FrancophonIA/ELRC3.0 huggingface dataset:
English: The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing.
Danish: Den forbigående proteinuri er ikke et tegn på nyreskade, hvilket der skal tages hensyn til ved urinprøver.
English: Tell your doctor or nurse - if you are allergic to idarucizumab or to any other of the substances listed in section 6.
Danish: Fortæl det til lægen eller sundhedspersonalet - hvis du er allergisk over for idarucizumab eller et af de øvrige indholdsstoffer, angivet i afsnit 6.
English: Based on the pharmacokinetic properties and the high specificity in binding to dabigatran, clinically relevant interactions with other medicinal products are considered unlikely.
Danish: Baseret på de farmakokinetiske egenskaber og den meget specifikke binding til dabigatran betragtes klinisk relevante interaktioner med andre lægemidler som usandsynlige.
English: It will not remove other medicines used to prevent the formation of blood clots.
Danish: Den virker ikke på anden medicin, der anvendes til at forhindre dannelse af blodpropper.
English: Based on its mechanism of action and the characteristics of proteins no carcinogenic or genotoxic effects are anticipated.
Danish: Baseret på virkningsmekanismen og proteiners karakteristika forventes ingen karcinogene eller genotoksiske virkninger.
English: Restoration of haemostasis was achieved in 80.3% of evaluable patients who had serious bleeding and normal haemostasis was observed in 93.4% of patients who required an urgent procedure.
Danish: Hæmostase blev opnået hos 80,3 % af de evaluerbare patienter, der havde alvorlig blødning, og normal hæmostase blev observeret hos 93,4 % af de patienter, der krævede en akut procedure.
English: The solution should not be exposed to light for more than 6 hours (in unopened vial and/or in-use).
Danish: Opløsningen må ikke eksponeres over for lys i mere end 6 timer (i ikke anbrudt hætteglas og/eller under brug).
English: Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Parenterale lægemidler som Praxbind skal kontrolleres visuelt for partikler og misfarvning før administration.
English: What you need to know when you receive Praxbind 3.
Danish: Det skal du vide, når du får Praxbind 3.
English: It is unlikely that Praxbind will influence the effect of other medicines or that other medicines will influence Praxbind.
Danish: Det er ikke sandsynligt, at Praxbind vil påvirke anden medicin, eller at anden medicin vil påvirke Praxbind.
English: Idarucizumab is produced by recombinant DNA technology in Chinese Hamster Ovary cells.
Danish: Idarucizumab produceres med rekombinant dna-teknologi i ovarieceller fra kinesiske hamstere.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Danish: • Når risikostyringssystemet ændres, særligt som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Reversal was only evaluable for those patients showing prolonged coagulation times prior to idarucizumab treatment.
Danish: Reverteringen kunne kun evalueres for de patienter, der viste forlænget koagulationstid før behandlingen med idarucizumab.
English: The idarucizumab-dabigatran complex is characterised by a rapid on-rate and extremely slow off-rate resulting in a very stable complex.
Danish: Idarucizumab-dabigatran-komplekset er karakteriseret ved en hurtig dannelsesrate og ekstremt langsom omdannelsesrate, hvilket resulterer i et meget stabilt kompleks.
English: The recommended dose of Praxbind contains 4 g sorbitol as an excipient.
Danish: Den anbefalede dosis af Praxbind indeholder 4 g sorbitol som hjælpestof.
English: Safety pharmacology studies have demonstrated no effects on the respiratory, central nervous or cardiovascular system.
Danish: Sikkerhedsfarmakologiske studier har ikke vist påvirkning af respirationssystemet, centralnervesystemet eller det kardiovaskulære system.
English: The line must be flushed with sodium chloride 9 mg/ml (0.9 %) solution for injection prior to and at the end of infusion.
Danish: Slangen skal skylles med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske før og efter infusionen.
English: No formal interaction studies with Praxbind and other medicinal products have been performed.
Danish: Der er ikke udført formelle interaktionsstudier mellem Praxbind og andre lægemidler.
English: This suggests that idarucizumab has no prothrombotic effect.
Danish: Dette tyder på, at idarucizumab ikke har protrombotisk virkning.
English: Praxbind does not affect any functions in the body as such, so your doctor may decide to give you this medicine, if the expected benefits outweigh any potential risks.
Danish: Praxbind påvirker ikke kroppens funktioner, så lægen kan beslutte at give dig medicinen, hvis de forventede fordele opvejer de mulige risici.
