EPTIFIBATIDE STRIDES 0.75 Mg/Ml Solution for Infusion

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

EPTIFIBATIDE

Tillgänglig från:

Strides Arcolab International Limited

INN (International namn):

EPTIFIBATIDE

Dos:

0.75 Mg/Ml

Läkemedelsform:

Solution for Infusion

Receptbelagda typ:

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

Bemyndigande status:

Authorised

Tillstånd datum:

0000-00-00

Bipacksedel

Dimension: 600 x 420 mm 
Front Side
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPTIFIBATIDE STRIDES  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, 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 Infusion is and what it is used for
2.  What you need to know before you are given Eptifibatide Infusion
3.  How to use Eptifibatide Infusion 
4.  Possible side effects
5.  How to store Eptifibatide Infusion
6.  Contents of the pack and other information
1.  WHAT EPTIFIBATIDE INFUSION IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Eptifibatide Strides 0.75 mg/ml, Solution for Infusion’ but in the 
rest of the leaflet it will be called ‘Eptifibatide Infusion’.
Eptifibatide  Infusion  contains  the  active  ingredient  eptifibatide.  It  is  an  inhibitor  of  platelet 
aggregation. This means that it helps to prevent blood clots from
forming. 
Eptifibatide Infusion 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
INFUSION
YOU MUST NOT BE GIVEN EPTIFIBATIDE INFUSION:
•
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 
bleedin

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eptifibatide Strides 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 ml contains 1.6 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion
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