Plasma-Lyte A (Page 3 of 3)

HOW SUPPLIED

PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in VIAFLEX plastic containers is available as shown below:

Code

Size
(mL)

NDC

2B2544

1000

NDC 0338-0221-04

2B2543

500

NDC 0338-0221-03

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION

To Open

Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration

1.
Suspend container from eyelet support.
2.
Remove protector from outlet port at bottom of container.
3.
Attach administration set. Refer to complete directions accompanying set.

To Add Medication

To add medication before solution administration

1.
Prepare medication site.
2.
Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
3.
Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

1.
Close clamp on the set.
2.
Prepare medication site.
3.
Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
4.
Remove container from IV pole and/or turn to an upright position.
5.
Evacuate both ports by squeezing them while container is in the upright position.
6.
Mix solution and medication thoroughly.
7.
Return container to in use position and continue administration.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-00-1559

Rev. August 2019

Baxter, Plasma-Lyte, Viaflex, and PL 146 are trademarks of Baxter International Inc.

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL

Carton Label
(click image for full-size original)

PLASMA-LYTE® A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) Carton Label

PLASMA-LYTE® A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) Carton Label

2B2544X 14-1000 ML

VIAFLEX® CONTAINER

PLASMA-LYTE® A INJ PH 7.4 (MULTIPLE

ELECTROLYTES INJ, TYPE 1, USP)

EXP

XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT

XXXXX

PRIMARY BAR CODE

(01) 50303380221047

NOTE: YY=Year, MM=Month and date will always be 00. Lot and Exp. Date added at time of printing.

Secondary bar code human readable is variable and will be

added at time of printing. The parenthesis are not

encoded in actual bar code.

Container Label
(click image for full-size original)

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection Type 1 USP) 1000mL Container Label

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection Type 1 USP) 1000mL Container Label

2B2544

NDC 0338-0221-04

Plasma-Lyte A

Injection pH 7.4

(Multiple Electrolytes Injection

Type 1 USP)

1000 mL

Each 100 mL contains 526 mg Sodium Chloride USP 502

mg Sodium Gluconate USP 368 mg Sodium Acetate

Trihydrate USP 37 mg Potassium Chloride USP 30 mg

Magnesium Chloride USP pH adjusted with Sodium

Hydroxide ph 7.4 (6.5 to 8.0) mEq/L Sodium 140

Potassium 5 Magnesium 3 Chloride 98 Acetate 27

Gluconate 23 Osmolarity 294 mOsmol/L (calc) Sterile

Nonpyrogenic Single dose container Additives may be

incompatible Consult with pharmacist if available When

introducing additives use aseptic technique Mix thoroughly

Do not store Dosage Intravenously as directed by a

physician See directions Cautions Squeeze and inspect

inner bag which maintains product sterility Discard if leaks

are found Must not be used in series connections Do not

use unless solution is clear Rx Only Store unit in

moisture barrier overwrap at room temperature

(25°C/77°F) until ready to use Avoid excessive heat See

insert

VIAFLEX container PL 146 plastic

BAXTER PLASMA-LYTE VIAFLEX and PL 146 are

trademarks of Baxter International Inc

For product information 1-800-933-0303

Baxter

Baxter Healthcare Corporation

Deerfield IL 60015 USA

Made in USA

PLASMA-LYTE A
sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0221
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 526 mg in 100 mL
SODIUM GLUCONATE (GLUCONIC ACID and SODIUM CATION) SODIUM GLUCONATE 502 mg in 100 mL
SODIUM ACETATE (ACETATE ION and SODIUM CATION) SODIUM ACETATE 368 mg in 100 mL
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 37 mg in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 30 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0221-03 500 mL in 1 BAG None
2 NDC:0338-0221-04 1000 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017378 02/02/1979
Labeler — Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 059140764 ANALYSIS (0338-0221), LABEL (0338-0221), MANUFACTURE (0338-0221), PACK (0338-0221), STERILIZE (0338-0221)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 194684502 ANALYSIS (0338-0221)

Revised: 08/2019 Baxter Healthcare Corporation

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