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Cardioxane 500mg powder for solution for infusion (2012)

Active ingredients: Dexrazoxane

Product Name and Form

CARDIOXANE 500mg, powder for solution for infusion.

Pharmaceutical form

Powder for solution for infusion.

Sterile, pyrogen free, white to off-white, lyophilised powder.

Qualitative and Quantitative Composition

Dexrazoxane 500.00mg as its hydrochloride salt.

For a vial of powder.

For a full list of excipients, see section 6.1.

Chemical substance
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

Not applicable.

Pack sizes and Marketing

Vials (Type I brown glass), containing 500 mg of powder, closed with a chlorobutyl rubber stopper and an aluminium cap with pre-cut strip. The product is further enclosed in an outer carton. It is supplied in packs of 1 and 4 vials. Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR

1 September 2006 / 16 February 2012

Marketing authorization number:

PL 00101/0937