Active ingredients: Baclofen
Lioresal Intrathecal Injection 50micrograms/1ml.
Lioresal Intrathecal Infusion 10mg/5ml.
Lioresal Intrathecal Infusion 10mg/20ml.
Solutions for intrathecal injection and intrathecal infusion.
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.
Baclofen is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid (GABA) derivative, chemically unrelated to other antispastic agents.
Water for injections
Colourless glass ampoules, glass type I, according to Ph. Eur.
Novartis Pharmaceuticals UK Limited, Trading as Ciba Laboratories, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England
Lioresal Intrathecal Injection 50micrograms/1ml: 31 January 2003
Lioresal Intrathecal Infusion 10mg/20ml: 31 January 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