POLIBAR Powder for rectal suspension Ref.[2536] Active ingredients: Barium sulfate

Posology

Polibar is for rectal (enema) administration.

The administered dose of Polibar will depend on the patient in question and the section of the gastrointestinal tract to be viewed.

Adults

Usual Dosage Range 150-750 g barium sulfate in a suitable suspension.

Double contrast of the large bowel – Give as required between 60-115% w/v.

Single contrast of the large bowel – Give as required between 20-40% 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.

This pack is for single-use only. Polibar 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.

Unit dose prefilled enema bag composed of polyvinylchloride containing 397 g, 567 g or 680 g of product. Not all pack sizes may be marketed.

Adults

Polibar should be suspended over the density range of 20-115% w/v (20-60% w/w).

Reconstitution information for use of Polibar is provided below.

Attach clamp to tubing and close. Study the appropriate graph below. This shows the density range and how much water to use for each density. Measure the indicated quantity of warm (40°C) water and add this to the bag through the red snap-cap seal. Hold the bag by the finger holes and shake vigorously for 10-20 seconds. When ready to use shake again, 10-20 seconds. Then with the thumb and forefinger pop the red ball at the bag tube junction into the bag. Run barium through the tubing – attach rectal tube. The kit is now ready.

Water to be added (mL): 397 g enema bag.

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