FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: antithrombotic agents, direct thrombin inhibitors, ATC code: B01AE07.
Danish: Farmakoterapeutisk klassifikation: antitrombosemidler, direkte virkende trombin-inhibitorer, ATCkode: B01AE07
English: • Whenever the risk management system is modified, especially as th result of new information being received that may lead to significant change to the benefit/risk profile or as the result.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benifit-forholdet, eller som følge af, at en vigtig milepæl
English: Substances influencing gastric pH
Danish: Stoffer, der påvirker gastrisk pH
English: Management of bleeding complications
Danish: Behandling af blødningskomplikationer
English: Surgery and interventions
Danish: Kirurgi og indgreb
English: Surgical and medical procedures Wound drainage
Danish: Kirurgiske og medicinske procedurer Sårdrænage
English: Depending on the clinical situation appropriate supportive treatment, such as surgical haemostasis and blood volume replacement, should be undertaken at the prescriber's discretion.
Danish: Afhængigt af den kliniske tilstand bør passende understøttende behandling, såsom kirurgisk hæmostase og erstatning af blodtab, foretages efter den ordinerende læges skøn.
English: For dose modifications in this population see table 2 above.
Danish: For dosismodifikationer hos denne population, se tabel 2 ovenfor.
English: In a study performed with 24 healthy subjects, when Pradaxa was co-administered with digoxin, no changes on digoxin and no clinically relevant changes on dabigatran exposure have been observed.
Danish: I et studie med 24 raske personer, hvor Pradaxa blev givet samtidigt med digoxin, så man ingen ændringer i eksponeringen af digoxin og ingen klinisk relevante ændringer i eksponeringen af dabigatran.
English: Duration of dabigatran etexilate treatment ranged from 6 to 36 months (median 534.0 days).
Danish: Varigheden af dabigatranetexilat-behandlingen varierede fra 6 til 36 måneder (gennemsnit 535,0 dage).
English: Tables 20-22 display details of key results in the overall population:
Danish: Tabel 20-22 viser i detaljer de vigtigste resultater i den samlede population:
English: • Do not push the capsules through the blister foil.
Danish: • Tryk ikke kapslen gennem blisterfolien.
English: Currently available data are described in section 4.8 and 5.1, but no recommendation on a posology can be made.
Danish: 4.8 og 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: 4.7 Effects on ability to drive and use machines Pradaxa has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Pradaxa påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Due to the pharmacological mode of action, the use of Pradaxa may be associated with an increased risk of occult or overt bleeding from any tissue or organ.
Danish: På grund af den farmakologiske virkningsmekanisme, kan anvendelsen af Pradaxa være forbundet med en øget risiko for okkult eller åben blødning fra alle væv eller organer.
English: D-55216 Ingelheim am Rhein Germany and
Danish: D-55216 Ingelheim am Rhein Tyskland og
English: Since thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus.
Danish: Da trombin (serinprotease) fremmer ændringen af fibrinogen til fibrin i koagulationskaskaden, vil en hæmning af trombin forhindre udviklingen af tromber.
English: A prospective, randomized, open-label, multicenter, exploratory study with blinded, centrally adjudicated endpoint evaluation (RE-CIRCUIT) was conducted in 704 patients who were under stable anticoagulant treatment.
Danish: Et prospektivt, randomiseret, open-label, eksplorativt multicenterstudie med blindet, uafhængig central evaluering af endepunkter (RE-CIRCUIT) blev udført hos 704 patienter, der var i stabil behandling med antikoagulantia.
English: They have not been studied and are therefore not recommended for concomitant treatment with Pradaxa.
Danish: De er ikke blevet undersøgt, og samtidig behandling med Pradaxa kan derfor ikke anbefales.
English: This resulted in a removal of 50 % to 60 % of dabigatran concentrations, respectively.
Danish: Dette resulterede i en reduktion af dabigatrankoncentrationerne på henholdsvis 50 % og 60 %.
English: The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Danish: Indehaveren af markedsføringstilladelsen skal for hver terapeutisk indikation fremstille uddannelsesmateriale rettet mod de læger, som forventes at ordinere/anvende Pradaxa.
English: Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity.
Danish: Dabigatranetexilat er et lav-molekylært prodrug, som ikke udviser nogen farmakologisk aktivitet.
English: Thereafter two capsules once a day should be taken for a total of 10 days.
Danish: Fra næste dag skal du tage 2 kapsler én gang dagligt i totalt 10 dage.
