For Animal Use Only

Description

2.5% Dextrose and 0.45% 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. Discard unused portion. Composition, osmolarity, pH, concentration and caloric content are shown in Table 1.

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 tests for plastic containers as well as by tissue culture toxicity studies.

Clinical Pharmacology

2.5% Dextrose and 0.45% 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.

Indications and Usage

2.5% Dextrose and 0.45% Sodium Chloride Injection, USP is indicated as a source of water, electrolytes, and calories.

Contraindications

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

Warnings

2.5% Dextrose and 0.45% 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.

2.5% 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 intravenous administration of 2.5% Dextrose and 0.45% 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 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP may result in significant hypokalemia.

In patients with diminished renal function, administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP may result in sodium retention.

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.

Precautions

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 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

2.5% Dextrose and 0.45% Sodium Chloride 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

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

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

2.5% Dextrose and 0.45% Sodium Chloride Injection, USP in plastic container is supplied as follows:

List Number     Size (mL)     Code             NDC
04933-04-10     1000             2B8224         0044-4933-10

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

To Open

Tear overwrap down side at slit and remove solution container. 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:
Abbott Laboratories
North Chicago, IL 60064

For customer service call (888) 299-7416

Printed in USA

07-19-69-189

Rev. August 2012

Principal Display Panel

04933-04-10
Veterinary 2.5% Dextrose and 0.45% Sodium Chloride Injection USP
1000 ml