FrancophonIA/ELRC3.0 huggingface dataset:
English: These studies revealed no evidence of impaired fertility or harm to the foetus due to eptifibatide.
Danish: Disse undersøgelser viste ingen tegn på forringet fertilitet eller fosterskade på grund af eptifibatid.
English: MI could also be reported following CEC adjudication of an investigator report.
Danish: MI kunne også rapporteres efter bedømmelse fra den blindede sikkerhedskomité af en investigatorrapport.
English: Potentially, an overdose of eptifibatide could result in bleeding.
Danish: En overdosering af eptifibatid kan potentielt resultere i blødninger.
English: Administration of eptifibatide by intravenous bolus and infusion causes up to a 5-fold increase in bleeding time.
Danish: Indgift af eptifibatid ved intravenøs bolus og infusion forårsager op til 5 gange stigning i blødningstiden.
English: Intravenous use Read the package leaflet before use.
Danish: Intravenøs anvendelse Læs indlægssedlen inden brug.
English: Eptifibatide Accord is also intended for concurrent use with acetylsalicylic acid, as it is part of standard management of patients with acute coronary syndromes, unless its use is contraindicated.
Danish: Eptifibatid Accord er også beregnet til anvendelse samtidig med acetylsalicylsyre, idet dette er en del af standardbehandlingen af patienter med akutte koronarsyndromer, medmindre anvendelse er kontraindiceret.
English: The reduction in the incidence of endpoint events in patients receiving eptifibatide appeared early during treatment.
Danish: Reduktionen i forekomsten af effektmålshændelser hos patienter, der modtog eptifibatid, viste sig tidligt i behandlingen.
English: A total of 1,250 patients underwent PCI within 72 hours after randomisation, in which case they received intravenous unfractionated heparin to maintain an activated clotting time (ACT) of 300-350 seconds.
Danish: I alt 1.250 patienter gennemgik PCI inden for 72 timer efter randomisering, og de modtog da intravenøs ufraktioneret heparin for at vedligeholde en aktiveret koagulationstid (ACT) på 300-350 sekunder.
English: The primary endpoint of the study was the occurrence of death from any cause or new myocardial infarction (MI) (evaluated by a blinded Clinical Events Committee) within 30 days of randomisation.
Danish: Det primære endepunkt for undersøgelsen var død uanset årsag eller nyt myokardieinfarkt (MI) (vurderet af en blindet sikkerhedskomite (CEC)) inden for 30 dage efter randomisering.
English: Heparin administration
Danish: Heparin-indgift
English: Patients were to undergo an invasive strategy for further management after receiving study drug for 12 to 96 hours.
Danish: Patienterne skulle gennemgå yderligere invasiv behandling efter at have fået forsøgsmedicinen i 12-96 timer.
English: Arterial sheaths may be removed when coagulation has returned to normal (e.g. when activated clotting time (ACT) is less than 180 seconds (usually 2-6 hours after discontinuation of heparin).
Danish: Arteriespidsen kan fjernes, når koagulationen er vendt tilbage til det normale, svarende til at aktiveret koagulationstid (ACT) er mindre end 180 sekunder (almindeligvis 2-6 timer efter seponering af heparin).
English: If serious bleeding occurs that is not controllable with pressure, the Eptifibatide Accord infusion should be stopped immediately and any unfractionated heparin that is given concomitantly.
Danish: Hvis der forekommer alvorlig blødning, der ikke kan kontrolleres med tryk, skal infusionen med Eptifibatid Accord og eventuel ufraktioneret heparin, der gives samtidig, stoppes øjeblikkeligt.
English: If the patient requires emergency or urgent cardiac surgery during the course of eptifibatide therapy, terminate the infusion immediately.
Danish: Hvis patienten har behov for akut eller øjeblikkelig hjertekirurgi under behandlingen med eptifibatid, så afslut straks infusionen.
English: Not relevant, as Eptifibatide Accord is intended for use only in hospitalised patients.
Danish: Ikke relevant, da Eptifibatid Accord kun er beregnet til patienter indlagt på hospital.
English: If PCI is to be performed in the setting of UA/NQMI, monitor the activated clotting time (ACT) to maintain a value between 300-350 seconds.
Danish: Hvis der skal foretages PCI med udførelse som for UA/NQMI, så hold øje med den aktiverede koagulationstid (ACT) for at bibeholde en værdi mellem 300-350 sekunder.
English: For a particular adverse reaction, if data was available from both PURSUIT and ESPRIT, then the highest reported incidence was used to assign adverse reaction frequency.
Danish: Hvis en specifik bivirkning blev rapporteret i både PURSUIT og ESPRIT, blev den højest rapporterede hændelse anvendt til bestemmelse af bivirkningsfrekvensen.
English: Patients could be medically managed, proceed to coronary artery bypass graft (CABG), or undergo percutaneous coronary intervention (PCI).
Danish: Patienterne kunne behandles medicinsk, fortsætte til koronar bypassoperation (CABG) eller gennemgå perkutan koronarintervention (PCI).
English: Specifically, no patients experienced an intracranial bleed.
Danish: Helt specifikt fik ingen patienter en hjerneblødning.
English: In ESPRIT, bleeding events were reported at 48 hours, and non-bleeding events were reported at 30 days.
Danish: I ESPRIT blev blødningshændelser rapporteret ved 48 timer og ikkeblødningshændelser ved 30 dage.
English: Pharmacotherapeutic group: Antithrombotic agent (platelet aggregation inhibitors excl. heparin), ATC code: B01AC16
Danish: Farmakoterapeutisk klassifikation: Antitrombotisk middel (trombocytaggregationshæmmere, eksklusive heparin), ATC-kode: B01AC16
English: The experience in humans with overdose of eptifibatide is extremely limited.
Danish: Erfaring med overdosering af eptifibatid hos mennesker er yderst begrænset.
English: 319, Pinner Road, Harrow Middlesex HA1 4HF United Kingdom
Danish: 319, Pinner Road, Harrow Middlesex HA1 4HF Storbritannien
English: Administration of eptifibatide is associated with an increase in major and minor bleeding as classified by the criteria of the TIMI study group.
Danish: Administration af eptifibatid er forbundet med en stigning i antallet af større og mindre blødninger, klassificeret efter TIMI study group kriterierne.
English: During treatment with eptifibatide in this study, minor bleeding was a very common complication (> 1/10, or 13.1 % for eptifibatide versus 7.6 % for placebo).
Danish: Under behandling med eptifibatid i denne undersøgelse var mindre blødning en meget almindelig komplikation (> 1/10 eller 13,1 % for eptifibatid mod 7,6 % for placebo).
English: The mechanism, whether immune- and/or non-immune-mediated, by which eptifibatide may induce thrombocytopenia is not fully understood.
Danish: Mekanismen, hvad enten den er immun- og/eller ikke-immunmedieret, hvormed eptifibatid inducerer trombocytopeni, kendes ikke i detaljer.
English: If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/minute.
Danish: Hvis du har nedsat nyrefunktion, kan dosis blive nedsat til 1 mikrogram/kg/minut.
English: It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes.
Danish: Det bruges til voksne med tegn på svær koronarinsufficiens defineret som spontane og nylige brystsmerter med unormale ændringer i elektrokardiogrammet eller biologiske forandringer.
English: In the same population, plasma elimination half-life is approximately 2.5 hours, plasma clearance 55 to 80 ml/kg/hr and volume of distribution of approximately 185 to 260 ml/kg.
Danish: I samme population er plasmaeliminationshalveringstiden cirka 2,5 timer, plasmaclearance 55 til 80 ml/kg/time og fordelingsvolumen cirka 185 til 260 ml/kg.
