FrancophonIA/ELRC3.0 huggingface dataset:
English: Speak to your doctor immediately if you experience any of the following possible signs and symptoms of bleeding: swelling, discomfort, unusual pain or headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding of gums, unusual long bleeding cuts, abnormal menstrual flow or vaginal bleeding, blood in your urine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or coffee ground like material.
Danish: Kontakt straks lægen, hvis du oplever nogle af de følgende mulige tegn og symptomer på blødning: hævelse, ubehag, usædvanlige smerter eller hovedpine, svimmelhed, bleghed, svaghed, usædvanlige blå mærker, næseblod, blødende gummer, usædvanlig langvarig blødning fra sår, unormal menstruation eller blødning fra skeden, blod i urinen, som kan være lyserød eller brun, rød/sort afføring, ophostning af blod, opkastning af blod eller substans, der ligner kaffegrums.
English: The concomitant use of dabigatran etexilate with the fixed-dose combination of the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure of dabigatran and may increase the risk of bleeding.
Danish: Samtidig anvendelse af dabigatranetexilat og fastdosiskombinationen af P-gphæmmerne glecaprevir/pibrentasvir har vist sig at øge eksponeringen af dabigatran, og kan øge blødningsrisikoen.
English: Additionally, dabigatran exposure (at trough and peak) was assessed in a prospective open label randomized pharmacokinetic study in NVAF patients with severe renal impairment (defined as creatinine clearance [CrCl] 15-30 mL/min) receiving dabigatran etexilate 75 mg twice daily.
Danish: Derudover blev dabigatraneksponering (ved trough og peak) vurderet i et prospektivt, open-label, randomiseret, farmakokinetisk studie hos NVAF-patienter med svært nedsat nyrefunktion (defineret som kreatininclearance [CrCL] 15-30 ml/min), der fik dabigatranetexilat 75 mg to gange dagligt.
English: Caution should be exercised when Pradaxa is co-administered with posaconazole.
Danish: Ved samtidig administration af Pradaxa og posaconazol bør der udvises forsigtighed.
English: Gastroesophagitis
Danish: Gastroøsofagitis
English: • The cap opens by pushing and turning.
Danish: • Skruelåget åbnes ved at trykke låget ned og dreje det.
English: Injury, poisoning and procedural complications Traumatic haemorrhage
Danish: Traumer, forgiftninger og behandlingskomplikationer Traumatisk blødning
English: While certain patient subgroups are at an increased risk of major bleeding when treated with an anticoagulant, the excess bleeding risk for dabigatran is due to GI bleeding, typically seen within the first 3-6 months following initiation of Pradaxa therapy.
Danish: Mens visse patient delpopulationer har en øget risiko for alle alvorlige blødninger, ved behandling med antikoagulantia, er der for dabigatran en øget risiko for GI blødning ved dabigatran, som typisk ses inden for de første 3-6 måneder af behandlingen med Pradaxa.
English: Pradaxa ® Information for Healthcare Professionals
Danish: ® Information til sundhedspersonale
English: glomerular filtration rate (CrCL,) [mL/min]
Danish: glomerulær filtrationshastighed (CrCL) [ml/min]
English: Major bleeding occurred in 0.97 per 100 patient-years.
Danish: Større blødningshændelser opstod hos 0,97 pr. 100 patientår.
English: No double dose should be taken to make up for missed individual doses.
Danish: Der må ikke tages dobbeltdosis som erstatning for glemte doser.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i originalpakningen for at beskytte mod fugt.
English: It is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
Danish: Det er meget vigtigt at tage Pradaxa før og efter operationen nøjagtigt på de tidspunkter, som du har fået fortalt af lægen.
English: Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats and treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the vein of your legs and lungs A forgotten dose can still be taken up to 6 hours prior to the next due dose.
Danish: Forebyggelse af blodpropper i hjernen og andre steder i kroppen ved unormal hjerterytme og behandling af blodpropper i vener i ben og lunger samt forebyggelse af nye En glemt dosis kan stadig tages op til 6 timer før næste dosis skal tages.
English: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
Danish: Forebyggelse af apopleksi og systemisk emboli hos voksne patienter med non-valvulær atrieflimren (NVAF) og med en eller flere risikofaktorer, såsom tidligere apopleksi eller transitorisk cerebral iskæmi (TCI), alder ≥ 75 år, hjertesvigt (NYHA-klasse ≥ 2), diabetes mellitus eller hypertension.
English: There is limited amount of data from the use of Pradaxa in pregnant women.
