CISATRACURIUM Solution for injection/infusion

Active ingredients: Cisatracurium

Product name and form

Cisatracurium 2 mg/ml Solution for Injection/Infusion.

Pharmaceutical Form

Solution for injection/infusion.

Colourless to pale yellow or greenish yellow solution.

pH: 3.0-3.7

Osmolarity: 8 mOsmol/l

Qualitative and quantitative composition

Cisatracurium 2 mg as cisatracurium besilate 2.7 mg per 1 ml.

One vial of 2.5 ml contains 5 mg of cisatracurium as cisatracurium besilate 6.7 mg.

One vial of 5 ml contains 10 mg of cisatracurium as cisatracurium besilate 13.4 mg.

One vial of 10 ml contains 20 mg of cisatracurium as cisatracurium besilate 26.8 mg.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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

List of Excipients

Benzenesulfonic acid (for pH adjustment)
Water for injections

Pack sizes and marketing

Clear Type I glass vials with rubber stopper; packs of 1 and 5 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Marketing authorization dates and numbers

PL 04515/0234

Date of first authorisation: 20/10/2011

Date of latest renewal: 22/08/2016