FrancophonIA/ELRC3.0 huggingface dataset:
English: 297/352 patients (84.4%) received the low-dose regimen of andexanet, while 55 patients (15.6%) received the high-dose regimen.
Danish: 297/352 patienter (84,4 %) fik lav-dosis regime med andexanet, mens 55 patienter (15,6 %) fik højdosis regime.
English: Portola Netherlands B.V. Prins Bernhardplein 200 1097 JB Amsterdam Netherlands
Danish: Prins Bernhardplein 200 1097 JB Amsterdam Holland
English: Administration of andexanet alfa as a bolus followed by continuous infusion resulted in a sustained decrease in anti-FXa activity.
Danish: Administration af andexanet alfa som en bolus efterfulgt af kontinuerlig infusion resulterede i et vedvarende fald i anti-FXa-aktivitet.
English: • Large (60 mL or larger) sterile syringe.
Danish: • Stor (60 ml eller større) steril sprøjte.
English: Gently swirl each vial until all of the powder is completely dissolved.
Danish: Hvirvl forsigtigt hvert hætteglas rundt, indtil alt pulver er fuldstændigt opløst.
English: Following administration of Ondexxya and cessation of a major bleed, re-anticoagulation should be considered to prevent thrombotic events due to the patient's underlying medical condition.
Danish: Efter administration af Ondexxya og standsning af en større blødning bør genstart af antikoagulation overvejes til forebyggelse af trombotiske hændelser på grund af patientens tilgrundliggende medicinske tilstand.
English: The anti-FXa activity returned to the placebo levels and above approximately two hours after the end of a bolus or infusion dependent on dosage.
Danish: Anti-FXa-aktiviteten returnerede til placeboniveauerne og derover ca. to timer efter afslutningen af en bolus eller infusion afhængig af dosis.
English: The interaction between andexanet alfa and TFPI has not been fully characterized.
Danish: Interaktionen mellem andexanet alfa og TFPI er ikke fuldstændigt klarlagt.
English: Ondexxya is supplied in glass vials as a white to off-white powder for solution for infusion, which is reconstituted (dissolved) before use.
Danish: Ondexxya leveres i glas-hætteglas som et hvidt til offwhite pulver til infusionsvæske, opløsning, der rekonstitueres (opløses) før brug.
English: 8 mg/min for 120 minutes (960 mg)
Danish: 8 mg/min i 120 minutter (960 mg)
English: Based on what is known about the disposition kinetics of native FXa, andexanet alfa is likely rapidly broken down in plasma by endogenous proteases, consistent with its relatively short effective half-life (one hour).
Danish: Baseret på, hvad man ved om disponeringskinetikken for nativ FXa, nedbrydes andexanet alfa sandsynligvis hurtigt i plasma af endogene proteaser, hvilket er overensstemmende med dets relativt korte effektive halveringstid (én time).
English: Reversal of apixaban
Danish: Revertering af apixaban
English: Therefore, treatment monitoring should be based mainly on clinical parameters indicative of appropriate response (i.e., achievement of haemostasis), lack of efficacy (i.e., re-bleeding), and adverse events (i.e., thromboembolic events).
Danish: Behandlingsovervågning bør derfor overvejende baseres på kliniske parametre, der er tegn på passende respons (det vil sige opnåelse af hæmostase), manglende virkning (det vil sige fornyet blødning) og utilsigtede hændelser (det vil sige tromboemboliske hændelser).
English: Vial (unopened) Two years stored at 2°C to 8°C.
Danish: Hætteglas (uåbnet) 2 år ved opbevaring 2 °C til 8 °C.
English: There are no data from the use of andexanet alfa in pregnant women.
Danish: Der er ingen data fra anvendelse af andexanet alfa til gravide kvinder.
English: Use of andexanet alfa in conjunction with other supportive measures Andexanet alfa can be used in conjunction with standard haemostatic supportive measures, which should be considered as medically appropriate.
