ATRIANCE Solution for infusion Ref.[9065] Active ingredients: Nelarabine

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Atriance 5 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless solution.

Qualitative and quantitative composition

Each ml of solution contains 5 mg of nelarabine.

Each vial contains 250 mg of nelarabine.

Excipient with known effect: Each ml of solution contains 1.725 mg (75 micromols) of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nelarabine

Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G. Accumulation of ara-GTP in leukaemic blasts allows for preferential incorporation of ara-GTP into deoxyribonucleic acid (DNA) leading to inhibition of DNA synthesis. This results in cell death. Other mechanisms may contribute to the cytotoxic effects of nelarabine. In vitro, T-cells are more sensitive than B-cells to the cytotoxic effects of nelarabine.
List of Excipients

Sodium chloride
Water for injections
Hydrochloric acid (to adjust the pH)
Sodium hydroxide (to adjust the pH)

Pack sizes and marketing

Clear glass (Type I) vial with a bromobutyl rubber stopper, and an aluminium seal with a red snap-off cap.

Each vial contains 50 ml of solution. Atriance is supplied in packs of 1 vial or 6 vials.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/07/403/001-002

Date of first authorisation: 22 August 2007

Date of latest renewal: 16 June 2017

Drugs

Drug Countries
ATRIANCE Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom
 
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