English: Compared to placebo, eptifibatide administered as 180/2.0 significantly reduced the incidence of the primary endpoint events (table 1): this represents around 15 events avoided for 1,000 patients treated:
Danish: Sammenlignet med placebo reducerede eptifibatid indgivet som 180/2,0 signifikant hyppigheden af primære endepunkts-hændelser (Tabel 1); dette svarer til 15 undgåede hændelser per 1.000 patienter behandlet:
English: Of the patients in PURSUIT, 13 % were managed with PCI during eptifibatide infusion, of whom approximately 50 % received intracoronary stents; 87 % were managed medically (without PCI during eptifibatide infusion).
Danish: 13 % af patienterne i PURSUIT blev behandlet med PCI under infusionen med eptifibatid, heraf fik cirka 50 % intrakoronare stents, og 87 % blev behandlet medicinsk (uden PCI under infusionen med eptifibatid).
English: • either ST-segment changes: ST depression > 0.5 mm of less than 30 minutes or persistent ST elevation > 0.5 mm not requiring reperfusion therapy or thrombolytic agents, T-wave inversion (> 1 mm),
Danish: • enten ST-segmentændringer: ST-depression > 0,5 mm i mindre end 30 minutter eller vedvarende ST-forhøjelse > 0,5 mm, der ikke krævede reperfusionsbehandling eller trombolytiske midler, T-takinversion (> 1 mm)
English: For this diagnosis, within 24 hours after the index PCI procedure, there had to be at least two CK-MB values ≥ 3 x the upper limit of normal; thus, validation by the CEC was not required.
Danish: For denne diagnose skulle der inden for 24 timer efter den registrerede PCI-procedure være mindst to CK-MB-værdier ≥ 3 x den øvre grænse af normalområdet.
English: Results on the primary endpoint were mainly attributed to the reduction of enzymatic MI occurrence, identified as the occurrence of early elevation of cardiac enzymes after PCI (80 out of 92 MIs in the placebo group vs. 47 out of 56 MIs in the eptifibatide group).
Danish: Resultaterne af det primære effektmål var hovedsageligt kendetegnet ved reduktion i forekomsten af enzymatisk MI, identificeret som forekomsten af tidlig forøgelse af kardielle enzymer efter PCI (80 ud af 92 myokardieinfarkter i placebogruppen over for 47 ud af 56 i eptifibatid-gruppen).
English: In a post hoc analysis of the EARLY ACS trial the risk benefit of dose reduction in patients with moderate renal impairment is inconclusive.
Danish: En post hoc-analyse af EARLY ACS-forsøget var inkonklusiv, hvad angår risiciene i forhold til fordelene ved dosisreduktion hos patienter med moderat nedsat nyrefunktion.
English: In PURSUIT, bleeding and non-bleeding events were collected from hospital discharge to the 30 day visit.
Danish: I PURSUIT blev blødningshændelser og ikke-blødningshændelser samlet fra hospitalsudskrivelse og indtil kontrol 30 dage efter.
English: Clinical Trials
Danish: Kliniske undersøgelser
English: Rash, application site disorders such as urticaria.
Danish: Udslæt, reaktioner på indgivelsesstedet såsom urticaria.
English: < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: sjælden (≥ 1/10.000 til < 1/1000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: Your doctor will weigh up the benefit to you against the risk to your baby of using Eptifibatide Accord while you are pregnant.
Danish: Lægen vil opveje fordelene for dig ved at få Eptifibatid Accord, mens du er gravid, op mod risikoen for dit ufødte barn.
English: There is no experience with eptifibatide and low molecular weight heparins.
Danish: Der er ingen erfaringer med eptifibatid og lavmolekylære hepariner.
English: Use in patients with more severe renal impairment is contraindicated (see section 4.3).
Danish: Anvendelse hos patienter med mere alvorlig nyreinsufficiens er kontraindiceret (se pkt.
English: Toxicology studies conducted with eptifibatide include single and repeated dose studies in the rat, rabbit and monkey, reproduction studies in the rat and rabbit, in vitro and in vivo genetic toxicity studies, and irritation, hypersensitivity and antigenicity studies.
