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ATENATIV Pwd. Sol. (2007)

Active ingredients: Antithrombin III

Product Name and Form

Atenativ 50 IU/mL, powder and solvent for solution for infusion.

Pharmaceutical form

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.

Chemical substance
Description
Antithrombin III
List of excipients

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.

Marketing authorization holder
Authorization dates
Marketing authorization number: