MultiXS

Originaltext auf Französisch.

In Kanada zugelassenes natürliches Gesundheitsprodukt

Andere Namen

HDXS, MultiX Suspension, SmoothHD, SmoothHD-105%

Inhaber

Voyageur Pharmaceuticals Ltd.

NPN oder DIN-HM

80109788

Status

Aktive Lizenz

Lizenzdatum

10. Mai 2021

Überarbeitungsdatum

14. Mai 2024

Form

Suspension

Verabreichungsweg

Orale

Art des Antrags

Non traditionnelle

Zusammensetzung

Arzneiliche Zusammensetzung nicht angegeben.

Nicht arzneiliche Inhaltsstoffe

Carraghénine de sodium, Gomme de xanthane, Sorbitol, 4-hydroxy-3-méthoxybenzaldéhyde, Gomme arabique, Sorbate de potassium, Eau purifiée, Acide citrique monohydraté, Citrate de sodium, Poly(sorbate) 80, Siméthicone, Benzoate de sodium, Sacharinate de sodium

In Kanada empfohlene Dosen

In Kanada zugelassene Verwendungen

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

Originaltext auf Englisch.

Eine in Kanada zugelassene Verwendung ist keine in der Europäischen Union zugelassene gesundheitsbezogene Angabe. Beachten Sie das Register gesundheitsbezogener Angaben.

Warnhinweise in Kanada

Known Adverse Reactions : Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium formulations are infrequent and usually mild. 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 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 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 1:1000 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 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 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. In rare occasions following repeated administration, severe stomach cramps and diarrhea may occur. These are transitory in nature and are not considered serious.

Originaltext auf Englisch.

Cautions and Warnings : For professional use only. Do not use if the inner seal is broken or missing. Discard any unused suspension.

Originaltext auf Englisch.

Contra-Indications : Known or suspected fistula, perforation or obstruction in any part of the gastrointestinal tract, recent rectal biopsy or known hypersensitivity to barium sulfate or any of the non-medicinal ingredients. Patients with hereditary fructose intolerance should not take this product without first consulting their physician. 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 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 aspired 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 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. 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 pregnancy is not established.

Originaltext auf Englisch.

Quelle

Amtlicher Health-Canada-Eintrag, Zulassung 80109788

Licensed Natural Health Products Database (LNHPD), Health Canada: zugelassene Produkte, Inhaltsstoffe, Dosierungen, Verwendungen und Warnhinweise, abgerufen am 27. Oktober 2026.

Contains information licensed under the Open Government Licence – Canada (Health Canada, LNHPD)

Originaltext auf Englisch.

Die unter demselben Namen in Europa verkaufte Rezeptur kann abweichen. Diese Angaben ersetzen keinen ärztlichen oder pharmazeutischen Rat.

Liste in der amtlichen Überarbeitung vom 14. Mai 2024 (Register: Licensed Natural Health Products Database (LNHPD), Health Canada: zugelassene Produkte, Inhaltsstoffe, Dosierungen, Verwendungen und Warnhinweise).

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