Lactated Ringers: Product Information

LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride and calcium chloride injection, solution
Nova-Tech, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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).

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.

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.

WARNING:

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

Store between 15°C-30°C (59°F-86°F)

TAKE TIME OBSERVE LABEL DIRECTIONS

KEEP OUT OF REACH OF CHILDREN

STERILE SOLUTION

FOR ANIMAL USE ONLY

CAUTION:

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

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

1000 ml product label
(click image for full-size original)
1000 ml product label
(click image for full-size original)

LACTATED RINGERS
lactated ringers injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:65207-803
Route of Administration INTRAVENOUS, SUBCUTANEOUS, INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 600 mg in 100 mL
SODIUM LACTATE (LACTIC ACID) SODIUM LACTATE 310 mg in 100 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CATION 30 mg in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 20 mg in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65207-803-60 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/18/2020
Labeler — Nova-Tech, Inc. (196078976)
Registrant — Nova-Tech, Inc. (196078976)
Establishment
Name Address ID/FEI Operations
Nova-Tech, Inc. 196078976 manufacture, api manufacture

Revised: 03/2020 Nova-Tech, Inc.

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