Label: COMPOUND SODIUM LACTATE- sodium chloride, potassium chloride, sodium lactate, and calcium chloride injection, solution

For Animal Use Only

COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. It is supplied in single dose VIAFLEX plastic containers for intravenous administration.  It contains no antimicrobial agents.  Any unused portion should be discarded.

The composition and ionic concentration of COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection are shown in Tables 1 and 2 below.

COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.

COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection should be used with great care, if at all, in animals with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection should be used with great care, if at all, in animals with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.
COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection should be used with great care in animals with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.
COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection should not be administered simultaneously with blood through the same administration set because of the likelihood of coagulation.
The intravenous administration of COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection 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.
In patients with diminished renal function, administration of COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection may result in sodium or potassium retention.
COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection is not for use in the treatment of lactic acidosis.

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 animal warrants such evaluation.
COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection must be used with caution. Excess administration may result in metabolic alkalosis.
Caution must be exercised in the administration of COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection to patients receiving corticosteroids or corticotropin.
Do not administer unless solution is clear and seal is intact.
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 animal, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

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 animal, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

As directed by a veterinarian. Dosage is dependent upon the age, weight and clinical condition of the animal 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 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.

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

COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection is supplied in following pack size:

• 5L solution in single dose VIAFLEX plastic containers.

Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. It is recommended the product be stored at room temperature below 30°C/86ºF.