FrancophonIA/ELRC3.0 huggingface dataset:
English: The inducing effect was diminished resulting in dabigatran exposure close to the reference by day 7 after cessation of rifampicin treatment.
Danish: Efter seponering af rifampicin aftog induktorvirkningen resulterende i en dabigatraneksponering tæt på referenceværdien på 7. dagen.
English: Patient Information
Danish: • Patientoplysningskort
English: You can continue to take Pradaxa if your heart beat needs to be restored to normal by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation.
Danish: Hvis dit hjerteslag skal vende tilbage til normalen ved en procedure kaldet kardiovertering eller ved en procedure kaldet kateterablation for atrieflimren, kan du fortsætte med at tage Pradaxa.
English: Minor:
Danish: Mindre betydende:
English: The pharmacokinetics and pharmacodynamics of dabigatran etexilate administered twice daily for three consecutive days (total 6 doses) at the end of standard anticoagulant therapy were assessed in an open-label safety and tolerability study in 9 stable adolescents (12 to < 18 years).
Danish: Farmakokinetiske og -dynamiske parametre blev undersøgt i et open-label studie af sikkerhed og tolerance hos 9 unge raske (12 til < 18 år), der fik dabigatranetexilat 2 gange dagligt i 3 sammenhængende dage (i alt 6 doser) umiddelbart efter afslutning af standard-antikoagulansbehandling.
English: • the 90th percentile of aPTT at trough (10-16 hours after the previous dose) was 62 seconds,
Danish: • 90-percentilen for aPTT ved trough (10-16 timer efter den forrige dosis) var 62 sekunder,
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om Pradaxa på det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: They are ranked under headings of System Organ Class (SOC) and frequency using the following convention: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opstillet i henhold til systemorgan klasse (SOC) og hyppighed i henhold til følgende klassifikation: Meget almindelig (≥1/10); almindelig (≥1/100 til, <1/10); ikke almindelig (≥1/1.000 til, <1/100); sjælden (≥1/10.000 til, <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Taking Pradaxa may increase the risk of bleeding.
Danish: • Det kan øge risikoen for blødninger at tage Pradaxa
English: For treatment of DVT and PE, with dabigatran etexilate 150 mg twice daily,
Danish: For behandling af DVT og LE med dabigatranetexilat 150 mg 2 gange dagligt gjaldt følgende:
English: Table 1: Dose recommendations for SPAF, DVT and PE Dose recommendation
Danish: Tabel 1: Dosisanbefalinger for SPAF, DVT og LE Dosisanbefaling
English: Patients with moderate renal impairment (CrCL between 30-50 mL/min) had on average 2.29-fold and 1.81-fold higher pre- and post-dose dabigatran plasma concentrations, respectively, when compared with patients without renal impairment (CrCL ≥ 80 mL/min).
Danish: Patienter med moderat nedsat nyrefunktion (CrCl mellem 30-50 ml/min) havde i gennemsnit mellem 2,29 gange og 1,81 gange højere præ- og post-dosis dabigatranplasmakoncentrationer, i forhold til patienter uden nedsat nyrefunktion (CrCl ≥ 80 ml/min).
English: Table 2: Duration of use for SPAF and DVT/PE Indication Duration of use
Danish: Tabel 2: Behandlingsvarighed for SPAF og DVT/LE Indikation Behandlingsvarighed
English: If surgery cannot be delayed the risk of bleeding may be increased.
Danish: Hvis operation ikke kan udsættes, kan der være en øget risiko for blødning, som skal indgå i overvejelserne om nødvendigheden af intervention.
English: Concomitant use of Pradaxa with mild to moderate P-glycoprotein (P-gp) inhibitors, i.e. amiodarone, quinidine or verapamil
Danish: Samtidig behandling med Pradaxa og svage til moderate P-glykoprotein(P-gp)-inhibitorer, f.eks. amiodaron, kinidin eller verapamil
English: In the phase III study RE-LY (SPAF, see section 5.1) the overall rate of MI was 0.82, 0.81, and 0.64 % / year for dabigatran etexilate 110 mg twice daily, dabigatran etexilate 150 mg twice daily and warfarin, respectively, an increase in relative risk for dabigatran of 29 % and 27 % compared to warfarin.
