FrancophonIA/ELRC3.0 huggingface dataset:
English: The patient should continue with the regular 15 mg twice daily intake as recommended on the following day.
Danish: Næste dag skal patienten fortsætte med den ordinerede dosering på 15 mg to gange dagligt.
English: 6.7 per 100 patient years
Danish: 6,7 per 100 patientår
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF TREATMENT INITIATION PACK IN WALLET (42 FILM-COATED TABLETS OF 15 MG AND 7 FILM-COATED TABLETS OF 20 MG)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED STARTPAKNING I OMSLAG (42 FILMOVERTRUKNE TABLETTER MED 15 MG OG 7 FILMOVERTRUKNE TABLETTER MED 20 MG)
English: Table 7: Efficacy results from phase III COMPASS Study
Danish: Tabel 7: Virkningsresultater fra fase III COMPASS Studiepopulation
English: Erythromycin (500 mg three times a day), which inhibits CYP3A4 and P-gp moderately, led to a 1.3 fold increase in mean rivaroxaban AUC and Cmax.
Danish: Erythromycin (500 mg tre gange dagligt), som hæmmer CYP3A4 og P-gp i moderat grad, medførte en stigning på 1,3 gange i det gennemsnitlige AUC og Cmax for rivaroxaban.
English: Xareltoa) 6 or 12 months N=602
Danish: 6 eller 12 måneder N = 602
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 2.5 MG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON FOR 2,5 MG
English: Hypromellose 2910 Titanium dioxide (E 171) Iron oxide yellow (E 172)
Danish: Hypromellose 2910 Titandioxid (E 171) Gul jernoxid (E 172)
English: This mixture should be immediately followed by food.
Danish: Når du har indtaget denne blanding, skal du umiddelbart derefter spise et måltid mad.
English: Symptomatic recurrent VTE* 8
Danish: Symtomatisk recidiverende VTE* 86
English: If an invasive procedure or surgical intervention is required, Xarelto 10 mg should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
Danish: Såfremt der er behov for invasive indgreb eller kirurgi, skal Xarelto 10 mg så vidt muligt seponeres mindst 24 timer før indgrebet, baseret på den behandlende læges kliniske vurdering.
English: Xareltoa) 3, 6 or 12 months N=1,731
Danish: 3, 6 eller 12 måneder N=1.731
English: Each tablet contains 15 mg or 20 mg of rivaroxaban.
Danish: Hver tablet indeholder 15 mg eller 20 mg rivaroxaban.
English: In the Einstein Extension study (see Table 9) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Danish: I studiet Einstein Extension (se tabel 9) viste rivaroxaban sig superiør sammenlignet med placebo med hensyn til primære og sekundære effektendepunkter.
English: The pharmacokinetic/pharmacodynamic (PK/PD) relationship between rivaroxaban plasma concentration and several PD endpoints (factor Xa inhibition, PT, aPTT, Heptest) has been evaluated after administration of a wide range of doses (5 - 30 mg twice a day).
Danish: Det farmakokinetiske/farmakodynamiske forhold (PK/PD) mellem rivaroxabans plasmakoncentrationer og forskellige PD-endepunkter (faktor Xa-hæmning, PT, aPTT, Heptest) er blevet evalueret efter indgivelse i et bredt dosisinterval (5 - 30 mg to gange dagligt).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WALLET OF TREATMENT INITIATION PACK (42 FILM-COATED TABLETS OF 15 MG AND 7 FILM-COATED TABLETS OF 20 MG) (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OMSLAG MED STARTPAKNING (42 FILMOVERTRUKNE TABLETTER MED 15 MG OG 7 FILMOVERTRUKNE TABLETTER MED 20 MG) (UDEN BLUE BOX)
English: Each 15 mg film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4.
Danish: Hver 15 mg filmovertrukket tablet indeholder 24,13 mg lactose (som monohydrat), se pkt.
