FrancophonIA/ELRC3.0 huggingface dataset:
English: Breast-feeding should be discontinued during treatment with Pradaxa.
Danish: Amningen skal indstilles, mens der behandles med Pradaxa.
English: EXP Once opened, the product must be used within 4 months.
Danish: EXP Efter anbrud: Anvendes indenfor 4 måneder.
English: blood in the urine that stains the urine pink or red), or under the skin - Indigestion
Danish: blod i urinen, der farver urinen pink eller rød) eller under huden - fordøjelsesbesvær.
English: At the end of the follow-up VTE events in patients treated with dabigatran etexilate was 6.9 % vs. 10.7 % among the placebo group (hazard ratio 0.61 (95% CI 0.42, 0.88), p=0.0082).
Danish: Ved afslutningen af observationsperioden havde 6,9 % af de dabigatranbehandlede patienter haft en VTE mod 10,7 % af patienterne i placebogruppen (hazard ratio 0,61 (95 % CI 0,42; 0,88), p=0,0082).
English: 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: De anbefalede doser af Pradaxa og behandlingsvarigheden for primær forebyggelse af venøs tromboemboli ved ortopædkirurgi er vist i tabel 1.
English: It is recommended to wait 24 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Danish: Det anbefales, at man venter 24 timer efter den sidste Pradaxa-dosis, før man skifter til en parenteral antikoagulans (se pkt.
English: Limited clinical data in patients < 50 kg are available.
Danish: For patienter < 50 kg er kun begrænsede data tilgængelige.
English: The capsule should be swallowed whole with a glass of water, to ensure delivery to the stomach.
Danish: Kapslen bør sluges hel med et glas vand for at lette passagen til mavesækken.
English: Patients aged 75 or above *For patients with moderate renal impairment concomitantly treated with verapamil see Special populations
Danish: *For patienter med moderat nedsat nyrefunktion, som samtidig behandles med verapamil, se Særlige populationer
English: There was no influence on male fertility.
Danish: Der observeredes ingen påvirkning af fertiliteten hos handyr.
English: Based on dabigatran concentrations and clinical assessment, the dose was subsequently modified to a target dose of 2.14 (± 10 %) mg/kg of dabigatran etexilate (100 % of the adult dose adjusted for the patient's weight).
Danish: Ud fra koncentrationen af dabigatran og en klinisk evaluering blev dosis efterfølgende justeret til måldosis af dabigatranetexilat på 2,14 (± 10 %) mg/kg kropsvægt (100 % af voksendosis justeret i forhold til patientens vægt).
English: Clinical trials for the prevention of thromboembolism in patients with prosthetic heart valves
Danish: Kliniske studier med forebyggelse af tromboemboli hos patienter med kunstige hjerteklapper:
English: Never skip a dose or stop the intake of Pradaxa
Danish: Du må aldrig springe en dosis over, eller stoppe med at at tage Pradaxa ® uden at have talt med din læge.
English: Not known (frequency cannot be estimated from the available data): - Difficulty in breathing or wheezing - A fall in the amount of haemoglobin in the blood (the substance in the red blood cells) - A fall in the number of red cells in the blood - Yellowing of the skin or whites of the eyes, caused by liver or blood problems - Hair loss
Danish: Ikke kendt (hyppigheden kan ikke beregnes ud fra de tilgængelige data): - vejrtrækningsbesvær eller hvæsende vejrtrækning - nedsat indhold af hæmoglobin i blodet (substans i de røde blodlegemer) - nedsat antal røde blodlegemer - gulfarvning af huden eller af det hvide i øjnene på grund af lever- eller blodproblemer - hårtab.
English: An effect on female fertility was observed in the form of a decrease in implantations and an increase in pre-implantation loss at 70 mg/kg (5-fold the plasma exposure level in patients).