Danish: Der er ikke tilstrækkelig data for behandling af gravide kvinder med Pradaxa.
English: Of the 704 enrolled patients, 317 underwent atrial fibrillation ablation on uninterrupted dabigatran and 318 underwent atrial fibrillation ablation on uninterrupted warfarin.
Danish: Ud af de 704 patienter i studiet, gennemgik 317 patienter, der fik dabigatran, og 318 patienter, der fik warfarin, ablation for atrieflimren.
English: Common (may affect up to 1 in 10 people): - A fall in the amount of haemoglobin in the blood (the substance in the red blood cells) - Unusual laboratory test results on liver function
Danish: Almindelige bivirkninger (kan forekomme hos højst 1 ud af 10 brugere): - nedsat indhold af hæmoglobin i blodet (stoffet i de røde blodlegemer) - unormale prøveresultater for leverfunktionen.
English: 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.
Danish: Efter oral 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.
English: - The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and hydroxypropylcellulose.
Danish: - Øvrige indholdsstoffer er vinsyre, akaciegummi, hypromellose, dimeticon 350, talcum og hydroxypropylcellulose.
English: The primary objective of these studies was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the primary endpoint which was the composite of recurrent symptomatic DVT and/or PE and related deaths within the 6 month treatment period.
Danish: Det primære mål var, om dabigatranetexilat var non-inferior i forhold til warfarin til reduktion af forekomsten af det sammensatte primære endepunkt, recidiverende symptomatisk DVT og/eller LE og relateret død indenfor den 6 måneder lange behandlingsperiode.
English: 4 days before
Danish: 4 dage før
English: tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.
Danish: •kontakt straks lægen, hvis dine ben bliver følelsesløse eller svage, eller du får problemer med tarmen eller blæren efter endt anæstesi, da det er nødvendigt med akut behandling
English: UFH can be administered at doses necessary to maintain a patent central venous or arterial catheter or during catheter ablation for atrial fibrillation (see section 4.3).
Danish: UFH kan gives i doser, der er nødvendige for at opretholde et åbent centralt vene- eller arteriekateter, eller under kateterablation for atrieflimren (se pkt.
English: Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient (see table 1 above).
Danish: Dosisjustering bør overvejes, efter vurdering af de potentielle fordele og risici for den enkelte patient (se tabel 1 ovenfor).
English: Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient (see table 2 above).
Danish: Dosisjustering bør overvejes, efter vurdering af de potentielle fordele og risici for den enkelte patient (se tabel 2 ovenfor).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pradaxa in all subsets of the paediatric population for the granted indications (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Pradaxa hos alle undergrupper af den pædiatriske population for de godkendte indikationer (se pkt.
English: Table 8: Other interactions
Danish: Tabel 8: Andre interaktioner
English: stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).
Danish: mavesår, skade eller blødning i hjernen, en nylig operation i hjernen eller øjnene) - hvis du har øget tendens til at bløde.
English: There is no relevant use of Pradaxa in the paediatric population for the indication of prevention of stroke and systemic embolism in patients with NVAF.
Danish: Det er ikke relevant for den pædiatriske population at anvende Pradaxa til indikationen forebyggelse af apopleksi og systemisk emboli ved NVAF.
English: Women of childbearing potential should avoid pregnancy during treatment with Pradaxa.
Danish: Kvinder bør undgå at blive gravide, mens de er i behandling med Pradaxa.
English: The greatest elevation of dabigatran exposure was observed with the first dose of an immediate release formulation of verapamil administered one hour prior to the dabigatran etexilate intake (increase of Cmax by about 2.8-fold and AUC by about 2.5-fold).
Danish: Den største stigning i dabigatraneksponering sås ved første dosis af en verapamilformulering med umiddelbar frigivelse af det aktive stof, givet en time før dabigatranetexilat-indtagelse (stigning i Cmax med omkring 2,8 gange og i AUC med omkring 2,5 gange).
English: • Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole, cyclosporine, itraconazole, dronedarone and the fixed-dose combination glecaprevir/pibrentasvir (see section 4.5)
Danish: • Samtidig behandling med de følgende potente P-gp-inhibitorer: systemisk ketoconazol, ciclosporin, itraconazol, dronedaron eller fastdosiskombinationen glecaprevir/pibrentasvir (se pkt.
English: Dabigatran inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.
Danish: Dabigatran hæmmer frit trombin, fibrinbundet trombin og trombininduceret trombocytaggregation.
