FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit was driven by a reduction in CV death and MI and appeared early with a constant treatment effect over the entire treatment period (see Table 4 and Figure 1).
Danish: Dette skyldtes primært en reduktion i kardiovaskulære dødsfald og myokardieinfarkter og optrådte hurtigt med en konstant behandlingseffekt over hele behandlingsperioden (se tabel 4 og figur 1).
English: Time period
Danish: Tidsperiode
English: If you have had a major hip operation you will usually take the tablets for 5 weeks.
Danish: Hvis du har fået foretaget en større hofteoperation, skal du normalt tage tabletterne i 5 uger.
English: If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.
Danish: Hvis din læge tror, at du har øget risiko for at få mavesår, kan han eller hun også ordinere forebyggende behandling.
English: Vascular pseudoaneurysmC
Danish: Vaskulær pseudoaneurismeC
English: breathlessness, chest pain or angina pectoris, which may be signs of bleeding.
Danish: brystsmerter eller angina pectoris, da det kan være tegn på blødning.
English: The tablet may be crushed and mixed with water or apple puree immediately before you take it.
Danish: Tabletten kan knuses og blandes med vand eller æblemos, umiddelbart før du tager den.
English: - Fatal bleeding event p = 0.32164
Danish: - Dødelig blødningshændelse p = 0,32164
English: Possible side effects which may be a sign of severe allergic reactions
Danish: Bivirkninger, der kan være tegn på alvorlige allergiske reaktioner
English: Table 2: Bleeding* and anaemia events rates in patients exposed to rivaroxaban across the completed phase III studies
Danish: Tabel 2: Forekomst af blødning* og anæmi hos patienter eksponeret for rivaroxaban i alle gennemførte fase III-studier
English: Study data indicate that such patients may benefit less from treatment with rivaroxaban (see section 5.1).
Danish: Data fra studier indikerer, at disse patienter kan have mindre gavn af behandling med rivaroxaban (se pkt.
English: If you need to have an operation it is very important to take Xarelto before and after the operation exactly at the times you have been told by your doctor.
Danish: Hvis du skal opereres er det yderst vigtigt, at du tager Xarelto før og efter operationen på præcist de tidspunkter, som lægen har angivet.
English: Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.
Danish: Rivaroxaban hæmmer ikke trombin (aktiveret faktor II), og der er ikke vist nogen effekt på blodpladerne.
English: When Xarelto 20 mg tablets are taken together with food increases in mean AUC by 39% were observed when compared to tablet intake under fasting conditions, indicating almost complete absorption and high oral bioavailability.
Danish: Når Xarelto 20 mg-tabletter tages sammen med mad, iagttages en forøgelse af middel-AUC på 39 % sammenlignet med tabletindtagelse under fastende betingelser, hvilket er et tegn på næsten fuldstændig absorption og stor oral biotilgængelighed.
English: Taking too much Xarelto increases the risk of bleeding.
Danish: Hvis du tager for meget Xarelto, øges risikoen for blødning.
English: Oral absorption of rivaroxaban is almost complete and oral bioavailability is high (80 - 100%) for the 2.5 mg and 10 mg tablet dose, irrespective of fasting/fed conditions.
Danish: Den orale absorption af rivaroxaban er næsten fuldstændig, og den orale biotilgængelighed er høj (80100 %) for 2,5 mg- og 10 mg-tabletten uafhængigt af fastende tilstand eller fødeindtagelse.
English: Among patients receiving dual antiplatelets therapy 98.8% received clopidogrel, 0.9% received ticlopidine and 0.3% received prasugrel.
Danish: Blandt patienterne, som fik dobbelt antitrombotisk behandling, fik 98,8 % clopidogrel, 0,9 % fik ticlopidin og 0,3 % fik prasugrel.
English: Group 3 received dose-adjusted VKA plus DAPT for 1, 6 or 12 months followed by dose-adjusted VKA plus low-dose ASA.
Danish: Gruppe 3 fik dosisjusteret VKA plus DAPT i 1, 6 eller 12 måneder efterfulgt af dosisjusteret VKA plus lavdosis ASA.
English: No specific studies with rivaroxaban in humans have been conducted to evaluate effects on fertility.
Danish: Der er ikke foretaget specifikke studier hos mennesker for at evaluere virkningen på fertiliteten.
English: At least 18 hours should elapse after the last administration of rivaroxaban before removal of an epidural catheter.
Danish: Der skal gå mindst 18 timer efter sidste administration af rivaroxaban, før et epiduralkateter fjernes.
