Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: NordMedica A/S, Jaegersborg, Alle 164, DK-2820, Gentofte, Denmark
Amsidine 50mg/ml Concentrate and Solvent for Solution for Infusion.
| Pharmaceutical Form |
|---|
|
Concentrate and solvent for solution for infusion. Concentrate is a clear, bright orange/red coloured solution and solvent for infusion is clear colourless solution. The pH of the combined solution is 3.5-4.5. |
Each vial contains 75mg amsacrine in 1.5ml (50mg per ml).
Each solvent vial contains 13.5ml of Lactic acid and water for injection to give a concentration of 0.0353M L-Lactic acid.
Each ml of the combined solution of the concentrate when diluted with the solvent contains 5mg amsacrine per ml.
For a full list of exipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Acridinyl Anisidide |
Amsidine is a sterile antitumour chemotherapeutic agent for intravenous infusion. Although not completely clarified, the mode of action of amsacrine is related to its property of binding the DNA through intercalation and external (electrostatic) forces. |
| List of Excipients |
|---|
|
Concentrate: N,N Dimethylacetamide Solvent: L-lactic acid |
Concentrate vial: 2ml clear Type I, Ph. Eur. neutral glass vial containing 1.5ml amsacrine solution.
Solvent vial: 20ml clear Type I, Ph. Eur. neutral glass vial contains 13.5ml of 0.0353M L-lactic acid.
Each carton contains 6 vials of concentrate and 6 vials of solvent.
NordMedica A/S, Jaegersborg, Alle 164, DK-2820, Gentofte, Denmark
PA1828/001/001
Date of first authorisation: 05 March 1984
Date of last renewal: 05 March 2009
| Drug | Countries | |
|---|---|---|
| AMSIDINE | Estonia, Ireland, Netherlands, United Kingdom |
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