INTEGRILIN

מדינה: אינדונזיה

שפה: אינדונזית

מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

מרכיב פעיל:

INTEGRILIN

זמין מ:

MERCK SHARP & DOHME PHARMA - Indonesia

INN (שם בינלאומי):

INTEGRILIN

כמות:

0,75 MG/ML

טופס פרצבטיות:

CAIRAN INJEKSI

יחידות באריזה:

DUS, VIAL @ 100 ML

תוצרת:

SCHERING PLOUGH LABO N.V. - Belgium

תאריך אישור:

2019-01-21

מאפייני מוצר

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