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Special attention must be given to recognizing the signs and symptoms of overdosageespecially during the initial screening and dose-titration phase of treatmentbut also during re-introduction of LIORESAL INTRATHECAL after a period of interruption in therapy.
Extreme caution must be used when filling an FDA approved implantable pumpSuch pumps should only be refilled through the reservoir refill septumInadvertent injection into the subcutaneous tissue can occur if the reservoir refill septum is not properly accessedSome pumps are also equipped with a catheter access port that allows direct access to the intrathecal catheterDirect injection into this catheter access port or inadvertent injection into the subcutaneous tissue may cause a life-threatening overdose.
Continuous InfusionThe mean CSF clearance for LIORESAL INTRATHECALbaclofen injectionwas approximately 30 mL/hour in a study involving ten patients on continuous intrathecal infusionConcurrent plasma concentrations of baclofen during intrathecal administration are expected to be low0-5 ng/mL
Screening Patients should be infection-free prior to the screening trial with LIORESAL INTRATHECALbaclofen injectionbecause the presence of a systemic infection may interfere with an assessment of the patient’s response to bolus LIORESAL INTRATHECAL.
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