English: One prospective, open-label, non-randomized, uncontrolled study (RE-VERSE AD) was conducted to investigate the treatment of adult patients who presented with dabigatran-related life-threatening or uncontrolled bleeding (Group A) or who required emergency surgery or urgent procedures (Group B).
Danish: Et prospektivt, åbent, ikke-randomiseret, ikke-kontrolleret studie (RE-VERSE AD) blev udført for at undersøge behandlingen af voksne patienter, der havde dabigatran-relateret livstruende eller ukontrolleret blødning (gruppe A), eller som krævede akut operation eller akutte procedurer (gruppe B).
English: In these studies the doses of idarucizumab ranged from 20 mg to 8 g and the infusion times ranged from 5 minutes to 1 hour.
Danish: I disse studier var dosis af idarucizumab inden for intervallet 20 mg til 8 g og infusionstiden i intervallet 5 minutter til 1 time.
English: Based on pharmacokinetic data from 12 patients with liver disease, the AUC of idarucizumab was increased by 10% as compared to patients without liver disease.
Danish: Baseret på farmakokinetiske data fra 12 patienter med leversygdom, var AUC for idarucizumab forhøjet med 10 %, sammenlignet med patienter uden leversygdom.
English: OTHER - Printing on inside of lid
Danish: ANDET - Tekst på indersiden af låget
English: Following the intravenous infusion of a 5 g dose, the geometric mean volume of distribution at steady state (Vss) was 8.9 L (geometric coefficient of variation (gCV) 24.8 %).
Danish: Efter intravenøs infusion af 5 g var det geometriske middelfordelingsvolumen ved steady state (Vss) 8,9 l (geometrisk variationskoefficient (gCV) 24,8 %).
English: Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 48 hours, if stored in the original package in order to protect from light.
Danish: Før brug kan det uåbnede hætteglas opbevares ved stuetemperatur (op til 30 °C) i op til 48 timer, hvis det opbevares i den originale yderpakning (for at beskytte mod lys).
English: There is no information on the effects of this medicine in pregnant or breast-feeding women.
Danish: Der foreligger ingen information om virkningen af denne medicin hos gravide eller ammende kvinder.
English: After intravenous administration of 5 g idarucizumab, 32.1 % (gCV 60.0 %) of the dose was recovered in urine within a collection period of 6 hours and less than 1 % in the following 18 hours.
Danish: Efter intravenøs administration af 5 g idarucizumab blev 32,1 % (gCV 60,0 %) af dosis genfundet i urinen inden for en opsamlingsperiode på 6 timer og mindre end 1 % i de følgende 18 timer.
English: There is no information on the use of Praxbind in children.
Danish: Der er ingen information om brug af Praxbind hos børn.
English: Based on population pharmacokinetic analyses, sex, age, and race do not have a clinically meaningful effect on the pharmacokinetics of idarucizumab.
Danish: Baseret på farmakokinetiske populationsanalyser har køn, alder og race ingen klinisk betydende virkning på idarucizumabs farmakokinetik.
English: Administration of a second 5 g dose of Praxbind may be considered in the following situations:
Danish: Det kan overvejes at administrere endnu en Praxbind-dosis på 5 g i følgende situationer:
English: Pradaxa can be given again 24 hours after Praxbind administration.
Danish: Pradaxa kan normalt gives igen 24 timer efter administration af Praxbind.
English: Dabigatran exerts pronounced effects on parameters of the endogenous thrombin potential (ETP).
Danish: Dabigatran påvirker i udtalt grad parametrene for endogent trombinpotentiale (ETP).
English: In patients with hereditary fructose intolerance, parenteral administration of sorbitol has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death.
Danish: Hos patienter med arvelig fructoseintolerans har parenteral administration af sorbitol været forbundet med hypoglykæmi, hypofosfatæmi, metabolisk acidose, øget urinsyre, akut leversvigt med ophør af ekskretorisk funktion og syntese samt død.
English: This medicinal product contains 50 mg sodium per dose, equivalent to 2.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 50 mg natrium pr. dosis, svarende til 2,5 % af den WHO-anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: This medicine has been designed to only bind to dabigatran.
Danish: Denne medicin er udviklet til kun at binde til dabigatran.
English: There are no data on the effect of Praxbind on fertility (see section 5.3).
