natgillin/translations-raw huggingface dataset:
Ovennævnte undersøgelser er således ikke velegnede til at vurdere toksiciteten af eptifibatid på reproduktionsfunktionen (se pkt 4.6). 
Consequently these studies are not suitable to evaluate the toxicity of eptifibatide on reproductive function (see section 4.6).
Resultaterne af det primære endepunkt blev hovedsageligt tillagt forekomsten af myokardieinfarkt. 
Results on the primary endpoint were principally attributed to the occurrence of myocardial infarction.
Dato for første markedsføringstilladelse: 11th januar 2016 
Date of first authorisation: 11th January 2016
Andre mulige blødningssteder, såsom det centrale og perifere nervesystem og retroperitoneale steder, skal også kontrolleres nøje. 
Other potential bleeding sites such as central and peripheral nervous system and retroperitoneal sites, must be carefully considered too.
Selv om eptifibatid kan dialyseres, er det usandsynligt, at der skulle opstå behov for dialyse. 
Thus, although eptifibatide can be dialysed, the need for dialysis is unlikely.
MI blev påvist ved CK-MB-laboratorieundersøgelseskriterier. 
MI was identified per the CK-MB core laboratory criteria.
GUSTO svær/livstruende blødning var ikke almindelig og sammenlignelig i de to behandlingsgrupper (0,8 %). 
GUSTO severe/life threatening bleeding was uncommon and comparable in both treatment groups (0.8 %).
Anafylaktiske reaktioner. 
Anaphylactic reactions.
Blødning har i sjældne tilfælde vist sig at være meget alvorlig eller endog livstruende. 
Very rarely, bleeding has become severe and even fatal.
Fortæl det til lægen, hvis du er gravid, har mistanke om at du er gravid, eller planlægger at blive gravid. 
Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby.
Eptifibatid Accord bør ikke anvendes under graviditet, medmindre det er klart nødvendigt. 
Eptifibatide Accord should not be used during pregnancy unless clearly necessary.
Eptifibatid-behandlede patienter, der havde en protrombintid (PT) > 14,5 sekunder og fik warfarin samtidig, syntes ikke at have øget risiko for blødning. 
Eptifibatide -treated patients who had a prothrombin time (PT) > 14.5 seconds and received warfarin concomitantly did not appear to be at an increased risk of bleeding.
Bortskaf al ikke anvendt lægemiddel efter åbning. 
Discard any unused medicinal product after opening.
Patienterne kunne kun inkluderes, hvis de havde haft hjerteiskæmi i hvile (≥ 10 minutter) inden for de sidste 24 timer og havde: 
Patients could be enrolled only if they had experienced cardiac ischemia at rest (≥ 10 minutes) within the previous 24 hours and had:
Øvrige bivirkninger, der kan forekomme hos patienter, der har behov for denne slags behandling, er forbundet med den sygdom, du behandles for, såsom hurtigt eller uregelmæssigt hjerteslag, lavt blodtryk, shock eller hjertestop. 
Other events that may occur in patients, who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heartbeat, low blood pressure, shock or cardiac arrest.
Denne undersøgelse var en 726-centre, 27-lande, dobbeltblind, randomiseret, placebokontrolleret undersøgelse af 10.948 patienter, der havde UA eller NQMI. 
This study was a 726-center, 27-country, double-blind, randomised, placebo-controlled study in 10,948 patients presenting with UA or NQMI.
Der foreligger ikke tilstrækkelige data om brugen af eptifibatid hos gravide kvinder. 
There are no adequate data from the use of eptifibatide in pregnant women.
Gruppen 180/1,3 blev stoppet efter en interimanalyse, som tidligere anført i protokollen, da de to aktive behandlingsarme syntes at have samme blødningsfrekvens. 
The 180/1.3 arm was stopped after an interim analysis, as prespecified in the protocol, when the two active-treatment arms appeared to have a similar incidence of bleeding.
Reproduktionsundersøgelser på dyr, hvor eptifibatid viser en lignende farmakologisk aktivitet som hos mennesker, findes ikke. 
Reproduction studies in animal species where eptifibatide shows a similar pharmacologic activity as in humans are not available.
Beslutningen om at foretage trombocyttransfusion bør baseres på en individuel klinisk vurdering. 
The decision to use platelet transfusions should be based upon clinical judgment on an individual basis.
