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You can count on Lioresal® for 100% sterility from start to finish1

This brief video will demonstrate the appropriate procedure for refilling the Medtronic Synchromed™ II Pump with the newly redesigned Lioresal® Intrathecal (baclofen injection) refill kit with a 100% sterile presentation and streamline packaging. This video is a supplementary instructional demonstration, and should not take the place of clinical training.

 

For additional safety information, including BOX WARNING, please review the Lioresal® Intrathecal (baclofen injection) prescribing information and the SynchroMed® II Drug Infusion System Brief Statement.

 

 

*An intuitively redesigned kit that mirrors your clinical flow.

  1. Saol Therapeutics Inc. Data on file: NDA 020075 Lioresal; 3.2.P.8 Stability and 3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitment.

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage

Contraindications

Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOXED WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.