FDA Label for Dextrose

Description

5% Dextrose Injection, USP in the MINI-BAG Plus Container is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single dose powdered drug. It contains no antimicrobial agents. Each 100 mL contains 5 g of Dextrose Hydrous, USP. The osmolarity is 252 m0smol/L (calculated). The pH is 4.0 (3.2 to 6.5). The chemical structure for Dextrose Hydrous, USP is shown below.

D-Glucose monohydrate Chemical Structure - image 01

The MINI-BAG Plus Container is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered drug vial having a 20 mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient.

The VIAFLEX plastic Container is fabricated from polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25° C/77° F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. 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

5% Dextrose Injection, USP has value as a source of water and calories. It has a caloric content of approximately 170 kcal/L. It is capable of inducing diuresis depending on the clinical condition of the patient.

Indications And Usage

5% Dextrose Injection, USP is indicated as a source of water and calories and may also be used as diluent for reconstitution of a powdered drug product packaged in a vial with a 20 mm closure.

Contraindications

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

Warnings

Dextrose injections should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutive 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 injections may result in significant hypokalemia.

For use only with a single dose powdered drug vial with a 20 mm closure.

Do not administer unless drug is completely dissolved and drug vial is empty.

Additives may be incompatible.

Do not remove drug vial at any time prior to or during administration.

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

General

Do not administer unless solution is clear and all seals are intact. Dextrose injections should be used with caution in patients with overt or subclinical diabetes mellitus.

Laboratory Tests

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.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies with 5% Dextrose Injection, USP have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Animal reproduction studies have not been conducted with 5% Dextrose Injection, USP. It is also not known whether Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose Injection, USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 5% Dextrose Injection, USP is administered to a nursing woman.

Pediatric Use

Dextrose is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE ). As reported in the literature, the dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

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 MINI-BAG Plus Containers are intended for intravenous administration using sterile equipment.

Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier.

To Open

Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the 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 should diminish gradually.

Prior to use, check that the vial adaptor cover is intact. Check the solution container for minute leaks by squeezing inner bag firmly. If leaks are found or if the vial adaptor cover is not intact, discard product as sterility may be impaired.

To Assemble And Reconstitute

See other side for detailed instructions.

Additives may be incompatible.

How Supplied

5% Dextrose Injection, USP in MINI-BAG Plus Container is available 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/77° F).

Use Aseptic Technique

MINI-BAG PLUS CONTAINER DIRECTIONS - image 02

• 7.Remove port protector. Attach administration set per its directions. (see Dosage and Administration, To Open).
• 8.Hang container on I.V. pole and prime set per directions. Ensure that vial is empty of drug and solution. Repeat step 6 if drug and solution remain in vial.
  Warning: Do not use in series connections.
• 9.Administer medication per directions. Use within specified time for drug stability. Refer to drug package insert.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

Baxter, Mini-Bag Plus, and Viaflex are trademarks of Baxter International Inc.

07-19-72-617
Rev. February 2018

Package Label - Principle Display Panel

5% Dextrose Injection, USP Representative Container Label NDC 0338-0551-11 - image 03

LOT EXP

•  5% Dextrose
  Injection USP

2B0040
NDC 0338-0551-11

MINI-BAG Plus Container

50mL EACH 50 mL CONTAINS 2.5 g DEXTROSE HYDROUS
USP pH 4.0 (3.2 TO 6.5) OSMOLARITY 252
mOsmol/L (CALC) STERILE NONPYROGENIC READ PACKAGE
INSERT FOR FULL INFORMATION ADDITIVES MAY BE INCOMPATIBLE
DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN CAUTIONS
MUST NOT BE USED IN SERIES CONNECTIONS DO NOT ADMINISTER
SIMULTANEOUSLY WITH BLOOD DO NOT USE UNLESS SOLUTION IS
CLEAR RX ONLY

Baxter Logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN USA

VIAFLEX SINGLE DOSE CONTAINER
PL 146 PLASTIC
BAXTER VIAFLEX MINI-BAG
AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

BREAK SEAL AND MIX BEFORE USE

Carton Label

Lot:PXX Exp:XX XX

QTY:80-50mL

Code: 2B0040

NDC: 0338-0551-11

5% DEXTROSE INJECTION, USP

IN MINI-BAG PLUS CONTAINER

(17) XXXX00 (10) PXX

(01) 50303380551113