Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)
E-Z-EM Canada Inc
ORAL
PRESCRIPTION DRUG
For use in Computed Tomography to opacify the GI tract. 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.
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
unapproved drug other
NEULUMEX- BARIUM SULFATE SUSPENSION E-Z-EM CANADA 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._ ---------- NDC 32909-927-03 NEULUMEX™ BARIUM SULFATE SUSPENSION (0.1% W/V) DESCRIPTION: 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 . 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: 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: For use in Computed Tomography to opacify the GI tract. CONTRAINDICATIONS: 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: 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 4 and should remain available for at Les hele dokumentet