ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactions have been identifiedfrom spontaneous reporting or clinical studies of barium sulfate administeredorally. Because the reactions are reported voluntarily from populationof uncertain size, it is not always possible to reliably estimatetheir frequency or to establish causal relationship to 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. VARIBARTHIN LIQUID is contraindicated in patients with:known or suspected perforation of the gastrointestinal (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 VARIBAR THIN LIQUID. known or suspected perforation of the gastrointestinal (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 VARIBAR THIN LIQUID. 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 VARIBAR THIN LIQUID (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 VARIBAR THIN LIQUID (4).

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. For oral use only- once reconstituted,administer by infant bottle, syringe, spoon, or cup. The recommendeddose is: Adults: mL Pediatric patients months and older: mL to mL Pediatric patients younger than months of age: 0.5 mL to1 mLDuring single modified barium swallow examination, multipledoses may be administeredMaximum cumulative dose: 80 mL (2.1)Must reconstitute supplied powder with water prior to use.See Full Prescribing Information for reconstitution instructions (2.2). During single modified barium swallow examination, multipledoses may be administered. Maximum cumulative dose: 80 mL (2.1). Must reconstitute supplied powder with water prior to use.See Full Prescribing Information for reconstitution instructions (2.2). 2.1 Recommended Dosingand Administration Instructions. The recommended dose of reconstituted VARIBAR THIN LIQUIDadministered orally by infant bottle, syringe, spoon, or cup is:Adults: mLPediatric patients months and older: mL to mLPediatric patients younger than months of age: 0.5 mLto mL During single modified barium swallow examination, multipledoses of VARIBAR THIN LIQUID may be administered, to assess the patientduring multiple swallows and different radiographic views.The maximum cumulative dose is 80 mL.For oral use onlyAdvise patients to hydrate following the barium sulfateprocedure.. The recommended dose of reconstituted VARIBAR THIN LIQUIDadministered orally by infant bottle, syringe, spoon, or cup is:Adults: mLPediatric patients months and older: mL to mLPediatric patients younger than months of age: 0.5 mLto mL Adults: mL. Pediatric patients months and older: mL to mL. Pediatric patients younger than months of age: 0.5 mLto mL During single modified barium swallow examination, multipledoses of VARIBAR THIN LIQUID may be administered, to assess the patientduring multiple swallows and different radiographic views.. The maximum cumulative dose is 80 mL.. For oral use only. Advise patients to hydrate following the barium sulfateprocedure.. 2.2 Instructions forReconstitution. The VARIBAR THIN LIQUID powder must be reconstituted prior to administrationby healthcare provider according to the following instructions:Add water to the fill line on the bottle labelReplace the lid securelyInvert the bottle and tap with fingers to mix the powderinto the waterShake vigorously for 30 seconds. Let stand for minutesRefill with water to the fill line on the bottle label andreshake thoroughly.Once reconstituted, write the discard after date on theimmediate container label. After reconstitution, store in refrigeratorat 2C to 8C (36oF to 46oF) for up to 72 hours.Reconstitution yields approximately 300 mL of VARIBAR THINLIQUID oral suspension containing 0.4 grams of barium sulfate permL (40% w/v) and should be homogeneous and white to lightly colored.. Add water to the fill line on the bottle label. Replace the lid securely. Invert the bottle and tap with fingers to mix the powderinto the water. Shake vigorously for 30 seconds. Let stand for minutes. Refill with water to the fill line on the bottle label andreshake thoroughly.. Once reconstituted, write the discard after date on theimmediate container label. After reconstitution, store in refrigeratorat 2C to 8C (36oF to 46oF) for up to 72 hours.. Reconstitution yields approximately 300 mL of VARIBAR THINLIQUID oral suspension containing 0.4 grams of barium sulfate permL (40% w/v) and should be homogeneous and white to lightly colored.

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 H1J2Z4ForBraccoDiagnostics Inc.Monroe Township, NJ 08831VARIBAR is registered trademark of E-Z-EM,Inc.. 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)].

SPL UNCLASSIFIED SECTION.

