VARIBAR N

Texto original en francés.

Producto de salud natural autorizado en Canadá

Otros nombres

Barium sulfate suspension USP

Titular

E-Z-EM Canada Inc.

NPN o DIN-HM

80111068

Estado

Licencia activa

Fecha de licencia

29 de junio de 2021

Fecha de revisión

31 de agosto de 2021

Forma

Suspension

Vía de administración

Orale

Tipo de solicitud

Générale (non traditionelle)

Composición

Composición medicinal no indicada.

Ingredientes no medicinales

Benzoate de sodium, Poly(sorbate) 80, Glycérine, Eau purifiée, Saveur de pomme, Xylitol, Citrate de sodium dihydraté, Saccharinate de sodium, Sorbate de potassium, NA, Maltodextrine, Siméthicone, Gomme de xanthane, Carboxyméthylcellulose de sodium

Dosis recomendadas en Canadá

Usos autorizados en Canadá

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

Texto original en inglés.

Un uso autorizado en Canadá no es una declaración de propiedades saludables autorizada en la Unión Europea. Consulte el registro de declaraciones de propiedades saludables.

Advertencias en Canadá

Cautions and Warnings : Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease. Hypersensitivity 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 as evidenced by hayfever and eczema, food allergies, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction. A mild allergic reaction would most likely include generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will generally respond to an antihistamine such as 50 mg of diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 500,000) laryngeal edema, bronchospasm or hypotension. Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately with 0.3 - 0.5 cc of 1:1000 epinephrine subcutaneously. If bronchospasm predominates, 0.25 - 0.50 gram of intravenous aminophylline should be given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids, even if given intravenously, exert no significant effect on the acute allergic reaction for a few hours. The administration of these steroid agents should not be regarded as emergency measures for the treatment of allergic reactions. Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardiac following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature and are best treated by having the patient lie flat for an additional 10 to 30 minutes under observation. Intra-abdominal Barium Leakage: The use of VARIBAR products is contraindicated in patients at high risk of perforation of the GI tract. Administration of VARIBAR products may result in leakage of barium from the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation. Delayed Gastrointestinal Transit and Obstruction: Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure.

Texto original en inglés.

Cautions and Warnings : 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.

Texto original en inglés.

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.

Texto original en inglés.

Fuente

Ficha oficial de Health Canada, licencia 80111068

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias, consultado el 27 de octubre de 2026.

Contient des informations visées par la Licence du gouvernement ouvert – Canada (Santé Canada, BDPSNH)

Texto original en francés.

La fórmula vendida en Europa con el mismo nombre puede ser diferente. Esta información no sustituye el consejo de un médico o farmacéutico.

Lista en la revisión oficial del 31 de agosto de 2021 (registro: Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias).

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