Dextrose 50% Solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Animart

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 50 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

OTC

Therapeutic indications:

Dextrose 50% Solution is indicated for use as an aid in the treatment of uncomplicated primary ketosis in cattle. FOR ANIMAL USE ONLY

Authorization status:

unapproved drug other

Summary of Product characteristics

DEXTROSE- DEXTROSE INJECTION, SOLUTION
ANIMART
_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._
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DEXTROSE 50% SOLUTION
INDICATIONS:
Dextrose 50% Solution is indicated for use as an aid in the treatment
of uncomplicated primary ketosis
in cattle.
DOSAGE AND ADMINISTRATION:
The usual dose is 50 mL per 100 lbs of body weight. Administer
intravenously only. Dosage may be
repeated in 8 to 10 hours or on successive days if necessary.
CAUTION:
Warm to body temperature and administer slowly. This product contains
no preservatives. Do not use is
solution is not clear. Entire contents should be used upon opening.
Discard any unused portion.
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
EACH 100 ML CONTAINS:
Dextrose H O.........................50 g
Water for Injection...................q.s.
STORE BETWEEN 15 DEGREES C - 30 DEGREES C (59 DEGREES F - 86 DEGREES
F).
TAKE TIME OBSERVE LABEL DIRECTIONS
Net Contents: 500 mL
Manufactured by:
Nova-Tech, Inc.
Grand Island, NE 68801 USA
18-801 Iss. 4-14
RMS# 92-1070
Lot No. Exp. Date
2
DEXTROSE
dextrose injection, solution
PRODUCT INFORMATION
PRODUCT T YPE
OTC ANIMAL DRUG
ITE M CODE (SOURCE )
NDC:236 8 5-8 0 1
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G) (ANHYDROUS DEXTROSE -
UNII:5SL0 G7R0 OK)
DEXTROSE
MONOHYDRATE
50 g
in 10 0 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:236 8 5-8 0 1-50
50 0 mL in 1 BOTTLE, PLASTIC
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 6 /12/20 14
LABELER -
Animart (023151574)
REGISTRANT -
Animart (023151574)
Animart
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
No va-Tech, Inc.
19 6 0 78 9 76
manufacture, api manufacture
Revised: 7/