CLEXANE INJECTION 4000 IU (40mg)0.4 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ENOXAPARIN SODIUM

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

B01AB05

Dosage:

4000 anti-Xa IU (40mg)/0.4 ml

Pharmaceutical form:

INJECTION

Composition:

ENOXAPARIN SODIUM 4000 IU (40mg)/0.4 ml

Administration route:

SUBCUTANEOUS, INTRAVASCULAR

Prescription type:

Prescription Only

Manufactured by:

Sanofi Winthrop Industrie

Authorization status:

ACTIVE

Authorization date:

2012-02-06

Patient Information leaflet

CLEXANE
®  

      [sanofi logo] 

PRODUCT SUMMARY 
1. 
TRADE NAME OF THE MEDICINAL PRODUCT  
Concentration of 10000 anti-Xa IU equivalent to 100 mg enoxaparin
sodium in each 
ml of the solution: 

Clexane 2000 anti-Xa IU/0.2 ml 
Clexane 4000 anti-Xa IU/0.4 ml 
Clexane 6000 anti-Xa IU/0.6 ml 
Clexane 8000 anti-Xa IU/0.8 ml 
Clexane 10000 anti-Xa IU/1.0 ml 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active Ingredient: Enoxaparin sodium 

Solvent: Water for injection 

Each ml of the solution contains 10000 anti-Xa IU equivalent to 100
mg enoxaparin 
sodium. One mg (0.01 ml) of enoxaparin sodium corresponds
approximately to 100 
anti-Xa IU. 

CLEXANE 2000 anti-Xa IU is equivalent to 20 mg, CLEXANE 4000 anti-Xa
IU is 
equivalent to 40 mg, CLEXANE 6000 anti-Xa IU is equivalent to 60 mg,
CLEXANE 
8000 anti-Xa IU is equivalent to 80 mg and CLEXANE 10000 anti-Xa IU
is 
equivalent to 100 mg. 

3. PHARMACEUTICAL 
FORM 
 Solution 
for 
injection 

CLINICAL PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Prophylaxis of venous thromboembolic disease (prevention of blood
clot formation in 
the veins), in particular those which may be associated with
orthopedic or general 
surgery.  

Prophylaxis of venous thromboembolic disease in medical patients
bedridden due to 
acute illnesses. 

Treatment of established deep vein thrombosis. 

Prevention of thrombus formation in extracorporeal circulation during
haemodialysis. 

Treatment of unstable angina and non-Q-wave myocardial infarction,
administered 
concurrently with aspirin. 

Treatment of acute ST-segment Elevation Myocardial
Infarction (STEMI), in 
combination with a thrombolytic agent, in patients to be managed
medically or with 
subsequent Percutaneous Coronary Intervention (PCI). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
 Adults: 

Prophylaxis of venous thromboembolic disease in surgical patients: 
In patients with a moderate thromboembolism r

Summary of Product characteristics

SG/CLE/0421/CCDSv12
CLEXANE
®
[sanofi logo]
PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Concentration of 10000 anti-Xa IU equivalent to 100 mg enoxaparin
sodium in each
ml of the solution:
Clexane 2000 IU (20mg)/0.2 ml
Clexane 4000 IU (40mg)/0.4 ml
Clexane 6000 IU (60mg)/0.6 ml
Clexane 8000 IU (80mg)/0.8 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Enoxaparin sodium
Solvent: Water for injection
Each ml of the solution contains 10000 anti-Xa IU equivalent to 100 mg
enoxaparin
sodium. One mg (0.01 ml) of enoxaparin sodium corresponds
approximately to 100
anti-Xa IU.
CLEXANE 2000 IU is equivalent to 20 mg, CLEXANE 4000 IU is equivalent
to 40
mg, CLEXANE 6000 IU is equivalent to 60 mg and CLEXANE 8000 IU is
equivalent
to 80 mg.
3.
PHARMACEUTICAL FORM
Solution for injection
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of venous thromboembolic disease (prevention of blood clot
formation in
the veins), in particular those which may be associated with
orthopedic or general
surgery.
Prophylaxis of venous thromboembolic disease in medical patients
bedridden due to
acute illnesses.
Treatment of established deep vein thrombosis.
Prevention of thrombus formation in extracorporeal circulation during
haemodialysis.
Treatment of unstable angina and non-Q-wave myocardial infarction,
administered
concurrently with aspirin.
Treatment
of
acute
ST-segment
Elevation
Myocardial
Infarction
(STEMI),
in
combination with a thrombolytic agent, in patients to be managed
medically or with
subsequent Percutaneous Coronary Intervention (PCI).
SG/CLE/0421/CCDSv12
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Prophylaxis of venous thromboembolic disease in surgical patients:
In patients with a moderate thromboembolism risk (e.g. abdominal
surgery) the
recommended dose of enoxaparin sodium is 2000 anti-Xa IU (0.2 ml) once
daily by
subcutaneous injection. In general surgery, the first injection should
be given 2 hours
before the surgical procedure. In patients with a high risk of
thromboembolic (