Danish: Toksikologiundersøgelser udført med eptifibatid omfatter undersøgelser med gentagne doser hos rotter, kaniner og aber, reproduktionsundersøgelser hos rotter og kaniner, in vitro og in vivo genetiske toksicitetsundersøgelser og irritations-, overfølsomheds- og antigenicitetsundersøgelser.
English: Similar differences were noted for TIMI major haemorrhage (118 [2.5 %] in early routine use vs. 83 [1.8 %] in delayed provisional use; p=0.016).
Danish: Tilsvarende forskelle blev konstateret for TIMI major blødning (118 [2,5 %] ved tidlig rutinemæssig brug i forhold til 83 [1,8 %] ved forsinket provisorisk brug; p=0,016).
English: Unlike the approved posology in the EU, the study used a double bolus of study drug (separated by 10 minutes) before the infusion.
Danish: I modsætning til den godkendte dosering i EU blev der i forsøget brugt en dobbelt bolus af forsøgsmedicinen (med 10 minutters mellemrum) inden infusionen.
English: Talk to your doctor or hospital pharmacist or nurse before using Eptifibatide Accord.
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger Eptifibatid Accord.
English: Patients most likely to benefit from eptifibatide treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina.
Danish: De patienter, som med størst sandsynlighed vil have gavn af behandling med eptifibatid, er dem med høj risiko for at udvikle myokardieinfarkt inden for de første 3-4 dage efter debut af den akutte angina.
English: Safety measures to prevent this from happening include blood tests and careful checking by the healthcare professionals taking care of you.
Danish: De forholdsregler, der tages for at undgå blødning, inkluderer blodprøver og omhyggelige lægeundersøgelser.
English: On the day of PCI, prior to catheterization, 53.2 % received a thienopyridine (clopidogrel 52.7 %; ticlopidine 0.5 %) - mostly as a loading dose (300 mg or more).
Danish: På dagen for PCI, før kateterindføringen, fik 53,2 % et thienopyridin (clopidogrel 52,7 %; ticlopidin 0,5 %) - oftest som en høj initialdosis (300 mg eller mere).
English: Unlike the approved posology in the EU, all patients in this trial were administered a double bolus before the infusion (see section 5.1).
Danish: I modsætning til den godkendte dosering i EU fik alle patienter i dette forsøg en dobbelt bolus før infusionen (se pkt.
English: The primary endpoint of the trial was death (D), MI, urgent target vessel revascularisation (UTVR), and acute antithrombotic rescue with GP IIb/IIIa inhibitor therapy (RT) within 48 hours of randomisation.
Danish: Undersøgelsens primære effektmål var død (D), MI, akut revaskularisering af arterien (UTVR), og akut antitrombotisk reddende behandling med GP IIb/IIIa inhibitor (RT) inden for 48 timer efter randomiseringen.
English: Cardiac arrest, congestive heart failure, atrial fibrillation, hypotension, and shock, which are commonly reported events from the PURSUIT trial, were events related to the underlying disease.
Danish: Hjertestop, hjerteinsufficiens, atrieflimren, hypotension og shock, som er almindeligt rapporterede hændelser fra PURSUIT undersøgelsen, var hændelser relateret til den bagvedliggende sygdom.
English: When followed by a 2.0 microgram/kg/min continuous infusion, this regimen produces a > 80 % inhibition of ADP-induced ex vivo platelet aggregation, at physiologic calcium concentrations, in more than 80 % of patients.
Danish: Ved efterfølgende 2,0 mikrogram/kg/minut kontinuerlig infusion giver dette regimen en > 80 % hæmning af ADP-induceret ex vivo trombocytaggregation, ved fysiologiske calciumkoncentrationer, hos mere end 80 % af patienterne.
English: In patients undergoing CABG, the incidence of bleeding was not increased by eptifibatide compared to the patients treated with placebo.
Danish: Hos patienter, der gennemgik CABG, øgede eptifibatid ikke forekomsten af blødninger sammenlignet med patienter behandlet med placebo.
English: − During use of Eptifibatide Accord, you will be checked carefully for any signs of unusual or unexpected bleeding.