Danish: Der foreligger ingen data om indvirkningen af Praxbind på fertilitet (se pkt.
English: In Phase I studies Praxbind has been investigated in subjects with a creatinine clearance ranging from 44 to 213 mL/min.
Danish: Praxbind er i fase I-studier undersøgt hos forsøgspersoner med kreatininclearance fra 44 til 213 ml/min.
English: Once opened, Praxbind is intended for immediate use.
Danish: Efter åbning skal Praxbind anvendes omgående.
English: This occurred 1-24 hours after administration of idarucizumab mainly at timepoints ≥12 hours.
Danish: Dette sås 1-24 timer efter administration af idarucizumab, primært efter ≥ 12 timer.
English: The majority of the patients showed sustained reversal of dabigatran plasma concentrations up to 12 hours (≥90%).
Danish: Hos de fleste af patienterne opnåedes vedvarende antidoteffekt mod dabigatran i plasma i op til 12 timer (≥ 90 %).
English: A complete and sustained reversal of dabigatran-induced clotting time prolongation was observed immediately after the idarucizumab infusion, lasting over the entire observation period of at least 24 h.
Danish: En komplet og vedvarende ophævelse af dabigatran-induceret forlænget koagulationstid sås straks efter idarucizumab-infusionen og blev opretholdt i hele observationsperioden på mindst 24 timer.
English: After dabigatran has been removed from your body, you are not protected from the formation of blood clots.
Danish: Når dabigatrans virkning er neutraliseret, er du ikke længere beskyttet mod dannelse af blodpropper.
English: The investigated population consisted of healthy subjects and subjects exhibiting specific population characteristics covering age, body weight, race, sex and renal impairment.
Danish: Den undersøgte population bestod af raske frivillige og forsøgspersoner med forskellige populationskarakteristika, herunder alder, legemsvægt, race, køn og nedsat nyrefunktion.
English: It is unknown whether idarucizumab is excreted in human milk.
Danish: Det er ukendt, om idarucizumab udskilles i human mælk.
English: Immediately after the administration of idarucizumab, the plasma concentrations of unbound dabigatran were reduced by more than 99 %, resulting in levels with no anticoagulant activity.
Danish: Straks efter administration af idarucizumab blev plasmakoncentrationen af ubundet dabigatran reduceret med over 99 %, hvilket gav niveauer uden antikoagulerende aktivitet.
English: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product shall be used immediately after opening.
Danish: Ud fra en mikrobiologisk betragtning skal præparatet anvendes straks efter åbningen, medmindre åbningsmetoden udelukker risiko for mikrobiel kontaminering.
English: No dose adjustment is required in elderly patients aged 65 years and above (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter på 65 år og derover (se pkt.
English: These tests were used to assess the anticoagulant effect of dabigatran.
Danish: Disse test blev anvendt til at vurdere dabigatrans antikoagulerende virkning.
English: This medicine contains 50 mg sodium (main component of cooking/table salt) per dose.
Danish: Dette lægemiddel indeholder 50 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. dosis (2 hætteglas).
English: It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity, approximately 300-fold more potent than the binding affinity of dabigatran for thrombin.
Danish: Det er et humaniseret monoklonalt antistoffragment (Fab), som binder til dabigatran med meget høj affinitet, cirka 300 gange stærkere end dabigatrans bindingsaffinitet til trombin.
English: None of the patients re-dosed with idarucizumab tested positive for anti-idarucizumab antibodies.
Danish: Ingen af patienterne, der igen blev doseret med idarucizumab, testede positive for anti-idarucizumab-antistoffer.
English: Idarucizumab was rapidly eliminated with a total clearance of 47.0 mL/min (gCV 18.4 %), an initial half-life of 47 minutes (gCV 11.4 %) and a terminal half-life of 10.3 h (gCV 18.9 %).
Danish: Idarucizumab blev udskilt hurtigt med en total clearance på 47,0 ml/min (gCV 18,4 %), en initial halveringstid på 47 minutter (gCV 11,4 %) og en terminal halveringstid på 10,3 t (gCV 18,9 %).
English: Most patients in both Groups A and B, achieved complete reversal of the anticoagulant effect of dabigatran (dTT: 98.7%; ECT: 82.2%; aPTT: 92.5% of evaluable patients, respectively) in the first 4 hours after administration of 5 g idarucizumab.
Danish: De fleste patienter i såvel gruppe A som gruppe B opnåede komplet antidoteffekt (hhv. dTT: 98,7 %; ECT: 82,2 %; aPTT: 92,5 % af evaluerbare patienter) i de første 4 timer efter administration af 5 g idarucizumab.
English: Three randomised, double-blind, placebo-controlled Phase I studies in 283 subjects (224 treated with idarucizumab) were conducted to assess the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of idarucizumab, given alone or after administration of dabigatran etexilate.
Danish: 3 randomiserede, dobbeltblinde, placebokontrollerede fase I-studier med 283 forsøgspersoner (224 behandlet med idarucizumab) blev gennemført for at vurdere idarucizumabs sikkerhed, virkning, tolerabilitet, farmakokinetik og farmakodynamik, når idarucizumab blev givet alene eller efter administration af dabigatranetexilat.
English: Praxbind is for single-use only and does not contain preservatives.
Danish: Praxbind er kun til engangsbrug og indeholder ingen konserveringsmidler.
English: Preclinical data reveal no special hazard for humans based on repeated dose toxicity studies of up to four weeks in rats and two weeks in monkeys.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af toksicitet efter gentagne doser i op til fire uger hos rotter og to uger hos aber.
English: BATCH NUMBER Lot
Danish: FREMSTILLERENS BATCHNUMBER Lot
English: Patients being treated with dabigatran have underlying disease states that predispose them to thromboembolic events.
Danish: Patienter, der behandles med dabigatran, har underliggende sygdomme, der prædisponerer for tromboemboliske hændelser.
English: In a phase III trial the safety of Praxbind has been evaluated in 503 patients, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with Pradaxa (dabigatran etexilate), as well as in 224 volunteers in phase I trials.
Danish: Praxbinds sikkerhed er undersøgt i et fase III-studie hos 503 patienter, som havde ukontrolleret blødning eller krævede akut operation eller akutte procedurer, og som var i behandling med Pradaxa (dabigatranetexilat), samt hos 224 frivillige i fase I-studier.
English: Restricted to hospital use only.
Danish: Kun til brug på hospitaler.
English: Idarucizumab treatment normalised both thrombin lag time ratio and time to peak ratio to baseline levels as determined 0.5 to 12 hours after the end of the idarucizumab infusion.
Danish: Behandling med idarucizumab normaliserede både trombins lag time ratio og tiden til peak ratio til baselineniveauer målt 0,5 til 12 timer efter afsluttet infusion af idarucizumab.
English: No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.
Danish: Der er ikke observeret uforligeligheder mellem Praxbind og infusionssæt af polyvinylchlorid, polyethylen eller polyurethan eller sprøjter af polypropylen.
English: Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate.
Danish: Behandling med Praxbind kan anvendes sammen med standard understøttende behandling og monitorering, som bør overvejes alt efter medicinsk relevans.
English: Based on these data and the extent of reversal of the anticoagulant effect of dabigatran in patients, renal impairment does not impact the reversal effect of idarucizumab.
Danish: Baseret på disse data og den antidoteffekt på dabigatrans antikoagulerende virkning, der er observeret hos patienter, har nedsat nyrefunktion ikke nogen indvirkning på idarucizumabs antidotvirkning.
English: Praxbind must not be mixed with other medicinal products.
Danish: Praxbind må ikke blandes med andre lægemidler.
English: Pre-existing antibodies with cross-reactivity to idarucizumab were detected in approximately 12 % (33/283) of the phase I subjects and 3.8% (19/501) of the patients.
Danish: Der blev påvist allerede eksisterende antistoffer med krydsreaktivitet over for idarucizumab hos cirka 12 % (33/283) af fase I-forsøgspersonerne og hos 3,8 % (19/501) af patienterne.
English: Idarucizumab has been studied in 58 patients with varying degrees of hepatic impairment.
Danish: Idarucizumab er blevet undersøgt hos 58 patienter med forskellige grader af nedsat leverfunktion.
English: Detailed instructions for your doctor or nurse on how to administer Praxbind can be found at the end of this package leaflet (see 'Handling instructions').
Danish: I slutningen af denne indlægsseddel findes en detaljeret vejledning til lægen eller sygeplejersken i, hvordan Praxbind gives (se ”Brugervejledning”).
English: Based on pharmacokinetic data from 347 patients with different degrees of renal function (median creatinine clearance 21 - 99 mL/min) it is estimated that mean idarucizumab exposure (AUC0-24h) increases by 38% in patients with mild (CrCl 50-<80 mL/min), by 90% in moderate (30-<50 mL/min) and by 146% in severe (0-<30 mL/min) renal impairment.
