FrancophonIA/ELRC3.0 huggingface dataset:
English: A trauma model in pigs was performed using a blunt liver injury after dosing with dabigatran to achieve supratherapeutic concentrations of about 10-fold of human plasma levels.
Danish: Der blev brugt en traumemodel med grise med stump leverskade for at opnå supraterapeutiske koncentrationer af dabigatran på cirka 10 gange humant plasmaniveau.
English: Serum samples from 283 subjects in phase I trials (224 volunteers treated with idarucizumab) and 501 patients were tested for antibodies to idarucizumab before and after treatment.
Danish: Serumprøver fra 283 forsøgspersoner i fase I-studier (224 frivillige behandlet med idarucizumab) og 501 patienter blev testet for antistoffer mod idarucizumab før og efter behandling.
English: • patients require a second emergency surgery/urgent procedure and have prolonged clotting times.
Danish: • hvis patienten skal have foretaget endnu en akut operation/akut procedure og har forhøjede koagulationsparametre.
English: The transient proteinuria usually peaked about 4 h after idarucizumab administration and normalised within 12-24 hours.
Danish: Den forbigående proteinuri havde som regel maksimum ca. 4 timer efter administration af idarucizumab og blev typisk normaliseret inden for 12-24 timer.
English: Effect of idarucizumab on the exposure and anticoagulant activity of dabigatran
Danish: Idarucizumabs virkning på dabigatran-eksponering og dabigatrans antikoagulerende aktivitet
English: Thrombotic events were reported in 34 patients (23 out of the 34 patients were not on antithrombotic therapy at the time of the event) and in each of these cases, the thrombotic event could be attributed to the underlying medical condition of the patient.
Danish: Der er rapporteret om trombotiske hændelser hos 34 patienter (23 ud af 34 patienter var ikke i antitrombotisk behandling på tidspunktet for hændelsen).
English: If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.
Danish: Hvis Praxbind administreres til disse patienter, skal de holdes under intensiveret lægeopsyn i 24 timer efter Praxbind-eksponeringen.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Praxbind should be discontinued immediately and appropriate therapy initiated.
Danish: I tilfælde af en anafylaktisk reaktion eller anden alvorlig allergisk reaktion skal Praxbind straks seponeres og relevant behandling iværksættes.
English: Idarucizumab alone has shown no procoagulant effect measured as ETP.
Danish: Idarucizumab har ikke i sig selv vist prokoagulerende virkning målt som ETP.
English: No anti-idarucizumab antibodies were detected in these subjects prior to the second administration.
Danish: Der blev ikke påvist anti-idarucizumab-antistoffer hos disse forsøgspersoner før genadministrationen.
English: Solution for injection/infusion
Danish: Intravenøs injektion/infusion.
English: The following information is intended for healthcare professionals only:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale.
English: Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:
Danish: Praxbind er en specifik antidot mod dabigatran og er indiceret til voksne patienter, der behandles med Pradaxa (dabigatranetexilat), når det er nødvendigt hurtigt at modvirke dabigatrans antikoagulerende virkning:
English: After administration of Praxbind, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.
Danish: Efter administration af Praxbind kan anden antitrombotisk behandling til enhver tid iværksættes (fx lavmolekylært heparin), hvis patienten er klinisk stabil, og der er opnået tilstrækkelig hæmostase.
English: Pradaxa (dabigatran etexilate) treatment can be re-initiated 24 hours after administration of Praxbind, if the patient is clinically stable and adequate haemostasis has been achieved.
Danish: Behandling med Pradaxa (dabigatranetexilat) kan genoptages 24 timer efter administration af Praxbind, hvis patienten er klinisk stabil, og der er opnået tilstrækkelig hæmostase.
English: In patients with hereditary fructose intolerance there is a risk for serious adverse reactions, which must be weighed against the benefit of an emergency treatment with Praxbind.
Danish: Patienter med arvelig fruktoseintolerans risikerer alvorlige bivirkninger, som skal afvejes mod fordelen ved en akut behandling med Praxbind.
English: No treatmentrelated effects have been identified in reproductive tissues of either sex during repeat dose intravenous toxicity studies of up to four weeks in the rat and two weeks in monkeys.
