DEXALYTE SOLUTION injection, solution

Dexalyte Solution by

Drug Labeling and Warnings

Dexalyte Solution by is a Animal medication manufactured, distributed, or labeled by Henry Schein, Nova-Tech, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Indications:

For use in conditions associated with fluid and electrolyte loss, such as
dehydration, shock, vomiting and diarrhea, particularly when an immediate source of
energy is also indicated. 

Contraindications:

Do not administer intraperitoneally to horses.

Caution:

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

Dosage And Administration:

Warm solution to body temperature and administer slowly
(10 to 30 mL per minute) by intravenous or intraperitoneal injection, using strict aseptic
procedures.
Adult Cattle and Horses - 1000 to 2000 mLCalves, Ponies and Foals - 500 to 1000 mLAdult Sheep and Swine - 500 to 1000 mLThese are suggested dosages. The actual amount and rate of fluid 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 500 mL of sterile
aqueous solution contains:
Dextrose  H2O .....................12.50 g
Sorbitol.................................12.50 g
Sodium Lactate........................3.95 g
Sodium Chloride.......................2.40 g
Potassium Chloride...................0.37 g
Magnesium Chloride  6H2O.......0.21 g
Calcium Chloride  2H2O............0.19 g

Milliequivalents per liter

Cations
Sodium............................153 mEq/L
Potassium............................9 mEq/L
Calcium...............................6 mEq/L
Magnesium..........................4 mEq/L
Anions
Chloride...........................101 mEq/L
Lactate..............................71 mEq/L
Osmolarity (calc.)        602 mOsmol/L

PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS

Reorder #: 005940

Questions? (855) 724-3461

Manufactured by:Nova-Tech, Inc.Grand Island, NE 68801

Distributed by:
Henry Schein Animal Health
Dublin, OH 43017
www.henryscheinvet.com

Lot No.            Exp. Date

AH-005940-01
Rev: 1017

18-804
RMS 92-563

ELECTROLYTES - DEXTROSE

1000 mL (33.814 fl oz)

VETERINARY INDICATIONS

FOR ANIMAL USE ONLY

WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OF CHILDREN

CAUTION:

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

STORAGE AND HANDLING

Store between 15°-30°C (59°-86F).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEXALYTE SOLUTION 
dexalyte solution injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-6405
Route of Administration	INTRAVENOUS, INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK)	Dextrose Monohydrate	12.50 g  in 500 mL
Sorbitol (UNII: 506T60A25R) (Sorbitol - UNII:506T60A25R)	Sorbitol	12.50 g  in 500 mL
Sodium Lactate (UNII: TU7HW0W0QT) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Lactate	3.95 g  in 500 mL
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698)	Sodium Chloride	2.40 g  in 500 mL
Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152)	Potassium Chloride	0.37 g  in 500 mL
Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium Chloride	0.21 g  in 500 mL
Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium Chloride	0.19 g  in 500 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6405-1	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6405-5	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2016

Labeler - Henry Schein (603750329)

Registrant - Henry Schein (603750329)

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