FrancophonIA/ELRC3.0 huggingface dataset:
English: With improving monitoring of INR the observed benefits of dabigatran etexilate compared to warfarin diminish.
Danish: Med en forbedret overvågning af INR vil de observerede fordele ved dabigatranetexilat aftage i forhold til warfarin.
English: In addition, dabigatran AUCτ,ss and Cmax,ss and the coagulation measures for dabigatran effect or the inhibition of platelet aggregation as measure of clopidogrel effect remained essentially unchanged comparing combined treatment and the respective mono-treatments.
Danish: Hertil kommer, at dabigatran AUCτ,ss og Cmax,ss og koagulationsparametrerne for dabigatrans virkning eller hæmningen af trombocytaggregationen som målestok for clopidogrels virkning, forblev stort set uændret når kombinationsbehandling blev sammenlignet med de respektive monoterapier.
English: There was no stroke/systemic embolism/TIA (composite) event in the dabigatran etexilate arm, and one event (TIA) in the warfarin arm from the time of ablation and until 8 weeks post-ablation.
Danish: Der var ingen apopleksi/systemisk emboli/TCI (sammensat hændelse) i armen med dabigatranetexilat og én hændelse (TCI) i armen med warfarin fra ablationstidspunktet til 8 uger efter.
English: No change in dabigatran exposure was seen in 12 subjects with moderate hepatic insufficiency (Child Pugh B) compared to 12 controls (see sections 4.2 and 4.4).
Danish: Man så ingen ændring i dabigatran-eksponering hos 12 patienter med moderat nedsat leverfunktion (Child Pugh B) sammenlignet med 12 kontrolpersoner (se pkt.
English: Dabigatran is subject to conjugation forming pharmacologically active acylglucuronides.
Danish: Dabigatran konjugeres under dannelse af farmakologisk aktive acylglucuronider.
English: Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Danish: Blødningskomplikationer kan vise sig som svaghed, bleghed, svimmelhed, hovedpine eller uforklarlig hævelse, dyspnø og uforklarligt shock.
English: Alanine aminotransferase increased
Danish: Forhøjet alanin-aminotransferase
English: Patients with an increased bleeding risk (see sections 4.4, 4.5, 5.1 and 5.2) should be closely monitored clinically (looking for signs of bleeding or anaemia).
Danish: Patienter med øget blødningsrisiko (se pkt 4.4, 4.5, 5.1 og 5.2) bør klinisk nøje overvåges (for tegn på blødning eller anæmi).
English: After switching from 3-day treatment of once daily 40 mg enoxaparin s.c., 24 hours after the last dose of enoxaparin the exposure to dabigatran was slightly lower than that after administration of dabigatran etexilate (single dose of 220 mg) alone.
Danish: Efter skift fra 3-dages behandling med 40 mg enoxaparin s.c. én gang dagligt 24 timer efter den sidste dosis af enoxaparin, var eksponeringen for dabigatran lidt lavere end efter administration af kun dabigatranetexilat (enkelt dosis på 220 mg).
English: There were 5897 patients enrolled, representing 49 % of patients originally randomly assigned to receive dabigatran etexilate in RE-LY and 86 % of RELY-ABLE-eligible patients.
Danish: 5.897 patienter blev inkluderet, svarende til 49 % af de dabigatranbehandlede patienter i RE-LY og til 86 % af de RELY-ABLE-inkluderbare patienter.
English: Prevention of blood clot formation after knee or hip replacement surgery Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Danish: Forebyggelse af, at blodpropper dannes efter knæ- eller hofteoperation Fortsæt næste dag med den daglige dosis Pradaxa på samme tid, som du plejer.
English: In this small number of adolescents, dabigatran etexilate capsules were apparently tolerated with only three mild and transient gastrointestinal adverse events reported by two patients.
Danish: Hos denne lille gruppe af unge var dabigatranetexilatkapsler tilsyneladende tolereret, idet kun 2 patienter rapporterede tre lette og kortvarige gastrointestinale bivirkninger.
English: You should start treatment with Pradaxa within 1-4 hours after surgery finishes, taking a single capsule.
Danish: Behandlingen med Pradaxa bør starte 1-4 timer efter operationen med 1 kapsel.
English: Although Pradaxa does not in general require routine anticoagulant monitoring, the measurement of dabigatran related anticoagulation may be helpful to detect excessive high exposure to dabigatran in the presence of additional risk factors.
Danish: Selvom der er ikke behov for rutinemæssig monitorering af behandlingen med Pradaxa, kan måling af dabigatran-relateret antikoagulation være en hjælp til at detektere for høj eksponering for dabigatran ved tilstedeværelse af yderligere risikofaktorer.
English: This is explained by completed dabigatran absorption after 2 hours.
Danish: Dette kan forklares ved, at absorptionen af dabigatran sker inden for 2 timer.
English: Pradaxa dabigatran etexilate
Danish: Pradaxa dabigatranetexilat
English: RELY-ABLE (Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial)
Danish: RELY-ABLE (langtids-multicenterstudie med fortsat dabigatranbehandling for patienter med atrieflimren, som havde fuldført RE-LY-studiet)
English: You should not breast-feed while you are taking Pradaxa.
Danish: Du må ikke amme, mens du tager Pradaxa.
English: Peel off the backing foil and remove the capsule.
Danish: Fjern bagsidefolien og tag kapslen ud.
English: Two randomized, parallel group, double-blind studies were performed in patients previously treated with anticoagulation therapy.
Danish: I 2 randomiserede, dobbeltblinde, parallelgruppe-studier indgik tidligere antikoagulansbehandlede patienter.
English: Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants.
Danish: Pradaxa indeholder det aktive stof dabigatranetexilat, og hører til en gruppe lægemidler, der kaldes antikoagulantia (blodfortyndende lægemidler).
English: Bottle: Once opened, the medicine must be used within 4 months.
Danish: Beholder: Når beholderen er åbnet, skal medicinen anvendes i løbet af højst 4 måneder.
English: There is no data on the use of Pradaxa in patients undergoing hip fracture surgery.
Danish: Der findes ingen data vedrørende brugen af Pradaxa til patienter, der har gennemgået operation for hoftefraktur.
English: In the event of haemorrhagic complications, Pradaxa treatment must be discontinued and the source of bleeding investigated.
Danish: I tilfælde af blødningskomplikationer skal behandlingen med Pradaxa seponeres og kilden til blødningen undersøges.
English: Table 9: Number of patients studied, maximum daily dose in phase III studies Indication
Danish: Tabel 9: Antal undersøgte patienter, maksimal daglig dosis i fase III-studier Indikation
English: In the three active controlled DVT/PE phase III studies, a higher rate of MI was reported in patients who received dabigatran etexilate than in those who received warfarin: 0.4% vs. 0.2% in the shortterm RE-COVER and RE-COVER II studies; and 0.8% vs. 0.1% in the long-term RE-MEDY trial.
Danish: I de 3 aktivt-kontrollerede DVT/LE fase III-studier blev der rapporteret en højere frekvens af MI hos patienter, der fik dabigatranetexilat, end hos dem, der fik warfarin; i de to korterevarende studier RECOVER and RE-COVER II henholdsvis 0,4 % vs. 0,2 % og i det længerevarende RE-MEDY-studie 0,8 % vs. 0,1 %.
English: Pradaxa should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation.
Danish: Pradaxa bør anvendes med forsigtighed ved tilstande med en øget risiko for blødning eller ved samtidig brug af lægemidler, der påvirker hæmostasen ved at hæmme trombocytaggregationen.
English: Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
Danish: Ved korte behandlingsforløb (mindst 3 måneder) afvejes mod forbigående risikofaktorer (fx nylig operation, traume, immobilisering) og ved længerevarende behandlingsforløb mod permanente risikofaktorer eller idiopatisk DVT eller LE.
