Alfa Veterinary Dextrose and Sodium Chloride

Manufacturer
Laboratorios Alfa SRL | JMM Services
Effective date
2025-08-13
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 02:44:52

Label at a glance#

ProductAlfa Veterinary Dextrose and Sodium Chloride
Active ingredientDEXTROSE MONOHYDRATE, SODIUM CHLORIDE
Label structure14 sections

Indications and uses

Veterinary 5% Dextrose in 0.9% Sodium Chloride, USP is indicated as a source of water, electroytes 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 discolorations prior to administration whenever solution and container permit. All injections in plastic containers are intended for intravenous administration using sterile equipment. Ad...

Storage and handling

Store below 30ºC (86ºF).

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Veterinary 5% dextrose in 0.9% Sodium Chloride Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment in single dose containers for intravenous administration. Discard unused portion. It contains no antimicrobial agents.

 Table 1. Veterinary 5% Dextrose in 9% Sodium Chloride Injection, USP
Size (mL)       Composition (g/ 100mL)    *Osmolarity
    (mOsmol/L)
    (Calculated) 
pH     Concentration
        (mEq/L) 
   Caloric Content (kcal/L) 
      Dextrose 1H2O            Sodium
   Chloride, USP (NaCl)
   Sodium   Chloride
   100        5.5                         0.9           586           3.2-6.5       154       154                   170   
   250 
   500 
   1000 

No venting is necessary during infusion.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Veterinary 5% Dextrose in 0.9% Sodium Chloride Injection, USP has value as a source of water, electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

INDICATIONS AND USAGE

VETERINARY INDICATIONS SECTION

Veterinary 5% Dextrose in 0.9% Sodium Chloride, USP is indicated as a source of water, electroytes and calories.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Solutions containing 5% Dextrose in 0.9% Sodium Chloride Injection, USP may be contraindicated in patients with known allergy to corn or corn products.

WARNINGS

WARNINGS SECTION

Excessive administration of 5% Dextrose in 0.9% Sodium Chloride Injection, USP may result in significant hypokalemia.

Veterinary 5% Dextrose in 0.9% 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.

Veterinary 5% Dextrose in 0.9% Sodium Chloride Injection, USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudo agglutination or hemolysis.

The container label for these injections bears the statement: Do not administer simultaneously with blood.

The intravenous administration of veterinary 5% Dextrose in 0.9% Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, or pulmonary edema.

The risk of dilutive states is inversely proportional to the electrolyte concentration 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.

In patients with diminished renal function, administration of veterinary 5% Dextrose in 0.9% Sodium Chloride Injection, USP may result in sodium retention proportional to the electrolyte concentrations of the injections.

Keep out of the reach of children.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

PRECAUTIONS

PRECAUTIONS SECTION

5% Dextrose in 0.9% Sodium Chloride Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

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 veterinary 5% Dextrose in 0.9% Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotrophin.

Veterinary 5% Dextrose in 0.9% Sodium Chloride Injection, USP should be used with caution in patients with known subclinical or overt diabetes mellitus.

Do not administer unless solution is clear and both seal and container are 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 discolorations 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 pharmacist, 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. Discard unused portion.

OVERDOSAGE

OVERDOSAGE SECTION

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

STORAGE 

STORAGE AND HANDLING SECTION

Store below 30ºC (86ºF).

PRECAUTION FOR USE OF THE BOTTLE

INSTRUCTIONS FOR USE SECTION

This is a single dose container and does not contain preservatives. If leaks are found, discard solution as sterility may be impaired.

Use the solution immediately after the bottle is opened, discard the remaining one. Discard unused portion. If supplemental medication is desired follow directions below:

Do not administer simultaneously with blood.
Do not use it unless solution is clear and seal is intact, the solution containing dextrose may be contraindicated in patients with a known allergy to corn or corn products.

Preparation and administration

Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired.
Suspend container from eyelet support.
Remove Plastic protector from ports area at the bottom of container.
Hold the bottle in vertical position and inset pyrogen free IV administration set in the outlet port. Use aseptic Technique.

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 inlet port and inject.

3. Mix solution and medication thoroughly. Return container to in-use position and continue administration. 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 inlet port and inject.

4. Remove container from IV pole and/or turn to an upright position.

5. Mix solution and medication thoroughly.

6. Return container to in use position and continue administration.

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

PACKAGE INSERT

SPL PATIENT PACKAGE INSERT SECTION

For Animal Use Only

Insert Dextrose 5 Sodium Chloride 0.9_page 1Insert Dextrose 5 Sodium Chloride 0.9_page 1Insert Dextrose 5 Sodium Chloride 0.9_page 2Insert Dextrose 5 Sodium Chloride 0.9_page 2Insert Dextrose 5 Sodium Chloride 0.9_page 3Insert Dextrose 5 Sodium Chloride 0.9_page 3Insert Dextrose 5 Sodium Chloride 0.9_page 4Insert Dextrose 5 Sodium Chloride 0.9_page 4Insert Dextrose 5 Sodium Chloride 0.9_page 5Insert Dextrose 5 Sodium Chloride 0.9_page 5Insert Dextrose 5 Sodium Chloride 0.9_page 6Insert Dextrose 5 Sodium Chloride 0.9_page 6