Danish: Der blev observeret en påvirkning af fertiliteten hos hundyr ved et fald i implantationer og en øgning i præimplantationstab ved doser på 70 mg/kg (5 gange plasmaeksponeringen hos patienter).
English: When dabigatran etexilate (150 mg) was co-administered with oral verapamil, the Cmax and AUC of dabigatran were increased but the magnitude of this change differs depending on timing of administration and formulation of verapamil (see sections 4.2 and 4.4).
Danish: Cmax og AUC af dabigatran øgedes ved samtidig indtagelse af dabigatranetexilat (150 mg) og oral verapamil, men omfanget af denne ændring afhænger af administrationstidspunktet og verapamil formuleringen (se pkt.
English: In the RE-LY study, a total of 18,113 patients were randomized, with a mean age of 71.5 years and a mean CHADS2 score of 2.1.
Danish: Disse havde en gennemsnitsalder på 71,5 år og en gennemsnitlig CHADS2 score på 2,1.
English: Dabigatran, the active moiety of dabigatran etexilate mesilate, is persistent in the environment.
Danish: Den aktive del af dabigatranetexilatmesilat, dabigatran, nedbrydes ikke i miljøet.
English: • Inform your doctor about your intake of Pradaxa
Danish: • Informér din læge om, at du tager Pradaxa
English: There are no data available for 110 mg twice daily Pradaxa treatment in patients undergoing catheter ablation for atrial fibrillation (see section 4.2).
Danish: Der foreligger ingen data for behandling med Pradaxa 110 mg to gange dagligt hos patienter, der gennemgår kateterablation for atrieflimren (se pkt.
English: - if you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack.
Danish: - hvis du har haft et hjerteanfald eller har en erkendt risiko for at få et hjerteanfald.
English: Use of proton-pump inhibitors
Danish: Brug af protonpumpehæmmere
English: Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (CrCL 30-50 mL/min), should be treated with caution (see sections 4.4 and 5.1).
Danish: Patienter med risiko for blødning eller patienter med risiko for overeksponering, især patienter med moderat nedsat nyrefunktion (CrCl 30-50 ml/min), bør behandles med forsigtighed (se pkt 4.4 og 5.1).
English: Nervous system disorders Intracranial haemorrhage
Danish: Nervesystemet Intrakraniel blødning
English: Prevention of blood clot formation after knee or hip replacement surgery The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).
Danish: Forebyggelse af, at blodpropper dannes efter knæ- eller hofteoperation Den anbefalede dosis er 220 mg én gang om dagen (taget som 2 kapsler Pradaxa på 110 mg).
English: In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).
Danish: I det præ-og postnatale studie sås en øget føtal mortalitet ved doser, der var toksiske for moderdyrene (en dosis svarende til en plasmaeksponering 4 gange højere end observeret hos patienter).
English: All bleeding events which occurred during warfarin therapy are included except for those during the overlap period between warfarin and parenteral therapy.
Danish: For warfarin gør det samme sig gældende med undtagelse af de blødninger, der forekom i den overlappende periode mellem warfarin og parenterel behandling.
English: VKA to Pradaxa: The VKA should be stopped.
Danish: Behandling med VKA stoppes.
English: Table 5: Transporter interactions
Danish: Tabel 5: Transporter-interaktioner
English: 2015;131:157-164] in more than 134,000 elderly patients with NVAF in the United States (contributing more than 37,500 patientyears of on-therapy follow-up time) dabigatran etexilate (84 % patients treated with 150 mg bid, 16 % patients treated with 75 mg bid) was associated with a reduced risk of ischemic stroke (hazard ratio 0.80, 95 % confidence interval [CI] 0.67 - 0.96), intracranial haemorrhage (hazard ratio 0.34, CI 0.26 - 0.46), and mortality (hazard ratio 0.86, CI 0.77 - 0.96) and increased risk of gastrointestinal bleeding (hazard ratio 1.28, CI 1.14 - 1.44) compared to warfarin.
