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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Animal Use Only
Description

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.

Table 1 - Composition (g/L)

Sodium chloride 6

Sodium lactate 3.22

Potassium chloride 0.4

Calcium chloride 0.27

Table 2 - Ionic concentration (mEq/L)

Sodium 131

Potassium 5

Calcium 4

Chloride 111

Lactate 29
Indications

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

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

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.
OverDosage

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

Directions for Use of VIAFLEX 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 plastic protector from outlet port at bottom of container.
3. Attach administration 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 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.
PRINCIPAL DISPLAY PANEL

Table 1 - Composition (g/L)
Sodium chloride	6
Sodium lactate	3.22
Potassium chloride	0.4
Calcium chloride	0.27

Table 2 - Ionic concentration (mEq/L)
Sodium	131
Potassium	5
Calcium	4
Chloride	111
Lactate	29

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

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 86046-8611
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 g in 1 L
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	3.22 g in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	400 mg in 1 L
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	270 mg in 1 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 86046-8611-2	5 L in 1 CONTAINER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/10/2015

Labeler - Baxter Healthcare Pty Ltd (750455891)

Name	Address	ID/FEI	Business Operations
Establishment
Baxter Healthcare Pty Ltd		750455891	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
US Salt		002246361	api manufacture

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

COMPOUND SODIUM LACTATE by

Drug Labeling and Warnings

Drug Details [pdf]

Directions for Use of VIAFLEX plastic container