E-Z-HD

/ Promedico

E-Z-HD must be administered orally. The powder must be reconstituted prior to administration.
The administered dose of E-Z-HD will depend on the patient in question and the section of the gastrointestinal tract to be viewed.
Adults: The contents of one prefilled bottle (340 g) are dispersed in 65 mL of water to produce a 250 % w/v suspension which is swallowed by the patient after a suitable gas producing agent has been administered.
Children: The dosage will be dependent on the size, age, health state and anatomical region to be imaged of the child. Individual requirements should be determined, from experience, by the radiologist.
Elderly: There are no special dosage recommendations. The dosage should be determined, from experience, by the radiologist.

This medicinal product is for diagnostic use only.
E-Z-HD is a high density suspension for use as a radiopaque agent during X-ray visualisation of the upper gastro-intestinal tract (oesophagus, stomach and duodenum). It is designed for optimal use in double contrast X-ray examinations.

Immune System Disorders: Hypersensitivity to barium sulfate or to any of the excipients.
Gastrointestinal Disorders: Patients with any of the following should not receive E-Z-HD:
– a known or suspected fistula, perforation or obstruction in any part of the
gastrointestinal tract
– gastrointestinal haemorrhage
– gastrointestinal ischemia
– megacolon or toxic megacolon
– necrotising entercolitis
– severe constipation
– severe impaired gastric emptying
E-Z-HD should not be used for infants with swallowing disorders.
Surgical and Medical Procedures: Barium sulfate should not be administered immediately before or immediately after gastrointestinal surgery, including snare polypectomy or ‘hot’ colonic biopsy. If post procedural leakage is expected the product must not be used.
Do not use during and up to four weeks after radiotherapy to the rectum or prostate.
Injury, Poisoning and Procedural Complications: Do not use if there are new injuries or chemical burns of the gastrointestinal tract.

See prescribing information for full details.

Skin and subcutaneous disorders together with immune system disorders, reflecting allergic reactions either to barium sulfate or the product excipients, are among the most commonly reported effects; for example urticaria, erythema and rash.
Gastrointestinal disorders are also one of the most frequently reported class of undesirable effects; for example diarrhoea, nausea, abdominal pain/distention, constipation.
See prescribing information for full details.

No interaction studies have been performed.
Barium sulfate is biologically inert and there are no known interactions with other medicinal products. However, the presence of barium sulfate formulations in the gastrointestinal tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimise any potential change in absorption, the separate administration of barium sulfate from that of other medicines should be considered.
Other examinations of the same area of the gastrointestinal tract with another contrast agent may be complicated by the presence of barium sulfate (residue) in the gastrointestinal tract up to several days following the examination with barium contrast media.

Pregnancy: Following oral or rectal administration, barium sulfate is absorbed systemically in negligible amounts. Though barium sulfate is pharmacologically inert, no studies of its mutagenic or teratogenic potential are available.
Although this product is not contraindicated in pregnancy, we would like to point out that radiographic procedures may damage the foetus, particularly during the first trimester of pregnancy. Any examination should only be carried out after careful consideration of the benefit/risk of the procedure.
Lactation: Since the absorption of barium sulfate is negligible, its use is not contraindicated during breastfeeding.

Barium sulfate is non-toxic and absorbed systemically in negligible amounts.
Repeated use within a very short period of time has led to abdominal cramps, nausea, vomiting, diarrhoea, and constipation. These symptoms are transitory in nature and may be allowed to resolve without medical intervention or may be treated according to currently accepted standards of care.