Danish: 2015;131:157-164] hos over 134.000 ældre patienter med NVAF i USA (der bidrager med behandlingsopfølgningstid på over 37.500 patientår), var dabigatranetexilat (84 % patienter behandlet med 150 mg to gange dagligt, 16 % patienter behandlet med 75 mg to gange dagligt) forbundet med en nedsat risiko for iskæmisk apopleksi (hazard ratio 0,80; 95 % konfidensinterval [CI] 0,67 - 0,96), intrakraniel blødning (hazard ratio 0,34; CI 0,26 - 0,46) og mortalitet (hazard ratio 0,86; CI 0,77 - 0,96) og en øget risiko for gastrointestinal blødning (hazard ratio 1,28; CI 1,14 - 1,44), sammenlignet med warfarin.
English: Subjects randomized to Pradaxa 110 mg twice daily or 150 mg twice daily had a significantly lower risk for life-threatening bleeds and intracranial bleeding compared to warfarin [p < 0.05].
Danish: Patienter randomiseret til 110 mg Pradaxa 2 gange dagligt eller 150 mg 2 gange dagligt, havde en signifikant lavere risiko for livstruende blødning og intrakraniel blødning i forhold til warfarin behandlede [p <0,05].
English: It is recommended to continue with the remaining daily doses of Pradaxa at the same time of the next day.
Danish: Det anbefales at fortsætte med Pradaxa som planlagt på samme tid næste dag.
English: Pradaxa treatment (150 mg twice daily) does not need to be interrupted in patients undergoing catheter ablation for atrial fibrillation (see section
Danish: Det er ikke nødvendigt at pausere behandlingen med Pradaxa (150 mg to gange dagligt) hos patienter, der gennemgår kateterablation for atrieflimren (se pkt.
English: A higher anti-FXa/FIIa activity was observed after dabigatran etexilate administration with enoxaparin pre-treatment compared to that after treatment with dabigatran etexilate alone.
Danish: Efter forudgående behandling med enoxaparin sås en højere anti-FXa/FIIa aktivitet for dabigatran i forhold til behandling med dabigatranetexilat alene.
English: 21.7 % of patients had mild renal impairment (CrCL > 50 - < 80 mL/min) and 4.5% of patients had a moderate renal impairment (CrCL between 30 and 50 mL/min).
Danish: 21,7 % havde let nedsat nyrefunktion (CrCL > 50 - < 80 ml/min), og 4,5 % havde moderat nedsat nyrefunktion (CrCL mellem 30 og 50 ml/min).
English: Use of fibrinolytic medicinal products for the treatment of acute ischemic stroke The use of fibrinolytic medicinal products for the treatment of acute ischemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the upper limit of normal (ULN) according to the local reference range.
Danish: Behandling af akut iskæmisk apopleksi med fibrinolytika Det kan overvejes at anvende fibrinolytika ved behandling af akut apopleksi, hvis patientens dTT, ECT eller aPTT ikke overstiger den øvre værdi af det lokalt definerede normalområde (ULN).
English: ECT [x-fold upper limit of normal] aPTT [x-fold upper limit of normal] INR
Danish: ECT [x gange øvre normalgrænse] aPTT [x gange øvre normalgrænse] INR
English: Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Elective surgery
Danish: Elektiv kirurgi
English: The study compared 150 mg twice daily uninterrupted dabigatran etexilate with uninterrupted INR-adjusted warfarin in catheter ablation of paroxysmal or persistent atrial fibrillation.
Danish: Studiet sammenlignede kontinuert behandling med dabigatranetexilat 150 mg to gange dagligt med kontinuert behandling med INR-justeret warfarin ved kateterablation for paroksystisk eller vedvarende atrieflimren.
English: • Strong P-gp inhibitors (see section 4.3 and
Danish: • Potente P-gp-inhibitorer (se pkt.