I PURSUIT-undersøgelsen var der 9 patienter, som fik bolus- og/eller infusionsdoser, der var mere end dobbelt så store som den anbefalede dosis, eller som blev identificeret af investigator til at have modtaget en overdosering. 
In the PURSUIT trial, there were 9 patients who received bolus and/or infusion doses more than double the recommended dose, or who were identified by the investigator as having received an overdose.
Komponenten MI kunne defineres som asymptomatisk med enzymatisk stigning i CK-MB eller ny Q-tak. 
The component MI could be defined as asymptomatic with enzymatic elevation of CK-MB or new Q wave.
Bivirkningerne er inddelt efter systemorganklasse og hyppighed. 
The undesirable effects are listed by body system and frequency.
De fleste bivirkninger hos de patienter, der fik behandling med eptifibatid, var generelt relateret til blødninger eller til kardiovaskulære hændelser, der forekommer hyppigt hos denne patientpopulation. 
The majority of adverse reactions experienced by patients treated with eptifibatide were generally related to bleeding or to cardiovascular events that occur frequently in this patient population.
- Eptifibatid Accord er ikke beregnet til anvendelse hos børn eller unge under 18 år. 
- Eptifibatide Accord is not intended for use in children or adolescents less than 18 years of age.
Efter fjernelse af indføringsspidsen skal omhyggelig hæmostase sikres under nøje observation. 
After removal of the introducer sheath, careful haemostasis must be ensured under close observation.
0,034a a: Pearsons chi-square-test af forskellen mellem placebo og eptifibatid. 
0.034a a: Pearson's chi-square test of difference between placebo and eptifibatide.
Eptifibatid Accord er ikke forligeligt med furosemid. 
Eptifibatide Accord is not compatible with furosemide.
De udførte dyreforsøg er utilstrækkelige med hensyn til virkningerne for graviditetens, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt. 
Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Der blev ikke påvist statistisk signifikant fordel ved tidlig rutinemæssig eptifibatid-strategi i den subgruppe af patienter, som blev behandlet medicinsk eller i perioderne med medicinsk behandling inden PCI eller CABG. 
No statistically significant benefit of early routine eptifibatide strategy was demonstrated in the subgroup of patients who were managed medically or during the medical management periods prior to PCI or CABG.
ESPRIT-undersøgelsen anvendte et simplificeret heparin-regimen under PCI, som bestod af en initial bolus på 60 enheder/kg, med en målsætning for ACT på 200-300 sekunder. 
The ESPRIT trial used a simplified regimen of heparin during PCI that consisted of an initial bolus of 60 units/kg, with a target ACT of 200 - 300 seconds.
Eptifibatid Accord anbefales normalt ikke til brug under graviditet. 
Eptifibatide Accord is not usually recommended for use during pregnancy.
Under behandling med eptifibatid er der en betydelig stigning i blødningshyppigheden, især i det femorale arterieområde, hvor kateterspidsen indføres. 
During treatment with eptifibatide there is a significant increase in bleeding rates, especially in the femoral artery area, where the catheter sheath is introduced.
Ingen uventede toksiske virkninger for et stof med denne farmakologiske profil blev observeret, og fundene var prediktive for klinisk erfaring med blødningshændelser som værende den hovedsagelige bivirkning. 
No unexpected toxic effects for an agent with this pharmacologic profile were observed and findings were predictive of clinical experience, with bleeding effects being the principal adverse event.
En øget risiko for blødning kan også observeres hos patienter, som får tidlig administration af eptifibatid (f.eks. ved diagnosticeringen) sammenlignet med patienter, som får det umiddelbart før PCI, som set i EARLY ACS-forsøget. 
An increased risk of bleeding may also be observed in patients who receive early administration of eptifibatide (e.g. upon diagnosis) compared to receiving it immediately prior to PCI, as seen in the Early ACS trial.
De fleste patienter fik acetylsalicylsyre (75-325 mg en gang daglig). 
The vast majority of patients received acetylsalicylic acid (75-325 mg once daily).
Forlænget blødningstid 
Prolongation of bleeding time
Produktet bør administreres af speciallæger med erfaring i behandling af akutte koronarsyndromer. 
It should be administered by specialist physicians experienced in the management of acute coronary syndromes.
Seponer ufraktioneret heparin. 
Discontinue unfractionated heparin.
Trombocytopeni, der opstår efter første eksponering for en GP-IIb/IIIa-hæmmer, kan måske forklares ved det faktum, at antistoffer er naturligt til stede hos nogle normale individer. 