Danish: Der er ikke påvist behandlingsrelaterede virkninger i reproduktivt væv hos nogen af kønnene under toksicitetsstudier med gentagne intravenøse doser hos rotter (op til fire uger) og aber (to uger).
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate (see section 4.2).
Danish: For at reducere denne risiko skal det overvejes at genoptage den antikoagulerende behandling, så snart det er klinisk hensigtsmæssigt (se pkt.
English: 24 hours after the idarucizumab infusion, re-administration of dabigatran etexilate resulted in expected anticoagulant activity.
Danish: Fornyet administration af dabigatranetexilat 24 timer efter infusion af idarucizumab resulterede i forventet antikoagulerende aktivitet.
English: The primary endpoint was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, based on central laboratory determination of dilute thrombin time (dTT) or ecarin clotting time (ECT).
Danish: Det primære effektmål var maksimal revertering af dabigatrans antikoagulerende virkning (i % af patienter) inden for 4 timer efter administration af idarucizumab, baseret på central laboratoriets bestemmelse af fortyndet trombintid (dTT) eller ecarin-koagulationstid (ECT).
English: Praxbind is for single-use only and does not contain preservatives (see section 6.3).
Danish: Praxbind er kun til engangsbrug og indeholder ingen konserveringsmidler (se pkt.
English: Praxbind solution for injection/infusion is a clear to slightly opalescent, colourless to slightly yellow solution supplied in a glass vial closed with a butyl rubber stopper and an aluminium cap.
Danish: Praxbind injektions-/infusionsvæske, opløsning, er en klar til let opaliserende, farveløs til lys gullig opløsning i et hætteglas lukket med en butylgummiprop og en aluminiumshætte.
English: Preclinical investigations with idarucizumab have shown no interactions with
Danish: Prækliniske undersøgelser med idarucizumab har ikke vist interaktion med
English: • if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or
Danish: • hvis en eventuel ny blødning vil være potentielt livstruende, og der ses forhøjede koagulationsparametre, eller
English: No dose adjustment is required in renally impaired patients.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: Representative values for pharmacokinetic and pharmacodynamics parameters were established on the basis of healthy subjects aged 45-64 years receiving 5 g idarucizumab (see sections 5.1 and 5.2).
Danish: Repræsentative værdier for farmakokinetiske og farmakodynamiske parametre blev fastlagt på basis af raske frivillige i alderen 45-64 år, som fik 5 g idarucizumab (se pkt.
English: In a subset of patients, recurrence of plasma levels of unbound dabigatran and concomitant elevation of clotting tests was observed, possibly due to re-distribution of dabigatran from the periphery.
Danish: I en subgruppe af patienter forekom der igen ubundet dabigatran i plasma samtidig med forlænget koagulationstid, muligvis på grund af redistribution af dabigatran fra perifert væv.
English: For storage conditions after opening of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter anbrud af lægemidlet, se pkt.
English: Thus idarucizumab will not reverse the effects of other anticoagulants.
Danish: Idarucizumab modvirker derfor ikke effekten af andre antikoagulantia.
English: In one subject, treatment-emergent anti-idarucizumab antibodies were detected after the second administration.
Danish: Hos én forsøgsperson blev der påvist behandlingsrelaterede anti-idarucizumab-antistoffer efter genadministrationen.
English: 50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminium cap and a label with integrated hanger.
Danish: 50 ml injektions-/infusionsvæske i et hætteglas (type I-glas) med butylgummiprop, aluminiumshætte og en etiket med indbygget ophængningsfunktion.
English: Re-administration of dabigatran etexilate
Danish: Genadministration af dabigatranetexilat
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 dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: No impact on the pharmacokinetics or the reversal effect of idarucizumab or hypersensitivity reactions were observed.
Danish: Der blev ikke observeret nogen påvirkning af idarucizumabs farmakokinetik eller antidotvirkning, og der sås ingen overfølsomhedsreaktioner.
English: For additional instructions for use and handling see section 6.6.
Danish: 6.6 for yderligere instruktioner i brug og håndtering.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTLLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Idarucizumab exhibited multiphasic disposition kinetics and limited extravascular distribution.
