FrancophonIA/ELRC3.0 huggingface dataset:
English: • The blister foil should only be peeled off, when a hard capsule is required.
Danish: • Blisterfolien må kun fjernes, når der er behov for en kapsel.
English: In a clinical trial the rate of heart attacks with Pradaxa was numerically higher than with warfarin.
Danish: I et af de kliniske studier var hyppigheden af hjerteanfald numerisk højere med Pradaxa end med warfarin.
English: RE-SONATE demonstrated dabigatran etexilate was superior to placebo for the prevention of recurrent symptomatic DVT/PE events including unexplained deaths, with a risk reduction from 5.6 % to 0.4 % (relative risk reduction 92 % based on hazard ratio ) during the treatment period (p<0.0001).
Danish: RE-SONATE viste, at dabigatranetexilat var superior overfor placebo til forebyggelse af recidiverende symptomatisk DVT/LE inklusive uforklarlig død i behandlingsperioden (p<0,0001), med en risikoreduktion på fra 5,6 % til 0,4 % (relativ risikoreduktion på 92 % baseret på hazard ratio).
English: • The backing foil should be peeled off and the capsule can be removed.
Danish: • Folien på bagsiden fjernes, og kapslen kan tages ud.
English: Taking too much Pradaxa increases the risk of bleeding.
Danish: Hvis du har taget for meget Pradaxa, øges risikoen for blødning.
English: A non-interventional study (GLORIA-AF) prospectively collected (in its second phase) safety and effectiveness data in newly diagnosed NVAF patients on dabigatran etexilate in a real-world setting.
Danish: Under anden fase af et non-interventionsstudie (GLORIA-AF) blev der prospektivt indsamlet data for sikkerhed og virkning hos nydiagnosticerede NVAF-patienter på dabigatranetexilat i daglig klinisk praksis.
English: 60 x 1 hard capsule
Danish: 60 x 1 hårde kapsler
English: An unexplained fall in haemoglobin and/or haematocrit or blood pressure should lead to a search for a bleeding site.
Danish: Et uforklarligt fald i hæmoglobin og/eller hæmatokrit eller blodtryk bør føre til udredning for en evt. blødningskilde.
English: For patients with moderate renal impairment (CrCL 30-50 mL/min) the recommended dose of Pradaxa is also 300 mg taken as one 150 mg capsule twice daily.
Danish: Hos patienter med moderat nedsat nyrefunktion (CrCL 30-50 ml/min) er den anbefalede dosis af Pradaxa også 300 mg som 1 kapsel a 150 mg 2 gange dagligt.
English: The RE-LY extension study (RELY-ABLE) provided additional safety information for a cohort of patients which continued the same dose of dabigatran etexilate as assigned in the RE-LY trial.
Danish: Opfølgningsstudiet for RE-LY (RELY-ABLE) indsamlede yderligere sikkerhedsoplysninger fra en gruppe patienter i fortsat behandling med samme dosis dabigatranetixilat som i RE-LY studiet.
English: Other patients at increased risk of bleeding
Danish: Andre patienter med en øget blødningsrisiko
English: In view of the long half-life of amiodarone the potential for an interaction may exist for weeks after discontinuation of amiodarone (see sections 4.2 and 4.4).
Danish: I lyset af den lange halveringstid for amiodaron kan en interaktion forekomme i flere uger efter ophør med amiodaron (se pkt.
English: Intracranial bleeding GI bleeding Fatal bleeding Minor bleeding Any bleeding
Danish: Intrakraniel blødning GI blødning Letal blødning Mindre blødning Alle blødninger
English: There are no data available for 110 mg twice daily Pradaxa treatment.
Danish: Der foreligger ingen data for behandling med Pradaxa 110 mg to gange dagligt.
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
Danish: Dette kan inkludere aktuel eller nylig gastrointestinal ulceration, maligne neoplasmer med høj risiko for blødning, nylig hjerne- eller rygmarvsskade, nylig hjerne-, rygmarvs- eller øjenoperation, nylig intrakraniel blødning, øsofagusvaricer eller mistanke herom, arteriovenøse malformationer, vaskulære aneurismer eller større intraspinale eller intracerebrale vaskulære abnormaliteter
English: Tables 18-19 display results of the primary efficacy and safety endpoint in relevant sub-populations:
Danish: Tabel 18-19 viser resultater af de primære sikkerhedsendepunkter i relevante delpopulationer:
English: Some bleeding events (MBEs/CRBEs; any bleeding) were significantly lower at a nominal alpha level of 5% in patients receiving Pradaxa as compared with those receiving warfarin.
