Veterinary 5% Dextrose Injection, USP

Manufacturer
Zoetis Inc. | Baxter Healthcare Corporation
Effective date
2016-08-09
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:39:59

Label at a glance#

ProductVeterinary Dextrose
Active ingredientDEXTROSE MONOHYDRATE
Label structure13 sections

Indications and uses

5% Dextrose Injection, USP is indicated as a source of water and calories.

Dosage and administration

As directed by a veterinarian. 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 plastic containers are intended for intravenous administration using sterile equipment. Addi...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For Animal Use Only

Description

DESCRIPTION SECTION

5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents.
Discard unused portion. Composition, osmolarity, pH, and caloric content are shown in table 1.

Table 1
Table 1
Structural Formula
Structural Formula

The plastic container is fabricated from a specially formulated polyvinyl chloride. 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 test for plastic containers as well as by tissue culture toxicity studies.

Clinical Pharmacology

CLINICAL PHARMACOLOGY SECTION

5% Dextrose Injection, USP has value as a source of water and calories.
It is capable of inducing diuresis depending on the clinical condition of the patient.

Indications and Usage

INDICATIONS & USAGE SECTION

5% Dextrose Injection, USP is indicated as a source of water and calories.

Contraindications

CONTRAINDICATIONS SECTION

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

Warnings

WARNINGS SECTION

5% Dextrose Injection, 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 5% Dextrose 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 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.

Adverse Reactions

ADVERSE REACTIONS SECTION

Reactions which may occur because of the injection 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.

Precautions

PRECAUTIONS SECTION

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.

5% Dextrose Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

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

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

As directed by a veterinarian. 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 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 veterinarian, if available. If, in the informed judgment of the veterinarian, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced.
Do not store solutions containing additives.

OverDosage

OVERDOSAGE SECTION

In an event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See Warnings , Precautions  and Adverse Events .

How Supplied

HOW SUPPLIED SECTION

5% Dextrose Injection, USP in plastic container is available as follows:

    Size (mL)     Code             
   1000             2B8264         

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); brief exposure up to 40°C/104°F does not adversely affect the product.

Directions for Use of plastic container

SPL UNCLASSIFIED SECTION

To Open

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.

.

Preparation for Administration
1. Suspend container from eyelet support.
2. Remove 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.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Manufactured for:

Zoetis Inc.

Kalamazoo, MI 49007

For customer service call (888) 963-8471

Printed in USA

07-19-74-710

30603600

Rev. October 2015

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Veterinary 5% Dextrose Injection USP   
1000 ml

 

Label for Veterinary DextroseLabel for Veterinary Dextrose

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309778dextrose 5 % Injectable SolutionPSN1
309778glucose 50 MG/ML Injectable SolutionSCD1
309778dextrose 5 % Injectable SolutionSY1
309778dextrose 5 GM per 100 ML Injectable SolutionSY1
309778dextrose 50 MG/ML Injectable SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54771-4934-1Veterinary Dextrose1000 mL in 1 CONTAINERINJECTION, SOLUTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-4934VETERINARY DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [ZOETIS INC.]11 package rows20160809_344bc51a-0ce2-4adc-9241-c93ea081cdcc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54771-493454771-4934-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE MONOHYDRATELX22YL083GACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.672264e3-9709-4bba-2a9d-12bf70c7396a2026-06-24Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.10e98cb0-31a5-4ad1-3eaa-aa4af387a42d2026-06-02Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.40fd1ac4-39bb-45fb-ba99-4fb65481f2312026-04-09Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Company8e7046f8-841e-465a-af69-af9fb3d6799d2026-03-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLC3b8f2692-4371-4f1a-95af-b41842131fdd2026-03-13Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBECTON DICKINSON AND COMPANY32132016-1870-481b-9816-e11beb03ca0b2026-01-08Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.cb578dba-094c-4787-951d-763d12fd06e12025-11-01Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical Inc.cdf35d11-fbc8-4f8e-85a8-33220312c0b42025-10-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3eff8bcd-6a33-428f-e063-6394a90afa682025-09-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Companybfc4224a-2fc9-4137-b4c6-9d2d6d9484132025-07-30Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3842a9c0-8b15-1c94-e063-6394a90ae1202025-07-18Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation36e9478c-5df0-4b47-b97d-de3626d7cb292025-06-30Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFRESENIUS KABI USA, LLC576a22d8-5f2f-497e-80ad-1842ca74bb532024-08-22Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.