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Orgaran (2012)

Active ingredients: Danaparoid sodium

Product Name and Form

Orgaran, 750 anti-Xa units, solution for injection.

Pharmaceutical form

Solution for injection.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Danaparoid sodium

Danaparoid sodium has been shown both in animal models and in human studies to be an effective antithrombotic substance. At therapeutic doses danaparoid sodium 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.
Sodium chloride Ph. Eur.
Hydrochloric acid Ph. Eur.
Water Ph. Eur.

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Organon Laboratories Limited
Cambridge Science Park
Milton Road
Cambridge
CB4 0FL

14 April 1993 / 09 October 1998

Marketing authorization number:

PL: 0065/0125