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SPC, UK: LIORESAL Solutions for injection (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lioresal Intrathecal Injection 50micrograms/1ml. Lioresal Intrathecal Infusion 10mg/5ml. Lioresal Intrathecal Infusion 10mg/20ml.

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 ...

Pharmaceutical form

Solutions for intrathecal injection and intrathecal infusion.

Therapeutic indications

Lioresal Intrathecal is indicated in patients with severe chronic spasticity of spinal or cerebral origin (associated with injury, multiple sclerosis, cerebral palsy) who are unresponsive to oral baclofen ...

Posology and method of administration

Intrathecal administration of Lioresal through an implanted delivery system should only be undertaken by physicians with the necessary knowledge and experience. Specific instructions for implantation, ...

Contraindications

Known hypersensitivity to baclofen or any of its excipients (see section 6.1). The drug should not be administered by any route other than intrathecal.

Special warnings and precautions for use

Intrathecal baclofen therapy is valuable but hazardous. Careful pre-operative assessment is mandatory. The patient must be given adequate information regarding the risks of this mode of treatment, and ...

Interaction with other medicinal products and other forms of interaction

The co-administration of other intrathecal agents with Lioresal Intrathecal is not recommended. An attempt should be made to reduce or discontinue concomitant oral antispastic medications, preferably before ...

Pregnancy and lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women. Oral baclofen increases the incidence of omphaloceles (ventral hernias) in the foetuses of rats at high doses. No teratogenic ...

Effects on ability to drive and use machines

Central nervous system (CNS) depressant effects such as somnolence and sedation have been reported in some patients receiving baclofen, and patients should be advised to exercise due caution. Other listed ...

Undesirable effects

Some of the adverse reactions listed below have been reported in patients with spasticity of spinal origin but could also occur in patients with spasticity of cerebral origin. Adverse reactions that are ...

Overdose

Special attention should be given to recognising the signs and symptoms of overdosage at all times, but especially during the initial screening and dose-titration phases and also during reintroduction ...

Pharmacodynamic properties

Antispastic with a spinal site of attack ATC Code: M03BX01 Baclofen depresses both monosynaptic and polysynaptic reflex transmission in the spinal cord by stimulating the GABAß receptors. Baclofen is a ...

Pharmacokinetic properties

Because of the slow CSF circulation and the baclofen concentration gradient from the lumbar to the cisternal CSF the pharmacokinetic parameters observed in this fluid and as described below should be interpreted ...

Preclinical safety data

Local tolerance Subacute and subchronic studies with continuous intrathecal baclofen infusion in two species (rat, dog) revealed no signs of local irritation or inflammation on histological examination. ...

List of excipients

Sodium chloride Water for injections

Incompatibilities

If alternative baclofen concentrations are required Lioresal Intrathecal may be diluted under aseptic conditions with sterile preservative-free sodium chloride for injections. The ampoules should not be ...

Shelf life

Lioresal Intrathecal Injection 50micrograms/1ml: 3 years. Lioresal Intrathecal Infusion 10mg/20ml: 5 years. Lioresal Intrathecal Infusion 10mg/5ml: 3 years.

Special precautions for storage

Protect from heat (store below 30°C). Medicines should be kept out of the reach and sight of children.

Nature and contents of container

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

Special precautions for disposal and other handling

Each ampoule is intended for single use only, and any unused solution should be discarded. Ampoules should not be either frozen or autoclaved.

Marketing authorization holder

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

Marketing authorization number(s)

Lioresal Intrathecal Injection 50micrograms/1ml: PL 00101/0500 Lioresal Intrathecal Infusion 10mg/20ml: PL 00101/0501 Lioresal Intrathecal Infusion 10mg/5ml: PL 00101/0502

Date of first authorization / renewal of the authorization

Lioresal Intrathecal Injection 50micrograms/1ml: 31 January 2003 Lioresal Intrathecal Infusion 10mg/20ml: 31 January 2003 Lioresal Intrathecal Infusion 10mg/5ml: 3 September 2004

Date of revision of the text

26 June 2017

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