Danish: Idarucizumab udviste flerfaset kinetik og begrænset ekstravaskulær fordeling.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection/infusion contains 50 mg idarucizumab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml injektions-/infusionsvæske, opløsning, indeholder 50 mg idarucizumab.
English: Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
Danish: Hvis der ikke gives antitrombotisk behandling, udsættes patienten for den trombotiske risiko ved den underliggende sygdom eller tilstand.
English: Handling instructions:
Danish: Brugervejledning:
English: Pack size of 2 vials.
Danish: Pakning med 2 hætteglas.
English: No dose adjustment is required in patients with hepatic injury (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med leverskade (se pkt.
English: The pharmacodynamics of idarucizumab after administration of dabigatran etexilate were investigated in 141 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Danish: Idarucizumabs farmakodynamik efter administration af dabigatranetexilat er undersøgt hos 141 forsøgspersoner i fase I-studier, og data fra en repræsentativ subgruppe på 6 raske frivillige i alderen 45 til 64 år, som fik en dosis på 5 g som intravenøs infusion, præsenteres i det følgende afsnit.
English: The pharmacokinetics of idarucizumab were investigated in 224 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Danish: Idarucizumabs farmakokinetik er undersøgt hos 224 forsøgspersoner i fase I-studier, og data fra en repræsentativ subgruppe på 6 raske frivillige i alderen 45 til 64 år, som fik en dosis på 5 g som intravenøs infusion, præsenteres.
English: Dabigatran prolongs the clotting time of coagulation markers such as diluted Thrombin Time (dTT), Thrombin Time (TT), activated Partial Thromboplastin Time (aPTT) and Ecarin Clotting Time (ECT), which provide an approximate indication of the anticoagulation intensity.
Danish: Dabigatran forlænger koagulationstiden af koagulationsmarkører som fortyndet trombintid (dTT), trombintid (TT), aktiveret partiel tromboplastintid (aPPT) og ecarin-koagulationstid (ECT), som giver et tilnærmelsesvist udtryk for antikoagulationsintensiteten.
English: • recurrence of clinically relevant bleeding together with prolonged clotting times, or
Danish: • hvis der igen forekommer klinisk relevant blødning, samtidig med forhøjede koagulationsparametre, eller
English: No local irritation of the blood vessel was observed after i.v.
Danish: Der sås ingen lokal irritation af blodkar efter i.v.- eller paravenøs administration af idarucizumab.
English: Studies to assess the potential reproductive effects of idarucizumab have not been performed.
Danish: Der er ikke gennemført studier til evaluering af idarucizumabs virkning på reproduktion.
English: 6.1 List of excipients sodium acetate trihydrate acetic acid sorbitol polysorbate 20 water for injection
Danish: 6.1 Hjælpestoffer natriumacetattrihydrat eddikesyre sorbitol polysorbat 20 vand til injektionsvæsker
English: Additionally, no idarucizumab binding to human reproductive tissues was observed in a tissue cross-reactivity study.
Danish: Et studie af krydsreaktivitet i væv viste heller ingen binding af idarucizumab i humant reproduktivt væv.
English: The risk of using Praxbind in patients with known hypersensitivity (e.g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment.
Danish: Risikoen ved at anvende Praxbind til patienter med kendt overfølsomhed (fx anafylaktoid reaktion) over for idarucizumab eller et eller flere af hjælpestofferne skal nøje afvejes mod den potentielle fordel af en sådan akut behandling.
English: After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature.
Danish: Efter åbning af hætteglasset er idarucizumab påvist at være kemisk og fysisk stabilt i 6 timer ved stuetemperatur.
English: Therefore, in patients with hereditary fructose intolerance the risk of treatment with Praxbind must be weighed against the potential benefit of such an emergency treatment.
Danish: Derfor skal risikoen ved anvendelse af Praxbind til patienter med arvelig fructoseintolerans afvejes mod den potentielle fordel af en sådan akut behandling.
English: What Praxbind contains - The active substance is idarucizumab.
Danish: Praxbind indeholder - Aktivt stof: idarucizumab.
English: The transient proteinuria is a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously.
