Klean-Prep 69g Sachet Powder For Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
KLEAN PREP 69g, sachet powder 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 |
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 |
3 PHARMACEUTICAL FORM
Powder for oral solution.
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, eg 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 250ml 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 30ml/minute.
Children: There is no recommended dosage.
Renal patients: No dosage adjustment need be made.
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
- toxic colitis and toxic megacolon
- congestive cardiac failure (NYHA class III or IV)
4.4 Special warnings and precautions for use
The fluid content of Klean-Prep when reconstituted with water dose not replace regular fluid intake and adequate fluid intake must be maintained
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.
There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbance.
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.
Convulsions associated with severe hyponatreamia in patients taking Klean Prep have been reported (see section 4.8).
Patients may also develop confusional state/disorientation associated with hyponatraemia (see section 4.8).
Should nausea, vomiting, abdominal distension or pain arise, the rate of administration should be slowed down or temporarily stopped until symptoms subside.
In debilitated patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte, renal function test and ECG as appropriate.
Caution should be used in patients with an impaired gag reflex, reflux oesophagitis, or diminished levels of consciousness.
Klean-Prep contains aspartame, which is metabolised to phenylalanine. This may be harmful for patients with phenylketonuria.
4.5 Interactions 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. Fertility, 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:
|
System Organ Class |
Adverse reaction |
|
Immune system disorders |
Allergic reactions including anaphylactic reaction, dyspnoea, skin reactions (see below) |
|
Metabolism and nutrition disorders |
Electrolyte disturbances, specifically Hypokalaemia, hyponatraemia and dehydration. |
|
Nervous System Disorders |
Convulsions (see section 4.4), confusional state/disorientation,( see section 4.4), headaches and dizziness |
|
Cardiac disorders |
Transient increase in blood pressure, arrhythmia, palpitations. |
|
Gastrointestinal disorders |
Vomiting, nausea, abdominal pain, anal discomfort, abdominal distension, flatulence. |
|
Skin and subcutaneous tissue disorders |
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema. |
|
General disorders and administration site conditions |
Rigors, malaise, pyrexia and thirst. |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov .uk/yellowcard.
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.
6.1 List of excipient(s)
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 69gm white powder, in a box of 4 sachets
6.6 Special precautions for disposal
The solution should be used within 24 hours.
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
14/08/1991 / 12/02/2004
10 DATE OF REVISION OF THE TEXT
20/09/2016