natgillin/translations-raw huggingface dataset:
INTEGRILIN should not be used during pregnancy unless clearly necessary.
INTEGRILIN ne treba primjenjivati tijekom trudnoće osim u slučaju jasne potrebe.
− if you have been treated with another medicineof the same type as Integrilin.
− ako ste bili liječeni nekim drugim lijekom istog djelovanja kao Integrilin.
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.
Drugi događaji koji se mogu pojaviti u bolesnika koji trebaju ovu vrstu liječenja uključuju one koji su povezani sa stanjem zbog kojeg se liječite, kao što su brz ili nepravilan rad srca, niski krvni tlak, šok ili zastoj rada srca.
The carcinogenic potential of eptifibatide has not been evaluated in long-term studies.
Kancerogeni potencijal eptifibatida nije ocijenjen u dugotrajnim ispitivanjima.
Your doctor will weigh up the benefit to you against the risk to your baby of using Integrilin while you are pregnant.
Vaš će liječnik procijeniti korist primjene lijeka Integrilin za Vas i rizik za Vaše dijete tijekom trudnoće.
The extent of eptifibatide binding to human plasma protein is about 25 %.
Opseg vezivanja eptifibatida na proteine plazme u ljudi iznosi oko 25 %.
What Integrilin is and what it is used for What you need to know before you are given Integrilin How to use Integrilin
Što je Integrilin i za što se koristi Što morate znati prije nego počnete primati Integrilin Kako primjenjivati Integrilin
− marked ECG changes (in particular ST-segment abnormalities)
− izražene promjene EKG-a (osobito poremećaji ST-segmenta)
0.034a a: Pearson's chi-square test of difference between placebo and eptifibatide.
0,034a a Pearsonov hi-kvadrat test razlike između placeba i eptifibatida.
According to epidemiological findings, a higher incidence of cardiovascular events has been associated with certain indicators, for instance:
Prema epidemiološkim podacima, veća incidencija kardiovaskularnih događaja bila je povezana s određenim pokazateljima, na primjer:
The clinical relevance of such enzymatic MIs is still controversial.
Klinički značaj tih enzimskih infarkta još uvijek je kontroverzan.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent published on the European medicines web-portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Take special care with Integrilin:
Budite posebno oprezni s lijekom Integrilin:
− elevated heart rate or blood pressure
− ubrzana srčana frekvencija ili povišeni krvni tlak
INTEGRILIN must not be used to treat patients with:
INTEGRILIN ne smiju koristiti bolesnici:
The vast majority of patients received acetylsalicylic acid (75-325 mg once daily).
Velika većina bolesnika primala je acetilsalicilnu kiselinu (75-325 mg jednom na dan).
− raised cardiac enzymes or markers (e.g. CK-MB, troponins) and
− povišeni srčani enzimi ili markeri (npr. CK-MB, troponini) i
− if you have had a brain tumour or a condition that affects the blood vessels around the brain.
− ako ste imali tumor na mozgu ili stanje koje utječe na krvne žile oko mozga.
Not relevant, as INTEGRILIN is intended for use only in hospitalised patients.
Nije relevantno, budući da je INTEGRILIN namijenjen liječenju isključivo hospitaliziranih bolesnika.
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.
Skupina 180/1,3 zaustavljena je nakon interim analize predviđene planom ispitivanja, kad se ustanovilo da dvije aktivno liječene skupine imaju sličnu incidenciju krvarenja.
− Before and during your treatment with Integrilin, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding.
Prije i tijekom liječenja lijekom Integrilin, kao mjera sigurnosti služi provjera uzoraka Vaše krvi, kako bi se smanjila mogućnost neočekivanog krvarenja.
− if you had a major operation or severe injury during the past 6 weeks.
− ako ste imali veliki operativni zahvat ili tešku ozljedu tijekom proteklih 6 tjedana.
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.
U preporučenim terapijskim dozama primijenjenim u ispitivanju PURSUIT koje je uključivalo gotovo 11 000 ispitanika, krvarenje je bila najčešća komplikacija tijekom terapije eptifibatidom.
What you need to know before you are given Integrilin
Što morate znati prije nego počnete primati Integrilin
− anaemia (decreased number of red blood cells).
− anemija (smanjeni broj crvenih krvnih stanica).
