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FRAXIPARINE MULTIDOSE INJECTION 9500 IU AXA/ML

Product Information

Registration Status: Active

SIN11872P

FRAXIPARINE MULTIDOSE INJECTION 9500 IU AXA/ML is approved to be sold in Singapore with effective from 2002-05-04. It is marketed by DCH AURIGA SINGAPORE, with the registration number of SIN11872P.

This product contains Nadroparin 9500 iu AXA/ml in the form of INJECTION. It is approved for INTRAVENOUS, SUBCUTANEOUS use.

This product is manufactured by ASPEN NOTRE DAME DE BONDEVILLE in FRANCE.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Nadroparin is a low molecular weight heparin (LMWH) which, when bound to antithrombin III (ATIII), accelerates the inactivation of factor II and factor Xa. Nadroparin halts the coagulation pathway by inhibiting the activation of thrombin (factor IIa) by factor Xa. The amplification of the fibrin clotting cascade is stopped once factors Xa and IIa are inactivated. It is derived from porcine sources and has a mean molecular size of 5000 daltons. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.

Indication

Nadroparin is used for prophylaxis of thromboembolic disorders and general surgery in orthopedic surgery, treatment of deep vein thrombosis, prevention of clotting during hemodialysis and treatment of unstable angina and non-Q wave myocardial infarction

Mechanism of Action

The mechanism of action for nadroparin is similar to all other LMWHs. Like all LMWHs, nadroparin has a pentasaccharide sequence which binds to ATIII, which potentiates the action of ATIII. This complex greatly accelerates the inactivation of factor Xa and factor IIa. As a result, the coagulation cascade is inhibited.

Pharmacokinetics

Absorption
Absorption is linear. The bioavailability of nadroparin after subcutaneous administration is about 89%.
Distribution
3.59L
Metabolism
Nadroparin is metabolized in the liver.
Elimination

Clearance

The clearance of nadroparin is 21.4 +/- 7.0mL/min

Toxicity

Osteopenia with extended use, skin necrosis, thrombocytosis, severe immunologically-mediated thrombocytopenia, eosinophilia (rare), calcinosis rarely occurs at the injection site, severe bleeding, transient elevation of liver transaminases.

Active Ingredient/Synonyms

Nadroparin | Nadroparin |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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