FrancophonIA/ELRC3.0 huggingface dataset:
English: All symptomatic treatment should be given according to the physician's judgement.
Danish: Al symptomatisk behandling skal gives ud fra lægens vurdering.
English: The educational pack must be available for distribution for all therapeutic indications prior to launch ) in the Member State.
Danish: Uddannelsesmaterialet skal være klar til distribution for alle terapeutiske indikationer før lancering i medlemslandet.
English: Duration of maintenance dose
Danish: Varighed af vedligeholdelsesdosis
English: All patients underwent a Trans-oesophageal Echocardiography (TEE) prior to catheter ablation.
Danish: Alle patienterne fik foretaget transøsofageal ekkokardiografi (TEE) før kateterablation.
English: This effect was seen primarily in patients ≥ 75 years.
Danish: Denne virkning sås primært hos patienter ≥ 75 år.
English: Close clinical surveillance
Danish: Tæt klinisk overvågning
English: CrCL(mL/min) 30 ≤ and < 50 50 ≤ and < 80
Danish: CrCL (ml/min) 30 ≤ og < 50 50 ≤ og < 80
English: Cardioversion (SPAF)
Danish: Kardiovertering (SPAF)
English: SPECIAL STORAGE CONDITIONS Keep the bottle tightly closed.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Hold beholderen tæt tillukket.
English: • Information on medicinal products that are contraindicated or which should be used with caution due to an increased risk of bleeding and/or increased dabigatran exposure
Danish: • Information om lægemidler, der er kontraindiceret eller som bør anvendes med forsigtighed pga. øget risiko for blødning og/eller øget dabigatran eksponering
English: Myocardial Infarction (MI)
Danish: Myokardieinfarkt (MI)
English: Concomitant use not recommended
Danish: Samtidig anvendelse ikke anbefalet
English: A surgery / intervention should be delayed if possible until at least 12 hours after the last dose.
Danish: Hvis muligt, bør operation/indgreb udsættes i mindst 12 timer efter sidste dosis.
English: Itraconazole, cyclosporine
Danish: Itraconazol, ciclosporin
English: • Lesion or condition, if considered a significant risk factor for major bleeding.
Danish: • Læsion eller tilstand, der betragtes som en betydende risikofaktor for en større blødning.
English: The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia.
Danish: Tegnene, symptomerne og sværhedsgraden (herunder dødeligt udfald) vil variere i forhold til placeringen og graden eller omfanget af blødningen og/eller anæmien.
English: Relative risk was highest in patients ≥ 75 years.
Danish: Den relative risiko var størst hos patienter ≥ 75 år.
English: In this situation Pradaxa and verapamil should be taken at the same time.
Danish: I denne situation bør Pradaxa og verapamil tages på samme tid.
English: Coagulation tests may become unreliable following administration of suggested coagulation factor concentrates.
Danish: Koagulationstest kan blive upålidelige efter administration af ovenstående koagulationsfaktor-koncentrater.
English: This is considered to be due to the carry-over effect of enoxaparin treatment, and regarded as not clinically relevant.
Danish: Dette anses for en carry-over-effekt af enoxaparinbehandlingen, og betragtes ikke som klinisk relevant.
English: After an intravenous dose, the dabigatran-derived radioactivity was eliminated primarily in the urine (85 %).
Danish: Efter en intravenøs dosis blev radioaktiviteten stammende fra dabigatran primært udskilt med urinen (85 %).
English: • Active clinically significant bleeding
Danish: • Aktiv klinisk signifikant blødning
English: ® TT (Anti-FIIa) 1.36 fold, respectively.
Danish: ® TT (Anti-FIIa) 1,36 gange.
English: If possible, Pradaxa should be discontinued at least 24 hours before invasive or surgical procedures.
Danish: Hvis muligt, bør Pradaxa seponeres mindst 24 timer før invasive/kirurgiske procedurer.
English: Therefore, related medicinal product interactions are not expected with dabigatran.
Danish: Der forventes derfor ingen dertil relaterede lægemiddelinteraktioner med dabigatran.
