Plasma-lyte A Injection

Plasma-lyte A Injection
SPL v2
SPL
SPL Set ID aa35e576-d939-47c2-a9d1-8638e261f51c
Route
INTRAVENOUS
Published
Effective Date 2024-10-14
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (526 mg) Sodium Cation (502 ug)
Inactive Ingredients
Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Active Since 2024-11-06

Description

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


Medication Information

Description

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

Health Care Provider Letter
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

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2

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3

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4

_

5

_

6

_

7

_

8

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9


Structured Label Content

Health Care Provider Letter
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


Advanced Ingredient Data


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