Extension Tubing and Clamp
Powerful long-lasting durability with diamond-like carbon coating that resists the wear from gear revolutions*
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A sudden stop in therapy can result in serious baclofen withdrawal symptoms, such as high fever, changed mental status, muscle stiffness, and in 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
Your intrathecal baclofen pump gives you medicine to help with your muscle tone problems
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A refill template, included in the Lioresal ® Intrathecal (baclofen injection) refill kit, can be used to assist in locating the refill septum
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Some medicines can affect how baclofen works
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Lioresal ® Intrathecal (baclofen injection) is a muscle relaxant and antispastic medication that is used for the management of severe spasticity caused by injury to or certain conditions of the brain or spinal cord
The refill kit model 8551 is intended for use in refilling the SynchroMed® II programmable pump, as part of ongoing patient therapy maintenance for targeted drug delivery, also known as intrathecal drug delivery
Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMed ® Infusion Systems, and associated instructions
Fentanyl or sufentanyl is added to baclofen and bupivacaine or clonidine solution
Item Number
Thus, intrathecal pump refills and intrathecal pump malfunctioning have been allocated as urgent patient procedures during the COVID-19 pandemic [ 16 ]
Lioresal drug ampules contained witin Medtronic Lot N0016487 bear the Lioresal ® Intrathecal (baclofen injection) Important Safety Information Indications and Usage
Noridian has seen problems in the past that included unnecessary frequency of interrogation and refills of the pump every month despite having a pump of 2 or 3 month capacity
Each milliliter of GABLOFEN contains baclofen USP 50 mcg, 500 mcg, 1,000 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5
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A sudden stop in therapy can result in serious baclofen withdrawal symptoms, such as high fever, changed mental status, muscle stiffness, and in rare cases, may result in the loss of function of many vital organs and death
Lioresal® Intrathecal is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for Ready-to-use vial
66794-157-02
For long term treatment, the drug is placed into a pump that is surgically placed under the skin of your abdomen
UNSPSC Code
Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) Even with lower dosages compared to oral baclofen, spasticity is significantly less frequent and less severe with ITB Therapy SM with Lioresal ® Intrathecal, as demonstrated in improvements in Modified Ashworth Scale (MAS) scores within 1 hour of therapy (maximal effect 2-4 hours) in 12 spasticity patients
Contraindications The Refill Kit is contraindicated when the presence of infection is known or suspected
c9009 - baclofen intrathecal refill kit, per 2000 mcg The above description is abbreviated
Recommendations for managing baclofen withdrawal appear elsewhere in the peer-reviewed literature The drug is stable in solution at 37° C and compatible with CSF
Depending upon the model selected by your doctor, the pump is about two to three inches in diameter, 3/4 to one inch thick, weighing four to six ounces, and approximately the size of a hockey puck
Special notice 24 Limited Warranty 25
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monitoring of the infusion system, refill scheduling and procedures, and pump alarms
9% saline solution, the pump system is indicated for use in patient populations of 12 years and older (adolescents and adults)
Each refill kit includes the
Make sure you keep your scheduled refill visits so you don’t run out of medication (baclofen)
Helpful workflow guides and simple steps for refill and implant Built-in auto-calculations
Designed by physicians for physicians for use with Gablofen® pre-filled syringes and
Gablofen, intrathecal baclofen, treats patients who have experienced a stroke, brain or
Treatment with Lioresal ® Intrathecal (also known as Intrathecal Baclofen Therapy [ITB]) to help manage severe spasticity works by delivering precise doses of baclofen into the fluid surrounding the spinal
Fentanyl or sufentanyl is added to baclofen and bupivacaine or clonidine solution
Screening Phase: Prior to pump 2
The RFP can be clearly located as a hypoechoic rectangle between the hyperechoic lines of the Delayed pump refill can cause serious withdrawal syndrome and in the case of baclofen life-threatening events may occur such as rhabdomyolysis, seizure, coma and even death
The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray
As with most medications, you can experience overdose (drug dose is too high) or withdrawal (drug dose is too low)
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Lioresal ® Intrathecal (baclofen injection) is a muscle relaxant and antispastic that is indicated for use in the management of severe spasticity of cerebral or spinal origin
2000 mcg/mL
Check with your local Medicare contractor or other payers for specific coding and billing instructions
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Even with lower dosages compared to oral baclofen, spasticity is significantly less frequent and less severe with ITB Therapy SM with Lioresal ® Intrathecal, as demonstrated in improvements in Modified Ashworth Scale (MAS) scores within 1 hour of therapy (maximal effect 2-4 hours) in 12 spasticity patients
9–631 μg/day)
This code description may also have The drug is stable in solution at 37° C and compatible with CSF
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Depending upon the model selected by your doctor, the pump is about two to three inches in diameter, 3/4 to one inch thick, weighing four to six ounces, and approximately the size of a hockey puck