SynchroMed Refill Kits by Medtronic USA. His medical history included SCI, aspiration pneumonia, septic shock, disseminated intravascular coagulopathy, severe metabolic acidosis, hepatic toxicity, and status epilepticus. For details see our Return Policy.We use cookies for Google Analytics and session tracking for your secure shopping experience. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Because of the risks associated with the screening procedure and the adjustment of dosage following pump implantation, these phases must be conducted in a medically supervised and adequately equipped environment following the instructions outlined in the Dosage and Administration section.Following surgical implantation of the pump, particularly during the initial phases of pump use, the patient should be monitored closely until it is certain that the patient’s response to the infusion is acceptable and reasonably stable.On each occasion that the dosing rate of the pump and/or the concentration of LIORESAL INTRATHECAL (baclofen injection) in the reservoir is adjusted, close medical monitoring is required until it is certain that the patient’s response to the infusion is acceptable and reasonably stable.It is mandatory that the patient, all patient caregivers, and the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatment. Prior to implantation of a device for chronic intrathecal infusion of LIORESAL INTRATHECAL, patients must show a response to LIORESAL INTRATHECAL in a screening trial (see Dosage and Administration).Hypersensitivity to baclofen. Nonetheless, many of the more commonly reported reactions — somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma— appear clearly drug-related.The most frequent (≥1%) adverse events reported during all clinical trials are shown in the following table. In clinical trials, only 3 of 150 patients required daily doses greater than 1000 mcg/ day.LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Fetal structural abnormalities were not observed in mice or rabbits.Safety and effectiveness in pediatric patients below the age of 4 have not been established.A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral LIORESAL. Clinicians should monitor patients carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation.
For spasticity of spinal cord origin, chronic infusion of LIORESAL INTRATHECAL 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. Extreme caution must be used when filling an FDA-approved implantable pump, following strict aseptic technique and ensuring refill directly into the reservoir and not the catheter access port.Reservoir refills are sterile, procedures that need to be scheduled, and it is important that patients keep their scheduled refill appointments. Our articles are resourced from reputable online pages. All medical personnel and caregivers should be instructed in 1) the signs and symptoms of overdose, 2) procedures to be followed in the event of overdose and 3) proper home care of the pump and insertion site.Extreme caution must be used when filling an FDA approved implantable pump.
The precise mechanism of action of baclofen as a muscle relaxant and antispasticity agent is not fully understood. Risk of life-threatening overdose during pump refills. 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 SynchroMedUnderstand the conditions under which a patient with a SynchroMed™ II drug infusion pump can receive an MRI.Access product manuals from the Medtronic Manual Library by searching for the product name or model number.