Danish: Den forbigående proteinuri er en fysiologisk reaktion på overbelastning af nyrernes proteinudskillelse efter intravenøs bolusinjektion/korttidsinfusion af 5 g idarucizumab.
English: How to use Praxbind
Danish: Sådan skal du bruge Praxbind
English: Praxbind (2x2.5 g/50 mL) is administered intravenously, as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
Danish: Praxbind (2 x 2,5 g/50 ml) administreres intravenøst som to på hinanden følgende infusioner, der hver især indgives over 5-10 minutter, eller som en bolusinjektion.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTLLER ANSVARLIG FOR BATCHFRIGIVELSE
English: A key secondary endpoint was the restoration of haemostasis.
Danish: Et vigtigt sekundært effektmål var opnåelse af hæmostase.
English: Praxbind is a reversal agent specific for dabigatran (Pradaxa), a blood thinner medicine that blocks a substance in the body, which is involved in blood clot formation.
Danish: Pradaxa er et blodfortyndende lægemiddel, der blokerer et stof i kroppen, som er involveret i dannelsen af blodpropper.
English: Mild symptoms of potential hypersensitivity (pyrexia, bronchospasm, hyperventilation, rash or pruritus) were reported.
Danish: Der er rapporteret lette symptomer på mulig overfølsomhed (pyreksi, bronkospasme, hyperventilation, udslæt eller kløe), men der kunne ikke fastlægges nogen årsagssammenhæng til idarucizumab.
English: An impact of hepatic impairment, assessed by hepatic injury as determined by elevated liver function tests, on the pharmacokinetics of idarucizumab has not been observed.
Danish: Det er ikke blevet observeret, at nedsat leverfunktion, vurderet ved leverskade bestemt ud fra forhøjede leverfunktionsprøver, påvirker idarucizumabs farmakokinetik.
English: Praxbind causes transient proteinuria as a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously (see section 5.2).
Danish: Praxbind forårsager forbigående proteinuri som en fysiologisk reaktion på overbelastning af nyrernes proteinudskillelse efter intravenøs bolusinjektion/korttidsinfusion af 5 g idarucizumab (se pkt.
English: Reproductive and developmental toxicity studies have not been performed, given the nature and the intended clinical use of the medicinal product.
Danish: På grund af lægemidlets karakter og påtænkte kliniske anvendelse er der ikke gennemført studier af reproduktions- og udviklingstoksicitet.
English: • The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL)
Danish: • Anbefalet dosis af Praxbind er 5 g (2 x 2,5 g/50 ml).
English: Package leaflet: Information for the patient and user Praxbind 2.5 g/50 mL solution for injection/infusion idarucizumab
Danish: Indlægsseddel: Information til patienten og brugeren Praxbind 2,5 g/50 ml injektions-/infusionsvæske, opløsning idarucizumab
English: - The other ingredients are sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20 and water for injection.
Danish: - Øvrige indholdsstoffer: natriumacetattrihydrat, eddikesyre, sorbitol, polysorbat 20 og vand til injektionsvæske.
English: Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect.
Danish: Idarucizumab binder kraftigt og specifikt til dabigatran og dets metabolitter og neutraliserer den antikoagulerende virkning.
English: Each vial contains 2.5 g idarucizumab in 50 mL.
Danish: Hvert hætteglas indeholder 2,5 g idarucizumab i 50 ml.
English: The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL).
Danish: Den anbefalede dosis af Praxbind er 5 g (2 x 2,5 g/50 ml).
English: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Danish: Ved antidotbehandling mod dabigatran udsættes patienten for den trombotiske risiko ved den underliggende sygdom.
English: Preclinical pharmacodynamics
Danish: Præklinisk farmakodynamik
English: LIST OF EXCIPIENTS Excipients: Sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20, water for injection.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: Natriumacetattrihydrat, eddikesyre, sorbitol, polysorbat 20, vand til injektionsvæsker.
English: The recommended dose is 5 g (2 vials of 50 mL).
Danish: Den anbefalede dosis er 5 g (2 hætteglas med 50 ml).
English: Treatment-emergent possibly persistent anti-idarucizumab antibodies with low titers were observed in 4 % (10/224) of the phase I subjects and 1.6% (8/501) of the patients suggesting a low immunogenic potential of idarucizumab.
