Source: European Medicines Agency (EU) Revision Year: 2015 Publisher: Dendreon UK Limited, 41 Chalton Street, London, NW1 1JD, United Kingdom Tel: (0)20 7554 2222 Fax: (0)20 7554 2201 dendreonuk@dendreon.com
Provenge 50 × 106 CD54+ cells/250mL dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Dispersion for infusion. The dispersion is slightly cloudy, with a cream-to-pink colour. |
Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T).
One bag contains autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 × 106 autologous CD54+ cells.
The cellular composition and the cell number per dose of Provenge will vary according to the patient’s leukapheresis. In addition to antigen presenting cells (APCs), the final product thus contains T cells, B cells, natural killer (NK) cells, and other cells.
Excipients with known effect: This medicinal product contains approximately 800 mg of sodium and 45 mg of potassium per infusion.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sipuleucel-T |
Sipuleucel-T is an autologous cellular immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers. Peripheral blood mononuclear cells collected from the patients are cultured with PAP-GM-CSF, a fusion protein consisting of PAP linked to granulocyte-macrophage colony-stimulating factor (GM-CSF) an immune cell activator. During ex vivo culture with PAP-GM-CSF, activated APCs (antigen presenting cells) take up and process the recombinant target antigen into peptides that are then presented to T cells. |
| List of Excipients |
|---|
|
Sodium chloride |
250 mL dispersion in a bag (breathable polyolefin tri-laminate with 3 sample ports (2 spike ports and 1 port with sealed tubing)).
Dendreon UK Limited, 41 Chalton Street, London, NW1 1JD, United Kingdom
Tel: (0)20 7554 2222
Fax: (0)20 7554 2201
dendreonuk@dendreon.com
EU/1/13/867/001
| Drug | Countries | |
|---|---|---|
| PROVENGE | Estonia |
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