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 | 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) |
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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
