SODIUM BICARBONATE injection

Sodium Bicarbonate by

Drug Labeling and Warnings

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

Drug Details [pdf]

INDICATIONS:

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

COMPONENTS

Each mL contains:

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

(equal to 1 mEq/mL)

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

Dosage and Administration:

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

SPL UNCLASSIFIED SECTION

RMS 92-307

L814-100312

Lot No.

Exp. Date

PhoenixTM

Manufactured for:

Clipper Distributing Company, LLC.

St. Joseph, MO 64507

Trademarks are the property of

Clipper Distributing Company, LLC

Take Time Observe Label Directions

Manufactured by:

Nova-Tech, Inc. Grand Island, NE 68801

for Neogen Corporation.

STORAGE AND HANDLING

Store at temperatures between 15°and 30°C (59°-86°F).

WARNINGS AND 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

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.

Package Insert

SODIUM BICARBONATE 8.4%

STERILE NONPYROGENIC SOLUTION

FOR VETERINARY USE ONLY

DESCRIPTION: Sodium Bicarbonate 8.4% is a sterile
nonpyrogenic 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, horses,
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.

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.

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

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.

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.

RMS# 92-516 NTI# 18-9078

Neogen

944 Nandino Blvd

Lexington, KY 40511

859-254-1221 or 800-525-2022

inform@neogen.com

www.neogen.com

L1556-0316

Sodium Bicarbonate

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE 
sodium bicarbonate injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 57319-357
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: 57319-357-05	100 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/20/2011

Labeler - Phoenix (150711039)

Registrant - Nova-Tech, Inc (196078976)

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