KLEAN-PREP Powder for oral solution Ref.[28210] Active ingredients: Macrogol Potassium chloride Sodium bicarbonate Sodium chloride Sodium sulfate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Norgine Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

4.1. Therapeutic indications

For colonic lavage prior to diagnostic examination or surgical procedures requiring a clean colon, e.g. colonoscopy, barium enema or colonic resection.

4.2. Posology and method of administration

Adults

Each sachet should be dissolved in 1 litre of water. The usual dose is up to 4 sachets taken at a rate of 250 ml every 10 to 15 minutes until the total volume is consumed or rectal effluent is clear, or as directed by the physician.

The solutions from all 4 sachets should be drunk within 4 to 6 hours. Alternatively, administration may be divided, for example, taking 2 sachets during the evening before the examination, and the remaining 2 sachets on the morning of the examination.

If administration is by nasogastric tube, the usual rate should be 20 to 30 ml/minute.

Children

There is no recommended dosage.

Renal patients

No dosage adjustment need be made.

4.9. Overdose

In case of gross accidental overdosage, where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit juices, should be given.

6.3. Shelf life

Sachets: 3 years.

Solution after reconstitution: 24 hours.

6.4. Special precautions for storage

Sachets: Store in a dry place. Do not store above 25°C.

Reconstituted solution: Store in a refrigerator (2–8°C).

6.5. Nature and contents of container

Sachets containing 69 gm white powder, in a box of 4 sachets.

6.6. Special precautions for disposal and other handling

The solution should be used within 24 hours.

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