natgillin/translations-raw huggingface dataset:
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.
Zdravilo Eptifibatide Accord je namenjeno tudi za sočasno uporabo z acetilsalicilno kislino, ker je del standardne sheme vodenja bolnikov z akutnim koronarnim sindromom, če zanj ni kontraindikacij.
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Because of its short half-life and rapid clearance, the activity of eptifibatide may be halted readily by discontinuing the infusion.
Zaradi kratkega razpolovnega časa in hitrega očistka eptifibatida pa lahko njegovo delovanje hitro ustavite s prekinitvijo infuzije.
In a post hoc analysis of the EARLY ACS trial the risk benefit of dose reduction in patients with moderate renal impairment is inconclusive.
V post hoc analizi preskušanja EARLY ACS razmerje koristi in tveganj znižanja odmerka pri bolnikih z zmerno okvaro ledvic ni omogočilo dokončnih sklepov.
Eptifibatide Accord is not compatible with furosemide.
Zdravilo Eptifibatide Accord ni združljivo s furosemidom.
Shock, hypotension, phlebitis.
Pogosti šok, hipotenzija, flebitis.
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.
Večje tveganje krvavitev se lahko pojavi tudi pri bolnikih, ki prejmejo eptifibatid zgodaj (npr. ob postavitvi diagnoze), v primerjavi s tistimi, ki ga prejmejo tik pred perkutanim koronarnim posegom, kot je pokazala študija Early ACS.
No genotoxic effects were observed with eptifibatide.
Genotoksičnih učinkov pri eptifibatidu niso opažali.
Unlike the approved posology in the EU, the study used a double bolus of study drug (separated by 10 minutes) before the infusion.
V nasprotju z odmerjanjem, odobrenim v EU, so v študiji pred infundiranjem uporabili dvojni bolus raziskovanega zdravila (v presledku 10 minut).
During treatment with eptifibatide there is a significant increase in bleeding rates, especially in the femoral artery area, where the catheter sheath is introduced.
Med zdravljenjem z eptifibatidom se znatno poveča pogostnost krvavitev, zlasti v predelu femoralne arterije, kjer se vstavi vodilo katetra.
It is contraindicated in patients with clinically significant hepatic impairment.
Zdravilo je kontraindicirano pri bolnikih s klinično pomembno jetrno okvaro.
In healthy subjects, renal excretion accounted for approximately 50 % of total body clearance; approximately 50 % of the amount cleared is excreted unchanged.
Pri zdravih osebah gre približno 50 % celotnega telesnega očistka na račun ledvičnega izločanja, približno 50 % očiščene količine pa se izloči v nespremenjeni obliki.
The mechanism, whether immune- and/or non-immune-mediated, by which eptifibatide may induce thrombocytopenia is not fully understood.
Mehanizem - imunski in/ali neimunski - po katerem lahko eptifibatid povzroči trombocitopenijo, ni povsem pojasnjen.
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:
V primerjavi s placebom je eptifibatid uporabljen po shemi 180/2,0 statistično značilno zmanjšal incidenco pojavov primarnega končnega cilja (Tabela 1): to pomeni približno 15 preprečenih pojavov na 1.000 zdravljenih bolnikov.
GUSTO severe/life threatening bleeding was uncommon and comparable in both treatment groups (0.8 %).
Hude/smrtno nevarne krvavitve po GUSTO so bile občasne in v obeh terapevtskih skupinah primerljive (0,8 %).
The data sources used to determine adverse reaction frequency descriptors included two phase III clinical studies (PURSUIT and ESPRIT).
Klinične raziskave Vir podatkov za ugotovitev pogostnosti neželenih učinkov sta dve klinični študiji III. faze (PURSUIT
Emergency or semi-elective surgery
Urgentno ali polurgentno kirurško zdravljenje
Monitor these patients closely with regard to bleeding.
Takšne bolnike morate skrbno spremljati zaradi možnih krvavitev.
This increase is readily reversible upon discontinuation of the infusion with bleeding times returning towards baseline in approximately 6 (2-8) hours.
To podaljšanje je hitro reverzibilno po prenehanju infuzije in čas krvavitve se vrne proti izhodiščni vrednosti v približno 6 (od 2 do 8) urah.
