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Uses
PrismaSol solution is indicated in adults and children for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolytes and acid-base imbalances. PrismaSol solution may also be used in case of drug poisoning when CRRT is used to remove filterable substances.
History
There is currently no drug history available for this drug.
Other Information
PrismaSol solution is a clear, sterile solution free of bacterial endotoxins. This solution is used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration.
It contains no bacteriostatic or antimicrobial agents.
PrismaSol solution is packaged in a two-compartment bag. The small compartment A contains electrolytes and the large compartment B contains buffer. The final reconstituted solution (5000 mL) is obtained after breaking the red frangible pin between compartment A and B and mixing both solutions.
Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 • 2 H2O).
Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 • 6H2O).
Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 • H2O).
Lactic acid, USP, is chemically designated CH3CH(OH)COOH.
Sodium chloride, USP, is chemically designated NaCl.
Potassium chloride, USP, is chemically designated KCl.
Sodium bicarbonate, USP, is chemically designated NaHCO3.
The pH of the final solution is in the range of 7.0 to 8.5.
Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di 2-ethylhexyl phthalate (DEHP), up to 3 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by in-vitro toxicity studies.
Sources
Prismasol Bgk0/2.5 Manufacturers
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Gambro Renal Products
Prismasol Bgk0/2.5 | Gambro Renal Products
2.1 Individualization of TreatmentsThe mode of therapy, solute formulation, flow rates and length of therapy should be selected by the physician responsible for managing treatment depending on the clinical condition of the patient as well as the patient's fluid, electrolyte, acid base and glucose balance. PrismaSol solution can be administered into the extra-corporeal circuit before (pre-dilution) and/or after the hemofilter or hemodiafilter (post-dilution).
In post-dilution hemofiltration, the replacement rate should not be greater than one third of the blood flow rate; e.g., for blood flow of 100 mL/min, equivalent to 6000 mL/hour, post-filter replacement rate should not exceed 2000 mL/hour.
2.2 Directions for usePrismaSol solution should be inspected visually for particulate matter and discoloration prior to administration. Use only if the solution is clear and all seals are intact. Press bag firmly to test for any leakage. Do not use if container is damaged or leaking.
When connecting solution bags, follow the instructions in this leaflet for correct use of the access ports. Incorrect use of the access port or other restrictions to fluid flow might lead to incorrect patient weight loss and may result in machine alarms.
Continuing treatment without resolving the originating cause may result in patient injury or death.
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) by breaking the red frangible pin immediately before use and mixing the contents of compartments A and B.
As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted solution should be used immediately.
Due to chemical reasons, after removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment.
Step 1 Immediately before use, remove the overwrap from the bag and mix the solutions in the two different compartments.
Open the seal by breaking the red frangible pin between the two compartments of the bag. The frangible pin will remain in the bag. (See Figure 1 beside)
Step 2 Make sure all the fluid from the small compartment A is transferred into the large compartment B. (See Figure 2 beside)
Step 3 Rinse the small compartment A twice by pressing the mixed solution back into the small compartment A and then back into the large compartment B. (See Figure 3 beside) Step 4 When the small compartment A is empty: shake the large compartment B so that the contents mix completely. (See Figure 4 beside)
The solution is now ready to use and the bag can be hung on the equipment.Step 5 The replacement line may be connected to the bag through either the luer connector or the injection connector (or spike connector).
Step 5a The luer connector is a needle-less and swabbable connector. Remove the cap with a twist and pull motion, and connect the male luer lock on the replacement line to the female luer receptor on the bag. (See Figure 5a beside)
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. Step 5b If the injection connector (or spike connector) is used, first remove the snap-off cap. Then introduce the replacement line spike through the rubber septum of the bag connector. (See Figure 5b beside)
Ensure that the spike is fully inserted and verify that the fluid is flowing freely during use.Additions: The large compartment B is fitted with an injection connector (or spike connector) for the addition of drugs after reconstitution of the solution. When introducing additives, use aseptic techniques.
Phosphate: Phosphate up to 1.2 mmol/L may be added to the solution. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/L.
Other drugs: Some drugs may be incompatible with PrismaSol solution. In general, other drugs should be administered through a different line.
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Gambro Renal Products
Prismasol Bgk0/2.5 | Gambro Renal Products
2.1 Individualization of TreatmentsThe mode of therapy, solute formulation, flow rates and length of therapy should be selected by the physician responsible for managing treatment depending on the clinical condition of the patient as well as the patient's fluid, electrolyte, acid base and glucose balance. PrismaSol solution can be administered into the extra-corporeal circuit before (pre-dilution) and/or after the hemofilter or hemodiafilter (post-dilution).
In post-dilution hemofiltration, the replacement rate should not be greater than one third of the blood flow rate; e.g., for blood flow of 100 mL/min, equivalent to 6000 mL/hour, post-filter replacement rate should not exceed 2000 mL/hour.
2.2 Directions for usePrismaSol solution should be inspected visually for particulate matter and discoloration prior to administration. Use only if the solution is clear and all seals, including the peel seal between the compartments, are intact. Press bag firmly to test for any leakage. Do not use if container is damaged or leaking.
When connecting solution bags, follow the instructions in this leaflet for correct use of the access ports. Incorrect use of the access port or other restrictions to fluid flow might lead to incorrect patient weight loss and may result in machine alarms. Continuing treatment without resolving the originating cause may result in patient injury or death.
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) by opening the peel seal immediately before use and mixing the contents of compartments A and B.
As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted solution should be used immediately.
Due to chemical reasons, after removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment.
Step 1 Immediately before use, remove the overwrap from the bag and mix the solutions in the two different compartments. Hold the small compartment with both hands and squeeze it until an opening is created in the peel seal. (See Figure 1 beside) Step 2 Squeeze with both hands on the large compartment until the peel seal between the two compartments is entirely open. Shake gently to mix. (See Figure 2 beside)
The solution is now ready for use and can be hung on the equipment.Step 3 The replacement line may be connected to the bag through either of the luer connector or the injection connector (or spike connector).
Step 3a The luer connector is a needle-less and swabbable connector. Remove the cap with a twist and pull motion, and connect the male luer lock on the replacement line to the female luer receptor on the bag. (See Figure 3a beside)
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. Step 3b If the injection connector (or spike connector) is used, first remove the snap-off cap. Then introduce the replacement line spike through the rubber septum of the bag connector. (See Figure 3b beside)
Ensure that the spike is fully inserted and verify that the fluid is flowing freely during use.Additions: The large compartment B is fitted with an injection connector (or spike connector) for the addition of drugs after reconstitution of the solution. When introducing additives, use aseptic techniques.
Phosphate: Phosphate up to 1.2 mmol/L may be added to the solution. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/L.
Other drugs: Some drugs may be incompatible with PrismaSol solution. In general, other drugs should be administered through a different line.
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