English: Instructions for opening the blisters
Danish: Anvisninger i at åbne blisterne
English: Additional requirements in patients with mild to moderate renal impairment and in patients aged over 75 years:
Danish: Yderligere krav hos patienter med let til moderat nedsat nyrefunktion og hos patienter over 75 år:
English: RE-NOVATE (hip)
Danish: RE-NOVATE (hofte)
English: • Management of overdose situations
Danish: • Håndtering af overdosering
English: which would be 1.8-fold compared to baseline.
Danish: hvilket er 1,8 gange længere end ved baseline.
English: In these four phase III trials, 16,709 patients were exposed to Pradaxa (see Table 9).
Danish: I disse 4 fase III-studier blev 16.709 patienter eksponeret over for Pradaxa (se tabel 9).
English: The ECT can provide a direct measure of the activity of direct thrombin inhibitors.
Danish: ECT kan give et direkte mål for aktiviteten af direkte trombinhæmmere.
English: The Prescriber Guide should contain the following key safety messages:
Danish: Ordinationsvejledningen skal indeholde følgende hovedpunkter om sikkerhed:
English: When to seek medical advice
Danish: Hvornår skal du søge lægehjælp?
English: Mean on-therapy follow-up time was 18.3 months.
Danish: Gennemsnitlig opfølgningstid for behandlingen var 18,3 måneder.
English: A dose reduction should be either considered or is recommended as indicated in section 4.2.
Danish: En dosisreduktion bør enten overvejes eller anbefales som indikeret i pkt.
English: The following pictogram illustrates how to take Pradaxa capsules out of the blister
Danish: Følgende piktogram viser, hvordan du skal tage kapslerne ud af blisteren
English: The efficacy and safety have not been established for DVT/PE patients with active cancer.
Danish: Virkning og sikkerhed er ikke klarlagt for DVT/LE-patienter med aktiv kræft.
English: You should not take Pradaxa if you are pregnant unless your doctor advises you that it is safe to do so.
Danish: Du må ikke tage Pradaxa, hvis du er gravid, medmindre din læge siger, at det er sikkert nok for dig.
English: Indication for anticoagulation
Danish: Indikation for antikoagulation
English: Pradaxa treatment should not be discontinued without medical advice.
Danish: Behandlingen med Pradaxa må ikke seponeres uden medicinsk rådgivning.
English: Four positional isomers, 1-O, 2-O, 3-O, 4-O-acylglucuronide exist, each accounts for less than 10 % of total dabigatran in plasma.
Danish: Der findes fire positionelle isomerer, 1-O, 2-O, 3-O og 4-O-acylglucuronid, som hver tegner sig for mindre end 10 % af den samlede dabigatran i plasma.
English: The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters.
Danish: Der kan være en øget risiko for spinalt eller epiduralt hæmatom i tilfælde af traumatisk eller gentagen punktur og ved langvarig brug af epidural katetre.
English: After multiple doses a terminal half-life of about 12-14 hours was observed.
Danish: Efter gentagen indtagelse observeredes en terminal halveringstid på 12-14 timer.
English: Number of patients treated with Pradaxa
Danish: Antal patienter behandlet med Pradaxa
English: The safety of Pradaxa has been evaluated in ten phase III studies including 23,393 patients exposed to Pradaxa (see Table 10).
Danish: Pradaxas sikkerhed er blevet evalueret i 10 fase III-studier, der inkluderede 23.393 patienter, som blev eksponeret for Pradaxa (se tabel 10).
English: • Bacterial endocarditis
Danish: • Bakteriel endocarditis
English: Component of a multipack, can´t be sold separately.
Danish: Delpakning - kan ikke sælges separat.
English: Please complete this section or ask your doctor to do it.
Danish: Udfyld dette afsnit eller bed din læge om at gøre det. Patientinformation
English: Dabigatran prolongs the thrombin time (TT), ECT, and aPTT.
Danish: Dabigatran forlænger trombintiden (TT), ECT og aPTT.