English: In clinical trials, Pradaxa was associated with higher rates of major gastrointestinal (GI) bleeding.
Danish: I kliniske studier var Pradaxa forbundet med en højere frekvens af alvorlig gastrointestinal (GI) blødning.
English: Treatment initiation on the day of surgery 1-4 hours after completed surgery
Danish: Påbegyndelse af behandlingen på operationsdagen 1-4 timer efter operationen er udført
English: For both surgery types, treatment should not be started if there is bleeding from the site of operation.
Danish: Ved begge slags operationer er det sådan, at behandlingen ikke påbegyndes, hvis det stadig bløder fra operationssåret.
English: The oral bioavailability may be increased by 75 % after a single dose and 37 % at steady state compared to the reference capsule formulation when the pellets are taken without the Hydroxypropylmethylcellulose (HPMC) capsule shell.
Danish: Den orale biotilgængelighed kan være øget med 75 % efter en enkelt dosis og med 37 % ved steady state efter gentagne doser, hvis pellets indtages uden HPMC-kapselskallen i forhold til indtagelse af en hel kapsel.
English: •An instruction how to take Pradaxa
Danish: •Instruktion i, hvordan man tager Pradaxa
English: In particular you should tell your doctor before taking Pradaxa, if you are taking one of the medicines listed below:
Danish: Fortæl det især til lægen, før du tager Pradaxa, hvis du tager et af de nedenstående lægemidler:
English: Contact your doctor if you experience indigestion after taking Pradaxa.
Danish: Kontakt lægen, hvis du oplever fordøjelsesbesvær, efter du har taget Pradaxa.
English: Diseases / procedures with special haemorrhagic risks
Danish: Sygdomme / procedurer med speciel blødningsrisiko
English: 24 hours before
Danish: 24 timer før
English: The mean CHADS2 and HAS-BLED scores were 1.9 and 1.2, respectively.
Danish: Gennemsnitlige CHADS2- og HAS-BLED-scorer var hhv. 1,9 og 1,2.
English: However, limited clinical data with another P-gp substrate (everolimus) suggest that the inhibition of P-gp with tacrolimus is weaker than that observed with strong P-gp inhibitors.
Danish: Dog antyder begrænsede kliniske data med et andet P-gp-substrat (everolimus), at tacrolimus hæmmer P-gp i mindre grad end potente P-gp-inhibitorer.
English: Active Cancer Patients (DVT/PE)
Danish: Patienter med aktiv kræft (DVT/LE)
English: In the studied patient population of RE-MODEL and RE-NOVATE (5,539 patients treated), 51 % suffered from concomitant hypertension, 9 % from concomitant diabetes, 9 % from concomitant coronary artery disease and 20 % had a history of venous insufficiency.
Danish: I den undersøgte patientpopulation i RE-MODEL og RE-NOVATE (5539 behandlede patienter) havde 51 % samtidig hypertension, 9 % samtidig diabetes, 9 % samtidig koronararterie-sygdom og 20 % havde samtidig dårlig venefunktion.
English: The median CrCL in RE-LY was 68.4 mL/min.
Danish: Den mediane CrCl i RE-LY var 68,4 ml/min.
English: Pradaxa should be stopped before elective surgery High risk of bleeding or major surgery
Danish: Pradaxa skal stoppes før elektiv kirurgi Høj blødningsrisiko eller større kirurgisk indgreb
English: When taking Pradaxa capsules out of the blister pack, the following instructions should be followed:
Danish: Når en kapsel tages ud af blisterpakningen skal følgende instruktioner følges:
English: In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Danish: Navnlig for patienter, der er tredobbelt positive (for lupus antikoagulans, anticardiolipin-antistoffer og anti-beta 2glykoprotein I-antistoffer), kan behandling med DOAK være forbundet med øget forekomst af recidiverende trombotiske hændelser i forhold til behandling med vitamin K-antagonister.
English: Selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs)
Danish: Selektive serotonin-genoptagelseshæmmere (SSRIer) eller selektive serotonin-noradrenalingenoptagelseshæmmere (SNRIer)
English: Specific pharmacokinetic phase I studies with elderly subjects showed an increase of 40 to 60 % in the AUC and of more than 25 % in Cmax compared to young subjects.
Danish: Specifikke farmakokinetiske fase I-studier viste, at hos ældre er AUC 40-60 % større og Cmax mere end 25 % højere end hos unge.
English: Tear off one individual blister from the blister card along the perforated line
Danish: Afriv en enkelt blister fra blisterkortet langs den perforerede linie.