English: Discontinuation of Pradaxa
Danish: Seponering af Pradaxa
English: INFORMATION IN BRAILLE Pradaxa 75 mg
Danish: INFORMATION I BRAILLESKRIFT Pradaxa 75 mg
English: Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors
Danish: Forebyggelse af apopleksi og systemisk emboli hos voksne patienter med NVAF med en eller flere risikofaktorer
English: When excessive dabigatran exposure is identified in patients at high risk of bleeding, a reduced dose of 220 mg taken as one 110 mg capsule twice daily is recommended.
Danish: Når for høj dabigatraneksponering er identificeret hos patienter med høj risiko for blødning, anbefales en reduceret dosis på 220 mg som 1 kapsel á 110 mg 2 gange dagligt.
English: The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
Danish: Den anbefalede daglige dosis er 300 mg som 1 kapsel a 150 mg 2 gange dagligt.
English: Subjects randomized Stroke and/or systemic embolism Incidences (%) Hazard ratio over warfarin (95 % CI) p value superiority p=0.2721
Danish: Apopleksi og/eller systemisk emboli Forekomst (%) Hazard ratio sammenlignet med warfarin (95 % CI) p value superiority p=0,2721
English: • Renal function should also be assessed when a decline in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products ).
Danish: • Under behandlingen bør nyrefunktionen vurderes, hvis der opstår kliniske situationer med mistanke om fald i nyrefunktionen (f.eks. hypovolæmi, dehydrering eller ved samtidig behandling med visse andre lægemidler).
English: No treatment experience is available for this subpopulation of patients, and therefore the use of Pradaxa is not recommended in this population.
Danish: Der er således ingen erfaringer med behandling, hvorfor Pradaxa ikke kan anbefales til denne delpopulation af patienter.
English: Pradaxa 75 mg are hard capsules with an opaque, white cap and an opaque, white body.
Danish: Pradaxa 75 mg er hårde kapsler med en uigennemsigtig, hvid top og en uigennemsigtig, hvid bund.
English: Patients following elective knee replacement surgery single capsule of 110 mg Pradaxa
Danish: Efter elektiv knæalloplastik Enkelt kapsel med 110 mg Pradaxa
English: Skin and subcutaneous tissue disorder Skin haemorrhage
Danish: Hud og subkutane væv Blødning i huden
English: Patients with elevated liver enzymes > 2 ULN were excluded in controlled clinical trials investigating the VTE prevention following elective hip or knee replacement surgery.
Danish: Patienter med forhøjede levertal, defineret som > 2 gange øvre normalgrænse (ULN), var udelukket fra de kliniske studier, hvor forebyggelse af VTE efter elektiv hofte- eller knæalloplastik blev undersøgt.
English: prevent the formation of blood clots in the veins after knee or hip replacement surgery.
Danish: - forhindre, at der dannes blodpropper i venerne efter en knæ- eller hofteoperation.
English: Table 12: Number (%) of patients experiencing the adverse reaction bleeding
Danish: Tabel 12: Antallet (%) af patienter, der fik bivirkningen blødning.
English: The most commonly reported events are bleedings occurring in approximately 14 % of patients treated short-term for elective hip or knee replacement surgery, 16.6 % in patients with atrial fibrillation treated long-term for the prevention of stroke and systemic embolism, and in 14.4 % of patients treated for DVT/PE.
Danish: De oftest rapporterede hændelser er blødninger, der forekommer hos cirka 14 % af patienterne behandlet kortvarigt efter elektiv hofte-eller knæalloplastik, hos 16,6 % af patienterne med atrieflimren behandlet langvarigt for at forebygge apopleksi og systemisk emboli og hos 14,4 % af patienterne behandlet for DVT/LE.
English: The most commonly reported events are bleedings occurring in approximately 16.6 % in patients with atrial fibrillation treated long-term for the prevention of stroke and systemic embolism and in 14.4 % of patients treated for DVT/PE.