English: If the treatment cannot be started until the day after surgery, dosing should be started with 2 capsules once a day.
Danish: Hvis behandlingen først kan begynde dagen efter operationen, skal du begynde med at tage 2 kapsler én gang dagligt.
English: Concomitant use contraindicated (see section 4.3)
Danish: Samtidig anvendelse kontraindiceret (se pkt.
English: Patients who receive concomitant verapamil*, amiodarone, quinidine
Danish: Patienter i samtidig behandling med verapamil*, amiodaron, kinidin
English: Table 10: Number of patients studied, maximum daily dose in phase III studies Indication
Danish: Tabel 10: Antal undersøgte patienter, maksimal daglig dosis i fase III-studier Indikation
English: From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.
Danish: Fra 6 timer før næste planlagte dosis skal den glemte dosis ikke tages.
English: No dose adjustment is necessary (see section 5.2).
Danish: Ingen dosisjustering er nødvendig (se pkt 5.2).
English: Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs (see section 4.5).
Danish: Nøje observation af tegn på blødning anbefales hos patienter, der samtidigt behandles med NSAID (se pkt.
English: On subsequent days absorption of dabigatran is rapid with peak plasma concentrations attained 2 hours after medicinal product administration.
Danish: De efterfølgende dage er absorptionen af dabigatran hurtig med Cmax opnået 2 timer efter lægemiddeladministration.
English: Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long acting antiplatelet medicinal products have been used.
Danish: Det bør tillige overvejes at administrere trombocytkoncentrater ved trombocytopeni, eller hvis langtidsvirkende trombocythæmmende lægemidler har været anvendt.
English: Patients can stay on Pradaxa while being cardioverted.
Danish: Patienter kan forblive på Pradaxa i forbindelse med kardiovertering.
English: Patients at risk of bleeding
Danish: Patienter med risiko for blødning
English: In the RE-SONATE study, which compared dabigatran etexilate to placebo, the rate of MI was 0.1% for patients who received dabigatran etexilate and 0.2% for patients who received placebo
Danish: I RE-SONATE-studiet, som sammenlignede dabigatranetexilat med placebo, var frekvensen af MI 0,1% for patienter i dabigatranetexilat-armen og 0,2% for patienter i placebo-armen.
English: prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
Danish: - forhindre blodpropper i hjernen (apopleksi) og i andre blodkar i kroppen, hvis du har en form for uregelmæssig hjerterytme, der kaldes non-valvulær atrieflimren, og mindst en yderligere risikofaktor.
English: Since dabigatran is excreted predominantly by the renal route adequate diuresis must be maintained.
Danish: Da dabigatran hovedsageligt udskilles via nyrerne, skal tilstrækkelig diurese opretholdes.
English: RE-MEDY, warfarin controlled study, enrolled patients already treated for 3 to 12 months with the need for further anticoagulant treatment and RE-SONATE, the placebo controlled study, enrolled patients already treated for 6 to 18 months with Vitamin K inhibitors.
Danish: I RE-MEDY, som er et warfarinkontrolleret studie, indgik patienter tidligere behandlet i 3 til 12 måneder og med behov for yderligere antikoagulansbehandling og i RE-SONATE, som er et placebokontrolleret studie, indgik patienter tidligere behandlet i 6 til 18 måneder med vitamin Kantagonist.
English: Hepatic impairment or liver disease expected to have any impact on survival is contraindicated (see section 4.3).
Danish: Nedsat leverfunktion og anden leversygdom, som forventes at have indvirkning på overlevelsen, er kontraindiceret (se pkt.
English: If you forget to take Pradaxa
Danish: Hvis du har glemt at tage Pradaxa
English: After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase-catalysed hydrolysis in plasma and in the liver.
Danish: Efter oral indtagelse absorberes dabigatranetexilat hurtigt og omdannes til dabigatran via esterasekatalyseret hydrolyse i plasma og i leveren.
