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
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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) |