Indications and Purposes
| 1 Indications And Usage Gablofen 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 Gablofen 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. Gablofen 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 Gablofen [See Clinical Studies (14)] . Prior To Implantation Of A Device For Chronic Intrathecal Infusion Of Gablofen, Patients Must Show A Response To Gablofen In A Screening Trial [See Dosage And Administration (2.2)] . · Gablofen 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 ) · Gablofen 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 Gablofen Therapy. ( 1 ) |
All Formulated Excipients (0 Total)
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