Glaxo Operations UK Ltd. (Trading as Glaxo Wellcome Operations) Harmire Road
Glaxo Operations UK Ltd. (posluje kao Glaxo Wellcome Operations) Harmire Road
PURSUIT trial
Ispitivanje PURSUIT
Reproduction studies in animal species where eptifibatide shows a similar pharmacologic activity as in humans are not available.
Nisu provedena reproduktivna ispitivanja na životinjama gdje bi eptifibatid pokazao sličnu farmakološku aktivnost kao u ljudi.
Arterial sheaths may be removed when coagulation has returned to normal (e.g. when activated clotting time (ACT) is less than 180 seconds (usually 26 hours after discontinuation of heparin).
Arterijske uvodnice mogu se odstraniti kad se koagulacija vrati u normalu (npr. kad je aktivirano vrijeme zgrušavanja (ACT) manje od 180 sekundi (obično 2-6 sati nakon prestanka davanja heparina).
− hypersensitivity to the active substance or to any of the excipients listed in section 6.1
− preosjetljivi na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
− During use of Integrilin, you will be checked carefully for any signs of unusual or unexpected bleeding.
Tijekom primjene lijeka Integrilin, posebna pažnja bit će usmjerena uočavanju bilo kakvih znakova neuobičajenog i neočekivanog krvarenja.
An increased risk of bleeding may also be observed in patients who receive early administration of INTEGRILIN (e.g. upon diagnosis) compared to receiving it immediately prior to PCI, as seen in the Early ACS trial.
Povećani rizik od krvarenja se može vidjeti i u bolesnika koji rano prime INTEGRILIN (npr. odmah po postavljenoj dijagnozi), u odnosu na primjenu neposredno prije PCI, kao što je zamijećeno u ‘Early
It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes.
Koristi se u odraslih bolesnika s teškom koronarnom insuficijencijom, koja se definira kao spontana i nedavna bol u prsima s elektrokardiografskim abnormalnostima ili biološkim promjenama.
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.
Ispitivanje PURSUIT je provođeno u vrijeme kada je standard liječenja akutnih koronarnih sindroma bio različit od današnjeg u pogledu primjene tienopiridina i rutinske ugradnje intrakoronarnih stentova.
There are no adequate data from the use of eptifibatide in pregnant women.
Nema odgovarajućih podataka o primjeni eptifibatida u trudnica.
Please refer to the Normosol R Summary of Product Characteristics for details on its composition.
Molimo pogledati Sažetak opisa svojstava Normosol R otopine za detaljni sastav iste.
INTEGRILIN and thrombolytic agents
INTEGRILIN i trombolitici
GUSTO severe/life threatening bleeding was uncommon and comparable in both treatment groups (0.8%).
GUSTO kriterijima, jako/životno ugrožavajuće krvarenje je bilo manje često i usporedivo u pojavnosti za obje ispitivane skupine (0,8 %).
If serious bleeding occurs that is not controllable with pressure, the INTEGRILIN infusion should be stopped immediately and any unfractionated heparin that is given concomitantly.
Dođe li do ozbiljnog krvarenja koje se ne da zaustaviti pritiskom, valja odmah prekinuti infuziju lijeka INTEGRILIN i nefrakcioniranog heparina koji se istodobno primjenjuje.
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 < 1/1,000); very rare (< 1/10,000).
Učestalosti su definirane kao: vrlo često (>1/10), često (>1/100, i <1/10), manje često (>1/1000, i <1/100), rijetko (>1/10 000, i <1/1000),
INTEGRILIN is intended for use with acetylsalicylic acid and unfractionated heparin.
INTEGRILIN je namijenjen za primjenu zajedno s acetilsalicilnom kiselinom i nefrakcioniranim heparinom.
To avoid the possibility of interactions with other medicines please tell your doctor or hospital pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Kako biste izbjegli mogućnost pojave interakcija s drugim lijekovima obavijestite liječnika,bolničkog ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
The reduction in the incidence of endpoint events in patients receiving eptifibatide appeared early during treatment.
Smanjenje incidencije događaja mjere ishoda u bolesnika koji su primali eptifibatid pojavilo se u ranoj fazi liječenja.