Danish: 5.1) var risikoen for MI overordnet 0,82; 0,81 og 0,64 % pr. år for dabigatranetexilat 110 mg 2 gange dagligt, for dabigatranetexilat 150 mg 2 gange dagligt og for warfarin, henholdsvis en numerisk stigning i relativ risiko for dabigatran på 29 % og 27 % i forhold til warfarin.
English: Table 8 shows the adverse reactions ranked under headings of System Organ Classes (SOC) and frequency using the following convention: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Tabel 8 viser bivirkninger opdelt efter systemorganklasser i henhold til MedDRA og hyppighed i henhold til følgende klassifikation: 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); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Pradaxa to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min) (see sections 4.3, 4.4 and 5.2).
Danish: • Før påbegyndelse af behandling med Pradaxa bør nyrefunktionen vurderes ved beregning af kreatininclearance (CrCL) for at ekskludere patienter med svært nedsat nyrefunktion (CrCL < 30 ml/min) (se pkt.
English: INFORMATION IN BRAILLE Pradaxa 150 mg
Danish: INFORMATION I BRAILLESKRIFT Pradaxa 150 mg
English: The ECT was not measured in patients treated for prevention of VTEs after hip or knee replacement surgery with 220 mg dabigatran etexilate once daily.
Danish: ECT blev ikke målt hos patienter, der fik 220 mg dabigatranetexilat én gang dagligt til forebyggelse af VTE efter hofte- eller knæalloplastik.
English: Pradaxa is available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsules in aluminium perforated unit dose blisters.
Danish: Pradaxa fås i pakninger med 10 x 1, 30 x 1 eller 60 x 1 kapsel i perforerede aluminium-blisterkort.
English: For patients randomized to warfarin, the median time in therapeutic range (INR 2.0 to 3.0) was 60.6 %.
Danish: Patienter randomiseret til warfarin var i det terapeutiske interval (INR 2,0 til 3,0) i gennemsnit 60,6 % af tiden.
English: Capsule shell Carrageenan Potassium chloride Titanium dioxide Indigo carmine (E132) Hypromellose
Danish: Kapselskal carrageenan kaliumchlorid titandioxid (E 171) indigocarmin (E 132) hypromellose (HPMC-kapselskal)
English: Multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in perforated aluminium unit dose blisters.
Danish: Multipakning med 2 pakninger af 50 x 1 hårde kapsler (100 hårde kapsler) som perforerede aluminiums enkeltdosis-blistre.
English: There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Pradaxa: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparins (LMWH), and heparin derivatives (fondaparinux, desirudin), thrombolytic medicinal products, and vitamin K antagonists, rivaroxaban or other oral anticoagulants (see section 4.3), and antiplatelet aggregation medicinal products such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinpyrazone (see section 4.4).
Danish: Der er ingen eller kun begrænset erfaring med følgende behandlinger givet samtidig med Pradaxa, hvor en øget risiko for blødning eventuelt kan forekomme: Antikoagulantia, såsom ufraktioneret heparin (UFH), lavmolekylære hepariner (LMWH) og heparinderivater (fondaparinux, desirudin), trombolytika og vitamin K-antagonister, rivaroxaban eller andre orale antikoagulantia (se pkt.
English: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Danish: Primær forebyggelse af venøs tromboemboli hos voksne patienter efter elektiv total hofte- eller knæalloplastik.
English: Table 28: Half-life of total dabigatran in healthy subjects and subjects with impaired renal function.
Danish: Table 28: Halveringstid for total dabigatran hos raske og hos patienter med nedsat nyrefunktion.
English: - Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin,
Danish: - medicin, der mindsker blodets evne til at størkne (f.eks. warfarin, phenprocoumon,
English: 95 % confidence interval VTE-related deaths 95 % confidence interval All-cause deaths
Danish: 95 % konfidensinterval Død uanset årsag 95 % konfidensinterval
English: Furthermore, concomitant use of antiplatelets, ASA or clopidogrel approximately doubled major bleeding rates with both dabigatran etexilate and warfarin (see section 4.4).
Danish: Desuden ca. fordobler samtidig administration af trombocythæmmerne ASA eller clopidogrel risikoen for en større blødning for både dabigatranetexilat og warfarin (se pkt.
English: Concomitant administration of a loading dose of 180 mg ticagrelor and 110 mg dabigatran etexilate (in steady state) increased the dabigatran AUCτ,ss and Cmax,ss by 1.49-fold and 1.65-fold, respectively, compared with dabigatran etexilate given alone.
Danish: Ved samtidig administration af en initialdosis på 180 mg ticagrelor og 110 mg dabigatranetexilat (i steady state) steg AUCτ,ss og Cmax,ss for dabigatran henholdsvis 1,49 gange og 1,65 gange sammenlignet med dabigatranetexilat alene.
English: Patients on Pradaxa who undergo surgery or invasive procedures are at increased risk for bleeding.
Danish: Pradaxa kan eventuelt pauseres hos patienter, der skal opereres eller undergå invasive procedurer, eftersom der er en øget risiko for blødning.
English: Do not break, chew, or empty the pellets from the capsule.
Danish: Kapslen må ikke åbnes eller tygges eller tømmes.
English: PHARMACEUTICAL FORM AND CONTENTS 10 x 1 hard capsule
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 10 x 1 hårde kapsler
English: Hazard ratio vs placebo (95% confidence interval)
Danish: Hazard ratio vs. placebo (95 % konfidensinterval)
English: Pradaxa treatment does not need to be interrupted (see section 5.1).
Danish: Det er ikke nødvendigt at pausere behandlingen med Pradaxa (se pkt.
English: • the 90th percentile of dabigatran plasma concentrations measured at trough (10-16 hours after the previous dose) was about 146 ng/ml,
Danish: • 90-percentilen for dabigatran-plasmakoncentrationerne ved trough (10-16 timer efter den forrige dosis) var ca. 146 ng/ml,
English: Table 11: Adverse reactions
Danish: Tabel 11: Bivirkninger
English: • an ECT at trough (10-16 hours after the previous dose), elevated approximately 3-fold upper limit of normal refers to the observed 90
Danish: • en ECT ved trough (10-16 timer efter den forrige dosis), forhøjet ca. 3 gange i forhold til den øvre normalgrænse, svarer til 90-percentilen for den observerede ECT-forlængelse på 103 sekunder,
English: Table 16: Bleeding events in study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) Pradaxa 150 mg twice daily
Danish: Tabel 16: Blødninger forekommet under forebyggelse af DVT og LE i studiet RE-SONATE Pradaxa 150 mg 2 gange dagligt
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om Pradaxa findes på det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: Anticoagulants and antiplatelet aggregation medicinal products
Danish: Antikoagulantia og trombocytfunktionshæmmere
English: Hence, the integrity of the HPMC capsules should always be preserved in clinical use to avoid unintentionally increased bioavailability of dabigatran etexilate (see section 4.2).
Danish: For at undgå en utilsigtet øget biotilgængelighed af dabigatranetexilat bør HPMCkapslerne derfor altid indtages uåbnede (se pkt.
English: Major or severe bleeding may occur, these constitute the most serious side effects and, regardless of location, may become disabling, life-threatening or even lead to death.
Danish: Alvorlig eller svær blødning kan forekomme og kan, uafhængigt af hvor blødningen forekommer, være invaliderende, livstruende eller endog med dødelig udgang.
English: The expiry date refers to the last day of that month.
Danish: Brug ikke Pradaxa efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: For elderly patients > 75 years, a dose reduction is recommended (see table 1 above and sections 4.4 and 5.1).
