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.
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.
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
14 April 1993 / 09 October 1998
|Austria, Canada, Finland, France, Ireland, Japan, Netherlands
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.