Lioresal Intrathecal (2012)
Active ingredients: Baclofen
Product Name and Form
Lioresal Intrathecal Injection 50micrograms/1ml.
Lioresal Intrathecal Infusion 10mg/5ml.
Lioresal Intrathecal Infusion 10mg/20ml.
Solutions for intrathecal injection and intrathecal infusion.
Qualitative and Quantitative Composition
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.
Water for injections
Pack sizes and Marketing
Colourless glass ampoules, glass type I, according to Ph. Eur.
Novartis Pharmaceuticals UK Limited
Trading as Ciba Laboratories
Frimley Business Park
Lioresal Intrathecal Injection 50micrograms/1ml: 1 February 2003
Lioresal Intrathecal Infusion 10mg/20ml: 1 February 2003
Lioresal Intrathecal Infusion 10mg/5ml: 3 September 2004
Lioresal Intrathecal Injection 50micrograms/1ml: PL 00101/0500
Lioresal Intrathecal Infusion 10mg/20ml: PL 00101/0501
Lioresal Intrathecal Infusion 10mg/5ml: PL 00101/0502