English: Test (trough value)
Danish: Test (trough-værdi)
English: Pradaxa should be temporarily discontinued.
Danish: Pradaxa bør seponeres midlertidigt.
English: The clinical studies have been conducted in a patient population with a mean age > 65 years.
Danish: I de kliniske studier havde patientpopulationen en gennemsnitsalder på > 65 år.
English: The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.
Danish: Metoden, der skal anvendes til at estimere nyrefunktionen (CrCL i ml/min), er Cockcroft-Gaultmetoden.
English: Transporter interactions
Danish: Transporter-interaktioner
English: Based on in vitro results a similar effect as with ketoconazole may be expected.
Danish: Baseret på in vitro-resultater kan der forventes en virkning, som svarer til ketoconazols.
English: Both dose strengths of Pradaxa had also a statistically significant lower total bleed rate.
Danish: For begge doser af Pradaxa var der også en statistisk signifikant lavere forekomst af alle blødninger.
English: No difference was found for major bleeding (hazard ratio 0.97, CI 0.88 - 1.07).
Danish: Der blev ikke fundet nogen forskel for større blødning (hazard ratio 0,97; CI 0,88 - 1,07).
English: Although high aPTT values should be interpreted with caution, a high aPTT value indicates that the patient is anticoagulated.
Danish: Selvom høje aPTT-værdier bør tolkes med forsigtighed, indikerer en høj aPTT værdi, at patienten er antikoaguleret.
English: • Inform your doctor about all medicines you are currently taking.
Danish: • Informér din læge om anden medicin, som du også tager.
English: There were no differences in the phase 3 clinical studies for efficacy and safety data between men and women.
Danish: Der var ingen forskelle mellem mænd og kvinder i de kliniske fase 3-studier med hensyn til effekt og sikkerhed.
English: If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Pradaxa.
Danish: Hvis du er kvinde i den fødedygtige alder, bør du undgå graviditet, mens du tager Pradaxa.
English: There was no significant interaction of treatment effects with the subgroups of renal function and CHADS2 score.
Danish: Der var ingen signifikant indvirkning på behandlingseffekten mellem subgrupper af forskellig nyrefunktionsstatus og CHADS2-score.
English: No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Danish: Der er ikke observeret klinisk relevante inter-etniske forskelle mellem kaukasiske, afro-amerikanske, latin-amerikanske, japanske eller kinesiske patienter.
English: Contact your doctor immediately if you have taken too many Pradaxa capsules.
Danish: Kontakt straks lægen, hvis du har taget for mange kapsler med Pradaxa.
English: All secondary and sensitivity analyses of the primary endpoint and all secondary endpoints showed superiority of dabigatran etexilate over placebo.
Danish: Alle sekundære analyser og sensitivitetsanalyser af det primære endepunkt og alle sekundære endepunkter viste, at dabigatranetexilat var superior overfor placebo.
English: Thereafter two capsules once a day should be taken for a total of 28-35 days.
Danish: Fra næste dag skal du tage 2 kapsler én gang dagligt i totalt 28-35 dage.
English: DVT/PE prevention (RE-MEDY, RESONATE)
Danish: DVT/LE-forebyggelse (RE-MEDY, RESONATE)
English: Maintenance dose starting on the first day after surgery
Danish: Vedligeholdelsesdosis, der starter den første dag efter operationen
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 March 2008
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 18. marts 2008 Dato for seneste fornyelse: 08. januar 2018
English: Faecal excretion accounted for 6 % of the administered dose.
Danish: Udskillelse gennem fæces udgjorde ca. 6 % af den administrerede dosis.
English: Assessment of renal function prior to and during Pradaxa treatment
Danish: Vurdering af nyrefunktionen før og under behandling med Pradaxa
English: • Congenital or acquired coagulation disorders
Danish: • Medfødte eller erhvervede koagulationsforstyrrelser
English: Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.
Danish: Derfor skal muligheden for en blødning overvejes, når tilstanden for alle antikoagulerede patienter evalueres.
