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PrismaSol Solution

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PrismaSol Solution

INDICATIONS

PrismaSol solution (sterile hemofiltration hemodiafiltration 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.

DOSAGE AND ADMINISTRATION

Individualization of Treatments

The mode of therapy, solute formulation, flow rates and length oftherapy 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 (sterile hemofiltration hemodiafiltration 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 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.

Directions for use

PrismaSol solution (sterile hemofiltration hemodiafiltration 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.

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 compartment 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 immediately after use.

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 overwap, the solution is stable for 24 hours including the duration of the treatment.

  1. Remove the overwrap from the bag immediately before use and discard any other packaging materials. Open the seal by breaking the red frangible pin between the two compartments ofthe bag. The frangible pin wil remain in the bag. (See Figure I below)
  2. Directions for use - illustration 1

  3. Make sure all the fluid from the small comparment A is transferred into the large compartment B. (See Figure II below)
  4. Directions for use - illustration 2

  5. Rinse the small compartment A twice by pressing the mixed solution back into the small compartment A and then back into the large comparment B. (See Figure III below)
  6. Directions for use - illustration 3

  7. When the small compartment A is empty: shake the large compartment B so that the contents mix completely. The solution is now ready to use and the bag can be hung on the equipment. (See Figure iv below)
  8. Directions for use - illustration 4

  9. The replacement line may be connected to either of the two access ports.
    1. If the luer access is used, remove the cap and connect the male luer lock on the replacement line to the female luer receptor on the bag; tighten. Using thumb and fingers, break the blue frangible pin at its base, and move it back and forth. Do not use a tool. Verify that the pin is completely separated and that the fluid is flowing freely. The pin will remain in the luer port during the treatment. (See Figure V.a below)
    2. Directions for use - illustration 5

    3. If the injection port is used, first remove the snap-off cap. Then introduce the spike through the rubber septum. Verify that the fluid is flowing freely. (See Figure V.b below)
    4. Directions for use - illustration 6

Additions:

The large compartment B is fitted with an injection port 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 (sterile hemofiltration hemodiafiltration solution) . In general, other drugs should be administered through a different line.

HOW SUPPLIED

PrismaSol solution (sterile hemofiltration hemodiafiltration solution) is supplied in a two-compartment bag made of Poly (vinyl chloride) (PVC). The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a red frangible pin. The bag is overwrapped with a transparent overpouch.

Container Fil Volume NDC
PrismaSol BGK412.5 5000 mL 24571-105-05
PrismaSol BGK2/3.5 5000 mL 24571-103-05
PrismaSol BGK0/2.5 5000 mL 24571-108-05
PrismaSol B22GK4/2.5 5000 mL Not yet available
PrismaSol BGK4/0/1.2 5000 mL Not yet available
PrismaSol BGK2/0 5000 mL 24571-102-05
PrismaSol B22GK4/0 5000 mL Not yet available
PrismaSol B22GK2/0 5000 mL Not yet available
PrismaSol BK0/0/1.2 5000 mL Not yet available
PrismaSol BK0/3.5 5000 mL 24571-101-05

Not all formulations may be marketed.

Storage conditions

Store at 25°C (77°F); excursions permitted to 15° - 30°C (59°- 86°F). (See USP Controlled Room Temperature).

Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals have been damaged.

Manufactured by: Gambro, 1845 Mason Avenue, Daytona Beach, FL 32117, USA. FDA revision date: 10/10/2008

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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