Eptifibatide Accord is not usually recommended for use during pregnancy.
Zdravila Eptifibatide Accord po navadi ni priporočljivo uporabljati med nosečnostjo.
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.
Infuzijo zdravila Eptifibatide Accord morate nemudoma ustaviti, če nastopijo okoliščine, ki zahtevajo trombolitično zdravljenje, če mora bolnik na nujen koronarni premostitveni poseg ali če potrebuje intraaortno balonsko črpalko.
− if you have or have had severe hypertension (high blood pressure).
− če imate ali ste kdaj imeli močno zvišan krvni tlak (hipertenzijo);
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.
Zastoj srca, kongestivno srčno popuščanje, atrijska fibrilacija, hipotenzija in šok, pogosto zabeleženi dogodki v študiji PURSUIT, so bili povezani z osnovno boleznijo.
Changes during eptifibatide treatment result from its known pharmacological action, i.e., inhibition of platelet aggregation.
Spremembe med zdravljenjem z eptifibatidom nastanejo zaradi njegovega znanega farmakološkega delovanja, tj. zavrtja agregacije trombocitov.
Ask your hospital pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte bolnišničnim farmacevtom.
Eptifibatide Accord is chemically and physically compatible with 0.9 % sodium chloride solution for infusion and with dextrose 5 % in Normosol R with or without potassium chloride up to 92 hours when stored at 20-25°C.
Zdravilo Eptifibatide Accord je kemijsko in fizikalno združljivo z 0,9 % raztopino natrijevega klorida za infundiranje in s 5 % dekstrozo v Normosolu R, z ali brez kalijevega klorida, do 92 ur pri shranjevanju pri temperaturi 20 °C - 25 °C.
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.
9 bolnikov takih, ki so prejeli bolusni in/ali infuzijski odmerek, ki je bil več kot dvakrat večji od priporočenega odmerka, oz. ki so jih raziskovalci označili kot prejemnike prevelikega odmerka.
However, treatment with eptifibatide was associated with antibodies that recognise GPIIb/IIIa occupied by eptifibatide, suggesting an immune-mediated mechanism.
Vendar je bilo zdravljenje z eptifibatidom povezano s protitelesi, ki prepoznajo z eptifibatidom zasedeni GPIIb/IIIa, in to kaže na imunski mehanizem.
Consequently the use of Eptifibatide Accord is not recommended in these circumstances (see section 4.5).
Uporaba zdravila Eptifibatide Accord pri takšnih bolnikih torej ni priporočljiva (glejte poglavje 4.5).
Bleeding is most common at the arterial access site in patients undergoing percutaneous arterial procedures.
Krvavitve se najpogosteje pojavijo na mestu arterijskega dostopa pri bolnikih, pri katerih izvajamo perkutani arterijski poseg.
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.
Če se pojavi hujša krvavitev, ki je ni mogoče obvladati s pritiskom, morate nemudoma ustaviti infuzijo zdravila Eptifibatide Accord in morebitno sočasno uporabo nefrakcioniranega heparina.
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.
Primarni končni cilj študije je bila smrt iz kakršnegakoli vzroka ali nov miokardni infarkt (MI) (po oceni Komisije za klinične pojave (KKP), ki ni imela podatka o skupini) v roku 30 dni od randomizacije.
These studies revealed no evidence of impaired fertility or harm to the foetus due to eptifibatide.
Te študije niso pokazale nobenih znakov zmanjšane plodnosti ali škodljivih učinkov eptifibatida na plod.
Eptifibatide Accord should not be used during pregnancy unless clearly necessary.
Zdravila Eptifibatide Accord ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes.
Uporablja se pri odraslih z znaki hude koronarne insuficience, ki je opredeljena kot nedavna spontana bolečina v prsih z nepravilnostmi v EKG ali biološkimi spremembami.
Cardiac arrest, ventricular fibrillation, ventricular tachycardia, congestive heart failure, atrioventricular block, atrial fibrillation.
Pogosti srčni zastoj, ventrikularna fibrilacija, ventrikularna tahikardija, kongestivno srčno popuščanje, atrioventrikularni blok, atrijska fibrilacija;
PURSUIT was conducted at a time when the standard of care of managing acute coronary syndromes was different from that of present times in terms of thienopyridine use and the routine use of intracoronary stents.
Študija PURSUIT je bila opravljena v času, ko je bilo standardno zdravljenje za obvladovanje akutnih koronarnih sindromov drugačno od trenutnega, kar zadeva uporabo tienopiridina in rutinske uporabe intrakoronarnih žilnih opornic.
Any unused medicine after opening should be thrown away.
Morebitni neporabljeni ostanek zdravila po odprtju morate zavreči.
Thus, although eptifibatide can be dialysed, the need for dialysis is unlikely.
Čeprav eptifibatid lahko odstranimo iz telesa z dializo, je torej malo verjetno, da bo ta potrebna.
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).
Teratološke študije so bile opravljene s kontinuirano intravensko infuzijo eptifibatida pri brejih podganah s skupnimi dnevnimi odmerki do 72 mg/kg/dan (približno 4-kratni priporočeni največji dnevni odmerek za človeka na podlagi telesne površine) in pri brejih kunčjih samicah s skupnimi dnevnimi odmerki do 36 mg/kg/dan (približno 4-kratni priporočeni največji dnevni odmerek za človeka na podlagi telesne površine).
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.
Primarni končni cilj študije je vključeval smrt (D), miokardni infarkt (MI), urgentno revaskularizacijo prizadete žile (UTVR) in akutno antitrombotično terapijo z zaviralcem GP IIb/IIIa) (RT) v roku 48 ur po randomizaciji.
Bleeding events were more frequent in patients receiving concurrent heparin while undergoing PCI, when ACT exceeded 350 seconds (see section 4.4, heparin use).
Krvavitve so bile pogostejše pri bolnikih, ki so med perkutano koronarno intervencijo sočasno dobivali heparin, če je AČS presegal 350 sekund (glejte poglavje 4.4, Uporaba heparina).
• 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),
• bodisi spremembe spojnice ST: znižanje spojnice ST za > 0,5 mm za manj kot 30 minut ali trdovratno zvišanje spojnice ST za > 0,5 mm, ki ni zahtevalo reperfuzijske terapije ali trombolitičnih zdravil, inverzijo vala T (> 1 mm), • ali povečanje vrednosti CK-MB.
ESPRIT trial
Študija ESPRIT
Before using, inspect the vial contents.
Pred uporabo preglejte vsebino viale.
Major bleeding was also very common and reported more frequently with eptifibatide than with placebo in the PURSUIT study (> 1/10 or 10.8 % versus 9.3 %), but it was infrequent in the vast majority of patients who did not undergo CABG within 30 days of inclusion in the study.
Tudi večje krvavitve so bile v študiji PURSUIT zelo pogoste in pogosteje opisane med zdravljenjem z eptifibatidom kot s placebom (> 1/10 ali 10,8 % v primerjavi z 9,3 %), a niso bile pogoste pri veliki večini bolnikov, pri katerih ni bil narejen obvod koronarne arterije v 30 dneh od vključitve v študijo.
If either a confirmed platelet decrease to < 100,000/mm3 or acute profound thrombocytopenia is observed, discontinuation of each treatment medication having known or suspected thrombocytopenic effects, including eptifibatide, heparin and clopidogrel, should be considered immediately.
Če se pojavi potrjeno zmanjšanje števila trombocitov na < 100.000 celic/mm3, ali akutna izrazita trombocitopenija, je treba nemudoma prekiniti uporabo zdravil, za katere je znano ali se domneva, da učinkujejo trombocitopenično, vključno z eptifibatidom, heparinom in klopidogrelom.
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.
4.8 Neželeni učinki Večina neželenih učinkov, ki so jih imeli bolniki, zdravljeni z eptifibatidom, je bila praviloma povezana s krvavitvami ali kardiovaskularnimi pojavi, ki so v tej populaciji bolnikov tudi sicer pogosti.
What Eptifibatide Accord is and what it is used for What you need to know before you are given Eptifibatide Accord How to use Eptifibatide Accord
Kaj je zdravilo Eptifibatide Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Eptifibatide Accord Kako uporabljati zdravilo Eptifibatide Accord
ESPRIT: This was a double-blind, multicentre, randomized, parallel-group, placebo-controlled trial evaluating the safety and efficacy of eptifibatide therapy in patients scheduled to undergo nonemergent percutaneous coronary intervention (PCI) with stent implantation.
ESPRIT: To je bila dvojno slepa, multicentrična, randomizirana, s placebom kontrolirana študija vzporednih skupin za oceno varnosti in učinkovitosti zdravljenja z eptifibatidom pri bolnikih s predvideno neurgentno perkutano koronarno intervencijo (PCI) z namestitvijo žilne opornice.
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.
V 72 urah po randomizaciji so perkutani koronarni poseg opravili pri skupaj 1.250 bolnikih, ki so jim v tem primeru intravensko dajali nefrakcioniran heparin, da so aktivirani čas strjevanja (AČS) ves čas ohranjali med 300 in 350 sekundami.
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).
Manjše krvavitve so bile v tej študiji med zdravljenjem z eptifibatidom zelo pogost zaplet (> 1/10 ali 13,1 % za eptifibatid v primerjavi s 7,6 % za placebo).
Administration of eptifibatide is associated with an increase in major and minor bleeding as classified by the criteria of the TIMI study group.
Uporabo eptifibatida spremlja večja pogostnost večjih in manjših krvavitev, razvrščenih po merilih raziskovalne skupine TIMI.
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.
Nefrakcioniran heparin so jim dajali intravensko ali subkutano po presoji zdravnika, najpogosteje v obliki intravenskega bolusa po 5.000 enot/h, ki mu je sledila kontinuirana infuzija po 1.000 enot/h.
− Eptifibatide Accord is recommended for use only in adult, hospitalised patients in coronary care units.
− Zdravilo Eptifibatide Accord priporočamo za uporabo le pri odraslih bolnikih, hospitaliziranih na bolnišničnih koronarnih oddelkih.
− Before and during your treatment with Eptifibatide Accord, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding.
− Pred in med zdravljenjem z zdravilom Eptifibatide Accord bodo pri vas opravili krvne preiskave kot varnostni ukrep za zmanjšanje možnosti za pojav nepričakovanih krvavitev.
If the platelet count falls below 100,000/mm3, further platelet counts are required to rule out pseudothrombocytopenia.
Če se število trombocitov zmanjša pod 100.000 celic/mm3, bodo potrebne dodatne določitve števila trombocitov, da izključite psevdotrombocitopenijo.
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.
V študiji ESPRIT so uporabili poenostavljen režim odmerjanja heparina ob perkutanem koronarnem posegu, ki je sestojil iz začetnega bolusa 60 enot/kg, tarčni AČS pa je bil med 200 in 300 sekund.
The need for blood transfusions was increased modestly by eptifibatide treatment (11.8 % versus 9.3 % for placebo).
Zdravljenje z eptifibatidom je zmerno povečalo potrebo po transfuzijah krvi (11,8 % v primerjavi z 9,3 % pri placebu).
Minor bleeding was defined in the PURSUIT trial as spontaneous gross haematuria, spontaneous haematemesis, observed blood loss with a haemoglobin decrease of more than 3 g/dl, or a haemoglobin decrease of more than 4 g/dl in the absence of an observed bleeding site.
Kot manjše krvavitve so bile v študiji PURSUIT opredeljene spontana močna hematurija, spontana hematemeza, opažena izguba krvi z znižanjem hemoglobina za več kot 3 g/dl, ali znižanje hemoglobina za več kot 4 g/dl brez opaženega mesta krvavitve.
Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do 1/100), redki (≥ 1/10.000 do
The effect of eptifibatide is observed immediately after administration of a 180 microgram/kg intravenous bolus.
Učinek eptifibatida je opazen takoj po dajanju intravenskega bolusa 180 mikrogramov/kg.
Not relevant, as Eptifibatide Accord is intended for use only in hospitalised patients.
Podatek ni potreben, ker je zdravilo Eptifibatide Accord namenjeno samo zdravljenju hospitaliziranih bolnikov.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
It is not recommended for use in children and adolescents below 18 years of age, due to a lack of data on safety and efficacy.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
What Eptifibatide Accord is and what it is used for
Kaj je zdravilo Eptifibatide Accord in za kaj ga uporabljamo
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.
Če temu sledi trajna infuzija 2,0 mikrograma/kg/min, lahko taka shema pri več kot 80 % bolnikov povzroči > 80 % zaviranje z ADP-jem inducirane agregacije trombocitov ex vivo pri fiziološki koncentraciji kalcija.