Danish: Forekomsten af visse blødninger (MBE/CRBE; enhver blødning) var signifikant lavere ved et nominelt alfa-niveau på 5 % hos patienter, som fik Pradaxa, sammenlignet med patienter behandet med warfarin.
English: Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:
Danish: Kontakt din læge, hvis du har eller har haft en sygdom, især:
English: If not otherwise specifically described, close clinical surveillance (looking for signs of bleeding or anaemia) is required when dabigatran is co-administered with strong P-gp inhibitors.
Danish: Hvis ikke andet er udtrykkeligt beskrevet, bør der være tæt klinisk overvågning (nøje observation for tegn på blødning eller anæmi), når dabigatran gives samtidig med stærke P-gp-inhibitorer.
English: Patients with gastritis, esophagitis or gastroesophageal reflux
Danish: Patienter med gastritis, øsofagitis or gastroøsofageal refluks
English: The safety of Pradaxa has been evaluated in a pivotal study investigating the prevention of stroke and systemic embolism in patients with atrial fibrillation, in two active controlled DVT/PE treatment trials and in one active controlled DVT/PE prevention trial.
Danish: Pradaxas sikkerhed er blevet evalueret i et pivotalt studie, der undersøgte forebyggelse af apopleksi og systemisk emboli hos patienter med atrieflimren, i 2 aktivt kontrollerede studier med DVT/LEbehandling, og i 1 aktivt kontrolleret forebyggende DVT/LE-studie.
English: Clopidogrel In young healthy male volunteers, the concomitant administration of dabigatran etexilate and clopidogrel resulted in no further prolongation of capillary bleeding times compared to clopidogrel monotherapy.
Danish: Clopidogrel Hos unge, raske mænd medførte samtidig administration af dabigatranetexilat og clopidogrel ikke yderligere forlængelse af kapillær blødning i forhold til clopidogrel monoterapi.
English: The clinical benefit of dabigatran with regard to stroke and systemic embolism prevention and decreased risk of ICH compared to warfarin is preserved across individual subgroups, e.g. renal impairment, age, concomitant medicinal product use such as anti-platelets or P-gp inhibitors.
Danish: Den kliniske fordel ved dabigatran i forhold til forebyggelse af apopleksi og systemisk emboli og nedsat risiko for intrakraniel blødning sammenlignet med warfarin er bevaret på tværs af individuelle subgrupper, f.eks. nedsat nyrefunktion, alder og samtidig behandling med lægemidler såsom trombocythæmmere eller P-gp-inhibitorer.
English: This regimen resulted in a geometric mean trough concentration of 155 ng/ml (gCV of 76.9 %), measured immediately before administration of the next dose and in a geometric mean peak concentration of 202 ng/ml (gCV of 70.6 %) measured two hours after the administration of the last dose.
Danish: Dette behandlingsregime førte til en geometrisk gennemsnitlig trough-koncentration på 155 ng/ml (gCV 76,9 %), målt straks før administration af den næste dosis, og til en geometrisk gennemsnitlig peakkoncentration på 202 ng/ml (gCV 70.6 %), målt to timer efter administration af den sidste dosis.
English: -if you fall or injure yourself during treatment, especially if you hit your head.Please seek urgent medical attention.
Danish: -hvis du falder eller kommer til skade, især hvis du slår hovedet, skal du straks søge lægehjælp.
English: • Renal function should be assessed during treatment with Pradaxa at least once a year or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).
Danish: • Under behandling med Pradaxa bør nyrefunktionen vurderes mindst en gang årligt eller oftere, hvis der opstår kliniske situationer med mistanke om, at der kan indtræde et fald eller en forringelse i nyrefunktionen (f.eks. hypovolæmi, dehydrering eller ved samtidig behandling med visse andre lægemidler).
English: Aspartate aminotransferase increased
Danish: Forhøjet aspartat-aminotransferase
English: Since the patient populations treated in the three indications are not comparable and bleeding events are distributed over several System Organ Classes (SOC), a summary description of major and any bleeding are broken down by indication and provided in tables 12-16 below.
Danish: Eftersom patientpopulationerne behandlet for de 3 indikationer ikke er sammenlignelige, og blødningerne er fordelt over flere organklasser (SOC), er en kortfattet beskrivelse af alvorlige og alle blødninger, opdelt efter indikation, angivet i tabel 12 og 16 nedenfor.
English: Take special care with Pradaxa
Danish: Vær særlig forsigtig med Pradaxa
English: Any bleeding
Danish: Alle blødninger
English: Patients who develop acute renal failure must discontinue Pradaxa (see also section 4.3).
