FrancophonIA/ELRC3.0 huggingface dataset:
English: - For the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery, no dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) or moderate renal impairment (creatinine clearance 30- 49 ml/min) (see section 5.2).
Danish: - Til forebyggelse af VTE hos voksne patienter, der gennemgår planlagt hofteleds- eller knæledsalloplastik, kræves der ingen dosisjustering hos patienter med let nedsat nyrefunktion (kreatinclearance 50 - 80 ml/min) eller moderat nedsat nyrefunktion (kreatininclearance 3049 ml/min) (se pkt.
English: The primary efficacy outcome (all stroke, transient ischaemic attack, non-CNS systemic embolism, myocardial infarction (MI) and cardiovascular death) occurred in 5 (0.5%) patients in the rivaroxaban group (n = 978) and 5 (1.0%) patients in the VKA group (n = 492; RR 0.50; 95% CI 0.15
Danish: Det primære effektmål (enhver forekomst af apopleksi, transitorisk iskæmisk attak, ikke-CNS systemisk emboli, myokardieinfarkt (MI) og kardiovaskulær død) forekom hos 5 (0,5 %) patienter i rivaroxabangruppen (n = 978) og hos 5 (1,0 %) patienter i VKA-gruppen (n = 492; RR 0,50; 95 % KI 0,15-1,73;
English: With a systemic clearance of about 10 l/h, rivaroxaban can be classified as a low-clearance substance.
Danish: Rivaroxaban har en systemisk clearance på omkring 10 l/t og kan således klassificeres som et lægemiddel med lav clearance.
English: Patients with recent acute coronary syndrome a)
Danish: Patienter med nyligt akut koronarsyndrom a)
English: No data are available for such patients with a history of stroke/TIA.
Danish: Der foreligger ingen data for sådanne patienter med apopleksi/TIA i anamnesen.
English: Symptomatic recurrent VTE*
Danish: Symptomatisk recidiverende VTE*
English: The primary safety endpoint, clinically significant bleeding events, occurred in 109 (15.7%), 117 (16.6%), and 167 (24.0%) subjects in group 1, group 2 and group 3, respectively (HR 0.59; 95% CI 0.47-0.76; p<0.001, and HR 0.63; 95% CI 0.50-0.80; p<0.001, respectively).
Danish: Det primære sikkerhedsendepunkt, klinisk signifikante blødningshændelser, forekom hos henholdvis 109 (15,7 %), 117 (16,6 %) og 167 (24,0 %) patienter i gruppe 1, gruppe 2 og gruppe 3 (henholdvis HR 0,59; 95 % KI 0,47-0,76; p<0,001 og HR 0,63; 95 % KI 0,50-0,80; p<0,001).
English: Day 22 onwards
Danish: Fra og med dag 22
English: Tell your doctor immediately if you experience any of the following side effects: - swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.
Danish: Fortæl det øjeblikkeligt til lægen, hvis du oplever en eller flere af følgende bivirkninger: - hævelse af ansigt, læber, mund, tunge eller hals, synkebesvær, nældefeber og åndedrætsbesvær, pludseligt blodtryksfald.
English: In addition to the phase III ROCKET AF study, a prospective, single-arm, post-authorization, noninterventional, open-label cohort study (XANTUS) with central outcome adjudication including thromboembolic events and major bleeding has been conducted.
Danish: Ud over fase III-studiet ROCKET AF er der efter godkendelse gennemført et åbent, prospektivt, ikkeinterventions-kohortestudie med en enkelt arm (XANTUS) med central evaluering af resultaterne, herunder tromboemboliske hændelser og alvorlige blødninger.
English: Therefore, Xarelto is not recommended for use in children below 18 years of age.
Danish: Der foreligger ingen data, og derfor bør Xarelto ikke anvendes til børn eller unge under 18 år.
English: Table 6: Safety results from phase III ATLAS ACS 2 TIMI 51 Study population
Danish: Tabel 6: Sikkerhedsresulater fra fase III ATLAS ACS 2 TIMI 51 Studiepopulation
English: Therefore, the use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics such as ketoconazole, itraconazole, voriconazole and posaconazole or HIV protease inhibitors.
