VETONE- saline solution 0.9% intravenous infusion injection, solution

VETONE by

Drug Labeling and Warnings

VETONE by is a Animal medication manufactured, distributed, or labeled by MWI, Sypharma Pty Ltd, New Zealand Salt Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

VETONE SALINE SOLUTION 0·9% INJECTION 250ML

VETONE SALINE SOLUTION 0·9% INJECTION 1000ML

INGREDIENTS AND APPEARANCE

VETONE 
saline solution 0.9% intravenous infusion injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-934
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 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-934-25	24 in 1 CARTON
1		250 mL in 1 BAG
2	NDC: 13985-934-01	12 in 1 CARTON
2		1000 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/09/2018

Labeler - MWI (019926120)

Registrant - Sypharma Pty Ltd (753786292)

Establishment
Name	Address	ID/FEI	Business Operations
Sypharma Pty Ltd		753786292	manufacture, pack, sterilize

Establishment
Name	Address	ID/FEI	Business Operations
New Zealand Salt Company Limited		594169799	api manufacture