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DEXTROSE AND SODIUM CHLORIDE injection, solution
[Baxter Healthcare Corporation]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL New Drug Application
Drug Label Sections

DESCRIPTION

Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

Table 1
*
Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions ( ≥ 600 mOsmol/L) may cause vein damage.
Size (mL)Composition (g/L)*Osmolarity (mOsmol/L) (calc.)pHIonic Concentration (mEq/L)Caloric Content (kcal/L)
**Dextrose Hydrous, USPSodium Chloride, USP (NaCl)SodiumChloride
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP500 1000254.52804.5
(3.2 to 6.5)		777785
5% Dextrose and 0.2% Sodium Chloride Injection, USP250 500 10005023214.0
(3.2 to 6.5)		3434170
5% Dextrose and 0.33% Sodium Chloride Injection, USP250 500 1000503.33654.0
(3.2 to 6.5)		5656170
5% Dextrose and 0.45% Sodium Chloride Injection, USP250 500 1000504.54064.0
(3.2 to 6.5)		7777170
5% Dextrose and 0.9% Sodium Chloride Injection, USP250 500 10005095604.0
(3.2 to 6.5)		154154170
10% Dextrose and 0.9% Sodium Chloride Injection, USP500 100010098134.0
(3.2 to 6.5)		154154340
Chemical Structure

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

Dextrose and Sodium Chloride Injection, 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.

INDICATIONS AND USAGE

Dextrose and Sodium Chloride Injection, USP is indicated as a source of water, electrolytes, and calories.

CONTRAINDICATIONS

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

WARNINGS

Dextrose and Sodium Chloride Injection, 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.

Dextrose injections with low electrolyte concentrations should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. The container label for these injections bears the statement: Do not administer simultaneously with blood.

The intravenous administration of Dextrose and Sodium Chloride Injection, 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 injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

Excessive administration of Dextrose and Sodium Chloride Injection, USP may result in significant hypokalemia.

In patients with diminished renal function, administration of Dextrose and Sodium Chloride Injection, USP may result in sodium retention.

PRECAUTIONS

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.Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

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.

Caution must be exercised in the administration of Dextrose and Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

Dextrose and Sodium Chloride Injection, 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 Dextrose and Sodium Chloride Injection, USP. It is also not known whether Dextrose and Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose and Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of Dextrose and Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of dextrose and sodium chloride 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.

Newborns – especially those born premature and with low birth weight – are at increased risk of developing hypo– or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

The infusion of hypotonic fluids together with the non-osmotic secretion of ADH may result in hyponatremia. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency (applies to solutions containing less than 0.9% sodium chloride).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Dextrose and Sodium Chloride Injection, 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 Dextrose and Sodium Chloride Injection, USP is administered to a nursing mother.

Geriatric Use

Clinical studies of Dextrose and Sodium Chloride Injection, 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 other drug therapy.

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

ADVERSE REACTIONS

- Anaphylactic reaction, hypersensitivity, and chills

- Hyponatremia (applies to solutions containing less than 0.9% Sodium Chloride)

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.

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. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

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

Dextrose and Sodium Chloride Injection, USP in VIAFLEX plastic container is supplied as follows:

CodeSize (mL)NDCProduct Name
2B10235000338-0073-032.5% Dextrose and 0.45% Sodium Chloride Injection, USP
2B102410000338-0073-04
2B10922500338-0077-025% Dextrose and 0.2% Sodium Chloride Injection, USP
2B10935000338-0077-03
2B109410000338-0077-04
2B10822500338-0081-025% Dextrose and 0.33% Sodium Chloride Injection, USP
2B10835000338-0081-03
2B108410000338-0081-04
2B10722500338-0085-025% Dextrose and 0.45% Sodium Chloride Injection, USP
2B10735000338-0085-03
2B107410000338-0085-04
2B10622500338-0089-025% Dextrose and 0.9% Sodium Chloride Injection, USP
2B10635000338-0089-03
2B106410000338-0089-04
2B11635000338-0095-0310% Dextrose and 0.9% Sodium Chloride Injection, USP
2B116410000338-0095-04

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

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

*For Bar Code Position Only
071970015

07-19-70-015 Rev. December 2012

BAXTER, VIAFLEX and PL 146 are trademarks of
Baxter International Inc.

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

Container Label

5% Dextrose and 0.9% Sodium Chloride Injection USP, 500mL Container Label

2B1063Q 24-500 ML

VIAFLEX® CONTAINER

5% DEXTROSE AND

0.9% SODIUM CHLORIDE INJ, USP

EXP

XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT

XXXXX

PRIMARY BAR CODE

(01) 50303380089036

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 parentheses are not encoded in actual bar code.

Carton Label

5% Dextrose and 0.9% Sodium Chloride Injection USP, 500mL Carton Label

2B1063

NDC 0338-0089-03

5% Dextrose and

0.9% Sodium Chloride

Injection USP

500 mL

EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP

900 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5)

mEq/L SODIUM 154 CHLORIDE 154 HYPERTONIC

OSMOLARITY 560 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 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

DEXTROSE AND SODIUM CHLORIDE 
dextrose and sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0338-0073
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE450 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:0338-0073-03500 mL in 1 BAG
2NDC:0338-0073-041000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01669703/22/1971
DEXTROSE AND SODIUM CHLORIDE 
dextrose and sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0338-0077
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE200 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:0338-0077-02250 mL in 1 BAG
2NDC:0338-0077-03500 mL in 1 BAG
3NDC:0338-0077-041000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01668912/08/1970
DEXTROSE AND SODIUM CHLORIDE 
dextrose and sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0338-0081
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE330 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:0338-0081-02250 mL in 1 BAG
2NDC:0338-0081-03500 mL in 1 BAG
3NDC:0338-0081-041000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01668703/22/1971
DEXTROSE AND SODIUM CHLORIDE 
dextrose and sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0338-0085
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE450 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:0338-0085-02250 mL in 1 BAG
2NDC:0338-0085-03500 mL in 1 BAG
3NDC:0338-0085-041000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01668303/22/1971
DEXTROSE AND SODIUM CHLORIDE 
dextrose and sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0338-0089
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE900 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:0338-0089-02250 mL in 1 BAG
2NDC:0338-0089-03500 mL in 1 BAG
3NDC:0338-0089-041000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01667812/09/1970
DEXTROSE AND SODIUM CHLORIDE 
dextrose and sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0338-0095
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE10 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE900 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:0338-0095-03500 mL in 1 BAG
2NDC:0338-0095-041000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01669603/22/1971
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Corporation059140764MANUFACTURE(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095), ANALYSIS(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095), LABEL(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095), PACK(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095), STERILIZE(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095)

Revised: 02/2013
Document Id: 0f757dc5-d8cb-4a3a-b227-bc925bdcd749
Set id: dcbf1907-1841-4afc-ab5d-a9893a2d7256
Version: 2
Effective Time: 20130205
 
Baxter Healthcare Corporation

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