natgillin/translations-raw huggingface dataset:
Kvinder bør undgå at blive gravide, mens de er i behandling med dabigatran- etexilat.
Women of child-bearing potential should avoid pregnancy during treatment with dabigatran etexilate.
Der findes ingen kliniske data for effekten af Pradaxa på nyfødte, der ammes.
There are no clinical data of the effect of dabigatran on infants during breast feeding.
Amningen skal indstilles, mens der behandles med Pradaxa.
Lactation should be discontinued during treatment with Pradaxa.
I alt 10. 084 patienter blev behandlet med mindst en dosis lægemiddel i 4 aktivt- kontrollerede forsøg med henblik på forebyggelse af VTE.
A total of 10.084 patients were treated in 4 actively controlled VTE prevention trials with at least one dose of the medicinal product.
Af disse blev 5. 419 behandlet med 150 mg eller 220 mg Pradaxa om dagen, mens 389 fik doser, der var mindre end 150 mg dagligt, og 1. 168 fik doser, der var større end 220 mg dagligt.
Of these 5419 were treated with 150 mg or 220 mg daily of Pradaxa, while 389 received doses less than 150 mg daily and 1168 received doses in excess of 220 mg daily.
Hyppigheden af alvorlige blødninger (inklusive blødninger fra sår) er mindre end 2%.
The most commonly reported adverse reactions are bleedings occurring in total in approximately 14% of patients; the frequency of major bleeds (including wound site bleedings) is less than 2%.
Opdelingen er efter dosering.
6 The table 1 shows the number (%) of patients experiencing bleeding events during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.
Blødningstilfælde opdelt i alvorlige og alle blødninger i de registreringsrelevante hofte - og knæ forsøg.
Table 1 Bleeding events broken down to major and any bleeding in the pivotal hip and knee study
Dabigatran- etexilat, Dabigatran- etexilat, Enoxaparin 150 mg 220 mg N (%) N (%) N (%)
Dabigatran etexilate 150 mg
Behandlede
Enoxaparin
patienter 1866 (100, 0) 1825 (100, 0) 1848 (100, 0)
N (%)
Alvorlige blødninger
Treated Major Bleeding Any bleeding
24 (1, 3)
1866(100.0) 24 (1.3) 258(13.8)
33 (1, 8)
1825(100.0) 33 (1.8) 251(13.8)
27 (1, 5)
1848(100.0) 27 (1.5) 247(13.4)
Meget almindelig (≥1/ 10); almindelig (≥1/ 100 til, < 1/ 10); ikke almindelig (≥1/ 1. 000til, < 1/ 100); sjælden (≥1/ 10. 000 til, < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
Table 2 shows the adverse reactions ranked under headings of SOC and frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Systemorganklasse / Standardbetegnelse
SOC / Preferred Term.
Dabigatran- etexilat Dabigatran- etexilat 150 mg 220 mg N (%) N (%)
Dabigatran etexilate 150 mg
Enoxaparin N (%)
Enoxaparin
Behandlede patienter Blod og lymfesystem
Number of patients treated
2737 (100) 2682 (100)
2682(100)
Almindelig
Blood and lymphatic system disorders Common
Thrombocytopeni
Thrombocytopenia
Hæmatom Traumatisk hæmatom Sårblødning
Haematoma Traumatic haematoma Wound haemorhhage
Luftveje, thorax og mediastinum Ikke almindelig
Respiratory and thoracic system disorders Uncommon
Mave- tarmkanalen Almindelig
Gastrointestinal disorders Common
7 Systemorganklasse / Standardbetegnelse
Gastrointestinal haemorrhage
Enoxaparin N (%)
33 (1.2)
33 (1, 2) 17 (0, 6)
17 (0.6)
12 (0, 4)
12 (0.4)
5 (0, 6) 5
5 (0.6) 5
4 (0, 2)
4 (0.
