Država: Indonezija
Jezik: indonezijski
Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
EPTIFIBATIDE
ORGANON PHARMA INDONESIA TBK - Indonesia
EPTIFIBATIDE
0.75 MG
INJEKSI
DUS, 1 VIAL @ 100 ML
PATHEON ITALIA S.P.A - Italy
2021-06-17
INTEGRILIN™ SOLUTION FOR INJECTION Eptifibatide COMPOSITION The solution for intravenous infusion is a single dose 100 ml vial containing 0.75 mg/ml. DESCRIPTION INTEGRILIN Solution for Injection is a clear, colorless solution which contains the active ingredient, eptifibatide, a synthetic cyclic heptapeptide containing six amino acids, including one cysteine amide, and one mercaptopropionyl (des-amino cysteinyl) residue. INTEGRILIN is formulated as a sterile solution for injection in two dosage administration forms, bolus and intravenous infusion. Eptifibatide is an inhibitor of platelet aggregation and belongs to the class of RGD (arginine-glycine-aspartate)-mimetics. Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP) IIb/IIIa receptors. 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. The effect of eptifibatide is observed immediately after administration of a 180 microgram/kg intravenous bolus. 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. Platelet inhibition was reversed readily, with a >50% return of platelet function towards baseline 4 hours after stopping a continuous infusion of 2.0 microgram/kg-min. Measurements of ADP-induced ex vivo platelet aggregation at physiologic calcium concentrations (D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone [PPACK] anticoagulant) in patients presenting with unstable angina and non-Q-wave myocardial infarction showed a concentration-dependent inhibition with an IC 50 (50% inhibitory concentration) of 557 ng/ml and an IC 80 (80% inhibitory concentration) of 1107 ng/ml. DISETUJUI OLEH BPOM: 01/07/2021 ID: EREG10 Pročitajte cijeli dokument