Alceran (melfalan) powder for solution for injections 50 mg. №1 vial

Description

Composition

active ingredient: melphalan;

1 powder vial contains melphalan 50 mg

excipients: K12, dilute hydrochloric acid;

1 solvent vial contains sodium, propylene glycol, ethanol 96%, water for injection.

Indications.

When administered by regional arterial perfusion treatment:

– localized malignant melanoma of the extremities, localized soft tissue sarcoma of the extremities.

When administered intravenously alone or in combination with other cytostatics treatment:

– multiple myeloma (in medium or high therapeutic doses);

– late stages of ovarian carcinoma;

– Stage IV neuroblastoma.

If oral melphalan is not possible, melphalan can be given at the usual doses for the treatment of multiple myeloma.

Contraindications.

Hypersensitivity to melphalan or to any component of the drug.

Breastfeeding.

Dosage and Administration.

Except where regional perfusion is indicated, Alkeran injectable is for intravenous administration only.

When administered intravenously, it is recommended to slowly inject Alkeran into the solution for intravenous administration, has a high infusion rate, through the membrane injection port. If direct injection into a solution that is infused at a high rate is not possible, Alkerantm can be diluted in an intravenous infusion bottle.

Injectable Alkerantm is incompatible with solutions containing glucose, therefore it is recommended to use only 0.9% sodium chloride solution.

With further dilution, the Alkeran solution loses stability, the rate of its decomposition increases with increasing temperature. At room temperature approximately
25 ° C, the time from the preparation of the solution for injection to the completion of the infusion should not exceed 1.5 hours.

If any signs of turbidity or crystallization appear during dissolution or dilution, the solution must be disposed of.

It is necessary to prevent the possible entry of Alkeran outside the vessels; in case of poorly defined peripheral veins, it is advisable to administer the drug through central vein catheterization.

Administration into the central veins is recommended when using high doses of Alkeran injection solution with or without transplantation (autologous bone marrow, allogeneic or hematopoietic stem cells), since when injected into peripheral veins, the drug may enter beyond the vessels and cause damage to the relevant local tissues.

To conduct regional arterial perfusion, one should refer to the special literature on methodological recommendations.