LIORESAL Solutions for infusion

Active ingredients: Baclofen

Product name and form

Lioresal Intrathecal Injection 50micrograms/1ml.

Lioresal Intrathecal Infusion 10mg/5ml.

Lioresal Intrathecal Infusion 10mg/20ml.

Pharmaceutical Form

Solutions for intrathecal injection and intrathecal infusion.

Qualitative and quantitative composition

Active substance: b-(Aminomethyl)-p-chlorohydrocinnamic acid (= baclofen), a racemic mixture of the R, (-) and S, (+) isomers

One ampoule of 1 ml contains 50 micrograms baclofen, (50 micrograms/ml).

One ampoule of 5 ml contains 10 mg baclofen, (2000 micrograms/ml).

One ampoule of 20 ml contains 10 mg baclofen, (500 micrograms/ml).

For excipients see section 6.1 List of excipients.

Active Ingredient
Description

Baclofen is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid (GABA) derivative, chemically unrelated to other antispastic agents.

List of Excipients

Sodium chloride
Water for injections

Pack sizes and marketing

Colourless glass ampoules, glass type I, according to Ph. Eur.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, Trading as Ciba Laboratories, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England

Marketing authorization dates and numbers

Lioresal Intrathecal Injection 50micrograms/1ml: PL 00101/0500

Lioresal Intrathecal Infusion 10mg/20ml: PL 00101/0501

Lioresal Intrathecal Infusion 10mg/5ml: PL 00101/0502

Lioresal Intrathecal Injection 50micrograms/1ml: 31 January 2003

Lioresal Intrathecal Infusion 10mg/20ml: 31 January 2003

Lioresal Intrathecal Infusion 10mg/5ml: 3 September 2004

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, United States, South Africa