Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bracco U.K. Limited, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ, United Kingdom
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.
E-Z-HD is indicated in adults and children.
E-Z-HD must be administered orally. The powder must be reconstituted prior to administration (see section 6.6).
The administered dose of E-Z-HD will depend on the patient in question and the section of the gastrointestinal tract to be viewed.
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.
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.
There are no special dosage recommendations. The dosage should be determined, from experience, by the radiologist.
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.
Shelf life: Two years.
This pack is for single-dose use only. E-Z-HD should be administered immediately following reconstitution and must not be stored.
Store below 25°C.
Unit dose bottle (containing 340 g of E-Z-HD) composed of high density polyethylene (HDPE) with a polypropylene screw-on lid having a liner of three-ply co-extruded material (a foamed, low density polyethylene core between two solid layers of low density polyethylene).
Reconstitution information for use of E-Z-HD is provided below.
Any unused, opened product or waste material should be disposed of in accordance with local requirements.
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