Eptifibatide Accord

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

eptifibatide

Available from:

Accord Healthcare S.L.U.

ATC code:

B01AC16

INN (International Name):

eptifibatide

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Myocardial Infarction

Therapeutic indications:

Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin.Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).

Product summary:

Revision: 6

Authorization status:

Authorised

Authorization date:

2016-01-11

Patient Information leaflet

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPTIFIBATIDE ACCORD 0.75 MG/ML SOLUTION FOR INFUSION
eptifibatide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or hospital
pharmacist or nurse.
-
If you get any side effects talk to your doctor or hospital pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Eptifibatide Accord is and what it is used for
2.
What you need to know before you are given Eptifibatide Accord
3.
How to use Eptifibatide Accord
4.
Possible side effects
5.
How to store Eptifibatide Accord
6.
Contents of the pack and other information
1.
WHAT EPTIFIBATIDE ACCORD IS AND WHAT IT IS USED FOR
Eptifibatide Accord is an inhibitor of platelet aggregation. This
means that it helps to prevent blood
clots from forming.
It is used in adults with manifestation of severe coronary
insufficiency defined as spontaneous and
recent chest pain with electrocardiographic abnormalities or
biological changes. It is usually given
with aspirin and unfractionated heparin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN EPTIFIBATIDE ACCORD
_ _
DO NOT USE EPTIFIBATIDE ACCORD:
-
if you are allergic to eptifibatide or any of the other ingredients of
this medicine (listed in section
6).
-
if you have recently had bleeding from your stomach, intestines,
bladder or other organs, for
example if you have seen abnormal blood in your stool or urine (except
from menstrual bleeding)
in the past 30 days.
-
if you have had a stroke within the past 30 days or any haemorrhagic
stroke (also, be sure your
doctor knows if you ever had a stroke).
-
if you have had a brain tumour or a condition that affects the blood
vessels around the brain.
-
if you had a major operation or severe injury during the past 6 weeks.
-
if you have or have had bleeding problems.

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Eptifibatide Accord 0.75 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 0.75 mg of eptifibatide.
One vial of 100 ml of solution for infusion contains 75 mg of
eptifibatide.
Excipient with known effect:
Each vial contains 172 mg (7.5 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eptifibatide Accord is intended for use with acetylsalicylic acid and
unfractionated heparin.
Eptifibatide Accord is indicated for the prevention of early
myocardial infarction in adults presenting
with unstable angina or non-Q-wave myocardial infarction, with the
last episode of chest pain occurring
within 24 hours and with electrocardiogram (ECG) changes and/or
elevated cardiac enzymes.
Patients most likely to benefit from Eptifibatide Accord treatment are
those at high risk of developing
myocardial infarction within the first 3-4 days after onset of acute
angina symptoms including for
instance those that are likely to undergo an early PTCA (Percutaneous
Transluminal Coronary
Angioplasty) (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This product is for hospital use only. It should be administered by
specialist physicians experienced in
the management of acute coronary syndromes.
Eptifibatide Accord solution for infusion must be used in conjunction
with Eptifibatide Accord
solution for injection.
Concurrent administration of heparin is recommended unless this is
contraindicated for reasons such as
a history of thrombocytopenia associated with use of heparin (see
‘Heparin administration’, section 4.4).
Eptifibatide Accord is also intended for concurrent use with
acetylsalicylic acid, as it is part of standard
management of patients with acute coronary syndromes, unless its use
is contraindicated.
Posology
_Adults (_

_18 years of a