Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Organon Laboratories Limited Cambridge Science Park Milton Road Cambridge CB4 0FL
Orgaran, 750 anti-Xa units, solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. |
Orgaran 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 Ph. Eur. |
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.
Organon Laboratories Limited
Cambridge Science Park
Milton Road
Cambridge
CB4 0FL
PL: 0065/0125
14 April 1993 / 09 October 1998
| Drug | Countries | |
|---|---|---|
| ORGARAN | Austria, Canada, Finland, France, Ireland, Japan, Netherlands |
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