Animal NDC 13985-934-01 Vetone
Saline Solution 0.9% Intravenous Infusion

Animal Product Information

Field Name Field Value
Animal NDC Code 13985-934-01
Proprietary Name Vetone 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 Saline Solution 0.9% Intravenous Infusion 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 Mwi
Product Type Prescription Animal Drug
Usage Information
    VetOne Saline Solution 0.9% Intravenous Infusion is indicated as a source of water and electrolytes.
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.

Vetone Images

Vetone 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



Vetone® Saline Solution 0·9% Intravenous Infusion



STERILE NONPYROGENIC SOLUTION

For Animal Use Only


Description



VetOne Saline Solution 0.9% Intravenous Infusion is a sterile, non-pyrogenic solution intended

for water and electrolytes replenishment in single dose containers. May be administered

intravenously using aseptic technique. It contains no antimicrobial agents. Discard any unused

portion. Composition, osmolarity, pH and ionic concentration are shown in Table 1

The container is free of PVC and phthalates. The container meets the requirements of USP and is

registered with US FDA


Clinical Pharmacology



VetOne Saline Solution 0.9% Intravenous Infusion is intended to restore water and electrolytes.

It is capable of inducing diuresis, depending on the clinical condition of the patient.


Indications And Usage



VetOne Saline Solution 0.9% Intravenous Infusion is indicated as a source of water and electrolytes.


Contraindications



None known


Warnings



VetOne Saline Solution 0.9% Intravenous Infusion 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 VetOne Saline Solution 0.9% Intravenous Infusion can cause fluid

and/or solute overloading resulting in dilution of serum electrolyte concentrations, over-hydration,

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 VetOne Saline Solution 0.9% Intravenous

Infusion may result in sodium retention.


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.


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 VetOne Saline Solution 0.9% Intravenous

Infusion to patients receiving corticosteroids or corticotrophin.

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


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 discolouration 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 judgement

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 over-hydration or solute overload, re-evaluate the patient and institute appropriate

corrective measures. See Warnings, Precautions and Adverse Events.


Packs Supplied



VetOne Saline Solution 0.9% Intravenous Infusion in plastic container is available as follows:

Exposure of pharmaceutical products to heat should be minimized· Avoid excessive heat. It is

recommended the product be stored at room temperature (86°F/30°C). Protect from freezing·


Directions For Use Of Plastic Container



To Open

Tear overwrap at silt 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 solution container 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 inlet/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 0.63mm to 0.80mm need 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 mixthoroughly.

To add medication during solution administration

1. Close the clamp on the administration set.

2. Prepare medication site.

3. Using syringe with 0.63mm to 0.80mm needle, puncture 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 THS DRUG TO USE BY OR ON THE ORDER OF A LICENSED

VETERINARIAN


Information For Owners/Caregivers



Made in Australia

Manufactured by:

Sypharma Pty Ltd

27 Healey Road Dandenong

Victoria 3175 Australia

Distributed by: MW

Boise, ID 83705

www.VetOne.net

ISS. 04/18


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