Klean-Prep powder

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Macrogols 59 g;  ; Potassium chloride 0.7425 g; Sodium bicarbonate 1.685 g;  ; Sodium chloride 1.465 g; Sodium sulfate 5.685 g;  

Available from:

CARSL Consulting

INN (International Name):

Macrogols 59 g

Pharmaceutical form:

Powder for oral solution

Composition:

Active: Macrogols 59 g   Potassium chloride 0.7425 g Sodium bicarbonate 1.685 g   Sodium chloride 1.465 g Sodium sulfate 5.685 g   Excipient: Aspartame Vanilla

Units in package:

Sachet, 4 dose units

Class:

Pharmacy only

Prescription type:

Restricted

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Product summary:

Package - Contents - Shelf Life: Sachet, - 4 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at or below 25°C

Authorization date:

1990-03-27

Summary of Product characteristics

New Zealand Data Sheet KLEAN-PREP Powder for Oral Solution
Page 1 of 6
NEW ZEALAND DATASHEET
1
PRODUCT NAME
KLEAN-PREP
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of KLEAN-PREP contains the following active ingredients:
Macrogol 3350
59.000 g
(Polyethylene glycol 3350)
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
Contains aspartame.
3
PHARMACEUTICAL FORM
KLEAN-PREP is a whitish powder which, when dissolved in water, gives a
clear, colourless
solution for oral administration.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
KLEAN-PREP is indicated for colonic lavage prior to diagnostic
examination or surgical
procedures requiring a clean colon, e.g. colonoscopy, barium enema or
colonic resection.
4.2
Dose 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 care
should be taken in the rate of
administration (see section 4.4).
CHILDREN: There is no recommended dosage for children.
RENAL PATIENTS: No dosage adjustment need be made.
New Zealand Data Sheet KLEAN-PREP Powder for Oral Solution
Page 2 of 6
4.3
Contraindications
Use in patients with:

Hypersensitivity to the active substances or to any of the excipients.

Congestive cardiac failure (NYHA class III and IV).

Known or suspected gastrointestinal obstruction or perforation, ileus,
gastric retention,
to