FrancophonIA/ELRC3.0 huggingface dataset:
English: In such cases a coagulation test (see sections 4.4 and 5.1) may help to determine whether haemostasis is still impaired.
Danish: 4.4 og 5.1) kan hjælpe med at afgøre, om hæmostasen stadig er nedsat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én hård kapsel indeholder 110 mg dabigatranetexilat (som mesilat).
English: Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
Danish: Én hård kapsel indeholder 150 mg dabigatranetexilat (som mesilat).
English: - Reflux of gastric juice into the gullet - Vomiting - Difficulty in swallowing - Unusual laboratory test results on liver function
Danish: - tarmlyde - betændelse i spiserør og mave - sure opstød - opkastning - besvær med at synke - unormale prøveresultater for leverfunktionen.
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 150 mg hard capsules dabigatran etexilate
Danish: LÆGEMIDLETS NAVN Pradaxa 150 mg hårde kapsler dabigatranetexilat
English: MINIMUM PARTICULARS TO APPEAR ON WHITE BLISTERS OR STRIPS BLISTER FOR 75 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ HVID BLISTER ELLER STRIP BLISTER TIL 75 mg
English: Age ≥ 75 years
Danish: Patienter på 75 år eller derover
English: PHARMACEUTICAL FORM AND CONTENTS 60x1 hard capsules.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 60 x 1 hårde kapsler.
English: Dabigatran plasma concentrations observed at 72 hrs were relatively low, between 32.9 ng/mL and 97.2 ng/mL at final doses between 100 mg and 150 mg (gMean dose normalized total dabigatran plasma concentration of 0.493 ng/mL/mg).
Danish: Plasmakoncentrationen af dabigatran ved slut doser på mellem 100 mg og 150 mg (gennemsnitsdosis normaliseret ved total dabigatranplasmakoncentration på 0,493 ng/ml/mg), observeret efter 72 timer, var relativt lave, mellem 32,9 ng/ml og 97,2 ng/ml.
English: Steady state (after day 3) geometric mean dabigatran peak plasma concentration, measured around 2 hours after 220 mg dabigatran etexilate administration, was 70.8 ng/mL, with a range of 35.2-162 ng/mL (25
Danish: Steady-state (efter dag 3) angivet som en geometrisk gennemsnitsværdi af peakplasmakoncentrationen målt ca. 2 timer efter indtagelse af 220 mg dabigatranetexilat var 70,8 ng/ml, med et interval på 35,2-162 ng/ml (25.-75. percentil).
English: • Patients with severe renal impairment (CrCL < 30 mL/min)
Danish: • Svært nedsat nyrefunktion (CrCL < 30 ml/min)
English: under the skin, into a joint, from or after an injury or after an operation - Haematoma formation or bruising occurring after an operation - Blood detected in the stools by a laboratory test - A fall in the number of red cells in the blood - A decrease in the proportion of red cells in the blood - Allergic reaction - Vomiting - Frequent loose or liquid bowel movements - Feeling sick - Wound secretion (liquid exuding from the surgical wound) - Liver enzymes increased - Yellowing of the skin or whites of the eyes, caused by liver or blood problems
Danish: fra eller efter et uheld, eller efter en operation - blodudtrækninger eller blå mærker efter operation - blod i afføringen fundet ved laboratorieanalyse - nedsat antal røde blodlegemer - allergisk reaktion - opkastning - hyppig løs eller vandtynd afføring - utilpashed - sårsekret (udsivning af væske fra operationssåret).
English: The dabigatran geometric mean trough concentration, measured at trough in the morning, at the end of the dosing interval (i.e. 12 hours after the 150 mg dabigatran evening dose), was on average 91.0 ng/mL, with a range of 61.0-143 ng/mL (25
Danish: Dabigatrans geometriske gennemsnits trough-koncentration, målt om morgenen ved slutningen af et doseringsinterval (dvs. 12 timer efter aftendosen på 150 mg dabigatran), var i gennemsnit 91,0 ng/ml, med et interval på 61,0143 ng/ml (25.-75. percentil).
English: The Boehringer Ingelheim logo is printed on the cap and “R150” on the body of the capsule.
Danish: Boehringer Ingelheims logo er trykt på hætten, og ”R150” på bunden af kapslen.
English: Table 2: Factors which may increase the haemorrhagic risk.
Danish: Tabel 2: Faktorer, der kan øge blødningsrisikoen.
English: A phase II study examined dabigatran etexilate and warfarin in a total of 252 patients with recent mechanical valve replacement surgery (i.e. within the current hospital stay) and in patients who received a mechanical heart valve replacement more than three months ago.
