Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Clinigen Healthcare B.V., Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ, Schiphol, The Netherlands
Savene 20 mg/ml powder and solvent for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder and solvent for concentrate for solution for infusion. Powder vial: White to off-white lyophilisate. |
Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).
Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of Savene solvent.
Excipients with known effects:
Solvent bottle:
Potassium 98 mg/500 ml or 5.0 mmol/l.
Sodium 1.61 g/500 ml or 140 mmol/l.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dexrazoxane |
Dexrazoxane has two major mechanisms of action, chelation of iron and inhibition of topoisomerase II. It is not known to what extent each of these mechanisms contributes to the preventive effect on tissue destruction following anthracycline extravasation. |
| List of Excipients |
|---|
|
Powder vial: none Solvent bottle: Sodium chloride |
Savene powder: Amber-coloured, 36-ml, glass type I vial with stopper made of chlorobutyl rubber and a flip-off cap.
Savene solvent: 500 ml solution in bottles made of Type-I (Ph.Eur.) glass.
Pack sizes: Savene is available as an emergency kit consisting of 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
Clinigen Healthcare B.V., Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ, Schiphol, The Netherlands
EU/1/06/350/001
Date of first authorisation: 28 July 2006
Date of latest renewal: 18 July 2011
| Drug | Countries | |
|---|---|---|
| SAVENE | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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