English: If you are taking amiodarone, quinidine or verapamil containing medicines the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).
Danish: Hvis du tager medicin, der indeholder amiodaron, kinidin eller verapamil, er den anbefalede dosis 150 mg én gang dagligt (taget som 2 kapsler på 75 mg).
English: The rate of the combination of MBEs/CRBEs and the rate of any bleeding was significantly lower at a nominal alpha level of 5 % in patients receiving placebo as compared with those receiving Pradaxa.
Danish: Hyppigheden af MBE/CRBE og hyppigheden af enhver blødning var signifikant lavere ved et nominelt alfa-niveau på 5% ved placebo, sammenlignet med Pradaxa.
English: SPAF and DVT/PE
Danish: SPAF og DVT/LE
English: If a medical device (stent) has been deployed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with stenting, you can be treated with Pradaxa after your physician has decided that normal control of blood coagulation is achieved.
Danish: Hvis du, ved en procedure kaldet perkutan koronar intervention med stenting, har fået indsat medicinsk udstyr (en stent) i en blodåre for at holde den åben, kan du blive behandlet med Pradaxa, efter lægen har besluttet, at en normal kontrol af blodstørkningen er blevet opnået.
English: Subacute surgery/interventions
Danish: Subakutte operationer/indgreb
English: Once the bottle is opened, the medicinal product must be used within 4 months.
Danish: Når beholderen er åbnet, skal kapslerne anvendes inden for 4 måneder.
English: A prospective, randomized, open-label, blinded endpoint (PROBE) study (Phase IIIb) to evaluate dual-therapy with dabigatran etexilate (110 mg or 150 mg bid) plus clopidogrel or ticagrelor (P2Y12 antagonist) vs. triple-therapy with warfarin (adjusted to a INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin was conducted in 2725 patients with non valvular atrial fibrillation who underwent a PCI with stenting (RE-DUAL PCI).
Danish: Et prospektivt, randomiseret, open-label studie (fase IIIb) med blindet endepunkt (PROBE) til evaluering af dobbeltterapi med dabigatranetexilat (110 mg eller 150 mg to gange dagligt) plus clopidogrel eller ticagrelor (P2Y12-antagonist) vs. trippelterapi med warfarin (justeret til INR 2,0-3,0) plus clopidogrel eller ticagrelor og aspirin, blev udført hos 2.725 patienter med non-valvulær atrieflimren, der gennemgik PCI med stenting (RE-DUAL PCI).
English: Primary prevention of Venous Thromboembolism in Orthopaedic Surgery The recommended doses of Pradaxa and the duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery are shown in table 1.
Danish: Primær forebyggelse af venøs tromboemboli ved ortopædkirurgi De anbefalede doser af Pradaxa og behandlingsvarigheden for primær forebyggelse af venøs tromboemboli ved ortopædkirurgi er vist i tabel 1.
English: • Do not stop intake of Pradaxa
Danish: • Stop ikke med at tage Pradaxa
English: Active substance exposure in the primary VTE prevention studies was about 40 % to 50 % higher in female patients and no dose adjustment is recommended.
Danish: Hos kvinderne i det primære VTE forebyggelsesstudie sås, at eksponeringen til aktiv stof var ca. 4050 % højere - der anbefales ingen dosisjustering.
English: If you are taking verapamil containing medicines, your doctor will tell you to use a reduced dose of Pradaxa.
Danish: Hvis du tager medicin, der indeholder verapamil, vil lægen fortælle dig, at du skal bruge en reduceret dosis Pradaxa.
English: Since the patient populations treated in the three indications are not comparable and bleeding events are distributed over several System Organ Classes (SOC), a summary description of major and any bleeding are broken down by indication and are provided in tables 11-14 below.
Danish: Patientpopulationerne behandlet for de 3 indikationer er ikke sammenlignelige, og blødningerne fordelt over flere organklasser (SOC), er en kortfattet beskrivelse af alvorlige og alle blødninger, og derfor opdelt efter indikation, angivet i tabel 11-14 nedenfor.
English: Furthermore, bleeding occurred in 19.4 % of patients in the DVT/PE prevention trial RE-MEDY and in 10.5 % of patients in the DVT/PE prevention trial RE-SONATE.
Danish: Derudover forekom blødning hos 19,4 % af patienterne i DVT/LE-forebyggelsesstudiet RE-MEDY og hos 10,5 % af patienterne i DVT/LEforebyggelsesstudiet RE-SONATE.