English: Elderly patients outside of the United States (≥80 years of age for all countries, ≥70 years of age for Japan) were randomly assigned to the dabigatran etexilate 110 mg dual-therapy group or the warfarin triple-therapy group.
Danish: Ældre patienter uden for USA (≥80 år i alle lande, ≥70 år i Japan) blev randomiseret til gruppen med dabigatranetexilat 110 mg dobbeltterapi eller til gruppen med warfarin trippelterapi.
English: When clinically relevant bleeding occurs, treatment should be interrupted.
Danish: Ved klinisk relevant blødning, skal behandlingen afbrydes.
English: Other dabigatran related anti-coagulation tests were not changed significantly by the pre-treatment of enoxaparin.
Danish: Der var ikke andre dabigatran relaterede antikoagulation test, der var ændret væsentligt ved forbehandling med enoxaparin.
English: Spinal anaesthesia/epidural anaesthesia/lumbar puncture
Danish: Spinal anæstesi/epidural anæstesi/lumbalpunktur
English: When the calibrated dTT assay delivers a dabigatran plasma concentration result at or below the limit of quantification, an additional coagulation assay such as TT, ECT or aPTT should be considered.
Danish: Når den kalibrerede dTT-analyse angiver en dabigatran-plasmakoncentration på eller under grænsen for kvantificering, bør yderligere en koagulationsanalyse overvejes såsom TT, ECT eller aPTT.
English: DVT/PE The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Danish: DVT/LE Behandlingsvarigheden skal individualiseres efter nøje vurdering af behandlingsfordele i forhold til risikoen for blødninger (se pkt.
English: SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in RE-LY in all treatment groups,
Danish: SSRI og SNRI øgede risikoen for blødning i alle behandlingsarmene i RE-LY.
English: None of these diseases showed an impact on the effects of dabigatran on VTE-prevention or bleeding rates.
Danish: Ingen af disse sygdomme havde indflydelse på dabigatrans effekt på forebyggelse af VTE eller blødningstilfælde.
English: These observations in real-world settings are consistent with the established safety and efficacy profile for dabigatran etexilate in the RE-LY study in this indication.
Danish: Disse observationer fra daglig klinisk praksis er i overensstemmelse med de etablerede profiler for sikkerhed og virkning for dabigatranetexilat i RE-LY-studiet for denne indikation.
English: Interaction with P-gp inducers
Danish: Interaktion med P-gp-induktorer
English: Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa.
Danish: Pantoprazol og andre protonpumpehæmmere (PPI) blev givet sammen med Pradaxa i kliniske studier, og samtidig PPI-behandling syntes ikke at reducere virkningen af Pradaxa.
English: • Esophagitis, gastritis or gastroesophageal reflux Limited data is available in patients < 50 kg (see section 5.2).
Danish: • Øsofagitis, gastritis eller gastroøsofageal refluks Data for patienter < 50 kg er begrænsede (se pkt.
English: 18 months (%)
Danish: Forekomst (%)
English: Clearance of dabigatran by haemodialysis was investigated in 7 patients with end-stage renal disease (ESRD) without atrial fibrillation.
Danish: Elimination af dabigatran ved hæmodialyse blev undersøgt hos 7 patienter med nyresygdom i slutstadiet (ESRD) uden atrieflimren.
English: The capsules can be taken with or without food.
Danish: Kapslerne kan tages med eller uden mad.
English: Enrolled patients continued to receive the same double-blind dabigatran etexilate dose randomly allocated in RE-LY, for up to 43 months of follow up after RE-LY (total mean follow-up RE-LY + RELY-ABLE, 4.5 years).
Danish: De inkluderede patienter fortsatte med samme dobbeltblindede dabigatranetexilatdosis i op til 43 måneder efter RE-LY (samlet gennemsnitlig opfølgning RE-LY + RELY-ABLE var 4,5 år).
English: ® can be taken with or without food.
Danish: ® kan tages med eller uden mad.
English: • Low body weight (< 50 kg)
Danish: Mindre betydende: • Lav legemsvægt (< 50 kg)
English: Bleeding reactions
Danish: Blødningsreaktioner
English: The administration of a proton-pump inhibitor (PPI) can be considered to prevent GI bleeding.
Danish: Administrationen af en protonpumpehæmmer (PPI) kan overvejes, for at forhindre blødning i mavetarm-kanalen.
English: In atrial fibrillation patients females had on average 30 % higher trough and post-dose concentrations.