Danish: Et fase II-studie undersøgte dabigatranetexilat og warfarin hos i alt 252 patienter, som enten:
English: In patients with moderate renal impairment (CrCL 30-50 mL/min), a dose reduction is recommended (see table 1 above and sections 4.4 and 5.1).
Danish: Der anbefales en dosisreduktion hos patienter med moderat nedsat nyrefunktion (CrCL 30-50 ml/min) (se tabel 1 ovenfor og pkt.
English: Table 4: Factors which may increase the haemorrhagic risk.
Danish: Tabel 4: Faktorer, der kan øge blødningsrisikoen.
English: The Boehringer Ingelheim logo is printed on the cap and “R75” on the body of the capsule.
Danish: Boehringer Ingelheims logo er trykt på toppen og ”R75” på bunden af kapslen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én hård kapsel indeholder 150 mg dabigatranetexilat (som mesilat).
English: Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
Danish: Én hård kapsel indeholder 110 mg dabigatranetexilat (som mesilat).
English: Table 19: Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies.
Danish: Tabel 19: Alvorlige blødningstilfælde set i henholdsvis RE-MODEL- og RE-NOVATE-studierne
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Danish: Luftveje, thorax og mediastinum Næseblod
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
Danish: Behandling af dyb venetrombose (DVT) og lungeemboli (LE) samt forebyggelse af recidiverende DVT og LE hos voksne.
English: What you need to know before you take Pradaxa 3.
Danish: Det skal du vide, før du begynder at tage Pradaxa Sådan skal du tage Pradaxa Bivirkninger
English: The point estimate for incidence of Major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 17).
Danish: 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 17).
English: - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - Difficulty in swallowing - A decrease in the proportion of red cells in the blood
Danish: - alvorlig allergisk reaktion, som medfører hævelser i ansigtet eller svælget - udslæt fremtrædende som mørkerøde, hævede, kløende buler forårsaget af en allergisk reaktion - besvær med at synke - nedsat antal røde blodlegemer.
English: - The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, and hypromellose.
Danish: - Selve kapslen består af carrageenan, kaliumchlorid, titandioxid (E171), indigocarmin (E132) og hypromellose (HPMC-kapselskal).
English: Table 22: Analysis of all cause and cardiovascular survival during the study period in RE-LY. Pradaxa 110 mg twice daily
Danish: Tabel 13: Blødninger forekommet under behandling af DVT og LE i studiet RE-MEDY Pradaxa 150 mg 2 gange dagligt
English: - Blood-stained discharge from the site of entry of a catheter into a vein - Coughing of blood or blood stained sputum - A fall in the number of platelets in the blood - A fall in the number of red cells in the blood after an operation - Serious allergic reaction which causes difficulty in breathing or dizziness - Serious allergic reaction which causes swelling of the face or throat - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel (incl.
Danish: hvor et kateter går ind i venen - blodigt udflåd fra det sted, hvor et kateter går ind i en vene - ophostning af blod eller blodigt spyt - nedsat antal blodplader - nedsat antal røde blodlegemer efter en operation - alvorlig allergisk reaktion, som medfører vejrtrækningsbesvær eller svimmelhed - alvorlig allergisk reaktion, som medfører hævelser i ansigtet eller svælget - udslæt fremtrædende som mørkerøde, hævede, kløende buler forårsaget af en allergisk reaktion - pludselig ændring af hudens farve og udseende - kløe - mavesår eller sår i tarmen (inkl.
English: Table 24: Hazard Ratio and 95 % CI for major bleeds by subgroups Endpoint
Danish: Tabel 24: Hazard ratio og 95 % CI for alvorlige blødninger i delpopulationer
English: The point estimate for incidence of major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 10).
Danish: 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 10).
English: Better results were seen with the 220 mg dose where the point estimate of Major VTE was slightly better than enoxaparin (table 17).
Danish: Ved en dosis på 220 mg dabigatran var punktestimatet for alvorlige VTE og VTE-relateret død en anelse bedre end for enoxaparin (tabel 17).
English: - The capsule shell contains carrageenan, potassium chloride, titanium dioxide, and hypromellose.
Danish: Selve kapslen består af carrageenan, kaliumchlorid, titandioxid (E171) og hypromellose (HPMC-kapselskal).
English: Table 11: Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation
Danish: Tabel 11 Blødningsrelaterede hændelser fra et studie, der undersøgte forebyggelse af tromboembolisk apopleksi og systemisk emboli hos patienter med atrieflimren.
English: Table 5 summarises discontinuation rules before invasive or surgical procedures.