Danish: Der anbefales en dosisreduktion til ældre patienter > 75 år (se tabel 1 ovenfor og pkt.
English: Pradaxa 110 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Danish: Pradaxa 110 mg, hårde kapsler, fås også i polypropylen-(plastik-)beholdere med 60 hårde kapsler.
English: Table 18: Hazard Ratio and 95 % CI for stroke/systemic embolism by subgroups
Danish: Tabel 18: Hazard ratio og 95 % CI for apopleksi/systemisk emboli i delpopulationer Endepunkt
English: For patients randomized to warfarin, the median time in therapeutic range (INR 2.0-3.0) was 64.9 %.
Danish: Patienter randomiseret til warfarin var i det terapeutisk interval (INR 2,0-3,0) i gennemsnit 64,9 % af tiden.
English: Table 16: Analysis of first occurrence of ischemic or haemorrhagic strokes during the study period in RE-LY.
Danish: Tabel 16: Opgørelse af første forekomst af iskæmisk eller hæmoragisk apopleksi i løbet af studiesperioden i RE-LY.
English: Pradaxa 110 mg twice daily
Danish: Pradaxa 110 mg 2 gange dagligt
English: Table 21: Analysis of first occurrence of ischemic or haemorrhagic strokes during the study period in RE-LY.
Danish: Tabel 21: Opgørelse af første forekomst af iskæmisk eller hæmoragisk apopleksi i løbet af studiesperioden i RE-LY.
English: The incidence of the primary endpoint was 15.4 % (151 patients) in the dabigatran etexilate 110 mg dual-therapy group as compared with 26.9 % (264 patients) in the warfarin triple-therapy group (HR 0.52; 95% CI 0.42, 0.63; P<0.0001 for non-inferiority and P<0.0001 for superiority) and 20.2 % (154 patients) in the dabigatran etexilate 150 mg dual-therapy group as compared with 25.7 % (196 patients) in the corresponding warfarin triple-therapy group (HR 0.72; 95% CI 0.58, 0.88; P<0.0001 for non-inferiority and P=0.002 for superiority).
Danish: Forekomsten af det primære endepunkt var 15,4 % (151 patienter) i gruppen med dabigatranetexilat 110 mg dobbeltterapi, sammenlignet med 26,9 % (264 patienter) i gruppen med warfarin trippelterapi (HR 0,52; 95 % CI 0,42; 0,63; P<0,0001 for non-inferioritet, og P<0,0001 for superioritet) og 20,2 % (154 patienter) i gruppen med dabigatranetexilat 150 mg dobbeltterapi, sammenlignet med 25,7 % (196 patienter) i den tilsvarende gruppe med warfarin trippelterapi (HR 0,72; 95 % CI 0,58; 0,88;
English: 220 mg Pradaxa once daily taken as 2 capsules of 110 mg
Danish: 220 mg Pradaxa én gang dagligt i form af 2 kapsler a 110 mg
English: Clarithromycin When clarithromycin (500 mg twice daily) was administered together with dabigatran etexilate in healthy volunteers, increase of AUC by about 1.19-fold and Cmax by about 1.15-fold was observed.
Danish: Clarithromycin Hos raske frivillige, blev der observeret en stigning i AUC med omkring 1,19 gange og i Cmax med omkring 1,15 gange, når clarithromycin (500 mg 2 gange dagligt) blev givet sammen med dabigatranetexilat.
English: Hepatic function abnormal/ Liver function Test abnormal
Danish: Lever og galdeveje Unormal leverfunktion/unormal leverfunktionstest
English: ECT [x-fold upper limit of normal] No data aPTT [x-fold upper limit of normal] > 1.3 INR
Danish: ECT [x gange øvre normalgrænse] Ingen data aPTT [x gange øvre normalgrænse]
English: However, for patients with high risk of bleeding, a dose reduction of Pradaxa to 220 mg taken as one 110 mg capsule twice daily should be considered (see sections 4.4 and 5.2).