8 (0, 3)
2)
2) 8 (0, 3) 2
8 (0.3) 2
(0, 1)
(0.1)
Lever og galdeveje Ikke almindelig
Hepatobiliary disorders Uncommon
Forhøjet alanin - aminotransferase
Alaninine aminotransferase increased
Forhøjet aspartat - aminotransferase
Aspartate aminotransferase increased
(0, 3)
(0.2)
5
Hepatic function abnormal/ Liver function Test
15 (0, 5)
10 (0.4)
10 (0, 4)
N (%)
7
N (%)
Forhøjede leverenzymer Hyperbilirubinæmi Forhøjede transaminaser
Hepatic enzyme increased Hyperbilirubinaemia Transaminases increased
4 4 0
4 (0.2) 4 (0.1) 0 (0.0)
(0, 2) (0, 1) (0, 1)
5 (0.2) 3 (0.1) 2 (0.1)
11 (0, 4) 4 (0, 1) 1 (0, 0)
11 (0.4) 4 (0.1) 1 (0.0)
Hud og subkutant væv Almindelig
Skin and subcutaneous tissue disorder Common
Knogler, led, muskler og bindevæv Ikke almindelig
Musculoskeletal and connective tissue and bone disorders Uncommon
7 (
7 (
Blødning ved injektions - stedet
Injection site haemorrhage Bloody discharge Catheter site haemorrhage
Sårsekret Postoperativ anæmi Hæmatom efter procedure Blødning efter procedure Sekretion efter procedure
Wound secretion Anaemia postoperative Post procedural haematoma Post procedural haemorrhage
130 87 45 54 34
130 87 45 54
(4, 9) (3, 2) (1, 7) (2, 0) (1, 3)
(4.9) (3.2) (1.7) (2.0)
93 120 78 56 31
93 120 78 56
(3, 0) (3, 7) (2, 5) (1, 8) (1, 0)
(3.0) (3.7) (2.5) (1.8)
Kirurgiske og medicinske procedurer Ikke almindelig
Surgical and medial procedures Uncommon
Drænage efter procedure Sårdrænage
Post procedural drainage Wound drainage
8 Ud over de rapporterede ALAT- resultater er de laboratoriedata, som er fundet i fase 3- forsøgene præsenteret i Tabel 3.
Beyond the reported ALT findings the following laboratory chemistry data had been measured in phase 3 studies as presented in table 3.
ALAT- fund ved laboratoriemonitorering i Fase 3- forsøgene
ALT findings the following laboratory chemistry
Dabigatran- etexilat Dabigatran- etexilat 150 mg 220 mg
Dabigatran etexilate 150 mg
N (%) N (%)
N (%)
Totalt antal patienter med alanin- aminotransferase forhøjet til 3 x øvre normalgrænse
Total rates of Alaninine aminotransferase increased 3 x ULN
68 (2, 5) 58 (2, 2)
58 (2.2)
Der findes ingen antidot mod dabigatran.
There is no antidote to dabigatran.
Doser af dabigatran- etexilat ud over det anbefalede udsætter patienten for forøget blødningsrisiko.
Doses of dabigatran etexilate beyond those recommended, expose the patient to increased risk of bleeding.
I tilfælde af blødningskomplikationer skal behandlingen standses og kilden til blødningen findes.
In the event of haemorrhagic complications, treatment must be discontinued and the source of bleeding investigated.
Da dabigatran hovedsagelig udskilles via nyrerne, skal der opretholdes en tilstrækkelig diurese.
Since dabigatran is excreted predominantly by the renal route adequate diuresis must be maintained.
Der bør overvejes påbegyndelse af passende behandling, fx kirurgisk hæmostase eller transfusion af friskfrosset plasma.
The initiation of appropriate treatment, e. g. surgical haemostasis or the transfusion of fresh frozen plasma should be considered.
Dabigatran kan fjernes ved dialyse, men der forligger ingen klinisk erfaring fra de kliniske forsøg, der kan demonstrere nytten heraf.
