ADVERSE REACTIONS SECTION.

ADVERSEREACTIONS:. Adverse reactions,such as nausea, vomiting, diarrhea and abdominal cramping, accompanyingthe use of barium sulfate formulations are infrequent and usuallymild. Severe reactions (approximately in 1,000,000) and fatalities(approximately in 10,000,000) have occurred. Procedural complicationsare rare, but may include aspiration pneumonitis, granuloma formation,intravasation, embolization and peritonitis following intestinal perforation,vasovagal and syncopal episodes, and fatalities.

CLINICAL PHARMACOLOGY SECTION.

CLINICALPHARMACOLOGY:. Barium sulfate, due to its highmolecular density is opaque to x-rays and, therefore, acts as positivecontrast agent for radiographic studies. Barium sulfate is biologicallyinert and, therefore, is not absorbed or metabolized by the body,and is eliminated from the GI tract unchanged.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. This product should not be used in patients withknown or suspected gastrointestinal perforation or hypersensitivityto barium sulfate or any component of this barium sulfate formulation.

DESCRIPTION SECTION.

DESCRIPTION:. NeuLumEX is barium sulfate suspension 0.1% w/v,0.1% w/w for oral administration. Each 100 mL contains 0.1 bariumsulfate. Barium sulfate, due to its high molecular density is opaqueto x-rays and therefore, acts as positive contrast agent for radiographicstudies. The active ingredient is barium sulfate and its structuralformula is BaSO4. Barium sulfate occurs asa fine, white, odorless, tasteless, bulky powder which is free fromgrittiness. Its aqueous suspensions are neutral to litmus. It is practicallyinsoluble 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, potassiumsorbate, purified water, saccharin sodium, simethicone emulsion, sodiumbenzoate, and sorbitol.

DOSAGE & ADMINISTRATION SECTION.

DOSAGEAND ADMINISTRATION:. The volumeof the CT barium sulfate suspension to be administered will dependon the degree and extent of contrast required in the area(s) underexamination and on the technique employed.. For OralAdministration: GI Tract Marking:. The patient should begin drinking NeuLumEXapproximately 20 30 minutes prior to the scheduled procedure. Itis recommended that the patient consume multiple bottles, about 900mL to 1,350 mL total volume prior to the exam or use as directed byphysician. For improved gastric marking have patient consume the final200 mL immediately prior to scan. Bowel marking is consistent dueto the uniformity of the 0.1% concentration of BaSO4. Bowel lumen marking can be improved by increasing the volume ofNeuLumEX consumed (see below). Other dosing regimens may be followedas applicable. In patients where marking is problematic, such as obesityand delayed transit, improved marking may be possible by increasingthe total volume of NeuLumEX administered up to 1,800 mL or four (4)bottles.

DRUG INTERACTIONS SECTION.

Drug Interactions:. The presence of barium sulfate formulations inthe GI tract may alter the absorption of therapeutic agents takenconcomitantly. In order to minimize any potential change in absorption,the separate administration of barium sulfate from that of other agentsshould be considered.

GENERAL PRECAUTIONS SECTION.

General:. Diagnostic procedures which involve the use ofradiopaque contrast agents should be carried out under the directionof personnel with the requisite training and with thorough knowledgeof the particular procedure to be performed. history of bronchialasthma, atopy, as evidenced by hay fever and eczema, or previousreaction to contrast agent, warrant special attention. Caution shouldbe exercised with the use of radiopaque media in severely debilitatedpatients and in those with marked hypertension or advanced cardiacdisease. Ingestion of barium is not recommended in patients with ahistory of food aspiration. If barium studies are required in thesepatients or in patients in whom integrity of the swallowing mechanismis unknown, proceed with caution. If barium is aspirated into thelarynx, further administration should be immediately discontinued.. Informationfor Patients:. Before administrationof this product, patients receiving barium sulfate diagnostic agentsshould be instructed to:Inform their physician if they are pregnant.Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).Inform their physician about any other medications theyare currently taking.Seek immediate medical attention if they experience an allergicreaction after using this product.. Inform their physician if they are pregnant.. Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).. Inform their physician about any other medications theyare currently taking.. Seek immediate medical attention if they experience an allergicreaction after using this product.. Drug Interactions:. The presence of barium sulfate formulations inthe GI tract may alter the absorption of therapeutic agents takenconcomitantly. In order to minimize any potential change in absorption,the separate administration of barium sulfate from that of other agentsshould be considered.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. NeuLumEX is supplied in the following quantity: 450 mL bottles, NDC 32909-927-03Rx OnlySHAKE WELL PRIOR TO USEManufactured byE-Z-EM Canada Incfor Bracco Diagnostics Inc.Monroe Township, NJ 08831Tel: 1-516-333-8230 1-800-544-4624rev. 02/20 CL110501.

INDICATIONS & USAGE SECTION.

INDICATIONSAND USAGE:. For use in Computed Tomography to opacify the GI tract.

INFORMATION FOR PATIENTS SECTION.

Informationfor Patients:. Before administrationof this product, patients receiving barium sulfate diagnostic agentsshould be instructed to:Inform their physician if they are pregnant.Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).Inform their physician about any other medications theyare currently taking.Seek immediate medical attention if they experience an allergicreaction after using this product.. Inform their physician if they are pregnant.. Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).. Inform their physician about any other medications theyare currently taking.. Seek immediate medical attention if they experience an allergicreaction after using this product.

NURSING MOTHERS SECTION.

Nursing Mothers:. Barium sulfate products may be used duringlactation.

OVERDOSAGE SECTION.

OVERDOSAGE:. On rare occasions following repeated administration,severe stomach cramps, nausea, vomiting, diarrhea or constipationmay occur. These indicated responses can be present in both fluoroscopicand CT procedures. These are transitory in nature and are not consideredserious. Symptoms may be treated according to currently accepted standardsof medical care.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

NeuLumEx CartonNDC 32909-927-03. NeuLumEx 32909-927-03 carton.

PRECAUTIONS SECTION.

PRECAUTIONS:. General:. Diagnostic procedures which involve the use ofradiopaque contrast agents should be carried out under the directionof personnel with the requisite training and with thorough knowledgeof the particular procedure to be performed. history of bronchialasthma, atopy, as evidenced by hay fever and eczema, or previousreaction to contrast agent, warrant special attention. Caution shouldbe exercised with the use of radiopaque media in severely debilitatedpatients and in those with marked hypertension or advanced cardiacdisease. Ingestion of barium is not recommended in patients with ahistory of food aspiration. If barium studies are required in thesepatients or in patients in whom integrity of the swallowing mechanismis unknown, proceed with caution. If barium is aspirated into thelarynx, further administration should be immediately discontinued.. Informationfor Patients:. Before administrationof this product, patients receiving barium sulfate diagnostic agentsshould be instructed to:Inform their physician if they are pregnant.Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).Inform their physician about any other medications theyare currently taking.Seek immediate medical attention if they experience an allergicreaction after using this product.. Inform their physician if they are pregnant.. Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).. Inform their physician about any other medications theyare currently taking.. Seek immediate medical attention if they experience an allergicreaction after using this product.. Drug Interactions:. The presence of barium sulfate formulations inthe GI tract may alter the absorption of therapeutic agents takenconcomitantly. In order to minimize any potential change in absorption,the separate administration of barium sulfate from that of other agentsshould be considered.. Usagein Pregnancy:. Radiation is known to cause harmto the unborn fetus exposed in utero. Therefore, radiographic proceduresshould only be used when, in the judgement of the physician, its useis deemed essential to the welfare of the pregnant patient.. Nursing Mothers:. Barium sulfate products may be used duringlactation.

PREGNANCY SECTION.

Usagein Pregnancy:. Radiation is known to cause harmto the unborn fetus exposed in utero. Therefore, radiographic proceduresshould only be used when, in the judgement of the physician, its useis deemed essential to the welfare of the pregnant patient.

SPL UNCLASSIFIED SECTION.

ALLERGICREACTIONS:. Due to the increased likelihoodof allergic reactions in atopic patients, it is important that completehistory of known and suspected allergies as well as allergic-likesymptoms, 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 in 250,000). Such reactionswill generally respond to an antihistamine such as 50 mg of diphenhydramineor its equivalent. In the rarer, more serious reactions (approximately1 in 1,000,000) laryngeal edema, bronchospasm or hypotension coulddevelop. Severe reactions which may require emergency measures areoften characterized by peripheral vasodilation, hypotension, reflextachycardia, dyspnea, agitation, confusion and cyanosis, progressingto unconsciousness. Treatment should be initiated immediately with0.3 to 0.5 cc of 1:1000 epinephrine subcutaneously. If bronchospasmpredominates, 0.25 to 0.50 grams of intravenous aminophylline shouldbe given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids,even if given intravenously, exert no significant effect on the acuteallergic reactions for few hours. The administration of these agentsshould not be regarded as emergency measures for the treatment ofallergic reactions. Apprehensive patients may develop weakness, pallor,tinnitus, diaphoresis and bradycardia following the administrationof any diagnostic agent. Such reactions are usually non-allergic innature and are best treated by having the patient lie flat for anadditional 10 to 30 minutes under observation.

STORAGE AND HANDLING SECTION.

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

WARNINGS SECTION.

WARNINGS:. Rarely, severe allergic reactions of an anaphylactoidnature, have been reported following administration of barium sulfatecontrast agents. Appropriately trained personnel and facilities shouldbe available for emergency treatment of severe reactions and shouldremain available for at least 30 to 60 minutes following administration,since delayed reactions can occur.