English: In the clinical studies mucosal bleedings (e.g. gastrointestinal, genitourinary) were seen more frequently during long term Pradaxa treatment compared with VKA treatment.
Danish: I de kliniske studier blev mukosale blødninger (f.eks. gastrointestinale, urogenitale) hyppigere observeret under langvarig behandling med Pradaxa, sammenlignet med VKA-behandling.
English: Procedures such as spinal anaesthesia may require complete haemostatic function.
Danish: Procedurer, som f.eks. spinal anæstesi, kan kræve en helt upåvirket hæmostatisk funktion.
English: Renal function (CrCL in mL/min)
Danish: Nyrefunktion (CrCL i ml/min)
English: Almost half (45.8 %) of the RE-LY patients had a CrCL > 50-< 80 mL/min.
Danish: Hos næsten halvdelen (45,8 %) af RE-LY patienterne var CrCl > 50- < 80 ml/min.
English: Tell your doctor immediately, if you experience a serious allergic reaction which causes difficulty in breathing or dizziness.
Danish: Kontakt straks lægen, hvis du får en alvorlig allergisk reaktion, som medfører vejrtrækningsbesvær eller svimmelhed.
English: The effect was progressively decreased with administration of an extended release formulation (increase of Cmax by about 1.9-fold and AUC by about 1.7-fold) or administration of multiple doses of verapamil (increase of Cmax by about 1.6-fold and AUC by about 1.5-fold).
Danish: Effekten blev progressivt mindsket ved administration af en verapamilformulering med forlænget frigivelse (stigning i Cmax med omkring 1,9 gange og i AUC med omkring 1,7 gange) eller administration af flere doser verapamil (stigning i Cmax med omkring 1,6 gange og i AUC med omkring 1,5 gange).
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsforanstaltnnger (PSUR'er)
English: Pradaxa has no known effects on the ability to drive or use machines.
Danish: Pradaxa påvirker ikke evnen til at køre bil eller betjene maskiner.
English: The rates of outcome events including, major bleed and other bleeding events were consistent with those seen in RE-LY.
Danish: Hyppigheden af alvorlig blødning og andre blødningstilfælde var i overensstemmelse med den, der blev set i RE-LY.
English: In case of intolerability to Pradaxa, patients should be instructed to immediately consult their treating physician in order to be switched to alternate acceptable treatment options for prevention of stroke and systemic embolism associated with atrial fibrillation or for DVT/PE.
Danish: Ved intolerans for Pradaxa, bør patienterne instrueres i straks at kontakte deres behandlende læge for at blive omstillet til alternative behandlingsmuligheder for forebyggelse af apopleksi og systemisk emboli i forbindelse med atrieflimren eller for DVT/LE.
English: Major bleeding rates with this dose were comparable to warfarin.
Danish: Antallet af alvorlige blødninger med denne dosis var sammenligneligt med warfarin.
English: Pantoprazole When Pradaxa was co-administered with pantoprazole, a decrease in the dabigatran AUC of approximately 30 % was observed.
Danish: Ved samtidig indtagelse af Pradaxa og pantoprazol så man et fald i dabigatran-AUC på ca. 30 %.
English: Pradaxa doses beyond those recommended expose the patient to increased risk of bleeding.
Danish: Doser af Pradaxa ud over det anbefalede udsætter patienten for forøget risiko for blødning.
English: Any GI bleeds *HR not estimable as there is no event in either one treatment
Danish: Alle GI-blødninger *HR er ikke mulig at beregne, da der ikke forekom nogen hændelse i nogen af behandlingerne.
