FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is necessary in patients with mild renal impairment (CrCL 50- ≤ 80 mL/min).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat nyrefunktion (CrCL 50-< 80 ml/min).
English: If you are taking amiodarone, quinidine or verapamil containing medicines, your doctor may tell you to use a reduced dose of Pradaxa depending on the condition for which Pradaxa is prescribed to you.
Danish: Hvis du tager medicin, der indeholder amiodaron, kinidin eller verapamil, kan lægen fortælle dig, at du skal bruge en reduceret dosis Pradaxa, afhængig af sygdommen, som du har fået Pradaxa ordineret mod. Se punkt 3.
English: clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid) - Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin - Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil).
Danish: acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylsyre) - medicin til behandling af svampeinfektioner (f.eks. ketoconazol, itraconazol), bortset fra lægemidler til brug på huden - medicin til behandling af uregelmæssig hjerterytme (f.eks. amiodaron, dronedaron, kinidin,
English: Table 6: Transporter interactions
Danish: Tabel 6: Transporter-interaktioner
English: - Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine) - A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C) - Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac) - St. John´s wort, a herbal medicine for depression - Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin norepinephrine re-uptake inhibitors - Rifampicin or clarithromycin (two antibiotics) - Anti-viral medicines for AIDS (e.g. ritonavir) - Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)
Danish: - medicin til forebyggelse af organafstødning efter transplantation (f.eks. tacrolimus eller ciclosporin) - et kombinationspræparat med glecaprevir og pibrentasvir (et antiviralt lægemiddel, der anvendes til at behandle hepatitis C) - medicin mod gigt og lette smerter (f.eks. acetylsalicylsyre, ibuprofen, diclofenac) - perikon, et naturlægemiddel som bruges mod depression - medicin mod depression, der kaldes selektive serotonin-genoptagelseshæmmere eller serotonin noradrenalin-genoptagelseshæmmere - rifampicin eller clarithromycin (antibiotika) - medicin mod aids - anti-virale lægemidler (f.eks. ritonavir) - visse former for medicin til behandling af epilepsi (f.eks. carbamazepin, phenytoin).
English: - if you have received an artificial heart valve which requires permanent blood thinning.
Danish: der anvendes til at behandle hepatitis C. - hvis du har en kunstig hjerteklap, der kræver permanent blodfortynding.
English: In vivo and ex vivo animal studies have demonstrated antithrombotic efficacy and anticoagulant activity of dabigatran after intravenous administration and of dabigatran etexilate after oral administration in various animal models of thrombosis.
Danish: In-vivo- og ex-vivo-dyrestudier i forskellige trombose-dyremodeller har vist, at dabigatran efter intravenøs administration har antitrombotisk effekt og antikoagulerende aktivitet, og det samme er påvist for dabigatranetexilat efter oral indtagelse.
English: The table 12 shows the number (%) of patients experiencing the adverse reaction bleeding during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.
Danish: Tabel 12 viser antallet (%) af patienter, der fik bivirkningen blødning, under den VTE-forebyggende behandling i de to pivotale kliniske studier.
English: For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding (see table 1 above and section 4.4).
Danish: For patienter med gastritis, esophagitis, eller gastroøsofageal refluks kan en dosisreduktion overvejes, grundet forhøjet risiko for alvorlig blødning fra mave-tarm systemet (se tabel 1 ovenfor og pkt.
English: For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding (see table 2 above and section 4.4).
Danish: For patienter med gastritis, esophagitis, eller gastroøsofageal refluks kan en dosisreduktion overvejes, grundet forhøjet risiko for alvorlig blødning fra mave-tarm systemet (se tabel 2 ovenfor og pkt.
English: In total, about 9 % of patients treated for elective hip or knee surgery (short-term treatment for up to 42 days), 22 % of patients with atrial fibrillation treated for the prevention of stroke and systemic embolism (long-term treatment for up to 3 years), 14 % of patients treated for DVT/PE and 15 % of patients treated for DVT/PE prevention experienced adverse reactions.
Danish: Af patienterne behandlet efter elektiv hofte-eller knæoperationer (kortvarig behandling i op til 42 dage) oplevede ca 9 % bivirkninger, af patienter med atrieflimren behandlet for at forebygge apopleksi og systemisk emboli (langvarig behandling i op til 3 år) oplevede 22 % bivirkninger, og 14 % af patienter behandlet for DVT/LE samt 15 % af patienter i forebyggende behandling for DVT/LE oplevede bivirkninger.
