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Animal NDC 86046-8611-2 Compound Sodium Lactate

Sodium Chloride, Potassium Chloride, Sodium Lactate, And Calcium Chloride

Animal Product Information

Field Name Field Value
Animal NDC Code 86046-8611-2
Proprietary Name Compound Sodium Lactate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sodium Chloride, Potassium Chloride, Sodium Lactate, And Calcium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Baxter Healthcare Pty Ltd
Product Type Prescription Animal Drug
Usage Information
    COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.
Active Ingredient(s)
  • Sodium Chloride
  • Sodium Lactate
  • Potassium Chloride
  • Calcium Chloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • WATER (059QF0KO0R)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Compound Sodium Lactate Images

Compound Sodium Lactate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



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/86°F.


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.


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* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.