2.1 Recommended Dosingand Administration Instructions. The recommended dose of reconstituted VARIBAR THIN LIQUIDadministered orally by infant bottle, syringe, spoon, or cup is:Adults: mLPediatric patients months and older: mL to mLPediatric patients younger than months of age: 0.5 mLto mL During single modified barium swallow examination, multipledoses of VARIBAR THIN LIQUID may be administered, to assess the patientduring multiple swallows and different radiographic views.The maximum cumulative dose is 80 mL.For oral use onlyAdvise patients to hydrate following the barium sulfateprocedure.. The recommended dose of reconstituted VARIBAR THIN LIQUIDadministered orally by infant bottle, syringe, spoon, or cup is:Adults: mLPediatric patients months and older: mL to mLPediatric patients younger than months of age: 0.5 mLto mL Adults: mL. Pediatric patients months and older: mL to mL. Pediatric patients younger than months of age: 0.5 mLto mL During single modified barium swallow examination, multipledoses of VARIBAR THIN LIQUID may be administered, to assess the patientduring multiple swallows and different radiographic views.. The maximum cumulative dose is 80 mL.. For oral use only. Advise patients to hydrate following the barium sulfateprocedure.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryVARIBAR THIN LIQUIDis not absorbed systemically following oral administration, and maternaluse is not expected to result in fetal exposure to the drug.. 8.2 Lactation. Risk SummaryVARIBAR THIN LIQUIDis not 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. The efficacy of VARIBAR THIN LIQUID in pediatricpatients is based on successful opacification of the pharynx duringmodified barium swallow examinations [see Clinical Pharmacology(12.1)]. Safety and dosingrecommendations in pediatric patients are based on clinical experience.VARIBAR THIN LIQUID is contraindicatedin pediatric patients with trachea-esophageal fistula. [seeContraindications (4)]. Pediatricpatients with history of asthma or food allergies may be at increasedrisk for development of hypersensitivity reactions [see Warningsand Precautions (5.1)]. Monitorpatients with cystic fibrosis or Hirschsprung disease for bowel obstructionafter use [see Warnings and Precautions (5.3)].. 8.5 GeriatricUse. Clinicalstudies of VARIBAR THIN LIQUID did not include sufficient numbersof subjects aged 65 and over to determine whether they respond differentlyfrom younger subjects. Other reported clinical experience has notidentified differences in responses between the elderly and youngerpatients. In general, dose selection for an elderly patient shouldbe cautious, usually starting at the low end of the dosing range,reflecting the greater frequency of decreased hepatic, renal, or cardiacfunction, and of concomitant disease or other drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1)Intra-abdominal leakage: May occur in conditions such asGI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis,severe stenosis or obstructing lesions of the GI tract (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: Aspiration may occur during themodified barium swallow examination, monitor the patient for aspiration(5.4). Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1). Intra-abdominal leakage: May occur in conditions such asGI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis,severe stenosis or obstructing lesions of the GI tract (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: Aspiration may occur during themodified barium swallow examination, monitor the patient 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 and trainedpersonnel should be immediately available for treatment of hypersensitivityreaction.. 5.2 Intra-abdominalBarium Leakage. The use of VARIBAR THIN LIQUID is contraindicated in patients athigh risk of perforation of the GI tract [see Contraindications(4)]. Administration of VARIBARTHIN LIQUID may result in leakage of barium from the GI tract in thepresence of conditions such as carcinomas, GI fistula, inflammatorybowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis,and in patients with severe stenosis at any level of the GI tract,especially if it is distal to the stomach. The barium leakage hasbeen associated with peritonitis and granuloma formation.. 5.3 DelayedGastrointestinal Transit 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 lead to abdominal pain, appendicitis, bowel obstruction,or rarely perforation. Patients with the following conditions areat higher risk for developing obstruction or baroliths: severe stenosisat any level of the GI tract, impaired GI motility, electrolyte imbalance,dehydration, on low residue diet, taking medications that delayGI motility, constipation, pediatric patients with cystic fibrosisor Hirschsprung disease, and the elderly [see Use in SpecificPopulations (8.4, 8.5)]. To reduce the risk of delayedGI transit and obstruction, patients should maintain adequate hydrationafter the barium sulfate procedure.. 5.4 AspirationPneumonitis. The use of VARIBAR THIN LIQUID is contraindicated in patients withtrachea-esophageal fistula [see Contraindications (4)]. Oral administration of bariumis associated with aspiration pneumonitis, especially in patientswith history of food aspiration or with compromised swallowing mechanism.Vomiting following oral administration of barium sulfate may leadto aspiration pneumonitis.In patients at risk for aspiration, beginthe procedure with small ingested volume of VARIBAR THIN LIQUID.Monitor the patient closely for aspiration, discontinue administrationof VARIBAR THIN LIQUID if aspiration is suspected, and monitor fordevelopment of aspiration pneumonitis.. 5.5 Systemic Embolization. Barium sulfate products may occasionallyintravasate into the venous drainage of the GI tract and enter thecirculation as barium embolus leading to potentially fatal complicationswhich include systemic and pulmonary embolism, disseminated intravascularcoagulation, septicemia and prolonged severe hypotension. Althoughthis complication is exceedingly uncommon after oral administrationof barium sulfate suspension, monitor patients for potential intravasationwhen administering barium sulfate.