Danish: Hos kvindelige AF-patienter måltes i gennemsnit 30 % højere trough og post-dosis koncentrationer.
English: • One individual blister should be teared off from the blister card along the perforated line.
Danish: • En enkelt blister rives af blisterkortet langs den perforerede linie.
English: Pradaxa should only be given if the benefit outweighs bleeding risks.
Danish: Pradaxa bør kun gives, hvis fordelene opvejer risikoen for blødning.
English: Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran.
Danish: Ranitidin Samtidig indtagelse af ranitidin og Pradaxa havde ingen klinisk relevant virkning på omfanget af dabigatran-absorptionen.
English: 10 days (knee replacement surgery) or 28-35 days (hip replacement surgery)
Danish: 10 dage (knæalloplastik) eller 28-35 dage (hoftealloplastik)
English: Pradaxa affects blood clotting, so most side effects are related to signs such as bruising or bleeding.
Danish: Pradaxa virker på blodets størkning, så de fleste bivirkninger er tegn på blå mærker eller blødninger.
English: Direct acting Oral Anticoagulants (DOACs) including dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Danish: Direkte virkende orale antikoagulantia (DOAK), herunder dabigatranetexilat, anbefales ikke til patienter med tidligere trombose, som er diagnosticerede med antifosfolipidsyndrom.
English: The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Danish: Indehaveren af markedsføringstilladelsen skal også sørge for, at der i hver pakning er et Patientkort med teksten fra bilag III.
English: Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma.
Danish: Dabigatran er en potent, kompetitiv, reversibel, direkte trombin-hæmmer, og er den i plasma aktive del af lægemidlet.
English: Do not take Pradaxa
Danish: Tag ikke Pradaxa
English: The median CrCL in the RE-COVER study was 100.4 mL/min.
Danish: Den gennemsnitlige CrCL i RE-COVER-studiet var 100,4 ml/min.
English: However, the aPTT test has limited sensitivity and is not suitable for precise quantification of anticoagulant effect, especially at high plasma concentrations of dabigatran.
Danish: Følsomheden af aPTT-testen er dog begrænset, og testen er ikke anvendelig til præcis kvantificering af den antikoagulerende virkning - især ikke ved høje dabigatran-plasmakoncentrationer.
English: Plasma concentrations of dabigatran showed a biexponential decline with a mean terminal half-life of 11 hours in healthy elderly subjects.
Danish: Plasmakoncentrationer for dabigatran viste et bieksponentielt fald med en middel halveringstid på 11 timer hos raske ældre.
English: • Push and turn for opening.
Danish: • Tryk låget ned og drej for at åbne beholderen.
English: Effects observed in the repeated dose toxicity studies were due to the exaggerated pharmacodynamic effect of dabigatran.
Danish: De virkninger, der blev observeret i de udførte toksiske studier med gentagen indtagelse skyldtes udelukkende dabigatrans store farmakodynamiske effekt.
English: Recovery of the total radioactivity ranged from 88-94 % of the administered dose by 168 hours post dose.
Danish: 168 timer efter administration lå genindvindingen af den samlede radioaktivitet på 88-94 % af den administrerede dosis.
English: • Thrombocytopenia or functional platelet defects
Danish: • Trombocytopeni eller funktionelle trombocytaggregation defekter
English: Catheter ablation for atrial fibrillation (SPAF)
Danish: Kateterablation for atrieflimren (SPAF)
English: An increased risk was seen in the elderly (≥ 75 years) for the 150 mg twice daily dose regimen.
Danish: En øget risiko blev observeret hos ældre (≥ 75 år) for dosisprogrammet med 150 mg to gange dagligt.
English: • Follow your doctor's instructions when taking Pradaxa ®.
Danish: • Følg altid lægens anvisning, når du tager Pradaxa ®.
English: LMWH The concomitant use of LMWHs, such as enoxaparin and dabigatran etexilate has not been specifically investigated.
Danish: LMWH Samtidig anvendelse af LMWH (såsom enoxaparin) og dabigatran er ikke specifikt blevet undersøgt.
English: The calibrated quantitative diluted TT (dTT) test provides an estimation of dabigatran plasma concentration that can be compared to the expected dabigatran plasma concentrations.
Danish: Den kalibrerede kvantitative fortyndede TT- (dTT-) test giver en estimeret dabigatranplasmakoncentration, der kan sammenlignes med de forventede dabigatran-plasmakoncentrationer.