Danish: Xarelto bør derfor ikke anvendes til patienter, der får samtidig systemisk behandling med azolantimykotika som f.eks. ketoconazol, itraconazol, voriconazol og posaconazol eller hiv-proteasehæmmere.
English: Symptomatic VTE occurred in 57 (0.6%) patients in the rivaroxaban group (n=8,778) and 88 (1.0%) of patients in the standard-of-care group (n=8,635; HR 0.63; 95% CI 0.43-0.91); safety population).
Danish: Symptomatisk VTE forekom hos 57 patienter (0,6 %) i rivaroxaban-gruppen (n = 8.778) og hos 88 patienter (1,0 %) i standardbehandlingsgruppen (n = 8.635; HR 0,63; 95 %-KI: 0,43 - 0,91; sikkerhedspopulation).
English: Treatment dose and duration after surgery
Danish: Behandlingsdosis ogvarighed efter operationen
English: Fatal PE/death where PE cannot be ruled out Major or clinically relevant non-major bleeding
Danish: Dødelig PE/død hvor PE ikke kan udelukkes Større eller klinisk relevant mindre blødning
English: Figure 1: Time to first occurrence of primary efficacy endpoint (CV death, MI or stroke)
Danish: Figur 1: Tid til første forekomst af det primære effektendepunkt (kardiovaskulær død, myokardieinfarkt eller apopleksi)
English: PP/Aluminium foil blisters in a wallet containing 49 film-coated tablets: 42 film-coated tablets Xarelto 15 mg and 7 film-coated tablets Xarelto 20 mg.
Danish: Blisterpakninger af PP/aluminiumsfolie i et omslag med 49 filmovetrukne tabletter: 42 filmovertrukne Xarelto 15 mg og 7 filmovertrukne tabletter Xarelto 20 mg.
English: Batch
Danish: BATCHNUMBER
English: a) Rivaroxaban 20 mg once daily * p < 0.0001 (superiority), HR: 0.185 (0.087 - 0.393)
Danish: a Rivaroxaban 20 mg én gang dagligt * p < 0,0001 (superioritet), HR: 0,185 (0,087 - 0,393)
English: For the initial 3 week treatment of acute DVT 15 mg rivaroxaban was administered twice daily.
Danish: I den indledende 3-ugersbehandling af akut DVT fik patienterne 15 mg rivaroxaban to gange dagligt.
English: Due to the increased bleeding risk care is to be taken if patients are treated concomitantly with any other anticoagulants (see sections 4.3 and 4.4).
Danish: På grund af den øgede blødningsrisiko skal der udvises forsigtighed hos patienter, der får samtidig behandling med andre antikoagulantia (se pkt.
English: Treatment Dose
Danish: Behandlingsdosis
English: Warfarin titrated to a target INR of 2.5 (therapeutic range 2.0 to 3.0)
Danish: Warfarin titreret til en mål-INR på 2,5 (behandlingsinterval
English: Overall list of possible side effects
Danish: Samlet liste over bivirkninger
English: Table 4: Efficacy results from phase III ATLAS ACS 2 TIMI 51 Study population
Danish: Tabel 4: Virkningsresultater fra fase III ATLAS ACS 2 TIMI 51 Studiepopulation
English: There is no clinical experience with the use of 15 mg or 20 mg rivaroxaban in these situations.
Danish: Der er ingen klinisk erfaring med anvendelse af 15 mg eller 20 mg rivaroxaban i disse situationer .
English: rectal haemorrhage), gastrointestinal and abdominal pains, dyspepsia, nausea, constipationA, diarrhoea, vomitingA
Danish: Gingival blødning, blødning fra mavetarm-kanalen (herunder rektal blødning), gastrointestinale og abdominale smerter, dyspepsi, nausea, obstipationA, diaré, opkastningA
English: Major bleeding occurred in 35 (0.4%) and 29 (0.3%) of patients in the rivaroxaban and standard-of-care groups (HR 1.10; 95% CI 0.67-1.80).
