Angiox 250 mg powder for concentrate for solution for inject - United Kingdom[英国药品]

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Angiox 250 mg powder for concentrate for solution for inject

2014-06-18 16:16:39 来源: 作者: 【大中小】浏览:399次评论:0条

For doctors

What is it and how is it used?

Angioxcontains a substance called bivalirudin whichis an antithrombotic medicine. Antithrombotics are medicines which prevent the formation of blood clots (thrombosis).

Angioxis used to treat patients :

What do you have to consider before using it?

Do not use Angiox

Check with the doctor if you are unsure.

Take special care with Angiox

Taking other medicines

Please tell your doctor

Because these medicines may increase the risk of side effects such as bleeding when given at the same time as Angiox.

Pregnancy and breast-feeding

You must tell the doctor if :

Angiox should not be used during pregnancy, unless clearly necessary. Your doctor will decide whether or not this treatment is appropriate for you.
If you are breast-feeding, the doctor will decide whether Angiox should be used.

Driving and using machines

No studies of the effects on the ability to drive and use machines have been performed, but the effects of this medicine are known to be short-term. Angiox is only given when a patient is in hospital. It is, therefore, unlikely to affect your ability to drive or to use machines.

How is it used?

Your treatment with Angiox will be supervised by a doctor. The doctor will decide how much Angiox you receive, and will prepare the medicine.

Angiox is for injection, followed by infusion (drip), into a vein (never into a muscle). This is administered and supervised by a doctor experienced in caring for patients with heart disease.

The dose given depends on your weight and on the kind of treatment you are being given.

Dosage

For patients with acute coronary syndromes (ACS) the recommended starting dose is :

0.1 mgkg body weight as an injection, followed by an infusion drip of 0.25 mgkg body weight per hour.

If, after this, you then need percutaneous coronary intervention (PCI) treatment, the dosage will be increased to:

0.5 mgkg body weight for the injection, followed by an infusion of 1.75 mgkg body weight, per hour.

If you need to have a coronary artery bypass graft operation, treatment with bivalirudin will either be stopped one hour before the operation or an additional dose of 0.5 mg/kg body weight will be given by injection followed by an infusion of 1.75 mg/kg body weight per hour.

For patients starting with percutaneous coronary intervention (PCI) the recommended dose is:

0.75 mgkg body weight as an injection, followed immediately by an infusion of 1.75 mgkg body weight, per hour. The infusion may continue for up to 4 hours.

If you have mild kidney problems, the dose of Angiox may need to be reduced.

The doctor will decide for how long you should be treated.

If you receive more of this medicine than you should
Your doctor will decide how to treat you, including stopping the drug and monitoring for signs of ill effects.

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

What are possible side effects?

Like all medicines, Angiox can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.

If side effects occur, they may need medical attention.

The most common, important side effect of treatment with Angiox, is bleeding which could occur anywhere in the body. This can become serious, and may, rarely, be fatal. Bleeding is more likely to occur when Angiox is used in combination with other anticoagulant or antithrombotic medicines (see section 2 ‘Taking other medicines’).

If you get any of the following, potentially serious, side effects:

If you get any of the following, (potentially less serious), side effects:

Uncommon side effects:

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

How should it be stored?

Keep out of the reach and sight of children.

Angiox is not to be used after the expiry date which is stated on the label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Lyophilised (freeze-dried) powder: Do not store above 25°C.

Reconstituted solution : Store in a refrigerator (2–8 ^oC). Do not freeze.
Diluted solution: Do not store above 25ºC. Do not freeze.

The solution should be a clear to slightly opalescent, colourless to slightly yellow solution. The doctor will check the solution and will discard it, if it contains particles or is discoloured.

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For doctors

What is it?

Angiox is a powder that is made up into a solution for injection or infusion (drip into a vein). It contains the active substance bivalirudin.

What is it used for?

