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PROLEUKIN Powder for solution for injection or infusion (2020)

Active ingredients: Aldesleukin

Product Name and Form

PROLEUKIN 18 × 106 IU.

Powder for solution for injection or infusion.

Pharmaceutical form

Powder for solution for injection or infusion.

The powder is sterile, white and lyophilized.

Qualitative and Quantitative Composition

After reconstitution with 1.2 ml water for injections, according to the instructions (see section 6.6), each 1 ml solution contains 18 × 106 IU (1.1 mg) aldesleukin.

Each vial of Proleukin powder for solution for injection or infusion contains 22 × 106 IU aldesleukin. Aldesleukin is produced by recombinant DNA technology using an Escherichia coli strain which contains a genetically engineered modification of the human Interleukin-2 (IL-2) gene.

Proleukin contains less than 23mg sodium per 1ml, and can be considered as ‘sodium-free’.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Aldesleukin

Aldesleukin, a lymphokine, is produced by recombinant DNA technology and acts as a regulator of the immune response. The biological activities of aldesleukin and native human IL-2, a naturally occurring lymphokine, are comparable. The administration of aldesleukin in murine tumour models has been shown to reduce both tumour growth and spread. The exact mechanism by which aldesleukin-mediated immunostimulation leads to antitumour activity is not yet known.

List of excipients

Mannitol (E421)
Sodium laurilsulfate
Sodium dihydrogen phosphate dihydrate (pH adjuster)
Disodium hydrogen phosphate dihydrate (pH adjuster)

Pack sizes and Marketing

Proleukin is supplied in 5 ml single-use clear Type I glass vials with a stopper of synthetic rubber. The product is supplied in carton boxes of 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Clinigen Healthcare Ltd., Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom

18th October 2006 / 01 December 2009

Marketing authorization number:

PL 31644/0003