English: Stroke or non-CNS systemic embolism was recorded in 0.8 per 100 patient years.
Danish: Apopleksi eller systemisk non-CNS-emboli blev rapporteret med en hyppighed på 0,8 pr. 100 patientår.
English: The median time on treatment was 13 months and overall treatment duration was up to almost 3 years.
Danish: Mediantiden i behandling var 13 måneder, og den samlede behandlingsvarighed var op til næsten 3 år.
English: Patients must have had symptomatic HF for at least 3 months and left ventricular ejection fraction (LVEF) of ≤40% within one year of enrollment.
Danish: Patienterne skulle have haft symptomatisk HF i minimum 3 måneder og en venstre ventrikel uddrivningsfraktion (LVEF) på ≤40 % indenfor det første år af deres deltagelse i studiet.
English: The analysis of the pooled results of the phase III studies corroborated the data obtained in the individual studies regarding reduction of total VTE, major VTE and symptomatic VTE with rivaroxaban 10 mg once daily compared to enoxaparin 40 mg once daily.
Danish: Analysen af de samlede resultater fra fase III-studierne understøttede de data, der blev indsamlet i de enkelte studier vedrørende en reduktion i det samlede antal VTE'er, alvorlige VTE'er og symptomatiske VTE'er med 10 mg rivaroxaban én gang dagligt sammenlignet med 40 mg enoxaparin én gang dagligt.
English: Talk to your doctor or pharmacist before taking Xarelto.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Xarelto.
English: Clinical surveillance in line with anticoagulation practice is recommended throughout the treatment period.
Danish: Sædvanlig klinisk antikoagulationsovervågning anbefales i hele behandlingsperioden.
English: Therefore, the use of Xarelto in combination with dual antiplatelet therapy in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events.
Danish: Derfor skal brugen af Xarelto i kombination med dobbelt antitrombotisk behandling hos patienter med en kendt øget risiko for blødning opvejes mod fordelen med hensyn til forebyggelse af aterotrombotiske hændelser.
English: The relationship between rivaroxaban concentration and factor Xa activity was best described by an Emax model.
Danish: Forholdet mellem koncentrationen af rivaroxaban og faktor Xa-aktiviteten blev bedst beskrevet af en Emax-model.
English: When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg once daily.
Danish: Når forlænget forebyggelse af recidiverende DVT og PE er indiceret (efter mindst 6 måneders behandling af DVT eller PE), er den anbefalede dosis 10 mg én gang dagligt.
English: At baseline, the median ejection fraction was 34% (IQR: 28%-38%) and 53% of subjects were NYHA Class III or IV.
Danish: Ved baseline var medianen af uddrivningsfraktionen 34 % (IQR: 28 % - 38 %) og 53 % af patienterne var NYHA klasse III eller IV.
English: Xarelto belongs to a group of medicines called antithrombotic agents.
Danish: Xarelto tilhører en gruppe medicin, der kaldes antitrombotika.
English: Patients experiencing these adverse reactions should not drive or use machines.
Danish: Patienter, der oplever disse bivirkninger, bør ikke føre motorkøretøj eller betjene maskiner.
English: Protamine sulphate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban.
Danish: Protaminsulfat og vitamin K forventes ikke at påvirke rivaroxabans antikoagulerende aktivitet.
English: Table 3: All adverse reactions reported in patients in phase III clinical trials or through postmarketing use*
Danish: Tabel 3: Alle indberettede bivirkninger hos patienter i kliniske fase III-studier eller efter markedsføring*
English: A 29% and 56% decrease in AUC and Cmax compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine.
Danish: Der blev rapporteret en 29 % og 56 % reduktion i AUC og Cmax, sammenlignet med tabletten, når rivaroxabangranulat frigøres i den proksimale tyndtarm.
English: Intake with food does not affect rivaroxaban AUC or Cmax at the 2.5 mg and 10 mg dose.
Danish: Indtagelse af mad påvirker ikke rivaroxabans AUC eller Cmax efter en 2,5 mg- og 10 mg-dosis.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ”sodiumfree”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. den er i det væsentlige natrium-fri.
English: The readout for PT is to be done in seconds, because the INR is only calibrated and validated for coumarins and cannot be used for any other anticoagulant.
Danish: PT skal måles i sekunder, da INR kun kalibreres og valideres for coumariner og ikke kan anvendes i forbindelse med andre antikoagulantia.
English: Xarelto was non-inferior to warfarin for the primary composite endpoint of stroke and non-CNS systemic embolism.