English: • A specific reversal agent (Praxbind ®) is available (please refer to the Summary of Product
Danish: • En specifik antidot (Praxbind ®) er tilgængelig (der henvises til produktresuméer for Pradaxa ® og
English: In general, it can be assumed that these measures of anti-coagulant activity may reflect dabigatran levels and can provide guidance for the assessment of bleeding risk, i.e. exceeding the 90
Danish: Generelt kan det antages, at disse mål for antikoagulationsaktiviteten kan reflektere dabigatranniveauerne og være en hjælp til vurdering af blødningsrisikoen.
English: This study demonstrated that dual-therapy with dabigatran etexilate and a P2Y12 antagonist significantly reduced the risk of bleeding vs. warfarin triple-therapy with non-inferiority for composite of thromboembolic events in patients with atrial fibrillation who underwent a PCI with stenting.
Danish: Dette studie viste, at dobbeltterapi med dabigatranetexilat og en P2Y12-antagonist reducerede blødningsrisikoen signifikant vs. warfarin trippelterapi, med non-inferioritet for de samlede tromboemboliske hændelser, hos patienter med atrieflimren, der gennemgik PCI med stenting.
English: Amiodarone When Pradaxa was co-administered with a single oral dose of 600 mg amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.
Danish: Ved samtidig indtagelse af Pradaxa og 600 mg amiodaron som enkeltdosis, forblev absorptionsgraden og absorptionshastigheden af amiodaron og dets aktive metabolit DEA praktisk taget uændret.
English: Rare Injury, poisoning and procedural complications Traumatic haemorrhage
Danish: Sjælden Traumer, forgiftninger og behandlingskomplikationer Traumatisk blødning
English: Bleeding events for both treatments are counted from the first intake of Pradaxa or warfarin after the parenteral therapy has been discontinued (oral only treatment period).
Danish: De anførte blødningshændelser inkluderer alle blødninger registreret fra første indtagelse af Pradaxa eller warfarin efter ophør af parenterel behandling (kun oral behandlingsperiode).
English: Patients undergoing catheter ablation for atrial fibrillation
Danish: Patienter, der gennemgår kateterablation for atrieflimren
English: Therefore INR tests should not be performed.
Danish: Derfor bør der ikke foretages INR-måling.
English: Tacrolimus has been found in vitro to have a similar level of inhibitory effect on Pgp as that seen with itraconazole and cyclosporine.
Danish: In vitro viser tacrolimus en hæmmende effekt på P-gp, som svarer til effekten af itraconazol og ciclosporin.
English: This exploratory study showed that dabigatran etexilate was associated with a significant reduction in MBE rate compared with INR-adjusted warfarin in the setting of ablation.
Danish: Dette eksplorative studie viste, at dabigatranetexilat blev forbundet med en signifikant reduktion i hyppigheden af MBE ved ablation sammenlignet med INRjusteret warfarin.
English: During the additional 2.5 years of treatment in RELY-ABLE, with a maximum exposure of over 6 years (total exposure in RELY + RELY-ABLE), the long-term safety profile of dabigatran etexilate was confirmed for both test doses 110 mg b.i.d.
Danish: Gennem de yderligere 2,5 års behandling i RELY-ABLE, med en maksimal eksponering på over 6 år (total eksponering i RELY + RELY-ABLE) bekræftedes langtids-sikkerhedsprofilen for dabigatranetexilat for begge studiedoser, hhv. 110 mg to gange dagligt og 150 mg to gange dagligt.
English: The primary objective in this study was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the composite endpoint stroke and systemic embolism.
Danish: Det primære mål med dette studie var at fastslå, om dabigatranetexilat var non-inferior til warfarin i at reducere forekomsten af det sammensatte endepunkt af apopleksi og systemisk emboli.
English: SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in all treatment groups of a phase III clinical trial comparing dabigatran to warfarin for stroke prevention in atrial fibrillation patients (RE-LY).
Danish: SSRI og SNRI øgede risikoen for blødning i alle behandlingsarmene i et fase III klinisk studie, der sammenlignede dabigatran med warfarin til forebyggelse af apopleksi hos patienter med atrieflimren (RE-LY).
