Plasma-Lyte 56 and Dextrose
 Plasma-Lyte M and Dextrose

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Plasma-Lyte 56 and Dextrose


Generic Name: Multiple Electrolytes and Dextrose Injection, Type 1, USP
Dosage Form: Injection

Plasma-Lyte 56 and Dextrose Description

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 234 mg Sodium Chloride, USP (NaCl); 128 mg Potassium Acetate, USP (C2H3KO2); and 32 mg Magnesium Acetate, Tetrahydrate (C4H6MgO4•4H2O). It contains no antimicrobial agents. pH 5.0 (4.0 to 6.5). The pH is adjusted with hydrochloric acid.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 40 mEq sodium, 13 mEq potassium, 3 mEq magnesium, 40 mEq chloride, and 16 mEq acetate. The osmolarity is 363 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 170 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 may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Plasma-Lyte 56 and Dextrose - Clinical Pharmacology

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) has value as a source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) produces a metabolic alkalinizing effect. Acetate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Indications and Usage for Plasma-Lyte 56 and Dextrose

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.

Contraindications

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose 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® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose 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® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate 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.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.

The intravenous administration of Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose 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® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) may result in sodium or potassium retention.

GENERAL 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® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose 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® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) to patients receiving corticosteroids or corticotropin.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with caution in patients with overt or subclinical diabetes mellitus.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP). It is also not known whether Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in pediatric patients have not been established by adequate and well controlled trials, however, the use of plasmalyte and dextrose 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.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible hemorrhage.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies with Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is administered to a nursing mother.

Geriatric Use

Clinical studies of Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose 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.

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.

Plasma-Lyte 56 and Dextrose 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.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

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 is Plasma-Lyte 56 and Dextrose Supplied

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in Viaflex® plastic containers is available as shown below:

Code Size (mL) NDC
2B2573 500 NDC 0338-0147-03
2B2574 1000 NDC 0338-0147-04

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 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

©Copyright 1982, 1983, 1984, 1989, 1994, Baxter Healthcare Corporation.

All rights reserved.

7-19-22-966


Plasma-Lyte 56 and Dextrose (Sodium chloride, potassium acetate, magnesium acetate and dextrose)
PRODUCT INFO
Product Code 0338-0147 Dosage Form INJECTION, SOLUTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Dextrose hydrous (dextrose) Active 5.00 GRAM  In 100.00 MILLILITER
Sodium Chloride (Sodium Chloride) Active 234.00 MILLIGRAM  In 100.00 MILLILITER
Potassium Acetate (Potassium Acetate) Active 128.00 MILLIGRAM  In 100.00 MILLILITER
Magnesium Acetate Tetrahydrate (Magnesium Acetate Tetrahydrate) Active 32.00 MILLIGRAM  In 100.00 MILLILITER
Water Inactive  
Hydrochloric acid Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0147-04 1000.00 MILLILITER In 1 BAG None
2 0338-0147-03 500.00 MILLILITER In 1 BAG None

Revised: 05/2006





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plasma-lyte m and dextrose, plasma-yte 56 and dextrose plasma-lyte m and dextrose, plasma-lte 56 and dextrose plasma-lyte m and dextrose, plasma-lye 56 and dextrose plasma-lyte m and dextrose, plasma-lyt 56 and dextrose plasma-lyte m and dextrose, plasma-lyte56 and dextrose plasma-lyte m and dextrose, plasma-lyte 6 and dextrose plasma-lyte m and dextrose, plasma-lyte 5 and dextrose plasma-lyte m and dextrose, plasma-lyte 56and dextrose plasma-lyte m and dextrose, plasma-lyte 56 nd dextrose plasma-lyte m and dextrose, plasma-lyte 56 ad dextrose plasma-lyte m and dextrose, plasma-lyte 56 an dextrose plasma-lyte m and dextrose, plasma-lyte 56 anddextrose plasma-lyte m and dextrose, plasma-lyte 56 and extrose plasma-lyte m and dextrose, plasma-lyte 56 and dxtrose plasma-lyte m and dextrose, plasma-lyte 56 and detrose plasma-lyte m and dextrose, plasma-lyte 56 and dexrose plasma-lyte m and dextrose, plasma-lyte 56 and dextose plasma-lyte m and dextrose, plasma-lyte 56 and dextrse plasma-lyte m and dextrose, plasma-lyte 56 and dextroe plasma-lyte m and dextrose, plasma-lyte 56 and dextros plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose lasma-lyte m and dextrose, plasma-lyte 56 and dextrose pasma-lyte m and dextrose, plasma-lyte 56 and dextrose plsma-lyte m and dextrose, plasma-lyte 56 and dextrose plama-lyte m and dextrose, plasma-lyte 56 and dextrose plasa-lyte m and dextrose, plasma-lyte 56 and dextrose plasm-lyte m and dextrose, plasma-lyte 56 and dextrose plasmalyte m and dextrose, plasma-lyte 56 and dextrose plasma-yte m and dextrose, plasma-lyte 56 and dextrose plasma-lte m and dextrose, plasma-lyte 56 and dextrose plasma-lye m and dextrose, plasma-lyte 56 and dextrose plasma-lyt m and dextrose, plasma-lyte 56 and dextrose plasma-lytem and dextrose, plasma-lyte 56 and dextrose plasma-lyte and dextrose, plasma-lyte 56 and dextrose plasma-lyte mand dextrose, plasma-lyte 56 and dextrose plasma-lyte m nd dextrose, plasma-lyte 56 and dextrose plasma-lyte m ad dextrose, plasma-lyte 56 and dextrose plasma-lyte m an dextrose, plasma-lyte 56 and dextrose plasma-lyte m anddextrose, plasma-lyte 56 and dextrose plasma-lyte m and extrose, plasma-lyte 56 and dextrose plasma-lyte m and dxtrose, plasma-lyte 56 and dextrose plasma-lyte m and detrose, plasma-lyte 56 and dextrose plasma-lyte m and dexrose, plasma-lyte 56 and dextrose plasma-lyte m and dextose, plasma-lyte 56 and dextrose plasma-lyte m and dextrse, plasma-lyte 56 and dextrose plasma-lyte m and dextroe, plasma-lyte 56 and dextrose plasma-lyte m and dextros, lpasma-lyte 56 and dextrose plasma-lyte m and dextrose, palsma-lyte 56 and dextrose plasma-lyte m and dextrose, plsama-lyte 56 and dextrose plasma-lyte m and dextrose, plamsa-lyte 56 and dextrose plasma-lyte m and dextrose, plasam-lyte 56 and dextrose plasma-lyte m and dextrose, plasm-alyte 56 and dextrose plasma-lyte m and dextrose, plasmal-yte 56 and dextrose plasma-lyte m and dextrose, plasma-ylte 56 and dextrose plasma-lyte m and dextrose, plasma-ltye 56 and dextrose plasma-lyte m and dextrose, plasma-lyet 56 and dextrose plasma-lyte m and dextrose, plasma-lyt e56 and dextrose plasma-lyte m and dextrose, plasma-lyte5 6 and dextrose plasma-lyte m and dextrose, plasma-lyte 65 and dextrose plasma-lyte m and dextrose, plasma-lyte 5 6and dextrose plasma-lyte m and dextrose, plasma-lyte 56a nd dextrose plasma-lyte m and dextrose, plasma-lyte 56 nad dextrose plasma-lyte m and dextrose, plasma-lyte 56 adn dextrose plasma-lyte m and dextrose, plasma-lyte 56 an ddextrose plasma-lyte m and dextrose, plasma-lyte 56 andd extrose plasma-lyte m and dextrose, plasma-lyte 56 and edxtrose plasma-lyte m and dextrose, plasma-lyte 56 and dxetrose plasma-lyte m and dextrose, plasma-lyte 56 and detxrose plasma-lyte m and dextrose, plasma-lyte 56 and dexrtose plasma-lyte m and dextrose, plasma-lyte 56 and dextorse plasma-lyte m and dextrose, plasma-lyte 56 and dextrsoe plasma-lyte m and dextrose, plasma-lyte 56 and dextroes plasma-lyte m and dextrose, plasma-lyte 56 and dextros e plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose p lasma-lyte m and