Eptifibatide, a synthetic cyclic heptapeptide containing six amino acids, including one cysteine amide and one mercaptopropionyl (desamino cysteinyl) residue, is an inhibitor of platelet aggregation and belongs to the class of RGD (arginine-glycine-aspartate)-mimetics.
Eptifibatid, sintetični ciklični heptapeptid s šestimi aminokislinami, vključno z eno cisteinamidno in eno merkaptopropionilno (dezaminocisteinilno) skupino, je zaviralec agregacije trombocitov in sodi v skupino RGD (arginin-glicin-aspartat)-mimetikov.
2 mg/ml : 3.45 mg/ml (0.150 mmol/ml) sodium For the full list of excipients, see section 6.1.
2 mg/ml: 3,45 mg/ml (0,150 mmol/ml) natrija Za celoten seznam pomožnih snovi glejte poglavje 6.1.
− During use of Eptifibatide Accord, you will be checked carefully for any signs of unusual or unexpected bleeding.
− Med uporabo zdravila Eptifibatide Accord vas bodo skrbno spremljali, da ugotovijo morebitne znake nenavadne ali nepričakovane krvavitve.
Other medicines and Eptifibatide Accord
Druga zdravila in zdravilo Eptifibatide Accord
There was no excessive bleeding in any of these patients, although one patient undergoing CABG surgery was reported as having had a moderate bleed.
Noben od teh bolnikov ni imel čezmerne krvavitve, le pri enem pa so poročali o zmerni krvavitvi med koronarno premostitveno operacijo.
Contents of the pack and other information What Eptifibatide Accord contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Eptifibatide Accord
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.
Trombocitopenijo, ki se pojavi po prvi izpostavljenosti zaviralcu GPIIb/IIIa, se lahko pojasni s tem, da so protitelesa pri nekaterih zdravih osebah naravno prisotna.
− if you have had a brain tumour or a condition that affects the blood vessels around the brain.
− če ste imeli možganski tumor ali katero od bolezni, ki vplivajo na možganske krvne žile;
Clinical Trials
KLINIČNI PODATKI
Intravenous use Read the package leaflet before use.
intravenska uporaba Pred uporabo preberite navodilo za uporabo!
Eptifibatide inhibits platelet aggregation in a dose- and concentration-dependent manner as demonstrated by ex vivo platelet aggregation using adenosine diphosphate (ADP) and other agonists to induce platelet aggregation.
Eptifibatid zavira agregacijo trombocitov odvisno od odmerka in koncentracije, kot je pokazala agregacija trombocitov ex vivo z uporabo adenozindifosfata (ADP) in drugih agonistov za indukcijo agregacije trombocitov.
In PURSUIT, bleeding and non-bleeding events were collected from hospital discharge to the 30 day visit.
V študiji PURSUIT so od odpusta iz bolnišnice do pregleda 30. dan beležili krvavitvene in nekrvavitvene dogodke.
Keep the vial in the outer package in order to protect from light.
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
However, in a population pharmacokinetic study there was no evidence of a pharmacokinetic interaction between eptifibatide and the following concomitant medicinal products: amlodipine, atenolol, atropine, captopril, cefazolin, diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, and warfarin.
V neki populacijski farmakokinetični študiji ni bilo znakov farmakokinetičnih interakcij, če so bolniki sočasno z eptifibatidom prejemali naslednja zdravila: amlodipin, atenolol, atropin, kaptopril, cefazolin, diazepam, digoksin, diltiazem, difenhidramin, enalapril, fentanil, furosemid, heparin, lidokain, lizinopril, metoprolol, midazolam, morfin, nitrate, nifedipin in varfarin.
Stop heparin administration if the ACT exceeds 300 seconds; do not administer until the ACT falls below 300 seconds.
Če AČS preseže 300 sekund, morate prenehati z dajanjem heparina in ga ne smete ponovno uporabiti, dokler AČS ne pade pod 300 sekund.
MI could also be reported following CEC adjudication of an investigator report.
Miokardni infarkt je bil lahko prijavljen tudi po presoji KKP, na podlagi njihove ocene poročila raziskovalcev.