Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
eptifibatide
GlaxoSmithKline (Ireland) Limited
B01AC16
eptifibatide
Antithrombotic agents
Angina, Unstable; Myocardial Infarction
Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin.Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes.Patients most likely to benefit from Integrilin 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 percutaneous transluminal coronary angioplasty (PTCA).
Revision: 26
Authorised
1999-07-01
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT INTEGRILIN 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 Integrilin is and what it is used for 2. What you need to know before you are given Integrilin 3. How to use Integrilin 4. Possible side effects 5. How to store Integrilin 6. Contents of the pack and other information 1. WHAT INTEGRILIN IS AND WHAT IT IS USED FOR Integrilin 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 INTEGRILIN YOU MUST NOT BE GIVEN INTEGRILIN: − 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. − if you have or have had difficulty with your blood Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT INTEGRILIN 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. Excipients with known effect Contains 161 mg of sodium per 100 ml vial 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 INTEGRILIN is intended for use with acetylsalicylic acid and unfractionated heparin. INTEGRILIN 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 INTEGRILIN 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. INTEGRILIN solution for infusion must be used in conjunction with INTEGRILIN 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). INTEGRILIN 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 _ _ 3 _Adults (_ ≥ _ 18 years of age) presenting with unstable angina (UA) or non-Q-wave Aqra d-dokument sħiħ