Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Atnahs Pharma UK Limited., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom
Leustat Injection.
| Pharmaceutical Form |
|---|
|
A sterile, buffered solution in vials containing 10 mg (1 mg/ml) of cladribine for dilution and subsequent continuous intravenous infusion. |
LEUSTAT (cladribine) Injection is a synthetic antineoplastic agent for continuous intravenous infusion. It is a clear, colourless, sterile, preservative-free, isotonic solution. LEUSTAT Injection is available in single-use vials containing 10 mg (1 mg/ml) of cladribine, a chlorinated purine nucleoside analogue. Each millilitre of LEUSTAT Injection contains 1 mg of the active ingredient, cladribine
Excipients with known effect:
Each 10 ml vial of LEUSTAT contains 38.2 mg of sodium (total sodium content from sodium chloride and dibasic sodium phosphate).
The solution has pH range of 5.5 to 8.0. Phosphoric acid and/or dibasic sodium phosphate may have been added to adjust the pH.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Cladribine |
Cladribine is a nucleoside analogue of deoxyadenosine. In resting cells cladribine causes DNA single-strand breaks, rapid nicotinamide adenine dinucleotide consumption, ATP depletion and cell death. |
| List of Excipients |
|---|
|
9.0 mg (0.15 mEq) of sodium chloride as an inactive ingredient |
LEUSTAT Injection is supplied as a sterile, preservative-free, isotonic solution containing 10 mg (1 mg/ml) of cladribine (as 10 ml) in a single-use, Ph Eur Type I glass 10 ml vial.
Atnahs Pharma UK Limited., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom
PL 43252/0030
3 February 1995
| Drug | Countries | |
|---|---|---|
| LEUSTAT | United Kingdom |
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