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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Lioresal Intrathecal (2012)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Περιεχόμενα

Name of the medicinal product

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

Qualitative and quantitative composition

Active substance b-(Aminomethyl)-p-chlorohydrocinnamic acid (= baclofen), a racemic mixture of the R, ...

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 ...

Posology and method of administration

Intrathecal administration of Lioresal through an implanted delivery system should only be undertaken ...

Contraindications

Known hypersensitivity to baclofen or any of its excipients (see section 6.1). The drug should not be ...

Special warnings and precautions for use

Intrathecal baclofen therapy is valuable but hazardous. Careful pre-operative assessment is mandatory. ...

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 ...

Pregnancy and lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women. Oral baclofen increases ...

Effects on ability to drive and use machines

Drowsiness has been reported in some patients receiving intrathecal baclofen, and patients should be ...

Undesirable effects

A causal link between the following observed events and the administration of baclofen cannot be reliably ...

Overdose

Special attention should be given to recognising the signs and symptoms of overdosage at all times, but ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antispastic with a spinal site of attack ATC Code: M03B X01 Baclofen depresses ...

Pharmacokinetic properties

Because of the slow CSF circulation and the baclofen concentration gradient from the lumbar to the cisternal ...

Preclinical safety data

Subacute and subchronic studies with continuous intrathecal baclofen infusion in two species (rat, dog) ...

List of excipients

Sodium chloride Water for injections

Incompatibilities

If alternative baclofen concentrations are required Lioresal Intrathecal may be diluted under aseptic ...

Shelf life

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

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 ...

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Trading as Ciba Laboratories Frimley Business Park Frimley Camberley ...

Marketing authorization number(s)

Lioresal® Intrathecal Injection 50micrograms/1ml: PL 00101/0500 Lioresal® Intrathecal Infusion 10mg/20ml: ...

Date of first authorization / renewal of the authorization

Lioresal® Intrathecal Injection 50micrograms/1ml: 1 February 2003 Lioresal® Intrathecal Infusion 10mg/20ml: ...

Date of revision of the text

11 May 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.