PLASMA-LYTE 148 (PH 7.4)- sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride injection, solution

Plasma-Lyte 148 (pH 7.4) by

Drug Labeling and Warnings

Plasma-Lyte 148 (pH 7.4) by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Bieffe Medital SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Healthcare Professional Letter

Please refer to the FDA-approved prescribing information for the drug product listed below:
Plasma-Lyte A Injection pH 7.4 (click here)

Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
Regular mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).

To report product quality issues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (https://productfeedback.baxter.com/)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

Baxter

Viaflo

GCCE0324

1000 mL

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Plasma-Lyte 148
(pH 7.4)

Solution for Infusion

pH 6.5 – 8.0
Isotonic
Osmolarity 295 m0sm/l (approx)

Formula per 1000ml
Sodium Chloride5.26 g
Potassium Chloride 0.37 g
Magnesium Chloride hexahydrate 0.30 g
Sodium Acetate trihydrate3.68 g
Sodium Gluconate5.02 g
Water for Injections
Sodium Hydroxide

mmol per 100 mL (approx)
Sodium 140 Chloride 98
Potassium 5 Acetate 27
Magnesium 1.5 Gluconate 23

IV administration
Read package leaflet before use
Keep out of the sight and reach of children
Do not remove from overwrap until ready for use
Do not use unless solution is clear without visible particles
and container undamaged
Do not reconnect partially used bags
Store below 30oC

POM
07
0

UN-35-03-560
1

Marketing Authorization Holder:
Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP 24 3SE
United Kingdom

Manufacturer:
Bieffe Medital S.A.

Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain

LOT

EXP

INGREDIENTS AND APPEARANCE

PLASMA-LYTE 148 (PH 7.4) 
sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9593
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	526 mg  in 100 mL
SODIUM GLUCONATE (UNII: R6Q3791S76) (GLUCONIC ACID - UNII:R4R8J0Q44B, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM GLUCONATE	502 mg  in 100 mL
SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM ACETATE	368 mg  in 100 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	37 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	30 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9593-10	10 in 1 CARTON	11/08/2024
1	NDC: 0338-9593-01	1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		11/08/2024

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Bieffe Medital SA		464755693	ANALYSIS(0338-9593) , LABEL(0338-9593) , MANUFACTURE(0338-9593) , PACK(0338-9593) , STERILIZE(0338-9593)