DEPOCYTE Suspension for injection Ref.[2692] Active ingredients: Cytarabine

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

Product name and form

DepoCyte 50 mg suspension for injection.

Pharmaceutical Form

Suspension for injection.

White to off-white suspension.

Qualitative and quantitative composition

One ml of suspension contains 10 mg cytarabine.

Each 5 ml vial contains 50 mg cytarabine.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Cytarabine

Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits DNA polymerase and may also inhibit certain acid kinase enzymes.

List of Excipients

Cholesterol
Triolein
Dioleoylphosphatidylcholine (DOPC)
Dipalmitoylphosphatidylglycerol (DPPG)
Sodium chloride
Water for injections

Pack sizes and marketing

Type I glass vial closed with a fluororesin faced butyl rubber stopper and sealed with an aluminium flip-off seal containing 50 mg cytarabine in 5 ml suspension.

DepoCyte is supplied in individual cartons each containing one single-dose vial.

Marketing authorization holder

Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

Marketing authorization dates and numbers

EU/1/01/187/001

Date of first authorisation: 11 July 2001
Date of latest renewal: 11 July 2011

Drugs

Drug Countries
DEPOCYTE Estonia, Lithuania

© 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.