EPTIFIBATIDE STRIDES 2 Mg/Ml Solution for Injection

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

EPTIFIBATIDE

Verfügbar ab:

Strides Arcolab International Limited

INN (Internationale Bezeichnung):

EPTIFIBATIDE

Dosierung:

2 Mg/Ml

Darreichungsform:

Solution for Injection

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

0000-00-00

Gebrauchsinformation

Dimension: 600 x 420 mm 
Front Side
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPTIFIBATIDE STRIDES 2 MG/ML SOLUTION FOR INJECTION
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, pharmacist or
nurse.
−
If you get any side effects, talk to your doctor, 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 Injection is and what it is used for
2.  What you need to know before you are given Eptifibatide
Injection
3.  How to use Eptifibatide Injection 
4.  Possible side effects
5.  How to store Eptifibatide Injection
6.  Contents of the pack and other information
1.  WHAT EPTIFIBATIDE INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Eptifibatide Strides 2 mg/ml, Solution for Injection’ but in the 
rest of the leaflet it will be called ‘Eptifibatide Injection’.
Eptifibatide Injection contains the active ingredient eptifibatide. It is an inhibitor of platelet 
aggregation. This means that it helps to prevent blood clots from
forming. 
Eptifibatide Injection is used in adults with manifestation of severe
coronary insufficiency 
defined as spontaneous and recent chest pain with electrocardiographic
abnormalities or bio-
logical changes. It is usually given with acetylsalicylic acid and
unfractionated heparin.
2.   WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN EPTIFIBATIDE
INJECTION
YOU MUST NOT BE GIVEN EPTIFIBATIDE INJECTION:
•
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

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eptifibatide Strides 2 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains 2 mg of eptifibatide.
One vial of 10 ml of solution for injection contains 20 mg of eptifibatide.
Excipient with known effect:
Each ml contains 1.6 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Clear, colourless solution
pH: Between 5.0 and 5.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eptifibatide is intended for use with acetylsalicylic acid and unfractionated heparin.
Eptifibatide 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 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.
Posology
_Adults ( 18 years of age) presenting with unstable angina (UA) or non-Q-wave myocardial infarction (NQMI)_
The recommended dosage is an intravenous bolus of 180 microgram/kg administered as soon as possible following
diagnosis, followed by a continuous infusion of 2.0 microgram/kg/min for up to 72 hours, until initiation of coronary
artery bypass gra