English: You may need to be checked by a doctor, as you may be at increased risk of bleeding.
Danish: Det kan være nødvendigt, at du bliver undersøgt af en læge, da du kan have en øget risiko for blødning.
English: In vitro interaction studies did not show any inhibition or induction of the principal isoenzymes of cytochrome P450.
Danish: In vitro-interaktionsstudier viste ingen hæmning eller induktion af de vigtigste isoenzymer af cytokrom P450.
English: Pradaxa treatment to Vitamin K antagonists (VKA):
Danish: Fra Pradaxa til vitamin K-antagonist (VKA):
English: Close clinical surveillance is recommended in patients with renal impairment.
Danish: Tæt klinisk overvågning anbefales hos patienter med nedsat nyrefunktion.
English: Pradaxa should not be used during pregnancy unless clearly necessary.
Danish: Pradaxa bør ikke anvendes under graviditet, medmindre det er på tvingende indikation.
English: Patients who underwent Percutaneous coronary intervention (PCI) with stenting
Danish: Patienter, som gennemgik perkutan koronar intervention (PCI) med stenting
English: Known bleeding complications such as compartment syndrome and acute renal failure due to hypoperfusion have been reported for Pradaxa.
Danish: Kendte blødningskomplikationer som kompartment syndrom og akut nyresvigt på grund af hypoperfusion er blevet rapporteret for Pradaxa.
English: The study included observational follow-up for 12 months after the conclusion of treatment.
Danish: RE-SONATE-studiet inkluderede en opfølgende observationsperiode på 12 måneder efter endt behandling.
English: 95 % confidence interval
Danish: 95 % konfidensinterval
English: ® is an oral anticoagulant (direct thrombin inhibitor).
Danish: ® er et oralt antikoagulans (direkte trombin-hæmmer).
English: This has been confirmed by in vivo studies with healthy volunteers, who did not show any interaction between this treatment and the following active substances: atorvastatin (CYP3A4), digoxin (P-gp transporter interaction) and diclofenac (CYP2C9).
Danish: Dette er bekræftet i in vivo-studier med raske frivillige, som ikke viste interaktion mellem dabigatran og følgende aktive stoffer: atorvastatin (CYP3A4), digoxin (P-gptransporterinteraktion) og diclofenac (CYP2C9).
English: • CrCL ≥ 50 mL/min, VKA should be started 3 days before discontinuing Pradaxa
Danish: • CrCL ≥ 50 ml/min, VKA bør startes 3 dage før ophør med Pradaxa
English: In actively controlled VTE prevention trials 6,684 patients were treated with 150 mg or 220 mg Pradaxa daily.
Danish: I aktivt-kontrollerede studier med henblik på forebyggelse af VTE blev 6.684 patienter behandlet med 150 mg eller 220 mg Pradaxa dagligt.
English: Date of birth
Danish: Fødselsdato
English: For the indication DVT/PE, the safety and efficacy of Pradaxa in children from birth to less than 18 years of age have not yet been established.
Danish: For indikationen DVT/LE er Pradaxas sikkerhed og virkning hos børn under 18 år endnu ikke klarlagt.
English: Dose reductions may be required in combination with some P-gp inhibitors (see sections 4.2, 4.3, 4.4 and 5.1).
Danish: Dosisreduktioner kan være nødvendige i kombination med nogle P-gp-inhibitorer (se pkt 4.2, 4.3, 4.4 og 5.1).
English: The relative risk of bleeding with dabigatran compared to warfarin increased with age.
Danish: Den relative risiko for blødning ved behandling med dabigatran sammenlignet med warfarin var større med stigende alder.
English: Postoperative phase
Danish: Post-operative fase
English: Patients should be instructed to contact the treating physician if they develop gastrointestinal symptoms such as dyspepsia (see section
Danish: Patienterne skal instrueres i at kontakte den behandlende læge, hvis de udvikler mave-tarm-symptomer, såsom dyspepsi (se pkt.
English: of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: (lægemiddelovervågning eller risikominimering) er nået.