Dabigatran can be dialysed; there is no clinical experience to demonstrate the utility of this approach in clinical studies.
Farmakoterapeutisk klassifikation: direkte trombin- hæmmere, ATC- kode:
Pharmacotherapeutic group: direct thrombine inhibitors, ATC code:
Dabigatran- etexilat 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.
Efter peroral indgift absorberes dabigatran- etexilat hurtigt og omdannes til dabigatran via esterasekatalyseret hy - drolyse i plasma og i leveren.
After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase- catalysed hydrolysis in plasma and in the liver.
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.
Dabigatran hæmmer også frit trombin, fibrinbundet trombin og trombininduceret trombocytaggregation.
Dabigatran also inhibits free thrombin, fibrin- bound thrombin and thrombin-induced platelet aggregation.
In vivo - og ex vivo- dyreforsøg i forskellige trombose- dyremodeller har vist, at dabigatran efter intravenøs administration har antitrombotisk effekt og antikoagulerende aktivitet, og det samme er påvist for dabigatran- etexilat efter peroral indgift.
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.
Man har i fase II- undersøgelser fundet en klar korrelation mellem dabigatran- koncentrationen i plasma og graden af antikoagulerende effekt.
There is a clear correlation between plasma dabigatran concentration and degree of anticoagulant effect based on phase II studies.
270 ng/ ml, med et forventet interval på 80 – 460 ng/ ml.
Steady state (after day 3) dabigatran peak plasma concentration, measured 2 - 4 hours after 220 mg dabigatran etexilate administration, is expected to be around 270 ng/ ml, with an expected range of 80 - 460 ng/ ml.
40 ng/ ml, med et forventet interval på 10 - 90 ng/ ml.
The dabigatran trough concentration, measured at the end of the dosing interval (24 hours after the last 220 mg dabigatran dose), is expected to be around 40 ng/ ml, with expected range of 10-90 ng/ ml.
Ethnicitet
Ethnic origin:
Mere end 99% af de indsamlede data stammer fra kaukasiere.
More than 99% of efficacy and safety data were generated in Caucasians.
9 Kliniske forsøg med forebyggelse af VTE ved større led- alloplastikoperationer:
Clinical trials in Venous Thromboembolism (VTE) prophylaxis following major joint replacement surgery:
Enoxaparin blev givet i en dosis på 40 mg dagen før operationen og dagligt derefter.
In 2 large randomized, parallel group, double-blind, dose– confirmatory trials, patients undergoing elective major orthopaedic surgery (one for knee replacement surgery and one for hip replacement surgery) received Pradaxa 75 mg or 110 mg within 1-4 hours of surgery followed by 150 mg or 220 mg daily thereafter, haemostasis having been secured, or enoxaparin 40 mg on the day prior to surgery and daily thereafter.
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.
I alt blev 2. 076 patienter (knæ) og 3. 494 (hofte) behandlet.
Totals of 2076 patients (knee) and 3494 (hip) were treated respectively.
Det primære endepunkt for begge forsøg var den samlede forekomst af VTE (inklusive lungeemboli, proksimal og distal DVT, hvad enten VTE var symptomatisk eller asymptomatisk (påvist ved rutine - flebografi) samt alle dødsfald uanset årsag.
Composite of total VTE (including PE, proximal and distal DVT, whatever symptomatic or asymptomatic detected by routine venography) and all-cause mortality constituted the primary end-point for both studies.
Et sekundært endepunkt, som betragtes med større klinisk relevans, var kombinationen af alvorlig VTE (inklusive lungeemboli og proksimal DVT påvist ved rutine - flebograf, hvad enten VTE var symptomatisk eller asymptomatisk) og VTE- relateret død.
9 Composite of major VTE (including PE and proximal DVT, whatever symptomatic or asymptomatic detected by routine venography) and VTE-related mortality constituted a secondary end-point and is considered of better clinical relevance.
Resultaterne fra begge forsøg 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.