English: In patients with moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 1529 ml/min) renal impairment the following dose recommendations apply:
Danish: Hos patienter med moderat nedsat nyrefunktion (kreatininclearance 30-49 ml/min) eller svært nedsat nyrefunktion (kreatininclearance 15-29 ml/min) anbefales følgende dosis:
English: In the Einstein Extension study (see Table 7) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Danish: I studiet Einstein Extension (se tabel 7) viste rivaroxaban sig superiør sammenlignet med placebo med hensyn til primære og sekundære effektendepunkter.
English: Each 20 mg film-coated tablet contains 21.76 mg lactose (as monohydrate), see section 4.4.
Danish: Hver 20 mg filmovertrukket tablet indeholder 21,76 mg lactose (som monohydrat), se pkt.
English: Oxidative degradation of the morpholinone moiety and hydrolysis of the amide bonds are the major sites of biotransformation.
Danish: Biotransformationen finder hovedsageligt sted ved oxidativ nedbrydning af morfolindelen og hydrolyse af amidbindingerne.
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 2.5 MG
Danish: YDRE KARTON OG ETIKET TIL HDPE-BEHOLDER FOR 2,5 MG
English: Fatal bleeding event
Danish: Dødelig blødningshændelse
English: (only applicable for outer carton, not applicable for bottle label)
Danish: (gælder kun ydre emballage, gælder ikke etiket til plastbeholder)
English: In the Einstein Extension study (see Table 8) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Danish: I studiet Einstein Extension (se tabel 8) viste rivaroxaban sig superiør sammenlignet med placebo med hensyn til primære og sekundære effektendepunkter.
English: Major and non-major clinically relevant bleeding events
Danish: Større og mindre klinisk relevante blødninger
English: In subjects with moderate renal impairment, erythromycin led to a 2.0 fold increase in mean rivaroxaban AUC and 1.6 fold increase in CRmax when compared to subjects with normal renal function.
Danish: Hos personer med moderat nedsat nyrefunktion medførte erythromycin en 2,0 gange forhøjelse i gennemsnitlig rivaroxaban AUC og en 1,6 gange forhøjelse i Cmax, sammenlignet med personer med normal nyrefunktion.
English: 42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban in a wallet.
Danish: 42 filmovertrukne tabletter med hver 15 mg rivaroxaban og 7 filmovertrukne tabletter med hver 20 mg rivaroxaban i et omslag.
English: Patients with CAD/PAD a)
Danish: Patienter med koronararteriesygdom (CAD) /perifer arteriesygdom (PAD) a)
English: Xarelto should be restarted as soon as possible after the invasive procedure or surgical intervention provided the clinical situation allows and adequate haemostasis has been established as determined by the treating physician (see section 5.2).
Danish: Efter invasive indgreb eller kirurgi skal Xarelto startes op igen hurtigst muligt, forudsat patientens kliniske tilstand tillader det, og der efter den behandlende læges vurdering er sikret tilstrækkelig hæmostase (se pkt.
English: Each tablet contains 2.5 mg of rivaroxaban.
Danish: Hver tablet indeholder 2,5 mg rivaroxaban.
English: Xarelto 2.5 mg, twice daily, N=5,115 n (%)
Danish: Xarelto 2,5 mg, to gange dagligt, N=5.115 n (%)
English: Converting from Vitamin K Antagonists (VKA) to Xarelto For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Xarelto therapy should be initiated once the INR is ≤ 2.5.
Danish: Skift fra vitamin-K-antagonister (VKA) til Xarelto For patienter, der behandles for DVT, PE og forebyggelse af recidiv, skal VKA-behandlingen seponeres, og Xarelto-behandlingen indledes, så snart INR ≤ 2,5.
English: 0.15 per 100 patient years** * For all rivaroxaban studies all bleeding events are collected, reported and adjudicated.
Danish: For alle rivaroxabanstudierne blev alle blødningshændelser indsamlet, rapporteret og bedømt.
English: Symptomatic recurrent PE
Danish: Symptomatisk recidiverende PE
English: From Day 22: One 20 mg tablet once a day (taken at same time each day) together with food.
Danish: Fra dag 22: Én 20 mg-tablet én gang dagligt (på samme tidspunkt hver dag) sammen med mad.
