Veterinary Lactated Ringer's Injection, USP

Manufacturer
Vedco, Inc. | Laboratorios Biogalenic SA de CV
Effective date
2017-03-31
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:40:04

Label at a glance#

ProductVeterinary Lactated
Active ingredientSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
Label structure13 sections

Indications and uses

Lactated Ringer's Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent

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 discoloration prior to administration whenever solution and container permit. All solutions for injections in plastic containers are intended for intravenous administration using sterile ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For Animal Use Only

Description

DESCRIPTION SECTION

Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents or preservatives. Discard unused portion. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1:

TableTable


Clinical Pharmacology

CLINICAL PHARMACOLOGY SECTION

Lactated Ringer's Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis, depending on the clinical condition of the patient.

Lactated Ringer's Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires consumption of hydrogen cations

Indications and Usage

INDICATIONS & USAGE SECTION

Lactated Ringer's Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent

Contraindications

CONTRAINDICATIONS SECTION

None known. 

Warnings

WARNINGS SECTION

Do not administer to horses by intraperitoneal injection.

Lactated Ringer's Injection, 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 with sodium retention.

Lactated Ringer's Injection, 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.

Lactated Ringer's Injection, USP should be used with great care, in patients with 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.

Lactated Ringer's Injection, USP should not be administered simultaneously with blood through the same administration set because of the likelihood of coagulation

The intravenous administration of Lactated Ringer's Injection, 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 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 lactated Ringer's Injection, USP may result in sodium or potassium retention.

Lactated Ringer's Injection, USP is not used for treatment of lactic acidosis.

Adverse Reactions

ADVERSE REACTIONS SECTION

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

PRECAUTIONS SECTION

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.

Lactated Ringer's Injection,USP must be used with caution. Excess administration may result in metabolic alkalosis.

Caution must be exercised in the administration of Lactated Ringer's Injection, USP to patients receiving corticosteroids or corticotrophin. 

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

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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 discoloration prior to administration whenever solution and container permit.

All solutions for injections in plastic containers are intended for intravenous administration using sterile equipment and aseptic technique.

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 judgment 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. Discard unused portion.

Over Dosage

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.

How Supplied

HOW SUPPLIED SECTION

Veterinary Lactated Ringer's Injection, USP in plastic container is available as follows:

How Supplied SectionHow Supplied Section

Plastic Container:

*PVC Free, DEHP Free and Latex Free Bag.

**The plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts withing the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in animals accourdint to USP biological tests for plastic containers, as well as tissue culture toxicity studies.

Storage:

STORAGE AND HANDLING SECTION

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored in the moisture overwrap at room temperature (25ºC/77ºF); brief exposure up to (40ºC/104ºF) does not adversely affect the product.


Directions for use of plastic container

DOSAGE & ADMINISTRATION SECTION

To Open
Tear overwrap down side 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 inner bag 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 protector from outlet port at bottom of container.

3.  Attach administration set.  Refer to complete directions accompanying set.

To Add Medication
WARNING:
  Additives may be incompatible.

To add medication before solution administration
1.  Prepare medication site.

2.  Using syringe with 19 to 22 gauge needle, puncture resealable 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 clamp on the set.

2.  Prepare medication site.

3.  Using syringe with 19 to 22 gauge needle, puncture resealable 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.

Manufactured for

BrandBrandDirections for use of plastic containerDirections for use of plastic container

Vedco, Inc.
5503 Corporate Dr.

St. Joseph, MO 64507  USA

Printed in El Salvador

For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Vedco, Inc. customer service at 1(888) 708-3326

© 2015 Vedco, Inc.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50989-898-16

Veterinary Lactated Ringer's Injection, USP
500 ml

500 Label500 Label

NDC 50989-898-17

Veterinary Lactated Ringer's Injection, USP
1000 ml

1000 Label1000 Label

NDC 50989-898-32

Veterinary Lactated Ringer's Injection, USP
5000 ml

5000 Label5000 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
847630lactated Ringers Injectable SolutionPSN5
847630calcium chloride 0.2 MG/ML / potassium chloride 0.3 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSCD5
847630calcium chloride 0.2 MG/ML / K+ chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY5
847630calcium chloride 0.2 MG/ML / Pot chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY5
847630calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringer's Injectable SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50989-898-16Veterinary Lactated500 mL in 1 CONTAINERINJECTION, SOLUTION5005
50989-898-17Veterinary Lactated1000 mL in 1 CONTAINERINJECTION, SOLUTION10005
50989-898-32Veterinary Lactated5000 mL in 1 CONTAINERINJECTION, SOLUTION50005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50989-898VETERINARY LACTATED (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [VEDCO, INC.]53 package rows20170331_5aca55b1-0afb-483d-a96e-e176ff1e5d66.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
50989-89850989-898-16, 50989-898-17, 50989-898-32

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 · 176 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
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsName 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

Reported adverse events (FAERS/openFDA)#

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