Danish: Til patienter med høj blødningsrisiko bør dosisreduktion til 220 mg som 1 kapsel a 110 mg 2 gange dagligt (se pkt.
English: The incidence of the composite efficacy endpoint of death, thromboembolic events (myocardial infarction, stroke, or systemic embolism) or unplanned revascularization in the two dabigatran etexilate dual-therapy groups combined was non-inferior to the warfarin triple-therapy group (13.7% vs. 13.4% respectively; HR 1.04; 95% CI: 0.84, 1.29; P=0.0047 for non-inferiority).There were no statistical differences in the individual components of the efficacy endpoints between either dabigatran etexilate dual-therapy groups and warfarin triple-therapy.
Danish: Forekomsten af det sammensatte endepunkt af død, tromboemboliske hændelser (myokardieinfarkt, apopleksi eller systemisk emboli) eller ikke planlagt revaskularisering i de to kombinerede grupper med dabigatranetexilat dobbeltterapi var non-inferior til gruppen med warfarin trippelterapi (hhv. 13,7 % vs. 13,4 %, HR 1,04; 95 % CI: 0,84; 1,29; P=0,0047 for non-inferioritet).
English: Table 2: Dose recommendations for SPAF, DVT and PE Dose recommendation
Danish: Tabel 2: Dosisanbefalinger for SPAF, DVT og LE Dosisanbefaling
English: Table 23: Hazard Ratio and 95 % CI for stroke/systemic embolism by subgroups
Danish: Tabel 23: Hazard ratio og 95 % CI for apopleksi/systemisk emboli i delpopulationer Endepunkt
English: Close clinical surveillance Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 3 above).
Danish: Nøje observation af tegn på blødning eller anæmi anbefales i hele behandlingsperioden, især hvis der er flere risikofaktorer (se tabel 3 ovenfor).
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 75 mg hard capsules
Danish: LÆGEMIDLETS NAVN Pradaxa 75 mg, hårde kapsler
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 100 (2 packs of 50x1) hard capsules.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 100 (2 pakker af 50 x 1) hårde kapsler.
English: Incidences (%) Risk ratio over enoxaparin 95 % CI
Danish: Forekomst (%) Hazard ratio sammenlignet med enoxaparin
English: In a dedicated study exclusively in patients with moderate renal impairment (creatinine clearance, CrCL 30-50 mL/min) treated with dabigatran etexilate 150 mg QD, the dabigatran geometric mean trough concentration, measured at the end of the dosing interval, was on average 47.5 ng/mL, with a range of 29.6 - 72.2 ng/mL (25
Danish: I et studie udelukkende med patienter med moderat nedsat nyrefunktion (kreatininclearance, CrCL 3050 ml/min), der fik dabigatranetexilat 150 mg en gang daglig, var dabigatrans geometriske gennemsnits-trough-koncentration, målt ved slutningen af doseringsintervallet gennemsnitligt 47,5 ng/ml, med et interval på 29,6 - 72,2 ng/ml (25.-75. percentil).
English: Bleeding can occur at any site during therapy with Pradaxa.
Danish: Blødning kan forekomme uden specifikt fokus under behandling med Pradaxa.
English: Capsules with white, opaque cap and white, opaque body of size 2 filled with yellowish pellets.
Danish: Kapslen: uigennemsigtig hvid top og uigennemsigtig hvid bund, størrelse 2 og indeholdende gullige pellets.
English: Close clinical surveillance Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 4 above).
Danish: Nøje observation af tegn på blødning eller anæmi anbefales i hele behandlingsperioden, især hvis der er flere risikofaktorer (se tabel 4 ovenfor).
English: The primary outcome (adjudicated major bleeding according to ISTH criteria) occurred in 5 (1.6 %) patients in the dabigatran etexilate group and 22 (6.9 %) patients in the warfarin group (risk difference −5.3%; 95% CI −8.4, −2.2; P=0.0009).
Danish: Større blødning evalueret i henhold til ISTH-kriterier, som var studiets primære endepunkt, forekom hos 5 (1,6 %) patienter i gruppen med dabigatranetexilat, og hos 22 (6,9 %) patienter i gruppen med warfarin (risikoforskel
English: Pradaxa 150 mg once daily
Danish: Pradaxa 150 mg 1 gang dagligt
English: FOLDING BOX AND LABEL FOR BOTTLE for 150 mg
Danish: FOLDEÆSKE OG ETIKET TIL BEHOLDER TIL 150 mg
English: Without specific guidance from your doctor do not change your anticoagulant treatment.
Danish: Skift ikke blodfortyndende medicinsk behandling, uden specifik rådgivning fra lægen.
English: INFORMATION IN BRAILLE Pradaxa 75 mg (only applicable for folding box, not applicable for bottle label)
Danish: INFORMATION I BRAILLESKRIFT Pradaxa 75 mg (kun på karton, ikke på etiket)
English: Capsules with light blue, opaque cap and light blue, opaque body of size 1 filled with yellowish pellets.
Danish: Kapslen: Uigennemsigtig lyseblå top og uigennemsigtig lyseblå bund, størrelse 1 og indeholdende gullige pellets.
English: Table 23: Half-life of total dabigatran in healthy subjects and subjects with impaired renal function.
Danish: Table 23: Halveringstid for total dabigatran hos raske og hos patienter med nedsat nyrefunktion.
English: In patients treated for DVT and PE with 150 mg dabigatran etexilate twice daily, the dabigatran geometric mean trough concentration, measured within 10−16 hours after dose, at the end of the dosing interval (i.e. 12 hours after the 150 mg dabigatran evening dose), was 59.7 ng/ml, with a range of 38.6 - 94.5 ng/ml (25th-75th percentile range).
Danish: Hos patienter i behandling for DTV og LE med 150 mg dabigatranetexilat 2 gange dagligt var den geometriske gennemsnits-trough-koncentration, målt i løbet af 10-16 timer efter dosering, i slutningen af dosisintervallet (dvs. 12 timer efter aftendosis på 150 mg dabigatran), 59,7 ng/ml med et interval på 38,6-94,5 ng/ml (25-75-percentil).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR BLISTER for 75 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FOLDEÆSKE TIL BLISTER til 75 mg
English: Other medicines and Pradaxa
Danish: Brug af anden medicin sammen med Pradaxa
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 110 mg hard capsules
Danish: LÆGEMIDLETS NAVN Pradaxa 110 mg, hårde kapsler
English: Clearance of dabigatran in patients with renal insufficiency may take longer (see section 5.2).
Danish: Hos patienter med nedsat nyrefunktion kan udskillelsen af dabigatran være forlænget (se pkt.
English: Multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) in perforated aluminium unit dose blisters.
Danish: Multipakning med 3 pakninger af 60 x 1 hårde kapsler (180 hårde kapsler) som perforerede aluminiums enkeltdosis-blistre.
English: blood in the urine that stains the urine pink or red), from piles, from the rectum,
Danish: blod i urinen der farver urinen pink eller rød), fra hæmorider, fra endetarmen, under huden, fra led,
English: No dose adjustment is required (see section
Danish: Ingen dosisjustering er nødvendig (se pkt.
English: When rapid reversal of the anticoagulation effect is required the specific reversal agent (Praxbind, idarucizumab) to Pradaxa is available.
Danish: Når det er nødvendigt hurtigt at modvirke den antikoagulerende virkning, er den specifikke antidot Praxbind (idarucizumab) tilgængelig.
English: In the trial program the rate of heart attacks with Pradaxa was higher than with warfarin.
Danish: I studieprogrammet var forekomsten af hjerteanfald højere med Pradaxa end med warfarin; samlet set var forekomsten lav.
English: Table 12: Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies
Danish: Tabel 12: Alvorlige blødningstilfælde set i henholdsvis RE-MODEL- og RE-NOVATE-studierne