VETone Lactated Ringer's Injection

Manufacturer
MWI | Sypharma Pty Ltd | New Zealand Salt Company Limited
Effective date
2018-09-04
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:52:14

Label at a glance#

ProductVETone
Active ingredientSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
Label structure5 sections

Label contents#

Full prescribing information#

STERILE NONPYROGENIC SOLUTIONFor Animal Use Only

SPL PATIENT PACKAGE INSERT SECTION

DESCRIPTION

DESCRIPTION SECTION

VetOne Lactated Ringer’s Injection is a sterile, non-pyrogenic solution intended for fluid and electrolyte

replenishment in single dose containers. May be administered intravenously, subcutaneously or

intraperitoneally (except in horses) using aseptic technique. It contains no antimicrobial agents.

Discard any unused portion. Composition, osmolarity, pH and ionic concentration are shown In Table 1

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*Sodium Lactate USP — (S)-enantiomer

Osmolarity (mOsmol/L) (calc): 273mOsmol per liter

pH: 6.5 (limit 6.0 - 7.5)

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

registered with US FDA.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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

hydration. A combination of multiple electrolytes and sodium lactate, an alkalinizing agent, will

provide electrolyte balance and normalize the pH of the acid-base of the physiological system.

INDICATIONS

INDICATIONS & USAGE SECTION

VetOne Lactated Ringer′s Injection is indicated as a source of water and electrolytes for all species. It is also

used as an alkalinizing agent.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

VetOne Lactated Ringer′s Injection is contraindicated in patients with a known hypersensitivity to sodium

lactate; congestive heart failure or severe impairment of renal function; clinical states in which the

administration of sodium and chloride is detrimental.

WARNINGS

WARNINGS SECTION

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 Lactated Ringer′s Injection 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 Lactated Ringer′s Injection 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 Lactated Ringer′s Injection should be used with great care in patients Wth metabolic or

respiratory alkalosis. The administration of lactate 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.

VetOne Lactated Ringer′s Injection should not be administered simultaneously with blood through the same

administration set because of likelihood of coagulation.

The intravenous administration of VetOne Lactated Ringer′s Injection 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 injections. 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 function, administration of VetOne Lactated Ringer′s Injection may result in

sodium or potassium retention.

Do not administer to horses by intraperitoneal injection. Do not administer to animals with inadequate

renal function. Not for use in lactic acidosis.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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

response, infection at the site of injection or allergic 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

PRECAUTIONS SECTION

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 Lactated Ringer′s Injection should be used with caution. Excess administration may result in metabolic

alkalosis.

Do not administer unless solution 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 occur, discontinue the infusion and evaluate the patient, institute appropriate therapeutic

countermeasures, and save remainder of the fluid for examination if deemed necessary.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

To be used as directed by a licensed veterinarian. The dosage of the VetOne Lactated Ringer′s Injection 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 doctor‚

it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced.

Do not store solutions containing additives.

OVERDOSAGE

OVERDOSAGE SECTION

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

SPL UNCLASSIFIED SECTION

VetOne Lactated Ringer′s Injection in plastic container is available as follows:

image descriptionimage description

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

SPL UNCLASSIFIED SECTION

TO Open

Tear owerwrap 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:

WARNINGS SECTION

FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED

VETERINARIAN.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

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

VetoneLactatedRingersInjection250ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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VetoneLactatedRingersInjection500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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VetoneLactatedRingersInjection1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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VetoneLactatedRingersInjection5000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130313275933059GTIN-13: 0313275933059
EAN-13: 0313275933059
GTIN-12: 313275933059
UPC-A: 313275933059
GTIN storage (14 digits): 00313275933059
LactatedRingersinjection 5000ml.jpg
BarcodeEAN-130313985933509GTIN-13: 0313985933509
EAN-13: 0313985933509
GTIN-12: 313985933509
UPC-A: 313985933509
GTIN storage (14 digits): 00313985933509
LactatedRingersInjection 500ml.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-933VETONE (LACTATED RINGERS SODIUM CHLORIDE,SODIUM LACTATE,POTASSIUM CHLORIDE,CALCIUM CHLORIDE) INJECTION, SOLUTION [MWI]2Unmatched20180904_5189ded0-c39b-4b29-b2a8-4667b726a062.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13985-93313985-933-25, 13985-933-50, 13985-933-01, 13985-933-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SalineSODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd4e9c21e5-f2f9-90e4-e063-6394a90acfe22026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsName fallback
generic name: SODIUM CHLORIDE
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC107af8bc-b6af-4b85-8c8a-ea757dcef1da2026-06-12Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsName fallback
generic name: SODIUM CHLORIDE
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsName fallback
generic name: SODIUM CHLORIDE
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsName fallback
generic name: SODIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.