ALFA VETERINARY 50% DEXTROSE- 50% dextrose injection, solution 
Laboratorios Alfa SRL

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DESCRIPTION

50% dextrose solution is sterile, non-pyrogenic for fluid and calorie replacement, and is supplied in single-dose containers for intravenous administration. Discard the unused portion. Does not contain antimicrobial agents.

Glucose (dextrose) is a monosaccharide sugar that is obtained by acid hydrolysis of corn starch. Chemically, glucose contains a pyramidal ring-5-atom of carbon and one of oxygen and in aqueous solution, there are two forms that are in equilibrium with the aldehyde form. The use can be anhydrous or with a water molecule.

The Plastic container, a semi-rigid bottle, is made of a low density polyethylene which is a flexible and resistant material that provides an excellent compatibility with a maximum number of pharmaceuticals, reducing the risk of interactions. No venting is necessary during infusion.

 Table 1. Veterinary 50% Dextrose Injection, USP
 Size (mL)     Composition
    (g/100 mL)
        *Osmolarity
        (mOsmol/L)
        (Calculated) 
pH   Caloric Content (kcal/L)
    Dextrose 1H2
 100          50              2780             3.2-6.5                 1700   
 250
 500
1000

No venting is necessary during infusion.

CLINICAL PHARMACOLOGY

Veterinary 50% Dextrose Injection, USP solution has value as a source of water and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

Glucose is a nutrient of the first order, provides 4.1 Kcal per gram and like all carbohydrates has the property of decreasing protein catabolism

INDICATIONS AND USAGE

50% dextrose solution is indicated as a source of water and calories. It is used to decrease the excessive pressure of spinal brain fluid, also as sclerosing to treat varicose veins and decrease intracranial pressure

WARNING

Veterinary 50% Dextrose Injection, USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudo agglutination or hemolysis.

The intravenous administration of 5% Dextrose Injection 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 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.

The container label for these injections bears the statement: Do not administer simultaneously with blood.
Keep out of the reach of children.

ADVERSE REACTIONS

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

Veterinary 50% Dextrose Injection, USP should be used with caution in patients with known 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.

This is a hypotonic solution and as such should not be used for resuscitation.

Do not administer unless solution is clear and both seal and container are intact.

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.

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. Discard unused portion.

OVERDOSAGE

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

Store below 30ºC (86ºF).

PRECAUTION FOR USE OF THE BOTTLE

This is a single dose container and does not contain preservatives.

Use the solution immediately after the bottle is opened, discard the remaining one.
Squeeze and inspect the bottle, discard if leaks are found or if the solution contains visible and solid particles.

Do not administer simultaneously with blood.
Do not use it unless solution is clear, and seal is intact.

DIRECTIONS FOR USE PLASTIC CONTAINER:

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:

Preparation and administration
1. Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired.
2. Suspend container from eyelet support.
3. Remove Plastic protector from ports area at the bottom of container.
4. 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 18 to 21 gauge needle, puncture inlet port and inject.
3. Mix solution and medication thoroughly. 

To add medication during solution administration
1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 18 to 21 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

For Animal Use Only

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Insert 2

Insert 3

Insert 4

Veterinary 5% Dextrose Injection,

NDC: :72483-206-10 1000 mL 50% Dextrose

NDC: 72483-206-05 500 mL 50% Dextrose

NDC: 72483-206-25 250 mL 50% Dextrose

NDC: 72483-206-01 100 mL 50% Dextrose

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ALFA VETERINARY 50% DEXTROSE 
50% dextrose injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:72483-206
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE5000 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72483-206-101000 mL in 1 BOTTLE, PLASTIC
2NDC:72483-206-05500 mL in 1 BOTTLE, PLASTIC
3NDC:72483-206-25250 mL in 1 BOTTLE, PLASTIC
4NDC:72483-206-01100 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/14/2019
Labeler - Laboratorios Alfa SRL (815941244)

Revised: 2/2020
Document Id: 69fea48d-627b-4732-bc56-27c2f72b5c26
Set id: f144127f-832e-4122-b18b-2d1508766d8a
Version: 1
Effective Time: 20200217
 
Laboratorios Alfa SRL