Prismasol Bgk2/0

FDA label, Vantive US Healthcare LLC, intravenous, effective 2025-05-31. Full label on DailyMed

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

Dosing in kidney impairment

Use only with extracorporeal dialysis equipment appropriate for CRRT 2.1 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. 2.2 Dosing Considerations PRISMASOL replacement solutions contain 4 different combinations of active ingredients (7 different products with varying ingredient amounts).

Preparation and administration

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Basis

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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.

Preparing the Solution 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 1 [See table below.] 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 If the injection connector (spike connector) is used, first remove the snap-off cap.

Then introduce the replacement line spike through the swabbable rubber septum of the bag connector. (See Figure 4 b beside) 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

Table 1: Concentrations of Active Ingredients in the 7 PRISMASOL and 2 PHOXILLUM Replacement Solutions after Mixing
Ca2+ mEq/LHCO3- mEq/LK+ mEq/LMg2+ mEq/LNa+ mEq/LHPO42- mmol/LCl- mEq/LLactate mEq/LDextrose mg/dLOsmolarity mOsm/L
Ca2+ = calcium, HCO3- = bicarbonate, K+ = potassium, Mg2+ = magnesium, Na+ = sodium, HPO42- = phosphate, Cl- = chloride; osmolarity is estimated
PRISMASOL Replacement Solutions
BGK0/2.52.53201.514001093100292
BGK4/2.52.53241.514001133100300
BGK2/3.53.532211400111.53100296
BGK2/00322114001083100291
B22GK4/002241.51400120.53100296
BGK4/0/1.203241.21400110.23100295
BK0/0/1.203201.21400106.230282
PHOXILLUM Replacement Solutions
BK4/2.52.53241.51401114.500294
B22K4/002241.5140112200290
Figure 2Step 1 Immediately before use, remove the overwrap from the bag and mix the solutions in the two different compartments. After removing the overwrap, inspect the bag for leakage by pressing firmly on the bag. Discard the bag if any leakage is detected since sterility cannot be assured. As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the mixed solution should be used immediately.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 beside)
Figure 3 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 3 beside)The solution is now ready to use and the bag can be hung on the equipment.
Figure 4aStep 3 The replacement line may be connected to the bag through either of the luer connector or the injection connector (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 4a 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.
Figure 4bStep 3b If the injection connector (spike connector) is used, first remove the snap-off cap. Then introduce the replacement line spike through the swabbable rubber septum of the bag connector. (See Figure 4b beside)Ensure that the spike is fully inserted and verify that the fluid is flowing freely during use.

Drug interactions

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Label text (2 paragraphs)

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.

Contraindications

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

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 bgk2/0. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

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. 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. In the U.S.

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. Clinical Considerations Maintenance of normal acid-base balance is important for fetal well-being.

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

Supply and cost

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Therapeutic equivalence (Orange Book)

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Price ladder

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