FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xarelto in all subsets of the paediatric population in the prevention of thromboembolic events (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Xarelto i alle undergrupper af den pædiatriske population ved forebyggelse af tromboemboliske hændelser (se pkt.
English: 20 mg once a day (15 mg once a day in patients with moderate renal impairment) Event rate (100 pt-yr)
Danish: 20 mg én gang dagligt (15 mg én gang dagligt for patienter med moderat nedsat nyrefunktion) Frekvens (per 100 patient-år)
English: Converting from Xarelto to parenteral anticoagulants Give the first dose of parenteral anticoagulant at the time the next Xarelto dose would be taken.
Danish: Skift fra Xarelto til parenterale antikoagulantia Første dosis af det parenterale antikoagulans administreres på tidspunktet for næste planlagte administration af Xarelto.
English: DOSE and DOSING SCHEME
Danish: DOSERING og DOSERINGSPLAN:
English: Treatment with Xarelto should be started as soon as possible after stabilisation of the ACS event (including revascularisation procedures); at the earliest 24 hours after admission to hospital and at the time when parenteral anticoagulation therapy would normally be discontinued.
Danish: Behandling med Xarelto bør startes snarest muligt efter stabilisering af AKShændelsen (herunder revaskularisationsprocedurer), tidligst 24 timer efter indlæggelse på hospitalet og på det tidspunkt, hvor parenteral antikoagulationsbehandling normalt ville blive seponeret.
English: Transfusion of 4 or more units of blood over a 48 hour period a) safety population, on treatment b) vs. placebo; Log-Rank p-value * statistically significant
Danish: Hypotension, der kræver behandling med intravenøse inotrope stoffer Kirurgisk intervention for vedvarende blødning Transfusion af 4 eller flere enheder af blod i løbet af en 48-timers periode a) sikkerhedspopulation, i behandling b) vs. placebo, Log-Rank p-værdi * statistisk signifikant
English: Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%.
Danish: Variationen i rivaroxabans farmakokinetik er moderat med interindividuel variation (variationskoefficient) i intervallet 30 - 40 %.
English: Symptomatic recurrent VTE* 36
Danish: Symtomatisk recidiverende VTE* 36
English: • ≥ 75 years of age if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine.
Danish: ● ≥ 75 år, hvis det administreres i kombination med ASA eller med ASA og clopidogrel eller ticlopidin.
English: The primary efficacy outcome was symptomatic recurrent VTE defined as the composite of recurrent DVT or fatal or non-fatal PE.
Danish: Det primære effektendepunkt var symptomatisk recidiverende VTE defineret som recidiverende DVT og dødelig eller ikke-dødelig PE.
English: Prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS)
Danish: Forebyggelse af aterotrombotiske hændelser hos patienter efter et akut koronarsyndrom (AKS)
English: Do not stop taking Xarelto without talking to your doctor first, because Xarelto prevents the development of a serious condition.
Danish: Du må ikke holde op med at tage Xarelto uden først at have talt med din læge, da Xarelto forebygger udvikling af en alvorlig tilstand.
English: In the pivotal double-blind ROCKET AF study, 14,264 patients were assigned either to Xarelto 20 mg once daily (15 mg once daily in patients with creatinine clearance 30 - 49 ml/min) or to warfarin titrated to a target INR of 2.5 (therapeutic range 2.0 to 3.0).
Danish: I det centrale dobbeltblindstudie ROCKET AF blev 14.264 patienter udvalgt til enten Xarelto 20 mg én gang dagligt (15 mg én gang dagligt for patienter med kreatininclearance 30 - 49 ml/min) eller warfarin titreret til en INR på 2,5 (behandlingsinterval 2,0-3,0).
English: The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water.
Danish: Den knuste tablet administreres i en smule vand via en mavesonde, hvoreften sonden skylles med vand.
English: PVC/PVDC/Aluminium foil blisters in cartons of 14 film-coated tablets.
Danish: Blisterpakninger af PVC/PVDC/aluminiumsfolie i æsker indeholdende 14 filmovertrukne tabletter.
English: Known complications secondary to severe bleeding such as compartment syndrome and renal failure due to hypoperfusion have been reported for Xarelto.
Danish: Der er for Xarelto indberettet kendte komplikationer sekundære til svær blødning som f.eks. kompartmentsyndrom og nyresvigt som følge af hypoperfusion.