Danish: De oftest rapporterede hændelser er blødninger, der forekommer hos cirka 16,6 % af atrieflimrenpatienterne behandlet for at forebygge apopleksi og systemisk emboli og hos 14,4 % af patienterne behandlet langvarigt for DVT/LE.
English: With chronic use in the RE-LY study, NSAIDs increased the risk of bleeding by approximately 50 % on both dabigatran etexilate and warfarin.
Danish: Langtidsbehandling med NSAID i RE-LY-studiet viste en øget blødningsrisiko på ca. 50 % for både dabigatranetexilat og warfarin.
English: Stroke and systemic embolism prevention in patients with atrial fibrillation
Danish: Forebyggelse af apopleksi og systemisk emboli hos patienter med atrieflimren
English: Limited data is available in patients < 50 kg (see section 5.2).
Danish: Data for patienter < 50 kg er begrænsede (se pkt.
English: 1-2 days before
Danish: 1-2 dage før
English: If you are taking amiodarone, quinidine or verapamil containing medicines, your doctor will tell you to use a reduced dose of Pradaxa.
Danish: Hvis du tager medicin, der indeholder amiodaron, kinidin eller verapamil, vil lægen fortælle dig, at du skal bruge en reduceret dosis Pradaxa.
English: Although rare in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.
Danish: Selvom det forekom sjældent i kliniske studier, er der set alvorlig eller svær blødning, der uafhængigt af placering kan have invaliderende, livstruende eller dødelig udgang.
English: ® before any surgery/invasive procedure.
Danish: ® før kirurgiske eller andre invasive procedurer.
English: In animal studies an effect on female fertility was observed in the form of a decrease in implantations and an increase in pre-implantation loss at 70 mg/kg (representing a 5-fold higher plasma exposure level compared to patients).
Danish: I dyrestudier blev der observeret en påvirkning af fertiliteten i hundyr med færre implantationer og et øget præimplantationstab ved doser på 70 mg/kg (5 gange højere plasmaeksponering end hos patienter).
English: blood in the urine that stains the urine pink or red), or under the skin - A fall in the number of red cells in the blood - Belly ache or stomach ache - Indigestion - Frequent loose or liquid bowel movements - Feeling sick
Danish: blod i urinen, der farver urinen pink eller rød) eller under huden - nedsat antal røde blodlegemer - mavesmerter - fordøjelsesbesvær - hyppig løs eller vandtynd afføring - utilpashed.
English: If you are taking verapamil containing medicines, you should be treated with a reduced Pradaxa dose of 220 mg taken as one 110 mg capsule twice a day, because your bleeding risk may be increased.
Danish: Er du også i behandling med verapamil-tabletter, så bør dosis af Pradaxa kun være 220 mg, der tages som 1 kapsel a 110 mg 2 gange dagligt, fordi din risiko for blødning kan være øget.
English: Dose of Pradaxa
Danish: Dosis af Pradaxa
English: Table 9: Number (%) of patients experiencing the adverse reaction bleeding
Danish: Tabel 9: Antallet (%) af patienter, der fik bivirkningen blødning.
English: The table 9 shows the number (%) of patients experiencing the adverse reaction bleeding during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.
Danish: Tabel 9 viser antallet (%) af patienter, der fik bivirkningen blødning under den VTE-forebyggende behandling i de to pivotale kliniske studier.
English: What you need to know before you take Pradaxa
Danish: Det skal du vide, før du begynder at tage Pradaxa
English: INFORMATION IN BRAILLE Pradaxa 110 mg
Danish: INFORMATION I BRAILLESKRIFT Pradaxa 110 mg
English: For situations of life-threatening or uncontrolled bleeding, when rapid reversal of the anticoagulation effect of dabigatran is required, the specific reversal agent (Praxbind, idarucizumab) is available (see section 4.9).
Danish: Ved livstruende eller ukontrolleret blødning, hvor det er nødvendigt hurtigt at modvirke dabigatrans antikoagulerende virkning, er den specifikke antidot Praxbind (idarucizumab) tilgængelig (se pkt.
