HYPERTONIC SALINE 7.2 % injection, solution

Hypertonic Saline 7.2 % by

Drug Labeling and Warnings

Hypertonic Saline 7.2 % by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Bimeda-MTC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Hypertonic Saline Solution 7.2%

Sterile - Preservative Free

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

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

Net Contents: 1000 mL

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: 50 to 100 mL per 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.

COMPOSITION:

Each 100 mL of sterile aqueous solution contains:

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

Milliequivalents per liter :

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

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

Total osmolarity is 2464 milliosmoles per litter.

PRECAUTIONS

CAUTION:

This product contains no preservatives. Do not use if solution is not clear. Use entire contents when first opened. Discard any unused solution.

STORAGE AND HANDLING

STORAGE:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYPERTONIC SALINE 7.2 % 
hypertonic saline 7.2 % injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-0264
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (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: 61133-0264-9	1000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2005

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

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