LACTATED RINGERS- lactated ringers injection, solution

Drug Labeling and Warnings

Drug Details [pdf]

PRECAUTIONS

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
NET CONTENTS: 1000 mL

INDICATIONS:

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

DOSAGE & ADMINISTRATION

DOSAGE AND 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.

STORAGE AND HANDLING

Store between 15 degrees C - 30 degrees C (59 degrees F - 86 degrees F)

DOSAGE FORMS & STRENGTHS

EACH 100 mL 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 Osmolar Concentration: 269 mOsmol per liter (calculated).

PRECAUTIONS

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. 

WARNINGS

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

INFORMATION FOR OWNERS/CAREGIVERS

Manufactured by

Nova-Tech, Inc.

Grand Island, NE 68801

TAKE TIME OBSERVE LABEL DIRECTIONS

Iss. 04-09

Manufactured for:

A and G Pharmaceuticals

Clarksburg, NJ 08510

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LACTATED RINGERS  
lactated ringers injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 57699-803
Route of Administration	INTRAVENOUS, SUBCUTANEOUS, INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Chloride	600 mg  in 1000 mL
Sodium Lactate (UNII: TU7HW0W0QT) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Lactate	310 mg  in 1000 mL
Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152)	Potassium Chloride	30 mg  in 1000 mL
Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium Chloride	20 mg  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57699-803-60	1000 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/25/2013

Labeler - A & G Pharmaceuticals, Inc. (182147033)

Registrant - A & G Pharmaceuticals, Inc. (182147033)

Establishment
Name	Address	ID/FEI	Business Operations
Nova-Tech Inc.		196078976	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
K+S KALI GmbH		507531213	api manufacture