MELPHALAN TILLOMED

50 MG POWDER & SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

STRENGTH
Each vial of powder contains Melphalan hydrochloride equivalent to 50 mg Melphalan. Each vial of solvent contains 10 ml of solvent. After reconstitution, each ml of reconstituted solution contains 5 mg Melphalan.

PACK SIZE
Each pack contains 1 vial of powder and 1 vial with solvent.

PHARMACEUTICAL FORM
Powder and solvent for solution for injection/infusion. Powder: White to pale yellow lyophillized powder. Solvent: A clear colourless solution, free from visible particles. Ph of the reconstituted solution is between 6.0 and 7.0.

SHELF LIFE
Unopened powder and solvent 2 years. Reconstituted solution: Once reconstituted the product should be used immediately. Any unused portion should be discarded. Melphalan has a limited shelf-life and the rate of decomposition increases rapidly as the temperature increases.

Reconstituted and further diluted solution for infusion: The maximum time from the start of reconstitution to the end of infusion should not exceed 1.5 hours at room temperature (approximately 25 degrees C).

THERAPEUTIC INDICATIONS

This medicine is indicated for:

  • at conventional intravenous dose: the treatment of multiple myeloma and advanced ovarian cancer.

  • at high intravenous dose: (with or without haematopoietic stem cell transplantation) the treatment of multiple myeloma and childhood neuroblastoma.

  • administered by regional arterial perfusion: the treatment of localised malignant melanoma of the extremities and localised soft tissue sarcoma of the extremities.

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