Danish: Større blødning forekom hos 35 (0,4 %) og 29 (0,3 %) af patienterne i hhv. rivaroxaban-gruppen og standardbehandlingsgruppen (HR 1,10; 95 %-KI: 0,67 - 1,80).
English: Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).
Danish: Xarelto, i kombination med acetylsalicylsyre (ASA) eller med ASA og clopidogrel eller ticlopidin, er indiceret til forebyggelse af aterotrombotiske hændelser hos voksne patienter efter et akut koronarsyndrom (AKS) med forhøjede hjertemarkører (se pkt.
English: 10 x 1 film-coated tablets 100 x 1 film-coated tablets
Danish: 10 x 1 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter
English: The effect of erythromycin is additive to that of renal impairment (see section 4.4).
Danish: Virkningen af erythromycin og virkningen af nedsat nyrefunktion er additive (se pkt.
English: After the administration of crushed Xarelto 15 mg or 20 mg film-coated tablets, the dose should be immediately followed by food.
Danish: Administration af knuste Xarelto 15 mg eller 20 mg filmovertrukne tabletter skal straks efterfølges af mad.
English: 28 per 100 patient years
Danish: 28 per 100 patientår
English: Xarelto 20 mg od N=1,107
Danish: Xarelto 20 mg én gang dagligt N = 1.107
English: Table 5: Safety results from phase III ROCKET AF Study population
Danish: Tabel 5: Sikkerhedsresultater af ROCKET AF fase III
English: uncommon cases of generalised pruritus), rash, ecchymosis, cutaneous and subcutaneous haemorrhage
Danish: Pruritus (herunder ikke almindelige tilfælde af generaliseret pruritus), udslæt, ekkymose, kutan og subkutan blødning
English: The dose should not be doubled within the same day to make up for a missed dose.
Danish: Patienten må ikke tage dobbelt dosis samme dag for et indhente en oversprunget dosis.
English: No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min) or moderate renal impairment (creatinine clearance 30 - 49 ml/min) (see section 5.2).
Danish: Der kræves ingen dosisjustering hos patienter med let nedsat nyrefunktion (kreatinclearance 5080 ml/min) eller moderat nedsat nyrefunktion (kreatininclearance 30 - 49 ml/min) (se pkt.
English: Tablet film coat: macrogol 3350, hypromellose 2910, titanium dioxide (E 171), iron oxide red (E 172).
Danish: Tablettens filmovertræk: macrogol 3350, hypromellose 2910, titandioxid (E 171), rød jernoxid (E 172).
English: Package leaflet: Information for the user Xarelto 2.5 mg film-coated tablets rivaroxaban This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Xarelto 2,5 mg filmovertrukne tabletter rivaroxaban Dette lægemiddel er underlagt supplerende overvågning.
English: 22 per 100 patient years
Danish: 22 per 100 patientår
English: Xarelto contains lactose.
Danish: Xarelto indeholder lactose.
English: 1.4 per 100 patient years
Danish: 1,4 per 100 patientår
English: A prospective, randomised, open-label, multicentre, exploratory study with blinded endpoint evaluation (X-VERT) was conducted in 1504 patients (oral anticoagulant naive and pre-treated) with non-valvular atrial fibrillation scheduled for cardioversion to compare rivaroxaban with dose-adjusted VKA (randomised 2:1), for the prevention of cardiovascular events.
Danish: Et prospektivt, randomiseret, åbent, eksploratorisk multicenterstudie med blindet endepunktsevaluering (X-VERT) blev gennemført hos 1.504 patienter (der var naive for oral antikoagulantia eller tidligere behandlede) med non-valvulær atrieflimren, som skulle have foretaget kardiovertering, for at sammenligne rivaroxaban med dosistilpasset VKA (randomiseret 2:1) i forhold til forebyggelse af kardiovaskulære hændelser.
