Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
NIPENT 10 mg powder for solution for injection, powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection, powder for solution for infusion. The vials contain a solid white to off-white cake or powder. The pH of reconstituted solution is 7.0–8.2. |
One vial contains 10 mg Pentostatin.
When reconstituted (see Section 6.6), the resulting solution contains pentostatin 2 mg/ml.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pentostatin |
Pentostatin is a potent transition state inhibitor of the enzyme adenosine deaminase. The greatest activity of ADA is found in cells of the lymphoid system with T-cells having higher activity than B-cells and T-cell malignancies higher ADA activity than B-cell malignancies. Pentostatin has been shown to have activity against a variety of lymphoid malignancies, but is most active against indolent cancers with lower ADA concentration, such as hairy cell leukaemia. |
| List of Excipients |
|---|
|
Mannitol |
NIPENT is supplied in single-dose, 10-mg vials packaged in individual cartons (packs of 1 vial).
Vials are made from Type I glass and siliconised stoppers.
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
PL 04515/0222
30th January 2009
| Drug | Countries | |
|---|---|---|
| NIPENT | Spain, France, Ireland, Malta, United Kingdom, United States |
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