Danish: Xarelto var ikke ringere end warfarin med hensyn til det sammensatte primære endepunkt for apopleksi og systemisk non-CNS-emboli.
English: Take the next tablet on the following day and then carry on taking a tablet once a day as normal.
Danish: Tag den næste tablet den efterfølgende dag, og fortsæt derefter med at tage én tablet om dagen som normalt.
English: Patients with an ACS under the age of 55 had to have either diabetes mellitus or a previous MI.
Danish: Patienter med AKS under 55 år skulle enten have diabetes mellitus eller tidligere have haft et myokardieinfarkt.
English: • Final Study Reports submitted by Q4 2020
Danish: • Indsendelse af endelig studierapport i 4. kvartal 2020.
English: Bayer Bitterfeld GmbH Ortsteil Greppin, Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Germany
Danish: Bayer Bitterfeld GmbH Ortsteil Greppin, Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Tyskland
English: Xarelto can be taken with or without food.
Danish: Xarelto kan tages sammen med eller uden mad.
English: Patients on treatment with Xarelto and ASA or with Xarelto and ASA plus clopidogrel/ticlopidine should only receive concomitant treatment with NSAIDs if the benefit outweighs the bleeding risk.
Danish: Patienter i behandling med Xarelto og ASA eller med Xarelto og ASA plus clopidogrel/ticlopidin bør kun få samtidig behandling med NSAID, hvis fordelen opvejer blødningsrisikoen.
English: Multipack: 100 (10 packs of 10 x 1) film-coated tablets.
Danish: Multipakke: 100 (10 pakker med 10 x 1) filmovertrukne tabletter.
English: Birth date:
Danish: Fødselsdato:
English: Maximum treatment duration
Danish: Maksimal varighed af behandlingen
English: Xarelto 20 mg once daily was compared with placebo.
Danish: Xarelto 20 mg én gang dagligt blev sammenlignet med placebo.
English: Any bleeding
Danish: Alle blødning
English: platelet count increased)A, Thrombocytopenia
Danish: forhøjet trombocyttal)A, trombocytopeni
English: A post-authorisation study programme that addresses the safety of rivaroxaban in the secondary prevention of Acute Coronary Syndrome (ACS) outside the clinical trial setting, especially with regard to incidence, severity, management and outcome of bleeding events in all population and particularly in patients at increased risk of bleeding consisting of the following remaining studies:
Danish: Et studieprogram efter markedsføringen af rivaroxabans sikkerhed ved sekundær forebyggelse af akut koronarsyndrom (AKS) uden for det kliniske studiemiljø, især med hensyn til incidens, sværhedsgrad, behandling og udfald af blødningshændelser i hele populationen og især hos patienter med øget blødningsrisiko, bestående af følgende resterende studier:
English: • congenital or acquired bleeding disorders
Danish: • medfødte eller erhvervede blødningsforstyrrelser
English: Epistaxis, haemoptysis
Danish: Epistaxis, hæmoptyse
English: Symptomatic PE and DVT 1
Danish: Symtomatisk PE og DVT 1
English: The median time on treatment was 19 months and overall treatment duration was up to 41 months.
Danish: Mediantiden for behandlingen var 19 måneder, og den samlede varighed af behandlingen var op til 41 måneder.
English: The risk of these events may be increased by the post-operative use of indwelling epidural catheters or the concomitant use of medicinal products affecting haemostasis.
Danish: Risikoen for disse hændelser kan stige ved postoperativ brug af permanent epiduralkateter eller samtidig brug af lægemidler, der påvirker hæmostasen.
English: No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding rivaroxaban pharmacokinetics and pharmacodynamics.
Danish: Der blev ikke observeret nogen klinisk relevante interetniske forskelle mellem kaukasiske (hvide), afroamerikanske, latinamerikanske, japanske og kinesiske patienter, hvad angår rivaroxabans farmakokinetik og farmakodynamik.
English: Paediatric population Safety and efficacy have not been established for children and adolescents up to 18 years.
Danish: Pædiatrisk population Sikkerhed og virkning hos børn og unge op til 18 år er ikke klarlagt.
English: Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of rivaroxaban.
Danish: De effekter, der blev observeret ved toksicitetsstudier ved multiple doser, skyldtes hovedsageligt rivaroxabans unormalt høje farmakodynamiske aktivitet.
English: Take Xarelto around the same time every day (for example, one tablet in the morning and one in the evening).
