Plasma-lyte A Injection, Solution
FDA Label NDC 0338-9591

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Company for the product Plasma-lyte A (NDC 0338-9591). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel

Container Label 0338-9591-01 (Image 18)

Container Label 0338-9591-01 (Image 18)

Container Label

JB2544 1000 mL DIN 02339358

PLASMA-LYTE A
INJECTION

PLASMA-LYTE A,
Injectable

Norme Baxter Std

APPROX mmol/L Na – 140 K – 5 Mg – 1.5 Cl – 98
ACETATE – 27 GLUCONATE – 23 mOsmol/L – 294
pH 7.4

INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT
RETABLISSEMENT HYDRO-ELECTROLYTIQUE PAR INJECTION
INTRAVEINEUSE

PER 100 mL SODIUM CHLORIDE USP – 526 mg / SODIUM GLUCONATE
- 502 mg / SODIUM ACETATE TRIHYDRATE USP – 368 mg /
POTASSIUM CHLORIDE USP – 37 mg / MAGNESIUM CHLORIDE
HEXAHYDRATE USP – 30 mg / WATER FOR INJECTION USP – qs
pH MAY BE ADJUSTED WITH SODIUM HYDROXIDE

PAR 100 mL CHLORURE DE SODIUM USP – 526 mg / GLUCONATE DE
SODIUM - 502 mg / ACETATE DE SODIUM TRIHYDRATE USP – 368 mg
CHLORURE DE POTASSIUM USP – 37 mg / CHLORURE DE MAGNESIUM
HEXAHYDRATE USP – 30 mg / EAU POUR INJECTION USP – qs
LE pH AJUSTE AVEC L’HYDROXYDE DE SODIUM

CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE
AND INSPECT BAG / SEE DIRECTIONS FOR USE / MUST NOT BE
USED IN SERIES CONNECTIONS / STORE AT 15°C TO 25°C

ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE/
PRESSER ET INSPECTER LE SAC / VOIR MODE D’EMPLOI / NE DOIT
PAS ETRE MONTE EN SERIE / GARDER ENTRE ET 15°C ET 25°C

NONPYROGENIC / STERILE / APYROGENE

VIAFLEX PVC CONTAINER / CONTENANT DE PVC

BAXTER PLASMA-LYTE AND VIAFLEX ARE TRADEMARKS OF BAXTER
INTERNATIONAL INC
BAXTER PLASMA-LYTE ET VIAFLEX SONT DES MARQUES DE
COMMERCE DE BAXTER INTERNATIONAL INC

Baxter Logo
Baxter Corporation
Mississauga ON L5C 0C2

No LATEX Label

07-25-77-284

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