DEXTROSE 50% SOLUTION- dextrose injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Available from:

MasterVet

Administration route:

INTRAVENOUS

Prescription type:

OTC

Therapeutic indications:

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

Authorization status:

unapproved drug other

Summary of Product characteristics

DEXTROSE 50% SOLUTION- DEXTROSE INJECTION, SOLUTION
MASTERVET
_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._
----------
DEXTROSE 50% SOLUTION
DOSAGE AND ADMINISTRATION:
Administer 50 mL per 100 lbs body weight intravenously only. Dosage
may be repeated
in 8 to 10 hours or on successive days as needed.
INDICATIONS
For use in cattle as an aid in the treatment of uncomplicated primary
ketosis.
CAUTION:
This product should be warmed to body temperature and administered
slowly. This
product contains no preservatives. Do not use if solution is not
clear. Entire contents
should be used opening. Discard any unused portion.
FOR ANIMAL USE ONLY.
KEEP OUT OF REACH OF CHILDREN.
CONTAINS
Dextrose H O................................................50% w/v
STORE BETWEEN 15°C-30°C (59°F-86°F).
TAKE TIME OBSERVE LABEL DIRECTIONS
Manufactured by:
Nova-Tech, Inc.
Grand Island, NE 68801 USA
18-801
RMS 92-2145
NDC# 86156-801-50
Dextrose 50% Solution
Sterile Solution
MasterVet
#13102
2
#13102
Net Contents:
500 mL (16.91 fl oz)
Assembled in USA
Lot No. Exp. Date
DEXTROSE 50% SOLUTION
dextrose injection, solution
PRODUCT INFORMATION
PRODUCT TYPE
OTC ANIMAL DRUG
ITEM CODE (SOURCE)
NDC:86156-801
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:86156-801-50
500 mL in 1 BOTTLE, PLASTIC
MasterVet
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
unapproved drug
other
03/13/2020
LABELER -
MasterVet (117591269)
REGISTRANT -
Nova-Tech, Inc. (196078976)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Nova-Tech, Inc.
196078976
analysis, api manufacture
Revised: 12/202