English: As protein binding is low, dabigatran can be dialysed; there is limited clinical experience to demonstrate the utility of this approach in clinical studies (see section 5.2).
Danish: Da der er en lav proteinbinding, kan dabigatran fjernes ved dialyse, men der forligger begrænset klinisk erfaring fra de kliniske studier, der kan demonstrere nytten heraf (se pkt.
English: The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational pack.
Danish: Indehaveren af markedsføringstilladelsen og den nationale ansvarlige myndighed skal blive enige om indhold og udformning af uddannelsesmaterialet og om en kommunikationsplan forud for udlevering af uddannelsesmaterialet.
English: Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted.
Danish: Der bør udvises forsigtighed, når behandlingen midlertidigt afbrydes pga. interventioner, og graden af antikoagulation bør overvåges.
English: Results of both studies showed that the antithrombotic effect of Pradaxa 220 mg and 150 mg were statistically non-inferior to that of enoxaparin on total VTE and all-cause mortality.
Danish: Resultaterne fra begge studier viste, at den antitrombotiske effekt af Pradaxa 220 mg og 150 mg ved total VTE og død uanset årsag statistisk set var non-inferior i forhold til enoxaparin.
English: In the RE-MODEL trial (knee replacement) treatment was for 6-10 days and in the RE-NOVATE trial (hip replacement) for 28-35 days.
Danish: I RE-MODEL (knæalloplastik) var behandlingstiden 6-10 dage og i RE-NOVATE (hoftealloplastik) 28-35 dage.
English: Paediatric population (DVT/PE)
Danish: Pædiatrisk population (DVT/LE)
English: ® is mainly eliminated by the kidneys; adequate diuresis must be maintained.
Danish: ® udskilles primært via nyrerne, og en tilstrækkelig diurese skal opretholdes.
English: Any GI bleeds *HR not estimable as there is no event in either one cohort/treatment
Danish: Alle GI-blødninger *HR er ikke mulig at beregne, da der ikke forekom nogen hændelse i denne kohort/behandling
English: Patient alert card inside.
Danish: Patientkort i pakningen.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Artical 107c(7) of Directive 1002/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c.
English: Interactions linked to dabigatran etexilate and dabigatran metabolic profile
Danish: Interaktioner knyttet til dabigatranetexilats og dabigatrans metaboliske profil
English: The parenteral anticoagulant should be discontinued and Pradaxa should be started 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)) (see section 4.5).
Danish: Den parenterale antikoagulans bør seponeres, og Pradaxa bør startes 0-2 timer før det planlagte tidspunkt for næste parenterale dosis eller samtidig med seponering ved kontinuerlig behandling (f.eks. intravenøs ufraktioneret heparin (UFH)) (se pkt.
English: The intended therapy was 6 months dabigatran etexilate 150 mg twice daily without need for monitoring.
Danish: Den tilsigtede behandling var 6 måneders dabigatranetexilat 150 mg 2 gange dagligt uden behov for monitorering.
English: • If you fall or injure yourself, especially if you hit your head, urgently seek medical advice.
Danish: • Hvis du falder/kommer til skade, især hvis du slår hovedet, skal du søge akut lægehjælp.
English: • Esophagitis, gastritis or gastroesophageal reflux
Danish: • Øsofagitis, gastritis eller gastroøsofageal refluks
English: Your doctor has initiated treatment with Pradaxa
Danish: Din læge har ordineret behandling med Pradaxa
English: As this patient alert card contains important information about your treatment, please carry this card with you at all times to inform healthcare professionals about your intake of Pradaxa
Danish: Patientkortet indeholder vigtige informationer, og du skal derfor altid have kortet på dig for at informere sundhedspersonale om din behandling med Pradaxa
English: If you are taking verapamil containing medicines and your kidney function is decreased by more than half, you should be treated with a reduced dose of 75 mg Pradaxa because your bleeding risk may be increased.
Danish: Hvis du tager medicin, der indeholder verapamil, og du har en nedsat nyrefunktion med mere end halvdelen, bør du behandles med en reduceret dosis på 75 mg Pradaxa, fordi din risiko for blødning kan være øget.
English: Dialysis was conducted with 700 mL/min dialysate flow rate, four hour duration and a blood flow rate of either 200 mL/min or 350-390 mL/min.
Danish: Dialysen blev udført med en dialysatgennemstrømningshastighed på 700 ml/min, var af fire timers varighed og med en blodgennemstrømningshastighed på enten 200 ml/min eller 350-390 ml/min.