E-Z-Paque

VARIBAR THIN LIQUID is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR THIN LIQUID is a radiopaque contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients ( 1 )

VARIBAR THIN LIQUID is contraindicated in patients with: known or suspected perforation of the gastrointestinal (GI) tract known obstruction of the GI tract high risk of GI perforation such as those with a recent GI 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 suspected tracheo-esophageal fistula or obtundation known severe hypersensitivity to barium sulfate or any of the 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 or aspiration ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of VARIBAR THIN LIQUID ( 4 )

Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available ( 5.1 ) Intra-abdominal leakage: May occur in conditions such as GI 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 maintain adequate hydration in days following barium sulfate procedure to avoid obstruction or impaction ( 5.3 ) Aspiration pneumonitis: Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration ( 5.4 )

5.1Hypersensitivity Reactions

Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy, food allergies, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions.