FDA label 811a1325-415a-416e-826a-47ab9af37e45

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
25c4d41f-bdcc-479e-a49f-96d7a2d46fc1
SPL ID
811a1325-415a-416e-826a-47ab9af37e45
Version
2
Effective date
2015-02-24
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:35:51

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Hemodynamic status and fluid, electrolyte and acid-base balance should be monitored. Abnormalities may be corrected by the use of appropriate formulations of PRISMASOL and PHOXILLUM solutions ( 5.1 ) Antidiabetic therapy may need adjustment during treatment with dextrose containing formulations ( 5.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Gambro at 1-800-651-2623 or FDA 1-800-FDA-1088 or www.fda.gov/medwatch 5.1 Electrolyte and Volume Abnormalities Monitor hemodynamic status and fluid, electrolyte and acid-base balance throughout the procedure. During hemofiltration or hemodiafiltration using PRISMASOL or PHOXILLUM replacement solutions, abnormalities in the plasma concentration of potassium, calcium, magnesium, and phosphate may develop. These abnormalities may be corrected by changing the formulations of replacement solution or by supplementation [see Dosage and Administration (2) ]. 5.2 Hyperglycemia with Dextrose Containing Solutions The use of PRISMASOL replacement solutions containing dextrose may increase the risk for hyperglycemia in patients with impaired glucose tolerance. Patients may require initiation of or modification of antidiabetic therapy during treatment with PRISMASOL solutions containing dextrose. Monitor blood glucose.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.