LEUSTAT Solution for infusion Ref.[8314] Active ingredients: Cladribine

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

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

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
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

Atnahs Pharma UK Limited., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom

Marketing authorization dates and numbers

PL 43252/0030

3 February 1995

Drugs

Drug Countries
LEUSTAT United Kingdom

© 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.