E-Z-PAQUE

Texto original en francés.

Producto de salud natural autorizado en Canadá

Otros nombres

Sufopaque

Titular

E-Z-EM Canada Inc.

NPN o DIN-HM

80026254

Estado

Licencia activa

Fecha de licencia

8 de julio de 2011

Fecha de revisión

3 de mayo de 2017

Forma

Poudre pour suspension

Vía de administración

Orale

Tipo de solicitud

Non traditionnelle

Composición

Ingredientes no medicinales

pectine, Acide citrique, Saveur de fraise, simethicone, citrate de sodium, Sodium Saccharin, propylèneglycol, Gomme de xanthane, Poly(sorbate) 80, Gum tragacanth, Carraghénine, Saveur de vanille, Sorbitol

Dosis recomendadas en Canadá

Usos autorizados en Canadá

Routine fluoroscopic studies. For radiography of the gastrointestinal tract. For use as radiological contrast media for upper and lower gastrointestinal procedures by conventional x-ray or computed tomography.

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

Contra-Indications : Known or suspected fistula, perforation or obstruction in any part of the gastrointestinal tract or recent rectal biopsy. Known hypersensitivity to barium sulfate or any components (see non-medicinal ingredients).

Texto original en inglés.

Cautions and Warnings : For professional use only. Precautions: 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. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease. Ingestion of barium is not recommended in patients with a history of food aspiration. If barium swallow studies are required in these patients or in patients, in whom integrity of the swallowing mechanism is unknown, proceed with caution. Administer initially small amounts such as a half-teaspoon of low-density barium and carefully observe swallowing under fluoroscopic control. If barium is aspirated into the larynx, further administration of barium should be immediately discontinued. If no aspiration is noted, additional barium may be given with continued fluoroscopic monitoring for aspiration. After any barium study of the G.I. tract, it is important to rehydrate the patient as quickly as possible to prevent impaction of the barium. 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. Usage in Pregnancy: 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. Overdosage: In rare occasions following repeated administration, severe stomach cramps and diarrhea may occur. These are transitory in nature and are not considered serious.

Texto original en inglés.

Known Adverse Reactions : 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. Procedural complications are rare, but may include aspiration pneumonitis, barium impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been shown to occur following or during barium enemas. Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivity. Vomiting following administration of barium sulfate may lead to aspiration pneumonitis. It is of the utmost importance to be completely prepared to treat any such occurrence. Allergic Reactions: Due to the increased likelihood of allergic reactions in atopic patients, it is important that a complete history of known and suspected allergies as well as allergic-like symptoms, e.g. rhinitis, bronchial asthma, eczema and urticaria, be obtained prior to any medical procedure utilizing the products. 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 could develop. 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 bradycardia 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. Overdosage: In rare occasions following repeated administration, severe stomach cramps and diarrhea may occur. These are transitory in nature and are not considered serious.

Texto original en inglés.

Fuente

Ficha oficial de Health Canada, licencia 80026254

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 3 de mayo de 2017 (registro: Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias).

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