English: With a loading dose of 300 mg or 600 mg clopidogrel, dabigatran AUCτ,ss and Cmax,ss were increased by about 30-40 % (see section 4.4) .
Danish: Ved en initialdosis på 300 mg eller 600 mg clopidogrel steg dabigatran AUCτ,ss og Cmax,ss med omkring 30-40 % (se pkt.
English: On treatment 2 (22.1 %) patients experienced mild related adverse events (gastrooesophageal reflux / abdominal pain; abdominal discomfort) and 1 (11.1 %) patient experienced a not related serious adverse event (recurrent VTE of the leg) in the post treatment period > 3 days after stop of dabigatran etexilate.
Danish: I studiet oplevede 2 patienter (22,1 %) lette behandlingsrelaterede bivirkninger (gastroøsofageal reflux/abdominalsmerter; abdominalt ubehag) og 1 patient (11,1 %) oplevede en ikke-relateret alvorlig bivirkning (tilbagevendende VTE i benet) i post-behandlingsperioden > 3 dage efter ophør af dabigatranetexilatbehandling.
English: • In case of major bleeding events, Pradaxa ® must be stopped immediately.
Danish: • Ved større blødninger skal behandling med Pradaxa ® straks stoppes.
English: The duration of treatment with fixed dose of dabigatran was 174.0 days without coagulation monitoring.
Danish: I behandlingperioden på 174,0 dage med fast dabigatrandosis blev koagulationen ikke monitoreret.
English: single capsule of 75 mg Pradaxa
Danish: Enkelt kapsel med 75 mg Pradaxa
English: Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit is of value to detect occult bleeding.
Danish: I tillæg til tilstrækkelig klinisk overvågning, er det derfor vigtigt at teste hæmoglobin/hæmatokrit i laboratoriet, for at detektere okkult blødning.
English: Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events
Danish: Patienter med høj risiko for død i forbindelse med operation, og hvor væsentlige risikofaktorer for udvikling af tromboemboli er til stede
English: In this case Pradaxa will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation.
Danish: I dette tilfælde skal behandling med Pradaxa midlertidigt stoppes, da der er en øget risiko for blødning under og kort efter en operation.
English: No other effects on female fertility were observed.
Danish: Der observeredes ingen andre påvirkninger af fertiliteten hos hundyr.
English: After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma.
Danish: Efter oral administration omdannes dabigatranetexilat hurtigt og fuldstændigt til den i plasma aktive form dabigatran.
English: Percutaneous coronary intervention (PCI) with stenting (SPAF) Patients with non valvular atrial fibrillation who undergo a PCI with stenting can be treated with Pradaxa in combination with antiplatelets after haemostasis is achieved (see section 5.1).
Danish: Perkutan koronar intervention (PCI) med stenting (SPAF) Patienter med non-valvulær atrieflimren, der gennemgår PCI med stenting, kan behandles med Pradaxa i kombination med trombocythæmmende midler, efter der er opnået hæmostase (se pkt.
English: P-gp inhibitors
Danish: P-gp-inhibitorer
English: 30 x 1 hard capsule
Danish: 30 x 1 hårde kapsler
English: 22.9 % and 22.5 % of the patients had a CrCL > 50-< 80 mL/min, and 4.1 % and 4.8 % had a CrCL between 30 and 50 mL/min in the RE-MEDY and RE-SONATE studies.
Danish: Henholdsvis 22,9 % og 22,5 % af patienterne havde CrCL > 50-< 80 ml/min, og henholdsvis 4,1 % og 4,8 % havde CrCL mellem 30 og 50 ml/min i RE-MEDY- og RE-SONATEstudierne.
English: - The active substance is dabigatran.
Danish: - Det aktive stof hedder dabigatran.
English: Tables 23-25 display results of the primary efficacy and safety endpoint in relevant sub-populations:
Danish: Tabel 23-25 viser resultater af de primære sikkerhedsendepunkter i relevante delpopulationer: