DESCRIPTION

Veterinary 0.9% Sodium Chloride solution is sterile and non-pyrogenic. It is a parenteral solution in a single-dose container containing sodium chloride in water for injection intended for intravenous administration. Discard the unused portion. Does not contain antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown in Table 1.

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.

The flexible bag is made from polyvinyl chloride (PVC), 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.

CLINICAL PHARMACOLOGY

Veterinary 0.9% Sodium Chloride Injection, USP solution has value as a source of water and electrolytes. It may induce diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

INDICATIONS AND USAGE

Veterinary 0.9% Sodium Chloride Injection, USP solution is indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. Used as a source of electrolytes and water for hydration.

CONTRAINDICATIONS

• These solutions are contraindicated where the administration of sodium or chloride could be clinically detrimental.

WARNINGS

• Veterinary 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
• Solutions containing sodium ions 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 is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
• In patients with diminished renal function, administration of the solution may result in sodium retention proportional to the electrolyte concentrations of the injections.
• Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient’s circulatory system status as a guide.
• The intravenous administration of Veterinary 0.9% Sodium Chloride solution 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

The container label for these injections bears the statement:

• Do not administer simultaneously with blood
• Keep out of the reach of children

PRECAUTIONS

• These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.
• Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.
• Additional essential electrolytes, minerals, and vitamins should be supplied as needed.
• Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.
• Infusion of more than one liter of isotonic (0.9%) sodium chloride per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect.
• To minimize the risk of possible incompatibilities arising from mixing any of these solutions with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
• Do not connect the plastic containers in series in order to avoid air embolism.
• If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. These solutions are intended for intravenous administration using sterile equipment. It is recommended that the intravenous administration apparatus be replaced at least once every 24 hours.
• This is a hypotonic solution and as such should not be used for resuscitation
• Do not administer unless the solution is clear, and both seal and container are intact

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

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

• Do not administer unless a solution is clear, and the seal is intact
• 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
• This product should be warmed to body temperature and administered slowly
• Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with a veterinarian, if available.
• If, in the informed judgment of the veterinarian, it is deemed advisable to introduce additives, use an aseptic technique. Mix thoroughly when additives have been introduced.
• Do not store any unused portion of the solution containing additives. Discard unused portion.

DIRECTIONS FOR USE OF PLASTIC BOTTLE:
To Open:
Remove the overwrap seal over the bottle cap. Visually inspect the container for leaks. If leaks or the seal is torn, broken, or missing, discard the solution as sterility may be impaired. Use the solution immediately after the bottle is opened. Discard unused portion. If supplemental medication is desired, follow the “To Add Medication” directions below.

Preparation and Administration
1. This is a single-dose container and does not contain preservatives.
2. Suspend the container from the eyelet support.
3. Remove the plastic protector from the outlet port area at the bottom of the container.
4. Hold the bottle in a vertical position and inset pyrogen-free IV administration set in the outlet port. Use aseptic Technique.

DIRECTIONS FOR USE OF FLEXIBLE BAGS:
To Open:
Remove the overwrap downside at the slit and remove the solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard the 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 the inner bag firmly. If leaks are found, discard the solution as sterility may be impaired. If supplemental medication is desired, follow the “To Add Medication” directions below.

Preparation and Administration
1. This is a single-dose container and does not contain preservatives.
2. Suspend the container from the eyelet support.
3. Remove the protector from the outlet port area at the bottom of the container.
4. Hold the bag in a vertical position and inset pyrogen-free IV administration set in the outlet port. Use an aseptic technique.

INTRODUCTION OF ADDITIVES:

To Add Medication
WARNING: Additives may be incompatible.

To add medication before solution administration
1. Prepare medication site.
2. Using a syringe with an 18-to-22 gauge needle, puncture the inlet port and inject.
3. Mix the solution and medication thoroughly. For high-density medication such as potassium chloride, squeeze ports while ports are upright and mixed thoroughly.

To add medication during solution administration
1. Close the clamp on the set.
2. Prepare medication site.
3. Using a syringe with an 18-to-22 gauge needle, puncture the inlet port and inject.
4. Remove the container from the IV pole and/or turn to an upright position.
5. Evacuate both ports by squeezing them while the container is in the upright position.
6. Mix the solution and medication thoroughly.
7. Return container to in-use position and continue administration.

HOW SUPPLIED

Veterinary 0.9% Sodium Chloride, USP (Injectable) solution is available in the following sizes:

STORAGE

• Store at room temperature 25ºC (77ºF)

PACKAGE INSERT

For Animal Use Only

0.9% Sodium Chloride injection (BOTTLES)

0.9% SODIUM CHLORIDE Injection, USP

For Veterinary Use Only 

NDC: 72483-203-10 1000 mL 0.9% Sodium Chloride
NDC: 72483-203-05 500 mL 5% 0.9% Sodium Chloride
NDC: 72483-203-25 250 mL 5% 0.9% Sodium Chloride
NDC: 72483-203-01 100 mL 5% 0.9% Sodium Chloride

0.9% Sodium Chloride injection (BAGS)

0.9% SODIUM CHLORIDE Injection, USP

For Veterinary Use Only

NDC: 72483-203-02 5000 mL0.9% Sodium Chloride


NDC: 72483-203-03 3000 mL 0.9% Sodium Chloride


NDC: 72483-203-04 1000 mL 0.9% Sodium Chloride


NDC: 72483-203-06 500 mL 5% 0.9% Sodium Chloride


NDC: 72483-203-07 250 mL 5% 0.9% Sodium Chloride


NDC: 72483-203-08 100 mL 5% 0.9% Sodium Chloride