Danish: Ud fra farmakokinetiske data for 347 patienter med forskellige grader af nedsat nyrefunktion (median kreatininclearance 21-99 ml/min) skønnes det, at den gennemsnitlige eksponering for idarucizumab (AUC0-24 h) øges med 38 % hos patienter med let nedsat nyrefunktion (CrCl 50-<80 ml/min), med 90 % hos patienter med moderat nedsat nyrefunktion (30-<50 ml/min) og med 146 % hos patienter med svært nedsat nyrefunktion (0-<30 ml/min).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Praxbind in one or more subsets of the paediatric population in the prevention and treatment of dabigatran associated haemorrhage (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Praxbind i en eller flere undergrupper af den pædiatriske population ved forebyggelse og behandling af dabigatran-associeret blødning (se pkt.
English: After you have received Praxbind, your doctor will decide on the continuation of your treatment to prevent blood clot formation.
Danish: Når du har fået Praxbind, vil din læge beslutte, hvordan du fremover skal behandles for at forhindre, at du får en blodprop.
English: A value above the normal range may reflect residual active dabigatran or other clinical conditions e.g., presence of other drugs or transfusion coagulopathy.
Danish: En værdi over normalområdet kan afspejle resterende dabigatranaktivitet eller andre kliniske tilstande, fx tilstedeværelse af andre lægemidler eller transfusionskoagulopati.
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.
Danish: For at reducere denne risiko skal det overvejes at genoptage den antikoagulerende behandling, så snart det er klinisk hensigtsmæssigt.
English: Studies to evaluate the mutagenic and carcinogenic potential of idarucizumab have not been performed.
Danish: Der er ikke gennemført studier til evaluering af idarucizumabs mutagene og karcinogene potentiale.
English: There are no data for the use of Praxbind in pregnant women.
Danish: Der foreligger ingen data om brug af Praxbind til gravide kvinder.
English: Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Since dabigatran is also excreted primarily via the kidneys, increases in the exposure to dabigatran are also seen with worsening renal function.
Danish: Da dabigatran også primært udskilles via nyrerne, ses også øget eksponering for dabigatran hos patienter med nedsat nyrefunktion.
English: D-88397 Biberach an der Riss Germany
Danish: D-88397 Biberach an der Riss Tyskland
English: Thrombin generation parameters
Danish: Parametre for trombindannelse
English: Dosage and adminstration:
Danish: Dosering og administration:
English: What you need to know when you receive Praxbind
Danish: Det skal du vide, når du får Praxbind
English: Compared to 272 patients without hepatic impairment, the median AUC of idarucizumab was changed by -6%, 37% and 10% in patients with AST/ALT elevations of 1 to <2x ULN (N=34), 2 to <3x ULN (N=3) and >3x ULN (N=21), respectively.
Danish: Sammenlignet med 272 patienter uden nedsat leverfunktion, blev den mediane AUC af idarucizumab ændret med -6 %, 37 % og 10 % hos patienter med forhøjede niveauer af ASAT/ALAT på hhv. 1 til <2 x ULN (N=34), 2 til <3 x ULN (N=3) og >3 x ULN (N=21).
English: 4 factor), activated PCCs (aPCCs) and recombinant factor VIIa.
Danish: indeholdende 3 eller 4 faktorer), aktiverede PCC'er (aPCC'er) og rekombinant faktor VIIa.
English: Other medicines and Praxbind
Danish: Brug af anden medicin sammen med Praxbind
English: • coagulation factor concentrates, such as prothrombin complex concentrates (PCCs, e.g. 3 factor and
Danish: • koagulationsfaktorkoncentrater som f.eks. protrombin-kompleks-koncentrater (PCC'er, f.eks.
English: A value in the normal range after administration of idarucizumab indicates that a patient is no longer anticoagulated.
Danish: Efter administration af idarucizumab indikerer en værdi i normalområdet, at en patient ikke længere er antikoaguleret.
English: The median peak dabigatran exposure in the investigated healthy subjects was in the range of a twice daily administration of 150 mg dabigatran etexilate in patients.
Danish: Den mediane maksimale eksponering for dabigatran hos de undersøgte raske frivillige svarede til administration af 150 mg dabigatranetexilat to gange dagligt.