Danish: - Under brugen af Eptifibatid Accord vil du blive omhyggeligt undersøgt for tegn på usædvanlig eller uventet blødning.
English: There was no excessive bleeding in any of these patients, although one patient undergoing CABG surgery was reported as having had a moderate bleed.
Danish: Der var ingen øget blødning hos nogen af disse patienter, selv om der er indberettet et tilfælde af moderat blødning under en CABGoperation.
English: Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis).
Danish: Teratologiske undersøgelser er udført med kontinuerlig intravenøs infusion af eptifibatid til drægtige rotter med totale daglige doser på op til 72 mg/kg/dag (omkring 4 gange den anbefalede maksimale humane dosis baseret på legemsoverfladeareal), og til drægtige kaniner med totale daglige doser på op til 36 mg/kg/dag (omkring 4 gange den anbefalede maksimale humane dosis baseret på legemsoverfladeareal).
English: Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin.
Danish: Eptifibatid Accord er beregnet til anvendelse sammen med acetylsalicylsyre og ufraktioneret heparin.
English: If the patient weighs < 70 kg, a bolus dose of 60 units/kg is recommended, followed by an infusion of 12 units/kg/hr.
Danish: Hvis patienten vejer < 70 kg, anbefales en bolusdosis på 60 enheder/kg, efterfulgt af en infusion på 12 enheder/kg/time.
English: This increase is readily reversible upon discontinuation of the infusion with bleeding times returning towards baseline in approximately 6 (2-8) hours.
Danish: Denne stigning er hurtig reversibel efter seponering af infusionen, og blødningstiden vender tilbage til udgangsværdien inden for cirka 6 (2-8) timer.
English: Adults (≥ 18 years of age) presenting with unstable angina (UA) or non-Q-wave myocardial infarction (NQMI)
Danish: Voksne (≥ 18 år) med ustabil angina (UA) eller non-Q-tak-myokardieinfarkt (NQMI)
English: Changes during eptifibatide treatment result from its known pharmacological action, i.e., inhibition of platelet aggregation.
Danish: Ændringer under behandling med eptifibatid er følger af den kendte farmakologiske virkning, det vil sige hæmning af trombocytaggregationen.
English: What you need to know before you are given Eptifibatide Accord Do not use Eptifibatide Accord:
Danish: Det skal du vide, før du begynder at få Eptifibatid Accord Brug ikke Eptifibatid Accord:
English: Early routine eptifibatide in this high-risk NSTE-ACS optimally-treated population who were managed with an invasive strategy did not result in a statistically significant reduction in the composite primary endpoint of rate of death, MI, RI-UR, and TBO within 96 hours compared with a regimen of delayed provisional eptifibatide (9.3 % in early eptifibatide patients vs. 10.0 % in patients assigned to delayed provisional eptifibatide; odds ratio=0.920; 95 % CI=0.802-1.055; p=0.234).
Danish: Tidlig rutinemæssig eptifibatid hos denne optimalt behandlede population med akut koronarsyndrom uden ST-elevation i højrisikogruppe, som blev behandlet med invasiv strategi, resulterede ikke i en statistisk signifikant reduktion i det sammensatte primære endepunkt (dødsrate, MI, RI-UR og TBO inden for 96 timer) sammenlignet med et regimen med forsinket provisorisk eptifibatid (9,3 % hos patienter med tidlig eptifibatid i forhold til 10,0 % hos patienter, der blev allokeret til forsinket provisorisk eptifibatid; odds ratio = 0,920; 95 % CI = 0,802-1,055; p = 0,234).
English: Bleeding is most common at the arterial access site in patients undergoing percutaneous arterial procedures.
Danish: Blødning er mest almindeligt ved det arterielle indstikssted hos patienter, der gennemgår perkutan arteriel intervention.
English: Eptifibatide Accord infusion should be stopped immediately if circumstances arise that necessitate thrombolytic therapy or if the patient must undergo an emergency CABG surgery or requires an intraortic balloon pump.