Danish: Anvendelse af andexanet alfa sammen med andre støtteforanstaltninger Andexanet alfa kan anvendes sammen med standardhæmostatiske støtteforanstaltninger, der vurderes at være medicinsk passende.
English: This is based on the specific anticoagulant medicine you take as well as on the dose and the time since your last dose of anticoagulant medicine.
Danish: Dette sker på baggrund af hvilket specifikt antikoagulant lægemiddel, du tager, samt størrelsen af og tidsrummet siden din sidste dosis af det antikoagulante lægemiddel.
English: Reduction in anti-FXa activity
Danish: Reduktion i anti-FXa-aktivitet
English: Clinical relevance in the target population (patients with uncontrolled or life-threatening bleeding who are anticoagulated due to high to very high risk of thrombosis) is unknown.
Danish: Den kliniske relevans i målpopulationen (patienter med ukontrolleret eller livstruende blødning, som får antikoagulationsbehandling på grund af høj til meget høj risiko for trombose) er ukendt.
English: In ANNEXA-4, intracranial haemorrhage (ICH) patients (GCS > 7 and haematoma volume < 60 mL) have been included.
Danish: I ANNEXA-4 er inkluderet patienter med intrakraniel blødning (ICH) (GCS > 7 og hæmatomvolumen < 60 ml).
English: • rapid or irregular heartbeat
Danish: • hurtig eller uregelmæssig hjerterytme
English: Annex IV Conclusions on the granting of the conditional marketing authorisation presented by the European Medicines Agency
Danish: Bilag IV Konklusioner vedrørende udstedelse af markedsføringstilladelse under betingede omstændigheder fremlagt af Det Europæiske Lægemiddelagentur
English: 4 mg/min for 120 minutes (480 mg)
Danish: 4 mg/min i 120 minutter (480 mg)
English: Restricted to hospital use only.
Danish: Begrænset til udelukkende hospitalsbrug.
English: It will not reverse the effects of non-FXa inhibitors.
Danish: Det vil ikke revertere virkningen af ikke-FXa-inhibitorer.
English: Reversal of rivaroxaban
Danish: Revertering af rivaroxaban
English: For the most efficient reconstitution of the needed dose, and to minimise errors, inject each vial needed with 20 mL of water for injections before proceeding to the next step.
Danish: For at opnå den mest effektive rekonstitution af den nødvendige dosis og for at minimere fejl injiceres hvert hætteglas, der skal bruges, med 20 ml vand til injektionsvæsker, før der fortsættes til det næste trin. 9.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSISR
English: Powder for solution for infusion White to off-white lyophilized powder
Danish: Pulver til infusionsvæske, opløsning Hvidt til offwhite lyofiliseret pulver
English: Reduction in anti-FXa activity correlates with restoration of thrombin generation.
Danish: Reduktionen i anti-FXa-aktivitet korrelerer med reetableringen af trombingenerering.
English: The posology was confirmed in a study in patients with acute major bleeding.
Danish: Doseringen er blevet bekræftet i et studie med patienter med akut større blødning.
English: In addition, independent pro-thrombotic effect of andexanet alfa cannot be ruled out.
Danish: Endvidere kan en uafhængig protrombotisk virkning af andexanet alfa ikke udelukkes.
English: Ondexxya is not recommended during pregnancy or if you have the potential to become pregnant and are not using birth control.
Danish: Ondexxya bør ikke anvendes under graviditet, eller hvis du er i stand til at blive gravid og ikke bruger prævention.
English: The most common side effects associated with Ondexxya in clinical trials of healthy people were infusion-related reactions with usually mild symptoms such as flushing or feeling hot (very common side effects which may affect more than 1 in 10 people).
Danish: De mest almindelige bivirkninger, der var forbundet med Ondexxya i kliniske studier med raske personer, var infusionsrelaterede reaktioner med sædvanligvis lette symptomer, såsom rødmen eller varmefølelse (meget almindelige bivirkninger, der kan forekomme hos flere end 1 ud af 10 personer).
English: Andexanet alfa has no or negligible influence on the ability to drive and use machines.
