Enoxaparin STADA Dosage/Direction for Use

Administration: SUBCUTANEOUS ROUTE (except for haemodialysis indication for solution for injection containing 4,000 anti-Xa IU/0.4 ml (40 mg/0.4 ml) and except for patients with acute ST-segment elevation myocardial infarction, in whom IV bolus administration is required for solution for injection containing 6,000 anti-Xa IU/0.6 ml (60 mg/0.6 ml).
These presentations are suitable for adults.
This drug is not to be injected via the intramuscular route.
One milliliter of solution for injection is equivalent to approximately 10,000 anti-Xa IU (100 mg/ml) of enoxaparin.
Subcutaneous injection technique: Injection should be made preferably when the patient is lying down. Enoxaparin STADA is administered by deep subcutaneous injection. Do not expel the air bubble from the syringe before the injection to avoid the loss of drug when using the 40 mg pre-filled syringes. The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.
The whole length of the needle should be introduced vertically into a skin fold gently held between the thumb and index finger. The skin fold should not be released until the injection is complete. Do not rub the injection site after administration (see Instruction for Use under Patient Counselling Information).
Intravenous (bolus) injection technique for the treatment of acute ST-segment elevation myocardial infarction only: Enoxaparin sodium should be administered through an intravenous line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Initial 3,000 anti-Xa IU (30 mg) bolus: For the initial 3,000 anti-Xa IU (30 mg) bolus, using an enoxaparin sodium graduated prefilled syringe, expel the excessive volume to retain only 3,000 anti-Xa IU/0.3 ml (30 mg/0.3 ml) in the syringe. The 3,000 anti-Xa IU (30 mg) dose can be directly injected into the intravenous line.
Additional bolus for patients treated by coronary angioplasty when last SC administration was given more than 8 hours before balloon inflation: For patients undergoing subsequent coronary angioplasty, an additional IV bolus of 30 anti-Xa IU/kg (0.3 mg/kg) is to be administered if last SC administration was given more than 8 hours before balloon inflation (see Treatment of acute ST-segment elevation myocardial infarction in combination with a thrombolytic agent in patients eligible or not for subsequent coronary angioplasty as follows).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 300 anti-Xa IU/ml (3 mg/ml).
To obtain a 300 anti-Xa IU/ml (3 mg/ml) solution, using a 6,000 anti-Xa IU (60 mg) enoxaparin sodium prefilled syringe, it is recommended to use a 50 ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) as follows: Withdraw 30 ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 6,000 anti-Xa IU (60 mg) enoxaparin sodium prefilled syringe into the 20 ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for administration into the intravenous line.
After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table as follows. It is recommended to prepare the dilution immediately before use. (See Table 2.)

