INTEGRILIN eptifibatide (as acetate) 75mg/100mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

eptifibatide, Quantity: 0.75 mg/mL

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; citric acid monohydrate

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INTEGRILIN is indicated for the treatment of patients with unstable angina or non-Q-wave myocardial infarction (see Clinical Trials). INDICATIONS AS AT 29 NOVEMBER 2001: INTEGRILIN is indicated for patients undergoing nonurgent percutaneous coronary intervention with intracoronary stenting (see Clinical Trials). INTEGRILIN is indicated for the treatment of patients with unstable angina or non-Q-wave myocardial infarction (see Clinical Trials).

Product summary:

Visual Identification: Clear, colourless solution.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-11-18

Patient Information leaflet

INTEGRILIN
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN INTEGRILIN?
INTEGRILIN contains the active ingredient eptifibatide and works by
helping to prevent blood clots by stopping the platelets in the
blood from sticking together.
INTEGRILIN is used in people with unstable angina (chest pain) to help
prevent heart attack and possible death as well as to
prevent the formation of blood clots when people have a surgical
procedure (percutaneous coronary intervention) to open an artery
and insert a tube (stent).
For more information, see Section 1. Why am I being given INTEGRILIN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN INTEGRILIN?
Do not use if you have ever had an allergic reaction to eptifibatide
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given INTEGRILIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with INTEGRILIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
Tell your doctor if you are taking any medicines to thin your blood,
to prevent blood clots, or to dissolve clots.
4.
HOW IS INTEGRILIN GIVEN?
•
INTEGRILIN is given in hospital by an injection into a vein followed
by an intravenous drip (infusion). The infusion usually lasts
for up to 3 or 4 days.
•
The dose given is based on your weight. Your doctor or hospital
pharmacist will work out the correct dose for you.
•
You may also be given aspirin and heparin.
More instructions can be found in Section 4. How is INTEGRILIN given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN INTEGRILIN?
LOOKING AFTER
YOUR MEDIC

Summary of Product characteristics

Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
INTEGRILIN™
(EPTIFIBATIDE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Eptifibatide (as acetate salt).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
INTEGRILIN is formulated as a sterile solution for injection in two
dosage administration forms,
bolus injection and intravenous infusion. The bolus injection is a
single dose 10 mL vial
containing eptifibatide 20 mg (2 mg/mL) and the solution for
intravenous infusion is a single
dose 100 mL vial containing eptifibatide 75 mg (0.75 mg/mL).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
INTEGRILIN is a clear, colourless solution. It is formulated as a
sterile solution for injection in
two dosage administration forms, bolus injection and intravenous
infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INTEGRILIN
is
indicated
for
patients
undergoing
nonurgent
percutaneous
coronary
intervention with intracoronary stenting (see Section 5.1
PHARMACODYNAMIC PROPERTIES,
CLINICAL TRIALS).
INTEGRILIN is indicated for the treatment of patients with unstable
angina or non-Q-wave
myocardial infarction (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES,
CLINICAL TRIALS).
4.2
DOSE AND METHOD OF ADMINISTRATION
INTEGRILIN is for hospital use only, by specialist physicians
experienced in the management
of acute coronary syndromes or PCI. There has been limited study of
eptifibatide in patients
with severe renal insufficiency (i.e. those with CrCl < 30 mL/min).
(See SECTION 5.1
PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS.)
•
_ADULTS (_

_18 YEARS OF AGE) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI):
_
The recommended dosage of eptifibatide in patients with creatinine
clearance ≥50 mL/min
(using the Cockcroft-Gault equation*) is an intravenous bolus of 180
µg/kg administered
immediately prior to the procedure, followed by a second bolus of 180
µg/kg 10 minutes
after the first bolus injection. Simultaneously with the first bolus,
a continuous infusion
should be started at a dose of 2