DBL HEPARIN SODIUM INJECTION BP (PORCINE) 5,000 IU/ML [SIN01766P]

Product Info

DBL HEPARIN SODIUM INJECTION BP (PORCINE) 5,000 IU/ML

[SIN01766P]

Indication

4.1 Therapeutic indications

Heparin is indicated for the prophylaxis and treatment of thromboembolic disorders such as thrombophlebitis, pulmonary embolism and occlusive vascular disease. It is also used to prevent thromboembolic complications arising from cardiac and vascular surgery, frostbite, dialysis and other perfusion procedures. Heparin is also used as an anticoagulant in blood transfusions.

Dosing

4.2 Dose and method of administration

Dosage

Low dose prophylaxis against postoperative venous thromboembolism: heparin sodium may be used. The usual dose is 5,000 units by deep subcutaneous injection 2 hours before surgery and repeated every 8 to 12 hours for 7 days or longer until the patient is fully ambulatory.

Adults

Treatment of established venous thrombosis or pulmonary embolism. Use heparin sodium. Treatment may be given by the following routes:

a) Continuous intravenous infusion: a bolus dose of 5,000 units may be given initially followed by an infusion of 20,000 to 40,000 units in 1 litre of sodium chloride intravenous infusion or glucose intravenous infusion over 24 hours.

b) Intermittent intravenous injection: an initial dose of 10,000 units followed by 5,000 to 10,000 units every 4 to 6 hours may be given.

c) Deep subcutaneous injection: the usual dose is 5,000 units injected intravenously followed by subcutaneous injection of 10,000 units 8 hourly or 15,000 units 12 hourly. A concentrated form of heparin injection should be used (e.g. 25,000 units/mL).

Children

A suggested dosage is 50 units/kg bodyweight initially by intravenous infusion followed by 100 units/kg bodyweight every 4 hours according to the clotting time.

Method of administration

Heparin may be given by intermittent intravenous injection, intravenous infusion or deep subcutaneous injection. It should not be given intramuscularly because of the danger of haematoma formation.

For single patient use. Use once only and discard any residue.

Contraindications

4.3 Contraindications

Heparin therapy is contraindicated in patients who are hypersensitive to the drug.

It should not be used in the following cases:

• in the presence of actual or potential haemorrhagic states, e.g. haemophilia, ascorbic acid deficiency, increased capillary fragility, hiatus hernia, neoplasms, retinopathy, bleeding haemorrhoids or other organic lesions likely to bleed;

• haemorrhagic vascular accident;

• threatened abortion;

• immediate postpartum period;

• subacute bacterial endocarditis or acute infectious endocarditis;

• severe hypertension;

• gastric or duodenal ulcers or other ulcerative conditions which may have a tendency to haemorrhage, e.g. ulcerative colitis;

• advanced renal or hepatic disease;

• during and immediately after spinal or major surgery, especially those involving the brain, eye or spinal cord;

• shock;

• severe thrombocytopenia or a history of thrombocytopenia with any kind of heparin or with pentosan polysulfate;

• patients in whom suitable blood coagulation tests, e.g. whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low dose heparin).

• hypersensitivity to heparin or to any of the excipients or pork products (e.g. anaphylactoid reactions).