CLEXANE INJECTION 10000 anti-Xa IU (100mg)/1ml

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

ENOXAPARIN SODIUM

Commercializzato da:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Codice ATC:

Pending

Dosaggio:

10000 anti-Xa IU (100mg)/1ml

Forma farmaceutica:

INJECTION

Via di somministrazione:

SUBCUTANEOUS, INTRAVASCULAR

Tipo di ricetta:

Prescription Only

Prodotto da:

Sanofi Winthrop Industrie

Data dell'autorizzazione:

2012-02-06

Foglio illustrativo

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