Prophylaxis: Prophylaxis against thromboembolism should be tailored according to the patient's risk. Risk factors include age >40 years, history of deep vein thrombosis or pulmonary embolism, surgery and other trauma, prolonged immobilisation, cardiac disease, obesity, malignancy, varicose veins, hypercoagulable states, pregnancy and the puerperium, oral contraceptives, severe infection, inflammatory bowel disease.
Patients with high risk of thromboembolism: Clexane dosage of 40 mg (0.4 mL; anti-Xa: 4000 IU) should be administered SC once daily. In high-risk patients undergoing surgery, the initial dose should be given approximately 12 hrs preoperatively.
Patients with a moderate risk of thromboembolism: The recommended Clexane dosage is 20 mg (0.2 mL; anti-Xa: 2000 IU) SC once daily. In moderate risk patients undergoing surgery, the initial dose should be given approximately 2 hrs preoperatively.
Prophylaxis should be continued for 7-10 days or until the risk of thromboembolism has diminished.
Under normal conditions of use, Clexane does not modify global clotting tests and therefore there is no need to perform these tests in order to monitor treatment.
Treatment of Deep Venous Thrombosis: The clinical trials which established the efficacy of Clexane in the treatment of deep venous thrombosis were conducted on patients who were initially treated with heparin and then changed to Clexane when a definitive diagnosis was established. However, the use of heparin prior to Clexane is not currently recommended. The average duration of therapy in the clinical trials was 10 days. No data are available on the safety of long-term treatment. Data on use in patients >65 years in these trials were limited.
Recommended Dosage: 1 mg/kg body weight (100 IU anti-Xa activity/kg body weight) twice daily SC.
Treatment of Unstable Angina and Non-Q-Wave Myocardial Infarction: Recommended Dose: 1 mg/kg (100 IU anti-Xa activity/kg) every 12 hrs by SC injection, administered concurrently with oral aspirin (100-325 mg once daily). Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and a maximum of 8 days.
Acute ST-Segment Elevation Myocardial Infarction (STEMI): With a thrombolytic agent, an initial IV bolus injection of 30 mg followed by an SC injection of 1mg/kg within 15 min, then every 12 hrs (a maximum of 10,000 anti-Xa IU for the first 2 SC doses) for 8 days or until discharged. In patients ≥75 years, the initial IV bolus injection should not be administered. An SC dose of 0.75 mg/kg every 12 hrs should be administered (maximum of 7500 anti-Xa IU for the first 2 injections only).
Haemodialysis: In patients undergoing repeated sessions of haemodialysis, the prevention of thrombosis in the extracorporeal blood circuit is obtained by injection of a dose of 1 mg/kg (100 IU anti-Xa activity/kg) into the arterial line of the dialysis circuit at the start of the session. This dose is usually sufficient for a 4-hr haemodialysis session. If fibrin rings are formed, a fresh injection of 0.5-1 mg/kg (50-100 IU anti-Xa activity/kg) should be made depending on the time before the end of the dialysis. In haemodialysis patients with a high risk of haemorrhage (in particular, in pre- or postoperative dialysed patients) or with a progressive haemorrhagic disorder, the dialysis sessions may be carried out by using a dose of 0.5 mg/kg (50 IU anti-Xa activity/kg) (double vascular access) or 0.75 mg/kg (75 IU anti-Xa activity/kg) (single vascular access).
SC Injection Technique: The SC injection of Clexane should be alternated between the left and right anterolateral abdominal wall using a different site for each injection.
The pre-filled syringes are ready for use and no attempt to expel air should be made before injection.
The whole length of the needle should be introduced vertically into the thickness of a skin fold gently held between the operator's thumb and finger. This skin fold should be held throughout the duration of the injection. When using the ampoules of enoxaparin, the volume should be measured precisely with a graduated syringe fitted with an appropriate needle for the SC injection.
Do not mix Clexane with other injections or infusions.
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