Danish: Tag tabletterne på omtrent samme tidspunkt hver dag (for eksempel én tablet om morgenen og én om aftenen).
English: Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability.
Danish: Rivaroxaban er en yderst selektiv, direkte faktor Xa-hæmmer med oral biotilgængelighed.
English: The frequencies of these side effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people).
Danish: Hyppighederne af disse bivirkninger er meget sjældne (anafylaktiske reaktioner, herunder anafylaktisk shock, kan påvirke op til 1 ud af 10.000 behandlede) og ikke almindelige (angioødem og allergisk ødem, kan påvirke op til 1 ud af 100 behandlede).
English: - you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms.
Danish: - du har fået stillet diagnosen høj risiko for at få en blodprop på grund af koronararteriesygdom eller perifer arteriesygdom, som giver dig symptomer.
English: • For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.
Danish: • Hos patienter, der gennemgår et større knæindgreb, anbefales en behandlingsvarighed på 2 uger.
English: Extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited (see section 5.1).
Danish: Ved forlængelse af behandlingen ud over 12 måneder skal der foretages en vurdering af den enkelte patient, da erfaring med behandling op til 24 måneder er begrænset (se pkt.
English: The most commonly reported bleedings were epistaxis (4.5 %) and gastrointestinal tract haemorrhage (3.8 %).
Danish: De hyppigst rapporterede blødninger var epistaxis (4,5 %) og blødning fra mave-tarm-kanalen (3,8 %).
English: Elimination of rivaroxaban from plasma occurs with terminal half-lives of 5 to 9 hours in young individuals, and with terminal half-lives of 11 to 13 hours in the elderly.
Danish: Eliminationen af rivaroxaban fra plasma foregår med terminale halveringstider på 5-9 timer hos unge og 11-13 timer hos ældre.
English: CAD with heart failure
Danish: CAD med hjertesvigt
English: As with other anticoagulants, patients taking Xarelto are to be carefully observed for signs of bleeding.
Danish: Som ved andre antikoagulantia bør patienter, som får Xarelto, overvåges nøje for tegn på blødning.
English: No clinically relevant interaction with food was observed (see section 4.2).
Danish: Der er ikke observeret nogen klinisk relevant interaktion med fødevarer (se pkt.
English: Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi.
Danish: Hæmning af faktor Xa afbryder blodkoagulationskaskadens intrinsiske og ekstrinsiske bane, og hæmmer både dannelsen af trombin og tromber.
English: On the fourth day after the last dose of warfarin, all tests (including PT, aPTT, inhibition of factor Xa activity and ETP) reflected only the effect of rivaroxaban.
Danish: På dag 4 efter sidste dosis warfarin afspejler samtlige test (herunder PT, aPTT, hæmning af faktor Xa-aktivitet og ETP) kun effekten af rivaroxaban.
English: Treatment with Xarelto is not recommended for these patients.
Danish: Behandling med Xarelto frarådes for disse patienter.
English: All-cause death
Danish: Død uanset årsag
English: No pharmacokinetic interaction was observed between warfarin and rivaroxaban.
Danish: Der er ikke iagttaget nogen farmakokinetisk interaktion mellem warfarin og rivaroxaban.
English: Unbound AUC was increased 2.6 fold.
Danish: Ubunden AUC var øget med en faktor 2,6.
English: In this case two 15 mg tablets may be taken at once.
Danish: I dette tilfælde er det i orden at tage to 15 mg-tabletter på én gang.
English: The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery.
Danish: Behandlingens varighed afhænger af den enkelte patients risiko for at udvikle venøs tromboemboli, hvilket igen afhænger af, hvilken type ortopædkirurgiske indgreb, der er tale om.
English: • acetylsalicylic acid plus clopidogrel or ticlopidine.
Danish: • acetylsalicylsyre plus clopidogrel eller ticlopidin.
English: • If the first and second characters are BT, the manufacturer is Bayer Bitterfeld GmbH
Danish: Hvis det første og andet tegn er BT, er fremstilleren Bayer Bitterfeld GmbH
English: Rivaroxaban 2.5 mg and 10 mg tablets can be taken with or without food.
Danish: Rivaroxaban 2,5 mg- og 10 mg-tabletter kan tages sammen med eller uden mad.
English: Rivaroxaban neither inhibits nor induces any major CYP isoforms like CYP3A4.
Danish: Rivaroxaban hverken hæmmer eller inducerer væsentlige CYP-isoformer såsom CYP3A4.
