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Name:Plasma-lyte 148
Manufacturer:Baxter Healthcare Coporation
Category:Prescription Marketed Drugs


Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP)in VIAFLEX Plastic Container

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

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Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP)
in VIAFLEX Plastic Container

DESCRIPTION

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2•3H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl2•6H2O). It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid. The pH is 5.5 (4.0 to 8.0).

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions may cause vein damage. The caloric content is 21 kcal/L.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) produces a metabolic alkalinizing effect. Acetate and gluconate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

INDICATIONS AND USAGE

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is compatible with blood or blood components. It may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. PLASMA-LYTE 148 Injection and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components.

CONTRAINDICATIONS

None known

WARNINGS

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate or gluconate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.

The intravenous administration of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

In patients with diminished renal function, administration of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) may result in sodium or potassium retention.

PRECAUTIONS

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) should be used with caution. Excess administration may result in metabolic alkalosis.

Caution must be exercised in the administration of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) to patients receiving corticosteroids or corticotropin.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP). It is also not known whether PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

Geriatric Use

Clinical studies of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

Do not administer unless solution is clear and seal is intact.

Drug/Laboratory Test Interactions

There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving Baxter gluconate containing Plasmalyte solutions. These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing Plasmalyte solutions should be interpreted cautiously and confirmed by other diagnostic methods.

ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

DOSAGE AND ADMINISTRATION

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

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

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To Open

Tear overwrap down side at slit and remove solution container. 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 plastic protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Additives may be incompatible.

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

*Bar Code Position Only

071955069

©Copyright 1982, 1983, 1989, 1993, Baxter Healthcare Corporation.

All rights reserved.

07-19-55-069

Rev. December 2007

Baxter, PLASMA-LYTE, VIAFLEX, and PL 146 are
trademarks of Baxter International Inc.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Container Label - 500 mL

Package Label - Container 500 mL

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
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN USA

Carton Label - 500 mL

Package Label - Carton 500 mL

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

LOT
XXXXX

PRIMARY BAR CODE

(01) 50303380179034

Container Label - 1000 mL

Package Label - Container 1000 mL

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
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN USA

Carton Label - 1000 mL

Package Label - Carton 1000 mL

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

LOT
XXXXX

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) SODIUM CHLORIDE 526 mg  in 100 mL
SODIUM GLUCONATE (SODIUM CATION) SODIUM GLUCONATE 502 mg  in 100 mL
SODIUM ACETATE (SODIUM CATION) SODIUM ACETATE 368 mg  in 100 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 37 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 30 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
HYDROCHLORIC ACID  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0338-0179-03 500 mL in 1 BAG None
2 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 Coporation (005083209)
Registrant - Baxter Healthcare Coporation (005083209)
Establishment
Name Address ID/FEI Operations
BAXTER HEALTHCARE CORPORATION 059140764 MANUFACTURE

Revised: 06/2009 Baxter Healthcare Coporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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