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Dextrose and Sodium Chloride Injection, USP in VIAFLEX Plastic Container | Dextrose and Sodium Chloride [Baxter Healthcare Corporation] | BioPortfolio

12:50 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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.

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.

Table 1.
Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.Osmolarity (mOsmol/L) (calc.) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L)
**Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Chloride
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 1000 25 4.5 280 4.5
(3.2 to 6.5)
77 77 85
5% Dextrose and 0.2% Sodium Chloride Injection, USP 250 500 1000 50 2 321 4.0
(3.2 to 6.5)
34 34 170
5% Dextrose and 0.33% Sodium Chloride Injection, USP 500 50 3.3 365 4.0
(3.2 to 6.5)
56 56 170
5% Dextrose and 0.45% Sodium Chloride Injection, USP 250 500 1000 50 4.5 406 4.0
(3.2 to 6.5)
77 77 170
5% Dextrose and 0.9% Sodium Chloride Injection, USP 250 500 1000 50 9 560 4.0
(3.2 to 6.5)
154 154 170

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.

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

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

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.

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.

Dextrose and Sodium Chloride Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

Administration of hypertonic solutions may cause venous irritation, including phlebitis. Hyperosmolar solutions should be administered with caution, if at all, to patients with hyperosmolar states. See Table 1.in the DESCRIPTION section for the osmolarities of the Dextrose and Sodium Chloride Injection, USP solutions.

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.

Studies with Dextrose and Sodium Chloride Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

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.

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.

The Use of Dextrose and Sodium Chloride, USP in pediatric patients is based on clinical practice.

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).

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.

- 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.

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.

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.

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

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.

Code Size (mL) NDC Product Name
2B1024 1000 0338-0073-04 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP
2B1092 250 0338-0077-02 5% Dextrose and 0.2% Sodium Chloride Injection, USP
2B1093 500 0338-0077-03
2B1094 1000 0338-0077-04
2B1083 500 0338-0081-03 5% Dextrose and 0.33% Sodium Chloride Injection, USP
2B1073 500 0338-0085-03 5% Dextrose and 0.45% Sodium Chloride Injection, USP
2B1074 1000 0338-0085-04
2B1063 500 0338-0089-03 5% Dextrose and 0.9% Sodium Chloride Injection, USP
2B1064 1000 0338-0089-04

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.

WARNING

Additives may be incompatible.

Baxter Healthcare Corporation Deerfield, IL 60015 USA

Printed in USA

Distributed in Canada byBaxter Corporation Mississauga, ON L5N 0C2

07-19-00-0209 Rev.February 2018

Baxter, and Viaflex are trademarks of Baxter International Inc.

Container Label

LOT EXP

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) STERILENONPYROGENIC 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 Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN USA

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Carton 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

Container Label

LOT EXP

2B1024 NDC 0338-0073-04

2.5% Dextrose and 0.45% Sodium Chloride Injection USP

1000 mL

EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP 450 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 77 CHLORIDE 77 OSMOLARITY 280 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 OFBAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USAMADE IN USA

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Carton Label

2B1024X 14-1000 ML

VIAFLEX® CONTAINER

2.5% DEXTROSE AND0.45% SODIUM CHLORIDE INJ, USP

EXPXXXXX

SECONDARY BAR CODE(17) XXXXX (10) XXXXX

LOTXXXXX

PRIMARY BAR CODE(01) 50303380073042

Container Label

LOT EXP

2B1092 NDC 0338-0077-02

5% Dextrose and 0.2% Sodium Chloride Injection USP

250 mL EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP 200 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 34 CHLORIDE 34 OSMOLARITY 321 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 Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USAMADE IN USA

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100

150

200

Carton Label

Carton Label

2B1092Q 36-250 ML

VIAFLEX® CONTAINER

5% DEXTROSE AND0.2% SODIUM CHLORIDE INJ, USP

EXPXXXXX

SECONDARY BAR CODE(17) YYMM00 (10) XXXXX

LOTXXXXX

PRIMARY BAR CODE(01) 50303380077026

Container Label

Container Label

LOT EXP

2B1083 NDC 0338-0081-03

5% Dextrose and 0.33% Sodium Chloride Injection USP

500 mL

EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP 330 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 56 CHLORIDE 56 OSMOLARITY 356 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 T 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 OFBAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

Baxter Logo BAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USA

MADE IN USA

07-25-34-096

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Carton Label

2B1083Q 24-500 ML

VIAFLEX® CONTAINER

5% DEXTROSE AND 0.33% SODIUM CHLORIDE INJ, USP

EXPXXXXX

SECONDARY BAR CODE(17) XXXXX (10) XXXXX

LOTXXXXX

PRIMARY BAR CODE(01) 50303380081030

Container Label

LOT EXP

2B1073 NDC 0338-0085-03

5% Dextrose and 0.45% Sodium Chloride Injection USP

500 mL

EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP 450 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 77 CHLORIDE 77 HYPERTONIC OSMOLARITY 406 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 Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN USA

1

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Carton Label

2B1073Q 24-500 ML

VIAFLEX® CONTAINER

5% DEXTROSE AND0.45% SODIUM CHLORIDE INJ, USP

EXPXXXXX

SECONDARY BAR CODE(17) YYMM00 (10) XXXXX

LOTXXXXX

PRIMARY BAR CODE(01) 50303380085038

Manufacturer

Baxter Healthcare Corporation

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