dextrose, plasma-lyte 56 and dextrose lpasma-lyte m and dextrose, plasma-lyte 56 and dextrose palsma-lyte m and dextrose, plasma-lyte 56 and dextrose plsama-lyte m and dextrose, plasma-lyte 56 and dextrose plamsa-lyte m and dextrose, plasma-lyte 56 and dextrose plasam-lyte m and dextrose, plasma-lyte 56 and dextrose plasm-alyte m and dextrose, plasma-lyte 56 and dextrose plasmal-yte m and dextrose, plasma-lyte 56 and dextrose plasma-ylte m and dextrose, plasma-lyte 56 and dextrose plasma-ltye m and dextrose, plasma-lyte 56 and dextrose plasma-lyet m and dextrose, plasma-lyte 56 and dextrose plasma-lyt em and dextrose, plasma-lyte 56 and dextrose plasma-lytem and dextrose, plasma-lyte 56 and dextrose plasma-lyte mand dextrose, plasma-lyte 56 and dextrose plasma-lyte ma nd dextrose, plasma-lyte 56 and dextrose plasma-lyte m nad dextrose, plasma-lyte 56 and dextrose plasma-lyte m adn dextrose, plasma-lyte 56 and dextrose plasma-lyte m an ddextrose, plasma-lyte 56 and dextrose plasma-lyte m andd extrose, plasma-lyte 56 and dextrose plasma-lyte m and edxtrose, plasma-lyte 56 and dextrose plasma-lyte m and dxetrose, plasma-lyte 56 and dextrose plasma-lyte m and detxrose, plasma-lyte 56 and dextrose plasma-lyte m and dexrtose, plasma-lyte 56 and dextrose plasma-lyte m and dextorse, plasma-lyte 56 and dextrose plasma-lyte m and dextrsoe, plasma-lyte 56 and dextrose plasma-lyte m and dextroes, pplasma-lyte 56 and dextrose plasma-lyte m and dextrose, pllasma-lyte 56 and dextrose plasma-lyte m and dextrose, plaasma-lyte 56 and dextrose plasma-lyte m and dextrose, plassma-lyte 56 and dextrose plasma-lyte m and dextrose, plasmma-lyte 56 and dextrose plasma-lyte m and dextrose, plasmaa-lyte 56 and dextrose plasma-lyte m and dextrose, plasma--lyte 56 and dextrose plasma-lyte m and dextrose, plasma-llyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyyte 56 and dextrose plasma-lyte m and dextrose, plasma-lytte 56 and dextrose plasma-lyte m and dextrose, plasma-lytee 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 556 and dextrose plasma-lyte m and dextrose, plasma-lyte 566 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 aand dextrose plasma-lyte m and dextrose, plasma-lyte 56 annd dextrose plasma-lyte m and dextrose, plasma-lyte 56 andd dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and ddextrose plasma-lyte m and dextrose, plasma-lyte 56 and deextrose plasma-lyte m and dextrose, plasma-lyte 56 and dexxtrose plasma-lyte m and dextrose, plasma-lyte 56 and dexttrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrrose plasma-lyte m and dextrose, plasma-lyte 56 and dextroose plasma-lyte m and dextrose, plasma-lyte 56 and dextrosse plasma-lyte m and dextrose, plasma-lyte 56 and dextrosee plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose pplasma-lyte m and dextrose, plasma-lyte 56 and dextrose pllasma-lyte m and dextrose, plasma-lyte 56 and dextrose plaasma-lyte m and dextrose, plasma-lyte 56 and dextrose plassma-lyte m and dextrose, plasma-lyte 56 and dextrose plasmma-lyte m and dextrose, plasma-lyte 56 and dextrose plasmaa-lyte m and dextrose, plasma-lyte 56 and dextrose plasma--lyte m and dextrose, plasma-lyte 56 and dextrose plasma-llyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyyte m and dextrose, plasma-lyte 56 and dextrose plasma-lytte m and dextrose, plasma-lyte 56 and dextrose plasma-lytee m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte mm and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m aand dextrose, plasma-lyte 56 and dextrose plasma-lyte m annd dextrose, plasma-lyte 56 and dextrose plasma-lyte m andd dextrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrose, plasma-lyte 56 and dextrose plasma-lyte m and ddextrose, plasma-lyte 56 and dextrose plasma-lyte m and deextrose, plasma-lyte 56 and dextrose plasma-lyte m and dexxtrose, plasma-lyte 56 and dextrose plasma-lyte m and dexttrose, plasma-lyte 56 and dextrose plasma-lyte m and dextrrose, plasma-lyte 56 and dextrose plasma-lyte m and dextroose, plasma-lyte 56 and dextrose plasma-lyte m and dextrosse, plasma-lyte 56 and dextrose plasma-lyte m and dextrosee, etc.



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