VETONE- osmosol-r sodium chloride,sodium gluconate,sodium acetate,potassium chloride and magnesium chloride 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]
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PATIENT PACKAGE INSERT
STERILE NONPYROGENIC SOLUTION
For Animal Use OnlyDESCRIPTION
VetOne OsmoSol–R (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 or subcutaneously using aseptic technique. It contains
no antimicrobial agents· Discard any unused portion. The pH is adjusted with Hydrochloric
Acid and⁄or Sodium Hydroxide. Composition,osmolarity, pH and ionic concentration are
shown in Tabe 1·
Osmolarity (mOsmol⁄L) (calc):294 mOsmol per litre
pH: 6.6 (limit 4.0 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 (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.
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 (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 (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 (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 (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 (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 (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 (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
(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 dscoloration
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 (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 isrecommended 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·
- OsmoSol™–R 1000ml
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INGREDIENTS AND APPEARANCE
VETONE
osmosol-r sodium chloride,sodium gluconate,sodium acetate,potassium chloride and magnesium chloride injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC: 13985-943 Route of Administration INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 526 mg in 100 mL Sodium Gluconate (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37, GLUCONIC ACID - UNII:R4R8J0Q44B) Sodium Gluconate 502 mg in 100 mL Sodium Acetate (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC) Sodium Acetate 368 mg in 100 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 37 mg in 100 mL MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE 30 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 13985-943-01 12 in 1 CARTON 1 1000 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/13/2018 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
Trademark Results [VETONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VETONE 87675521 5453626 Live/Registered |
MWI Veterinary Supply Co. 2017-11-07 |
 VETONE 87675505 5453625 Live/Registered |
MWI Veterinary Supply Co. 2017-11-07 |
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