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

Product name and form

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

Pharmaceutical Form

Powder for oral solution.

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

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 0.7425 g

The content of electrolyte ions per sachet when made up to one litre of water is as follows:

Sodium 125 mM
Sulfate 40 mM
Chloride 35 mM
Bicarbonate 20 mM
Potassium 10 mM

Excipient with known affect:

Aspartame 49mg per sachet.

For the full list of excipients, see 6.1.

Active Ingredient Description
Macrogol

High molecular weight (4000) macrogols are long linear polymers which retain water molecules by means of hydrogen bonds. When administered by the oral route, they lead to an increase in volume of intestinal fluids.

Potassium chloride

Potassium plays a vital physiological role in maintenance of normal electrical excitability of nerve and muscle. It is also important in the genesis and correction of imbalances of acid-base metabolism.

Sodium bicarbonate

Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

Sodium chloride

Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues. Changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue.

Sodium sulfate

Sodium Sulfate Anhydrous is the anhydrous, sodium salt form of sulfuric acid. Sodium sulfate anhydrous disassociates in water to provide sodium ions and sulfate ions. Sodium ion is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Sodium sulfate anhydrous is an electrolyte replenisher and is used in isosmotic solutions so that administration does not disturb normal electrolyte balance and does not lead to absorption or excretion of water and ions.

List of Excipients

Vanilla flavour
Aspartame 0.049 g per sachet

Pack sizes and marketing

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

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00322/0068

14/08/1991 / 12/02/2004

Drugs

Drug Countries
KLEAN-PREP France, Hong Kong, Ireland, Malta, Netherlands, New Zealand, Poland, Tunisia, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.