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DAUNOXOME Concentrate for solution for infusion (2014)

Active ingredients: Daunorubicin

Product Name and Form

DaunoXome 2 mg/mL concentrate for solution for infusion.

Pharmaceutical form

Concentrate for solution for infusion.

Each vial contains a translucent red liposomal dispersion free from visible particles.

Qualitative and Quantitative Composition

Daunorubicin present as citrate salt; equivalent to daunorubicin base, 2 mg/ml, encapsulated in liposomes.

Each single dose vial of DaunoXome contains 50 mg daunorubicin.

For excipients, see Section 6.1.

Chemical substance
Description
Daunorubicin

Daunorubicin is an anthracycline glycoside antibiotic and is a potent antileukaemic agent. It also has immunosuppressant effects. Daunorubicin may involve binding to DNA by intercalation between base pairs and inhibition of DNA and RNA synthesis by template disordering and steric obstruction.

List of excipients

Liposome:

Colfosceril stearate
Cholesterol
Citric acid

Buffer:

Sucrose
Glycine
Calcium chloride dihydrate
Hydrochloric acid
Sodium hydroxide
Water for injection

Pack sizes and Marketing

DaunoXome is presented in 50-ml sterile Type 1glass Ph. Eur. vial. Each vial contains 25 ml liquid for infusion. The closure consists of a butyl rubber stopper and aluminum ring seal fitted with a removable plastic cap. Each single-dose vial is packed in a white chipboard carton. Included in each carton are directions for use.

Pack size 1 × 25 mL.

Marketing authorization holder
Authorization dates

Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK

Date of first authorisation: 01 May 1996
Date of last renewal: 24 May 2010

Marketing authorization number:

PA1329/009/001