DAUNORUBICIN Powder for injection Ref.[8742] Active ingredients: Daunorubicin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Product name and form

Daunorubicin 20mg Powder for I.V. Injection.

Pharmaceutical Form

Vial containing a red lyophilised powder for intravenous administration following reconstitution in Water for Injections and dilution with saline.

Qualitative and quantitative composition

Each vial contains 21.4 mg daunorubicin hydrochloride (equivalent to 20 mg as base).

For the full list of excipients, see section 6.1.

Active Ingredient 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

Mannitol

Pack sizes and marketing

Glass vial with rubber cap.

Pack sizes of 1 vial and 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Marketing authorization dates and numbers

PL 17780/0310

8 June 1994

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