English: If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Danish: Hvis behandlingen påbegyndes senere end på operationsdagen, skal dosis fra første behandlingsdag være 2 kapsler én gang dagligt.
English: Myocardial infarction rates were slightly increased with dabigatran etexilate 110 mg twice daily and 150 mg twice daily compared to warfarin (hazard ratio 1.29; p=0.0929 and hazard ratio 1.27; p=0.1240, respectively).
Danish: Antallet af myokardieinfarkter var med dabigatranetexilat 110 mg 2 gange dagligt og 150 mg 2 gange dagligt lidt forhøjet, når sammenlignet med warfarin (hazard ratio 1,29, p=0,0929 og hazard ratio 1,27, p=0,1240, henholdsvis).
English: e.g. rifampicin, St. John´s wort (Hypericum perforatum), carbamazepine, or phenytoin
Danish: Såsom rifampicin, perikon (Hypericum perforatum), carbamazepin eller phenytoin)
English: In the clinical study 1160.88 in total, 9 adolescent patients (age 12 to < 18 years) with diagnosis of primary VTE received an initial oral dose of dabigatran etexilate of 1.71 (± 10 %) mg/kg bodyweight.
Danish: I alt 9 unge patienter (i alderen 12 til < 18 år) med diagnosen primær VTE indgik i det kliniske studie 1160.88; de fik en oral initialdosis af dabigatranetexilat på 1,71 (± 10 %) mg/kg kropsvægt.
English: The dabigatran AUC and Cmax were increased by about 1.6-fold and 1.5-fold, respectively.
Danish: AUC og Cmax for dabigatran var øget med hhv. ca. 1,6 gange og 1,5 gange.
English: • an ECT at trough (10-16 hours after the previous dose), elevated approximately 2.3-fold compared to baseline refers to the observed 90th percentile of ECT prolongation of 74 seconds,
Danish: • en ECT ved trough (10-16 timer efter den forrige dosis) forhøjet ca. 2,3 gange i forhold til baseline, svarer til 90-percentilen for den observerede ECT-forlængelse på 74 sekunder,
English: Anaphylactic reaction
Danish: Anafylaktisk reaction
English: The risk of bleedings may be increased in certain patient groups e.g. those patients with moderate renal impairment and/or on concomitant treatment affecting haemostasis or strong P-gp inhibitors (see section 4.4 Haemorrhagic risk).
Danish: Risikoen for blødninger kan være forhøjet hos visse patientgrupper, f.eks. patienter med moderat nedsat nyrefunktion, og/eller i en samtidig behandling, der påvirker hæmostasen, eller potente P-gp-inhibitorer (se pkt.
English: A specific reversal agent for dabigatran, idarucizumab, is available in case of uncontrollable bleeding (see Section 4.9).
Danish: En specifik antidot for dabigatran, idarucizumab, er tilgængeligt i tilfælde af ukontrollabel blødning (se pkt.
English: ASA Co-administration of ASA and 150 mg dabigatran etexilate twice daily may increase the risk for any bleeding from 12 % to 18 % and 24 % with 81 mg and 325 mg ASA, respectively (see section 4.4).
Danish: 4.4) ASA Samtidig indtagelse af ASA og 150 mg dabigatranetexilat 2 gange dagligt kan øge blødningsrisikoen fra 12 % til 18 % henholdsvis 24 % med 81 mg henholdsvis 325 mg ASA (se pkt.
English: Emergency surgery or urgent procedures
Danish: Akutte operationer/akutte procedurer
English: No imbalance in the rate of heart attacks was observed in patients treated with dabigatran versus patients treated with placebo.
Danish: Hyppigheden af hjerteanfald hos patienter behandlet med dabigatran svarede til hyppigheden af hjerteanfald hos patienter behandlet med placebo.
English: If your kidney function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).
Danish: Hvis din nyrefunktion er nedsat til mindre end det halve eller hvis du er 75 år eller ældre, er den anbefalede dosis 150 mg én gang dagligt (taget som 2 kapsler på 75 mg).
English: Gastrointestinal ulcer, including oesophageal ulcer
Danish: Mavesår, inklusive øsofagealt ulcus
English: • The hard capsules should not be pushed through the blister foil.
Danish: • Kapslen bør ikke trykkes ud gennem folien.
English: 2-3 days before
Danish: 2-3 dage før
English: For DVT/PE the recommendation for the use of Pradaxa 220 mg taken as one 110 mg capsule twice daily is based on pharmacokinetic and pharmacodynamic analyses and has not been studied in this clinical setting.