− evidence of gastrointestinal bleeding, gross genitourinary bleeding or other active abnormal bleeding within the previous 30 days of treatment
− s potvrđenim gastrointestinalnim krvarenjem, jakim urogenitalnim krvarenjem ili drugim abnormalnim krvarenjem unutar 30 dana prije liječenja
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.
Kardijalni arest, kongestivno zatajenje srca, fibrilacija atrija, hipotenzija i šok koji se ubrajaju u česte nuspojave iz PURSUIT ispitivanja, bile su događaji vezani uz podležeću bolest.
Blood and Lymphatic System Disorder
Poremećaji krvi i limfnog sustava
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).
Provedena su teratološka ispitivanja kontinuiranom intravenskom infuzijom eptifibatida skotnim ženkama štakora s ukupnim dnevnim dozama do 72 mg/kg/dan (oko 4 puta većoj od maksimalne preporučene dnevne doze za ljude, mjereno prema površini tijela) i kunića u ukupnoj dnevnoj dozi do 36 mg/kg/dan (oko 4 puta većoj od maksimalne preporučene dnevne doze za ljude, mjereno prema površini tijela).
− blood thinners (oral anticoagulants) or
− oralne antikoagulanse (lijekove za sprječavanje zgrušavanja krvi) ili
Discontinue unfractionated heparin.
Treba ukinuti heparin.
Integrilin is an inhibitor of platelet aggregation.
Integrilin je inhibitor agregacije trombocita.
− if you have or have had severe hypertension (high blood pressure).
− ako ste imali ili imate tešku hipertenziju (visoki krvni tlak)
Unlike the approved posology in the EU, all patients in this trial were administered a double bolus before the infusion (see section 5.1).
Za razliku od odobrenog načina doziranja lijeka u Europi, svi su bolesnici u tom ispitivanju primali dvostruku bolus dozu prije infuzije (vidjeti dio 5.1).
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.
Većina nuspojava u bolesnika liječenih eptifibatidom općenito je bila povezana s krvarenjem ili kardiovaskularnim događajima koji se često pojavljuju u toj populaciji bolesnika.
Co. Durham
Durham
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.
Ukupno je 1250 bolesnika podvrgnuto PCI unutar 72 sata nakon randomizacije, i tada su primili heparin intravenski kako bi se održalo aktivno vrijeme zgrušavanja (ACT) od 300-350 sekundi.
− skin rash (such as hives).
− osip kože (kao što je koprivnjača).
You must not be given Integrilin: − if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section
− ako ste alergični na eptifibatid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Results on the primary endpoint were principally attributed to the occurrence of myocardial infarction.
Rezultati primarne mjere ishoda prvenstveno su bili pripisani pojavi infarkta miokarda.
Since either repeat exposure with any GP IIb/IIIa ligand-mimetic agent (like abciximab or eptifibatide) or first-time exposure to a GP IIb/IIIa inhibitor may be associated with immune-mediated thrombocytopenic responses, monitoring is required, i.e. platelet counts should be monitored prior to treatment, within 6 hours of administration, and at least once daily thereafter while on therapy and immediately at clinical signs of unexpected bleeding tendency.
Obzirom da ponovna izloženost bilo kojem ligand-mimetiku za GP IIb/IIIa (poput abciksimaba ili eptifibatida) ili prva izloženost inhibitoru GP IIb/IIIa mogu biti povezani s imunološki posredovanim odgovorom u vidu trombocitopenije, praćenje je neophodno, tj. broj trombocita potrebno je provjeriti prije početka liječenja, unutar 6 sati od početka primjene, a nakon toga najmanje jednom dnevno tijekom samog liječenja te odmah ako nastupe klinički znakovi neočekivanog krvarenja.
In PURSUIT, bleeding and non-bleeding events were collected from hospital discharge to the 30 day visit.
U ispitivanju PURSUIT prikupljani su podaci za krvarenja i događaje nevezane uz krvarenja nakon otpusta iz bolnice do kontrolne posjete 30. dana.
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.
U ispitivanju PURSUIT, 9 je bolesnika primilo doze bolusa i/ili infuzije koje su bile dvostruko veće od onih preporučenih, ili za koje je ispitivač ustanovio da su primili preveliku dozu.