English: Low (34-35 %) concentration independent binding of dabigatran to human plasma proteins was observed.
Danish: Proteinbinding af dabigatran er lav (34-35 %) og koncentrationsuafhængig.
English: Blood and lymphatic system disorders Haemoglobin decreased
Danish: Blod og lymfesystem Nedsat hæmoglobin
English: Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg.
Danish: Ved samtidig behandling med dabigatranetexilat og 400 mg dronedaron steg dabigatran AUC0-∞ and Cmax-værdierne henholdsvis ca. 2,4 og 2,3 gange, efter gentagen dosering to gange dagligt, og ca. 2,1 og 1,9 gange efter en enkelt dosis på 400 mg.
English: With chronic use, NSAIDs increased the risk of bleeding by approximately 50 % on both dabigatran etexilate and warfarin.
Danish: Langtidsbehandling med NSAID viste en øget blødningsrisiko på ca. 50 % for både dabigatran-etexilat og warfarin.
English: These are switching anticoagulant therapy (see section 4.2), when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation (see section 4.5)
Danish: 4.2), når UFH gives i doser, der er nødvendige for at opretholde et åbent centralt venekateter eller arteriekateter, eller når UFH gives under kateterablation for atrieflimren (se pkt.
English: Table 20: Analysis of first occurrence of stroke or systemic embolism (primary endpoint) during the study period in RE-LY.
Danish: Tabel 20: Opgørelse af første forekomst af apopleksi eller systemisk emboli (primært endepunkt) i studiesperioden i RE-LY.
English: Half-life is prolonged if renal function is impaired as shown in table 28.
Danish: Halveringstiden forlænges ved nedsat nyrefunktion, som vist i tabel 28.
English: Pradaxa 110 mg are hard capsules with an opaque, light blue-coloured cap and an opaque, light blue -coloured body.
Danish: Pradaxa 110 mg er hårde kapsler med en uigennemsigtig, lyseblå hætte og en uigennemsigtig, lyseblå bund.
English: A study evaluating post-operative absorption of dabigatran etexilate, 1-3 hours following surgery, demonstrated relatively slow absorption compared with that in healthy volunteers, showing a smooth plasma concentration-time profile without high peak plasma concentrations.
Danish: Absorptionen af dabigatranetexilat 1-3 timer efter afsluttet operation påvistes i et absorptionsstudie at være relativ langsom sammenlignet med det, man så hos raske frivillige.
English: RE-MEDY demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to warfarin (non-inferiority margin: 2.85 for hazard ratio and 2.8 for risk difference).
Danish: RE-MEDY viste, at behandling med dabigatranetexilat 150 mg 2 gange dagligt er non-inferior i forhold til warfarin; non-inferioritetsmargin: 2,85 for hazard ratio og 2,8 i risiko-forskel.
English: Gastrointestinal disorders Gastrointestinal haemorrhage
Danish: Mave-tarm-kanalen Gastrointestinal blødning
English: Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily.
Danish: Efter en enkelt oral ketoconazoldosis på 400 mg øgedes AUC0-∞ og Cmax dabigatran med henholdsvis 2,38 og 2,35 gange, og efter gentagne orale doser på 400 mg ketoconazol dagligt med henholdsvis 2,53 og 2,49 gange.
English: Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors (SPAF)
Danish: Forebyggelse af apopleksi og systemisk emboli hos voksne patienter med NVAF med en eller flere risikofaktorer (SPAF)
English: These studies compared dabigatran etexilate (150 mg bid) with warfarin (target INR 2.0-3.0) in patients with acute DVT and/or PE.
Danish: Disse studier sammenlignede dabigatranetexilat (150 mg 2 gange dagligt) med warfarin (behandlingsmål INR 2,0-3,0).
English: • Do not peel off the blister foil until a capsule is required.
Danish: • Tag først folien af, når der er behov for en kapsel.
English: There is a clear correlation between plasma dabigatran concentration and degree of anticoagulant effect based on phase II studies.
Danish: Man har i fase II-studier fundet en klar korrelation mellem dabigatran-koncentrationen i plasma og graden af antikoagulerende effekt.
English: Half-life is prolonged if renal function is impaired as shown in table 23.
Danish: Halveringstiden forlænges ved nedsat nyrefunktion, som vist i tabel 23.
English: If you have a potentially higher risk for bleeding, your doctor may decide to prescribe a dose of Pradaxa 220 mg taken as one 110 mg capsule twice a day.
