Label: VETONE- osmosol-r 7.4 sodium chloride,sodium gluconate,sodium acetate,potassium chloride and magnesium chloride injection, solution

DESCRIPTION

VetOne OsmoSol–R 7·4 (Multiple Electrolyte Injection, Type 1, USP) is a sterile, non–pyrogenic

isotonic solution intended for fluid and electrolyte replenishment in single dose containers. May

be administered intravenously using aseptic technique. It contains no antimicrobial agents·

Discard any unused portion. The pH is adjusted with Sodium Hydroxide. Composition,

osmolarity, pH and ionic concentration and caloric content are shown in Tabe 1·

Osmolarity (mOsmol⁄L) (calc):294 mOsmol per litre

pH: 7·4 (limit 6.5 to 8.0)

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

USP and is registered with US FDA·

CLINICAL PHARMACOLOGY

A multiple electrolyte intravenous solution is intended to restore the electrolyte balance and

water for hydration· It is capable of inducing diuresis depending on the clinical condition of

the patient and produces a metabolic alkalinizing effect. Acetate and gluconate ions are

metabolized ultimately to carbon dioxide and water‚ which requires the consumption of

hydrogen cations·

INDICATIONS AND USAGE

VetOne OsmoSol–R 7·4 (Multiple Electrolyte Injection‚ Type 1‚ USP) is indicated as a source

of water and electrolytes for all species· It is also used as an alkalinizing agent.

VetOne OsmoSol–R 7·4 (Multiple Electrolyte Injection‚ Type 1‚ USP) is compatible with blood

or blood components. It may be administered prior to or following the infusion of blood

through the same administration set (i·e., as a priming solution), added to or infused

concurrently with blood components, or used as a diluent in the transfusion of packed

erythrocytes·

CONTRAINDICATIONS

None known

WARNINGS

The introduction of additives to any solution, regardless of type of container, requires special

attention to ensure that no incompatibilities result. While some incompatibilities are readily

absorbed, one must be aware that subtle physical, chemical and pharmacological incompatibilities

can occur. The medical literature, the package insert and other available sources of information

should be reviewed for thorough understanding of possible incompatibilities·

VetOne OsmoSol–R 7·4 (Multiple Electrolyte Injection‚ Type 1‚ 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 and sodium retention.

VetOne OsmoSol–R 7·4 (Multiple Electrolyte Injection‚ Type 1‚ USP) should be used with

great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions

in which potassium retention is present.

VetOne OsmoSol–R 7·4 (Multiple Electrolyte Injection‚ Type 1‚ USP) should be used with

great care in patients with metabolic or respiratory alkalosis. The administration of acetate

or gluconate 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·

The intravenous administration of VetOne OsmoSol–R 7·4 (Multiple Electrolyte Injection‚

Type 1‚ USP) can cause fluid and⁄or solute overloading resulting in dilution of serum

electrolyte concentrations, over-hydration, congested states, or pulmonary edema. The

risk of dilutional states is inversely proportional to the electrolyte concentrations of the

injection. The risk of solute overloading causing congested states with peripheral and

pulmonary edema is directly proportional to the electrolyte concentrations of the injections·

In patients with diminished renal functon, administration of VetOne OsmoSol–R 7·4

(Multiple Electrolyte Injection‚ Type 1‚ USP) may result in sodium or potassium retention·

ADVERSE REACTIONS

Adverse reactions may occur due to the solution or the technique of administration

including febrile response, infection at the site of injection or alergic reactions.

Prolonged intravenous infusion of this type of product may cause venous thrombosis

or phlebitis extending from the site of injection‚ extravasation, and hypervolemia·

If an adverse reaction does occur, discontinue the infusion and evaluate the patient,

institute appropriate therapeutic countermeasures, and save the remainder of the

fluid for examination if deemed necessary·

PRECAUTIONS

This is a single dose unit. It contains no preservatives. Use entire contents when

first opened·

Clinical evaluation and periodic laboratory determinations are necessary to monitor

changes in fluid balance, electrolyte concentrations, and acid base balance during

prolonged therapy or whenever the condition of the patient warrants such evaluation.

VetOne OsmoSol–R 7·4 (Multiple Electrolyte Injection‚ Type 1‚ USP) should be used

with caution. Excess administration may result in metabolic alkalosis·

Caution must be exercised in the administration of VetOne OsmoSol–R 7·4 (Multiple

Electrolyte Injection‚ Type 1‚ USP) to patients receiving corticosteroids or corticotropin·

Do not administer unless soution is clear and both seal and container are intact·

Solution must be warmed to body temperature prior to administration and administered

at a slow rate. Use solution promptly following initial entry·

Reactions which may occur because of the solution or the technique of administration‚

include febrile response, infection at the Site of injection, extravasation, and hypervolemia·

If an adverse reaction does occur, discontinue the infusion and evaluate the patient,

institute appropriate therapeutic countermeasures, and save the remainder of the fluid

for examination if deemed necessary·

DOSAGE AND ADMINISTRATION

To be used as directed by a licensed veterinarian. The dosage of the VetOne

OsmoSol–R 7·4 (Multiple Electrolyte Injection, Type 1, USP) is dependent upon

the age, weight and clinical conditions of the patient as well as laboratory

determinations. Parenteral drug products should be inspected visually for

particulate matter and discoloration prior to administration.

For use in one patient on one occasion only. Discard any unused portion.

Care should be taken with administration technique to avoid administration

site reactions and infection·

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 OsmoSol–R 7·4 (Multiple Electrolyte Injection‚ Type 1‚ USP) 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 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 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 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 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 THIS 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: MWI

Boise, ID 83705

www.VetOne.net

Iss. 04/18