E-Z-CAT Oral suspension Ref.[50234] Active ingredients: Barium sulfate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Bracco U.K. Ltd, Magdalen Centre, The Oxford Science Park, Oxford, OX4 4GA, United Kingdom

4.1. Therapeutic indications

This medicinal product is for diagnostic use only.

E-Z-CAT is indicated for the opacification of the gastro-intestinal tract prior to computerised axial tomography.

E-Z-CAT is indicated in adults and children.

4.2. Posology and method of administration

Posology

E-Z-CAT is for oral administration.

The suspension is diluted with water to obtain a desired concentration. Recommended dilutions are shown in section 6.6.

Method of Administration

Adults and the elderly: 350-450 mL of diluted suspension 30 minutes prior to the scan and the same volume 5 minutes prior to the scan, or, as directed by the physician.

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.

4.9. 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.

6.3. Shelf life

Two years.

This pack is for single-dose use only. E-Z-CAT should be administered immediately following dilution and must not be stored.

6.4. Special precautions for storage

Store below 25°C.

Do not freeze.

6.5. Nature and contents of container

High density polyethylene bottle with polypropylene screw-on cap with aluminium tamper-evident seal containing 225 mL.

6.6. Special precautions for disposal and other handling

Shake well before use. E-Z-CAT is intended for dilution prior to administration. Pour the contents into a litre container. Add water to give a total volume of 900 mL. Shake well to yield 900 mL of 1.2% w/v barium sulfate suspension. Alternatively, E-Z-CAT may be mixed to yield a different density:

Pour E-Z-CAT contents into mixing container:

  • Add water to 700 mL. Yield a 1.6 % w/v suspension.
  • Add water to 600 mL. Yield a 1.8 % w/v suspension.
  • Add water to 500 mL. Yield a 2.2 % w/v suspension.

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

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