Label: PLASMA-LYTE 148 (PH 7.4)- sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride injection, solution
- NDC Code(s): 0338-9593-01, 0338-9593-10
- Packager: Baxter Healthcare Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Unapproved drug for use in drug shortage
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 8, 2024
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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/)
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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 Hydroxidemmol per 100 mL (approx)
Sodium 140 Chloride 98
Potassium 5 Acetate 27
Magnesium 1.5 Gluconate 23IV 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 30oCPOM
07
0UN-35-03-560
1Marketing Authorization Holder:
Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP 24 3SE
United KingdomManufacturer:
Bieffe Medital S.A.Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
SpainLOT
EXP
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INGREDIENTS AND APPEARANCE
PLASMA-LYTE 148 (PH 7.4)
sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride injection, solutionProduct 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)