Thrombocytopenia occurring after first exposure to a GPIIb/IIIa inhibitor may be explained by the fact that antibodies are naturally present in some normal individuals.
På grund af dets korte halveringstid og hurtige clearance kan virkningen af eptifibatid hurtigt stoppes ved at afbryde infusionen. 
Because of its short half-life and rapid clearance, the activity of eptifibatide may be halted readily by discontinuing the infusion.
Ingen genotoksiske virkninger blev observeret med eptifibatid. 
No genotoxic effects were observed with eptifibatide.
Hvis patienten behøver semi-elektiv kirurgi, så stop infusionen med eptifibatid på et passende tidspunkt for at give tid til, at trombocytfunktionen kan vende tilbage til den normale. 
If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal.
Kvinder, ældre patienter, patienter med lav kropsvægt eller med moderat nyreinsufficiens (kreatininclearance ≥30 - <50 ml/min) kan have en øget blødningsrisiko. 
Women, the elderly, patients with low body weight or with moderate renal impairment (creatinine clearance > 30 - < 50 ml/min) may have an increased risk of bleeding.
Eptifibatid, indgivet alene, har ingen målelig effekt på protrombintiden (PT) eller aktiveret partiel tromboplastintid (aPTT). 
When administered alone, eptifibatide has no measurable effect on prothrombin time (PT) or activated partial thromboplastin time (aPTT).
Der var ingen tegn på svære bivirkninger forbundet med tilfældig indgift af store bolusdoser, hurtig infusion rapporteret som overdosering eller store kumulative doser. 
There was no indication of severe adverse reactions associated with administration of accidental large bolus doses, rapid infusion reported as overdose or large cumulative doses.
Det anbefales at afbryde amningen i behandlingsperioden. 
Interruption of breast-feeding during the treatment period is recommended.
Spørg på apoteket, hvordan du skal bortskaffe medicinrester. 
Ask your hospital pharmacist how to throw away medicines you no longer use.
Den tilgængelige kliniske dokumentation kan dog ikke stadfæste, at denne dosisjustering resulterer i en vedvarende fordel (se pkt. 
The available clinical evidence cannot however confirm that this dose modification results in a preserved benefit (see section 5.1).
Disse undersøgelser viste ingen tegn på forringet fertilitet eller fosterskade på grund af eptifibatid. 
These studies revealed no evidence of impaired fertility or harm to the foetus due to eptifibatide.
MI kunne også rapporteres efter bedømmelse fra den blindede sikkerhedskomité af en investigatorrapport. 
MI could also be reported following CEC adjudication of an investigator report.
En overdosering af eptifibatid kan potentielt resultere i blødninger. 
Potentially, an overdose of eptifibatide could result in bleeding.
Indgift af eptifibatid ved intravenøs bolus og infusion forårsager op til 5 gange stigning i blødningstiden. 
Administration of eptifibatide by intravenous bolus and infusion causes up to a 5-fold increase in bleeding time.
Intravenøs anvendelse Læs indlægssedlen inden brug. 
Intravenous use Read the package leaflet before use.
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. 
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.
Reduktionen i forekomsten af effektmålshændelser hos patienter, der modtog eptifibatid, viste sig tidligt i behandlingen. 
The reduction in the incidence of endpoint events in patients receiving eptifibatide appeared early during treatment.
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. 
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.
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. 
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.
Heparin-indgift 
Heparin administration
Patienterne skulle gennemgå yderligere invasiv behandling efter at have fået forsøgsmedicinen i 12-96 timer. 
Patients were to undergo an invasive strategy for further management after receiving study drug for 12 to 96 hours.
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). 
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).
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. 
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.
Hvis patienten har behov for akut eller øjeblikkelig hjertekirurgi under behandlingen med eptifibatid, så afslut straks infusionen. 
If the patient requires emergency or urgent cardiac surgery during the course of eptifibatide therapy, terminate the infusion immediately.
Ikke relevant, da Eptifibatid Accord kun er beregnet til patienter indlagt på hospital. 
Not relevant, as Eptifibatide Accord is intended for use only in hospitalised patients.
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. 
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.
Hvis en specifik bivirkning blev rapporteret i både PURSUIT og ESPRIT, blev den højest rapporterede hændelse anvendt til bestemmelse af bivirkningsfrekvensen. 
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.
