Dextrose anhydrous

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 )

• 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 Administration Instructions Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration
• Administration should only be under the direction of a physician competent in intensive care treatment including CRRT
• Use only with extracorporeal dialysis equipment appropriate for CRRT
• The prepared solution is for single patient use only
• Aseptic technique should be used throughout administration to the patient
• Discard any unused solution
• Dosing Considerations PRISMASOL replacement solutions contain 4 different combinations of active ingredients (7 different products with varying ingredient amounts)
• PHOXILLUM replacement solutions contain 2 different combinations of active ingredients (2 different products with varying ingredient amounts)
• PRISMASOL and PHOXILLUM are supplied in a two-compartment bag that must be mixed immediately prior to use [see Dosage and Administration ]: • Small compartment A (250 mL) containing an electrolyte solution, and • Large compartment B (4750 mL) containing the buffer solution
• See Table 1 for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions (total volume is 5 Liters). …

See Table 1 for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions [see Dosage and Administration (2.2) ] . PRISMASOL and PHOXILLUM are available in multiple combinations of ingredients and in multiple variations of strengths. See full Prescribing Information for detailed descriptions of each formulation. ( 2 , 3 , 11 )

• Safety and effectiveness have been established based on published clinical data of CRRT replacement solutions with compositions similar to PRISMASOL and PHOXILLUM used
• In adults and two hemofiltration studies
• In pediatric patients, including a study of newborns to 17 years old

The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.

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

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. 7.1 Citrate When used as an anticoagulant, citrate contributes to the overall buffer load and can reduce plasma calcium levels. Select the PRISMASOL/PHOXILLUM formulation(s) accordingly.

• 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 hyperkalem …

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. …

Storage conditions Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature] Do not freeze or expose to excessive heat. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.