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Animal NDC 65207-803-60 Lactated Ringers

Animal Product Information

Field Name Field Value
Animal NDC Code 65207-803-60
Proprietary Name Lactated Ringers What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Lactated Ringers What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Nova-tech, Inc.
Product Type Prescription Animal Drug
Usage Information
    For the correction of electrolyte depletion, metabolic acidosis and dehydrationof cattle, calves, horses, sheep and swine. 
Active Ingredient(s)
  • Potassium Chloride
  • Calcium Chloride
  • Sodium Chloride
  • Sodium Lactate
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Lactated Ringers Images

Lactated Ringers Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Composition



Each 100 mL of sterile aquious solution contains:

Sodium Chloride ............................ 600 mg
Sodium Lactate .............................. 310 mg
Potassium Chloride .......................... 30 mg
Calcium Chloride Dihydrate ............... 20 mg
Water for Injection .............................. q.s. 

The Calcium, Potassium and Sodium contents are approximately 2.7, 4.0, and 130 mEq/liter,
respectively. Total Osomolar concentration: 269 mOsm per liter (calculated). 

Each 100 mL contains Sodium Chloride 600 mg; Sodium Lactate 310 mg; Potassium Chloride 30 mg; Calcium Chloride, Dihydrate 20 mg in Water for Injection.

May contain HCL or NaOH for pH adjustment.

mEq/Liter: Sodium 130; Chloride 109; Lactate 28; Potassium 4.0; Calcium 2.7.

Osomolarity: 269 mOsmol/liter (calc.).

pH: 6.6 (6.0 - 7.5).


Indications



For the correction of electrolyte depletion, metabolic acidosis and dehydration
of cattle, calves, horses, sheep and swine. 


Dosage & Administration:



May be injected intravenously, subcutaneously or
intraperitoneally (except in horses) using strict aseptic technique.

Cattle and Horses: 2 to 5 mL per pound of body weight depending on size and condition
of animal, repeated 1 to 3 times daily or as needed.

Swine and Sheep: 2 to 5 mL per pound of body weight depending on size and condition
of animal, repeated 1 to 3 times daily or as needed.

If administered subcutaneously divide the dosage into several sites of injection and
massage points of injection to aid in absorption and help prevent inflammation and/or sloughing. 

As directed by a veterinarian. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.


Caution:



Solution should be warmed to body temperature prior to administration and
administered at a slow rate. This is a single dose unit. It contains no preservatives. Use entire
contents when first opened. 

Solution should be warmed to body temperature prior to administration and administered at a slow rate. Sterile nonpyrogenic solution. Use only if solution is clear and container is undamaged. This is a single dose unit. It contains no preservatives. Use promptly upon initial entry. If entire contents are not used, discard unused portion. Not for use in the treatment of lactic acidosis. Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found or if the solution contains visible solid particles.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.


Warning:



Do not administer to horses by intraperitoneal injection. Do not administer to
animals with inadequate renal function. Not for use in lactic acidosis. 


Storage And Handling



Store between 15°C-30°C (59°F-86°F)


Warnings And Precautions



TAKE TIME OBSERVE LABEL DIRECTIONS

KEEP OUT OF REACH OF CHILDREN

RX only.


Veterinary Indications



STERILE SOLUTION

FOR ANIMAL USE ONLY


Information For Owners/Caregivers



Manufactured by:

Nova-Tech, Inc.
Grand Island, NE 68801 USA

NDC# 65207-803-60

Nova-Tech®

Animal Health

Net Contents:

1000 mL (33.81 fl oz)

Lot No.

Exp. Date

Assembled in USA

NDC # 65207-803-61

18-803

RMS# 92-2111

365207803613

NDC # 65207-803-80

18-803

RMS 92-2112

365207803803


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.