NIMBEX Solution for injection / infusion

Active ingredients: Cisatracurium

Product name and form

Nimbex 2mg/ml solution for injection/infusion.

Pharmaceutical Form

Solution for injection/infusion.

Colourless to pale yellow or greenish yellow solution. Practically free from visible particulate matter.

Nimbex is an intermediate-duration, non-depolarising neuromuscular blocking agent for intravenous administration.

Qualitative and quantitative composition

Cisatracurium 2mg as cisatracurium besilate 2.68mg per 1ml.

One ampoule of 2.5ml contains 5mg of cisatracurium.

One ampoule of 5ml contains 10mg of cisatracurium.

One ampoule of 10ml contains 20mg of cisatracurium.

One ampoule of 25ml contains 50mg of cisatracurium.

For excipients, see Section 6.1.

Active Ingredient
Description

Cisatracurium is an intermediate-duration, non-depolarising benzylisoquinolinium skeletal muscle relaxant.

List of Excipients

Benzene sulfonic acid solution 32% w/v
Water for injections

Pack sizes and marketing

Nimbex 2mg/ml solution for injection/infusion:

2.5ml in ampoule (glass): box of 5.
5ml in ampoule (glass): box of 5.
10ml in ampoule (glass): box of 5.
25ml in ampoule (glass: box of 2.

Type I, clear, neutral glass ampoules.

NOT ALL PACK SIZES MAY BE MARKETED.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, City West Business Campus, Dublin 24, Ireland

Service-Tel: 0800 008 7392 (+44 1748 828 391)

Marketing authorization dates and numbers

PL 39699/0092

Date of first authorisation: 07 August 1995
Date of last renewal: 09 August 2010

Drugs

Drug
Countries
Austria, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Singapore, Tunisia, United Kingdom, United States, South Africa