English: The 2.5 mg twice daily regimen reduced mortality, and there is evidence that the lower dose had lower bleeding risks, therefore rivaroxaban 2.5 mg twice daily co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine is recommended for the prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers.
Danish: Derfor anbefales administration af rivaroxaban 2,5 mg to gange dagligt sammen med acetylsalicylsyre (ASA) alene eller sammen med ASA plus clopidogrel eller ticlopidin til forebyggelse af aterotrombotiske hændelser hos voksne patienter efter et AKS med forhøjede hjerte-biomarkører.
English: Day 1 to 21: One 15 mg tablet twice a day (one 15 mg tablet in the morning and one in the evening).
Danish: Dag 1 til 21: Én 15 mg-tablet to gange dagligt (én 15 mg-tablet morgen og én tablet aften).
English: If a dose is missed the patient should take Xarelto immediately and then continue the following day with once daily intake as before.
Danish: Hvis patienten glemmer at tage en dosis af Xarelto, skal han/hun tage denne dosis øjeblikkeligt, og fortsætte næste dag med den daglige dosis som før.
English: Xarelto 15 mg and 20 mg are to be taken with food (see section 4.2).
Danish: Xarelto 15 mg- og 20 mg-tabletter skal tages sammen med mad (se pkt.
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 (see section 5.2).
Danish: Det er bedst at indsætte eller fjerne et epiduralkateter eller udføre lumbalpunktur, når den antikoagulerende virkning af rivaroxaban vurderes til at være lav (se pkt.
English: Each brown-red film-coated tablet for week 4 contains 20 mg rivaroxaban.
Danish: Hver rødbrune filmovertrukket tablet for uge 4 indholder 20 mg rivaroxaban.
English: Rivaroxaban has not been studied in interventional clinical studies in patients undergoing hip fracture surgery to evaluate efficacy and safety.
Danish: Rivaroxabans virkning og sikkerhed hos patienter, som har fået foretaget hoftebrudskirurgi, er ikke blevet vurderet i interventionelle kliniske studier.
English: Package leaflet: Information for the user Xarelto 15 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Xarelto 15 mg filmovertrukne tabletter Xarelto 20 mg filmovertrukne tabletter
English: Tell your health care provider straight away if you have any signs or symptoms of bleeding such as the following: ♦ pain ♦ swelling or discomfort ♦ headache, dizziness or weakness ♦ unusual bruising, nosebleeds, bleeding of gums, cuts that take a long time to stop bleeding ♦ menstrual flow or vaginal bleeding that is heavier than normal ♦ blood in your urine which may be pink or brown, red or black stools ♦ coughing up blood, or vomiting blood or material that looks like coffee grounds
Danish: Start ikke behandlingen med Xarelto, hvis du ved, at du har risiko for blødninger, uden først at have talt med lægen om det. Fortæl det straks til lægen, hvis du får tegn på blødning som f.eks.: ♦ smerter ♦ hævelse eller ubehag ♦ hovedpine, svimmelhed eller svaghed ♦ usædvanligt mange blå mærker, næseblod, blødning fra tandkødet, sår, hvor blødningen er lang tid om at stoppe ♦ menstruation eller vaginalblødning, som er kraftigere end normalt ♦ blod i urinen, der kan være rosa- eller brunfarvet, rød eller sort afføring ♦ ophostning af blod eller opkastning af blod eller noget, der ligner kaffegrums.
English: To prevent blood clots in the brain (stroke) and other blood vessels in your body: If your heart beat needs to be restored to normal by a procedure called cardioversion, take Xarelto at the times your doctor tells you.
Danish: Hvis din hjerterytme skal bringes tilbage til den normale rytme ved en procedure, der hedder kardiovertering, skal du tage Xarelto på de tidspunkter, som lægen fortæller dig.
English: 2.5 per 100 patient years
Danish: 2,5 per 100 patientår
English: • Prescriber Guide
Danish: • Vejledning til den ordinerende læge
English: In patients receiving rivaroxaban for prevention of VTE 10 mg once daily the geometric mean concentration (90% prediction interval) 2 - 4 h and about 24 h after dose (roughly representing maximum and minimum concentrations during the dose interval) was 101 (7 - 273) and 14 (4 ‑ 51) mcg/l, respectively.