Ved 150 mg dabigatran var den procentuelle forekomst af alvorlige Ved 150 mg dabigatran var punktestimatet for alvorlig VTE og VTE- relateret død en anelse ringere end for enoxaparin (tabel 4).
The point estimate for incidence of Major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 4).
Ved en dosis på 220 mg dabigatran var punktestimatet for alvorlige VTE og VTE- relateret død en anelse bedre end for enoxaparin (tabel 4).
Better results were seen with the 220mg dose where the point estimate of Major VTE was slightly better than enoxaparin (table 4). "
I de kliniske forsøg havde patientpopulationen en gennemsnitsalder på > 65 år.
The clinical studies have been conducted in a patient population with a mean age > 65 years.
Der var ingen forskelle mellem mænd og kvinder i de kliniske fase 3- forsøg med hensyn til effekt og sikkerhed.
There were no differences in the phase 3 clinical studies for efficacy and safety data between men and women.
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 (5539 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.
Dette fremgår af tabel 4.
Data for the major VTE and VTE-related mortality endpoint were homogeneous with regards to the primary efficacy endpoint and are shown in table 4.
De data, der vedrører endepunktet for kombinationen af VTE og mortalitet uanset årsag, fremgår af tabel 5.
Data for the total VTE and all cause mortality endpoint are shown in table 5.
De data, der vedrører endepunktet blødninger, og som er vurderet til at være alvorlige, fremgår af tabel 6.
Data for adjudicated major bleeding endpoints are shown in tables 6 below.
Analyse af alvorlig VTE og VTE- relateret mortalitet i behandlingsperioden i de ortopædkirurgiske forsøg RE- MODEL og RE- NOVATE Forsøg RE- NOVATE (hofte)
Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopeadic surgery studies
Dabigatran- etexilat Dabigatran- etexilat 220 mg 150 mg
Dabigatran 150 mg
N Forekomst (%) Risiko ratio
Incidences (%) Risk ratio over
909 888 28 (3, 1) 38 (4, 3)
38 (4.3)
sammenlignet med enoxaparin
enoxaparin
0, 78 1, 09
1.09
95% konfidensinterval RE- MODEL (knæ)
95% CI RE-MODEL (knee)
0, 48, 1, 27 0, 70, 1, 70
0.70, 1.70
N Forekomst (%) Risiko ratio sammenlignet med
Incidences (%) Risk ratio over
506 527 13 (2, 6) 20 (3, 8) 0, 73 1, 08
20 (3.8)
511 18 (3, 5)
18 (3.5)
10 enoxaparin 95% konfidensinterval
95% CI
0, 36, 1, 47
0.36, 1.47
0, 58, 2, 01
0.58, 2.01
11 Tabel 5:
10 Table 5:
Analyse af total VTE og dødsfald uanset årsag under behandlingsperioden i de ortopædkirurgiske forsøg RE- MODEL og RE- NOVATE Forsøg RE- NOVATE (hofte)
Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies
Dabigatran- etexilat Dabigatran- etexilat 220 mg 150 mg
Dabigatran etexilate 150 mg
N Forekomst (%) Risiko sammenlignet enoxaparin
Incidences (%) Risk ratio over enoxaparin
ratio med
53 (6.0) 0.9
(0, 63, 1, 29)
(0.63, 1.29)
(0, 93, 1, 78)
(0.93, 1.78)
Forekomst (%) Risiko sammenlignet enoxaparin
Incidences (%) Risk ratio over enoxaparin
183 (36, 4) 0, 97
183 (36.4) 0.97
213 (40, 5) 1, 07
213 (40.5) 1.07
(0, 82, 1, 13)
(0.82, 1.13)
(0, 92, 1, 25)
(0.92, 1.25)
Alvorlige blødningstilfælde set i de enkelte RE- MODEL - og RE- NOVATE- forsøg Forsøg RE- NOVATE (hofte)
Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies
Behandlede patienter, N Antal alvorlige
Treated patients N Number of MBE N(%) RE-MODEL (knee)
1146 1163
1163 15 (1.3)
blødningstilfælde N (%) RE- MODEL (knæ)
Treated patients N Number of MBE N(%)
23 (2, 0) 15 (1, 3)
679 10 (1.5)
679 703
703 9 (1.3)
Efter peroral administration omdannes dabigatran- etexilat hurtigt og fuldstændigt til den i plasma aktive form dabigatran.
