NDC 32909-927-03 NeuLumEX™ BARIUM SULFATE SUSPENSION (0.1% w/v)

DESCRIPTION:

DESCRIPTION SECTION

NeuLumEX is a barium sulfate suspension 0.1% w/v, 0.1% w/w for oral administration. Each 100 mL contains 0.1 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: citric acid, natural gum, benzoic acid, sodium citrate, natural and artificial blueberry flavor, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, and sorbitol.

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. Barium sulfate is biologically inert and, therefore, is not absorbed or metabolized by the body, and is eliminated from the GI tract unchanged.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

For use in Computed Tomography to opacify the GI tract.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

This product should not be used in patients with known or suspected gastrointestinal perforation or hypersensitivity to barium sulfate or any component of this barium sulfate formulation.

WARNINGS:

WARNINGS SECTION

Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Appropriately trained personnel and facilities should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur.

PRECAUTIONS:

PRECAUTIONS SECTION

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

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, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities.

ALLERGIC REACTIONS:

SPL UNCLASSIFIED SECTION

Due to the increased likelihood of allergic reactions in atopic patients, it is important that a complete history of known and suspected allergies as well as allergic-like symptoms, e.g., rhinitis, bronchial asthma, eczema and urticaria, be obtained prior to any medical procedure utilizing these products. A mild allergic reaction would most likely include generalized pruritus, erythema or urticaria (approximately 1 in 250,000). Such reactions will generally respond to an antihistamine such as 50 mg of diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 1,000,000) laryngeal edema, bronchospasm or hypotension could develop. Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately with 0.3 to 0.5 cc of 1:1000 epinephrine subcutaneously. If bronchospasm predominates, 0.25 to 0.50 grams of intravenous aminophylline should be given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids, even if given intravenously, exert no significant effect on the acute allergic reactions for a few hours. The administration of these agents should not be regarded as emergency measures for the treatment of allergic reactions. Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature and are best treated by having the patient lie flat for an additional 10 to 30 minutes under observation.

OVERDOSAGE:

OVERDOSAGE SECTION

On rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. These indicated responses can be present in both fluoroscopic and CT procedures. These are transitory in nature and are not considered serious. Symptoms may be treated according to currently accepted standards of medical care.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

The volume of the CT barium sulfate suspension to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the technique employed.

STORAGE:

STORAGE AND HANDLING SECTION

USP controlled room temperature, 20° to 25°C (68° to 77°F). Protect from freezing.

HOW SUPPLIED:

HOW SUPPLIED SECTION

NeuLumEX is supplied in the following quantity: 450 mL bottles, NDC 32909-927-03 Rx Only SHAKE WELL PRIOR TO USE Manufactured by E-Z-EM Canada Inc for Bracco Diagnostics Inc. Monroe Township, NJ 08831 Tel: 1-516-333-8230 1-800-544-4624 rev. 02/20 CL110501

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeuLumEx Carton NDC 32909-927-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeuLumEx Bottle NDC 32909-927-03