Danish: Hos 4 % (10/224) af fase I-forsøgspersonerne og hos 1,6 % (8/501) af patienterne blev der observeret behandlingsrelaterede, muligvis vedvarende anti-idarucizumab-antistoffer med lave titre.
English: Idarucizumab is a specific reversal agent for dabigatran.
Danish: Idarucizumab er en specifik antidot mod dabigatran.
English: Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT).
Danish: Relevante koagulationsparametre er aktiveret partiel tromboplastintid (aPTT), fortyndet trombintid (dTT) eller ecarin-koagulationstid (ECT).
English: Figure 4 - Plasma-levels of unbound dabigatran in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Danish: Figur 4 - Plasmaniveauer af ubundet dabigatran i den repræsentative gruppe med raske frivillige (administration af idarucizumab eller placebo ved 0 t)
English: Subjects with a creatinine clearance below 44 mL/min have not been studied in Phase I. Depending on the degree of renal impairment the total clearance was reduced compared to healthy subjects, leading to an increased exposure of idarucizumab.
Danish: Afhængigt af graden af nedsat nyrefunktion var den totale clearance reduceret sammenlignet med clearance hos raske frivillige, hvilket medførte øget eksponering for idarucizumab.
English: Praxbind is used in adults in emergency situations where your doctor decides that rapid inactivation of the effect of Pradaxa is required - For emergency surgery/urgent procedures - In life-threatening or uncontrolled bleeding.
Danish: Praxbind anvendes til voksne i akutte situationer, hvor lægen beslutter, at det er vigtigt hurtigt at inaktivere Pradaxa.
English: • volume expanders.
Danish: • plasmasubstitutter.
English: In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see section 5.1).
Danish: I en subgruppe af patienter blev der målt ubundet dabigatran i plasma og forhøjede koagulationsparametre i op til 24 timer efter administration af idarucizumab som følge af redistribution (se pkt.
English: Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see section 5.1).
Danish: Relevante koagulationsparametre er aktiveret partiel tromboplastintid (aPTT), fortyndet trombintid (dTT) eller ecarin-koagulationstid (ECT) (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion
Danish: LÆGEMIDLETS NAVN Praxbind 2,5 g/50 ml injektions-/infusionsvæske, opløsning
English: It will not reverse the effects of other anticoagulants (see section 5.1).
Danish: Idarucizumab modvirker ikke virkningen af andre antikoagulantia (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 50 mL contains 2.5 g idarucizumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 50 ml indeholder 2,5 g idarucizumab.
English: Each 50 mL vial contains 2 g sorbitol and 25 mg sodium (see section 4.4).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Ét hætteglas med 50 ml indeholder 2 g sorbitol og 25 mg natrium (se pkt.
English: • other anticoagulants (e.g. thrombin inhibitors other than dabigatran, Factor Xa inhibitors including low-molecular weight heparin, vitamin K-antagonists, heparin).
Danish: andre antikoagulantia (f.eks. andre trombinhæmmere end dabigatran, faktor Xa-hæmmere,
English: • Intravenous administration as two consecutive infusions over 5 to 10 min each or as bolus injections
Danish: • Intravenøs administration som to på hinanden følgende infusioner, der hver især indgives over
English: No adverse reactions have been identified.
Danish: Der er ikke påvist bivirkninger.
English: Nine patients were re-dosed with idarucizumab.
Danish: 9 patienter blev igen doseret med idarucizumab.
English: PHARMACEUTICAL FORM AND CONTENTS solution for injection/infusion 2 vials of 50 mL each
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) injektions-/infusionsvæske, opløsning 2 hætteglas a 50 ml
English: Figure 3 - Reversal of dabigatran-induced clotting time prolongation determined by aPTT in patients from the RE-VERSE AD study (N=486)
Danish: Figur 3 - Revertering af dabigatran-induceret forhøjede koagulationsparametre udtrykt som aPTT hos patienter fra RE-VERSE AD-studiet (N=486)
English: Praxbind is used to rapidly trap dabigatran in order to inactivate its effect.
Danish: Praxbind anvendes til hurtigt at ophæve dabigatrans virkning.