SAVENE Powder and solvent for solution for infusion Ref.[9514] Active ingredients: Dexrazoxane

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

Product name and form

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.
Solvent bottle: Clear isotonic solution (295 mOsml/l, pH approx. 7.4).

Qualitative and quantitative composition

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
Potassium chloride
Magnesium chloride hexahydrate
Sodium acetate trihydrate
Sodium gluconate
Sodium hydroxide
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Clinigen Healthcare B.V., Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ, Schiphol, The Netherlands

Marketing authorization dates and numbers

EU/1/06/350/001

Date of first authorisation: 28 July 2006
Date of latest renewal: 18 July 2011

Drugs

Drug Countries
SAVENE Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom

© 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.