Angiox 250 mg powder for concentrate for solution for injectionor infusion

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 :

• with chest pain due to heart disease (acute coronary syndromes - ACS)
• who are having surgery to treat blockages in their blood vessels (angioplasty and/or percutaneous coronary intervention - PCI).

Do not use Angiox

• if you are allergic (hypersensitive) to bivalirudin or any of the other ingredients of Angiox (See section 6 for a list of these) or hirudins.
• if you have, or have recently had, any bleeding from your stomach, intestines, bladder or other organs, for example, if you have noticed abnormal blood in your stools or urine (except from menstrual bleeding).
• if you have, or have had, difficulty with your blood clotting (a low platelet count).
• if you have severe high blood pressure.
• if you have an infection of the heart tissue.
• if you have severe kidney problems or if you need kidney dialysis.

Check with the doctor if you are unsure.

Take special care with Angiox

• if bleeding occurs (if this happens, treatment with Angiox will be stopped). Throughout your treatment, the doctor will check you for any signs of bleeding.
• if you have been treated before with medicines similar to Angiox (e.g. lepirudin).
• before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction. Such a reaction is rare (affects 1 to 10 users in 10,000).
• if you are having radiation treatment in the vessels that supply blood to the heart (treatment called beta or gamma brachytherapy).
• if you are a child (less than 18 years of age), as this medicine is not appropriate for you.

Taking other medicines

Please tell your doctor

• if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
• If you are taking blood thinners (anticoagulants e.g. warfarin) or medicines to prevent blood clots (antithrombotics).

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 :

• you are pregnant or think you may be pregnant
• you are planning to become pregnant
• you are breast-feeding.

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.

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.

• When this treatment is finished, the infusion may go back to 0.25 mg/kg 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.

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:

• while you are in hospital: tell the doctor or nurse immediately ?
• after you?ve left hospital: go immediately to the Emergency Department of your nearest hospital -
• Bleeding ? a verycommon side effect.This could result in complications such as anaemia (a low blood cell count) or haematoma (bruising).
• Allergicreactions, such as hives (nettle rash), itching all over your body, tightness of the chest. These are uncommon reactions that may be serious or even fatal.
• Thrombosis (blood clots) a common side effect which may result in serious or fatal complications such as heart attack.
• Bleeding and bruising at the puncture site (after PCI treatment) which may be painful. These side effects are common.

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

• while you are in hospital: tell the doctor or nurse -
• after you?ve left hospital: go immediately to the Emergency Department of your nearest hospital -

Uncommon side effects:

• severe bruising (which may be due to a reduction in the number of platelets inyour blood. This may prevent your blood from clotting as well as it should)
• headache
• changes in blood pressure
• changes in the rate of your heart beat
• nausea (feeling sick) and/or vomiting (being sick)
• back pain
• chest pain
• shortness of breath
• rash

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

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.

What Angiox contains

• The active substance is bivalirudin.
• Each vial contains 250 mg bivalirudin.
• After reconstitution 1ml contains 50 mg bivalirudin.
• After dilution 1ml contains 5 mg bivalirudin. The other ingredients are mannitol and sodium hydroxide (for pH adjustment)

What Angiox looks like and contents of the pack

Angioxis a white to off-white powder in a glass vial.
Angiox is available in cartons containing 2 and 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

The Medicines Company UK Limited
115L Milton Park
Abingdon
Oxfordshire
OX14 4SA
UNITED KINGDOM

Manufacturer

Hälsa Pharma GmbH
Immermannstraße 9
33619 Bielefeld
GERMANY

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

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