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INTEGRILIN 0.75 mg/ml solution for infusion Eptifibatide
2013-10-30 21:43:46 来源: 作者: 【 】 浏览:510次 评论:0

For doctors

 

What is it and how is it used?

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.

What do you have to consider before using it?

You must not be given Integrilin:

Please tell your doctor if you have had any of these conditions. If you have any questions, ask your doctor or hospital pharmacist.

Take special care with Integrilin:

Taking other medicines
To avoid the possibility of interactions with other medicinal products please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Particularly:

If you are breast-feeding a baby, breast-feeding should be interrupted during the treatment period.

How is it used?

Integrilin is given into the vein by direct injection followed by an infusion (drip solution). The dose given is based on your weight. The recommended dose is 180 microgram/kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 microgram/kg/minute for up to 72 hours. If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/minute.

If percutaneous coronary intervention (PCI) is performed during Integrilin therapy, the intravenous solution may be continued for up to 96 hours.

You must also be given doses of aspirin (aspirin) and heparin (if not contraindicated in your case).

If you have any further questions on the use of this product, ask your doctor or hospital pharmacist.

What are possible side effects?

Like all medicines, Integrilin can cause side effects, although not everybody gets them.

Very common side effects These may affect more than 1 in 10 people

Common side effects These may affect up to 1 in 10 people

Uncommon side effects These may affect up to 1 in 100 people

Very rare side effects These may affect up to 1 in 10,000 people

If you notice any signs of bleeding, notify your doctor or nurse immediately. Very rarely, bleeding has become severe and even fatal. Safety measures to prevent this from happening include blood tests and careful checking by the healthcare professionals taking care of you.

If you develop severe allergic reaction or hives, notify your doctor or nurse immediately.

Other events that may occur in patients, who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heartbeat, low blood pressure, shock or cardiac arrest.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist .

How should it be stored?

Keep out of the reach and sight of children

Do not use after the expiry date (EXP) stated on the package and the vial. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Keep the vial in the outer package in order to protect from light. However, protection of Integrilin solution from light is not necessary during administration.

Before using, the vial contents should be inspected.
Integrilin should not be used if it is noticed that particulate matter or discoloration is present.

Any unused material after opening should be discarded.

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For doctors

What is it?

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 it used for?

Integrilin is used to prevent a myocardial infarction (heart attack) in adults. It is used in the following groups:

How is it 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 180 micrograms per kilogram body weight given as soon as possible after diagnosis. This is followed by a continuous infusion of 2.0 microgram/kg per minute which is continued for up to 72 hours, until the start of surgery, or until discharge from the hospital, whichever occurs first.
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 it 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). The active substance in Integrilin, eptifibatide, stops the platelets aggregating by blocking a protein called glycoprotein IIb/III on their surface that helps make them sticky. Integrilin greatly reduces the risk of a blood clot forming and helps prevent another heart attack.

How has it been studied?

Integrilin has been compared with placebo (dummy treatment) in a study involving 11,000 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 2,000 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 benefits has it 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?

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 it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Integrilin’s benefits are greater than its risks when used to prevent early myocardial infarction. The Committee recommended that Integrilin be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Integrilin on 1 July 1999. The marketing authorisation was renewed on 1 July 2004 and on 1 July 2009. The marketing authorisation holder is Glaxo Group Ltd.

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 Name

 INTEGRILIN 0.75 mg/ml solution for infusion

 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.

For a full list of excipients, see section 6.1.

 Pharmaceutical Form

 Solution for infusion.

Clear, colourless solution.

 Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

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