Prismasol Bgk0/2.5

FDA label, Vantive US Healthcare LLC, intravenous, effective 2014-01-24. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, Phosphate Binder, Potassium Salt

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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Basis

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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 use PrismaSol 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. The reconstituted solution is for single patient use only Aseptic technique should be used throughout administration to the patient.

Discard any unused solution. 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.

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.

Figure Figure 1 Figure 2 Figure 3a Figure 3b 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.

Drug interactions

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  • Prismasol Bgk0/2.5
Label text (1 paragraph)

As with the use of other replacement solutions, blood concentrations of filterable drugs may be influenced by CRRT. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment. In patients with cardiovascular disease, especially those using cardiac glycoside medications, plasma levels of calcium, potassium and magnesium must be carefully monitored.

Contraindications

There is no known contraindication to the use of PrismaSol solution. None

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for prismasol bgk0/2.5. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Pregnancy Category C. PrismaSol solution is a replacement solution of electrolytes, bicarbonate and dextrose and is pharmacologically inactive. Animal reproduction studies have not been conducted with PrismaSol solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PrismaSol solution with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm, or affect reproductive capacity. Maintenance of normal acid-base balance is important for fetal well being.

Lactation

8.3 Nursing Mothers PrismaSol solution is a replacement solution of electrolytes, bicarbonate and dextrose and is pharmacologically inactive. The components of PrismaSol solution are excreted in human milk. Appropriate administration of PrismaSol solution with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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