Danish: Hos patienter, der fik rivaroxaban 10 mg én gang dagligt til forebyggelse af venøs tromboemboli (VTE), var den geometriske middelkoncentration (90 % prediction-interval) 2-4 timer og ca. 24 timer efter administration henholdsvis 101 (7 - 273) og 14 (4 - 51) mikrog/l, hvilket stort set svarer til maksimums- og minimumskoncentrationerne i doseringsintervallet.
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 8).
Danish: Der blev udført en forudspecificeret samlet analyse af resultaterne fra Einstein DVT- og PE-studierne (se tabel 8).
English: Xarelto 2.5 mg, twice daily, N=5,114 n (%)
Danish: Xarelto 2,5 mg, to gange dagligt, N=5.114 n (%)
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 7).
Danish: Der blev udført en forudspecificeret samlet analyse af resultaterne fra Einstein DVT- og PE-studierne (se tabel 7).
English: Xareltoa) 3, 6 or 12 months N=4,150
Danish: 3, 6 eller 12 måneder N=4.150
English: Within the highest quartile according to centre, the Hazard Ratio (HR) with rivaroxaban versus warfarin was 0.74 (95% CI, 0.49 - 1.12).
Danish: I den højeste kvartil i henhold til center var hazard ratio (HR) for rivaroxaban i forhold til warfarin 0,74 (95 % KI, 0,491,12).
English: In individuals with mild (creatinine clearance 50 - 80 ml/min), moderate (creatinine clearance 30 - 49 ml/min) and severe (creatinine clearance 15 - 29 ml/min) renal impairment, rivaroxaban plasma concentrations (AUC) were increased 1.4, 1.5 and 1.6 fold respectively.
Danish: Hos personer med mild (kreatininclearance 50 - 80 ml/min), moderat (kreatininclearance 30 - 49 ml/min) og svær (kreatininclearance 15 - 29 ml/min) nedsat nyrefunktion sås der en stigning i plasmakoncentrationerne af rivaroxaban (AUC) på henholdsvis 1,4, 1,5 og 1,6 gange.
English: Concomitant treatment with any other anticoagulants, e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumstances of switching anticoagulant therapy (see section 4.2) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5).
Danish: Samtidig behandling med andre antikoagulantia, f.eks. ufraktioneret heparin (UFH), lavmolekylære hepariner (enoxaparin, dalteparin etc.), heparinderivater (fondaparinux etc.), orale antikoagulantia (warfarin, dabigatranetexilat, apixaban etc.), bortset fra i de specifikke tilfælde, hvor der skiftes antikoagulantionsbehandling (se pkt.
English: In subjects with mild renal impairment erythromycin (500 mg three times a day) led to a 1.8 fold increase in mean rivaroxaban AUC and 1.6 fold increase in CRmax when compared to subjects with normal renal function.
Danish: Hos personer med let nedsat nyrefunktion medførte erythromycin (500 mg tre gange dagligt) en 1,8 gange forhøjelse i gennemsnitlig rivaroxaban-AUC og en 1,6 gange forhøjelse i Cmax sammenlignet med personer med normal nyrefunktion.
English: The principal safety outcome (major bleeding) occurred in 6 (0.6%)and 4 (0.8%) patients in the rivaroxaban (n = 988) and VKA (n = 499) groups, respectively (RR 0.76; 95% CI 0.21-2.67; safety population).
Danish: Det primære sikkerhedsmål (større blødning) forekom hos 6 (0,6 %) og 4 (0,8 %) patienter i hhv. rivaroxaban-gruppen (n = 988) og VKA-gruppen (n = 499) (RR 0,76; 95 % KI 0,21-2,67; sikkerhedspopulation).
English: 5 film-coated tablets
Danish: 5 filmovertrukne tabletter
English: Localised oedemaA
Danish: Lokaliseret ødemA
English: Patients with moderate hepatic impairment were more sensitive to rivaroxaban resulting in a steeper PK/PD relationship between concentration and PT.
Danish: Det resulterede i et stejlere PK/PD-forhold mellem koncentration og PT.
