Indications
PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances. PRISMASOL and PHOXILLUM solutions are indicated: As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialyzable substances ( 1 )
Contraindications
PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products. Known hypersensitivities to PRISMASOL and PHOXILLUM solutions ( 4 )
Warnings and precautions
Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorus, other electrolytes and acid-base balance. Abnormalities may be corrected by the use of appropriate formulations and dosage of PRISMASOL and PHOXILLUM solutions ( 5.1 ) Treatment may affect glucose levels. Monitor blood glucose levels. Antidiabetic therapy adjustment or other corrective measures may be required during treatment ( 5.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
5.1Electrolyte and Volume Abnormalities PHOXILLUM and
PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, calcium, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately [ see Dosage and Administration (2) ].
PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.