Friday, October 21, 2016

Hypertonic Saline




Generic Name: sodium chloride injection

Dosage Form: FOR ANIMAL USE ONLY

INDICATIONS:


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



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.



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.



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



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



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










Hypertonic Saline 
sodium chloride  injection, solution










Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)13985-031
Route of AdministrationINTRAVENOUS, SUBCUTANEOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (Sodium Cation and Chloride Ion)Sodium Chloride7.2 g  in 1000 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
113985-031-491000 mL In 1 VIALNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/2007


Labeler - MWI/VetOne (019926120)

Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)









Establishment
NameAddressID/FEIOperations
Bimeda-MTC Animal Health, Division of Cross Vetpharm Group256232216manufacture
Revised: 11/2010MWI/VetOne




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