- Approval Id
- 8f855ec97b470ca3
- Drug Approval Emc Name
- KLEAN PREP 69g, sachet powder for oral solution
- Drug Name
- KLEAN PREP 69g, sachet powder for oral solution
- Company Address
- ARC Uxbridge, Building 01, Sanderson Road, Uxbridge, UB8 1DH, UK
- Company Telephone
- +44 (0) 1895 826 600
- Company Medical Info Direct Line
- +44 (0) 1895 826 606
- Company Medical Info Email
- medinfo@norgine.com
- Atc Code
- A06AD
- Legal Category
- Pharmacy
- Authorisation Holder
- Norgine Limited
New Road, Tir-Y-Berth, Hengoed,
Wales, CF82 8SJ, UK
- Authorisation Number
- PL 00322/0068
- Authorisation Date
- 14/08/1991 / 12/02/2004
- Instruction Authorisation Holder
- Norgine Limited
New Road, Tir-Y-Berth, Hengoed,
Wales, CF82 8SJ, UK
- Instruction Authorisation Number
- PL 00322/0068
- Instruction Authorisation Date
- 14/08/1991 / 12/02/2004
- Instruction Composition
- Each sachet of Klean-Prep contains the following active ingredients:
| | |
| --- | --- |
| Macrogol 3350 Anhydrous Sodium Sulfate Sodium Bicarbonate Sodium Chloride Potassium Chloride | 59.000 g 5.685 g 1.685 g 1.465 g 0.7425 g |
The content of electrolyte ions per sachet when made up to one litre of water is as follows:
| | |
| --- | --- |
| Sodium Sulfate Chloride Bicarbonate Potassium | 125 mM 40 mM 35 mM 20 mM 10 mM |
Excipient with known affect:
Aspartame 49mg per sachet.
For the full list of excipients, see 6.1.
- Instruction Dosage Form
- Powder for oral solution.
A whitish powder which, when dissolved in water, gives a clear, colourless solution for oral administration.
- Instruction 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
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 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 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 hypnoatraemia 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).
Cases of seizures associated with use of macrogol 3350 with electrolytes for bowel preparation were observed in patients either with or without prior history of seizures. These cases were mostly associated with electrolyte abnormalities such as severe hyponatraemia (see section 4.8). Use caution when prescribing macrogol 3350 with electrolytes in patients with a history of seizures, at increased risk of seizure or at risk of electrolyte disturbance. In case of neurologic symptoms, fluid and electrolyte abnormalities should be corrected.
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.
Cases of oesophageal rupture (Boerhaave syndrome) associated with excessive vomiting after intake (see section 4.8) of macrogol 3350 with electrolytes for bowel preparation has been reported post-marketing, mostly in elderly patients. Advise patients to stop administration and seek immediate medical assistance if they experience incoercible vomiting and subsequent chest, neck, and abdominal pain, dysphagia, hematemesis or dyspnoea.
Klean-Prep contains aspartame, which is metabolised to phenylalanine. This may be harmful for patients with phenylketonuria.
Ischaemic colitis
Post-marketing cases of ischaemic colitis, including serious, have been reported in patients treated with macrogol for bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischaemic colitis or in case of concomitant use of stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients presenting with sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis should be evaluated promptly.
Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
This medicinal product contains 125 mmol (2.9 g) sodium per sachet of treatment. To be taken into consideration by patients on a controlled sodium diet.
In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.4.5 Interaction with other medicinal products and other forms of interaction
The interaction of Klean-Prep with other medicinal products has not been studied. Theoretically, oral medication (e.g. oral contraceptive pill) taken one hour before, during and one hour after the administration of Klean-Prep may be flushed from the gastro-intestinal tract and not absorbed.
The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected.
Klean-Prep may result in a potential interactive effect if used with starch-based food thickeners. The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.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 | Seizures, 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 | Oesophageal rupture (Boerhaave syndrome), 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 or search for MHRA Yellow Card in the Google Play or Apple App store.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.
- Instruction Pharmacology
- 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.
