Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Clinigen Healthcare Ltd., Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom
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. |
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.
| Active Ingredient |
|---|
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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) |
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.
Clinigen Healthcare Ltd., Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom
PL 31644/0003
18th October 2006 / 01 December 2009
| Drug | Countries | |
|---|---|---|
| PROLEUKIN | Austria, Brazil, Canada, Spain, France, Netherlands, Singapore, United Kingdom, United States |
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