Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: ADIENNE S.r.l. S.U., Via Galileo Galilei, 19, 20867 Caponago (MB), Italy, tel: +39 0240700445, e-mail: adienne@adienne.com
PHELINUN 50 mg powder and solvent for concentrate for solution for infusion.
PHELINUN 200 mg powder and solvent for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder and solvent for concentrate for solution for infusion. Powder: white to pale yellow freeze-dried powder or cake. Solvent: clear colourless liquid solution. The pH of the reconstituted solution is between 6.0 and 7.0 and the osmolality is 75 mOsmol/kg. |
One vial of powder for concentrate for solution for infusion contains 50 mg melphalan (as melphalan hydrochloride).
After reconstitution with 10 ml of solvent, the final concentration of the solution is 5 mg/ml.
Excipients with known effect: When reconstituted, one vial contains 0.68 mmol (15.63 mg) of sodium, 400 mg of ethanol and 6.2 g of propylene glycol.
One vial of powder for concentrate for solution for infusion contains 200 mg melphalan (as melphalan hydrochloride).
After reconstitution with 40 ml of solvent, the final concentration of the solution is 5 mg/ml.
Excipients with known effect: When reconstituted, one vial contains 2.72 mmol (62.52 mg) of sodium, 1.6 g of ethanol and 24.9 g 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 (pH adjustment) Solvent: Water for injections |
Powder: Type I glass vial closed with coated chlorobutyl rubber stopper and sealed with aluminium flip-off cap.
Solvent: Type I glass vial closed with coated chlorobutyl rubber stopper and sealed with aluminium flip-off cap.
Pack size: one vial containing 50 mg or 200 mg melphalan and one vial containing 10 ml or 40 ml of solvent.
ADIENNE S.r.l. S.U., Via Galileo Galilei, 19, 20867 Caponago (MB), Italy, tel: +39 0240700445, e-mail: adienne@adienne.com
EU/1/20/1487/001
EU/1/20/1487/002
Date of first authorisation: 17 November 2020
| Drug | Countries | |
|---|---|---|
| PHELINUN | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania |
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