English: 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.
Danish: Det primære endepunkt for begge studier var den samlede forekomst af VTE (inklusive lungeemboli, proksimal og distal DVT, hvad enten VTE var symptomatisk eller asymptomatisk (påvist ved rutineflebografi) samt alle dødsfald uanset årsag.
English: The RE-LY study demonstrated that dabigatran etexilate, at a dose of 110 mg twice daily, is non-inferior to warfarin in the prevention of stroke and systemic embolism in subjects with atrial fibrillation, with a reduced risk of ICH, total bleeding and major bleeding.
Danish: RE-LY-studiet viste, at dabigatranetexilate 110 mg 2 gange dagligt er non-inferior til warfarin ved forebyggelse af apopleksi og systemisk emboli hos patienter med atrieflimren og medfører en reduceret risiko for intrakraniel blødning, totalblødning og alvorlige blødninger.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pradaxa in all subsets of the paediatric population in prevention of thromboembolic events for the granted indication (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 ved forebyggelse af tromboemboliske tilfælde (se pkt.
English: For situations when rapid reversal of the anticoagulant effect of Pradaxa is required the specific reversal agent (Praxbind, idarucizumab) antagonizing the pharmacodynamic effect of Pradaxa is available (see section 4.4).
Danish: I tilfælde, hvor det er nødvendigt hurtigt at modvirke Pradaxas antikoagulerende virkning, er den specifikke antidot Praxbind (idarucizumab), som modvirker Pradaxas farmakodynamiske virkning, tilgængelig (se pkt 4.4).
English: Data for the total VTE and all cause mortality endpoint are shown in table 18.
Danish: De data, der vedrører endepunktet for kombinationen af VTE og mortalitet uanset årsag, fremgår af tabel 18.
English: 150 mg Pradaxa once daily taken as 2 capsules of 75 mg
Danish: 150 mg Pradaxa én gang dagligt i form af 2 kapsler a 75 mg
English: In total, 22 % of patients with atrial fibrillation treated for the prevention of stroke and systemic embolism (long-term treatment for up to 3 years), 14 % of patients treated for DVT/PE and 15 % of patients treated for DVT/PE prevention experienced adverse reactions.
Danish: Af patienter med atrieflimren behandlet for at forebygge apopleksi og systemisk emboli (langvarig behandling i op til 3 år) oplevede 22 % bivirkninger, og 14 % af patienter behandlet for DVT/LE samt 15 % af patienter i forebyggende behandling for DVT/LE, oplevede bivirkninger.
English: Furthermore, Pradaxa is available in packs containing 60 x 1 capsules in aluminium perforated unit dose white blisters.
Danish: Desuden fås Pradaxa i pakninger med 60 x 1 kapsel i perforerede hvide aluminiums-blisterkort.
English: Wound secretion
Danish: Blodigt sekret
English: Table 11 shows the adverse reactions identified from studies and post-marketing data in the indications primary VTE prevention after hip or knee replacement surgery, prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation, DVT/PE treatment and DVT/PE prevention.
Danish: Tabel 11 viser bivirkninger registreret i studier og fra data efter markedsføring for indikationerne primær forebyggelse af VTE efter hofte-eller knæalloplastik, forebyggelse af tromboembolisk apopleksi og systemisk emboli hos patienter med atrieflimren, behandling af DVT/LE og forebyggelse af recidiverende DVT/LE.
English: No dose adjustment is necessary (see section 5.2), but close clinical surveillance is recommended in patients with a body weight < 50 kg (see section 4.4).
Danish: 5.2), men for patienter med en kropsvægt < 50 kg anbefales tæt klinisk overvågning (se pkt.
English: It is recommended to wait 12 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Danish: Det anbefales, at man venter 12 timer efter den sidste Pradaxa-dosis, før man starter op på parenteral antikoagulans (se pkt.