Osmotically-acting bowel preparations lead to a copious diarrhoea, resulting in extensive elimination of most of the product via the faeces. They can also lead to changes in electrolyte balance in the body, often with depletion of sodium and potassium. The additional sodium and potassium included in the Klean-Prep formulation help to balance the electrolytes. While some absorption of sodium takes place, the bulk of sodium is expected to be excreted in the faeces as the sodium salts of sulfate, the osmotic active ingredients included in the Klean-Prep composition.5.3 Preclinical safety data
Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Vanilla flavour
| | |
| --- | --- |
| Aspartame | 0.049 g per sachet |6.2 Incompatibilities
None are known.6.3 Shelf life
| | |
| --- | --- |
| Sachets: Solution after reconstitution: | 3 years 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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
Each sachet of Klean-Prep contains the following active ingredients:
| | |
| --- | --- |
| Macrogol 3350 Anhydrous Sodium Sulfate Sodium Bicarbonate Sodium Chloride Potassium Chloride | 59.000 g 5.685 g 1.685 g 1.465 g 0.7425 g |
The content of electrolyte ions per sachet when made up to one litre of water is as follows:
| | |
| --- | --- |
| Sodium Sulfate Chloride Bicarbonate Potassium | 125 mM 40 mM 35 mM 20 mM 10 mM |
Excipient with known affect:
Aspartame 49mg per sachet.
For the full list of excipients, see 6.1.
## Pharmaceutical Form
Powder for oral solution.
A whitish powder which, when dissolved in water, gives a clear, colourless solution for oral administration.
## 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
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 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 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 hypnoatraemia 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).
Cases of seizures associated with use of macrogol 3350 with electrolytes for bowel preparation were observed in patients either with or without prior history of seizures. These cases were mostly associated with electrolyte abnormalities such as severe hyponatraemia (see section 4.8). Use caution when prescribing macrogol 3350 with electrolytes in patients with a history of seizures, at increased risk of seizure or at risk of electrolyte disturbance. In case of neurologic symptoms, fluid and electrolyte abnormalities should be corrected.
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.
Cases of oesophageal rupture (Boerhaave syndrome) associated with excessive vomiting after intake (see section 4.8) of macrogol 3350 with electrolytes for bowel preparation has been reported post-marketing, mostly in elderly patients. Advise patients to stop administration and seek immediate medical assistance if they experience incoercible vomiting and subsequent chest, neck, and abdominal pain, dysphagia, hematemesis or dyspnoea.
Klean-Prep contains aspartame, which is metabolised to phenylalanine. This may be harmful for patients with phenylketonuria.
Ischaemic colitis
Post-marketing cases of ischaemic colitis, including serious, have been reported in patients treated with macrogol for bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischaemic colitis or in case of concomitant use of stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients presenting with sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis should be evaluated promptly.
Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
This medicinal product contains 125 mmol (2.9 g) sodium per sachet of treatment. To be taken into consideration by patients on a controlled sodium diet.
In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.4.5 Interaction with other medicinal products and other forms of interaction
The interaction of Klean-Prep with other medicinal products has not been studied. Theoretically, oral medication (e.g. oral contraceptive pill) taken one hour before, during and one hour after the administration of Klean-Prep may be flushed from the gastro-intestinal tract and not absorbed.
The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected.
Klean-Prep may result in a potential interactive effect if used with starch-based food thickeners. The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.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 | Seizures, 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 | Oesophageal rupture (Boerhaave syndrome), 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 or search for MHRA Yellow Card in the Google Play or Apple App store.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.
## 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.
Osmotically-acting bowel preparations lead to a copious diarrhoea, resulting in extensive elimination of most of the product via the faeces. They can also lead to changes in electrolyte balance in the body, often with depletion of sodium and potassium. The additional sodium and potassium included in the Klean-Prep formulation help to balance the electrolytes. While some absorption of sodium takes place, the bulk of sodium is expected to be excreted in the faeces as the sodium salts of sulfate, the osmotic active ingredients included in the Klean-Prep composition.5.3 Preclinical safety data
Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential.
## Pharmaceutical Particulars
6.1 List of excipients
Vanilla flavour
| | |
| --- | --- |
| Aspartame | 0.049 g per sachet |6.2 Incompatibilities
None are known.6.3 Shelf life
| | |
| --- | --- |
| Sachets: Solution after reconstitution: | 3 years 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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Company Detail Path
- /organization/norgine-limited
