SALINE- saline solution injection, solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Available from:
Clipper
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 0.9 g in 100 mL
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION
Therapeutic indications:
For use in replacement therapy of sodium, chloride and water which may become depleted in many diseases.  Because this solution is isotonic with body fluids, it may also be used as a solvent or diluent, for antibiotics and other pharmaceuticals and biologicals where compatible, and for washing mucous membranes and other tissue surfaces. FOR ANIMAL USE ONLY KEEP OUT OF REACH OF CHILDREN
Authorization status:
unapproved drug other
Authorization number:
57319-555-06, 57319-555-08

SALINE- saline solution injection, solution

Clipper

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Saline Solution 0.9%

INDICATIONS:

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

diseases. Because this solution is isotonic with body fluids, it may also be used as a solvent or diluent,

for antibiotics and other pharmaceuticals and biologicals where compatible, and for washing mucous

membranes and other tissue surfaces.

CAUTION:

This product contains no preservatives. Use entire contents when first opened. Discard any unused

solution.

DOSAGE AND ADMINISTRATION:

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. When used as a solvent or

diluent for pharmaceuticals and biologicals, follow manufacturer's directions.

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION:

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

COMPOSITION:

Each 100 mL of sterile aqueous solution contains:

Sodium Chloride ....................................... 0.9 g

Milliequivalents per liter

Cations

Sodium ....................................... 154 mEq/L

Anions

Chloride ..................................... 154 mEq/L

Total osmolarity is 308 milliosmoles per liter.

Store between 15 degrees C and 30 degrees C (59 degrees F and 86 degrees F).

TAKE TIME OBSERVE LABEL DIRECTIONS

SALINE

saline solution injection, solution

Product Information

Product T ype

PRESCRIPTION ANIMAL DRUG

Ite m Code (Source )

NDC:57319 -555

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

SODIUM CHLORIDE

0 .9 g in 10 0 mL

Clippe r

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:57319 -555-0 8

10 0 0 mL in 1 BOTTLE, PLASTIC

2

NDC:57319 -555-0 6

250 mL in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 5/0 5/20 14

Labeler -

Clipper (150711039)

Registrant -

Clipper (150711039)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

No va-Tech, Inc.

19 6 0 78 9 76

ma nufa c ture

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Mo rto n Salt, Inc

1376 58 0 43

api manufacture

Revised: 4/2014

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