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FDA Drug information

Plasma-Lyte A

Read time: 1 mins
Marketing start date: 26 Jan 2025
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Summary of product characteristics


Effective Time

20241014

Version

1

Spl Product Data Elements

Plasma-Lyte A Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM GLUCONATE GLUCONIC ACID SODIUM CATION SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER SODIUM HYDROXIDE

Brand Name

Plasma-Lyte A

Generic Name

Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride

Product Ndc

0338-9591

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 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 1 _ 2 _ 3 _ 4 _ 5 _ 6 _ 7 _ 8 _ 9 Container Label 0338-9591-01

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