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:
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The content of electrolyte ions per sachet when made up to one litre of water is as follows:
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For excipients, see 6.1.
3. Pharmaceutical Form
A whitish powder which, when dissolved in water, gives a clear, colourless solution for oral administration.
4. Clinical Particulars
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.
4.3 Contraindications
Use in patients with known or suspected gastrointestinal obstruction or perforation, ileus, gastric retention, toxic colitis and toxic megacolon.
Congestive cardiac failure (NYHA class III and IV)
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
No solid food should be eaten for at least 2 hours before taking KLEAN-PREP. The product should only be administered with caution to patients with impaired gag reflex, reflux oesophagitis, or those with diminished levels of consciousness and patients with ulcerative colitis.
Unconscious, semi-conscious patients or patients prone to aspiration or regurgitation should be observed during administration especially if this is via the nasogastric route. There have been reports of pulmonary oedema resulting from aspiration of macrogol lavage solutions requiring immediate treatment.
Although not expected due to the isotonic composition of the product, cases of electrolyte disturbances have been rarely reported in at-risk patients. Therefore, KLEAN-PREP should be used with care in patients at risk of electrolyte disturbance, such as patients with renal failure, mild (NYHA class I and II) congestive cardiac impairment (see also section 4.3), or those simultaneously treated with diuretics.
Should abdominal distension or pain arise, the rate of administration should be slowed down or temporarily stopped until symptoms subside.
KLEAN-PREP contains aspartame, which is metabolised to phenylalanine. This may be harmful for patients with phenylketonuria.
Caution should be used in the administration of KLEAN-PREP to elderly, fragile or debilitated patients.
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 borne in mind if the physician is considering administration.
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:
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Transient increases in blood pressure have been observed in association with bowel preparations.
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. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC Code: A06A D
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 the intestinal barrier (mucosa) with serum electrolytes and water to prevent the occurrence of potential clinically significant variations of net electrolyte or net water balance.
Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation.
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.
5.3 Preclinical Safety Data
Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Vanilla flavour
Aspartame.
6.2 Incompatibilities
None are known.
6.3 Shelf Life
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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 69gm 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.
ADMINISTRATIVE DATA
7. Marketing Authorisation Holder
Norgine Limited
Norgine House
Widewater Place
Moorhall Road
Harefield
UXBRIDGE
Middlesex UB9 6NS
United Kingdom.
8. Marketing Authorisation Number(S)
PL: 00322/0068.
9. Date Of First Authorisation/Renewal Of The Authorisation
August 1991/March 1997.
10. Date Of Revision Of The Text
Feb 2011
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