Danish: Patienter, som udvikler akut nyresvigt, skal stoppe behandlingen med Pradaxa (se også pkt.
English: The anticoagulant activity of dabigatran decreased with decreasing plasma concentrations and the PK/PD relationship was not affected by the procedure.
Danish: Dabigatrans antikoagulationsaktivitet aftog med faldende plasmakoncentration, og proceduren havde ingen indvirkning på de farmakokinetiske/farmakodynamiske forhold.
English: Pradaxa is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults.
Danish: Pradaxa anvendes til at forhindre, at der dannes blodpropper i venerne efter en knæ- eller hofteoperation hos voksne.
English: Concomitant administration is expected to result in decreased dabigatran concentrations.
Danish: Samtidig indtagelse forventes at resultere i nedsatte dabigatran-koncentrationer.
English: Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Danish: Fortsæt næste dag med den daglige dosis Pradaxa på samme tid, som du plejer.
English: In a small number of volunteers with severe renal insufficiency (CrCL 10-30 mL/min), the exposure (AUC) to dabigatran was approximately 6 times higher and the half-life approximately 2 times longer than that observed in a population without renal insufficiency (see sections 4.2, 4.3 and 4.4).
Danish: Hos nogle få frivillige med svært nedsat nyrefunktion (CrCL 10-30 ml/min) var eksponeringen (AUC) af dabigatran ca. 6 gange højere og halveringstiden ca. 2 gange længere end det, man så hos en population uden nedsat nyrefunktion (se pkt.
English: Concomitant use not recommended e.g. ritonavir and its combinations with other protease inhibitors
Danish: F.eks. ritonavir og dets kombinationer med andre proteaseinhibitorer
English: Patients should be instructed not to open the capsule as this may increase the risk of bleeding (see sections 5.2 and 6.6).
Danish: Patienterne bør informeres om, at kapslerne ikke må åbnes, da dette kan øge risikoen for blødning (se pkt.
English: Irrespective of therapy, the highest absolute risk of MI was seen in the following subgroups, with similar relative risk: patients with previous MI, patients ≥ 65 years with either diabetes or coronary artery disease, patients with left ventricular ejection fraction < 40 %, and patients with moderate renal dysfunction.
Danish: Uanset behandling blev den højeste risiko for myokardieinfarkt set i de følgende undergrupper og med samme relative risiko: Patienter med tidligere myokardieinfarkt, patienter ≥ 65 år med enten diabetes eller koronararteriesygdom, patienter med venstre ventrikel uddrivningsfraktion < 40 %, og patienter med moderat nedsat nyrefunktion.
English: RE-NOVATE (hip) Treated patients N Number of MBE N(%) RE-MODEL (knee) Treated patients N Number of MBE N(%)
Danish: RE-NOVATE (hofte) Behandlede patienter, N Antal alvorlige blødningstilfælde N (%) RE-MODEL (knæ) Behandlede patienter, N Antal alvorlige blødningstilfælde N (%)
English: ® without talking to your doctor, if you experience heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.
Danish: ® uden at have talt med din læge, hvis du oplever halsbrand, kvalme, opkastning, mavebesvær, oppustethed eller smerter i den øvre del af maven.
English: A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose.
Danish: En glemt dosis skal udelades, hvis den resterende tid til næste dosis, er under 6 timer.
English: Pradaxa treatment should be resumed / started after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established.
Danish: Behandling med Pradaxa bør genoptages/startes så hurtigt som muligt efter den invasive procedure eller det kirurgiske indgreb, forudsat at den kliniske situation tillader det, og tilstrækkelig hæmostase er blevet etableret.
English: - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Danish: - hvis du ved, at du har en sygdom, der hedder antifosfolipidsyndrom (en forstyrrelse i immunsystemet, der giver øget risiko for blodpropper), skal du sige det til lægen, som vil vurdere, om behandlingen skal ændres.
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, rivaroxaban, apixaban etc) except under specific circumstances.
Danish: • Samtidig behandling med en anden antikoagulans, f.eks. ufraktioneret heparin (UFH), lavmolekylær heparin (enoxaparin, dalteparin osv.), heparinderivater (fondaparinux osv.), oral antikoagulans (warfarin, rivaroxaban, apixaban osv.) undtagen under specifikke omstændigheder.
English: -if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots),tell your doctor who will decide if the treatment may need to be changed.