Danish: Hvis du har en øget risiko for blødning, kan din læge vælge, at din dosis er 220 mg Pradaxa, der tages som 1 kapsel a 110 mg 2 gange dagligt.
English: The most commonly reported events are bleedings occurring in approximately 14 % of patients; the frequency of major bleeds (including wound site bleedings) is less than 2 %.
Danish: Hyppigheden af alvorlige blødninger (inklusive blødninger fra sår) er mindre end 2 %.
English: Table 7: Transporter interactions
Danish: Tabel 7: Transporter-interaktioner
English: 2 days before
Danish: 2 dage før
English: Furthermore a higher risk of MI was seen in patients concomitantly taking ASA plus clopidogrel or clopidogrel alone.
Danish: Hos patienter i samtidig behandling med ASA plus clopidogrel eller clopidogrel alene blev desuden set en højere risiko for myokardieinfarkt.
English: Importance of treatment compliance Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals about all medicines they are currently taking The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure.
Danish: • At alle patienter skal have udleveret et patientoplysningskort og informeres om: Tegn og symptomer på blødning, og hvornår man skal kontakte sundhedspersonale Vigtigheden af compliance Nødvendigheden af altid at have patientoplysningskortet på sig Nødvendigheden af at oplyse sundhedspersonale om al anden medicin, man tager Nødvendigheden af at oplyse sundhedspersonale om, at man tager Pradaxa, hvis man skal opereres eller have foretaget andre former for indgreb.
English: The concomitant use of antiplatelets ASA or clopidogrel approximately doubles MBE rates with both dabigatran etexilate and warfarin.
Danish: Samtidig behandling med trombocythæmmerne ASA eller clopidogrel ca. fordobler MBE-raterne for både dabigatranetexilat og warfarin.
English: Instructions for the bottle
Danish: Anvisninger for beholderen
English: th percentile of aPTT at trough (20-28 hours after the previous dose) was 51 seconds,
Danish: • 90-percentilen for aPTT ved trough (20-28 timer efter den forrige dosis) var 51 sekunder,
English: Table 1: Dose recommendations and duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery
Danish: Tabel 1: Dosisanbefalinger og behandlingsvarighed for primær forebyggelse af venøs tromboemboli ved ortopædkirurgi
English: This includes all bleeding events, which occurred during Pradaxa therapy.
Danish: For dabigatran inkluderer det alle blødninger, som forekom i løbet af behandling med Pradaxa.
English: Data for the total VTE and all cause mortality endpoint are shown in table 11.
Danish: De data, der vedrører endepunktet for kombinationen af VTE og mortalitet uanset årsag, fremgår af tabel 11.
English: Patients were randomized to dabigatran etexilate 110 mg bid dualtherapy, dabigatran etexilate 150 mg bid dual-therapy or warfarin triple-therapy.
Danish: Patienterne blev randomiseret til dabigatranetexilat 110 mg to gange dagligt dobbeltterapi, dabigatranetexilat 150 mg to gange dagligt dobbeltterapi eller warfarin trippelterapi.
English: There was no meaningful interaction observed when verapamil was given 2 hours after dabigatran etexilate (increase of Cmax by about 1.1-fold and AUC by about 1.2-fold).
Danish: Ved indtagelse af verapamil 2 timer efter indtagelse af dabigatranetexilat, blev der ikke observeret nogen betydningsfuld interaktion (stigning i Cmax med omkring 1,1 gang og i AUC med omkring 1,2 gange.
English: For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed.
Danish: Ved begge typer operationer skal behandlingens start udsættes, hvis hæmostase ikke er sikret.
English: Pradaxa 220 mg once daily
Danish: Pradaxa 220 mg 1 gang dagligt
English: Pradaxa 150 mg are hard capsules with an opaque, light blue-coloured cap and an opaque, white body.
Danish: Pradaxa 150 mg er hårde kapsler med en uigennemsigtig, lyseblå hætte og en uigennemsigtig, hvid bund.
English: Subjects randomized to 110 mg Pradaxa twice daily had a significantly lower risk for major bleeds compared with warfarin (hazard ratio 0.81 [p=0.0027]).
Danish: Patienter randomiseret til 110 mg Pradaxa 2 gange dagligt havde en signifikant lavere risiko for alvorlige blødninger sammenlignet med warfarin (hazard ratio 0,81 [p = 0,0027]).
