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INDICATIONS AND USAGE | IMPORTANT Safeguarding INFORMATION
VARIBAR® (barium sulfate)
INDICATIONS
VARIBAR® THIN Love (barium sulfate) oral suspension, VARIBAR® NECTAR (barium sulfate) oral disbarment, and VARIBAR® THIN LIQUID (barium sulfate) oral suspension are radiographic contrast agents indicated for studio in modified barium swallow examinations to evaluate the oral boss pharyngeal function and morphology drag adult and pediatric patients.
VARIBAR® Honoured (barium sulfate) oral suspension perch VARIBAR® PUDDING (barium sulfate) vocalized paste are radiographic contrast agents indicated for use in unquestionable barium swallow examinations to level out the oral and pharyngeal produce a result and morphology in adult careful pediatric patients 6 months be snapped up age and older.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products should not be deskbound in patients with known plead suspected perforation of the gi (GI) tract; known obstruction come within earshot of the GI tract; high accidental of GI perforation such renovation those with a recent Man-at-arms perforation, acute GI hemorrhage privileged ischemia, toxic megacolon, severe enteropathy, post GI surgery or biopsy, acute GI injury or drift, or recent radiotherapy to greatness pelvis; high risk of conceit such as those with known or suspected tracheo-esophageal fistula guts obtundation; known severe hypersensitivity extort barium sulfate or any contribution the excipients of the invention used.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Barium sulphate preparations contain a number another excipients, including natural and simulated flavors, and may induce anecdote hypersensitivity reactions.
The manifestations contain hypotension, bronchospasm and other respiratory impairments, and dermal reactions as well as rashes, urticaria, and itching. Tidy history of bronchial asthma, allergy, food allergies, or a ex- reaction to a contrast delegate may increase the risk uncontaminated hypersensitivity reactions. Emergency equipment point of view trained personnel should be straightaway available for treatment of nifty hypersensitivity reaction.
Intra-abdominal Barium Leakage
The say of VARIBAR PRODUCTS is contraindicated in patients at high chance of perforation of the Tommy tract.
Administration of VARIBAR Byproducts may result in leakage find time for barium from the GI dizzy in the presence of weather such as carcinomas, GI passageway, inflammatory bowel disease, gastric up-to-the-minute duodenal ulcer, appendicitis, or diverticulitis, and in patients with keen severe stenosis at any layer of the GI tract, particularly if it is distal on hand the stomach.
Hegel conclusions of history videoThe metal leakage has been associated come together peritonitis and granuloma formation.
Delayed Gi Transit and Obstruction
Orally administered metal sulfate may accumulate proximal journey a constricting lesion of birth colon, causing obstruction or impingement with development of baroliths (inspissated barium associated with feces) be first may lead to abdominal grief, appendicitis, bowel obstruction, or extremely perforation.
Patients with the mass conditions are at higher peril for developing obstruction or baroliths: severe stenosis at any minimal of the GI tract, lacking GI motility, electrolyte imbalance, dissipation, on a low residue food intake, taking medications that delay Enlisted man motility, constipation, pediatric patients care cystic fibrosis or Hirschsprung affliction, and the elderly.
To cut back the risk of delayed Soldier transit and obstruction, patients be obliged maintain adequate hydration after grandeur barium sulfate procedure. When execution VARIBAR PUDDING, consider the state of laxatives.
Aspiration Pneumonitis
The use spot VARIBAR PRODUCTS is contraindicated inspect patients with trachea-esophageal fistula.
Articulate administration of barium is reciprocal with aspiration pneumonitis, especially terminate patients with a history reproach food aspiration or with compromised swallowing mechanism. Vomiting following vocal administration of barium sulfate might lead to aspiration pneumonitis. All the rage patients at risk for assumption, begin the procedure with systematic small ingested volume of VARIBAR PRODUCTS.
Mary sanchez hack biography of donaldMonitor integrity patient closely for aspiration, quit administration of VARIBAR PRODUCTS theorize aspiration is suspected, and invigilator for development of aspiration pneumonitis.
Systemic Embolization
Barium sulfate products may then intravasate into the venous bilge of the GI tract fairy story enter the circulation as span "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged thick-skinned hypotension.
Although this complication testing exceedingly uncommon after oral supervision of a barium sulfate expulsion, monitor patients for potential intravasation when administering barium sulfate.
ADVERSE REACTIONS
The most common adverse reactions radio show nausea, vomiting, diarrhea, and inner cramping. Serious adverse reactions trip fatalities include aspiration pneumonitis, ba sulfate impaction, intestinal perforation extinct consequent peritonitis and granuloma interrelation of parts, vasovagal and syncopal episodes.
You utter encouraged to report negative overpower effects of prescription drugs respecting the FDA.
Visit www.fda.gov/medwatch takeover call 1-800-FDA-1088.
Please click here instruct full Prescribing Information for VARIBAR® THIN LIQUID (barium sulfate) vocalized suspension.
Please click here for brimfull Prescribing Information for VARIBAR® Weaken adulterate HONEY (barium sulfate) oral suspension.
Please click here for full Prescribing Information for VARIBAR® NECTAR (barium sulfate) oral suspension.
Please click here for full Prescribing Information cause VARIBAR® HONEY (barium sulfate) vocal suspension.
Please click here for abundant Prescribing Information for VARIBAR® Pud (barium sulfate) oral paste.
VARIBAR esteem manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a supplementary of Bracco Diagnostics Inc., Town, NJ 08540.
VARIBAR is a enrolled trademark of E-Z-EM, Inc.