English: - If you are taking some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin ketoconazole tablets (used to treat Cushing's syndrome - when the body produces an excess of cortisol) some medicines for bacterial infections (e.g. clarithromycin, erythromycin) some anti-viral medicines for HIV / AIDS (e.g. ritonavir) other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section “Warnings and Precautions”)) anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid) dronedarone, a medicine to treat abnormal heart beat some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))
Danish: Hvis du tager visse former for medicin mod svampeinfektioner (f.eks. fluconazol, itraconazol, voriconazol, posaconazol), medmindre de kun smøres på huden ketoconazoltabletter (bruges til at behandle Cushings syndrom - når kroppen producerer for meget kortisol) visse former for medicin mod baterieinfektioner (f.eks. clarithromycin, erythromycin) visse former for virushæmmende medicin mod HIV/AIDS (f.eks. ritonavir) anden medicin til forebyggelse af blodpropper (f.eks. enoxaparin, clopidogrel eller vitamin-K-antagonister som f.eks. warfarin og acenocumarol, prasugrel og ticagrelor (se punktet ”Advarsler og forsigtighedsregler”)) betændelseshæmmende og smertestillende medicin (f.eks. naproxen eller acetylsalicylsyre) dronedaron, et lægemiddel, der bruges til behandling af unormal hjerterytme visse former for medicin til behandling af depression (selektive serotonin genoptagelseshæmmere (SSRI-præparater) eller serotonin/noradrenalingenoptagelseshæmmere (SNRI-præparater).
English: Xarelto contains the active substance rivaroxaban and is used in adults to - prevent blood clots in the veins after a hip or knee replacement operation.
Danish: Xarelto indeholder det aktive stof rivaroxaban og benyttes hos voksne til: - forebyggelse af blodpropper i venerne efter hofteleds- eller knæledsalloplastik (hofte- eller knæoperation).
English: Xarelto 10 mg od N=1,127
Danish: Xarelto 10 mg én gang dagligt N = 1.127
English: Among all randomised patients analysed according to ITT, primary events occurred in 269 on rivaroxaban (2.12% per year) and 306 on warfarin (2.42% per year) (HR 0.88; 95% CI, 0.74 - 1.03; P<0.001 for non-inferiority; P=0.117 for superiority).
Danish: Hos alle randomiserede patienter, der var blevet analyseret med hensyn til ITT (Intention to treat), forekom primære hændelser hos 269 på rivaroxaban (2,12 % pr. år) og 306 på warfarin (2,42 % pr. år) (HR 0,88; 95 % KI, 0,741,03; p < 0,001 for non-inferioritet; p = 0,117 for superioritet).
English: Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction with rivaroxaban (15 mg) but a relevant increase in bleeding time was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/IIIa receptor levels.
Danish: Der sås ingen farmakokinetisk interaktion mellem rivaroxaban (15 mg) og clopidogrel (initialdosis på 300 mg efterfulgt af en vedligeholdelsesdosis på 75 mg), men hos en undergruppe af patienter blev der observeret en relevant forlængelse af blødningstiden, som ikke var korreleret med trombocytaggregation, P-selektin eller GPIIb-/IIIa-receptorniveauerne.
English: Each pack of 49 film-coated tablets contains: 42 film-coated tablets of 15 mg rivaroxaban 7 film-coated tablets of 20 mg rivaroxaban
Danish: Hver pakke med 49 filmovertrukne tabletter indeholder: 42 filmovertrukne tabletter hver med 15 mg rivaroxaban 7 filmovertrukne tabletter hver med 20 mg rivaroxaban
English: For the initial treatment of acute PE 15 mg rivaroxaban was administered twice daily for three weeks.
Danish: I den indledende behandling af akut PE fik patienterne 15 mg rivaroxaban to gange dagligt i tre uger.
English: There was an increase in rivaroxaban exposure correlated to decrease in renal function, as assessed via creatinine clearance measurements.
Danish: Der sås en stigning i eksponeringen for rivaroxaban, som var korreleret med reduktionen i nyrefunktionen.
English: Treatment dose
Danish: Behandlingsdosering
English: Symptomatic recurrent DVT
Danish: Symptomatisk recidiverende DVT
English: 20 mg once a day taken at same time each day
Danish: 20 mg én gang dagligt tages på samme tidspunkt hver dag Dato for dosisændring
English: Placebo 6 or 12 months N=594
Danish: 6 eller 12 måneder N = 594
English: Tablet film coat: macrogol 3350, hypromellose 2910, titanium dioxide (E 171), iron oxide yellow (E 172).