English: What you need to know before you take Xarelto Do not take Xarelto
Danish: Det skal du vide, før du begynder at tage Xarelto Tag ikke Xarelto
English: If a dose is missed during the 15 mg twice daily treatment phase (day 1 - 21), the patient should take Xarelto immediately to ensure intake of 30 mg Xarelto per day.
Danish: Såfremt en dosis overspringes i den indledende behandlingsfase (dag 1 - 21) med 15 mg to gange dagligt, skal patienten straks tage Xarelto for at sikre en dosis på 30 mg Xarelto per dag.
English: PC (only applicable for outer carton, not applicable for bottle label) SN (only applicable for outer carton, not applicable for bottle label) NN (only applicable for outer carton, not applicable for bottle label)
Danish: PC (gælder kun ydre emballage, gælder ikke etiket til plastbeholder) SN (gælder kun ydre emballage, gælder ikke etiket til plastbeholder) NN (gælder kun ydre emballage, gælder ikke etiket til plastbeholder)
English: Initial treatment Xarelto 15 mg twice a day First 3 weeks Continuous treatment Xarelto 20 mg once a day Week 4 onwards Visit your doctor to ensure continued treatment.
Danish: Indledende behandling Xarelto 15 mg to gange dagligt Første 3 uger Fortsat behandling Xarelto 20 mg én gang dagligt Fra uge 4 og frem Konsultér din læge for at sikre fortsat behandling.
English: Hypotension, haematoma
Danish: Hypotension, hæmatom
English: Patients with recent acute coronary syndrome undergoing PCI a)
Danish: Patienter med nyligt akut koronarsyndrom, der gennemgik PCI a)
English: Swallow the tablet(s) preferably with water.
Danish: Tabletterne skal helst synkes med vand.
English: In patients undergoing major orthopaedic surgery, the 5/95 percentiles for PT (Neoplastin) 2 - 4 hours after tablet intake (i.e. at the time of maximum effect) ranged from 13 to 25 s (baseline values before surgery 12 to 15 s).
Danish: Hos patienter, som gennemgik større ortopædkirurgiske indgreb, lå 5/95-percentilerne for PT (Neoplastin) 2-4 timer efter indtagelse af tabletterne (dvs. da der var opnået maksimal effekt) på mellem 13 og 25 sekunder (baselineværdier før kirurgi 12 til 15 sek.).
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE.
Danish: Behandling af DVT, behandling af PE og forebyggelse af recidiverende DVT og PE Anbefalet dosis for indledende behandling af akut DVT eller PE er 15 mg to gange dagligt i de første tre uger og derefter fortsat behandling og forebyggelse af recidiverende DVT og PE med 20 mg én gang dagligt.
English: • Specialist Cohort Event Monitoring (SCEM) ACS Study With the submission of the last final study report from the programme, the MAH should provide an overview and discussion of the results from all studies of the programme in view of ACS patients.
Danish: Indehaveren af markedsføringstilladelsen skal ved indsendelsen af den sidste endelige studierapport fra programmet give et overblik over og diskussion af resultaterne af alle studierne i programmet omhandlende AKSpatienterne.
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation The Xarelto clinical programme was designed to demonstrate the efficacy of Xarelto for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Danish: Forebyggelse af apopleksi og systemisk emboli hos patienter med ikke-valvulær atrieflimren Det kliniske Xarelto-program var udformet med henblik på at påvise effekten af Xarelto til forebyggelse af apopleksi og systemisk emboli hos patienter med ikke-valvulær atrieflimren.
English: Of the administered rivaroxaban dose, approximately 2/3 undergoes metabolic degradation, with half then being eliminated renally and the other half eliminated by the faecal route.
Danish: Ca. 2/3 af den administrede rivaroxabandosis nedbrydes ved metabolisering, hvoraf halvdelen udskilles med urinen og den anden halvdel med fæces.
English: Table 8: Safety results from phase III COMPASS Study population
Danish: Tabel 8: Sikkerhedsresultater fra fase III COMPASS Studiepopulation
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see section 4.9 “Management of bleeding”).
Danish: Symptomerne og sværhedsgraden (herunder letal udgang) varierer i forhold til blødningens placering og graden eller omfanget af blødningen og/eller anæmien (se pkt.
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp), atorvastatin (substrate of CYP3A4 and P-gp) or omeprazole (proton pump inhibitor).