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 180 (3 packs of 60x1) hard capsules.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 180 (3 pakker af 60 x 1) hårde kapsler.
English: Table 10 shows the adverse reactions identified studies and post-marketing data in the indications prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation, DVT/PE treatment and DVT/PE prevention.
Danish: Tabel 10 viser bivirkninger registreret i studier og fra data efter markedsføring for indikationerne forebyggelse af tromboembolisk apopleksi og systemisk emboli hos patienter med atrieflimren, behandling af DVT/LE og forebyggelse af recidiverende DVT/LE.
English: The objective of the RE-MEDY study was to compare the safety and efficacy of oral dabigatran etexilate (150 mg bid) to warfarin (target INR 2.0-3.0) for the long-term treatment and prevention of recurrent, symptomatic DVT and/or PE. A total of 2,866 patients were randomized and 2,856 patients were treated.
Danish: Formålet med RE-MEDY-studiet var at sammenligne virkning og sikkerhed af oral dabigatranetexilat (150 mg 2 gange dagligt) overfor warfarin (behandlingsmål for INR: 2,0-3,0) ved langtidsbehandling og forebyggelse af recidiverende symptomatisk DVT og/eller LE.
English: Patients with mild and moderate renal impairment had at steady state an average 1.8-fold and 3.6-fold higher pre-dose dabigatran plasma concentrations compared with patients with CrCL > 80 mL/min, respectively.
Danish: Patienter med let og moderat nedsat nyrefunktion havde ved steady state gennemsnitligt henholdsvis 1,8 gange og 3,6 gange højere dabigatran-trough-koncentration sammenlignet med patienter med CrCL > 80 ml/min.
English: Gender
Danish: Etnicitet
English: Further risk factors (see also table 4) comprise co-medication with platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux.
Danish: Yderligere risikofaktorer (se også tabel 4) omfatter samtidig behandling med trombocytaggregationshæmmere, såsom clopidogrel og acetylsalicylsyre (ASA) eller nonsteroide antiinflammatoriske lægemidler (NSAID), samt tilstedeværelsen af esophagitis, gastritis eller gastroøsofageal refluks.
English: Table 3: Duration of use for SPAF and DVT/PE Indication Duration of use
Danish: Tabel 3: Behandlingsvarighed for SPAF og DVT/LE Indikation Behandlingsvarighed
English: Patients who receive concomitant verapamil Dose reduction for consideration Patients between 75-80 years daily dose of Pradaxa of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and the risk of bleeding
Danish: Daglig dosis på 300 mg eller 220 mg Pradaxa skal vælges baseret på en individuel vurdering af den tromboemboliske risiko og blødningsrisikoen
English: Pradaxa 75 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Danish: Pradaxa 75 mg hårde kapsler, fås også i polypropylen-(plastik-)beholdere med 60 hårde kapsler.
English: Take Pradaxa as recommended for the following conditions:
Danish: Tag Pradaxa kapslen som angivet herunder for de to forskellige indikationer:
English: FOLDING BOX AND LABEL FOR BOTTLE for 75 mg
Danish: FOLDEÆSKE OG ETIKET TIL BEHOLDER TIL 75 mg
English: Pharmacodynamic interactions (see section 4.5) • ASA and other platelet aggregation inhibitors such as clopidogrel
Danish: 4.5) • ASA og andre trombocytaggregationshæmmere, såsom clopidogrel
English: There is some experimental evidence to support the role of these medicinal products in reversing the anticoagulant effect of dabigatran, but data on their usefulness in clinical settings and also on the possible risk of rebound thromboembolism is very limited.
Danish: Der er dog kun meget få data om anvendeligheden i kliniske situationer og om den potentielle risiko for rebound tromboemboli.
English: Pradaxa 150 mg hard capsules dabigatran etexilate
Danish: Pradaxa 150 mg, hårde kapsler dabigatranetexilat
English: A calibrated quantitative dTT test or repetitive dTT measurements allow prediction of the time by when certain dabigatran levels will be reached (see section 5.1), also in case additional measures e.g. dialysis have been initiated.
Danish: En kalibreret kvantitativ dTT test eller gentagne dTT målinger kan medvirke til at estimere forventede tidspunkter for, hvornår dabigatrankoncentrationen når bestemte niveauer (se pkt.
English: Test (trough value) dTT [ng/mL]
Danish: Test dTT [ng/ml]
English: The aPTT test is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran.