English: In the pooled RE-COVER and RE-COVER II studies, a total of 5,153 patients were randomised and 5,107 were treated.
Danish: I alt 5.153 patienter blev randomiseret i de poolede RE-COVER og RE-COVER II-studier, og 5.107 patienter blev behandlet.
English: After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of Pradaxa.
Danish: Efter fjernelse af et kateter, skal der gå mindst 2 timer før administration af den første dosis Pradaxa.
English: Dabigatran etexilate and dabigatran are not metabolised by the cytochrome P450 system and have no in vitro effects on human cytochrome P450 enzymes.
Danish: Dabigatranetexilat og dabigatran metaboliseres ikke via cytokrom P450-systemet og har ingen virkning in vitro på humane cytokrom P450-enzymer.
English: It works by blocking a substance in the body which is involved in blood clot formation.
Danish: Det virker ved at blokere for et stof i kroppen, som bruges til at danne blodpropper.
English: Pradaxa treatment can be re-initiated 24 hours after administration of Praxbind (idarucizumab), if the patient is clinically stable and adequate haemostasis has been achieved.
Danish: Behandling med Pradaxa kan genoptages 24 timer efter administration af Praxbind (idarucizumab), hvis patienten er klinisk stabil, og der er opnået tilstrækkelig hæmostase.
English: Life-threatening bleeding was reported in 0.46 per 100 patient-years, intracranial haemorrhage in 0.17 per 100 patient-years and gastrointestinal bleeding in 0.60 per 100 patient-years.
Danish: Livstruende blødning blev rapporteret hos 0,46 pr. 100 patientår, intrakraniel blødning hos 0,17 pr. 100 patientår og gastrointestinal blødning hos 0,60 pr. 100 patientår.
English: DVT/PE treatment (RECOVER, RE-COVER II)
Danish: DVT/LE-behandling (RE-COVER, RECOVER II)
English: What Pradaxa contains
Danish: Pradaxa indeholder
English: There are limited efficacy and safety data for Pradaxa available in these patients and therefore they should be treated with caution.
Danish: Der er begrænsede data for Pradaxas virkning og sikkerhed i disse patienter, og der bør udvises forsigtighed ved behandling.
English: The amount of substance cleared by dialysis is proportional to the blood flow rate up to a blood flow rate of 300 mL/min.
Danish: Mængden af aktivt stof, der fjernes ved dialyse, er proportional med blodgennemstrømningshastigheden op til en blodgennemstrømningshastighed på 300 ml/min.
English: The International Normalised Ratio (INR) test is unreliable in patients on Pradaxa and false positive INR elevations have been reported.
Danish: Den internationale normaliserede ratio (INR) er upålidelig hos patienter i behandling med Pradaxa, og der er rapporteret falsk positive INR-stigninger.
English: Pharmacodynamic and kinetic factors
Danish: Farmakodynamiske og kinetiske faktorer
English: Excessive anticoagulation may require interruption of Pradaxa treatment.
Danish: Overdreven antikoagulation kan kræve afbrydelse af Pradaxa-behandling.
English: Precautions and management of the haemorrhagic risk For the management of bleeding complications, see also section 4.9.
Danish: Forsigtighedsregler og behandling af blødningsrisiko For behandling af blødningskomplikationer, se også pkt 4.9.
English: The primary endpoint was a combined endpoint of major bleeds based on ISTH definition or clinically relevant non-major bleeding event.
Danish: Det primære endepunkt var et kombineret endepunkt med større blødninger, baseret på ISTH-definitionen, eller klinisk relevante ikke-større blødningshændelser.
English: The volume of distribution of dabigatran of 60-70 L exceeded the volume of total body water indicating moderate tissue distribution of dabigatran.
Danish: Distributionsvolumen var 60-70 l, hvilket overstiger mængden af den samlede kropsvæske og antyder en moderat vævsdistribution af dabigatran.
English: Posaconazole Posaconazole also inhibits P-gp to some extent but has not been clinically studied.