After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma.
Den væsentligste metaboliske reaktion er en esterasekatalyseret hydrolyseret spaltning af prodruget dabigatran- etexilat til det aktive molekyle dabigatran.
The cleavage of the prodrug dabigatran etexilate by esterase-catalysed hydrolysis to the active principle dabigatran is the predominant metabolic reaction.
6, 5%.
The absolute bioavailability of dabigatran following oral administration of Pradaxa was approximately 6.5%.
Efter peroral administration af Pradaxa til raske frivillige ses en hurtig stigning i plasmakoncentrationen og Cmax opnås i løbet af 0, 5- 2, 0 timer efter administration.
After oral administration of Pradaxa in healthy volunteers, the pharmacokinetic profile of dabigatran in plasma is characterized by a rapid increase in plasma concentrations with Cmax attained within 0.5 and 2.0 hours post administration.
Forsøget viste en jævn plasmakoncentrationstids- kurve uden store stigninger i den maksimale plasmakoncentration.
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.
Cmax blev opnået 6 timer efter administration i den postoperative fase pga. faktorer som fx anæstesi, gastrointestinal parese og kirurgiske eftervirkninger, uafhængigt af den perorale lægemiddelformulering.
Peak plasma concentrations are reached at 6 hours following administration in a postoperative period due to contributing factors such as anesthesia, gastrointestinal paresis, and surgical effects independent of the oral medicinal product formulation.
Et andet forsøg viste, at langsom og forsinket absorption normalt kun ses på operationsdagen.
It was demonstrated in a further study that slow and delayed absorption is usually only present on the day of surgery.
Mad påvirker ikke biotilgængeligheden af dabigatran- etexilat, men forsinker tiden til maksimum - koncentration i plasma med 2 timer.
Food does not affect the bioavailability of dabigatran etexilate but delays the time to peak plasma concentrations by 2 hours.
12 Distribution:
11 Distribution:
Der fandtes en lav (34- 35%) koncentrationsuafhængig proteinbinding af dabigatran i plasma.
Low (34-35%) concentration independent binding of dabigatran to human plasma proteins was observed.
Distributionsvolumen for dabigatran var 60- 70 l, hvilket overstiger mængden af den samlede kropsvæske og antyder en moderat vævsdistribution af dabigatran.
The volume of distribution of dabigtran of 60 – 70 L exceeded the volume of total body water indicating moderate tissue distribution of dabigatran.
Plasmakoncentration for dabigatran viste en bieksponentiel nedbrydning med en middel halveringstid på 12- 14 timer hos raske frivillige og 14- 17 timer hos patienter efter en større ortopædkirurgisk operation.
Plasma concentrations of dabigatran showed a biexponential decline with a mean terminal half-life of 12 - 14 hours in healthy volunteers and 14 – 17 hours in patients undergoing major orthopaedic surgery.
Metabolisering og elimination af dabigatran blev undersøgt hos raske, mandlige forsøgspersoner efter en enkelt intravenøs dosis radioaktivt mærket dabigatran.
Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects.
Efter en intravenøs dosis blev radioaktiviteten stammende fra dabigatran primært udskilt med urinen (85%).
After an intravenous dose, the dabigatran-derived radioactivity was eliminated primarily in the urine (85%).
6% af den administrerede dosis.
Faecal excretion accounted for 6% of the administered dose.
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.
Der findes fire positionelle isomerer, 1- O, 2- O, 3- O og 4- O- acylglucuronid, som hver tegner sig for mindre end 10% af den samlede dabigatran i plasma.