Danish: -hvis du ved, at du har en sygdom, der hedder antifosfolipidsyndrom (en forstyrrelse i immunsystemet, der giver øget risiko for blodpropper), skal du sige det til lægen, som vil vurdere, om behandlingen skal ændres.
English: If you stop taking Pradaxa
Danish: Hvis du holder op med at tage Pradaxa
English: The objective of the RE-SONATE study was to evaluate superiority of dabigatran etexilate versus placebo for the prevention of recurrent symptomatic DVT and/or PE in patients who had already completed 6 to 18 months of treatment with VKA.
Danish: Formålet med RE-SONATE-studiet var at vurdere dabigatranetexilats superioritet overfor placebo ved forebyggelse af recidiverende symptomatisk DVT og/eller LE hos patienter tidligere behandlet med VKA i 6 til 18 måneder.
English: The effect by age on exposure to dabigatran was confirmed in the RE-LY study with an about 31 % higher trough concentration for subjects ≥ 75 years and by about 22 % lower trough level for subjects < 65 years compared to subjects between 65 and 75 years (see sections 4.2 and 4.4).
Danish: Alderens indflydelse på dabigatrans kinetik blev bekræftet i RE-LY-studiet med en cirka 31 % højere trough-koncentration for patienter ≥ 75 år og med omkring 22 % lavere trough-koncentration hos patienter < 65 år sammenlignet med patienter mellem 65 og 75 år (se pkt.
English: Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects.
Danish: Metabolisering og elimination af dabigatran blev undersøgt hos raske, mænd efter en enkelt intravenøs dosis radioaktivt mærket dabigatran.
English: • After removing the capsule, place the cap back on the bottle and tightly close the bottle right away after you take your dose.
Danish: • Når du har taget kapslen ud af beholderen, skal låget sættes på beholderen igen, og straks efter du har taget din dosis, skal beholderen lukkes tæt til.
English: In case of an overdose suspicion, coagulation tests can help to determine a bleeding risk (see sections 4.4 and 5.1).
Danish: I tilfælde af mistanke om overdosis, kan koagulationstest hjælpe til at påvise en evt. blødningsrisiko (se pkt 4,4 og 5,1).
English: The study included 4,859 patients on dabigatran etexilate (55% treated with 150 mg bid, 43% treated with 110 mg bid, 2% treated with 75 mg bid).
Danish: Studiet omfattede 4.859 patienter på dabigatranetexilat (55 % behandlet med 150 mg to gange dagligt, 43 % behandlet med 110 mg to gange dagligt, 2 % behandlet med 75 mg to gange dagligt).
English: The efficacy and safety was investigated in two multi-center, randomised, double blind, parallelgroup, replicate studies RE-COVER and RE-COVER II.
Danish: Virkning og sikkerhed hos patienter med akut DVT og/eller LE blev undersøgt i to multicenter, randomiserede, dobbeltblindede, parallelgruppe, duplicat-studier, RE-COVER og RE-COVER II.
English: Catheter ablation can be conducted in patients on 150 mg twice daily Pradaxa treatment.
Danish: Der kan udføres kateterablation hos patienter, der får behandling med Pradaxa 150 mg to gange dagligt.
English: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Danish: Når dabigatrans virkning reverteres, udsættes patienten for den trombotiske risiko ved den underliggende sygdom.
English: In the early post-operative patients, major bleeding manifested predominantly as haemorrhagic pericardial effusions, specifically in patients who started dabigatran etexilate early (i.e. on Day 3) after heart valve replacement surgery (see section 4.3).
Danish: Hos de nyligt opererede patienter blev der overvejende set større blødninger som hæmoragiske perikardie-effusioner, specielt hos patienter, som startede behandling med dabigatranetexilat hurtigt (på dag 3) efter udskiftning af hjerteklap (se pkt.
English: Protease inhibitors such as ritonavir
Danish: Proteaseinhibitorer, inklusive ritonavir
English: Particular caution should be exercised when Pradaxa is co-administered with verapamil, amiodarone, quinidine or clarithromycin (P-gp inhibitors) and particularly in the occurrence of bleeding, notably in patients having a mild to moderate renal impairment (see section 4.5).
Danish: Der skal udvises særlig forsigtighed, når Pradaxa administreres sammen med verapamil, amiodaron, kinidin eller clarithromycin (P-gp-inhibitorer), og især, hvis der forekommer blødning, specielt hos patienter med let til moderat nedsat nyrefunktion (se pkt.
English: In lifetime toxicology studies in rats and mice, there was no evidence for a tumorigenic potential of dabigatran up to maximum doses of 200 mg/kg.
