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Leustat Injection (2012)

Product Name and Form

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.

Qualitative and Quantitative Composition

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, and 9 mg (0.15 mEq) of sodium chloride as an inactive ingredient. 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.

List of excipients

9.0 mg (0.15 mEq) of sodium chloride as an inactive ingredient. Phosphoric acid and/or dibasic sodium phosphate to adjust the pH to a range of 5.5 to 8.0.

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Bucks
HP12 4EG

3 February 1995

Marketing authorization number:

PL 0242/0232