Danish: Filmovertræk af tablet: macrogol 3350, hypromellose 2910, titandioxid (E 171), gul jernoxid (E 172).
English: Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is estimated to be low.
Danish: Det er bedst at indsætte eller fjerne et epiduralkateter eller udføre lumbalpunktur, når den antikoagulerende virkning af rivaroxaban vurderes til at være lav.
English: Symptomatic recurrent VTE or major bleeding (net clinical benefit) * p<0.001(superiority) Xarelto 20 mg od vs ASA 100 mg od; HR=0.34 (0.20-0.59) ** p<0.001 (superiority) Xarelto 10 mg od vs ASA 100 mg od; HR=0.26 (0.14-0.47) + Xarelto 20 mg od vs. ASA 100 mg od; HR=0.44 (0.27-0.71), p=0.0009 (nominal) ++ Xarelto 10 mg od vs. ASA 100 mg od; HR=0.32 (0.18-0.55), p<0.0001 (nominal)
Danish: ** p < 0,001 (superioritet) Xarelto 10 mg én gang dagligt vs. ASA 100 mg én gang dagligt; HR = 0,26 (0,14-0,47) + Xarelto 20 mg én gang dagligt vs. ASA 100 mg én gang dagligt; HR = 0,44 (0,27-0,71), p = 0,0009 (nominel) ++ Xarelto 10 mg én gang dagligt vs. ASA 100 mg én gang dagligt; HR = 0,32 (0,18-0,55), p < 0,0001 (nominel)
English: Body weight No dose adjustment (see section 5.2)
Danish: Legemsvægt Ingen dosisjustering (se pkt.
English: Xarelto reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels.
Danish: - Hos voksne nedsætter Xarelto risikoen for at få endnu et hjerteanfald og for at dø af hjerte- og karsygdom.
English: Package leaflet: Information for the user Xarelto 10 mg film-coated tablets rivaroxaban This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Xarelto 10 mg filmovertrukne tabletter rivaroxaban Dette lægemiddel er underlagt supplerende overvågning.
English: Dosing schedule
Danish: Doseringsplan
English: The effect of rivaroxaban did not differ across the level of centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized quartiles (P=0.74 for interaction).
Danish: Der var ingen forskel i virkningen af rivaroxaban ved forskellige centerniveauer for TTR (Time in Target INR Range (tid i terapeutisk område) på 2,0-3,0) i de lige store kvartiler (p = 0,74 for interaktion).
English: Xarelto contains the active substance rivaroxaban and is used in adults to: - prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.
Danish: Xarelto indeholder det aktive stof rivaroxaban og benyttes hos voksne til: - forebyggelse af blodpropper i hjernen (apopleksi) og andre af kroppens blodkar, hvis du har en form for uregelmæssig hjerterytme, der kaldes for ikke-valvulær atrieflimren - behandling af blodpropper i venerne i benene (dyb venetrombose) og i blodkarrene i lungerne
English: No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min) (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat nyrefunktion (kreatininclearance 5080 ml/min, se pkt.
English: The recommended dose is 20 mg once daily, which is also the recommended maximum dose.
Danish: Forebyggelse af apopleksi og systemisk emboli Den anbefalede dosis er 20 mg én gang dagligt, hvilket samtidig er anbefalet maksimal dosis.
English: Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy (see section 4.3).
Danish: Xarelto er kontraindiceret under graviditet på grund af den potentielle reproduktionstoksicitet, risikoen for blødning og evidens for, at rivaroxaban passerer placenta (se pkt.
English: 4,541 patients undergoing total hip replacement surgery
Danish: 4.541 patienter, der fik foretaget hofteledsalloplastik
English: Fluconazole (400 mg once daily), considered as a moderate CYP3A4 inhibitor, led to a 1.4 fold increase in mean rivaroxaban AUC and a 1.3 fold increase in mean Cmax.
Danish: Fluconazol (400 mg én gang dagligt), der anses for at være en moderat CYP3A4-hæmmer, medførte en stigning i gennemsnitlig rivaroxaban-AUC med en faktor 1,4 og en stigning i gennemsnitlig Cmax med en faktor 1,3.
English: From Day 22: One 20 mg tablet once a day (taken at same time each day).
Danish: Fra dag 22: Én 20 mg-tablet én gang dagligt (på samme tidspunkt hver dag).
English: The use of activated charcoal to reduce absorption in case of rivaroxaban overdose may be considered.
Danish: Ved overdosering med rivaroxaban kan det overvejes at bruge aktivt kul til at reducere absorptionen.
English: PVC/PVDC/Aluminium foil blisters in cartons of 5, 10 or 30 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1 or 100 x 1 film-coated tablets.
Danish: Blisterpakninger af PVC/PVDC/aluminiumsfolie i æsker med 5, 10 eller 30 filmovertrukne tabletter eller perforerede enkeltdosisblistre i æsker med 10 x 1 eller 100 x 1 filmovertrukne tabletter.
English: For treatment after 3 weeks, the recommended dose is one tablet Xarelto 20 mg once a day.
Danish: Den anbefalede dosis efter 3 uger er én 20 mg-tablet Xarelto én gang dagligt.
English: The dose should not be doubled to make up for a missed dose.
Danish: Der må ikke tages en dobbeltdosis som erstatning for en manglende dosis.
English: 42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban (treatment initiation pack)
Danish: 42 filmovertrukne tabletter med hver 15 mg rivaroxaban og 7 filmovertrukne tabletter med hver 20 mg rivaroxaban (startpakning)
English: Xarelto is to be used with caution in patients with creatinine clearance 15 - 29 ml/min.
Danish: Xarelto skal anvendes med forsigtighed hos patienter med en kreatininclearance på 15 - 29 ml/min.
English: When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto.
Danish: Ved skift af patienter fra VKA til Xarelto vil der optræde en falsk stigning i INR-værdien efter indtagelse af Xarelto.
English: The recommendation for the use of 15 mg is based on PK modelling and has not been studied in this clinical setting (see sections 4.4, 5.1 and 5.2).
Danish: Anbefalingen af brug af 15 mg er baseret på farmakokinetisk modellering og er ikke undersøgt klinisk (se pkt.
English: The use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir).
Danish: Xarelto bør ikke anvendes til patienter, der får samtidig systemisk behandling med azolantimykotika (som f.eks. ketoconazol, itraconazol, voriconazol og posaconazol) eller hiv-proteasehæmmere (f.eks. ritonavir).
English: The incidence of the secondary safety outcome (major bleeding events) was lower in the rivaroxaban group (1.1% (26/2412)) than in the enoxaparin/VKA group (2.2% (52/2405)) with a HR 0.493 (95% CI: 0.308 - 0.789).
Danish: Frekvensen af det sekundære sikkerhedsendepunkt (større blødninger) var lavere i rivaroxabangruppen (1,1 % (26/2.412) end i enoxaparin/VKA-gruppen (2,2 % (52/2.405) med en HR på 0,493 (95 % KI: 0,308-0,789).
English: ASA 100 mg od N=9126 n (Cum.risk %)
Danish: N = 9.126 n (kumulativ risiko %)
English: SSRIs/SNRIs
Danish: SSRI-/SNRI-præparater
English: The tablets can be taken with or without food (see sections 4.5 and 5.2).
Danish: Tabletterne kan tages sammen med eller uden mad (se pkt.
English: Relationship:
Danish: Telefonnummer: Relation:
English: When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/(100 mcg/l).
Danish: Når der blev anvendt Neoplastin PT, var baseline PT omkring 13 s og hældningen var omkring 3-4 s/(100 mikrog/l).
English: Table 4: Efficacy results from phase III ROCKET AF Study population
Danish: Tabel 4: Virkningsresultater af ROCKET AF fase III
English: 2,509 patients undergoing total hip replacement surgery
Danish: 2.509 patienter, der fik foretaget hofteledsalloplastik
English: For PT, the linear intercept model generally described the data better.
Danish: Den lineære interceptmodel beskrev generelt data bedre for PT. Hældningen varierede betydeligt afhængig af de forskellige anvendte PT-reagenser.