SPC, UK: Proleukin (2011)

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.

For excipients, see section 6.1.

List of excipients

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

Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley
Camberley
Surrey
GU167SR

18th October 2006

Marketing authorization number:

PL 00101/0936