Polibar Plus, Liquid

Name: Polibar Plus, Liquid

Polibar Plus, Liquid Description

LIQUID POLIBAR PLUS® Barium Sulfate Suspension (105% w/v, 58% w/w) is a barium sulfate suspension for oral and rectal administration. Each 100 mL contains 105 g barium sulfate. Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO4. Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, solutions of acids and alkalies, and organic solvents.

Inactive Ingredients

acacia, citric acid, hydrochloric acid, natural and artificial vanilla flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium carrageenan, sodium citrate, sorbitol solution and xanthan gum.

Indications and Usage for Polibar Plus, Liquid

For radiography of the gastrointestinal tract.

Oral administration

Esophagus and Cardiac Series

Undiluted LIQUID POLIBAR PLUS® should be administered orally for double-contrast examination of the esophagus. Films are taken during rapid swallowing of barium sulfate.
Typical Adult Dose: 60 mL to 300 mL

Stomach

LIQUID POLIBAR PLUS® can be used for single or double-contrast examination of the stomach. It can be used undiluted or diluted 1:1 with water to produce a 52.5% w/v. Diluted LIQUID POLIBAR PLUS® is highly suited for a biphasic examination of the stomach. Following completion of the double-contrast examination of the stomach using E-Z-HD™ barium sulfate, undiluted or diluted 1:1 with water, LIQUID POLIBAR PLUS® may be used for the single phase of the study.
Typical Adult Dose: 150 mL to 340 mL of diluted or undiluted as applicable.

Small Bowel Series

LIQUID POLIBAR PLUS® can be used for small bowel series. It can be given alone or can be used following the completion of a double-contrast examination of the stomach using E-Z-HD™. It may be given either undiluted or in 1:1 dilution. Higher dilution will decrease the density of the barium sulfate but will increase the speed of the flow of contrast.
Typical Adult Dose: 340 mL to 750 mL of diluted or undiluted as applicable.

How is Polibar Plus, Liquid Supplied

LIQUID POLIBAR PLUS® is supplied as follows:
1900 mL jugs, Cat. No. L168, NDC 32909-168-02.

Rx Only (USA)

SHAKE WELL PRIOR TO USE

Manufactured by
E-Z-EM Canada Inc.
for E-Z-EM, Inc.
a subsidiary of Bracco Diagnostics Inc.
Monroe Township, NJ 08831
Tel: 1-516-333-8230 1-800 544-4624
rev. 08/14 TX1742

Liquid Polibar Plus Carton
NDC:32909-168-02

LIQUID POLIBAR PLUS 
barium sulfate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:32909-168
Route of Administration ORAL, RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
barium sulfate (barium sulfate) barium sulfate 1.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
acacia  
anhydrous citric acid  
dimethicone 350  
dimethicone 1000  
hydrochloric acid  
polysorbate 80  
potassium chloride  
potassium sorbate  
water  
saccharin sodium  
silicon dioxide  
sodium benzoate  
carrageenan  
trisodium citrate dihydrate  
sorbitol  
xanthan gum  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor VANILLA Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:32909-168-02 1900 mL in 1 JUG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/01/1984
Labeler - E-Z-EM Canada Inc (204211163)
Registrant - E-Z-EM, INC. (002041226)
Establishment
Name Address ID/FEI Operations
E-Z-EM Canada Inc 204211163 LABEL(32909-168), ANALYSIS(32909-168), PACK(32909-168), MANUFACTURE(32909-168)
Revised: 02/2015   E-Z-EM Canada Inc
(web3)