MELPHALAN Powder and solvent for solution for injection/infusion Ref.[8201] Active ingredients: Melphalan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Product name and form

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.

Qualitative and quantitative composition

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
Povidone

Solvent:

Water for injection
Sodium citrate
Propylene glycol
Ethanol

Pack sizes and marketing

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.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Marketing authorization dates and numbers

PL 31750/0136

09/05/2018

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