natgillin/translations-raw huggingface dataset:
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.
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.
De er ikke blevet undersøgt, og samtidig behandling med Pradaxa kan derfor ikke anbefales.
They have not been studied and are therefore not recommended for concomitant treatment with Pradaxa.
Dette resulterede i en reduktion af dabigatrankoncentrationerne på henholdsvis 50 % og 60 %.
This resulted in a removal of 50 % to 60 % of dabigatran concentrations, respectively.
Indehaveren af markedsføringstilladelsen skal for hver terapeutisk indikation fremstille uddannelsesmateriale rettet mod de læger, som forventes at ordinere/anvende Pradaxa.
The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Dabigatranetexilat er et lav-molekylært prodrug, som ikke udviser nogen farmakologisk aktivitet.
Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity.
Fra næste dag skal du tage 2 kapsler én gang dagligt i totalt 10 dage.
Thereafter two capsules once a day should be taken for a total of 10 days.
I kliniske studier var Pradaxa forbundet med en højere frekvens af alvorlig gastrointestinal (GI) blødning.
In clinical trials, Pradaxa was associated with higher rates of major gastrointestinal (GI) bleeding.
Påbegyndelse af behandlingen på operationsdagen 1-4 timer efter operationen er udført
Treatment initiation on the day of surgery 1-4 hours after completed surgery
Ved begge slags operationer er det sådan, at behandlingen ikke påbegyndes, hvis det stadig bløder fra operationssåret.
For both surgery types, treatment should not be started if there is bleeding from the site of operation.
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.
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.
•Instruktion i, hvordan man tager Pradaxa
•An instruction how to take Pradaxa
Fortæl det især til lægen, før du tager Pradaxa, hvis du tager et af de nedenstående lægemidler:
In particular you should tell your doctor before taking Pradaxa, if you are taking one of the medicines listed below:
Kontakt lægen, hvis du oplever fordøjelsesbesvær, efter du har taget Pradaxa.
Contact your doctor if you experience indigestion after taking Pradaxa.
Sygdomme / procedurer med speciel blødningsrisiko
Diseases / procedures with special haemorrhagic risks
24 timer før
24 hours before
Gennemsnitlige CHADS2- og HAS-BLED-scorer var hhv. 1,9 og 1,2.
The mean CHADS2 and HAS-BLED scores were 1.9 and 1.2, respectively.
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.
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.
Patienter med aktiv kræft (DVT/LE)
Active Cancer Patients (DVT/PE)
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.
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.
Den mediane CrCl i RE-LY var 68,4 ml/min.
The median CrCL in RE-LY was 68.4 mL/min.
Pradaxa skal stoppes før elektiv kirurgi Høj blødningsrisiko eller større kirurgisk indgreb
Pradaxa should be stopped before elective surgery High risk of bleeding or major surgery
Når en kapsel tages ud af blisterpakningen skal følgende instruktioner følges:
When taking Pradaxa capsules out of the blister pack, the following instructions should be followed:
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.
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.
Selektive serotonin-genoptagelseshæmmere (SSRIer) eller selektive serotonin-noradrenalingenoptagelseshæmmere (SNRIer)
Selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs)
Specifikke farmakokinetiske fase I-studier viste, at hos ældre er AUC 40-60 % større og Cmax mere end 25 % højere end hos unge.
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.
Afriv en enkelt blister fra blisterkortet langs den perforerede linie.
Tear off one individual blister from the blister card along the perforated line
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.
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.
Ved klinisk relevant blødning, skal behandlingen afbrydes.
When clinically relevant bleeding occurs, treatment should be interrupted.
Der var ikke andre dabigatran relaterede antikoagulation test, der var ændret væsentligt ved forbehandling med enoxaparin.
Other dabigatran related anti-coagulation tests were not changed significantly by the pre-treatment of enoxaparin.
Spinal anæstesi/epidural anæstesi/lumbalpunktur
Spinal anaesthesia/epidural anaesthesia/lumbar puncture
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.
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.
DVT/LE Behandlingsvarigheden skal individualiseres efter nøje vurdering af behandlingsfordele i forhold til risikoen for blødninger (se pkt.
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).
SSRI og SNRI øgede risikoen for blødning i alle behandlingsarmene i RE-LY.
SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in RE-LY in all treatment groups,
Ingen af disse sygdomme havde indflydelse på dabigatrans effekt på forebyggelse af VTE eller blødningstilfælde.
None of these diseases showed an impact on the effects of dabigatran on VTE-prevention or bleeding rates.
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.
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.
Interaktion med P-gp-induktorer
Interaction with P-gp inducers
Pantoprazol og andre protonpumpehæmmere (PPI) blev givet sammen med Pradaxa i kliniske studier, og samtidig PPI-behandling syntes ikke at reducere virkningen af Pradaxa.
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.
• Øsofagitis, gastritis eller gastroøsofageal refluks Data for patienter < 50 kg er begrænsede (se pkt.
• Esophagitis, gastritis or gastroesophageal reflux Limited data is available in patients < 50 kg (see section 5.2).
Forekomst (%)
18 months (%)
Elimination af dabigatran ved hæmodialyse blev undersøgt hos 7 patienter med nyresygdom i slutstadiet (ESRD) uden atrieflimren.
Clearance of dabigatran by haemodialysis was investigated in 7 patients with end-stage renal disease (ESRD) without atrial fibrillation.
Kapslerne kan tages med eller uden mad.
The capsules can be taken with or without food.
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).
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).
® kan tages med eller uden mad.
® can be taken with or without food.
Mindre betydende: • Lav legemsvægt (< 50 kg)
• Low body weight (< 50 kg)
Blødningsreaktioner
Bleeding reactions
Administrationen af en protonpumpehæmmer (PPI) kan overvejes, for at forhindre blødning i mavetarm-kanalen.
The administration of a proton-pump inhibitor (PPI) can be considered to prevent GI bleeding.
Hos kvindelige AF-patienter måltes i gennemsnit 30 % højere trough og post-dosis koncentrationer.
In atrial fibrillation patients females had on average 30 % higher trough and post-dose concentrations.
• En enkelt blister rives af blisterkortet langs den perforerede linie.
• One individual blister should be teared off from the blister card along the perforated line.
Pradaxa bør kun gives, hvis fordelene opvejer risikoen for blødning.
Pradaxa should only be given if the benefit outweighs bleeding risks.
Ranitidin Samtidig indtagelse af ranitidin og Pradaxa havde ingen klinisk relevant virkning på omfanget af dabigatran-absorptionen.
Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran.
10 dage (knæalloplastik) eller 28-35 dage (hoftealloplastik)
10 days (knee replacement surgery) or 28-35 days (hip replacement surgery)
Pradaxa virker på blodets størkning, så de fleste bivirkninger er tegn på blå mærker eller blødninger.
Pradaxa affects blood clotting, so most side effects are related to signs such as bruising or bleeding.
Direkte virkende orale antikoagulantia (DOAK), herunder dabigatranetexilat, anbefales ikke til patienter med tidligere trombose, som er diagnosticerede med antifosfolipidsyndrom.
Direct acting Oral Anticoagulants (DOACs) including dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Indehaveren af markedsføringstilladelsen skal også sørge for, at der i hver pakning er et Patientkort med teksten fra bilag III.
The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Dabigatran er en potent, kompetitiv, reversibel, direkte trombin-hæmmer, og er den i plasma aktive del af lægemidlet.
Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma.
Tag ikke Pradaxa
Do not take Pradaxa
Den gennemsnitlige CrCL i RE-COVER-studiet var 100,4 ml/min.
The median CrCL in the RE-COVER study was 100.4 mL/min.
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.
However, the aPTT test has limited sensitivity and is not suitable for precise quantification of anticoagulant effect, especially at high plasma concentrations of dabigatran.
Plasmakoncentrationer for dabigatran viste et bieksponentielt fald med en middel halveringstid på 11 timer hos raske ældre.
Plasma concentrations of dabigatran showed a biexponential decline with a mean terminal half-life of 11 hours in healthy elderly subjects.
• Tryk låget ned og drej for at åbne beholderen.
• Push and turn for opening.
De virkninger, der blev observeret i de udførte toksiske studier med gentagen indtagelse skyldtes udelukkende dabigatrans store farmakodynamiske effekt.
Effects observed in the repeated dose toxicity studies were due to the exaggerated pharmacodynamic effect of dabigatran.
168 timer efter administration lå genindvindingen af den samlede radioaktivitet på 88-94 % af den administrerede dosis.
Recovery of the total radioactivity ranged from 88-94 % of the administered dose by 168 hours post dose.
• Trombocytopeni eller funktionelle trombocytaggregation defekter
• Thrombocytopenia or functional platelet defects
Kateterablation for atrieflimren (SPAF)
Catheter ablation for atrial fibrillation (SPAF)
En øget risiko blev observeret hos ældre (≥ 75 år) for dosisprogrammet med 150 mg to gange dagligt.
An increased risk was seen in the elderly (≥ 75 years) for the 150 mg twice daily dose regimen.
• Følg altid lægens anvisning, når du tager Pradaxa ®.
• Follow your doctor's instructions when taking Pradaxa ®.
LMWH Samtidig anvendelse af LMWH (såsom enoxaparin) og dabigatran er ikke specifikt blevet undersøgt.
LMWH The concomitant use of LMWHs, such as enoxaparin and dabigatran etexilate has not been specifically investigated.
Den kalibrerede kvantitative fortyndede TT- (dTT-) test giver en estimeret dabigatranplasmakoncentration, der kan sammenlignes med de forventede dabigatran-plasmakoncentrationer.
The calibrated quantitative diluted TT (dTT) test provides an estimation of dabigatran plasma concentration that can be compared to the expected dabigatran plasma concentrations.
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.
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).
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.
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.
Der bør udvises forsigtighed, når behandlingen midlertidigt afbrydes pga. interventioner, og graden af antikoagulation bør overvåges.
Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted.
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.
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.
I RE-MODEL (knæalloplastik) var behandlingstiden 6-10 dage og i RE-NOVATE (hoftealloplastik) 28-35 dage.
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.
Pædiatrisk population (DVT/LE)
Paediatric population (DVT/PE)
® udskilles primært via nyrerne, og en tilstrækkelig diurese skal opretholdes.
® is mainly eliminated by the kidneys; adequate diuresis must be maintained.
Alle GI-blødninger *HR er ikke mulig at beregne, da der ikke forekom nogen hændelse i denne kohort/behandling
Any GI bleeds *HR not estimable as there is no event in either one cohort/treatment
Patientkort i pakningen.
Patient alert card inside.
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c.
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.
Interaktioner knyttet til dabigatranetexilats og dabigatrans metaboliske profil
Interactions linked to dabigatran etexilate and dabigatran metabolic profile
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.
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).
Den tilsigtede behandling var 6 måneders dabigatranetexilat 150 mg 2 gange dagligt uden behov for monitorering.
The intended therapy was 6 months dabigatran etexilate 150 mg twice daily without need for monitoring.
• Hvis du falder/kommer til skade, især hvis du slår hovedet, skal du søge akut lægehjælp.
• If you fall or injure yourself, especially if you hit your head, urgently seek medical advice.
• Øsofagitis, gastritis eller gastroøsofageal refluks
• Esophagitis, gastritis or gastroesophageal reflux
Din læge har ordineret behandling med Pradaxa
Your doctor has initiated treatment with Pradaxa
Patientkortet indeholder vigtige informationer, og du skal derfor altid have kortet på dig for at informere sundhedspersonale om din behandling med Pradaxa
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
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.
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.
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.
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.
Med en forbedret overvågning af INR vil de observerede fordele ved dabigatranetexilat aftage i forhold til warfarin.
With improving monitoring of INR the observed benefits of dabigatran etexilate compared to warfarin diminish.
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.
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.
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.
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.
Man så ingen ændring i dabigatran-eksponering hos 12 patienter med moderat nedsat leverfunktion (Child Pugh B) sammenlignet med 12 kontrolpersoner (se pkt.
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).
Dabigatran konjugeres under dannelse af farmakologisk aktive acylglucuronider.
Dabigatran is subject to conjugation forming pharmacologically active acylglucuronides.
Blødningskomplikationer kan vise sig som svaghed, bleghed, svimmelhed, hovedpine eller uforklarlig hævelse, dyspnø og uforklarligt shock.
Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Forhøjet alanin-aminotransferase
Alanine aminotransferase increased
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).
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).
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).
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.
5.897 patienter blev inkluderet, svarende til 49 % af de dabigatranbehandlede patienter i RE-LY og til 86 % af de RELY-ABLE-inkluderbare patienter.
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.
Forebyggelse af, at blodpropper dannes efter knæ- eller hofteoperation Fortsæt næste dag med den daglige dosis Pradaxa på samme tid, som du plejer.
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.
Hos denne lille gruppe af unge var dabigatranetexilatkapsler tilsyneladende tolereret, idet kun 2 patienter rapporterede tre lette og kortvarige gastrointestinale bivirkninger.
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.
Behandlingen med Pradaxa bør starte 1-4 timer efter operationen med 1 kapsel.
You should start treatment with Pradaxa within 1-4 hours after surgery finishes, taking a single capsule.
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.
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.
Dette kan forklares ved, at absorptionen af dabigatran sker inden for 2 timer.
This is explained by completed dabigatran absorption after 2 hours.
Pradaxa dabigatranetexilat
Pradaxa dabigatran etexilate
RELY-ABLE (langtids-multicenterstudie med fortsat dabigatranbehandling for patienter med atrieflimren, som havde fuldført RE-LY-studiet)
RELY-ABLE (Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial)
Du må ikke amme, mens du tager Pradaxa.
You should not breast-feed while you are taking Pradaxa.
Fjern bagsidefolien og tag kapslen ud.
Peel off the backing foil and remove the capsule.