MultiXBa

Natural health product licensed in Canada

Other names

MultiX Rectal Powder

Licence holder

Voyageur Pharmaceuticals Ltd.

NPN or DIN-HM

80109042

Status

Active licence

Licence date

31 March 2021

Revision date

Not provided

Form

Poudre pour suspension

Route of administration

Rectale

Application type

Non traditionnelle

If this product were sold in France

No point flagged by the rules we apply.

A daily quantity is calculated only for an explicit adult oral dosage, stated per day and in a solid unit matching the product form. Ambiguous units, liquids, powders and paediatric doses are not extrapolated. A quantity not calculated is not compared with dose limits. This analysis does not constitute authorisation for sale in France or an assessment of safety or efficacy.

Composition

Non-medicinal ingredients

Poly(sorbate) 80, Sorbitol, NA, Citrate de sodium, Siméthicone, Pectine

Recommended doses in Canada

Uses authorised in Canada

For radiographic examination of the gastrointestinal tract. For use as a single or double contrast radiological medium for lower gastrointestinal procedures by conventional X-Ray.

A use authorised in Canada is not an authorised health claim in the European Union. See the health claims register.

Warnings in Canada

• Contre-indications

  Known or suspected fistula, perforation or obstruction of the lower gastrointestinal tract, recent rectal biopsy or known hypersensitivity to barium sulfate or any of the non medicinal ingredients.

• Précautions et mises en garde

  For professional use only. Do not use if the inner seal is broken or missing. Discard any unused reconstituted suspension. Diagnostic procedures that 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 excerised with the use of radiopaque media in severly 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 aspired into the larynx, further administartion 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 barium. To prevent barium impaction, the colon may also require the use of cathartics following the completion of the examination. Saline cathartics are recommended on a routine basis and especially in patients with a history of constipation unless clinically contraindicated. Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. When balloon retention tips are used, care should be given taken to avoid over-inflation of the balloon, since overfilling or asymmetrical filling with displacement of the tip may occur. Such a displacement can lead to rectal perforation or barium granulomas. Inflation of the balloon should be done under fluroscopic control by qualified professional personnel. 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. Safe use of barium sulfate in pregnant is not established.

• Effets indésirables connus

  Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Adverse reaction 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 pneueumonitis, 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. It is of the utmost importance to be completely prepared to treat any such occurrence. Allergic reactions: Due to the increased likelyhood 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 uticarial, 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 reaction will generally respond to antihistamine such as 50 mg of diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 500,000) laryneal edema, brochospasm or hypotension could develop. Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, or hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately with 0.3 - 0.5 cc of 1:000 epinephrine subcutaneously. If brochospasm 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 thesesteroid agents should not be reagrded as emergency measures for the treatment of allergic reactions. Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following administration of any diagnostic agent. Such reactions are usually non allergenic in nature and best treated by having the patient lie flat for an additional 10 to 30 minutes under observation. However, allergic reactions to the enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previous mentionedacute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients particularly those with a history of asthma or eczema should be evaluated for the alternative methods of administration in order to avoid these adverse reactions. All plastic/rubber accessories are disposable, single use devices that must not be reused or left in the body cavity for an extended period of time. In rare occassions following repeated administration, severe stomach cramps and diarrhea may occur. These are transitory in nature and are not considered serious.

Source

Official Health Canada record, licence 80109042

The formula sold in Europe under the same name may differ. This information does not replace advice from a doctor or pharmacist.

The evidence date of this ingredient list is unknown.

Has the product changed? Photograph the packaging.