Qualitative and quantitative composition
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40 mg Injection |
Enoxaparin sodium 40 mg (equivalent to 4,000 IU anti-Xa activity) in 0.4 mL Water for Injections |
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Pharmaceutical form
Solution for injection.
Clear, colourless to pale yellow solution.
Clinical particulars
Therapeutic indications
The prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthopaedic or general surgery.
The prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness.
The treatment of venous thromboembolic disease presenting with deep vein thrombosis, pulmonary embolism or both.
The treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI) in conjunction with thrombolytic drugs (fibrin or non-fibrin specific).
The prevention of thrombus formation in the extracorporeal circulation during haemodialysis.
Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively.
In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial dose administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for cancer and are not otherwise at risk for major bleeding complications, the recommended dosage is 40 mg (4,000 IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is established.
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Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both |
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Patient weight |
Kg |
Syringe label |
Dose (mg) |
Injection volume (ml) |
|
100mg/ml
Solution for Injection CLEXANE syringes |
40 |
60mg / 0.6ml |
60 od |
0.60 |
|
45
50 |
80mg / 0.8ml
80mg / 0.8ml |
67.5 od
75 od |
0.675
0.75 |
|
55
60
65 |
100mg / 1ml
100mg / 1ml
100mg / 1ml |
82.5 od
90 od
97.5 od |
0.825
0.90
0.975 |
|
150mg/ml
Solution for Injection CLEXANE Forte syringes |
70
75
80 |
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml |
105 od
112.5 od
120 od |
0.70
0.76
0.80 |
|
85
90
95
100 |
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml |
127.5 od
135 od
142.5 od
150 od |
0.86
0.90
0.96
1.00 |
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this table have been rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325mg once daily).
Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days.
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Dosage chart for 1mg/kg SC treatment of UA or NSTEMI |
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Patient weight |
Kg |
Syringe label |
Dose (mg) |
Injection volume (ml) |
|
100mg/ml
Solution for Injection CLEXANE syringes |
40 |
40mg / 0.4ml |
40 bd |
0.40 |
|
45
50
55
60 |
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml |
45 bd
50 bd
55 bd
60 bd |
0.45
0.50
0.55
0.60 |
|
65
70
75
80 |
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml |
65 bd
70 bd
75 bd
80 bd |
0.65
0.70
0.75
0.80 |
|
85
90
95
100 |
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml |
85 bd
90 bd
95 bd
100 bd |
0.85
0.90
0.95
1.00 |
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150mg/ml
Solution for Injection CLEXANE Forte syringes |
105
110
115
120 |
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml |
105 bd
110 bd
115 bd
120 bd |
0.70
0.74
0.78
0.80 |
|
125
130
135
140
145
150 |
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml |
125 bd
130 bd
135 bd
140 bd
145 bd
150 bd |
0.84
0.88
0.90
0.94
0.98
1.00 |
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this table have been rounded up to the nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2 Posology and method of administration: Elderly.
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Dosage chart for 1mg/kg SC treatment of STEMI |
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Patient weight |
Kg |
Syringe label |
Dose (mg) |
Injection volume (ml) |
|
100mg/ml
Solution for Injection CLEXANE syringes |
40 |
40mg / 0.4ml |
40 bd |
0.40 |
|
45
50
55
60 |
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml |
45 bd
50 bd
55 bd
60 bd |
0.45
0.50
0.55
0.60 |
|
65
70
75
80 |
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml |
65 bd
70 bd
75 bd
80 bd |
0.65
0.70
0.75
0.80 |
|
85
90
95
100 |
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml |
85 bd
90 bd
95 bd
100 bd |
0.85
0.90
0.95
1.00 |
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150mg/ml
Solution for Injection CLEXANE Forte syringes |
105
110
115
120 |
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1) |
105 bd (1)
110 bd (1)
115 bd (1)
120 bd (1) |
0.70 (1)
0.74 (1)
0.78 (1)
0.80 (1) |
|
125
130
135
140
145
150 |
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1) |
125 bd (1)
130 bd (1)
135 bd (1)
140 bd (1)
145 bd (1)
150 bd (1) |
0.84 (1)
0.88 (1)
0.90 (1)
0.94 (1)
0.98 (1)
1.00 (1) |
(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this table have been rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3mg/kg of enoxaparin sodium should be administered.
