DAUNOBLASTIN Powder for solution for injection Ref.[50439] Active ingredients: Daunorubicin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa Tel: +27 (0)11) 320 6000 / 0860 734 937 (Toll-free South Africa)

Product name and form

DAUNOBLASTIN Injection.

Pharmaceutical Form

Powder for solution for injection.

Orange-red freeze-dried cake.

Qualitative and quantitative composition

Each vial contains 20 mg daunorubicin hydrochloride.

Contains sugar alcohol (mannitol).

Excipients with known effect: Each vial contains 100 mg mannitol.

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

Colourless glass vial containing 20 mg daunorubicin hydrochloride.

Marketing authorization holder

Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa
Tel: +27 (0)11) 320 6000 / 0860 734 937 (Toll-free South Africa)

Marketing authorization dates and numbers

V/26/239

05 December 1988

Drugs

Drug Countries
DAUNOBLASTIN Estonia, South Africa

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