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A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with Lioresal.

Continuous InfusionNo additional information is available for pediatric patients.

All patients receiving intrathecal baclofen therapy are potentially at risk for withdrawalEarly symptoms of baclofen withdrawal may include return of baseline spasticitypruritushypotensionand paresthesiasPriapism may develop or recur if treatment with intrathecal baclofen is interruptedSome clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexiainfectionsepsismalignant hyperthermianeuroleptic-malignant syndromeor other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.

Adverse experiences reported during all U.Sstudiesboth controlled and uncontrolledare shown in the following tableEight of 474 patients who received chronic infusion via implanted pumps had adverse experiences which led to a discontinuation of long term treatment in the preand post-marketing studies.

The most frequent1adverse events reported during all clinical trials are shown in the following tableNine patients discontinued long term treatment due to adverse events.

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the pharmacological effect of lioresal is used in the treatment of the different muscle traumas which are accompanied by the painful muscle spasms, and poor motion activity.

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