E-Z-PAQUE Powder for oral suspension Ref.[27910] Active ingredients: Barium sulfate

Posology

E-Z-Paque is primarily intended for use in the upper gastro-intestinal tract.

The administered dose of E-Z-Paque will depend on the patient in question and the section of the gastrointestinal tract to be viewed.

Adults: Single contrast of the oesophagus, stomach and duodenum – give orally 175 to 300 mL of suspension at 100 % w/v.

Small bowel – give orally 250 to 300 mL of suspension at 60 % w/v.

The actual administered dose should be determined from experience, by the radiologist.

Children: The dosage will be dependent on the size, age, health state and anatomic 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.

Method of administration

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

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.

Three years.

E-Z-Paque should be administered immediately following reconstitution and must not be stored.

Store below 25°C. Store in the original package.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

E-Z-Paque is presented as follows: Unit dose bottle (containing 177g E-Z-Paque) composed of a high density polyethylene (HDPE) with a polypropylene screw lid having a liner of three-ply co-extruded material (a foamed, low density polyethylene core between two solid layers of low density polyethylene).

Adults: E-Z-Paque should be suspended over the density range 60 to 100 % w/v.

Add water to approximately 2.5 cm above barium level. Secure lid, invert bottle and shake vigorously. Add more water to desired % w/v line on bottle. Replace lid and shake for 30 seconds.

Important: Always re-shake just prior to administration to the patient.

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