Danish: Andexanet alfa påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Detailed instructions for your doctor or nurse on how to give Ondexxya are given 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 Ondexxya skal gives (se “Håndteringsvejledning”).
English: The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin, and the gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the ability of the protein to assemble into the prothrombinase complex, thus removing any anti-coagulant effects.
Danish: Serinen i det aktive site er substitueret med alanin, hvilket gør molekylet ude af stand til at spalte og aktivere protrombin, og gamma-carboxyglutaminsyre (Gla)domænet er fjernet til eliminering af proteinets evne til at samles i protrombinasekomplekset, hvorved antikoagulationsvirkninger er fjernet.
English: Fertility There are no data on the effects of andexanet alfa on human fertility.
Danish: Fertilitet Der er ingen data om virkningen af andexanet alfa på human fertilitet.
English: Restoration of thrombin generation following administration was dose- and dose-regimen-dependent and did not correlate with anti-FXa-activity beyond approximately four hours (see below, “restoration of thrombin generation”).
Danish: Reetablering af trombingenerering efter administration var dosis- og dosisprogramafhængig og korrelerede ikke med anti-FXa-aktivitet efter ca. fire timer (se nedenfor “Reetablering af trombingenerering”).
English: Pro-coagulant factor treatments (e.g., 3- or 4-factor prothrombin complex concentrate (PCC)/activated PCC, recombinant factor VIIa, fresh frozen plasma) and whole blood should be avoided unless absolutely required, due to lack of data in combination with these treatments.
Danish: Behandlinger med prokoagulationsfaktorer (f.eks. 3- eller 4-faktor protrombinkomplekskoncentrat (PCC)/aktiveret PCC, rekombinant faktor VIIa, frisk frosset plasma) og fuldblod bør undgås, med mindre det er absolut nødvendigt, på grund af manglende data i kombination med disse behandlinger.
English: In a study comparing andexanet alfa pharmacokinetics in elderly (65-69 years) and younger (26-42 years) healthy subjects who had received apixaban, the pharmacokinetics of andexanet alfa in the elderly subjects were not statistically different than those in the younger subjects.
Danish: I et studie, der sammenlignede farmakokinetikken for andexanet alfa hos ældre (65-69 år) og yngre (26-42 år) raske forsøgspersoner, der havde fået apixaban, var farmakokinetikken for andexanet alfa hos de ældre forsøgspersoner ikke statistisk forskellig fra, hvad man observerede hos de yngre forsøgspersoner.
English: Reversal of the effects of other FXa inhibitors (e.g., fondaparinux, unfractionated heparin) with andexanet alfa has not been studied in humans.
Danish: Revertering af virkningen af andre FXa-inhibitorer (f.eks. fondaparinux, ufraktioneret heparin) med andexanet alfa er ikke blevet undersøgt hos mennesker.
English: Treatment of patients with more severe ICH with andexanet alfa has not been studied.
Danish: Behandling af patienter med en sværere grad af ICH med andexanet alfa er ikke blevet undersøgt.
English: • stomach pain or discomfort
Danish: • mavesmerter eller -ubehag
English: These markers were not measured in patients enrolled in the ANNEXA-4 study, but thromboembolic events have been observed (see section 5.1).
Danish: Disse markører blev ikke målt hos patienter indskrevet i ANNEXA-4-studiet, men der er observeret tromboemboliske hændelser (se pkt.
English: The two co-primary endpoints are: a) percent change in anti-FXa activity from baseline to the nadir between five minutes after the end of the bolus until the end of the infusion, and; b) rate of good or excellent (compared to poor or none) haemostatic efficacy within 12 hours after infusion, as rated by an independent endpoint adjudication committee .
Danish: De to co-primære endepunkter er: a) procentvis ændring i anti-FXa-aktivitet fra baseline til lavpunktet mellem fem minutter efter afslutningen af bolussen og indtil afslutningen af infusionen, og: b) hyppighed af god eller meget god (sammenlignet med dårlig eller ingen) hæmostatisk virkning inden for 12 timer efter infusion vurderet af en uafhængig komité til endepunktsvurdering.
English: Laboratory parameters as antiFXa activity, endogenous thrombotic potential (ETP), or markers of thrombosis might not be reliable for guidance.
Danish: Laboratorieparametre, såsom anti-FXa-aktivitet, endogent trombotisk potentiale (ETP) eller markører for trombose, er muligvis ikke troværdige vejledende værdier.
English: This medicine is for hospital use only.
Danish: Dette lægemiddel er udelukkende til hospitalsbrug.
English: If you suffer side effects when you are being given Ondexxya by infusion (drip), your doctor may decide to slow down or pause your treatment.
Danish: Hvis du får bivirkninger, mens du får Ondexxya ved infusion (drop), kan lægen beslutte at nedsætte hastigheden af eller holde en pause fra behandlingen.
English: Thirty-six of 352 patients with complete 30-day safety follow up (10.3%) had thrombotic events, including venous thromboembolism (VTE), myocardial infarction (MI), and stroke.
Danish: 36 ud af 352 patienter med fuldstændig 30-dages sikkerhedsopfølgning (10,3 %) havde trombotiske hændelser, herunder venøs tromboemboli (VTE), myokardieinfarkt (MI) og apopleksi.
English: For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Danish: Til voksne patienter, der behandles med en direkte faktor Xa (FXa)-inhibitor (apixaban eller rivaroxaban), når der er behov for revertering af antikoagulation på grund af livstruende eller ukontrolleret blødning.
English: Phase II studies of andexanet alfa in the presence of direct FXa inhibitors demonstrated the same dose proportional pharmacokinetics over the intended therapeutic dose range evaluated for both Cmax and area under the curve (AUC) with an effective half-life of approximately one hour.
Danish: Fase II-studier af andexanet alfa ved tilstedeværelsen af direkte FXa-inhibitorer viste den samme dosisproportionale farmakokinetik over det påtænkte terapeutiske dosisinterval ved evaluering af både Cmax og areal under kurven (AUC) med en effektiv halveringstid på ca. én time.
English: Administration using an intravenous bag
Danish: Administration ved anvendelse af en intravenøs pose
English: The antiFXa activity thresholds for normalization of thrombin generation (defined by mean ETP and standard deviations) were estimated to be 44.2 ng/mL (within one standard deviation of normal ETP) based on pooled data from Studies 14-503 and 14-504, as indicated in the figure.
Danish: Anti-FXaaktivitetsgrænserne for normalisering af trombingenerering (defineret ved gennemsnitlig ETP og standardafvigelser) blev estimeret til 44,2 ng/ml (inden for én standardafvigelse fra normal ETP) baseret på puljede data fra studie 14-503 og 14-504 som vist i figuren.
English: All used syringes, needles, and vials, including any unused portion of reconstituted solution, should be disposed of in accordance with local requirements.
Danish: Alle brugte sprøjter, kanyler og hætteglas, herunder en eventuel ikke anvendt del af den rekonstituerede opløsning, skal bortskaffes i henhold til lokale retningslinjer.
English: Therefore, dose adjustment is not considered needed for patients with hepatic impairment.
Danish: En dosisjustering vurderes derfor ikke nødvendig for patienter med nedsat leverfunktion.
English: According to region, death rates were 22.1% (31/140) in patients recruited in the European Union and 10.9% (23/211) in patients recruited in North America.
Danish: I forhold til regioner var dødelighedsraterne 22,1 % (31/140) hos patienter rekrutteret i EU og 10,9 % (23/211) hos patienter rekrutteret i Nordamerika.
English: The most frequently observed adverse reactions were mild or moderate infusion-related reactions (see table 4) comprising symptoms such as flushing, feeling hot, cough, dysgeusia, and dyspnoea occurring within a few minutes to a few hours of the infusion.
Danish: De hyppigst observerede bivirkninger var lette eller moderate infusionsrelaterede reaktioner (se tabel 4), der omfattede symptomer, såsom rødmen, varmefølelse, hoste, dysgeusi og dyspnø, som forekom inden for få minutter til få timer efter infusionen.
