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Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Symptoms of LIORESAL INTRATHECAL OverdoseDrowsinesslightheadednessdizzinesssomnolencerespiratory depressionhypothermiaseizuresrostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hrdurationIn most cases reportedcoma was reversible without sequelae after drug was discontinuedSymptoms of LIORESAL INTRATHECAL overdose were reported in a sensitive adult patient after receiving a 25 mcg intrathecal bolus.

It is mandatory that the patientall patient caregiversand the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatmentAll medical personnel and caregivers should be instructed in 1the signs and symptoms of overdose2procedures to be followed in the event of overdose and 3proper home care of the pump and insertion site.

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