INTEGRILIN IV INFUSION 0.75 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

EPTIFIBATIDE

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

B01AC16

Dosage:

0.75 mg/ml

Pharmaceutical form:

INJECTION

Composition:

EPTIFIBATIDE 0.75 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Patheon Italia, S.p.A.

Authorization status:

ACTIVE

Authorization date:

1999-11-11

Patient Information leaflet

Page 1 of 10 
INTEGRILIN*

 IV BOLUS & IV INFUSION 
Solution For Injection 
Brand of eptifibatide 

This insert contains basic prescribing information 
only. For more comprehensive information, a 
Professional Brochure is available to physicians on 
request 

FOR INJECTABLE ADMINISTRATION (Bolus for intravenous
injection; Intravenous infusion) 
DESCRIPTION OF PRODUCT: INTEGRILIN Solution for Injection is a
clear, colorless solution, 
which contains the active ingredient, eptifibatide (approved USAN
and INN nomenclature), 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. THE
BOLUS 
INJECTION is a single dose 10ml vial containing
eptifibatide 2mg/ml, and THE SOLUTION FOR 
INTRAVENOUS INFUSION is a
single dose 100ml vial containing eptifibatide 0.75mg/ml.  Inactive 
ingredients:  Citric acid monohydrate, sodium hydroxide, and water for injection. 

PRECLINICAL
INFORMATION: 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. No unexpected toxic effects for an
agent with this pharmacologic profile were observed 
and findings were predictive of clinical experience, with
bleeding effects being the principal 
adverse event. 
No genetic liability was observed with eptifibatide. 

Reproductive toxicity studies in rabbits which did
not show susceptibility to the pharmacologic 
action of eptifibitide even at high doses were negative. 

The carcinogenic potential of INTEGRILIN Solution 

Summary of Product characteristics

Integrilin® IV Bolus & IV infusion
Solution For Injection
Brand of eptifibatide
This insert contains basic prescribing information
only.
For
more
comprehensive
information,
a
Professional Brochure is available to physicians on
request
FOR INJECTABLE ADMINISTRATION (Bolus for intravenous injection;
Intravenous infusion)
DESCRIPTION OF PRODUCT: INTEGRILIN Solution for Injection is a clear,
colorless solution,
which contains the active ingredient, eptifibatide (approved USAN and
INN nomenclature), 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.
The bolus
injection
is
a
single
dose
10 ml vial
containing
eptifibatide
2 mg/ml,
and
the
solution
for
intravenous infusion is a single dose 100 ml vial containing
eptifibatide 0.75 mg/ml. Inactive
ingredients: Citric acid monohydrate, sodium hydroxide, and water for
injection.
PRECLINICAL INFORMATION: 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. No unexpected toxic effects for an agent with this
pharmacologic profile were observed
and findings were predictive of clinical experience, with bleeding
effects being the principal
adverse event. No genetic liability was observed with eptifibatide.
Reproductive toxicity studies in rabbits which did not show
susceptibility to the pharmacologic
action of eptifibitide even at high doses were negative.
The carcinogenic potential of INTEGRILIN Solution for Injection has
not been evaluated in long-
term studies.
CLINICAL PHARMACOLOGY AND PHARMACOKINETICS: Eptifibatide is an
inhibitor of platelet
aggregation and belongs to the class of RGD
(arginine-glycine-aspartate)
-
mimetics.
Eptifibatide rev