Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2024 Publisher: Novartis Pharmaceuticals UK Limited, Trading as Ciba Laboratories, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
Lioresal Intrathecal Injection 50micrograms/1ml.
Lioresal Intrathecal Infusion 10mg/5ml.
Lioresal Intrathecal Infusion 10mg/20ml.
| Pharmaceutical Form |
|---|
|
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).
Excipient with known effect:
Each ampoule of Lioresal Intrathecal 10 mg/20 mL contains 70.81 mg sodium.
For excipients see section 6.1 List of excipients.
| Active Ingredient |
|---|
|
Baclofen depresses monosynaptic and polysynaptic reflex transmission, probably by stimulating the GABAB-receptors. This stimulation in turn inhibits the release of the excitatory amino acids glutamate and aspartate. Neuromuscular transmission is unaffected by baclofen. Baclofen also exerts an antinociceptive effect. |
| List of Excipients |
|---|
|
Sodium chloride |
Colourless glass ampoules, glass type I, according to Ph. Eur.
Novartis Pharmaceuticals UK Limited, Trading as Ciba Laboratories, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
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
| Drug | Countries | |
|---|---|---|
| LIORESAL | Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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