VARIBAR P

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For use in radiography of the esophagus, pharynx and hypopharynx.

Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze · 2022-11-08

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Known Adverse Reactions : The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to VARIBAR products exposure: - Nausea, vomiting, diarrhea and abdominal cramping - Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred.

Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze · 2022-11-08

Traduzione non disponibile. Testo originale, lingua: inglese.

Cautions and Warnings : To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure. To prevent barium impaction in the colon may also require the use of cathartics following completion of the examination. Saline cathartics are recommended on a routine basis and especially in patients with a history of constipation unless clinically contraindicated. Aspiration Pneumonitis: The use of VARIBAR products is contraindicated in patients with trachea-esophageal fistula. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. In patients at risk for aspiration, begin the procedure with a small-ingested volume of VARIBAR products. Monitor the patient closely for aspiration, discontinue administration of VARIBAR products if aspiration is suspected, and monitor for development of aspiration pneumonitis. Systemic Embolization: Barium sulfate products may occasionally intravasate into the venous drainage of the GI tract and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate. Overdosage: In rare occasions following repeated administration, severe stomach cramps and diarrhea may occur. These are transitory in nature and are not considered serious. Pregnancy: VARIBAR products are not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the product. Radiation is known to cause harm to the unborn fetus exposed in utero. Therefore, radiographic procedures should only be used when, in the judgement of the physician, its use is deemed essential to the welfare of the pregnant patient. Safe use of barium sulfate in pregnancy is not established. Lactation: VARIBAR products are not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to the product. Pediatric Use: The efficacy of VARIBAR products in pediatric patients is based on successful opacification of the pharynx during modified barium swallow examinations. Safety and dosing recommendations in pediatric patients are based on clinical experience. VARIBAR products are contraindicated in pediatric patients with trachea-esophageal fistula. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Monitor patients with cystic fibrosis or Hirschsprung disease for bowel obstruction after use. Geriatric Use: Clinical studies of VARIBAR products did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze · 2022-11-08