Danish: Doseringen 220 mg som 1 kapsel á 110 mg 2 gange dagligt til indikationen DVT/LE er ikke undersøgt i kliniske studier, men udelukkende baseret på farmakokinetiske og farmakodynamiske analyser.
English: Use of platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux increase the risk of GI bleeding.
Danish: Behandling med trombocytaggregationshæmmere, såsom clopidogrel og acetylsalicylsyre (ASA) eller nonsteroide antiinflammatoriske lægemidler (NSAID), samt tilstedeværelsen af esophagitis, gastritis eller gastroøsofageal refluks øger risikoen for gastrointestinal blødning.
English: NSAIDs given for short-term analgesia have been shown not to be associated with increased bleeding risk when given in conjunction with dabigatran etexilate.
Danish: NSAID Korttidsbehandling med NSAID-præparater har vist sig ikke at være forbundet med øget blødningsrisiko, når det administreres samtidigt med dabigatranetexilat.
English: Pradaxa is available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsules, a multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in aluminium perforated unit dose blisters.
Danish: Pradaxa fås i pakninger med 10 x 1, 30 x 1 eller 60 x 1 kapsler, en multipakning indeholdende 3 x 60 x 1 kapsel (180 kapsler) eller en multipakning indeholdende 2 x 50 x 1 kapsel (100 kapsler) i perforerede aluminium-blisterkort.
English: The absolute bioavailability of dabigatran following oral administration of Pradaxa was approximately
Danish: Den absolutte biotilgængelighed af dabigatran efter oral indtagelse af Pradaxa var ca. 6,5 %.
English: For the primary endpoint, stroke and systemic embolism, no subgroups (i.e., age, weight, gender, renal function, ethnicity, etc.) were identified with a different risk ratio compared to warfarin.
Danish: For de primære endepunkter, apopleksi og systemisk emboli fandt man for alle delpopulationer (såsom alder, vægt, køn, nyrefunktion, etnicitet, mv.) samme risikoreduktion sammenlignet med warfarin.
English: • an aPTT ratio greater than 2-fold upper limit of normal (aPTT prolongation of about 80 seconds), at trough (10-16 hours after the previous dose) reflects the 90
Danish: • en aPTT-ratio, der er større end 2 gange den øvre normalgrænse (aPTT-forlængelse på ca. 80 sekunder), ved trough (10-16 timer efter den forrige dosis) svarer til 90-percentilen for observationerne.
English: Depending on local availability, a consultation of a coagulation expert should be considered in case of major bleedings.
Danish: I tilfælde af større blødninger bør det overvejes at konsultere en koagulationsekspert.
English: Indication SPAF and DVT/PE
Danish: Indikation SPAF og DVT/LE
English: More thromboembolic events (mainly strokes and symptomatic/asymptomatic prosthetic valve thrombosis) and more bleeding events were observed with dabigatran etexilate than with warfarin.
Danish: - for mere end 3 måneder siden har fået udskiftet en hjerteklap Der blev observeret flere tromboemboliske hændelser (hovedsageligt apopleksi og symptomatisk/asymptomatisk hjerteklaptrombose) og flere blødningstilfælde ved behandling med dabigatranetexilat end med warfarin.
English: Parenteral anticoagulants to Pradaxa:
Danish: Fra parenteral antikoagulans til Pradaxa:
English: - if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for dabigatranetexilat eller et af de øvrige indholdsstoffer i Pradaxa
English: Laboratory coagulation parameters
Danish: Koagulationsparametre i laboratoriet
English: The dose of 150 mg twice daily reduces significantly the risk of ischemic and haemorrhagic stroke, vascular death, ICH and total bleeding compared to warfarin.
Danish: En dosis på 150 mg 2 gange dagligt reducerer signifikant risikoen for iskæmisk og hæmoragisk apopleksi, vaskulær død, intrakraniel blødning og totalblødning i forhold til warfarin.
English: Based on dabigatran concentrations as determined by the diluted thrombin time test and clinical assessment, the dose was adjusted to the target dose of 2.14 (± 10%) mg/kg bodyweight of dabigatran etexilate.
Danish: Baseret på koncentrationen af dabigatran, bestemt ved fortyndet trombintid og klinisk evaluering, blev dosis justeret til en måldosis af dabigatranetexilat på 2,14 (± 10 %) mg/kg kropsvægt.
English: Table 9: Other interactions
Danish: Tabel 9: Andre interaktioner
English: ASA use Clopidogrel use
Danish: Brug af ASA Brug af clopidogrel