Therapeutic indications
For the prevention of thromboembolic events, including deep vein thrombosis, in patients undergoing general and orthopaedic surgery.
For the prevention of clotting in the extracorporeal circuit during haemodialysis in patients with chronic renal insufficiency.
Posology and method of administration
For prevention of thromboembolic events:
Administration is by subcutaneous injection.
Adults at low to moderate risk, e.g. patients undergoing general surgery:
3,500 anti-Factor Xa IU two hours before surgery and then once daily for 7 to 10 days post-operatively.
Adults at high risk, e.g. patients undergoing orthopaedic surgery:
In this high risk group the recommended dose is either a fixed dose of 4,500 anti-Factor Xa IU given 12 hours before surgery followed by a once daily dose, or 50 anti-Factor Xa IU/kilogram body weight 2 hours before surgery followed by a once daily dose for 7 to 10 days post-operatively.
For haemodialysis:
The dose of innohep® should be given into the arterial side of the dialyser or intravenously. The dialyser can be primed by flushing with 500-1000ml isotonic sodium chloride (9mg/ml) containing 5,000 anti-Factor Xa IU innohep® per litre.
Patients with chronic renal insufficiency:
a) Short-term haemodialysis (up to 4 hours)
A bolus dose of 2,000 - 2,500 anti-Factor Xa IU into the arterial side of the dialyser (or intravenously).
b) Long-term haemodialysis (more than 4 hours)
A bolus dose of 2,500 anti-Factor Xa IU into the arterial side of the dialyser (or intravenously) followed by 750 anti-Factor Xa IU/hour infused into the extracorporeal circuit.
Dosage adjustment
The bolus innohep® dose may be adjusted (increased or decreased) by 250 - 500 anti-Factor Xa IU until a satisfactory response is obtained.
Additional innohep® (500 - 1,000 anti-Factor Xa IU) may be given if concentrated red cells or blood transfusions (which may increase the likelihood of clotting in the dialyser) are given during dialysis or additional treatment beyond the normal dialysis duration is employed.
Dose monitoring
Determination of plasma anti-Factor Xa may be used to monitor the innohep® dose during haemodialysis. Plasma anti-Factor Xa, one hour after dosing should be within the range 0.4 - 0.5 IU/ml.
