Electrolyte Solution with Dextrose: Product Information

ELECTROLYTE SOLUTION WITH DEXTROSE- dextrose monohydrate, sorbitol, sodium lactate, sodium chloride, potassium chloride, magnesium chloride and calcium chloride injection, solution
Nova-Tech, Inc.

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.

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. Do not use if solution is not clear. Discard any unused solution.

DOSAGE & 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 & 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.

TAKE TIME OBSERVE LABEL DIRECTIONS

Manufactured by:

Nova-Tech, Inc.
Grand Island, NE 68801 USA

18-804

RMS 92-331

NDC# 65207-805-60

Nova-Tech®

Animal Health

I.V. Solution Injection

Net Contents:

1000 mL (33.81 fl oz)

Assembled in USA

Lot No.

Exp. Date

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Caution:

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

COMPOSITION

Each 500 mL of sterile aqueous
solution contains:
Dextrose • H2 O…………………….12.50 g

Sorbitol……………………………..12.50 g

Sodium Lactate…………………….3.95 g

Sodium Chloride……………………2.40 g

Potassium Chloride………………..0.37 g

Magnesium Chloride . 6H2 O………0.21 g

Calcium Chloride . 2H2 O…………..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

Store between 15°C-30°C (59CF-86°F).

1000 mL Label
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500 mL Label
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1000 mL Label
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500 mL Label
(click image for full-size original)

ELECTROLYTE SOLUTION WITH DEXTROSE
dexolyte injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:65207-804
Route of Administration INTRAVENOUS, INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextrose Monohydrate (Anhydrous Dextrose) Dextrose Monohydrate 12.50 g in 500 mL
Sorbitol (Sorbitol) Sorbitol 12.50 g in 500 mL
Sodium Lactate (Sodium Cation) Sodium Lactate 3.95 g in 500 mL
Sodium Chloride (Chloride Ion) Sodium Chloride 2.40 g in 500 mL
Potassium Chloride (Potassium Cation) Potassium Chloride 0.37 g in 500 mL
Magnesium Chloride (Magnesium Cation) Magnesium Chloride 0.21 g in 500 mL
Calcium Chloride (Calcium Cation) Calcium Chloride 0.19 g in 500 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65207-804-50 500 mL in 1 BOTTLE, PLASTIC None
2 NDC:65207-804-60 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/16/2020
Labeler — Nova-Tech, Inc. (196078976)
Registrant — Nova-Tech, Inc. (196078976)
Establishment
Name Address ID/FEI Operations
Nova-Tech, Inc. 196078976 manufacture, api manufacture

Revised: 03/2020 Nova-Tech, Inc.

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