DEXTROSE- dextrose monohydrate injection

Dextrose by

Drug Labeling and Warnings

Dextrose by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Bimeda-MTC Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

INDICATIONS:

For use as an aid in the treatment of uncomplicated ketosis in cattle.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION:

Cattle:  100 to 500 mL depending on size and condition of animal.  For intravenous use only.  Solution should be warmed to body temperature and administered slowly.  This product is sterile in unopened container.  Contains no preservative.  If entire contents are not used, discard unused portion.  Handle under strict aseptic conditions.

DESCRIPTION

COMPOSITION:

Each 100 mL contains:

Dextrose Monohydrate ...............50 g

Water for Injection.....................q.s.

May contain hydrochloric acid or sodium hydroxide for pH adjustment.

2525 m0smol/liter (Calculated)

Caloric Value per liter:  1700

Hypertonic                       pH 3.5-6.5

STORAGE AND HANDLING

STORAGE:

STORE BETWEEN 15°C-30°C (59°F-86°F).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEXTROSE 
dextrose monohydrate injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 61133-0295
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	50 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-0295-5	500 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/28/2016

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

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