DAUNOXOME Concentrate for solution for infusion (2014)
Active ingredients: Daunorubicin
Product Name and Form
DaunoXome 2 mg/mL concentrate for solution for infusion.
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.
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.
Calcium chloride dihydrate
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.
Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK
Date of first authorisation: 01 May 1996
Date of last renewal: 24 May 2010