Animal NDC 72483-203-01 Alfa Veterinary 0.9% Sodium Chloride

Sodium Chloride Injection, Solution

Animal Product Information

Field Name Field Value
Animal NDC Code 72483-203-01
Proprietary Name Alfa Veterinary 0.9% Sodium Chloride 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 Injection, Solution 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 Laboratorios Alfa Srl
Product Type Prescription Animal Drug
Usage Information
    Veterinary 0.9% Sodium Chloride is indicated as a source of water and electrolytes.Veterinary 0.9% Sodium Chloride injection, USP is also indicated for use as a priming solution in hemodialysis procedures.
Active Ingredient(s)
  • Sodium 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.

Alfa Veterinary 0.9% Sodium Chloride 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



Description



Veterinary 0.9% Sodium Chloride Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment in single dose containers for intravenous administration. Discard unused portion. It contains no antimicrobial agents.

Table 1: Veterinary 0.9% Sodium Chloride Injection, USP
 Size (mL)

Compostion(mg/100 mL)

pHIonic Concentration (mEq/L)

 Sodium Chloride,

USP (NaCl)

 Osmolarity (mOsmol/L)
(Calculated)
SodiumChloride
 100900    308    4.5-7.0        154     154 
 250
 500
 1000

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.


Other Safety Information



CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.


Indications And Usage



Veterinary 0.9% Sodium Chloride is indicated as a source of water and electrolytes.


Veterinary 0.9% Sodium Chloride injection, USP is also indicated for use as a priming solution in hemodialysis procedures.


Contraindications



None known


Warnings



None known


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 veterinary 0.9% Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotrophin.

Do not administer unless solution is clear, and seal is intact.


Dosage & 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 discolorations 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. Discard unused portion.


Overdosage



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

In an event of over hydration or solute overload, re-evaluate the patient and institute appropriate corrective measures.

See Warnings, Precautions and Adverse Reactions.


Packaging Ndc 72483-203-10 1000 Ml In Plastic Bottle; Ndc 72483-203-05 500 Ml In Plastic Bottle; Ndc 72483-203-25 250 Ml In Plastic Bottle; Ndc 72483-203-01 100 Ml In Plastic Bottle



NDC 72483-203-10 1000 mL in Plastic Bottle

NDC 72483-203-05 500 mL in Plastic Bottle

NDC 72483-203-25 250 mL in Plastic Bottle

NDC 72483-203-01 100 mL in Plastic Bottle


Storage



Store below 30​0C (86​0​F).

Store below 30°C (86°F)


Directions For Use Plastic Container



Preparation and administration (Use Aspetic Technique):

  • Check for minute leaks by squeezing the container firmly. If leaks are found discard solutions as sterility may be impaired.
  • Suspend container from eyelet support. 
  • Remove Plastic protector from port area at bottom of container. 
  • Hold bottle in vertical position and insert IV administration set in outlet port.
  • To add Medication: 

    WARNING: Additives may be incompatible.

    • Prepare medication site. 
    • Using syringe with 19 to 22 gauge needle, puncture inlet port and inject. 
    • Mix solution and medication thoroughly. Return container to in-use position and continue administration.
    • Preparation and administration

      • Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired.
      • Suspend container from eyelet support.
      • Remove Plastic protector from ports area at the bottom of container.
      • Hold the bottle in vertical position and inset pyrogen free IV administration set in the outlet port. Use aseptic technique.
      • To Add Medication
        WARNING:Additives may be incompatible.
        To add medication before solution administration.

        • Prepare medication site.
        • Using syringe with 19 to 22 gauge needle, puncture inlet port and inject.
        • Mix solution and medication thoroughly. Return container to in-use position and continue administration. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
        • To add medication during solution administration

          • Close clamp on the set.
          • Prepare medication site.
          • Using syringe with 19 to 22 gauge needle, puncture inlet port and inject.
          • Remove container from IV pole and/or turn to an upright position.
          • Mix solution and medication thoroughly.
          • Return container to in use position and continue administration.

Caution



Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.


Precaution For Use Of The Bottle



This is a single dose container and does not contain preservatives.

Use the solution immediately after the bottle is opened, discard the remaining one.
Squeeze and inspect the bottle, discard if leaks are found or if the solution contains visible and solid particles.

Do not administer simultaneously with blood.
Do not use it unless solution is clear and seal is intact, the solution containing dextrose may be contraindicated in patients with a known allergy to corn or corn products.


Package Insert



For Animal Use Only


Principal Display Panel



0.9% Sodium Chloride Injection, USP 

Veterinary Use

Sterile and NonProgenic Solution

Keep out of reach of Children.

For Animal Use Only.

Take Time - Observe label directions

Manufactured by:

Laboratorios Alfa, SRL

Santo Domingo

Domincan Republic

www.laboratoriosalfa.com

+1-809-544-0222


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