PEDIATRIC USE SECTION.

8.4 Pediatric Use. ENTERO VU 24% is not indicated for pediatricuse.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. Barium sulfate is biologically inert andhas no known pharmacological effects.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. Under physiological conditions, barium sulfatepasses through the gastrointestinal tract in an unchanged form andis absorbed only in small, pharmacologically insignificant amounts.

PREGNANCY SECTION.

8.1 Pregnancy. Risk SummaryENTERO VU 24% is not absorbed systemicallyfollowing oral administration, and maternal use is not expected toresult in fetal exposure to the drug.

SPL UNCLASSIFIED SECTION.

2.1 Recommended Dosing. The recommended oral dose of ENTERO VU 24% is:Adults: 600 mL The recommended oral dose of ENTERO VU 24% is:Adults: 600 mL Adults: 600 mL.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. Due to its high atomic number, barium (theactive ingredient in ENTERO VU 24%) is opaque to x-rays and thereforeacts as positive contrast agent for radiographic studies.. 12.2 Pharmacodynamics. Barium sulfate is biologically inert andhas no known pharmacological effects.. 12.3 Pharmacokinetics. Under physiological conditions, barium sulfatepasses through the gastrointestinal tract in an unchanged form andis absorbed only in small, pharmacologically insignificant amounts.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactions have beenidentified from spontaneous reporting or clinical studies of bariumsulfate administered orally. Because the reactions are reported voluntarilyfrom population of uncertain size, it is not always possible toreliably estimate their frequency or to establish causal relationshipto drug exposure:Nausea, vomiting, diarrhea and abdominal crampingSerious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Nausea, vomiting, diarrhea and abdominal cramping. Serious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Common adverse reactions includenausea, vomiting, diarrhea and abdominal cramping (6)To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. ENTERO VU 24% is contraindicated in patientswith the following conditions:known or suspected perforation of the GI tractknown obstruction of the GI tracthigh risk of GI perforation such as those with recentGI perforation, acute GI hemorrhage or ischemia, toxic megacolon,severe ileus, post GI surgery or biopsy, acute GI injury or burn,or recent radiotherapy to the pelvishigh risk of aspiration such as those with known or suspectedtracheo-esophageal fistula or obtundationknown severe hypersensitivity to barium sulfate or any ofthe excipients of ENTERO VU 24%. known or suspected perforation of the GI tract. known obstruction of the GI tract. high risk of GI perforation such as those with recentGI perforation, acute GI hemorrhage or ischemia, toxic megacolon,severe ileus, post GI surgery or biopsy, acute GI injury or burn,or recent radiotherapy to the pelvis. high risk of aspiration such as those with known or suspectedtracheo-esophageal fistula or obtundation. known severe hypersensitivity to barium sulfate or any ofthe excipients of ENTERO VU 24%. Known or suspected perforation of the gastrointestinal (GI)tract (4)Known obstruction of the GI tract (4)Conditions associated with high risk of GI perforation oraspiration (4)Known hypersensitivity to barium sulfate or any of the excipientsof ENTERO VU 24% (4). Known or suspected perforation of the gastrointestinal (GI)tract (4). Known obstruction of the GI tract (4). Conditions associated with high risk of GI perforation oraspiration (4). Known hypersensitivity to barium sulfate or any of the excipientsof ENTERO VU 24% (4).

DESCRIPTION SECTION.

11 DESCRIPTION. ENTERO VU 24% (barium sulfate)is radiographic contrast agent that is supplied as suspension(24% w/v) for oral administration. The active ingredient barium sulfateis designated chemically as BaSO4 with molecularweight of 233.4 g/mol, density of 4.5 g/cm3, and the following chemical structureENTERO VU 24% contains the following excipients:acacia, carrageenan, citric acid, methylcellulose, natural and artificialblueberry flavor, polysorbate 80, potassium chloride, potassium sorbate,purified water, saccharin sodium, simethicone emulsion, sodium benzoate,sodium citrate, sorbitol solution, and xanthan gum.. Barium Sulfate Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. For oral use only:Adults: Recommended dose is 600 mL (2.1) For oral use only:Adults: Recommended dose is 600 mL (2.1) Adults: Recommended dose is 600 mL (2.1). 2.1 Recommended Dosing. The recommended oral dose of ENTERO VU 24% is:Adults: 600 mL The recommended oral dose of ENTERO VU 24% is:Adults: 600 mL Adults: 600 mL. 2.2 Administration Instructions. For oral use onlyShake bottle vigorously prior to oral administration tofully suspend productAdminister undilutedDiscard any unused suspensionAdvise patients to hydrate following the barium sulfateprocedureAdvise patient at risk for constipation or delayed gastrointestinaltransit to monitor for worsening of their condition after administrationof barium sulfate and seek medical attention if worsening and adviseusing laxatives to enhance gastrointestinal transit.. For oral use only. Shake bottle vigorously prior to oral administration tofully suspend product. Administer undiluted. Discard any unused suspension. Advise patients to hydrate following the barium sulfateprocedure. Advise patient at risk for constipation or delayed gastrointestinaltransit to monitor for worsening of their condition after administrationof barium sulfate and seek medical attention if worsening and adviseusing laxatives to enhance gastrointestinal transit.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Oral suspension: barium sulfate(24% w/v) supplied in single-dose white HDPE plastic bottle as aready-to-use suspension for oral administration. Each bottle contains600 mL of suspension.. Oral Suspension: barium sulfate (24% w/v) supplied in singledose bottle (3). Oral Suspension: barium sulfate (24% w/v) supplied in singledose bottle (3).

GERIATRIC USE SECTION.

8.5 Geriatric Use. Clinical studies of ENTERO VU 24% did notinclude sufficient numbers of subjects aged 65 and over to determinewhether they respond differently from younger subjects. Other reportedclinical experience has not identified differences in responses betweenthe elderly and younger patients. In general, dose selection for anelderly patient should be cautious, usually starting at the low endof the dosing range, reflecting the greater frequency of decreasedhepatic, renal, or cardiac function, and of concomitant disease orother drug therapy.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGEAND HANDLING. 16.1 How SuppliedENTERO VU 24% (barium sulfate)is supplied as suspension (24% w/v) in single-dose HDPE plasticbottle containing 600 mL of barium sulfate suspension (24% w/v). Provided as: x 600 mL bottles(NDC 32909-146-06). 16.2 Storage and HandlingStore at USP controlled roomtemperature 20C to 25C (68F to 77 F). Protect from freezing.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. ENTERO VU 24% is indicated foruse in small bowel radiographic examinations to visualize the gastrointestinal(GI) tract in adult patients.. ENTERO VU 24% is radiographiccontrast agent indicated for use in small bowel radiographic examinationsto visualize the gastrointestinal (GI) tract in adult patients (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. After administration, advise patients to:Maintain adequate hydration [see Dosage and Administration(2.2) and Warnings and Precautions(5.3)].Seek medical attention for worsening of constipation orslow gastrointestinal passage [see Warnings and Precautions(5.3)].Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty [see Warnings andPrecautions (5.1)].Rx onlyManufacturedbyEZEM Canada IncAnjou (Quebec) Canada H1J2Z4ForBracco Diagnostics Inc.Monroe Township, NJ 08831CL10F501rev.06/20. Maintain adequate hydration [see Dosage and Administration(2.2) and Warnings and Precautions(5.3)].. Seek medical attention for worsening of constipation orslow gastrointestinal passage [see Warnings and Precautions(5.3)].. Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty [see Warnings andPrecautions (5.1)].