Dextrose 5% in 0.9% sodium chloride (Bottles)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextrose 5% in 0.9% Sodium Chloride Injection, USP

For Veterinary Use Only

Dextrose 5% in 0.9% Sodium Chloride 100 mL NDC 72483-205-01

Dextrose 5% in 0.9% Sodium Chloride 250 mL NDC 72483-205-25

Dextrose 5% in 0.9% Sodium Chloride 500 mL NDC 72483-205-05

Dextrose 5% in 0.9% Sodium Chloride 1000 mL NDC 72483-205-10

Bottle 5 Dextrose 0.9 Sodium Chloride_100 mlBottle 5 Dextrose 0.9 Sodium Chloride_100 mlBottle 5 Dextrose 0.9 Sodium Chloride_250 mlBottle 5 Dextrose 0.9 Sodium Chloride_250 mlBottle 5 Dextrose 0.9 Sodium Chloride_500 mlBottle 5 Dextrose 0.9 Sodium Chloride_500 mlBottle 5 Dextrose 0.9 Sodium Chloride_100 mlBottle 5 Dextrose 0.9 Sodium Chloride_100 ml

Dextrose 5% in 0.9% sodium chloride (Bags)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextrose 5% in 0.9% Sodium Chloride Injection, USP

For Veterinary Use Only

Dextrose 5% in 0.9% Sodium Chloride 100 mL NDC 72483-205-08

Dextrose 5% in 0.9% Sodium Chloride 250 mL NDC 72483-205-07

Dextrose 5% in 0.9% Sodium Chloride 500 mL NDC 72483-205-06

Dextrose 5% in 0.9% Sodium Chloride 1000 mL NDC 72483-205-04

Dextrose 5% in 0.9% Sodium Chloride 3000 mL NDC 72483-205-03

Dextrose 5% in 0.9% Sodium Chloride 5000 mL NDC 72483-205-02

Bag 5 Dextrose 0.9 Sodium Chloride_100 mlBag 5 Dextrose 0.9 Sodium Chloride_100 mlBag 5 Dextrose 0.9 Sodium Chloride_250 mlBag 5 Dextrose 0.9 Sodium Chloride_250 mlBag 5 Dextrose 0.9 Sodium Chloride_500 mlBag 5 Dextrose 0.9 Sodium Chloride_500 mlBag 5 Dextrose 0.9 Sodium Chloride_1000 mlBag 5 Dextrose 0.9 Sodium Chloride_1000 mlBag 5 Dextrose 0.9 Sodium Chloride_3000 mlBag 5 Dextrose 0.9 Sodium Chloride_3000 mlBag 5 Dextrose 0.9 Sodium Chloride_5000 mlBag 5 Dextrose 0.9 Sodium Chloride_5000 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2275615dextrose 5 % / sodium chloride 0.33 % in 100 ML InjectionPSN12
1795171dextrose 5 % / sodium chloride 0.33 % in 1000 ML InjectionPSN12
1795168dextrose 5 % / sodium chloride 0.33 % in 250 ML InjectionPSN12
1795170dextrose 5 % / sodium chloride 0.33 % in 500 ML InjectionPSN12
2275615100 ML glucose 50 MG/ML / sodium chloride 3.3 MG/ML InjectionSCD12
17951711000 ML glucose 50 MG/ML / sodium chloride 3.3 MG/ML InjectionSCD12
1795168250 ML glucose 50 MG/ML / sodium chloride 3.3 MG/ML InjectionSCD12
1795170500 ML glucose 50 MG/ML / sodium chloride 3.3 MG/ML InjectionSCD12
2275615100 ML Glucose 50 MG/ML / NaCl 3.3 MG/ML InjectionSY12
17951711000 ML Glucose 50 MG/ML / NaCl 3.3 MG/ML InjectionSY12
1795168250 ML Glucose 50 MG/ML / NaCl 3.3 MG/ML InjectionSY12
1795170500 ML Glucose 50 MG/ML / NaCl 3.3 MG/ML InjectionSY12
2275615dextrose 5 % / sodium chloride 0.33 % per 100 ML InjectionSY12
1795171dextrose 5 % / sodium chloride 0.33 % per 1000 ML InjectionSY12
1795168dextrose 5 % / sodium chloride 0.33 % per 250 ML InjectionSY12
1795170dextrose 5 % / sodium chloride 0.33 % per 500 ML InjectionSY12

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
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cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72483-205-01Alfa Veterinary Dextrose and Sodium Chloride100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10012
72483-205-05Alfa Veterinary Dextrose and Sodium Chloride500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION50012
72483-205-10Alfa Veterinary Dextrose and Sodium Chloride1000 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION100012
72483-205-25Alfa Veterinary Dextrose and Sodium Chloride250 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION25012

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72483-20572483-205-10, 72483-205-05, 72483-205-25, 72483-205-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
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.