VARIBAR P
Texto original en francés.
Producto de salud natural autorizado en Canadá
- Otros nombres
- Barium sulfate paste USP
- Titular
- E-Z-EM Canada Inc.
- NPN o DIN-HM
- 80111049
- Estado
- Licencia activa
- Fecha de licencia
- 28 de junio de 2021
- Fecha de revisión
- 8 de noviembre de 2022
- Forma
- Pâte
- Vía de administración
- Orale
- Tipo de solicitud
- Générale (non traditionelle)
Si este producto se vendiera en Francia
No se ha detectado ningún punto según las normas que aplicamos.
Solo se calcula una cantidad diaria para una posología oral explícita para adultos, expresada por día y en una unidad sólida correspondiente a la forma del producto. No se extrapolan las unidades ambiguas, los líquidos, los polvos ni las dosis pediátricas. Una cantidad no calculada no se compara con los límites de dosis. Este análisis no constituye una autorización de venta en Francia ni una evaluación de seguridad o eficacia.
Composición
Composición medicinal no indicada.
Ingredientes no medicinales
Saccharinate de sodium, Glycérine, Poly(sorbate) 80, Eau purifiée, Gomme de xanthane, Siméthicone, Maltodextrine, Saveur de vanille, Xylitol, Sorbate de potassium, Ethylvanilline, Carboxyméthylcellulose de sodium, Benzoate de sodium, NA
Dosis recomendadas en Canadá
| Población | Edad | Cantidad por toma | Frecuencia |
|---|---|---|---|
| Adultes | minimum : 19 ans | 5 mL | 1 Tous les jours |
| Adolescentes | minimum : 13 ans ; maximum : 18 ans | minimum : 1 mL ; maximum : 3 mL | 1 Tous les jours |
| Enfants | minimum : 0,5 ans ; maximum : 12 ans | minimum : 1 mL ; maximum : 3 mL | 1 Tous les jours |
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
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.
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.
Texto original en inglés.
Fuente
Ficha oficial de Health Canada, licencia 80111049
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.
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 (registro: Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias).