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Natural Product Number (NPN):
80108077
Market status:
Not Marketed
Licence Status:
Active
Brand name(s):
HDX ;
Vision HD ;
VisionHD-98%
Licence holder:
Voyageur Pharmaeuticals Ltd.
Dosage Form:
Powder for suspension
Recommended route of administration:

Oral

Recommended dose:
Sub population (Sub Pop.) Quantity (Qty) Frequency (Freq.)
Sub Pop. Age Min. Max. UoM Footnote1 Age Qty Min. Max. UoM Qty Freq. Min. Max. UoM Freq.
Adolescents 10 13 year(s) 1.0 Serving 1 daily
Adults and Adolescents 12 year(s) 1.0 Serving 1 daily
Children 4 9 year(s) 1.0 Serving 1 daily
Recommended use or purpose:
Double contrast radiography of the esophagus, stomach and duodenum. For use as a radiological contrast medium for upper and lower gastrointestinal procedures by conventional X-Ray and computed tomography (CT).
Risk Information:
Cautions and Warnings 
For professional use only. Do not store after mixing. 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. 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.
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.
Known Adverse Reactions 
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 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. 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 1:1000 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 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. In rare occassions following repeated administration, severe stomach cramps and diarrhea may occur. These are transitory in nature and are not considered serious.
List of medicinal ingredients:
Medicinal ingredients Quantity (Qty) Extract Potency
Sulfuric acid, barium salt (1:1) 98.45 % (w/w)
List of non-medicinal ingredients:
  • Ethyl maltol
  • PEG-20 glyceryl stearate
  • Simethicone
  • Sodium carrageenan
  • Sodium citrate
  • Sodium saccharin
  • Sorbitol
  • Vanilla
Date of licensing:
2021-02-10
Revised date of licence:
2024-05-09

Application information

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