Date of latest renewal: 09.07.2009
Datum zadnje obnove odobrenja: 09.07.2009
1 vial of 100 ml
1 bočica od 100 ml
− known history of intracranial disease (neoplasm, arteriovenous malformation, aneurysm)
− koji su bolovali od intrakranijalne bolesti (neoplazma, arteriovenska malformacija, aneurizma)
The experience in humans with overdose of eptifibatide is extremely limited.
Iskustvo s predoziranjem eptifibatidom u ljudi je krajnje ograničeno.
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).
Rezultati primarne mjere ishoda uglavnom se mogu pripisati smanjenju enzimskih IM, definiranih kao nastup ranog povišenja vrijednosti srčanih enzima nakon PCI (80 od 92 infarkta u placebo skupini vs 47 od 56 infarkta u skupini na eptifibatidu).
− thrombocytopenia (< 100,000 cells/mm3)
− s trombocitopenijom (< 100000 stanica/mm3)
− Integrilin is recommended for use only in adult, hospitalised patients in coronary care units.
Integrilin se preporučuje za primjenu jedino u odraslih bolesnika, koji se nalaze u bolnici u koronarnim jedinicama.
If either a confirmed platelet decrease to < 100,000/mm3 or acute profound thrombocytopaenia is observed, discontinuation of each treatment medication having known or suspected thrombocytopenic effects, including eptifibatide, heparin and clopidogrel, should be considered immediately.
Ako se utvrdi pad broja trombocita na < 100 000/mm3 ili akutno nastala teška trombocitopenija, treba odmah razmotriti prekid primjene svih lijekova za koje se zna ili za koje se sumnja da mogu imati trombocitopenični učinak, uključujući eptifibatid, heparin i klopidogrel.
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,
Međutim, u populacijskim farmakokinetičkim ispitivanjima nije bilo dokaza o farmakokinetičkim interakcijama između eptifibatida i sljedećih istodobno primijenjenih lijekova: amlodipina, atenolola, atropina, kaptoprila,
Consequently the use of INTEGRILIN is not recommended in these circumstances (see section 4.5).
Stoga se u takvim okolnostima ne preporučuje se primjena lijeka INTEGRILIN (vidjeti dio 4.5).
While Thrombolysis in Myocardial Infarction TIMI bleeding criteria were used to categorize the incidence of major and minor bleeding in both the PURSUIT and the ESPRIT trials, PURSUIT data was collected within 30 days while ESPRIT data was limited to events within 48 hours or discharge, whichever came first.
Thrombolysis in Myocardial Infarction) korišteni za kategorizaciju incidencije velikog i manjeg krvarenja i u ispitivanju PURSUIT i u ESPRIT, podaci za PURSUIT su prikupljani unutar 30 dana, dok su podaci za ESPRIT bili ograničeni na događaje unutar 48 sati ili do otpusta, što je nastupilo ranije.
If the platelet count falls below 100,000/mm3, further platelet counts are required to rule out pseudothrombocytopenia.
Ako broj trombocita padne ispod 100 000/mm3, treba ponoviti test broja trombocita kako bi se isključila pseudotrombocitopenija.
OTHER SPECIAL WARNING(S), IF NECESSARY Inspect the vial content.
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
INTEGRILIN 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.
INTEGRILIN je također namijenjen za istodobnu primjenu s acetilsalicilnom kiselinom (ASK), budući da je dio standardnog načina zbrinjavanja bolesnika s akutnim koronarnim sindromima, osim ako njegova primjena nije kontraindicirana.
This study was a 726-center, 27-country, double-blind, randomised, placebo-controlled study in 10,948 patients presenting with UA or NQMI.
Ovo ispitivanje provedeno je u 726 centara u 27 zemalja, kao dvostruko slijepo, randomizirano, placebom kontrolirano ispitivanje, u koje je uključeno 10 948 bolesnika sa simptomima NA ili NQIM.
In the subgroup of patients undergoing PCI, major bleeding was observed commonly, in 9.7 % of Integrilin-treated patients vs. 4.6 % of placebo-treated patients.
U podskupini bolesnika koji su podvrgnuti PCI-u, veliko krvarenje zabilježeno je često, u 9,7 % bolesnika liječenih lijekom INTEGRILIN naspram 4,6 % bolesnika koji su primali placebo.
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.
