Calcium Chloride, Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, And Potassium Chloride

1 INDICATIONS AND USAGE 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 )

6 ADVERSE REACTIONS The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolic acidosis Hypotension Acid-base disorders Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia Fluid imbalance

8.1 Pregnancy Risk Summary PRISMASOL and PHOXILLUM are pharmacologically inactive solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown.

5 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 5.1 Electrolyte and Volume Abnormalities PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. 4 CONTRAINDICATIONS PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products. Known hypersensitivities to PRISMASOL and PHOXILLUM solutions ( 4 )