KLEAN-PREP Powder for oral solution (2020)

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Περιεχόμενα

1. Name of the medicinal product

KLEAN-PREP 69g, sachet powders for oral solution.

2. Qualitative and quantitative composition

Each sachet of Klean-Prep contains the following active ingredients: Macrogol 3350 59.000 g Anhydrous Sodium Sulfate 5.685 g Sodium Bicarbonate 1.685 g Sodium Chloride 1.465 g Potassium Chloride ...

3. Pharmaceutical form

Powder for oral solution. A whitish powder which, when dissolved in water, gives a clear, colourless solution for oral administration.

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, ...

4.3. Contraindications

Do not use in patients with known or suspected: hypersensitivity to the active substances or to any of the excipients listed in section 6.1 gastrointestinal obstruction or perforation ileus gastric retention ...

4.4. Special warnings and precautions for use

The fluid content of Klean-Prep when reconstituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. No solid food should be eaten for at least 2 hours before ...

4.5. Interaction with other medicinal products and other forms of interaction

Oral medication taken within one hour of administration of Klean-Prep may be flushed from the gastro-intestinal tract and not absorbed.

4.6. Pregnancy and lactation

The preparation should only be used during pregnancy and lactation if considered essential by the physician. There is no experience of use during pregnancy. The purpose and mechanisms of use should be ...

4.7. Effects on ability to drive and use machines

There is no known effect on the ability to drive and use machines.

4.8. Undesirable effects

The most commonly experienced undesirable effects are gastrointestinal in nature. The following Adverse Events have been observed in post-marketing experience and therefore the frequencies are not known: ...

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.

5.1. Pharmacodynamic properties

ATC Code: A06AD Macrogol 3350 exerts its effects by virtue of its osmotic effect in the gut, which induces a laxative effect. Electrolytes are present in the formulation and are exchanged across ...

5.2. Pharmacokinetic properties

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine. Osmotically-acting bowel preparations ...

5.3. Preclinical safety data

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential.

6.1. List of excipients

Vanilla flavour Aspartame 0.049 g per sachet

6.2. Incompatibilities

None are known.

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.

7. Marketing authorization holder

Norgine Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

8. Marketing authorization number(s)

PL 00322/0068

9. Date of first authorization / renewal of the authorization

14/08/1991 / 12/02/2004

10. Date of revision of the text

21/09/2020

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