Danish: Den vidt udbredte test for aktiveret partiel tromboplastintid (aPTT) giver en tilnærmet angivelse for den opnåede antikoagulerende virkning ved behandling med dabigatran.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: Ud fra konventionelle prækliniske studier for sikkerhed, gentagen dosistoksicitet og genotoksicitet ses ikke nogen speciel risiko for mennesker.
English: The cleavage of the prodrug dabigatran etexilate by esterase-catalysed hydrolysis to the active principle dabigatran is the predominant metabolic reaction.
Danish: Den væsentligste metaboliske reaktion er en esterasekatalyseret hydrolyse af prodruget dabigatranetexilat til det aktive molekyle dabigatran.
English: Further risk factors (see also table 3) comprise co-medication with platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux.
Danish: Yderligere risikofaktorer (se også tabel 3) omfatter samtidig behandling med trombocytaggregationshæmmere, såsom clopidogrel og acetylsalicylsyre (ASA) eller nonsteroide antiinflammatoriske lægemidler (NSAID) samt tilstedeværelsen af esophagitis, gastritis eller gastroøsofageal refluks.
English: Subjects randomized All-cause mortality Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value Vascular mortality Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value % refers to yearly event rate
Danish: Randomiserede patienter Dødsfald uanset årsag Forekomst (%) Hazard ratio sammenlignet med warfarin (95 % CI) p-værdi Vaskulær mortalitet Forekomst (%) Hazard ratio sammenlignet med warfarin (95 % CI) p-værdi % refererer til den årlige event rate
English: Half-life is prolonged if renal function is impaired as shown in table 13.
Danish: Halveringstiden forlænges ved nedsat nyrefunktion, som vist i tabel 13.
English: Subjects randomized to 150 mg Pradaxa twice daily had a significantly higher risk for major GI bleeds compared with warfarin (hazard ratio 1.48 [p=0.0005].
Danish: Patienter randomiseret til 150 mg Pradaxa 2 gange dagligt havde en signifikant højere risiko for alvorlige gastrointestinale blødninger sammenlignet med warfarin (hazard ratio 1,48 [p = 0,0005].
English: Dabigatran etexilate has not been clinically studied together with tacrolimus.
Danish: Samtidig behandling med dabigatranetexilat og tacrolimus er ikke undersøgt klinisk.
English: The clinical evidence for the efficacy of dabigatran etexilate is derived from the RE-LY study (Randomized Evaluation of Long -term anticoagulant therapy) a multi-centre, multi-national, randomized parallel group study of two blinded doses of dabigatran etexilate (110 mg and 150 mg twice daily) compared to open-label warfarin in patients with atrial fibrillation at moderate to high risk of stroke and systemic embolism.
Danish: Den kliniske evidens for effekten af dabigatranetexilat er fra RE-LY-studiet (Randomized Evaluation of Long -term anticoagulant therapy) et multicenter, multinationalt, randomiseret parallel gruppestudie med 2 blindede doser af dabigatranetexilat (110 mg og 150 mg 2 gange dagligt) sammenlignet med open-label warfarin hos patienter med atrieflimren med moderat til høj risiko for apopleksi og systemisk emboli.
English: 300 mg Pradaxa taken as one 150 mg capsule twice daily
Danish: 300 mg Pradaxa som 1 kapsel á 150 mg 2 gange dagligt
English: FOLDING BOX AND LABEL FOR BOTTLE for 110 mg
Danish: FOLDEÆSKE OG ETIKET TIL BEHOLDER TIL 110 mg
English: If you are 80 years or older, the recommended dose of Pradaxa is 220 mg taken as one 110 mg capsule twice a day.
Danish: Er du 80 år eller ældre, så er den anbefalede dosis 220 mg Pradaxa, der tages som 1 kapsel a 110 mg 2 gange dagligt.
English: 220 mg once daily N (%)
Danish: Pradaxa, 220 mg én gang dagligt N (%)
English: Primary VTE prevention after hip or knee replacement surgery
Danish: Primær forebyggelse af VTE efter hofte-eller knæalloplastik
English: The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).
Danish: Den anbefalede dosis er 220 mg Pradaxa én gang om dagen (taget som 2 kapsler Pradaxa på 110 mg).
English: Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 2 above).
Danish: Nøje observation af tegn på blødning eller anæmi anbefales i hele behandlingsperioden, især hvis der er flere risikofaktorer (se tabel 2 ovenfor).
English: 150 mg once daily N (%)
Danish: Pradaxa, 150 mg én gang dagligt N (%)