English: At the time of the event 10/36 (27.8%) patients were on antithrombotic therapy.
Danish: På tidspunktet for hændelsen var 10/36 (27,8 %) patienter i antitrombotisk terapi.
English: Andexanet alfa is a recombinant form of human FXa protein that has been modified to lack FXa enzymatic activity.
Danish: Andexanet alfa er en rekombinant form af humant FXa-protein, der er blevet modificeret, så det mangler FXa-enzymatisk aktivitet.
English: The predominant mechanism of action is the binding and sequestration of the FXa inhibitor, although there may be a minor contribution from the inhibition of tissue factor pathway inhibitor (TFPI) activity through binding to TFPI.
Danish: Den primære virkningsmekanisme er bindingen og inaktiveringen af FXa-inhibitoren, omend der kan være et mindre bidrag fra inhibering af aktiviteten af vævsfaktorsystem-inhibitoren (TFPI) ved binding til TFPI.
English: Based on the existing data on clearance, no dose adjustment is recommended.
Danish: På baggrund af eksisterende data vedrørende clearance anbefales ingen dosisjustering.
English: Administration using a syringe pump 1.
Danish: Administration ved anvendelse af en sprøjtepumpe 1.
English: Factor Xa inhibitors are given to prevent clots in your blood vessels.
Danish: Faktor Xa-hæmmere gives for at forebygge blodpropper i dine blodkar.
English: Preliminary data suggest higher risk of thrombosis for patients receiving the higher dose of andexanet, previous lower dose of the anti-FXa inhibitor, and patients on rivaroxaban.
Danish: Indledende data tyder på en højere risiko for trombose hos patienter, der får den høje dosis af andexanet, tidligere lav dosis af anti-Fxainhibitor, og patienter på rivaroxaban.
English: Compared with patients recruited in North America, EU patients were significantly older (79.0 years vs. 76.3 years), more frequently had ICH as index event (72.9% vs. 59.0%) and more ICHs were intraparenchymal (54.9% vs. 34.4%).
Danish: Sammenlignet med patienter rekrutteret i Nordamerika var patienterne fra EU signifikant ældre (79,0 år vs. 76,3 år), havde hyppigere ICH som index-hændelse (72,9 % vs. 59,0 %), og flere ICH'er var intraparenkymale (54,9 % vs. 34,4 %).
English: The safety of andexanet alfa has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood within seven days prior to the bleeding event, as they were excluded from clinical trials.
Danish: Sikkerheden ved andexanet alfa er ikke blevet evalueret hos patienter, der har fået protrombinkomplekskoncentrater, rekombinant faktor VIIa eller fuldblod inden for syv dage før blødningshændelsen, da de var udelukket fra kliniske studier.
English: Remove the flip-top from each vial.
Danish: Fjern flip-låget fra hvert hætteglas.
English: Powder in a 20 mL vial (Type I glass) with a stopper (butyl rubber).
Danish: Pulver i et 20 ml-hætteglas (type I-glas) med en prop (butylgummi).
English: Andexanet alfa binds direct FXa inhibitors with high affinity, making them unavailable to exert their anticoagulant effects.
Danish: Andexanet alfa binder direkte FXa-inhibitorer med høj affinitet, hvilket gør dem ude af stand til at udøve deres antikoagulative virkning.
English: The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
Danish: Sikkerheden og virkningen er ikke blevet undersøgt hos patienter med nedsat leverfunktion (se pkt.
English: Non-cardiovascular deaths (n=27) included: respiratory failure (n=5), infection/sepsis (n=5), accident/trauma (n=2), cancer (n=1), and other/non-vascular cause (n=14).
Danish: Ikke-kardiovaskulære dødsfald (n = 27) indbefattede: respiratiossvigt (n = 5), infektion/sepsis (n = 5), uheld/traume (n = 2), cancer (n = 1) og anden/ikke-vaskulær årsag (n = 14).
