This relationship was most apparent for patients weighing less than 70 kg. Bleeding resulting in discontinuation of the study drug was more frequent among patients receiving Eptifibatide Injection than placebo 4. The overall incidence of stroke was 0. In addition there was 1 case of cerebral infarction in the Eptifibatide Injection group. In both cases, plasma for antibody detection was collected approximately 30 days after each dose.
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This medicine is authorised for use in the European Union. If you need more information about your medical condition or your treatment, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. Expand section Collapse section What is Integrilin? Integrilin is a medicine that contains the active substance eptifibatide. It is available as a solution for infusion drip into a vein and a solution for injection.
What is Integrilin used for? Integrilin is used to prevent a myocardial infarction heart attack in adults. It is used in the following groups: patients who have unstable angina a severe type of chest pain that varies in intensity ; patients who have already had a non-Q-wave myocardial infarction a type of heart attack , with chest pain in the last 24 hours and with abnormalities on the electrocardiogram ECG or signs of heart problems in the blood.
Integrilin is given with aspirin and unfractionated heparin other medicines that prevent blood clots. The patients most likely to benefit from a treatment with Integrilin are those at high risk of myocardial infarction in the three to four days after the start of acute sudden angina.
This includes patients who are having percutaneous transluminal coronary angiography PTCA, a type of surgery to clear the arteries supplying the heart. The medicine can only be obtained with a prescription. How is Integrilin used? Integrilin should be given into a vein by a doctor who has experience in the management of heart conditions. The recommended dose is a single injection of micrograms per kilogram body weight given as soon as possible after diagnosis.
This is followed by a continuous infusion of 2. Patients who have moderate problems with their kidneys should receive a lower dose during the infusion. Integrilin must not be used in patients with severe kidney problems.
If the patient undergoes a percutaneous coronary intervention PCI or angioplasty, a surgical procedure that is used to unblock narrowed coronary arteries , the treatment can be continued for up to 24 hours after surgery, with a maximum treatment duration of 96 hours. How does Integrilin work? Integrilin is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming.
When the blood clots, this is due to special cells in the blood called platelets sticking together aggregating. Integrilin greatly reduces the risk of a blood clot forming and helps prevent another heart attack.
How has Integrilin been studied? Integrilin has been compared with placebo dummy treatment in a study involving 11, patients who were in hospital and had signs that they may soon develop a heart attack, or who had already had a small heart attack.
An additional study compared Integrilin with placebo in 2, patients who were having PTCA to remove a blood clot from the coronary arteries and insert a stent a short tube that remains in the artery to stop it closing. In both studies, patients also received other medicines to prevent the blood clotting.
The main measure of effectiveness was the number of patients who had a heart attack or who died within 30 days of treatment. What benefit has Integrilin shown during the studies?
In the first study, Integrilin was more effective than placebo in preventing death or a heart attack during the 30 days after it was given. A similar benefit was seen in the second study. The main benefit was in the reduction in further heart attacks.
What is the risk associated with Integrilin? The most common side effect with Integrilin seen in more than 1 patient in 10 is bleeding, which may be severe. For the full list of all side effects reported with Integrilin, see the package leaflet.
Integrilin should not be used in people who may be hypersensitive allergic to eptifibatide or any of the other ingredients. It must not be used in patients who have bleeding problems or have a disease that may cause bleeding such as stroke or severe high blood pressure , or in patients with severe liver or kidney problems.
For the full list of restrictions, see the package leaflet. Why has Integrilin been approved? The Committee recommended that Integrilin be given marketing authorisation.
Other information about Integrilin The European Commission granted a marketing authorisation valid throughout the European Union for Integrilin on 1 July The marketing authorisation was renewed on 1 July and on 1 July The marketing-authorisation holder is Glaxo Group Ltd.
This relationship was most apparent for patients weighing less than 70 kg. The overall incidence of stroke was 0. In both cases, plasma for antibody detection was collected approximately 30 days after each dose. The development of antibodies to eptifibatide at higher doses has not been evaluated. Most of the serious nonbleeding adverse reactions consisted of cardiovascular reactions typical of a UA population. Fatal bleeding reactions have been reported. Acute profound thrombocytopenia, as well as immune-mediated thrombocytopenia, has been reported [see Adverse Reactions 6.
In any case, both heparin and Integrilin should be discontinued and sheath hemostasis should be achieved at least 2 to 4 hours before hospital discharge. Safety and efficacy of abciximab combined with dalteparin in the treatment of acute coronary syndromes. Eptifibatide Injection — FDA prescribing information, side effects and uses Tissue plasminogen activator in thrombolytic therapy. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Most major bleeding associated with Eptifibatide Injection has been at the arterial access site for cardiac catheterization or from the gastrointestinal or genitourinary tract. The following adverse reactions have been reported in postmarketing experience, primarily with Eptifibatide Injection in combination with heparin and aspirin: This relationship was most apparent for patients weighing less than 70 kg.
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Uses of Integrilin: It is used during a heart treatment to protect the arteries. It is used to lower the number of heart attacks in patients who have unstable angina or mild heart attacks. It may be given to you for other reasons. Talk with the doctor. If you have an allergy to eptifibatide or any other part of Integrilin eptifibatide. If you are allergic to Integrilin eptifibatide ; any part of Integrilin eptifibatide ; or any other drugs, foods, or substances.