ATENATIV Pwd. Sol. (2007)
Active ingredients: Antithrombin III
Product Name and Form
Atenativ 50 IU/mL, powder and solvent for solution for infusion.
Powder and solvent for solution for infusion.
Atenativ is supplied in freeze-dried form.
The concentrate is administered intravenously after reconstitution in the accompanying solution.
Qualitative and Quantitative Composition
Atenativ is presented as a powder and solvent for solution for infusion containing 500 IU, 1000 IU or 1500 IU lyophilised human plasma-derived antithrombin per vial.
The product contains 50 IU/mL human plasma-derived antithrombin when reconstituted with the accompanying solution (water for injections), i.e. 10 mL (500 IU), 20 mL (1000 IU), 30 mL (1500 IU).
For a full list of excipients, see section 6.1.
Sodium chloride
Human albumin
Acetyltryptophan
Sodium caprylate
Solvent/Diluent: water for injection.
Pack sizes and Marketing
Injection vial of type II glass (Ph.Eur.), 50 or 100 mL with a bromobutyl rubber stopper sealed with an aluminium pull-off cap.