ATRACURIUM BESYLATE Solution for injection

Active ingredients: Atracurium besilate

Product name and form

Atracurium Besilate 10 mg/ml Solution for Injection.

Pharmaceutical Form

Solution for injection.

A clear colourless or faint yellow solution.

Qualitative and quantitative composition

Atracurium besilate 10 mg/ml (equivalent to atracurium 7.5 mg/ml).

2.5 ml of solution contains 25 mg atracurium besilate.

5 ml of solution contains 50 mg atracurium besilate.

25 ml of solution contains 250 mg atracurium besilate.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Atracurium besilate is a non-depolarising neuromuscular blocking agent with an intermediate duration of action, administered intravenously to produce skeletal muscle relaxation.

List of Excipients

Benzenesulphonic acid
Water for injections

Pack sizes and marketing

2.5 ml: Type I glass ampoule in packs of 5 ampoules.

5 ml: Type I glass ampoule in packs of 5 ampoules.

25 ml: Type I glass vial with rubber stopper in packs of 1 vial.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 04515/0099

15 October 1996/14 October 2006