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a high risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular access.
Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is impaired (see also section 4.2 Posology and method of administration: Renal impairment; section 4.4 Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment, and Monitoring; section 5.2 Pharmacokinetic properties).
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Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged ≥75 years only) |
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Patient weight |
Kg |
Syringe label |
0.75mg/kg
Dose (mg) |
Adjusted dosing (mg) |
Injection volume (ml) |
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100mg/ml
Solution for Injection CLEXANE syringes |
40
45
50
55
60
65
70
75
80 |
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml |
30 bd
33.75 bd
37.5 bd
41.25 bd
45 bd
48.75 bd
52.5 bd
56.25 bd
60 bd |
30 bd
35 bd
37.5 bd
42.5 bd
45 bd
50 bd
52.5 bd
57.5 bd
60 bd |
0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60 |
|
85
90
95
100
105 |
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml |
63.75 bd
67.5 bd
71.25 bd
75 bd
78.75 bd (1) |
65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1) |
0.65
0.675
0.725
0.75
0.80 (1) |
|
110
115
120
125
130 |
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml |
82.5 bd (1)
86.25 bd (1)
90 bd (1)
93.75 bd (1)
97.5 bd (1) |
82.5 bd (1)
87.5 bd (1)
90 bd (1)
95 bd (1)
97.5 bd (1) |
0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1) |
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150mg/ml
Solution for Injection CLEXANE Forte syringes |
135
140
145
150 |
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml |
101.25 bd (1)
105 bd (1)
108.75 bd (1)
112.5 bd (1) |
102 bd (1)
105 bd (1)
111 bd (1)
114 bd (1) |
0.68 (1)
0.7 (1)
0.74 (1)
0.76 (1) |
(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this table have been rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal impairment and Monitoring; section 5.2 Pharmacokinetic properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30 ml/min), according to the following tables, since enoxaparin sodium exposure is significantly increased in this patient population:
Dosage adjustments for therapeutic dosage ranges
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Standard dosing |
Severe renal impairment |
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1 mg/kg SC twice daily |
1 mg/kg SC once daily |
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1.5 mg/kg SC once daily |
1 mg/kg SC once daily |
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For treatment of acute STEMI in patients <75 years of age |
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30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kg twice daily.
(Max 100mg for each of the first two SC doses) |
30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kg once daily.
(Max 100mg for first SC dose only) |
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For treatment of acute STEMI in elderly patients ≥75 years of age |
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0.75mg/kg SC twice daily without initial bolus.
(Max 75mg for each of the first two SC doses) |
1mg/kg SC once daily without initial bolus.
(Max 100mg for first SC dose only) |
Dosage adjustments for prophylactic dosage ranges
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Standard dosing |
Severe renal impairment |
|
40 mg SC once daily |
20 mg SC once daily |
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20 mg SC once daily |
20 mg SC once daily |
The recommended dosage adjustments do not apply to the haemodialysis indication.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min), careful clinical monitoring is advised.
Spinal/epidural anaesthesia
For patients receiving spinal/epidural anaesthesia see section 4.4 Special warnings and precautions for use: Spinal/epidural anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4 Special warnings and precautions for use: Low body weight and Monitoring; section 5.2 Pharmacokinetic properties).
Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation during haemodialysis; and via intravenous (bolus) injection through an intravenous line only for the initial dose of acute STEMI indication and before PCI when needed. It must not be administered by the intramuscular route.
To avoid accidental needle stick after injection, the prefilled syringes are fitted with an automatic safety device
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