DEXTROLYTE- electrolyte with dextrose injection, solution

DextroLyte by

Drug Labeling and Warnings

DextroLyte by is a Animal medication manufactured, distributed, or labeled by MWI (VetOne), Nova-Tech, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

For animal use only.  Keep out of reach of children and pets.

CAUTION:

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

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.

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 mL

Calves, Ponies and Foals: 500 to 1000 mL

Adult Sheep and Swine: 500 to 1000 mL

These 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.

CONTRAINDICTIONS:

Do not administer intraperitoneally to horses.

CONTAINS:

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

CAUTION:

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

STORAGE:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEXTROLYTE 
electrolyte with dextrose injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-804
Route of Administration	INTRAVENOUS, INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextrose Monohydrate (UNII: LX22YL083G) (Dextrose - UNII:IY9XDZ35W2)	Dextrose Monohydrate	12.50 g  in 500 mL
Sorbitol (UNII: 506T60A25R) (Sorbic acid - UNII:X045WJ989B)	Sorbitol	12.50 g  in 500 mL
Sodium Lactate (UNII: TU7HW0W0QT) (Lactic acid - UNII:33X04XA5AT)	Sodium Lactate	3.95 g  in 500 mL
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	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: 13985-804-01	1000 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/15/2011

Labeler - MWI (VetOne) (019926120)

Registrant - MWI (VetOne) (019926120)

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