Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Zavedos 5 mg Powder for Solution for Injection.
| Pharmaceutical Form |
|---|
|
Powder for Solution for Injection. Sterile, pyrogen-free, orange-red, freeze-dried powder in vial containing 5 mg of idarubicin hydrochloride, with 50 mg of lactose monohydrate. |
Each vial contains 5mg idarubicin hydrochloride.
The reconstituted solution contains 1mg/ml.
Excipients with known effect: Each vial contains 50mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Idarubicin |
Idarubicin is a DNA intercalating anthracycline which interacts with the enzyme topoisomerase II and has an inhibitory effect on nucleic acid synthesis. Idarubicin has been shown to have a higher potency with respect to daunorubicin and to be an effective agent against murine leukaemia and lymphomas both by i.v. and oral routes. |
| List of Excipients |
|---|
|
Lactose monohydrate |
Colourless glass vial, type I, with chlorobutyl rubber bung and aluminium seal with insert yellow polypropylene disk.
Zavedos 5mg Powder for Solution for Injection vials are available as single vials.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
PL 00057/1061
23 May 2002
| Drug | Countries | |
|---|---|---|
| ZAVEDOS | Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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