Label: VETERINARY 0.9% SODIUM CHLORIDE- sodium chloride injection, solution
- NDC Code(s): 86094-895-01
- Packager: Ivali LLC
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 26, 2018
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Description
0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents or preservatives. Discard unused portion. Composition, osmolarity, and ionic concentration are shown in Table 1:
- Clinical Pharmacology
- Indications and Usage
- Contraindications
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Warnings
0.9% Sodium Chloride Injection, USP 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 exists edema with sodium retention.
The intravenous administration of 0.9% Sodium Chloride Injection, USP 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 concentration 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 Sodium Chloride Injection, USP may result in sodium retention.
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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 patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
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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 0.9% Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.
Do not administer unless solution is clear and seal is intact.
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Dosage and 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 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. Discard unused portion.
- OverDosage
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How Supplied
Veterinary 0.9% Sodium Chloride Injection, USP in plastic container is available as follows:
NDC Code Size (mL) Product Name 86094-895-01 1000 0.9% Sodium Chloride Injection, USP Plastic Container:
PVC Free, DEHP Free and Latex Free Bag. The volumetric scales on the single dose plastic container should only be used as a reference. For precise dosage of volumes it is recommeded the use of IV Infusion pump or IV Burrette. - Storage:
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Directions for use of plastic container
To OpenTear 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 Administration1. Suspend container from eyelet support.
2. Remove protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions accompanying set.To Add Medication
WARNING: Additives may be incompatible.
To add medication before solution administration1. Prepare medication site.
2. Using syringe with 19 to 22 gauge needle, puncture resealable 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 administration1. 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.
Manufactured for:
IVALI LLC
18205 Biscayne Blvd., Suite 2202
Aventura FloridaPrinted in Argentina
For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call IVALI LLC. Customer service at 1-305-692-7665
IVALI is a trademark of IVALI LLC., all rights reserved.
© 2018 IVALI LLC. - Principal Display Panel
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INGREDIENTS AND APPEARANCE
VETERINARY 0.9% SODIUM CHLORIDE
sodium chloride injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86094-895 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 900 mg in 1000 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86094-895-01 1000 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/26/2018 Labeler - Ivali LLC (081136076) Establishment Name Address ID/FEI Business Operations LABORATORIOS JAYOR S.R.L. 979312485 manufacture, api manufacture