INTEGRILIN PACKAGE INSERT PDF

ANNEX I. SUMMARY OF PRODUCT CHARACTERISTICS. 1 INTEGRILIN is indicated for the prevention of early myocardial infarction in adults presenting. Package leaflet: Information for the patient. Integrilin mg/ml solution for infusion eptifibatide. Read all of this leaflet carefully before you start using this. 1. Package leaflet: Information for the patient. Eptifibatide Accord 2 mg/ml solution for injection eptifibatide. Read all of this leaflet carefully before you start using.

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We comply with the HONcode standard for trustworthy health information – verify here. In patients who received apckage, the corresponding loss in hemoglobin was estimated through an adaptation of the method of Landefeld et al. Patients Overall incidence of major bleeding 9.

Integrilin eptifibatide injection is supplied as a sterile solution in mL vials containing 20 mg of Integrilin NDC and mL vials containing 75 mg of Integrilin NDC A target aPTT of 50 to 70 seconds was recommended.

The infusion was continued for 72 hours, until hospital discharge, or until the time of CABG, whichever occurred first, except that if PCI was performed, the eptifibatide infusion was continued for 24 hours after the procedure, allowing for a duration of infusion up to 96 hours.

Eptifibatide Injection

These findings suggest acute thrombocytopenia after the administration of Integrilin intwgrilin develop as a result of naturally occurring drug-dependent antibodies or those induced by prior exposure to Integrilin. As shown in Table 7, each eptifibatide regimen reduced the rate of death, MI, or urgent intervention, although at 30 days, this finding was statistically significant only in the lower-dose eptifibatide group.

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FDA alerts for all medications. These studies revealed no evidence of harm to the fetus due to eptifibatide. This difference may be a true treatment difference, the effect of other differences in these subgroups, or a statistical anomaly. Subscribe to receive email notifications whenever new articles are published. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: The ESPRET study was a multicenter, double-blind, randomized, placebo-controlled study conducted in the United States and Canada that enrolled patients undergoing elective or urgent PCI with intended intracoronary stent placement.

Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous IV use with an empirical formula of C 35 H 49 N 11 O 9 S 2 and a molecular weight of If bleeding cannot be controlled by pressure, discontinue eptifibatide and concomitant heparin immediately. Bleeding at “other” locations occurred inset 0.

Eptifibatide Injection — AuroMedics Pharma LLC

iintegrilin In these studies, Integrilin inhibited ex vivo platelet aggregation induced by adenosine diphosphate ADP and other agonists in a dose- and concentration-dependent manner. Impact of eptifibatide on early ischemic events in acute ischemic coronary syndromes: As reported by the investigators, the occurrence of death from any cause or new MI for patients followed for at least days was reduced from Patients in clinical studies were older range: Angina amlodipineaspirincarvedilolmetoprololatenololMore Sixty-eight percent were men.

The activated partial thromboplastin time aPTT should be maintained between 50 and 70 seconds unless PCI is to be performed. Integrilin Rating No reviews – Add your review. Rapid and sustained coronary artery recanalization with combined bolus injection of recombinant tissue-type plasminogen activator and monoclonal antiplatelet GPIIbIIIa antibody in a canine preparation. Studies in healthy subjects enrolled only males; patient studies enrolled approximately one-third women.

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Studies in healthy subjects enrolled only males; patient studies enrolled approximately one-third women. Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. Early sheath removal is encouraged while Integrilin is being infused.

The ESPRIT study was a multicenter, double-blind, randomized, placebo-controlled study conducted in the United States and Canada that enrolled patients undergoing elective or urgent PCI with intended intracoronary stent placement. Instructions for Administration 1. Because animal reproduction studies are not always predictive of human response, Integrilin should be used during pregnancy only if clearly needed.

A minimum of 12 hours of infusion is recommended. To view content sources and attributions, please refer to our editorial policy. If a patient with low platelet counts is receiving Eptifibatide Injection, their platelet count should be monitored closely. Comparison of receptor occupancy and platelet aggregation response of eptifibatide administered intravenously in patients with unstable angina or non-Q-wave myocardial infarction.

Patients requiring thrombolytic therapy should have eptifibatide infusions stopped.