HYPERTONIC SALINE- sodium chloride injection, solution

Hypertonic Saline by

Drug Labeling and Warnings

Hypertonic Saline by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Bimeda, Inc., Bimeda-MTC Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

INDICATIONS:

For use in replacement therapy of sodium, chloride and water which may become depleted in many diseases.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION:

Horses/Cattle:  50 to 100 mL per 100 lb bodyweight.  Warm to body temperature and administer slowly by intravenous or subcutaneous injection.  The amount and rate of administration must be judged by the veterinarian in relation to the condition being treated and the clinical response of the animal, being careful to avoid overhydration.

DOSAGE FORMS & STRENGTHS

COMPOSITION:  Each 100 mL of sterile aqueous solution contains:

Sodium Chloride.............................7.2 g

Milliequivalents per liter

Cations:

Sodium.........................................1232mEq/L

Anions:

Chloride........................................1232mEq/L

Total osmolarity is 2464 milliomoles per liter.

PRECAUTIONS

CAUTION:  This product contains no preservatives.  Use entire contents when opened.  Discard any unused solution.

STORAGE AND HANDLING

Store at controlled room temperature between 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

PRINCIPAL DISPLAY PANEL

1000 mL

VETONE

Hypertonic Saline 7.2%

Solution

Sterile - Preservative Free

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

Keep out of reach of children.

For animal use only.

Net Contents:  1000 mL

INGREDIENTS AND APPEARANCE

HYPERTONIC SALINE 
sodium chloride injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-031
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698)	Sodium Chloride	7.2 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-031-49	1000 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2007

Labeler - MWI/VetOne (019926120)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda-MTC Animal Health		256232216	manufacture