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. Due to its high atomic number, barium (theactive ingredient in ENTERO VU 24%) is opaque to x-rays and thereforeacts as positive contrast agent for radiographic studies.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. No animal studies have beenperformed to evaluate the carcinogenic potential of barium sulfateor potential effects on fertility.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Entero Vu(TM)24% 600 ml Inner PackageBarium Sulfate SuspensionNDC: 32909-146-06Entero Vu(TM) 24% 600 ml Outer PackageBarium Sulfate SuspensionNDC: 32909-146-06. Entero Vu 24% Inner Package Label. Entero Vu 24% Outer Package Label.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryENTERO VU 24% is not absorbed systemicallyfollowing oral administration, and maternal use is not expected toresult in fetal exposure to the drug.. 8.2 Lactation. Risk SummaryENTERO VU 24% isnot absorbed systemically by the mother following oral administration,and breastfeeding is not expected to result in exposure of the infantto the drug.. 8.4 Pediatric Use. ENTERO VU 24% is not indicated for pediatricuse.. 8.5 Geriatric Use. Clinical studies of ENTERO VU 24% did notinclude sufficient numbers of subjects aged 65 and over to determinewhether they respond differently from younger subjects. Other reportedclinical experience has not identified differences in responses betweenthe elderly and younger patients. In general, dose selection for anelderly patient should be cautious, usually starting at the low endof the dosing range, reflecting the greater frequency of decreasedhepatic, renal, or cardiac function, and of concomitant disease orother drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1)Intra-abdominal barium leakage: May occur in conditionssuch as GI fistula, ulcer, inflammatory bowel disease, appendicitis, diverticulitis, severe stenosis or obstructing lesions of the GItract (5.2)Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure to avoidobstruction or impaction (5.3)Aspiration Pneumonitis: Patients with history of foodaspiration or with swallowing disorders are at increased risk. Monitorpatients for aspiration (5.4). Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1). Intra-abdominal barium leakage: May occur in conditionssuch as GI fistula, ulcer, inflammatory bowel disease, appendicitis, diverticulitis, severe stenosis or obstructing lesions of the GItract (5.2). Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure to avoidobstruction or impaction (5.3). Aspiration Pneumonitis: Patients with history of foodaspiration or with swallowing disorders are at increased risk. Monitorpatients for aspiration (5.4). 5.1 HypersensitivityReactions. Barium sulfate preparations contain number of excipients, includingnatural and artificial flavors and may induce serious hypersensitivityreactions. The manifestations include hypotension, bronchospasm andother respiratory impairments, and dermal reactions including rashes,urticaria and itching. history of bronchial asthma, atopy, foodallergies, or previous reaction to contrast agent may increasethe risk for hypersensitivity reactions. Emergency equipment andtrained personnel should be immediately available for treatment ofa hypersensitivity reaction.. 5.2 Intra-abdominalBarium Leakage. The use of ENTERO VU 24% is contraindicated in patients at high riskof perforation of the GI tract [see Contraindications (4)]. Administration of ENTERO VU24% may result in leakage of barium from the GI tract in the presenceof conditions that increase the risk of perforation such as knowncarcinomas, GI fistula, inflammatory bowel disease, gastric or duodenalulcer, appendicitis, diverticulitis, and in patients with severestenosis at any level of the GI tract, especially if it is distalto the stomach. Barium leakage has been associated with peritonitisand granuloma formation. 5.3 Delayed GastrointestinalTransit and Obstruction. Orally administered barium sulfate may accumulateproximal to constricting lesion of the colon, causing obstructionor impaction with development of baroliths (inspissated barium associatedwith feces) and may cause abdominal pain, appendicitis, bowel obstruction,or perforation. Patients with the following conditions are at higherrisk for developing obstruction or baroliths: severe stenosis atany level of the GI tract, impaired GI motility, electrolyte imbalance,dehydration, on low residue diet, on medications that delay GI motility,constipation, and the elderly [see Use in Specific Populations(8.5)]. To reduce the riskof delayed GI transit and obstruction, patients should maintain adequatehydration after the barium sulfate procedure.. 5.4 Aspiration Pneumonitis. The use of ENTERO VU 24% iscontraindicated in patients with trachea-esophageal fistula [see Contraindications (4)]. Oral administration of barium is associated with aspiration pneumonitis,especially in patients with history of food aspiration or with compromisedswallowing mechanism. Vomiting following oral administration of bariumsulfate may lead to aspiration pneumonitis. In patients at risk foraspiration, begin the procedure with small ingested volume of ENTEROVU 24%. Monitor the patient closely for aspiration, discontinue administrationof ENTERO VU 24% if aspiration is suspected, and monitor for developmentof aspiration pneumonitis.. 5.5 Systemic Embolization. Barium sulfate products may occasionallyintravasate into the venous drainage of the large bowel and enterthe circulation as barium embolus leading to potentially fatalcomplications which include systemic and pulmonary embolism, disseminatedintravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is uncommon after oral administrationof barium sulfate suspension, monitor patients for potential intravasationwhen administering barium sulfate.. 5.6 Risk with HereditaryFructose Intolerance. ENTERO VU 24% contains sorbitol which maycause severe symptoms if ingested by patients with hereditary fructoseintolerance. Severe symptoms may include the following: vomiting,hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, andkidney failure. Before administration of ENTERO VU 24% assess patientsfor history of hereditary fructose intolerance and avoid use inthese patients.