Patienterne kunne behandles medicinsk, fortsætte til koronar bypassoperation (CABG) eller gennemgå perkutan koronarintervention (PCI). 
Patients could be medically managed, proceed to coronary artery bypass graft (CABG), or undergo percutaneous coronary intervention (PCI).
Helt specifikt fik ingen patienter en hjerneblødning. 
Specifically, no patients experienced an intracranial bleed.
I ESPRIT blev blødningshændelser rapporteret ved 48 timer og ikkeblødningshændelser ved 30 dage. 
In ESPRIT, bleeding events were reported at 48 hours, and non-bleeding events were reported at 30 days.
Farmakoterapeutisk klassifikation: Antitrombotisk middel (trombocytaggregationshæmmere, eksklusive heparin), ATC-kode: B01AC16 
Pharmacotherapeutic group: Antithrombotic agent (platelet aggregation inhibitors excl. heparin), ATC code: B01AC16
Erfaring med overdosering af eptifibatid hos mennesker er yderst begrænset. 
The experience in humans with overdose of eptifibatide is extremely limited.
319, Pinner Road, Harrow Middlesex HA1 4HF Storbritannien 
319, Pinner Road, Harrow Middlesex HA1 4HF United Kingdom
Administration af eptifibatid er forbundet med en stigning i antallet af større og mindre blødninger, klassificeret efter TIMI study group kriterierne. 
Administration of eptifibatide is associated with an increase in major and minor bleeding as classified by the criteria of the TIMI study group.
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). 
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).
Mekanismen, hvad enten den er immun- og/eller ikke-immunmedieret, hvormed eptifibatid inducerer trombocytopeni, kendes ikke i detaljer. 
The mechanism, whether immune- and/or non-immune-mediated, by which eptifibatide may induce thrombocytopenia is not fully understood.
Hvis du har nedsat nyrefunktion, kan dosis blive nedsat til 1 mikrogram/kg/minut. 
If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/minute.
Det bruges til voksne med tegn på svær koronarinsufficiens defineret som spontane og nylige brystsmerter med unormale ændringer i elektrokardiogrammet eller biologiske forandringer. 
It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes.
I samme population er plasmaeliminationshalveringstiden cirka 2,5 timer, plasmaclearance 55 til 80 ml/kg/time og fordelingsvolumen cirka 185 til 260 ml/kg. 
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.
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: 
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:
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). 
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).
• 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) 
• 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),
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. 
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.
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). 
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).
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. 
In a post hoc analysis of the EARLY ACS trial the risk benefit of dose reduction in patients with moderate renal impairment is inconclusive.
I PURSUIT blev blødningshændelser og ikke-blødningshændelser samlet fra hospitalsudskrivelse og indtil kontrol 30 dage efter. 
In PURSUIT, bleeding and non-bleeding events were collected from hospital discharge to the 30 day visit.
Kliniske undersøgelser 
Clinical Trials
Udslæt, reaktioner på indgivelsesstedet såsom urticaria. 
Rash, application site disorders such as urticaria.
sjælden (≥ 1/10.000 til < 1/1000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra tilgængelige data). 
< 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Lægen vil opveje fordelene for dig ved at få Eptifibatid Accord, mens du er gravid, op mod risikoen for dit ufødte barn. 
Your doctor will weigh up the benefit to you against the risk to your baby of using Eptifibatide Accord while you are pregnant.
Der er ingen erfaringer med eptifibatid og lavmolekylære hepariner. 
There is no experience with eptifibatide and low molecular weight heparins.
Anvendelse hos patienter med mere alvorlig nyreinsufficiens er kontraindiceret (se pkt. 
Use in patients with more severe renal impairment is contraindicated (see section 4.3).
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. 
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.
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). 
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).
I modsætning til den godkendte dosering i EU blev der i forsøget brugt en dobbelt bolus af forsøgsmedicinen (med 10 minutters mellemrum) inden infusionen. 
Unlike the approved posology in the EU, the study used a double bolus of study drug (separated by 10 minutes) before the infusion.
Kontakt lægen eller sundhedspersonalet, før du bruger Eptifibatid Accord. 
Talk to your doctor or hospital pharmacist or nurse before using Eptifibatide Accord.
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. 
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.
De forholdsregler, der tages for at undgå blødning, inkluderer blodprøver og omhyggelige lægeundersøgelser. 
Safety measures to prevent this from happening include blood tests and careful checking by the healthcare professionals taking care of you.