Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
EPTIFIBATIDE
Strides Arcolab International Limited
EPTIFIBATIDE
2 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
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 Lees het volledige document
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 Lees het volledige document