Danish: Der blev ikke observeret nogen klinisk signifikante farmakokinetiske eller farmakodynamiske interaktioner, når rivaroxaban blev givet samtidigt med midazolam (substrat af CYP3A4), digoxin (substrat af P-gp), atorvastatin (substrat af CYP3A4 og P-gp) eller omeprazol (protonpumpehæmmer).
English: Patients with non-valvular atrial fibrillation who undergo PCI with stent placement A randomised, open-label, multicentre study (PIONEER AF-PCI) was conducted in 2,124 patients with non-valvular atrial fibrillation who underwent PCI with stent placement for primary atherosclerotic disease to compare safety of two rivaroxaban regimens and one VKA regimen.
Danish: Patienter med ikke-valvulær atrieflimren, som gennemgår PCI med indsat stent Et randomiseret, åbent, multicenterstudie (PIONEER AF-PCI) blev gennemført hos 2.124 patienter med ikke-valvulær atrieflimren, som gennemgik PCI med indsat stent mod primær aterosklerotisk sygdom for at sammenligne sikkerheden af to rivaroxaban-programmer og ét VKA-program.
English: Adverse reactions like syncope (frequency: uncommon) and dizziness (frequency: common) have been reported (see section 4.8).
Danish: Besvimelse (hyppighed: ikke almindelig) og svimmelhed (hyppighed: almindelig) er indberettet (se pkt.
English: Table 5: Efficacy results from phase III ATLAS ACS 2 TIMI 51 in patients undergoing PCI Study population
Danish: : Table 5: Virkningsresultater fra fase III ATLAS ACS 2 TIMI 51 hos patienter, der gennemgik PCI Studiepopulation
English: Fatal PE/death where PE cannot be ruled out
Danish: Dødelig PE eller død, hvor PE ikke kan udelukkes
English: - treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.
Danish: - behandling af blodpropper i venerne i benene (dyb venetrombose) og i blodkarrene i lungerne (lungeemboli) samt forebyggelse af nye blodpropper i blodkarrene i benene og/eller lungerne.
English: Symptomatic recurrent PE 2
Danish: Symptomatisk recidiverende PE 2
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with 500 mg acetylsalicylic acid.
Danish: Der blev ikke observeret nogen klinisk signifikante farmakokinetiske eller farmakodynamiske interaktioner ved samtidig indtagelse af rivaroxaban og 500 mg acetylsalicylsyre.
English: Start date
Danish: Startdato
English: There are no data in patients with creatinine clearance < 15 ml/min.
Danish: Der foreligger ingen data om patienter med kreatininclearance på < 15 ml/min.
English: There is limited experience of a reduced dose of 15 mg Xarelto once daily (or 10 mg Xarelto once daily for patients with moderate renal impairment [creatinine clearance 30 - 49 ml/min]) in addition to a P2Y12 inhibitor for a maximum of 12 months in patients with non-valvular atrial fibrillation who require oral anticoagulation and undergo PCI with stent placement (see sections 4.4 and 5.1).
Danish: Der er begrænset erfaring med en reduceret dosis på 15 mg Xarelto én gang dagligt (eller 10 mg Xarelto én gang dagligt hos patienter med moderat nedsat nyrefunktion [kreatininclearance 3049 ml/min]) i tillæg til en P2Y12-hæmmer i maksimalt 12 måneder hos patienter med ikke-valvulær atrieflimren, som kræver oral antikoagulation og som gennemgår PCI med indsat stent (se pkt.
English: Safety and efficacy of Xarelto have not been established in pregnant women.
Danish: Xareltos sikkerhed og virkning hos gravide kvinder er ikke klarlagt.
English: Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA) (see section 4.4).
Danish: Samtidig behandling af AKS med antitrombotisk medicin hos patienter med forudgående apopleksi eller forbigående iskæmisk anfald (TIA) (se pkt.
English: respective laboratory parameters)
Danish: Anæmi (herunder respektive laboratorieparametre)
English: If you have kidney problems, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Xarelto 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.
Danish: Hvis du har nyreproblemer, kan din læge beslutte at nedsætte dosis efter tre uger til én 15 mg-tablet Xarelto én gang dagligt, hvis risikoen for blødning er større end risikoen for at få en ny blodprop.
English: 4,832 patients with an acute symptomatic PE
Danish: 4.832 patienter med akut symtomatisk PE
English: In rats, increased IgG and IgA plasma levels were seen at clinically relevant exposure levels.
Danish: Hos rotter ansås de øgede IgG- og IgAplasmaniveauer for at være klinisk relevante eksponeringsniveauer.
English: INR values were within the therapeutic range a mean of 60.3% of the time for the mean treatment duration of 189 days, and 55.4%, 60.1%, and 62.8% of the time in the 3-, 6-, and 12-month intended treatment duration groups, respectively.
Danish: INR-værdierne var inden for det terapeutiske område som middelværdi 60,3 % af tiden for middel-behandlingsvarigheden på 189 dage, og henholdsvis 55,4 %, 60,1 % og 62,8 % af tiden i grupperne med planlagt behandlingstid i 3, 6 og 12 måneder.
English: No data are available for such patients with a history of stroke/ transient ischaemic attack (TIA).
Danish: Der foreligger ingen data for sådanne patienter med apopleksi/ transitorisk cerebral iskæmi (TIA) i anamnesen.
English: Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding and quantify the clinical relevance of overt bleeding, as judged to be appropriate.
Danish: Ud over den kliniske overvågning kan det derfor være af værdi at undersøge hæmoglobin/hæmatokrit for at opdage okkult blødning, og kvantificere den kliniske relevans af synlig blødning, hvis det skønnes nødvendigt.
English: Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE) and prevention of recurrence
Danish: Behandling af dyb venetrombose (DVT), lungeemboli (PE) og forebyggelse af recidiv
English: In patients receiving Xarelto for VTE prevention following elective hip or knee replacement surgery, this may be done by regular physical examination of the patients, close observation of the surgical wound drainage and periodic measurements of haemoglobin.
Danish: Hos patienter, der får Xarelto til forebyggelse af VTE efter planlagt hofteleds- eller knæledsalloplastik, kan det gøres ved regelmæssig lægeundersøgelse, hyppig observation af den kirurgiske sårdrænage og regelmæssig hæmoglobinbestemmelse.
English: Converting from parenteral anticoagulants to Xarelto For patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start Xarelto 0 to 2 hours before the time that the next scheduled administration of the parenteral medicinal product (e.g. low molecular weight heparins) would be due or at the time of discontinuation of a continuously administered parenteral medicinal product (e.g. intravenous unfractionated heparin).
Danish: For patienter, der aktuelt tager et parenteralt antikoagulans, skal det parenterale antikoagulans seponeres og Xarelto startes op 0 - 2 timer før det tidspunkt, hvor den næste planlagte administration af det parenterale lægemiddel (f.eks. lavmolekylært heparin) skulle have fundet sted, eller på tidspunktet for seponering af et kontinuerligt administreret parenteralt lægemiddel (f.eks. intravenøs ufraktioneret heparin).
English: PATIENT ALERT CARD Patient Alert Card
Danish: PATIENTKORT Patientkort
English: Prevention of venous thromboembolism in medically ill patients
Danish: Forebyggelse af venøs tromboemboli hos medicinsk syge patienter
English: Xarelto may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ”Possible side effects”).
Danish: Xarelto kan medføre svimmelhed (almindelig bivirkning) eller besvimelse (ikke almindelig bivirkning) (se punkt 4 ”Bivirkninger”).
English: Adjusted HRs comparing rivaroxaban and standard-of-care for major bleeding, recurrent VTE and all-cause mortality were 0.77 (95% CI 0.40 - 1.50), 0.91 (95% CI 0.54 - 1.54) and 0.51 (95% CI 0.24 - 1.07), respectively.
Danish: Justeret HR, der sammenligner rivaroxaban og standardbehandling for alvorlige blødninger, recidiverende VTE og død uanset årsag var henholdsvis 0,77 (95 % KI 0,40 - 1,50), 0,91 (95 % KI 0,54 - 1,54) og 0,51 (95 % KI 0,24 - 1,07).
English: If you have kidney problems and take one tablet Xarelto 20 mg once a day, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Xarelto 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.
Danish: Hvis du har nyreproblemer, og tager én 20 mg-tablet Xarelto én gang dagligt, kan din læge beslutte at nedsætte dosis efter tre uger til én 15 mg-tablet Xarelto én gang dagligt, hvis risikoen for blødning er større end risikoen for at få en ny blodprop.
English: If you forget to take Xarelto
Danish: Hvis du har glemt at tage Xarelto
English: If you stop taking Xarelto
Danish: Hvis du holder op med at tage Xarelto
English: The concomitant use of rivaroxaban with other strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbital or St. John's Wort (Hypericum perforatum)) may also lead to reduced rivaroxaban plasma concentrations.
Danish: Samtidig brug af rivaroxaban og andre stærke CYP3A4-induktorer (f.eks. phenytoin, carbamazepin, phenobarbital eller prikbladet perikon (hypericum perforatum)) kan også medføre et fald i plasmakoncentrationerne af rivaroxaban.
English: Xarelto should be used with caution in patients with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations (see section 4.5).
Danish: Xarelto skal anvendes med forsigtighed til patienter med nedsat nyrefunktion, når de samtidig får andre lægemidler, som øger plasmakoncentrationen af rivaroxaban (se pkt.
English: Other medicines and Xarelto
Danish: Brug af anden medicin sammen med Xarelto
English: Xarelto should not be used in combination with certain other medicines which reduce blood clotting such as prasugrel or ticagrelor other than acetylsalicylic acid and clopidogrel/ticlopidine.
Danish: Xarelto må ikke anvendes sammen med visse andre lægemidler, der nedsætter blodets evne til at størkne, f.eks. prasugrel eller ticagrelor.
English: Intracranial haemorrhage* Haemoglobin drop* 305
Danish: Hæmoglobin-infusion* 305
English: In individuals with mild, moderate and severe renal impairment the overall inhibition of factor Xa activity was increased by a factor of 1.5, 1.9 and 2.0 respectively as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 1.3, 2.2 and 2.4 respectively.
Danish: Hos personer med let, moderat og svært nedsat nyrefunktion var den samlede hæmning af faktor Xa-aktiviteten øget med en faktor på henholdsvis 1,5, 1,9 og 2,0 sammenlignet med raske frivillige.
English: 10 x 1 film-coated tablets.
Danish: 10 x 1 filmovertrukne tabletter.
English: Patients with a history of stroke or TIA were excluded.
Danish: Patienter med apopleksi eller TIA i anamnesen blev ekskluderet.
English: Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose 2910, sodium laurilsulphate, magnesium stearate.
Danish: Tabletkerne: mikrokrystallinsk cellulose, natriumcroscarmellose, lactosemonohydrat, hypromellose 2910, natriumlaurilsulfat, magnesiumstearat.
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation
Danish: Forebyggelse af apopleksi og systemisk emboli hos patienter med ikke-valvulær atrieflimren
English: All-cause death, MI or stroke
Danish: Død uanset årsag, MI eller apopleksi
English: To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban.
Danish: For at reducere den potentielle blødningsrisiko ved neuraksial (epidural/spinal) anæstesi eller spinalpunktur hos patienter i behandling med rivaroxaban bør rivaroxabans farmakokinetiske profil tages i betragtning.
English: In ACS patients, efficacy and safety of Xarelto 2.5 mg have been investigated in combination with the antiplatelet agents ASA alone or ASA plus clopidogrel/ticlopidine.
Danish: Hos patienter med akut koronarsyndrom (AKS) er virkningen af og sikkerheden af Xarelto ved 2,5 mg undersøgt i kombination med de antitrombotiske stoffer ASA alene eller ASA plus clopidogrel/ticlopidin.
English: The inhibition of factor Xa activity was increased by a factor of 2.6 in patients with moderate hepatic impairment as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 2.1.
Danish: Hæmningen af faktor Xa-aktiviteten steg med en faktor på 2,6 hos patienter med moderat nedsat leverfunktion sammenlignet med raske frivillige.
English: While patients are on both Xarelto and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of Xarelto.
Danish: I den periode, hvor patienten tager både Xarelto og VKA, bør INR tidligst måles 24 timer efter den seneste dosis Xarelto, men før den næste dosis.
English: In a study on male and female fertility in rats no effects were seen (see section 5.3).
Danish: I et fertilitetsstudie hos han- og hunrotter sås ingen virkninger (se pkt.
English: Posology The recommended dose is 2.5 mg twice daily.
Danish: Dosering Den anbefalede dosis er 2,5 mg to gange dagligt.
English: In addition these patients are to be carefully monitored for signs and symptoms of bleeding complications and anaemia after initiation of treatment (see section 4.8).
Danish: Desuden skal disse patienter omhyggeligt overvåges for tegn og symptomer på blødningskomplikationer og anæmi efter indledning af behandlingen (se pkt.
English: Possible side effects which may be a sign of severe skin reaction
Danish: Bivirkninger, der kan være tegn på alvorlige hudreaktioner