Indications and Purposes
| 1 Indications And Usage Baclofen Injection Is Indicated For Use In The Management Of Severe Spasticity In Adult And Pediatric Patients Age 4 Years And Above. Patients Should First Respond To A Screening Dose Of Intrathecal Baclofen Prior To Consideration For Long Term Infusion Via An Implantable Pump. For Spasticity Of Spinal Cord Origin, Chronic Infusion Of Baclofen Injection Via An Implantable Pump Should Be Reserved For Patients Unresponsive To Oral Baclofen Therapy, Or Those Who Experience Intolerable Cns Side Effects At Effective Doses. Patients With Spasticity Due To Traumatic Brain Injury Should Wait At Least One Year After The Injury Before Consideration Of Long Term Intrathecal Baclofen Therapy. Baclofen Injection Is Intended For Use By The Intrathecal Route In Single Bolus Test Doses (Via Spinal Catheter Or Lumbar Puncture) And, For Chronic Use, Only With The Medtronic Synchromed® Ii Programmable Pump Or Other Pumps Labeled For Intrathecal Administration Of Baclofen Injection [See Clinical Studies ( 14 )] . Prior To Implantation Of A Device For Chronic Intrathecal Infusion Of Baclofen Injection, Patients Must Show A Response To Baclofen Injection In A Screening Trial [See Dosage And Administration ( 2.2 )] . Baclofen Injection Is A Gamma-Aminobutyric Acid (Gaba) Ergic Agonist Indicated For Use In The Management Of Severe Spasticity Of Cerebral Or Spinal Origin In Adult And Pediatric Patients Age 4 Years And Above ( 1 ) Baclofen Injection Should Be Reserved For Patients Unresponsive To Oral Baclofen Therapy, Or Those Who Experience Intolerable Central Nervous System Side Effects At Effective Doses ( 1 ) Patients Should First Respond To A Screening Dose Of Intrathecal Baclofen Prior To Consideration For Long Term Infusion Via An Implantable Pump. ( 1 ) Spasticity Due To Traumatic Brain Injury: Wait At Least One Year After Injury Before Considering Baclofen Injection Therapy ( 1 ) |
All Formulated Excipients (0 Total)
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