Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Danaparoid Sodium 750 anti-Xa units/0.6 ml, solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. |
Danaparoid Sodium contains danaparoid sodium, which is a non-heparin mixture of low molecular weight sulphated glycosaminoglycuronans derived from animal mucosa, comprising heparan sulphate, dermatan sulphate and a minor amount of chondroitin sulphates. One ampoule (0.6mL) contains 750 amidolytic anti-factor Xa units danaparoid sodium and corresponding to 1250 anti-factor Xa units per mL. The anti-Xa unit is derived from the international heparin standard in an antithrombin containing buffer system.
For excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Danaparoid |
Danaparoid has been shown both in animal models and in human studies to be an effective antithrombotic substance. At therapeutic doses danaparoid has no or only a minor effect on haemostatic plug formation, platelet function and platelet aggregability with no significant effect on bleeding time at the recommended doses. |
| List of Excipients |
|---|
|
Sodium sulphite |
1-ml glass ampoules containing 750 anti-factor Xa units (0.6ml) danaparoid sodium per ampoule (1250 anti-factor Xa units/ml) in packs of 10 or 20 ampoules.
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
PL 39699/0057
14 April 1993/09 October 1998
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