English: NSAIDs/platelet aggregation inhibitors
Danish: NSAID'er/trombocytaggregationshæmmere
English: Converting from Vitamin K Antagonists (VKA) to Xarelto For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Xarelto therapy should be initiated once the International Normalised Ratio (INR) is ≤ 2.5.
Danish: Skift fra vitamin-K-antagonister (VKA) til Xarelto For patienter, der behandles for DVT, PE og forebyggelse af recidiv, skal VKA-behandlingen seponeres, og Xarelto-behandlingen indledes, så snart INR (International Normalised Ratio) ≤ 2,5.
English: Common (may affect up to 1 in 10 people) - reduction in red blood cells which can make the skin pale and cause weakness or breathlessness - bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleed, bleeding in the gum - bleeding into the eye (including bleeding from the whites of the eyes) - bleeding into tissue or a cavity of the body (haematoma, bruising) - coughing up blood - bleeding from the skin or under the skin - bleeding following an operation - oozing of blood or fluid from surgical wound - swelling in the limbs - pain in the limbs - impaired function of the kidneys (may be seen in tests performed by your doctor) - fever - stomach ache, indigestion, feeling or being sick, constipation, diarrhoea - low blood pressure (symptoms may be feeling dizzy or fainting when standing up) - decreased general strength and energy (weakness, tiredness), headache, dizziness - rash, itchy skin - blood tests may show an increase in some liver enzymes
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 behandlede) nedsat antal røde blodlegemer, hvilket kan medføre bleghed og svaghed eller åndenød blødning i maven eller tarmen, blødning i nyrer, urinveje og kønsorganer (herunder blod i urinen og kraftig menstruationsblødning), næseblødning, blødning fra gummerne blødning i øjet (herunder blødning fra bindehinden, det hvide i øjet) blodansamling i væv eller hulrum i kroppen (hæmatom, blå mærker) ophostning af blod blødning i huden eller under huden blødning efter operation sivning af blod eller væske fra operationssår hævede arme og ben smerter i arme og ben nedsat nyrefunktion (kan ses i blodprøver) feber mavesmerter, fordøjelsesbesvær, kvalme og opkastning, forstoppelse, diaré lavt blodtryk (symptomerne kan være svimmelhed eller besvimelse, når man rejser sig) manglende kræfter og energi (svaghed, træthed), hovedpine, svimmelhed udslæt, kløe stigning i visse leverenzymer påvist ved blodprøver.
English: Xarelto 2.5 mg, twice daily, N=3114 n (%)
Danish: Xarelto 2,5 mg, to gange dagligt, N=3.114 n (%)
English: Xareltoa) 3, 6 or 12 months N=2,419
Danish: 3, 6 eller 12 måneder N=2.419
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF TREATMENT INITIATION PACK (42 FILM-COATED TABLETS OF 15 MG AND 7 FILM-COATED TABLETS OF 20 MG) (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL STARTPAKNING (42 FILMOVERTRUKNE TABLETTER MED 15 MG OG 7 FILMOVERTRUKNE TABLETTER MED 20 MG) (MED BLUE BOX)
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 6).
Danish: Der blev udført en forudspecificeret samlet analyse af resultaterne fra Einstein DVT- og PE-studierne (se tabel 6).
English: If you are taking one 20 mg tablet or one 15 mg tablet once a day and have missed a dose, take it as soon as you remember.
Danish: Såfremt du tager én 20 mg-tablet eller én 15 mg-tablet én gang dagligt og er kommet til at glemme en dosis, skal du tage den, så snart du kommer i tanke om det. Du må ikke tage mere end én tablet på samme dag som erstatning for en glemt dosis.
English: Each tablet contains 10 mg of rivaroxaban.
Danish: Hver tablet indeholder 10 mg rivaroxaban.
English: When converting patients from VKAs to Xarelto, International Normalised Ratio (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 (International Normalized Ratio)-værdien efter indtagelse af Xarelto.
English: (only applicable for bottle label, not applicable for outer carton)
Danish: (gælder kun etiket til plastbeholder, gælder ikke ydre emballage )
English: Data on efficacy in this population are limited (see sections 4.2 and 5.1).
