E-Z-HD Powder for oral suspension Ref.[6381] Active ingredients: Barium sulfate

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

Therapeutic indications

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.

Posology and method of administration

Posology

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.

Method of Administration

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.

Overdose

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

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.

Special precautions for storage

Store below 25°C.

Nature and contents of container

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).

Special precautions for disposal and other handling

Reconstitution information for use of E-Z-HD is provided below.

  1. Add 65 mL of water to bottle.
  2. Secure lid and invert bottle, tapping base to loosen powder.
  3. Shake well for 10-20 secs. Leave until required.
  4. Immediately before giving to patient to drink shake again for 10-20 secs.

Any unused, opened product or waste material should be disposed of in accordance with local requirements.

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