Angiox is used to prevent blood clots in adults who are undergoing angioplasty, including patients who are having myocardial infarction (a heart attack) with ‘ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG). Angioplasty or ‘percutaneous coronary intervention’ (PCI) is a surgical procedure used to unblock the heart’s blood vessels.
Angiox is also used to treat adults with unstable angina (a type of chest pain that varies in severity) or myocardial infarction without ST segment elevation, who are about to undergo treatment such as PCI, a heart bypass or using other medicines.
Angiox is used together with aspirin and clopidogrel (medicines that help to prevent blood clots). The medicine can only be obtained with a prescription.

How is it used?

Angiox should be given by a doctor who has experience in the emergency care of patients with heart problems or in carrying out procedures on the heart.
The dose of Angiox and the duration of treatment depend on why it is being used. The first dose is given by injection into a vein, which is followed immediately by an infusion. In patients undergoing PCI, the infusion may be continued for up to 16 hours after the procedure. In patients being treated for angina or myocardial infarction without ST segment elevation, the duration of the infusion depends on how the patient is going to be treated. The speed of the infusion needs to be reduced in patients with moderate kidney problems who are undergoing PCI.
For more information, see the Summary of Product Characteristics (also part of the EPAR).

How does it work?

Blood clotting can be a problem when blood flow is disturbed in any way. Angiox is an anticoagulant, which means that it prevents the blood from clotting. The active substance in Angiox, bivalirudin, is a synthetic substance derived from hirudin, the anticoagulant substance produced by leeches. It specifically blocks one of the substances involved in the clotting process called thrombin. Thrombin is central to the processes involved in blood clotting. Using Angiox greatly reduces the risk of a blood clot forming. This can improve the effectiveness of PCI and help to maintain the flow of blood to the heart in patients with angina or myocardial infarction.

How has it been studied?

In PCI, Angiox, given in combination with a glycoprotein IIb/IIIa inhibitor (GPI, another type of medicine that helps to prevent blood clots), has been compared with the standard combination of heparin (another anticoagulant) and a GPI in two studies involving a total of almost 10,000 adults. Almost 4,000 of the patients were having PCI to treat myocardial infarction with ST segment elevation.
For the treatment of angina or myocardial infarction without ST segment elevation, the main study involved almost 14,000 adults and compared Angiox taken alone or with a GPI, with the combination of heparin and a GPI.
In all of the studies, the patients also received other medicines to prevent blood clots, such as aspirin, clopidogrel and abciximab. The main measure of effectiveness was the reduction in the number of patients who had an ‘ischaemic event’ (a problem caused by reduced blood flow) including death, a heart attack, urgent revascularisation (restoration of blood flow to the heart) or stroke after 30 days. The studies also looked at the number of patients who had major bleeding.

What benefits has it shown during the studies?

In both studies of patients undergoing PCI, Angiox in combination with a GPI was as effective as heparin with a GPI at preventing new ischaemic events. When used to treat angina or myocardial infarction without ST segment elevation, Angiox, given with or without a GPI, was as effective as the combination of heparin and a GPI in preventing deaths, heart attacks and revascularisations. It was most effective in patients who also took aspirin and clopidogrel. Major bleeding tended to be as common or less common with Angiox than with heparin.

What is the risk associated?

The most common side effect with Angiox (seen in more than 1 patient in 10) is minor bleeding. For the full list of all side effects reported with Angiox, see the Package Leaflet.
Angiox should not be used in people who may be hypersensitive (allergic) to bivalirudin, other hirudins, or any of the other ingredients. It must not be used in patients who have recently been bleeding, or who have severe high blood pressure, severe kidney problems or a heart infection. For the full list of restrictions, see the Package Leaflet.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Angiox is an acceptable substitute for heparin during PCI and in the treatment of angina and myocardial infarction. The Committee decided that Angiox’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Angiox to The Medicines Company UK Ltd on 20 September 2004. After five years, the marketing authorisation was renewed for a further five years.

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