HEPARIN SODIUM 1000 I. U./ml Solution for injection Ref.[7780] Active ingredients: Heparin

Route of Administration

By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection.

The intravenous injection volume of heparin injection should not exceed 15ml.

As the effects of heparin are short-lived, administration by intravenous infusion is preferable to intermittent intravenous injections.

Recommended dosage

Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris, acute peripheral arterial occlusion

Adults

Loading dose: 5,000 units intravenously (10,000 units may be required in severe pulmonary embolism).

Maintenance: 1,000-2,000 units/hour by intravenous infusion, or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly

Dosage reduction may be advisable.

Children and small adults

Loading dose: 50 units/kg intravenously.

Maintenance: 15-25 units/kg/hour by intravenous infusion, or 100 units/kg 4-hourly by intravenous injection.

Daily laboratory monitoring (ideally at the same time each day, starting 4-6 hours after initiation of treatment) is essential during full-dose heparin treatment, with adjustment of dosage to maintain an APTT value 1.5-2.5 x midpoint of normal range or control value.

In extracorporeal circulation and haemodialysis

Adults

Cardiopulmonary bypass:

Initially 300 units/kg intravenously, adjusted thereafter to maintain the activated clotting time (ACT) in the range 400-500 seconds.

Haemodialysis and haemofiltration:

Initially 1,000-5,000 units.

Maintenance: 1,000-2,000 units/hour, adjusted to maintain clotting time >40 minutes.

Heparin resistance

Patients with altered heparin responsiveness or heparin resistance may require disproportionately higher doses of heparin to achieve the desired effect. Also refer to section 4.4, Special warnings and precautions for use.

A potential hazard of heparin therapy is haemorrhage, but this is usually due to overdosage and the risk is minimised by strict laboratory control. Slight haemorrhage can usually be treated by withdrawing the drug. If bleeding is more severe, clotting time and platelet count should be determined. Prolonged clotting time will indicate the presence of an excessive anticoagulant effect requiring neutralisation by intravenous protamine sulfate, at a dosage of 1 mg for every 100 I.U. of heparin to be neutralised. The bolus dose of protamine sulfate should be given slowly over about 10 minutes and not exceed 50 mg. If more than 15 minutes have elapsed since the injection of heparin, lower doses of protamine will be necessary.

3 years.

Following the withdrawal of the first dose the remainder should be used within 28 days. After this period, any unused material should be discarded.

Do not store above 25°C.

Store in the original package.

Chemical and physical in use stability has been demonstrated for 28 days at 25°C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 25°C. Other in use storage times and conditions are the responsibility of the user.

5ml multidose neutral glass (Type 1, Ph Eur) vial. Carton contains 10 vials.

Each multidose vial should be restricted to use in a single patient.