Danish: Tabel 5 opsummerer seponeringsreglerne før invasive/kirurgiske procedurer.
English: Table 19: Hazard Ratio and 95 % CI for major bleeds by subgroups Endpoint
Danish: Tabel 19: Hazard ratio og 95 % CI for alvorlige blødninger i delpopulationer
English: Given the available clinical and kinetic data no adjustment is necessary (see section 5.2), but close clinical surveillance is recommended (see section 4.4).
Danish: 5.2), men tæt klinisk overvågning anbefales (se pkt.
English: EU/1/08/442/009 10 x 1 capsules EU/1/08/442/01030 x 1 capsules EU/1/08/442/011 60 x 1 capsules EU/1/08/442/019 60 x 1 capsules
Danish: EU/1/08/442/009 10 x 1 kapsler EU/1/08/442/010 30 x 1 kapsler EU/1/08/442/011 60 x 1 kapsler EU/1/08/442/019 60 x 1 kapsler
English: The recommended doses of Pradaxa in the indications SPAF, DVT and PE are shown in table 1.
Danish: De anbefalede doser af Pradaxa for indikationerne SPAF, DVT og LE vises i tabel 1.
English: the increase of dabigatran exposure is 1.56-fold and 1.46fold for Cmax and AUC, respectively.
Danish: Efter multiple doser af 90 mg ticagrelor 2 gange dagligt blev eksponeringen for dabigatran øget 1,56 og 1,46 gange for hhv. Cmax og AUC.
English: RE-MODEL (knee)
Danish: 95 % konfidensinterval RE-MODEL (knæ)
English: th th percentile range).The dabigatran geometric mean trough concentration, measured at the end of the dosing interval (i.e. 24 hours after a 220 mg dabigatran dose), was on average 22.0 ng/mL, with a range of 13.0-35.7 ng/mL (25
Danish: Dabigatrans geometriske gennemsnits-trough koncentration, målt ved slutningen af et doseringsinterval (dvs. 24 timer efter en dosis på 220 mgdabigatran), var gennemsnitlig 22,0 ng/ml, med et interval på 13,0-35,7 ng/ml (25.-75. percentil) (se pkt.
English: ulcer in the gullet) - Inflammation of the gullet and stomach
Danish: sår i spiserøret) - betændelse i spiserør og mave - sure opstød
English: MINIMUM PARTICULARS TO APPEAR ON WHITE BLISTERS OR STRIPS BLISTER FOR 110 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ HVID BLISTER ELLER STRIP BLISTER TIL 110 mg
English: No dose adjustment is necessary for concomitant use of amiodarone or quinidine (see sections 4.4, 4.5 and 5.2).
Danish: Ingen dosisreduktion ved samtidig behandling med amiodaron eller kinidin (se pkt.
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (DVT/PE)
Danish: Behandling af dyb venetrombose (DVT) og lungeemboli (LE) samt forebyggelse af recidiverende DVT og LE hos voksne (DVT/LE)
English: - if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).
Danish: - hvis du er allergisk over for dabigatranetexilat eller et af de øvrige indholdsstoffer i Pradaxa (angivet i punkt 6) - hvis du har svært nedsat nyrefunktion - hvis du bløder - hvis du har en sygdom, i et af dine organer, som øger risikoen for alvorlig blødning (f.eks. mavesår, skade eller blødning i hjernen, en nylig operation i hjernen eller øjnene) - hvis du har øget tendens til at bløde.
English: The dabigatran trough concentrations were about 20 % lower in patients with a body weight > 100 kg compared with 50-100 kg.
Danish: For patienter, der vejer > 100 kg, var trough-koncentrationen 20 % lavere sammenlignet med patienter på 50-100 kg. For de fleste patienter (80,8 %), der vejede > 50-100 kg sås ingen forskellig indvirkning.
English: Rare (may affect up to 1 in 1,000 people): - Bleeding - Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection or from the site of entry of a catheter into a vein - Blood-stained discharge from the site of entry of a catheter into a vein - Coughing of blood or blood stained sputum - A fall in the number of platelets in the blood - A fall in the number of red cells in the blood after an operation - Serious allergic reaction which causes difficulty in breathing or dizziness - Serious allergic reaction which causes swelling of the face or throat - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel (incl.