Danish: Infusion med Eptifibatid Accord skal afbrydes øjeblikkeligt, hvis der opstår situationer, der kræver trombolytisk behandling, eller hvis patienten skal gennemgå en akut CABG-operation eller har behov for en ballonpumpe i aorta.
English: The placebo arm was comparable (aspirin 99.7 %, clopidogrel 95.9 %, ticlopidin 2.6 %).
Danish: Placeboarmen var tilsvarende (acetylsalicylsyre 99,7 %, clopidogrel 95,9 %, ticlopidin 2,6 %).
English: Consequently the use of Eptifibatide Accord is not recommended in these circumstances (see section 4.5).
Danish: Eptifibatid Accord bør derfor ikke anvendes i sådanne tilfælde (se pkt.
English: Unfractionated heparin was administered intravenously or subcutaneously at the physician's discretion, most commonly as an intravenous bolus of 5,000 U followed by a continuous infusion of 1,000 U/h.
Danish: Ufraktioneret heparin blev indgivet intravenøst eller subkutant efter lægens skøn, oftest som en intravenøs bolus på 5.000 enheder efterfulgt af en kontinuerlig infusion af 1.000 enheder/time.
English: UA/NQMI: For a patient who weighs ≥ 70 kg, it is recommended that a bolus dose of 5,000 units is given, followed by a constant intravenous infusion of 1,000 units/hr.
Danish: UA/NQMI: Til en patient, der vejer ≥ 70 kg, anbefales det at give en bolusdosis på 5.000 enheder efterfulgt af en konstant intravenøs infusion på 1.000 enheder/time.
English: If the platelet count falls below 100,000/mm3, further platelet counts are required to rule out pseudothrombocytopenia.
Danish: Hvis blodpladetallet falder til < 100.000/mm3, er yderligere trombocyttællinger påkrævet for at udelukke pseudotrombocytopeni.
English: At the recommended therapeutic dose, as administered in the PURSUIT trial involving nearly 11,000 patients, bleeding was the most common complication encountered during eptifibatide therapy.
Danish: Ved den anbefalede terapeutiske dosis, som blev anvendt i PURSUIT-undersøgelsen med næsten 11.000 patienter, var blødning den hyppigste komplikation, der forekom under behandling med eptifibatid.
English: − The active substance is eptifibatide.
Danish: - Aktivt stof: eptifibatid.
English: In healthy subjects, renal excretion accounted for approximately 50 % of total body clearance; approximately 50 % of the amount cleared is excreted unchanged.
Danish: Hos raske personer udgjorde den renale udskillelse cirka 50 % af den totale udskillelse fra kroppen, cirka 50 % af den udskilte mængde udskilles uomdannet.
English: Stop heparin administration if the ACT exceeds 300 seconds; do not administer until the ACT falls below 300 seconds.
Danish: Indgiv ikke heparin, før ACT falder til under 300 sekunder.
English: The combination of reduced dose tenecteplase and eptifibatide compared to placebo and eptifibatide significantly increased the risk of both major and minor bleeding when administered concomitantly in an acute ST-elevation myocardial infarction study.
Danish: Kombination af reduceret dosis af tenecteplase og eptifibatid sammenlignet med placebo og eptifibatid øgede signifikant risikoen for både større og mindre blødninger, da de blev administreret samtidig i et akut ST-elevations myokardieinfarkt-studie.
English: The incidence of severe or life threatening bleeding events with eptifibatide was 1.9 % compared to 1.1 % with placebo.
Danish: Forekomsten af svære eller livstruende blødningshændelser med eptifibatid var 1,9 % sammenlignet med 1,1 % med placebo.
English: GUSTO moderate or severe/life threatening bleeding occurred significantly more often with early routine eptifibatide (7.4 % vs. 5.0 % in delayed provisional eptifibatide group; p <0.001).
Danish: GUSTO moderat eller svær/livstruende blødning forekom signifikant hyppigere ved tidlig rutinemæssig eptifibatid (7,4 % i forhold til 5,0 % i gruppen med forsinket provisorisk eptifibatid; p < 0,001).