HEPARIN INJECTION 5,000 IU/ML [SIN00714P]

Product Info

HEPARIN INJECTION 5,000 IU/ML

[SIN00714P]

4.1 Therapeutic indications
Heparin is indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism; in the treatment of myocardial infarction and arterial embolism; for prevention of clotting in arterial and heart surgery and for prevention of cerebral thrombosis. Heparin may also be used as an anticoagulant in blood transfusions, extra-corporal circulation, dialysis procedures, and for laboratory purposes.

4.2 Posology and method of administration
Heparin is usually administered by intravenous or subcutaneous injection. The intramuscular route cannot be recommended because of the high incidence of haematoma.
The increase in clotting time provided by heparin becomes apparent immediately after administration and lasts for 4 to 6 hours after intravenous injection and for about eight hours after subcutaneous injection.

Dosage
Haemodialysis: 7,500–12,500 international units is normally required per dialysis. Intravenous administration: 5,000–10,000 international units every four hours either by bolus injection or continuous infusion in Sodium Chloride Injection or Dextrose Injection. However, the dose should be monitored with coagulation tests performed just before each administration and varied according to individual response. The clotting time should be 2–3 times the control value.
Subcutaneous administration (Therapeutic dosage): Subcutaneous administration of 10,000 international units may be given every 8 hours after an initial intravenous bolus injection of 5,000 international units.
Low-dose heparin prophylaxis: 5,000 international units s.c. should be given two to six hours pre-operatively and every 8 –12 hours post-operatively for 10–14 days, or until the patient is mobile, whichever is the longer.
Myocardial infarction: 5,000 international units s.c. every twelve hours beginning during the twelve hours following the first sign of myocardial infarction.
Open heart surgery: Operations of less than two hours, 120 international units/kg/hour. For operations of longer duration, one and a half times this dose should be given. For each 450 ml of blood used, 2,000 international units are needed.
Treatment periods vary from 10–14 days in perioperative prophylaxis to as much as six weeks in the treatment of established thrombosis.
It is anticipated that heparin will have disappeared from the blood-stream 4 hours after intravenous injection of 5,000 international units and 6–8 hours after 10,000 international units and 15,000 international units of i.v. heparin, respectively.
In situations needing large amounts of heparin, as in cardio-pulmonary bypass, preservative-free heparin should be used. If this is unavailable and preserved heparin has to be used, then the most concentrated heparin solution should be chosen to minimise the quantity of preservative administered.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

It is also contraindicated when suitable blood coagulation tests – e.g. the whole-blood clotting time, partial thromboplastin time, – cannot be performed at the required intervals. There is usually no need to monitor the effect of low-dose heparin in patients with normal coagulation parameters. The drug is contraindicated during any uncontrolled active bleeding state (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Current or previous immune-mediated heparin-induced thrombocytopenia (type II) (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Active major haemorrhage and risk factors for major haemorrhage. Major haemorrhage is defined as fulfilling one of these four criteria:
1) Fatal bleeding. 2) Bleeding in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome. 3) Bleeding which induces a decrease in the haemoglobin level of 20g/L (1.24 mmol/L) or more. 4) Bleeding leading to transfusion of two or more units of whole blood or red blood cells.

Septic endocarditis.

Heparin LEO® is contra-indicated in locoregional anesthesia in patients receiving heparin for treatment rather than for prophylaxis. Heparin LEO® is also contraindicated for insertion of epidural catheter in patients receiving treatment doses. Removal or manipulation of an epidural catheter should only be done, when the benefit outweighs the risk (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Heparin LEO® contains 10 mg/ml of the preservative benzyl alcohol. This must not be given to premature babies or neonates due to the risk of gasping syndrome.