Danish: Data for virkningen hos denne patientgruppe er begrænsede (se pkt.
English: If you are taking one 15 mg tablet twice a day and have missed a dose, take it as soon as you remember.
Danish: Såfremt du tager én 15 mg-tablet to gange dagligt og er kommet til at glemme en dosis, skal du tage den, så snart du kommer i tanke om det. Du må ikke tage mere end to 15 mg-tabletter på samme dag.
English: Serious skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and DRESS syndrome, have been reported during post-marketing surveillance in association with the use of rivaroxaban (see section 4.8).
Danish: Alvorlige hudreaktioner, herunder Stevens-Johnsons syndrom/toksisk epidermal nekrolyse og DRESS syndrom (se pkt.
English: Xarelto administration should be discontinued if severe haemorrhage occurs (see section 4.9).
Danish: Behandlingen med Xarelto bør afbrydes, hvis der opstår svær blødning (se pkt.
English: Acute limb ischaemia a) intention to treat analysis set, primary analyses b) vs. ASA 100 mg; Log-Rank p-value * The reduction in the primary efficacy outcome was statistically superior.
Danish: vs. ASA 100 mg; Log-Rank p-værdi Reduktionen i det primære effektendepunkt var statistisk bedre.
English: In patients receiving rivaroxaban 2.5 mg twice daily for the prevention of atherothrombotic events in patients with ACS the geometric mean concentration (90% prediction interval) 2 - 4 h and about 12 h after dose (roughly representing maximum and minimum concentrations during the dose interval) was 47 (13 - 123) and 9.2 (4.4 - 18) mcg/l, respectively.
Danish: Hos patienter med AKS, der fik rivaroxaban 2,5 mg to gange dagligt til forebyggelse af aterotrombotiske hændelser, var den geometriske middelkoncentration (90 % prediction-interval) 24 timer og ca. 12 timer efter administration henholdsvis 47 (13 - 123) og 9,2 (4,4 - 18) mikrog/l, hvilket stort set svarer til maksimums- og minimumskoncentrationerne i doseringsintervallet.
English: From Day 22: 20 mg 1 tablet once a day (taken at same time each day) together with food.
Danish: Fra dag 22: 20 mg, én tablet én gang dagligt (på samme tidspunkt hver dag) sammen med mad.
English: Day 1 to 21: 15 mg 1 tablet twice a day (one 15 mg tablet in the morning and one in the evening) together with food.
Danish: Dag 1 til 21: 15 mg, én tablet to gange dagligt (én 15 mg tablet morgen og én tablet aften) sammen med mad.
English: Treatment of DVT, PE and prevention of recurrence
Danish: Behandling af dyb venetrombose (DVT), PE og forebyggelse af recidiv
English: Xarelto 2.5 mg bid in combination with ASA 100 mg od, N=9152 n (Cum.
Danish: Xarelto 2,5 mg to gange dagligt i kombination med ASA 100 mg én gang dagligt, N = 9.152 n (kumulativ risiko
English: The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a HR of 0.67 ((95% CI: 0.47 - 0.95), nominal p value p=0.027) in favour of rivaroxaban.
Danish: Den på forhånd fastsatte kliniske nettofordel (primært effektendepunkt plus større blødninger) indberettedes med en HR på 0,67 (95 % KI: 0,47 - 0,95), nominel p-værdi p = 0,027) til fordel for rivaroxaban.
English: Enoxaparin/VKAb) 3, 6 or 12 months N=1,718
Danish: Enoxaparin/VKAb) 3, 6 eller 12 måneder N=1.718
English: In the per-protocol population on treatment, stroke or systemic embolism occurred in 188 patients on rivaroxaban (1.71% per year) and 241 on warfarin (2.16% per year) (HR 0.79;
Danish: I per-protokolpopulationen under behandling, forekom apopleksi eller systemisk emboli hos 188 patienter på rivaroxaban (1,71 % pr. år) og 241 på warfarin (2,16 % pr. år) (HR 0,79; 95 % KI, 0,66-0,96; p < 0,001 for non-inferioritet).