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FDA Drug information

Lactated Ringers

Read time: 1 mins
Marketing start date: 12 Jan 2025
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Summary of product characteristics


Effective Time

20241202

Version

2

Spl Product Data Elements

Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION WATER Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION WATER

Brand Name

Lactated Ringers

Generic Name

Sodium chloride, potassium chloride, sodium lactate and calcium chloride

Product Ndc

0338-9600

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label JB2324 1000 mL DIN 00061085 Lactated Ringer’s Injection USP Lactate de Ringer USP, Injectable Lactated Ringer Lactate de Ringer APPROX mmol/L Na – 130 K – 4 Ca – 1.4 CI – 109 LACTATE – 28 mOsmol/L – 272 pH 6.5 INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT RETABLISSEMENT HYDRO-ELECTROLYTIQUE PAR INJECTION INTRAVENIEUSE PER 100 mL SODIUM CHLORIDE USP – 600 mg / SODIUM LACTATE – 310 mg / POTASSIUM CHLORIDE USP – 30 mg / CALCIUM CHLORIDE DIHYDRATE USP – 20 mg / WATER FOR INJECTION USP – qs PAR 100 mL CHLORURE DE SODIUM USP – 600 mg / LACTATE DE SO- DIUM – 310 mg / CHLORURE DE POTASSIUM USP – 30 mg / DIHYDRATE DE CHLORURE DE CALCIUM USP – 20 mg / EAU POUR INJECTION USP – qs CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE / NOT FOR USE IN THE TREATEMENT OF LACTIC ACIDOSIS / MUST NOT BE USED IN SERIES CONNECTIONS / DO NOT ADMINSTER SIMULTANEOUSLY WITH BLOOD STORE AT 15°C TO 25°C ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER ET INSPECTER LE SAC / VOIR MODE D’EMPLOI / NE PAS UTILISER DANS LE TRAITEMENT DE L’ACIDOSE LACTIQUE / NE DOIT PAS ETRE MONTE EN SERIE / NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG GARDER ENTRE 15°C ET 25°C NONPYROGENIC / STERILE / APYROGENE VIAFLEX PVC CONTAINER / CONTENANT DE PVC BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No Latex Label 88-70-20-487 1 _ 2 _ 3 _ 4 _ 5 _ 6 _ 7 _ 8 _ 9 Container Label JB2323 500 mL DIN 00061085 Lactated Ringer’s Injection USP Lactate de Ringer USP, Injectable Lactated Ringer Lactate de Ringer APPROX mmol/L Na – 130 K – 4 Ca – 1.4 CI 109 LACTATE – 28 mOsmol/L – 272 pH 6.5 INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT / RETABLISSE- MENT HYDRO-ELECTROLYTIQUE PAR INJECTION INTRAVENIEUSE PER 100 mL SODIUM CHLORIDE USP – 600 mg / SODIUM LACTATE – 310 mb / PO- TASSIUM CHLORIDE USP – 30 mg / CALCIUM CHLORIDE DIHYDRATE USP – 20 mg / WATER FOR INJECTION USP – qs PAR 100 mL CHLORURE DE SODIUM USP – 600 mg / LACTATE DE SODIUM – 310 mg / CHLORURE DE POTASSIUM USP – 30 mg / DIHYDRATE DECHLORURE DE CALCIUM USP – 20 mg / EAU POUR INJECTION USP – qs CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE / NOT FOR USE IN THE TREATEMENT OF LACTIC ACIDOSIS / MUST NOT BE USED IN SERIES CONNECTIONS / DO NOT ADMINSTER SIMULTANEOUSLY WITH BLOOD STORE AT 15°C TO 25°C ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER ET INSPECT- ER LE SAC / VOIR MODE D’EMPLOI / NE PAS UTILISER DANS LE TRAITEMENT DE L’ACIDOSE LACTIQUE / NE DOIT PAS ETRE MONTE EN SERIE / NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG GARDER ENTRE 15°C ET 25°C NONPYROGENIC / STERILE / APYROGENE VIAFLEX PVC CONTAINER / CONTENANT DE PVC BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No Latex Label 07-25-77-062 -1- _ -2- _ -3- _ -4- Container Label NDC 0338-9600-01 Container Label NDC 0338-9596-01

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