundære effektendepunkter.
English: Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first weeks of treatment.
Danish: Patienter ser ud til at have den højeste risiko for disse bivirkninger i begyndelsen af behandlingen: i de fleste tilfælde indtrådte bivirkningen inden for de første uger af behandlingen.
English: An additional retrospective analysis showed a nominally significant reduction in the incidence rates of stent thrombosis compared with placebo (see Table 4).
Danish: En yderligere retrospektiv analyse viste en nominelt signifikant reduktion i hyppigheden af stenttrombose sammenlignet med placebo (se tabel 4).
English: Few ACS patients with a prior stroke or TIA have been studied but the limited efficacy data available indicate that these patients do not benefit from treatment.
Danish: Få AKS-patienter med forudgående apopleksi eller TIA er blevet undersøgt, men de begrænsede tilgængelige data for virkning indikerer, at disse patienter ikke drager fordel af behandlingen.
English: After intravenous administration of a 1 mg dose the elimination half-life is about 4.5 hours.
Danish: Efter indgift af 1 mg intravenøst er halveringstiden for elimination ca. 4,5 timer.
English: The frequency of this side effect is very rare (up to 1 in 10,000).
Danish: Hyppigheden af denne bivirkning er meget sjælden (op til 1 ud af 10.000).
English: 34.9% of patients were treated with acetylsalicylic acid and 11.4% were treated with class III antiarrhythmic including amiodarone.
Danish: 34,9 % af patienterne blev behandlet med acetylsalicylsyre, mens 11,4 % blev behandlet med klasseIII-antiarytmika, herunder amiodaron.
English: • CAD patients with severe symptomatic heart failure.
Danish: ● CAD patienter med alvorlig symptomatisk hjertesvigt.
English: The overall median study treatment duration was 504 days.
Danish: Medianen for behandlingstiden i studiet var 504 dage.
English: If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Xarelto.
Danish: Hvis du har problemer med at sluge tabletten hel, skal du tale med din læge om andre måder at tage Xarelto på.
English: As incidence of adverse reactions did not increase and no new adverse reaction was identified, COMPASS study data were not included for frequency calculation in this table.
Danish: Da forekomsten af bivirkninger ikke steg, og der ikke blev identificeret nogen ny bivirkning, blev data fra COMPASS-studiet ikke inkluderet i hyppighedsberegningen i denne tabel.
English: In patients with mild and moderate heart failure the treatment effects for the COMPASS study subgroup were similar to those of the entire study population (see section CAD/PAD).
Danish: I patienter med mild til moderat hjertesvigt var effekten af behandlingen fra COMPASS studiets undergruppe det samme som for hele studiets patientpopulation (se afsnit CAD/PAD).
English: Data on efficacy (including thromboembolic events) in this population are limited.
Danish: Data for virkningen (inklusive tromboemboliske hændelser) hos denne patientgruppe er begrænsede.
English: • uncontrolled severe arterial hypertension
Danish: • ukontrolleret, svær arteriel hypertension
English: First 4 weeks treatment initiation pack: each pack of 49 film-coated tablets for the first 4 weeks of treatment contains:
Danish: Startpakning til de første 4 uger: Hver pakning med 49 filmovertrukne tabletter til de første 4 ugers behandling indeholder:
English: Unchanged rivaroxaban is the most important compound in human plasma, with no major or active circulating metabolites being present.
Danish: Uændret rivaroxaban er det vigtigste stof i humant plasma, idet der ikke forefindes nogen væsentlige eller aktive cirkulerende metabolitter.
English: No dose adjustment is necessary.
Danish: Der kræves ingen dosisjustering.
English: A pre-specified propensity score stratified analysis was used to adjust for measured baseline differences but residual confounding may, in spite of this, influence the results.
Danish: Der blev anvendt en forudspecificeret stratificeret tendensanalyse til at justere for målte forskelle ved baseline, men på trods af dette, kan residual confounding påvirke resultatet.
English: If you get Xarelto after an acute coronary syndrome, your doctor may tell you to also take clopidogrel or ticlopidine.
Danish: Hvis du får Xarelto efter et akut koronarsyndrom, kan din læge fortælle dig, at du også skal tage clopidogrel eller ticlopidin.
English: There were differences in patient baseline characteristics including age, cancer and renal impairment.
Danish: Der var forskelle i patientkarakteristika ved baseline, herunder alder, cancer og nedsat nyrefunktion.
English: Your doctor will tell you when to start treatment with Xarelto if you have been diagnosed with coronary artery disease or peripheral artery disease.
Danish: Din læge vil fortælle dig, hvornår du skal begynde behandlingen med Xarelto, hvis du er blevet diagnosticeret med koronararteriesygdom eller perifer arteriesygdom.
English: If you stop taking this medicine, it may increase your risk of having another heart attack or stroke or dying from a disease related to your heart or your blood vessels.
Danish: Hvis du holder op med at tage dette lægemiddel, kan det øge risikoen for, at du får endnu et hjerteanfald eller slagtilfælde, eller for, at du dør af en sygdom med relation til dit hjerte eller dine blodkar.
English: Please also notify:
Danish: Kontakt venligst også:
English: Also the first secondary endpoint (all-cause death, MI or stroke) was reduced significantly.
Danish: Det første sekundære endepunkt (dødsfald uanset årsag, MI eller apopleksi) blev også reduceret signifikant.
English: The safety of rivaroxaban has been evaluated in thirteen phase III studies including 53,103 patients exposed to rivaroxaban (see Table 1).
Danish: Sikkerheden af rivaroxaban er blevet undersøgt i 13 fase III-studier omfattende 53.103 patienter, der fik rivaroxaban (se tabel 1).
English: Increased LDHA, increased lipaseA, increased amylaseA
Danish: Forhøjet LDHA, forhøjet lipaseA, forhøjet amylaseA
English: It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.
Danish: Det fungerer ved at blokere en blodstørkningsfaktor i blodet (faktor Xa) og nedsætter således blodets tendens til at klumpe sig sammen.
English: The Prescriber Guide should contain the following key safety messages:
Danish: Vejledningen til den ordinerende læge skal indeholde følgende hovedpunkter om sikkerhed:
English: ♦ Tell your health care provider about any other medicines you are currently taking, took recently or intend to start taking, before you start Xarelto.
Danish: ♦ Informér sundhedspersonalet om evt. anden medicin, du tager lige nu, har taget for nylig, eller som du har til hensigt at begynde at tage, inden du begynder på at tage Xarelto.
English: I am under anticoagulation treatment with Xarelto (rivaroxaban)
Danish: Jeg får antikoagulationsbehandling med Xarelto (rivaroxaban)
English: Non-CABG TIMI major bleeding event
Danish: Non-CABG TIMI større blødningshændelse
English: Depending on local availability, a consultation with a coagulation expert should be considered in case of major bleedings (see section 5.1).
Danish: Afhængigt af lokal tilgængelighed bør det overvejes at konsultere en koagulationsekspert i tilfælde af større blødninger (se pkt.
English: Lesion or condition, if considered to be a significant risk for major bleeding.
Danish: Læsion eller tilstand, hvis den betragtes som værende af signifikant risiko for svær blødning.
English: For all patients, confirmation should be sought prior to cardioversion that the patient has taken Xarelto as prescribed.
Danish: For alle patienters vedkommende skal det så vidt muligt inden kardioverteringen bekræftes, at patienten har taget Xarelto som foreskrevet.
English: ♦ Xarelto must be taken exactly as prescribed by your doctor.
Danish: ♦ Xarelto skal tages nøjagtigt, som lægen har ordineret.
English: Rivaroxaban is metabolised via CYP3A4, CYP2J2 and CYP-independent mechanisms.
Danish: Rivaroxaban metaboliseres via CYP3A4, CYP2J2 og CYP-uafhængige mekanismer.
English: Given the predictable, dose-proportional pharmacokinetic profile of rivaroxaban, the bioavailability results from this study are likely applicable to lower rivaroxaban doses.
Danish: Ud fra den forudsigelige, dosisproportionale farmakokinetiske profil for rivaroxaban er det sandsynligt, at resultaterne for biotilgængelighed i dette studie også gælder for lavere rivaroxaban-doser.
English: This exploratory study showed comparable efficacy and safety between rivaroxaban and VKA treatment groups in the setting of cardioversion.
Danish: Dette eksploratoriske studie viste sammenlignelig virkning og sikkerhed mellem rivaroxaban- og VKA-grupperne i forhold til kardiovertering.
English: These patients also had reduced renal elimination of rivaroxaban, similar to patients with moderate renal impairment.
Danish: Disse patienter havde også nedsat renal elimination af rivaroxaban i lighed med patienter med moderat nedsat nyrefunktion.
English: Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.
Danish: Lægen har ordineret denne medicin til dig, fordi du har øget risiko for at få blodpropper efter en operation.
English: - Symptomatic bleeding in critical organ (non-fatal)
Danish: - Symptomatisk blødning i kritisk organ (ikke-dødelig)
English: The educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Xarelto and providing guidance on how to manage that risk.
Danish: Dette uddannelsesmateriale skal øge opmærksomheden om den potentielle risiko for blødning ved behandling med Xarelto og give vejledning i, hvorledes denne risiko håndteres.
English: - Without overnight stay p = 0.04983
Danish: - Uden overnatning p = 0,04983
English: Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant.
Danish: Tilstrækkelig, kontinuerlig antikoagulation skal sikres under skift fra et antikoagulans til et andet.
English: However, there is currently very limited clinical experience with the use of these medicinal products in individuals receiving rivaroxaban.
Danish: Der er imidlertid på nuværende tidspunkt yderst begrænsede erfaringer med brug af disse lægemidler hos personer, der får rivaroxaban.
English: All-cause mortality a) Safety population, on treatment * Nominally significant
Danish: Død uanset årsag a Sikkerhedspopulation, ved behandling * Nominelt signifikant
English: If necessary, your doctor may also give you the crushed Xarelto tablet through a stomach tube.
Danish: Hvis det er nødvendigt, kan din læge give dig den knuste Xarelto-tablet via en mavesonde.
English: Your doctor may decide to keep you under closer observation or change how you should be treated.
Danish: Lægen kan beslutte at holde dig under nøje observation eller ændre din behandling.
English: • acetylsalicylic acid or
Danish: • acetylsalicylsyre eller
English: Patients with prior stroke and/or TIA
Danish: Patienter med forudgående apopleksi og/eller TIA
English: 39 days
Danish: 39 dage
English: The 3-factor PCC reduced mean Neoplastin PT values by approximately 1.0 second within 30 minutes, compared to reductions of approximately 3.5 seconds observed with the 4-factor PCC.
Danish: 3-faktor PCC'en reducerede middelværdierne af neoplastin-PT med ca. 1,0 sekund inden for 30 minutter sammenlignet med reduktioner på ca. 3,5 sekunder observeret med 4-faktor PCC'en.
English: In contrast, the 3-factor PCC had a greater and more rapid overall effect on reversing changes in endogenous thrombin generation than the 4-factor PCC (see section 4.9).
Danish: Til gengæld havde 3-faktor PCC'en en større og hurtigere samlet effekt på ophævelse af ændringer i endogen trombingenerering end 4-faktor PCC'en (se pkt.
English: Pharmacokinetic data in patients
Danish: Farmakokinetiske data for patienter
English: CAD patients had multivessel CAD and/or prior MI. For patients < 65 years of age atherosclerosis involving at least two vascular beds or at least two additional cardiovascular risk factors were required.
Danish: CAD-patienterne havde CAD i flere kar og/eller tidligere MI. For patienter < 65 år var det nødvendigt med aterosklerose i mindst to karsystemer eller mindst to ekstra kardiovaskulære risikofaktorer.
English: Following completion of at least 6 months therapy for DVT or PE
Danish: Efter mindst 6 måneders behandling for DVT eller PE
English: 1.73; modified ITT population).
Danish: modificeret ITT-population).
English: Active clinically significant bleeding.
Danish: Aktiv, klinisk signifikant blødning.
English: There is neither scientific rationale for benefit nor experience with the use of the systemic haemostatic desmopressin in individuals receiving rivaroxaban.
Danish: Der er hverken videnskabeligt rationale for fordele ved eller erfaring med anvendelse af det systemiske hæmostatikum desmopressin hos personer, der får rivaroxaban.
English: ♦ INR values should not be used as they are not a dependable measure of the anticoagulant activity of Xarelto.
Danish: ♦ INR-test bør ikke anvendes, da det ikke er et pålideligt mål for Xareltos antikoagulerende aktivitet.
English: Treatment in combination with other antiplatelet agents, e.g. prasugrel or ticagrelor, has not been studied and is not recommended.
Danish: Behandling i kombination med andre antitrombotiske stoffer, f.eks. prasugrel eller ticagrelor, er ikke undersøgt og anbefales derfor ikke.
English: Stevens-Johnson syndrome/ Toxic Epidermal Necrolysis , DRESS syndrome
Danish: Stevens-Johnsons syndrom/toksisk epidermal nekrolyse, DRESS syndrom
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xarelto in one or more subsets of the paediatric population in the treatment of thromboembolic events.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Xarelto i en eller flere undergrupper af den pædiatriske population ved behandlingen af tromboemboliske hændelser.
English: To prevent blood clots in the veins after a hip or knee replacement operation: Take the first tablet 6 - 10 hours after your operation.
Danish: Til forebyggelse af blodpropper i venerne efter hofteleds- eller knæledsalloplastik: Tag den første tablet 6 - 10 timer efter operationen.
English: When the recommended dose is 10 mg once daily, no dose adjustment from the recommended dose is necessary.
Danish: Når den anbefalede dosis er 10 mg én gang dagligt, kræves der ingen dosisjustering af den anbefalede dosis.
English: Short duration of therapy (at least 3 months) should be considered in patients with DVT or PE provoked by major transient risk factors (i.e. recent major surgery or trauma).
Danish: En kort behandlingsvarighed (mindst 3 måneder) bør overvejes hos patienter med DVT eller PE fremkaldt af større midlertidige risikofaktorer (f.eks. nyligt større kirurgisk indgreb eller traume).
English: After at least 6 months: 10 mg or 20 mg
Danish: Efter mindst 6 måneder: 10 mg eller 20 mg
English: The final 1/3 of the administered dose undergoes direct renal excretion as unchanged active substance in the urine, mainly via active renal secretion.
Danish: Den sidste tredjedel af den administrerede dosis udskilles uændret i urinen, fortrinsvis via aktiv renal sekretion.
English: Data from animals indicate that rivaroxaban is secreted into milk.
Danish: Data fra dyrestudier indikerer, at rivaroxaban udskilles i mælk.
English: ♦ Xarelto thins the blood, which prevents you from getting dangerous blood clots.
Danish: ♦ Xarelto gør blodet tyndere, hvilket forhindrer dannelse af farlige blodpropper.
English: - if you have a liver disease which leads to an increased risk of bleeding - if you are pregnant or breast-feeding
Danish: - hvis du lider af en alvorlig leversygdom, som medfører øget risiko for blødning - hvis du er gravid eller ammer.
English: Due to a reduced extent of absorption an oral bioavailability of 66% was determined for the 20 mg tablet under fasting conditions.
Danish: Som følge af den begrænsede absorption konstateredes en oral biotilgængelighed på 66 % for 20 mgtabletten under fastende betingelser.
English: 93.2% of patients received ASA concomitantly plus thienopyridine treatment and 6.8% ASA only.
Danish: 93,2 % af patienterne fik ASA samtidigt plus thienopyridin-behandling, og 6.8 % fik ASA alene.
English: Results for secondary endpoints as tested in hierarchical order in the ITT analysis are displayed in Table 4.
Danish: Resultaterne for de sekundære endepunkter testet hierarkisk i ITT-analysen vises i tabel 4.
English: You must take Xarelto together with a meal.
Danish: Du skal tage Xarelto sammen med et måltid.
English: What should I know about Xarelto?
Danish: Hvad skal jeg vide om Xarelto?
English: The mean CHADS2 and HAS-BLED scores were both 2.0 in XANTUS, compared to a mean CHADS2 and HAS-BLED score of 3.5 and 2.8 in ROCKET AF, respectively.
Danish: Både den gennemsnitlige CHADS2- og HAS-BLED-score var 2,0 i XANTUS sammenholdt med en gennemsnitlig CHADS2- og HAS-BLED-score på henholdsvis 3,5 og 2,8 i ROCKET AF.
English: Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.
Danish: Beslutning om iværksættelse af behandling og behandlingsvarighed skal træffes under hensyntagen til de fastlagte anbefalinger vedrørende antikoagulerende behandling hos patienter, der skal kardioverteres.
English: The physician educational pack should contain:
Danish: Uddannelsesmaterialet til læger skal indeholde:
English: These results in clinical practice are consistent with the established safety profile in this indication.
Danish: Disse resultater ved klinisk praksis er konsistente med den etablerede sikkerhedsprofil ved denne indikation.
English: However, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
Danish: Det vides imidlertid ikke, præcist hvornår en tilstrækkelig lav antikoagulerende virkning nås hos den enkelte patient.
English: Major intracranial bleeding p = 0.59858
Danish: Større intrakranial blødning p = 0,59858
English: If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Xarelto.
Danish: Hvis der er mulighed for, at du kan blive gravid, skal du bruge effektiv prævention, mens du tager Xarelto.
English: If you forget to take a dose you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day.
Danish: Såfremt du glemmer en dosis, kan du tage to 15 mg-tabletter på én gang, således at du kommer op på i alt to tabletter (30 mg) samme dag.
English: If you miss a dose, take your next dose at the usual time.
Danish: Hvis du glemmer en dosis, skal du tage den næste dosis til sædvanlig tid.
English: In some cases as a consequence of anaemia, symptoms of cardiac ischaemia like chest pain or angina pectoris have been observed.
Danish: I nogle tilfælde er der som følge af anæmi set symptomer på kardial iskæmi som f.eks. brystsmerter eller angina pectoris.