Four positional isomers, 1-O, 2-O, 3-O, 4-O-acylglucuronide exist, each accounts for less than 10% of total dabigatran in plasma.
100 ml/ min, svarende til den glomerulære filtrationshastighed.
Dabigatran is eliminated primarily in the unchanged form in the urine, at a rate of approximately 100 ml/ min corresponding to the glomerular filtration rate.
2, 7 gange højere hos frivillige, med moderat nyreinsufficiens (CrCL mellem 30- 50 ml/ min) end hos dem uden nyreinsufficiens.
The exposure (AUC) of dabigatran after the oral administration of Pradaxa is approximately 2.7 fold higher in volunteers with moderate renal insufficiency (CrCL between 30 – 50 ml/ min) than in those without renal insufficiency.
4. 2, 4. 3 og 4. 4).
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).
Specifikke farmakokinetiske forsøg med ældre forsøgspersoner viste en stigning i AUC på 40- 60% og på mere end 25% i Cmax, sammenlignet med unge forsøgspersoner.
Specific pharmacokinetic 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.
Populationsbaserede farmakokinetiske forsøg har vurderet dabigatrans farmakokinetik efter gentagne doser til patienter (op til 88 år).
Population-based pharmacokinetic studies have evaluated the pharmacokinetics of dabigatran after repeated doses in patients (up to 88 years).
4. 2 og 4. 4).
The observed increase of dabigatran exposure correlated with the age-related reduction in creatinine clearance (see sections 4.2 and 4.4).
4. 2 og 4. 4).
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).
Vægt:
Body weight:
Dabigatrans farmakokinetik er blevet undersøgt i farmakokinetiske forsøg på forskellige populationer - hos patienter, der vejer mellem 48 og 120 kg.
Population pharmacokinetic studies have evaluated the pharmacokinetics of dabigatran in patients of 48 to 120 kg body weight.
4. 2 og 4. 4).
Body weight had a minor effect on the plasma clearance of dabigatran resulting in higher exposure in patients with low body weight (see section 4.2 and 4.4).
40- 50% højere end hos mandlige patienter, og der anbefales ingen dosisjustering.
Active substance exposure in female patients is about 40% to 50% higher than in male patients and no dose adjustment is recommended.
13 Etnisk oprindelse:
12 Ethnic origin:
Farmakokinetiske undersøgelser er blevet foretaget på kaukasiske og japanske frivillige forsøgspersoner efter indgift af en enkelt og af flere doser.
The pharmacokinetics of dabigatran was investigated in Caucasian and Japanese volunteers after single and multiple doses.
Etnisk oprindelse påvirker ikke dabigatrans farmakokinetik.
Ethnic origin does not affect the pharmacokinetics of dabigatran in a clinically relevant manner.
Der foreligger ingen farmakokinetiske data for sorte personer.
No pharmacokinetic data in black patients are available.
Farmakokinetiske interaktioner:
Pharmacokinetic interactions:
In vitro- interaktionsforsøg viste ingen hæmning eller induktion af de vigtigste isoenzymer af cytokrom P450.
In vitro interaction studies did not show any inhibition or induction of the principal isoenzymes of cytochrome P450.
Dette er bekræftet i in vivo- forsøg med raske frivillige, som ikke viste interaktion mellem dabigatran og følgende aktive stoffer: atorvastatin (CYP3A4), digoxin (P- glykoprotein- transporterinteraktion) og diclofenac (CYP2C9).
This has been confirmed by in vivo studies with healthy volunteers, who did not show any interaction between this treatment and the following active substances: atorvastatin (CYP3A4), digoxin (P- glycoprotein transporter interaction) and diclofenac (CYP2C9).
Dabigatran- eksponeringen hos raske frivillige steg med 60% ved tilstedeværelse af amiodaron.
Dabigatran exposure in healthy subjects was increased by 60% in the presence of amiodarone.