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LIORESAL INTRATHECALbaclofen injectionis indicated for use in the management of severe spasticityPatients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pumpFor spasticity of spinal cord originchronic infusion of LIORESAL INTRATHECAL via an implantable pump should be reserved for patients unresponsive to oral baclofen therapyor those who experience intolerable CNS side effects at effective dosesPatients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapyLIORESAL INTRATHECAL is intended for use by the intrathecal route in single bolus test dosesvia spinal catheter or lumbar punctureandfor chronic useonly in implantable pumps approved by the FDA specifically for the administration of LIORESAL INTRATHECAL into the intrathecal space.

Postmarketing ExperienceThe following adverse events have been reported during post-approval use of LIORESAL INTRATHECALBecause these events are reported voluntarily from a population of uncertain sizeit is not possible to reliably estimate their frequency.

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.

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a if you are hypersensitive to baclofen, you should not use lioresal intrathecal.

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