English: However the incidence rates were balanced between Xarelto and placebo for the components of fatal bleeding events, hypotension requiring treatment with intravenous inotropic agents and surgical intervention for ongoing bleeding.
Danish: Hyppighederne var imidlertid afbalancerede mellem Xarelto og placebo for komponenterne af dødelige blødningshændelser, hypotension, der krævede behandling med intravenøse inotrope stoffer og kirurgisk intervention for vedvarende blødning.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, phototoxicity, genotoxicity, carcinogenic potential and juvenile toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter en enkeltdosis, fototoksicitet, genotoksicitet, karcinogenicitet og juvenil toksicitet.
English: Due to limited absorption a ceiling effect with no further increase in average plasma exposure is expected at supratherapeutic doses of 50 mg rivaroxaban or above.
Danish: Den begrænsede absorption forventes at medføre en ceiling-effekt uden yderligere stigning i den gennemsnitlige plasmakoncentration ved supraterapeutiske doser på 50 mg rivaroxaban eller højere.
English: Do not take Xarelto and tell your doctor if any of these apply to you.
Danish: Lad være med at tage Xarelto, og fortæl det til din læge, hvis noget af overstående gælder for dig.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har vist reproduktiv toksicitet (se pkt.
English: a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome).
Danish: - en bivirkning, som giver udslæt, feber, betændelse i de indre organer, hæmatologiske unormaliteter og systemisk sygdom (DRESS syndrom).
English: The safety and efficacy of Xarelto in children aged 0 to 18 years have not been established.
Danish: Xareltos sikkerhed og virkning hos børn fra 0 til 18 år er ikke klarlagt.
English: Like all medicines, Xarelto can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som alla andra lægemidler give bivirkninger, men ikke alle får bivirkninger.
English: Treatment initiation pack for the first 4 weeks of treatment:
Danish: Startpakning til de første 4 ugers behandling:
English: The use of pantoprazole 40 mg once daily in addition to antithrombotic study medication in patients with no clinical need for a proton pump inhibitor showed no benefit in the prevention of upper gastrointestinal events (i.e. composite of upper gastrointestinal bleeding, upper gastrointestinal ulceration, or upper gastrointestinal obstruction or perforation); the incidence rate of upper gastrointestinal events was 0.39/100 patient-years in the pantoprazole 40 mg once daily group and 0.44/100 patient-years in the placebo once daily group.
Danish: Anvendelse af pantoprazol én gang dagligt sammen med antitrombotisk studiemedicin hos patienter uden klinisk behov for en protonpumpehæmmer viste ingen fordel i forebyggelsen af øvre gastrointestinale hændelser (dvs. øvre gastrointestinal blødning, øvre gastrointestinal ulceration eller øvre gastrointestinal obstruktion/perforation); incidensen af øvre gastrointestinale hændelser var 0,39/100 patientår i gruppen med 40 mg pantoprazol én gang dagligt og 0,44/100 patientår i gruppen med placebo én gang dagligt.
English: If you have had a major knee operation you will usually take the tablets for 2 weeks.
Danish: Hvis du har fået foretaget en større knæoperation, skal du normalt tage tabletterne i 2 uger.
English: Renal failure/acute renal failure secondary to a bleeding sufficient to cause hypoperfusion
Danish: Nyresvigt/akut nyresvigt sekundært til blødning, der er tilstrækkelig til at medføre hypoperfusion
English: If a dose is missed the patient should continue with the regular dose as recommended at the next scheduled time.
Danish: Hvis en dosis springes over, skal patienten fortsætte med den regelmæssige dosis som anbefalet på det næste skemalagte tidspunkt.
English: Over 12,800 patients were studied in four randomised controlled phase III clinical studies (Einstein DVT, Einstein PE, Einstein Extension and Einstein Choice) and additionally a predefined pooled analysis of the Einstein DVT and Einstein PE studies was conducted.
Danish: Mere end 12.800 patienter blev undersøgt i fire randomiserede kontrollerede kliniske fase III-studier (Einstein DVT, Einstein PE, Einstein Extension og Einstein Choice), og desuden blev der foretaget en foruddefineret samlet analyse af Einstein DVT og Einstein PE-studierne.
English: Xarelto is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of Xarelto have not been established in these clinical situations.
Danish: Xarelto anbefales ikke som alternativ til ufraktioneret heparin til patienter med lungeemboli, som er hæmodynamisk ustabile, eller som kan få behov for trombolyse eller lungeembolektomi, da Xareltos sikkerhed og virkning ikke er klarlagt i disse kliniske situationer.