English: For these patients, median anti-FXa activity at baseline was 149.7 ng/mL for patients taking apixaban, and 211.8 ng/mL for patients taking rivaroxaban.
Danish: Hos disse patienter var median anti-FXa-aktivitet ved baseline 149,7 ng/ml hos de patienter, der tog apixaban og 211,8 ng/ml hos de patienter, der tog rivaroxaban.
English: Based on population pharmacokinetics analysis, gender does not have a clinically meaningful effect on the pharmacokinetics of andexanet alfa.
Danish: På baggrund af en populationsfarmakokinetisk analyse har køn ikke en klinisk betydningsfuld indvirkning på farmakokinetikken for andexanet alfa.
English: Renal impairment: The effect of renal impairment on andexanet alfa exposure levels has not been evaluated.
Danish: Nedsat nyrefunktion: Virkningen af nedsat nyrefunktion på eksponeringsniveauerne af andexanet alfa er ikke blevet vurderet.
English: Paediatric population: The safety and efficacy of andexanet alfa in children and adolescents have not been established.
Danish: Pædiatrisk population: Andexanet alfas sikkerhed og virkning hos børn og unge er ikke klarlagt.
English: No thromboembolic events were observed in 223 healthy volunteers who received FXa inhibitors and were treated with andexanet alfa.
Danish: Ingen tromboemboliske hændelser blev observeret hos 223 raske frivillige, der fik FXa-inhibitorer og blev behandlet med andexanet alfa.
English: No neutralising antibodies or antibodies to factor X or FXa were detected.
Danish: Der blev ikke påvist neutraliserende antistoffer eller antistoffer mod faktor X eller FXa.
English: There is no clinical experience with overdose of andexanet alfa.
Danish: Der er ingen klinisk erfaring med overdosering af andexanet alfa.
English: Ondexxya contains the active ingredient andexanet alfa.
Danish: Ondexxya indeholder det aktive hjælpestof andexanet alfa.
English: To date, the occurrence of positive, non-neutralizing antibodies to andexanet alfa following treatment in patients in the ANNEXA-4 study (8.5% or 20/236 patients) has been similar to that observed in healthy subjects.
Danish: Til dato har forekomsten af positive, ikke-neutraliserende antistoffer mod andexanet alfa efter behandling hos patienter i ANNEXA-4-studiet (8,5 % eller 20/236 patienter) svaret til, hvad der blev observeret hos raske forsøgspersoner.
English: When andexanet alfa was administered as a bolus followed by a continuous infusion, the maximum decrease in unbound FXa inhibitors was rapid (within two minutes of the end of the bolus) and was sustained over the course of the infusion then gradually increased over time, reaching a maximum at approximately two hours following the end of infusion.
Danish: Når andexanet alfa blev administreret som en bolus efterfulgt af en kontinuerlig infusion, forekom det maksimale fald i ubundne FXa-inhibitorer hurtigt (inden for to minutter efter afslutning af bolussen), og det blev opretholdt under infusionen, hvorefter antallet steg gradvist over tid og nåede et maksimum ca. to timer efter afslutningen af infusionen.
English: Ten of 36 (27.8%) patients had restarted antithrombotic therapy at the time of the event, and all 36 patients had been anticoagulated for a prior history of VTE and/or atrial fibrillation at the time of receiving andexanet alfa (see sections 4.4 and 5.1).
Danish: 10 ud af 36 (27,8 %) patienter havde genstartet antitrombotisk terapi på tidspunktet for hændelsen, og alle 36 patienter havde været antikoaguleret for et tidligere tilfælde af VTE og/eller atrieflimmer på tidspunktet, hvor de fik andexanet alfa (se pkt.
English: Medical judgement should balance the benefits of anticoagulation with the risks of re-bleeding (see section 4.4).
Danish: En medicinsk vurdering skal afveje fordelene ved antikoagulation mod risiciene for fornyet blødning (se pkt.
English: Andexanet alfa is not suitable for pre-treatment of urgent surgery.
Danish: Andexanet alfa er ikke egnet til forbehandling ved akut operation.