Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
Melphalan 50 mg powder and solvent for solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection/infusion. Powder: a white to off-white freeze-dried powder or cake. Solvent: a clear colourless liquid/ solution. The pH of the reconstituted solution is 6.5. |
Each vial of powder contains melphalan hydrochloride equivalent to 50 mg melphalan.
After reconstitution with 10 ml of the solvent, the resultant solution contains 5 mg/ml melphalan.
Excipient with known effect: When reconstituted each vial contains 0.68 mmol (15.63 mg) of sodium, 0.52 ml (0.4 g) of ethanol and 6.0 ml of propylene glycol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Melphalan |
Melphalan is a bifunctional alkylating agent. Formation of carbonium intermediates from each of the two bis-2-chloroethyl groups enables alkylation through covalent binding with the 7-nitrogen of guanine on DNA, cross-linking the two DNA strands and thereby preventing cell replication. |
| List of Excipients |
|---|
|
Powder: Hydrochloric acid Solvent: Water for injection |
Powder: Clear, glass vial with a bromobutyl rubber stopper and aluminium collar with a plastic flip-top cover.
Pack size: one vial containing 50 mg melphalan.
Solvent: Clear, glass vial with a bromobutyl rubber stopper and aluminium collar with a plastic flip-top cover.
Pack size: one vial containing 10 ml of solvent.
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
PL 31750/0136
09/05/2018
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