Danish: Også posaconazol hæmmer i nogen grad P-gp, men det er ikke undersøgt klinisk.
English: ® thins the blood, which prevents you from getting dangerous bood clots.
Danish: ® fortynder blodet, hvilket forhindrer, at du får farlige blodpropper.
English: • Other medicinal products which may impair haemostasis
Danish: • Andre lægemidler, der kan påvirke hæmostasen
English: • Hepatic impairment or liver disease expected to have any impact on survival
Danish: • Nedsat leverfunktion eller leversygdom, som forventes at påvirke overlevelsen
English: Patients were eligible for the RELY-ABLE trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit.
Danish: Patienter kunne indkluderes i RELY-ABLE, hvis de ikke havde afbrudt studiemedicinen permanent efter sidste RE-LY-besøg.
English: Pradaxa can be given as soon as the INR is < 2.0.
Danish: Pradaxa-behandling startes når INR er < 2,0.
English: • Recommendation for kidney function measurement
Danish: • Anbefaling om måling af nyrefunktion
English: Diluted thrombin time (dTT), ecarin clotting time (ECT) and activated partial thromboplastin time (aPTT) may provide useful information, but results should be interpreted with caution due to inter-test variability (see section 5.1).
Danish: Fortyndet trombintid (dTT), ecarin-koagulationstid (ECT) og aktiveret partiel tromboplastintid (aPTT) kan give nyttig information, men resultaterne skal tolkes med forsigtighed, på grund af variabilitet fra test til test (se pkt.
English: Stroke occurred in 0.65 per 100 patient-years.
Danish: Slagtilfælde opstod hos 0,65 pr. 100 patientår.
English: • Contraindication for patients with prosthetic heart valves requiring anticoagulant treatment
Danish: • Kontraindiceret hos patienter med hjerteklapprotese, der kræver behandling med antikoagulans
English: P-gp substrate Digoxin
Danish: P-gp-substrater Digoxin
English: gMean (gCV%; range) half-life [h]
Danish: gMean (gCV %; range) halveringstid [h]
English: Dabigatran etexilate is a substrate for the efflux transporter P-gp.
Danish: Dabigatranetexilat er et substrat for efflukstransporteren P-gp.
English: Do not break, chew, or empty the pellets from the capsule since this may increase the risk of bleeding.
Danish: Lad være med at åbne eller tygge kapslen eller tage indholdet ud, da det kan øge blødningsrisikoen.
English: Pradaxa can be taken with or without food.
Danish: Pradaxa kan tages med eller uden mad.
English: Not known (frequency cannot be estimated from the available data): - Difficulty in breathing or wheezing - Hair loss
Danish: Ikke kendt (hyppigheden kan ikke beregnes ud fra de tilgængelige data): - vejrtrækningsbesvær eller hvæsende vejrtrækning - hårtab.
English: Traces of other metabolites were only detectable with highly sensitive analytical methods.
Danish: Kun med meget sensitive analytiske metoder kunne der identificeres spor af andre metabolitter.
English: Food does not affect the bioavailability of dabigatran etexilate but delays the time to peak plasma concentrations by 2 hours.
Danish: Mad påvirker ikke biotilgængeligheden af dabigatranetexilat, men forsinker tiden til maksimumkoncentration i plasma med 2 timer.
English: The median CrCL in the RE-MEDY and RE-SONATE studies were 99.0 mL/min and 99.7 mL/min, respectively.
Danish: Den gennemsnitlige CrCL i RE-MEDY- og RE-SONATE-studierne var henholdsvis 99,0 ml/min og 99,7 ml/min.
English: Dabigatran is eliminated primarily in the unchanged form in the urine, at a rate of approximately 100 mL/min corresponding to the glomerular filtration rate.
Danish: Dabigatran udskilles primært i uændret form med urinen med en hastighed på ca. 100 ml/min, svarende til den glomerulære filtrationshastighed.
English: For dose modifications in this population see table 1 above.
Danish: For dosismodifikationer hos denne population, se tabel 1 ovenfor.