PRISMASOL _BGK0/2.5- calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate_injection

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. The distribution of electrolytes, bicarbonate, and dextrose is determined by the patient's clinical condition, metabolic status, and residual renal function. The elimination and replacement of water, electrolytes and buffer depend on the patient's electrolyte and acid-base balance, metabolic status, residual renal function and ongoing physiologic losses through intestinal, respiratory and cutaneous routes.

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 ( 2. 2 Solution must be mixed prior to use ( 2. 2 Use only with extracorporeal dialysis equipment appropriate for CRRT ( 2. 3 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. 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 (2. 3) Small compartment A (250 mL) containing an electrolyte solution, and Large compartment B (4750 mL) containing the buffer solution. See Table 1 Table 1: Concentrations of Active Ingredients in the 7 PRISMASOL and 2 PHOXILLUM Replacement Solutions after Mixing Ca 2+ mEq/L HCO 3 - mEq/L K + mEq/L Mg 2+ mEq/L Na + mEq/L HPO 4 2- mmol/L Cl - mEq/L Lactate mEq/L Dextrose mg/dL Osmolarity mOsm/L Ca 2+ 3 - + 2+ + 4 2- PRISMASOL Replacement Solutions BGK0/2. 5 140 0 109 3 100 292 BGK4/2. 5 140 0 113 3 100 300 BGK2/3. 5 32 2 1 140 0 111. 5 3 100 296 BGK2/0 0 32 2 1 140 0 108 3 100 291 B22GK4/0 0 22 4 1. 5 140 0 120. 5 3 100 296 BGK4/0/1. 2 140 0 110. 2 3 100 295 BK0/0/1. 2 140 0 106. 2 3 0 282 PHOXILLUM Replacement Solutions BK4/2. 5 140 1 114. 5 0 0 294 B22K4/0 0 22 4 1. 5 140 1 122 0 0 290 The mode of therapy, solute formulation, flow rates, and length of PRISMASOL and PHOXILLUM replacement therapy in CRRT should be established by a physician based on the patient’s clinical condition, blood concentration of phosphate and other electrolytes, acid-base and glucose balance. Administer either PRISMASOL or PHOXILLUM into the extracorporeal circuit: Before (pre-dilution) the hemofilter or hemodiafilter, After (post-dilution) the hemofilter or hemodiafilter, or Before and after the hemofilter or hemodiafilter. Use only if the overwrap is not damaged, all seals are intact, peel seal is not broken, and the solution is clear. The solution may be warmed to 37°C/98. 6°F prior to removing the overwrap to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. After heating, verify that the solution remains clear and contains no particulate matter. The solutions are supplied in two different two-compartment bags made of polyolefin with a peel seal separating compartment A and B (see Figure 1 Follow the instructions below when connecting the solution bags for correct use of the access ports. Instructions for preparing solutions supplied in a two-compartment, polyolefin bag with a peel seal: Figure 1 Figure 2 Step 1 After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment. Hold the small compartment with both hands and squeeze it until an opening is created in the peel seal. (See Figure 2 Figure 3 Step 2 Figure 3 The solution is now ready to use and the bag can be hung on the equipment. Figure 4a Step 3 Step 3a Figure 4 Ensure that the connection is fully seated and tighten. The connector is now open. Verify that the fluid is flowing freely during use. When the replacement line is disconnected from the luer connector, the connector will close and the flow of the solution will stop. Figure 4b Step 3b Figure 4 Ensure that the spike is fully inserted and verify that the fluid is flowing freely during use. Figure 2 Figure 3 Figure 4a Figure 4b After mixing, additional drugs may be added to the bag via injection connector (spike connector) in large compartment B. In general, administer drugs other than phosphate through a different access line. When introducing drugs, use aseptic techniques and mix thoroughly prior to connecting the solution bag to the extracorporeal circuit. Do not use if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals after addition of medication. Phosphate: Up to 1. 2 mmol/L of phosphate can be added to the bag as potassium phosphate or sodium phosphate. The total potassium concentration of PRISMASOL solution should not exceed 4 mEq/L. Use sodium phosphate to add phosphate if the total potassium concentration in PRISMASOL solution is 4 mEq/L. PHOXILLUM Solutions: Phosphate:.

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

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products. Known hypersensitivities to PRISMASOL and PHOXILLUM solutions ( 4.

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. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Maintenance of normal acid-base balance is important for fetal well-being. The components of PRISMASOL and PHOXILLUM solutions are excreted in human milk. Appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant. 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.

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. 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.

BGK0/2.5- calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate_injection

PRISMASOL _BGK0/2.5- calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate_injection Product manual source documgent