Primarna mjera ishoda u ispitivanju bila je pojava smrti zbog bilo kojeg uzroka ili novi infarkt miokarda (IM) (prema evaluaciji zaslijepljenog Povjerenstva za kliničke događaje) unutar 30 dana od randomizacije.
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).
Na dan PCI, prije kateterizacije, 53,2 % bolesnika dobilo je tienopiridin (klopidogrel 52,7 %; tiklopidin 0,5 %)većinom kao udarnu dozu (300 mg ili više).
There were no notable differences observed with GUSTO severe bleeding rates.
Nisu zapažene razlike u stopama jakih krvarenja prema GUSTO kriterijima.
There is limited therapeutic experience with INTEGRILIN in patients for whom thrombolytic therapy is generally indicated (e.g. acute transmural myocardial infarction with new pathological Q-waves or elevated ST-segments or left bundle branch block in the ECG).
Ograničeno je terapijsko iskustvo s lijekom INTEGRILIN u bolesnika za koje je općenito indicirana trombolitička terapija (npr. akutni transmuralni infarkt miokarda s novim patološkim Q zupcima ili povišenim ST-segmentom ili kompletnim blokom lijeve grane u EKG-u).
Measurements of ADP-induced ex vivo platelet aggregation at physiologic calcium concentrations (Dphenylalanyl-L-prolyl-L-arginine chloromethyl ketone anticoagulant) in patients presenting with unstable angina and Non Q-Wave Myocardial Infarction showed a concentration-dependent inhibition with an IC50 (50 % inhibitory concentration) of approximately 550 ng/ml and an IC80 (80 % inhibitory concentration) of approximately 1,100 ng/ml.
Mjerenja ADP-om inducirane ex vivo agregacije trombocita pri fiziološkim koncentracijama kalcija (D-fenilalanil-Lprolil-L-arginin klorometil keton antikoagulans) u bolesnika s nestabilnom anginom i infarktom miokarda bez Q-zupca, pokazala su inhibiciju ovisnu o koncentraciji s IC50 (50 % inhibitorne koncentracije) od približno 550 ng/ml i IC80 (80 % inhibitorne koncentracije) od približno 1100 ng/ml.
EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome) was a study of early routine eptifibatide versus placebo (with delayed provisional use of eptifibatide in the catheterization laboratory) used in combination with antithrombotic therapies (ASA, UFH, bivalirudin, fondaparinux or low molecular weight heparin), in subjects with high-risk NSTE ACS.
Ispitivanje pod nazivom EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome) je bilo ispitivanje rane rutinske primjene eptifibatida u odnosu na placebo, (s odgođenom privremenom upotrebom eptifibatida u laboratoriju za kateterizaciju), primijenjenog u kombinaciji s antitrombotičkim lijekovima (ASK, UFH, bivalirudin, fondaparinux ili niskomolekularni heparin), u visokorizičnih NSTE ACS bolesnika.
Integrilin is not usually recommended for use during pregnancy.
Primjena lijeka Integrilin u trudnoći se obično ne preporučuje.
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.
U ispitivanju ESPRIT koristio se pojednostavljeni režim primjene heparina tijekom intervencije koji se sastojao od inicijalnog bolusa od 60 jedinica/kg, s ciljnim ACT od 200 - 300 sekundi.
Bleeding events were more frequent in patients receiving concurrent heparin while undergoing PCI, when ACT exceeded 350 seconds (see section 4.4, heparin use).
Krvarenje je bilo češće u bolesnika koji su istodobno primali heparin i bili podvrgnuti PCI, kad je ACT premašio 350 sekundi (vidjeti dio 4.4., Primjena heparina).
INTEGRILIN is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.
INTEGRILIN je indiciran za sprječavanje ranog infarkta miokarda u odraslih osoba koji imaju nestabilnu anginu ili infarkt miokarda bez Q-zupca, u kojih se posljednja epizoda boli u prsima dogodila u posljednja 24 sata i koji imaju promjene u elektrokardiogramu (EKG) i/ili povišene srčane enzime.
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.
Toksikološka ispitivanja provedena s eptifibatidom uključuju ispitivanja s pojedinačnim ili ponavljanim dozama na štakorima, kunićima i majmunima, ispitivanja utjecaja na reprodukciju štakora i kunića, in vitro i in vivo ispitivanja genotoksičnosti, te ispitivanja iritacije, preosjetljivosti i antigenosti.