Danish: Der var ingen tegn på tumorigent potentiale i livslange-studier med mus og rotter ved dabigatrandoser op til 200 mg/kg.
English: All patients received an initial oral dose of 1.71 (± 10%) mg/kg of dabigatran etexilate (80 % of the adult dose of 150 mg/70 kg adjusted for the patient's weight).
Danish: Alle patienter fik initialt 1,71 (± 10 %) mg/kg kropsvægt dabigatranetexilat (80 % af voksendosis på 150 mg/70 kg justeret i forhold til patientens vægt).
English: Caution should be exercised when interpreting these tests.
Danish: Testresultaterne bør tolkes med forsigtighed.
English: For patients randomized to warfarin, the mean percentage of time in therapeutic range (TTR) (INR 2-3) was 64.4 % (median TTR 67 %).
Danish: For patienter randomiseret til warfarin var den gennemsnitlige tid i terapeutisk niveau (TTR) (INR 2-3) 64,4 % (median TTR 67 %).
English: 300 mg Pradaxa taken as one 150 mg capsule twice daily following treatment with a parenteral anticoagulant for at least 5 days
Danish: 300 mg Pradaxa som 1 kapsel á 150 mg 2 gange dagligt efter forudgående parenteral antikoagulansbehandling i mindst 5 dage
English: • Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
Danish: • Kunstige hjerteklapper, der kræver behandling med antikoagulans (se pkt.
English: Peak plasma concentrations are reached at 6 hours following administration in a postoperative period due to contributing factors such as anaesthesia, gastrointestinal paresis, and surgical effects independent of the oral medicinal product formulation.
Danish: Cmax blev opnået 6 timer efter administration i den postoperative fase pga. faktorer som fx anæstesi, gastrointestinal parese og kirurgiske eftervirkninger, uafhængigt af den orale lægemiddelformulering.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
English: Pre-dosing of the probe inducer rifampicin at a dose of 600 mg once daily for 7 days decreased total dabigatran peak and total exposure by 65.5 % and 67 %, respectively.
Danish: Ved præmedicinering med induktoren rifampicin i en dosis på 600 mg én gang dagligt i 7 dage sås et fald i Cmax og i AUC af dabigatran på henholdsvis 65,5 % og 67 %.
English: Anaemia postoperative
Danish: Postoperativ anæmi
English: When taking a hard capsule out of the bottle, the following instructions should be observed:
Danish: Når en kapsel tages ud af kapselbeholderen, skal man være opmærksom på følgende:
English: Polypropylene bottle with a screw cap containing 60 hard capsules.
Danish: Polypropylenbeholder med skruelåg indeholdende 60 hårde kapsler.
English: • After taking the capsule out, the cap should be returned on the bottle right away and the bottle should be tightly closed.
Danish: • Når kapslen er taget ud af beholderen, skal låget straks sættes på beholderen igen, og beholderen lukkes tæt til.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Der er påvist reproduktionstoksicitet ved dyrestudier (se pkt.
English: You may also need to talk to your doctor during treatment with Pradaxa if you experience symptoms or if you have to undergo surgery.
Danish: Kontakt lægen, før du tager Pradaxa, og evt. mens du er i behandling med Pradaxa, hvis du får symptomer, eller hvis du skal opereres.
English: See further down and sections 4.4, 4.5, 5.1 and 5.2.
Danish: 4.4, 4.5, 5.1 og 5.2.
English: A forgotten dose can still be taken up to 6 hours prior to the next due dose.
Danish: En glemt dosis kan stadig tages op til 6 timer før næste dosis skal tages.
English: Patients with elevated liver enzymes > 2 ULN were excluded in the main trials.
Danish: Patienter med forhøjede levertal > 2 gange øvre normalgrænse (ULN) var udelukket fra de primære studier.
English: Pradaxa treatment to parenteral anticoagulant:
Danish: Fra Pradaxa til parenteral antikoagulans:
English: A dose reduction is recommended as indicated in section 4.2.
Danish: Der anbefales en dosisreduktion som indikeret i pkt.
English: According to the relatively low exposure, coagulation at 72 hrs (presumed dabigatran trough level at steady state or close to steady state conditions) was only slightly prolonged with aPTT at maximum 1.60 fold, ECT 1.86 fold, and Hemoclot
Danish: 72 timer efter behandlingsstart (formodet dabigatran-trough-niveau ved steady state eller tæt på steady state-betingelser) var koagulationen kun en smule forlænget med henholdsvis en aPTT med maksimum 1,60 gange, ECT 1,86 gange og Hemoclot