Danish: Sjældne bivirkninger (kan forekomme hos højst 1 ud af 1.000): - blødning - blødning kan forekomme i hjernen, fra operationssnittet, fra et injektionsted eller fra det sted, hvor et kateter går ind i venen - blodigt udflåd fra det sted, hvor et kateter går ind i en vene - ophostning af blod eller blodigt spyt - nedsat antal blodplader - nedsat antal røde blodlegemer efter en operation - alvorlig allergisk reaktion, som medfører vejrtrækningsbesvær eller svimmelhed - alvorlig allergisk reaktion, som medfører hævelser i ansigtet eller svælget - udslæt fremtrædende som mørkerøde, hævede, kløende buler forårsaget af en allergisk reaktion - pludselig ændring af hudens farve og udseende - kløe - mavesår eller sår i tarmen (inkl.
English: EU/1/08/442/005 10 x 1 capsules EU/1/08/442/006 30 x 1 capsules EU/1/08/442/007 60 x 1 capsules EU/1/08/442/018 60 x 1 capsules
Danish: EU/1/08/442/005 10 x 1 kapsler EU/1/08/442/006 30 x 1 kapsler EU/1/08/442/007 60 x 1kapsler EU/1/08/442/018 60 x 1 kapsler
English: Better results were seen with the 220 mg dose where the point estimate of Major VTE was slightly better than enoxaparin (table 10).
Danish: Ved en dosis på 220 mg dabigatran var punktestimatet for alvorlige VTE og VTE-relateret død en anelse bedre end for enoxaparin (tabel 10).
English: Dose reduction recommended Patients with moderate renal impairment (creatinine clearance (CrCL) 30-50 mL/min)
Danish: Patienter med moderat nedsat nyrefunktion (kreatininclearance (CrCL 30-50 ml/min)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En hård kapsel indeholder 75 mg dabigatranetexilat (som mesilat).
English: Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value
Danish: Hazard ratio sammenlignet med. warfarin (95 % CI) p-værdi
English: EU/1/08/442/001 10 x 1 capsules EU/1/08/442/002 30 x 1 capsules EU/1/08/442/003 60 x 1 capsules EU/1/08/442/017 60 x 1 capsules
Danish: EU/1/08/442/001 10 x 1 kapsler EU/1/08/442/002 30 x 1 kapsler EU/1/08/442/003 60 x 1 kapsler EU/1/08/442/017 60 x 1 kapsler
English: Dosing should be reduced as indicated in table 1 (see also sections 4.4 and 4.5).
Danish: Dosis af Pradaxa skal reduceres som indikeret i tabel 1 (se også pkt.
English: Treatment with Pradaxa in patients with severe renal impairment (CrCL < 30 mL/min) is contraindicated (see section 4.3).
Danish: Pradaxa er kontraindiceret hos patienter med svært nedsat nyrefunktion (CrCL < 30 ml/min) (se pkt.
English: Table 2 summarises factors which may increase the haemorrhagic risk.
Danish: I tabel 2 er anført faktorer, der kan øge blødningsrisikoen.
English: Primary Prevention of Venous Thromboembolism in Orthopaedic Surgery Steady state (after day 3) geometric mean dabigatran peak plasma concentration, measured around 2 hours after 220 mg dabigatran etexilate administration, was 70.8 ng/mL, with a range of 35.2-162 ng/mL (25th-75th percentile range).The dabigatran geometric mean trough concentration, measured at the end of the dosing interval (i.e. 24 hours after a 220 mg dabigatran dose), was on average 22.0 ng/mL, with a range of 13.0-35.7 ng/mL (25th-75th percentile range).
Danish: Primær forebyggelse af venøs tromboemboli ved ortopædkirurgi Steady-state (efter dag 3), angivet som en geometrisk gennemsnitsværdi af peakplasmakoncentrationen målt ca. 2 timer efter indtagelse af 220 mg dabigatranetexilat, var 70,8 ng/ml med et interval på 35,2-162 ng/ml (25.-75. percentil).
English: Table 27: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-SONATE study.
Danish: Tabel 27: Analyse af de primære og sekundære virkningsendepunkter (VTE er summen af DVT og/eller LE) indtil afslutningen af post-behandlingsperioden for RE-SONATE studiet.
English: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors (SPAF)
Danish: Forebyggelse af apopleksi og systemisk emboli hos voksne patienter med NVAF med en eller flere risikofaktorer (SPAF - stroke prevention in atrial fibrillation)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR 110 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL 110 mg
English: Table 11: Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies
Danish: Tabel 11:Analyse af total VTE og dødsfald uanset årsag under behandlingsperioden i de ortopædkirurgiske studier RE-MODEL og RE-NOVATE
English: Common (may affect up to 1 in 10 people): - Bleeding may happen from the nose, into the stomach or bowel, from the rectum, from penis/vagina or urinary tract (incl.
Danish: Almindelige bivirkninger (kan forekomme hos højst 1 ud af 10 brugere): - blødning fra næsen, i maven eller tarmen, fra endetarmen, fra penis/vagina eller urinvejene (inkl.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 180 (3 PACKS OF 60 HARD-CAPSULES) - WITHOUT BLUE BOX110 mg HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING MED 180 KAPSLER (3 PAKNINGER AF 60 HÅRDE KAPSLER) - UDEN BLUE BOX - 110 mg HÅRDE KAPSLER
English: The duration of use of Pradaxa in the indications SPAF, DVT and PE are shown in table 3.
Danish: Behandlingsvarigheden af Pradaxa for indikationerne SPAF, DVT og LE vises i tabel 3.
English: Because Pradaxa can impact the International Normalized Ratio (INR), the INR will better reflect VKA's effect only after Pradaxa has been stopped for at least 2 days.
Danish: • CrCL ≥ 30-< 50 ml/min, VKA bør startes 2 dage før ophør med Pradaxa Måling af den internationale normaliserede ratio (INR) som mål for VKAs effekt kan først anvendes mindst 2 dage efter, Pradaxa er blevet seponeret, idet Pradaxa kan påvirke INR.
English: Uncommon (may affect up to 1 in 100 people): - Bleeding - Bleeding may happen into a joint or from an injury - Bleeding may happen from piles - A fall in the number of red cells in the blood - Haematoma formation - Coughing of blood or blood stained sputum - Allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel - Inflammation of the gullet and stomach - Reflux of gastric juice into the gullet - Feeling sick - Vomiting - Belly ache or stomach ache - Frequent loose or liquid bowel movements - Unusual laboratory test results on liver function - Liver enzymes increased
Danish: Ikke almindelige bivirkninger (kan forekomme hos højst 1 ud af 100 brugere): - blødning - blødning kan forekomme i et led eller efter et uheld - blødning kan forekomme fra hæmoroider - nedsat antal røde blodlegemer - blå mærker - blodigt opspyt - allergisk reaktion - pludselig ændring af hudens farve eller udseende - kløe - mavesår eller sår i tarmen - betændelseslignende tilstand i spiserør og mave - sure opstød - kvalme - opkastning - mavesmerter - hyppig løs eller vandtynd afføring - unormale prøveresultater for leverfunktionen - stigning i leverenzymer.
English: Table 4 summarises factors which may increase the haemorrhagic risk.
Danish: I tabel 4 er anført faktorer, der kan øge blødningsrisikoen.
English: What Pradaxa looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Take Pradaxa as your physician has told you.
Danish: Tag Pradaxa efter lægens anvisning.
English: MINIMUM PARTICULARS TO APPEAR ON WHITE BLISTERS OR STRIPS BLISTER FOR 150 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ HVID BLISTER ELLER STRIP BLISTER TIL 150 mg
English: After discontinuation of study medication the effect was maintained until the end of the follow-up, indicating that the initial treatment effect of dabigatran etexilate was sustained.
Danish: Virkningen af dabigatranetexilat blev fastholdt, hvilket indikerer, at der efterfølgende var en virkning af dabigatranetexilat i 12 måneder.
English: Table 22: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-SONATE study.
Danish: Tabel 22: Analyse af de primære og sekundære virkningsendepunkter (VTE er summen af DVT og/eller LE) indtil afslutningen af post-behandlingsperioden for RE-SONATE studiet.
English: Pradaxa 150 mg twice daily vs. Warfarin
Danish: Pradaxa 150 mg 2 gange dagligt vs. warfarin
English: Pradaxa 110 mg twice daily vs. warfarin
Danish: Pradaxa 110 mg 2 gange dagligt vs. warfarin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR 150 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL 150 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En hård kapsel indeholder 150 mg dabigatranetexilat (som mesilat).
English: Steady state geometric mean dabigatran peak plasma concentration, measured around 2 hours after 150 mg dabigatran etexilate administration twice daily, was 175 ng/mL, with a range of 117-275 ng/mL (25
Danish: Steady-state (ved 2 gange dagligt dosering) angivet som geometrisk gennemsnitsværdi af peakplasmakoncentrationen målt ca. 2 timer efter indtagelse af 150 mg 2 gange dagligt dabigatranetexilat var 175 ng/ml, med et interval på 117-275 ng/ml (25.-75. percentil).
English: Table 18: Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies.
Danish: Tabel 18:Analyse af total VTE og dødsfald uanset årsag under behandlingsperioden i de ortopædkirurgiske studier RE-MODEL og RE-NOVATE
English: Table 3 summarises factors which may increase the haemorrhagic risk.
Danish: I tabel 3 er anført faktorer, der kan øge blødningsrisikoen.