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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.

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.

Chemical substance
Description
Baclofen

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
Authorization dates

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

Lioresal Intrathecal Injection 50micrograms/1ml: 1 February 2003

Lioresal Intrathecal Infusion 10mg/20ml: 1 February 2003

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

Marketing authorization number:

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

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

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