Plasma-Lyte 148 (Page 3 of 3)

HOW SUPPLIED

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in VIAFLEX plastic containers is available as shown below:

Code	Size (mL)	NDC
2B2534	1000	NDC 0338-0179-04
2B2533	500	NDC 0338-0179-03

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 PRECAUTIONS

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

07-19-00-1558

Rev. August 2019

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

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL

500 mL Container Label

500 mL Container Label

2B2533

NDC 0338-0179-03

PLASMA-LYTE 148
Injection

(Multiple Electrolytes Injection
Type 1 USP)

500 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 HYDROCHLORIC ACID pH 5.5
(4.0 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

FOR PRODUCT INFORMATION
1-800-933-0303

BAXTER PLASMA-LYTE VIAFLEX
AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

Baxter logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USAMADE IN USA

500 mL Viaflex Carton Label

500 mL Viaflex Carton Label

2B2533Q

24-500 ML

VIAFLEX CONTAINER

PLASMA-LYTE 148 INJECTION (MULTIPLE
ELECTROLYTES INJECTION, TYPE 1, USP)

EXP
XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOTXXXXX

PRIMARY BAR CODE

(01) 50303380179034

1000 mL Container Label

1000 mL Container Label

LOT

EXP

2B2534

NDC 0338-0179-04

Plasma-Lyte
148 Injection

(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 HYDROCHLORIC
ACID pH 5.5 (4.0 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 logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USAMADE IN USA

1000 mL Viaflex Carton Label

1000 mL Viaflex Carton Label

2B2534X

14-1000 ML
VIAFLEX® CONTAINER

PLASMA-LYTE® 148 INJECTION
(MULTIPLE ELECTROLYTES INJ, TYPE 1, USP)

EXP
XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOTXXXXX

PRIMARY BAR CODE

(01) 50303380179041

PLASMA-LYTE 148 sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0179 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 HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0338-0179-03 500 mL in 1 BAG None 2 NDC:0338-0179-04 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)

Registrant — Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Operations
Baxter Healthcare Corporation		059140764	ANALYSIS (0338-0179), MANUFACTURE (0338-0179), LABEL (0338-0179), PACK (0338-0179), STERILIZE (0338-0179)

Establishment
Name	Address	ID/FEI	Operations
Baxter Healthcare Corporation		194684502	ANALYSIS (0338-0179)

Revised: 08/2019 Baxter Healthcare Corporation