FDA Label for Plasma-lyte A
View Indications, Usage & Precautions
Plasma-lyte A Product Label
The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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