Lactic acid, Magnesium chloride, Sodium bicarbonate and Sodium chloride

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

PRISMASOL and PHOXILLUM solutions are pharmacologically inactive. The electrolyte concentrations in the solutions are chosen to restore plasma levels to clinically desired concentrations or maintain plasma levels at the desired concentrations. PRISMASOL and PHOXILLUM solutions are used as replacement solution to replace water and electrolytes removed during hemofiltration and hemodiafiltration. Bicarbonate (or precursor lactate) in the solution is used as an alkalinizing buffer to restore acid-base balance to a clinically desirable level.

• Therapy must be individualized based on the patient's clinical condition, fluid, electrolyte, acid-base and glucose balance. • Solution must be mixed prior to use. • Use only with extracorporeal dialysis equipment appropriate for CRRT

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products. Known hypersensitivities to PRISMASOL and PHOXILLUM solutions

• 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. • Treatment may affect glucose levels. Monitor blood glucose levels. • Antidiabetic therapy adjustment or other corrective measures may be required during treatment

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

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Do not freeze or expose to excessive heat.