Click on icon to see table/diagram/image

General recommendation: Regular monitoring of the platelet count is essential throughout the treatment due to the risk of heparin-induced thrombocytopenia (HIT) (see Precautions).
General: Prophylactic treatment of venous thromboembolic disease in surgery: Duration and dose of Enoxaparin STADA therapy are based upon patient risk. The thromboembolic risk for individual patient can be estimated using validated risk stratification models.
In patients with a moderate risk of thrombo-embolism, the recommended dose of enoxaparin sodium is 40 mg once daily by subcutaneous injection. In general surgery, the first injection should be given 2 hours before the surgical procedure.
Enoxaparin sodium treatment is usually prescribed for an average period of 7 to 10 days. A longer treatment duration may be appropriate in some patients and enoxaparin sodium should be continued for as long as there is a risk of venous thromboembolism and until the patient is ambulatory.
In patients with a high risk of thrombo-embolism the recommended dose of enoxaparin sodium given by subcutaneous injection, is 40 mg once daily, initiated 12 hours prior to surgery or 30 mg twice daily, initiated 12 to 24 hours after surgery.
For patients who undergo major orthopedic surgery with a high venous thromboembolism risk, a thromboprophylaxis up to 5 weeks is recommended.
For patients who undergo cancer surgery with a high venous thromboembolism risk, a thromboprophylaxis up to 4 weeks is recommended.
For special recommendations concerning dosing intervals for Spinal/Epidural Anesthesia and Percutaneous coronary revascularisation procedures (see Warnings).
Prophylactic treatment of deep vein thrombosis in acute medical conditions: Dosage: The dosage is 40 mg or 4,000 anti-Xa IU/0.4 ml injected subcutaneously once daily.
Duration of treatment: Therapeutic benefit has been established for a treatment duration of between 6 to 14 days.
To date, no efficacy and safety data are available concerning prophylaxis for more than 14 days. If the risk of venous thromboembolism persists, prolonged prophylactic treatment, particularly with oral anticoagulants, must be considered.
Prevention of clotting in extracorporeal: circulation/hemodialysis: Injection by the intravascular route (in the arterial line of the dialysis circuit).
In patients undergoing repeated hemodialysis sessions, prevention of clotting in the extrarenal purification system is obtained by injecting an initial dose of 100 anti-Xa IU/kg (1 mg/kg) in the arterial line of the dialysis circuit at the beginning of the session.
This dose, administered as a single intravascular bolus injection, is only suitable for hemodialysis sessions of 4 hours or less. It can be adjusted subsequently as a result of high inter- and intra-individual variability. However, if fibrin rings are found, for example after a longer than normal session, a further dose of 0.5 to 1 mg/kg may be given. The maximum recommended dose is 100 anti-Xa IU/kg (1 mg).
In hemodialysis patients at high risk of hemorrhage (particularly pre- and post-operative dialysis) or with active hemorrhage, dialysis sessions may be carried out using a dose of 50 anti-Xa IU/kg (0.5 mg/kg) (double vascular access) or 75 anti-Xa IU/kg (7.5 mg/kg) (single vascular access).
Curative treatment of deep vein thrombosis (DVT), with or without pulmonary embolism, without signs of clinical severity: Any suspected deep vein thrombosis should be quickly confirmed by the appropriate examinations.
Administration schedule and Dose: Enoxaparin STADA can be administered subcutaneously either as a single daily injection of 150 anti-Xa IU/Kg (1.5 mg/kg) or as twice daily injections of 100 anti-Xa IU/kg (1 mg/kg).
In patient with complicated thromboembolic disorders, a dose of 100 anti-Xa (1 mg) twice daily is recommended.
LMWH dosage has not been evaluated in terms of bodyweight in patients weighing more than 100 kg or less than 40 kg. The efficacy of LMWH treatment may be slightly lower in patients weighing more than 100 kg, and the risk of hemorrhage may be higher in patients weighing less than 40 kg. Specific clinical monitoring must be carried out in these patients.
DVT treatment duration: Treatment with low-molecular-weight heparin should be quickly replaced by oral anticoagulant therapy, unless contraindicated. Treatment duration with LMWH should not exceed 10 days, including the time needed to reach the required oral anticoagulant effect, except when this is difficult to achieve (see Precautions for use: Laboratory tests: Platelet monitoring under Precautions). Oral anticoagulant treatment should therefore be initiated as soon as possible.
Curative treatment of unstable angina/non-Q-wave myocardial infarction: A dose of 100 anti-Xa IU/kg (1 mg/kg) of enoxaparin is administered by subcutaneous injection twice daily at 12-hour intervals, in combination with aspirin (recommended doses: 75 to 325 mg orally, following a minimum loading dose of 160 mg). The recommended duration of treatment is about 2 to 8 days, until the patient is clinically stable.
Treatment of acute ST-segment elevation myocardial infarction in combination with a thrombolytic agent in patients eligible or not for subsequent coronary angioplasty: An initial IV bolus injection of 3,000 anti-Xa IU (30 mg) followed by an SC injection of 1 mg/kg within 15 minutes, then every 12 hours (a maximum of 10,000 anti-Xa (100 mg) for each of the first two SC doses followed by 1 mg/kg SC dosing for the remaining doses).
The first dose of enoxaparin should be administered at any time between 15 minutes before and 30 minutes after the start of thrombolytic treatment (whether fibrin-specific or not).
The recommended duration of treatment is 8 days, or until the patient is discharged from hospital if the hospitalization period is less than 8 days.
Concomitant treatment: administration of aspirin must be instituted as soon as possible after symptoms appear, and maintained at a dosage of between 75 mg and 325 mg daily for at least 30 days, unless otherwise indicated.
Patients treated by coronary angioplasty: If the last SC injection of enoxaparin was performed less than 8 hours before balloon inflation, no additional administration is necessary; if the last SC injection was performed more than 8 hours before balloon inflation, an IV bolus of 30 anti-Xa IU/kg (0.3 mg) of enoxaparin must be administered. In order to improve the accuracy of the volumes to be injected, it is recommended to dilute the drug to 300 IU/ml (3 mg/ml) (see Intravenous (bolus) injection technique for the treatment of acute ST-segment elevation myocardial infarction only as previously mentioned).
In patients aged 75 and over, treated for acute ST-segment elevation myocardial infarction, the initial IV bolus injection should not be administered. An SC dose of 75 anti-Xa IU/kg (7.5 mg/kg) every 12 hours should be administered (maximum of 7,500 anti-Xa IU (75 mg) for each of the first two injections only, followed by 0.75 mg/kg SC dosing for remaining doses).