LIQUID POLIBAR PLUS

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 BaSO 4 . 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.

For radiography of the gastrointestinal tract.

General The volume and concentration of LIQUID POLIBAR PLUS ® to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed. See applicable system below for typical adult dose. Patient Preparation for Colon Examinations In order to achieve optimum results, the colon must be cleansed prior to the use of a barium enema. This is usually accomplished by placing the patient on a low fat, low residue diet, combined with the use of laxatives and/or cathartics. A cleansing enema may also be used unless contraindicated.

Oral Administration This product should not be used in patients with known gastric or intestinal perforation or hypersensitivity to barium sulfate products. Rectal Administration This product should not be used in patients with known intestinal perforation or hypersensitivity to barium sulfate products.

Adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been reported following or during barium enema procedures. It is of the utmost importance to be completely prepared to treat any such occurrence.

STORAGE USP Controlled Room Temperature, 20 to 25°C (68 to 77°F). Protect from freezing.