NEOGENVET SODIUM BICARBONATE- sodium bicarbonate injection

NeogenVet Sodium Bicarbonate by

Drug Labeling and Warnings

NeogenVet Sodium Bicarbonate by is a Animal medication manufactured, distributed, or labeled by Neogen Corporation, Nova-Tech, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

USE IN SPECIFIC POPULATIONS

FOR ANIMAL USE ONLY

Each mL contains:

Sodium Bicarbonate..........................84 mg

(equal to 1 mEq/mL)

Water for Injection...........................q.s.

STORAGE AND HANDLING

Store at a temperature between 15°-30°C(59°-86°F). Avoid freezing.

USER SAFETY WARNINGS

KEEP OUT OF REACH OF CHILDREN

Indications:

For treatment fo metabolic acidosis. See package insert for specific indications.

Dosage and Administration:

Administer intravenously. See package insert for complete directions for use and dosage information.

Warning:

This is a sterile single dose vial. No preservatives have been added. Discard unused portion after use. Do not use if solution is hazy, cloudy, or contains a precipitate.

The total osmolar concentration of this package is approximately 2000 mOsm/L.

Read entire package insert before use.

Caution:

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

SPL UNCLASSIFIED SECTION

Item No. 09078

RMS 92-305

Made in the USA

NDC: 59051-9078-5

Sodium Bicarbonate 8.4%

Sterile Solution

Net Contents: 100 mL

Lot No.

Exp. Date:

Manufactured by: Nova-Tech, Grand Island, NE 68801

Manufactured for: Neogen Corporation Lexington, KY 40511

859-254-1221 animalsafety.neogen.com

L568-0518

Package Insert

NEOGENVet

SODIUM BICARBONATE 8.4%

STERILE NONPYROGENIC SOLUTION

FOR VETERINARY USE ONLY

DESCRIPTION: Sodium Bicarbonate 8.4% is a sterile nonpyrogentic preparation of sodium bicarbonate (NaHCO3) in water for Injection. Each 100 mL contains 8.4 grams of sodium bicarbonate (100 mEq/100 mL each of sodium and bicarbonate). This concentrated solution has an approximate pH of 7.8.

ACTIONS: Sodium Bicarbonate is useful in the treatment of metabolic acidosis due to a wide variety of causes. Sodium Bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis. Sodium Bicarbonate also alkalinizes the urine.

INDICATIONS: Sodium Bicarbonate is indicated in the treatment of metabolic acidosis which may be due to severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, cardiac arrest and severe primary lactic acidosis. Sodium Bicarbonate is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Sodium Bicarbonate 8.4% is indicated in the treatment of metabolic acidosis in cattle, horse, sheep, swine and dogs depending upon causative factor.

CONTRAINDICATIONS: Sodium Bicarbonate is contraindicated in animals losing chloride by vomiting and in animals receiving diuretics known to produce a hypochloremic alkalosis.

PRECAUTIONS: Bicarbonate therapy is directed at producing a substantial correction of low total CO2 content and blood pH, but risks of overdosage and alkalosis should be avoided. Repeated fractional doses and periodic monitoring by appropriate laboratory tests are therefore recommended to minimize the possibility of overdosage. Sodium Bicarbonate addition to parenteral solutions containing calcium should be avoided except where compatibility has been previously established. Precipitation or haze may result from sodium bicarbonate-calcium admixtures, and the resulting solution should not be administered.

HOW SUPPLIED: Sodium Bicarbonate 8.4% is supplied in a 100 mL single dose vial.

Store at a temperature between 15°-30° C (59°-86° F).

CAUTION: Federal law (U.S.A.) restricts this drug to use by or on the order of a licensed veterinarian.

NEOGEN

NEOGENVet

Sodium Bicarbonate 8.4%

STERILE NONPYROGENIC SOLUTION

FOR VETERINARY USE ONLY

DOSAGE AND ADMINISTRATION: Sodium Bicarbonate 8.4% is injected intravenously. Caution should be taken in emergencies where very rapid infusion of large quantities of bicarbonate is indicated, such as cardiac arrest. Sodium Bicarbonate solutions are hypertonic and may produce an undesirable rise in plasma sodium concentration during the process of correction of metabolic acidosis. During cardiac arrest, however, the risks from acidosis exceed those of hypernatremia. In cattle and horses, 200 to 300 mL of 8.4% solution may be given undiluted by rapid infusion using a needle and syringe.

Sodium Bicarbonate 8.4% solution is often added to other intravenous fluids for the less urgent forms of metabolic acidosis. The amount of bicarbonate to be given over a 4 to 8 hour period is approximately 2 to 5 mEq per kg of body weight (1-2.5 mL/lb body weight) depending upon the severity of the acidosis as judged by the lowering of total CO2 content, blood pH and clinical condition of the animal.

Bicarbonate therapy should always be planned in stepwise fashion since the degree of response from a given dose is not precisely predictable. Initially, an infusion of 2 to 5 mEq per kg of body weight over a period of 4 to 8 hours will produce a measurable improvement in the abnormal acid-base status of the blood. Completion of therapy is dependent upon the clinical response of the animal. If severe symptoms have abated, then frequency of administration and size of the dose should be reduced.

OVERDOSAGES: In case alkalosis occurs, the bicarbonate should be stopped and the animal managed according to the degree of alkalosis present. Sodium chloride injection (0.9%) may be given intravenously; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany, and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis.

WARNING: This is a sterile single dose vial. No preservatives have been added. Discard unused portion after use. Do not use if solution is hazy, cloudy or contains a precipitate.

Manufactured by: Nova-Tech, Grand Island, NE 68801

Manufactured for: Neogen Corporation, Lexington, KY 40511

859-254-1221 animalsafety.neogen.com L1556-0220

RMS# 92-516 NTI# 18-9078

NEOGEN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEOGENVET SODIUM BICARBONATE 
sodium bicarbonate injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 59051-9078
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	84 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59051-9078-5	100 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/10/2012

Labeler - Neogen Corporation (042125879)

Registrant - Nova-Tech, Inc (196078976)

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