البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
eptifibatide
Accord Healthcare S.L.U.
B01AC16
eptifibatide
Antithrombotic agents
Myocardial Infarction
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).
Revision: 6
Authorised
2016-01-11
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. اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة