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PLENVU®
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Prescribing Information

PLENVU® Prescribing Information

Presentation: PLENVU® is administered in two doses. Dose one is made up of 1 sachet containing: macrogol 3350 100g, sodium sulfate anhydrous 9g, sodium chloride 2g, potassium chloride 1g. Dose 2 is made up of 2 sachets (A and B). Sachet A contains: macrogol 3350 40g, sodium chloride 3.2g, potassium chloride 1.2g. Sachet B contains: sodium ascorbate 48.11g, ascorbic acid 7.54g. Indication: For bowel cleansing in adults, prior to any procedure requiring a clean bowel. Dosage: Adults: A course of treatment consists of two separate non-identical 500ml doses of PLENVU®. At least 500ml of additional clear fluid must be taken with each dose. Treatment can be taken according to a two-day or one-day dosing schedule. Two- day dosing schedule: First dose taken the evening before the procedure. Second dose in the early morning of the day of the procedure. Morning only dosing schedule: Both doses taken the morning of the procedure. The two doses should be separated by a minimum of 1 hour. Day before dosing schedule: Both doses taken the evening before the procedure. The two doses should be separated by a minimum of 1 hour. No solid food should be taken from the start of the course of treatment until after the clinical procedure. Consumption of all fluids should be stopped at least 2 hours prior to a procedure under general anaesthesia or 1 hour prior to a procedure without general anaesthesia. Children: Not recommended for use in children below 18 years of age. No special dosage adjustment is deemed necessary in patients with mild to moderate renal or hepatic impairment. of the excipients, gastrointestinal obstruction or perforation, ileus, disorders of gastric emptying (gastroparesis, gastric retention) phenylketonuria, glucose-6-phosphate dehydrogenase deficiency, toxic megacolon. Warnings and precautions: The fluid content of reconstituted PLENVU® does not replace regular fluid intake. Adequate fluid intake must be maintained. As with other macrogol containing products, allergic reactions including rash, urticaria, pruritus, angioedema and anaphylaxis are a possibility. Caution should be used with administration to frail or debilitated patients, in patients with impaired gag reflex, with the possibility of regurgitation or aspiration, or with diminished levels of consciousness, severe renal impairment, cardiac failure, those at risk of arrhythmia, dehydration or severe acute inflammatory bowel disease. In debilitated fragile 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. Any suspected dehydration should be corrected for before use of PLENVU®. There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparation, predominantly in patients with underlying cardiac risk factors and electrolyte disturbance. If patients develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes during or after treatment, plasma electrolytes should be measured, ECG monitored and any abnormality treated appropriately. If patients experience severe bloating, abdominal distension, or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms subside. The sodium content, 458.5mmol (10.5g), should be taken into consideration for patients on a controlled sodium diet. The potassium content, 29.4mmol (1.1g), should be taken into consideration by patients with reduced kidney function or those on a controlled potassium diet. Interactions: Medicinal products taken orally within one hour of starting colonic lavage with PLENVU® may be flushed from the gastrointestinal tract unabsorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected. Fertility, pregnancy and lactation: There are no data on the effects of PLENVU® on fertility in humans. There were no effects on fertility in studies in male and female rats. There are no or limited data from the use of PLENVU® active ingredients in pregnant women. Animal studies have shown indirect harmful effects with respect to reproductive toxicity. Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible. It is unknown whether PLENVU® active ingredients/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to abstain from PLENVU® therapy. Undesirable effects: Diarrhoea is an expected outcome. The following undesirable reactions have been reported during the use of PLENVU®: Common (≥1%, <10%): vomiting, nausea, dehydration. Uncommon (≥0.1%, <1%): abdominal distension, anorectal discomfort, abdominal pain, abdominal pain upper, abdominal pain lower, drug hypersensitivity, headache, migraine, somnolence, thirst, fatigue, asthenia, chills, pains, aches, palpitation, sinus tachycardia, transient increase in blood pressure, hot flush, transient increase in liver enzymes, hypernatraemia, hypercalcaemia, hypophosphataemia, hypokalaemia, decreased bicarbonate, anion gap increased/ decreased, hyperosmolar state. Prescribers should consult country approved Summary of Product Characteristics for further information in relation to undesirable effects. Overdose: In case of gross accidental overdose, where diarrhoea is severe, fluid replacement and electrolyte correction may be necessary. Price and pack sizes: Price and pack sizes vary according to country. Legal category: Prescribing status may vary according to country. Market authorisation holder: Norgine BV, Hogehilweg 7, 1101 CA Amsterdam ZO, The Netherlands. Product licence number: ATC code: A06AD65 Date International Prescribing Information prepared: September 2017 Company reference: GL/PLV/0917/0031

PLENVU® has varying availabilities and licensing internationally. Before prescribing, consult your country approved prescribing information, available from your local distributor or Norgine Limited.

PLENVU is a registered trademark of the Norgine group of companies.

Adverse events should be reported to your regulatory agency. Adverse events should also be reported to your local distributor or Norgine Limited, Norgine House, Moorhall Road, Harefield, Uxbridge, Middlesex, UB9 6NS, United Kingdom.
Email: globalmedinfo@norgine.com

MOVIPREP® Prescribing Information

INTERNATIONAL ABBREVIATED PRESCRIBING INFORMATION: MOVIPREP® and MOVIPREP® Orange (PEG 3350 + Sodium ascorbate + Ascorbic acid + Sodium sulfate anhydrous + Electrolytes)

Presentation: Two bags, each containing sachets A and B of powder for oral solution. Sachet A contains macrogol 3350 100g, sodium sulfate anhydrous 7.5g, sodium chloride 2.691g and potassium chloride 1.015g. Sachet B contains ascorbic acid 4.7g and sodium ascorbate 5.9g. Indication: For bowel cleansing prior to any clinical procedures requiring a clean bowel e.g. bowel endoscopy or radiology. Dosage: Adults aged 18 years and upwards: A course of treatment consists of two litres of MOVIPREP®. It is strongly recommended that one litre of clear liquid, which may include water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk, is also taken during the course of treatment. A litre of MOVIPREP® consists of one Sachet A and one Sachet B dissolved together in water to make one litre of solution. This reconstituted solution should be drunk over a period of one to two hours. This process should be repeated with a second litre of MOVIPREP® to complete this course. This course of treatment can be taken either as divided or as single doses and timing is dependent on whether the clinical procedure is conducted with or without general anaesthesia as specified below: For procedures conducted under general anaesthesia: 1. Divided doses: one litre of MOVIPREP® in the evening before and one litre of MOVIPREP® in the early morning of the day of the clinical procedure. 2. Single dose: two litres of MOVIPREP® in the evening before the clinical procedure or two litres of MOVIPREP® in the morning of the clinical procedure. For both single and divided doses: ensure consumption of MOVIPREP® as well as any other clear fluids has finished at least two hours before the start of the clinical procedure. For procedures conducted without general anaesthesia: 1. Divided doses: one litre of MOVIPREP® in the evening before and one litre of MOVIPREP® in the early morning of the day of the clinical procedure. Ensure consumption of MOVIPREP® has finished at least one hour before the start of the clinical procedure. 2. Single dose: two litres of MOVIPREP® in the evening before the clinical procedure or two litres of MOVIPREP® in the morning of the clinical procedure. Ensure consumption of MOVIPREP® has finished at least two hours before the start of the clinical procedure. For both single and divided doses: ensure consumption of any clear fluids has finished at least one hour before the clinical procedure. Patients should be advised to allow for appropriate time to travel to the colonoscopy unit. No solid food should be taken from the start of the course of treatment until after the clinical procedure. Children: Not recommended for use in children below 18 years of age. Contraindications: Hypersensitivity to the active substances or to any of the excipients, gastrointestinal obstruction or perforation, disorders of gastric emptying, ileus, toxic megacolon which complicates severe inflammatory conditions of the intestinal tract including Crohn’s disease and ulcerative colitis, phenylketonuria, glucose-6-phosphate dehydrogenase deficiency, unconscious patients. Warnings and precautions: Should be used with caution in debilitated or frail patients, patients with impaired gag reflex, with the possibility of regurgitation or aspiration, impaired consciousness, severe renal insufficiency, grade III or IV cardiac impairment, dehydration and severe acute inflammatory bowel disease, those at risk of arrhythmia, e.g. those on treatment for cardiovascular disease or who have thyroid disease. Dehydration should be corrected before use of MOVIPREP®. The fluid content of MOVIPREP® when reconstituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Semi-conscious patients or patients prone to aspiration or regurgitation should be closely observed during administration, especially if this is via a nasogastric route. Patients with glucose-6-phosphate dehydrogenase deficiency may be at risk of acute haemolysis due to the presence of ascorbate. MOVIPREP® contains aspartame (a source of phenylalanine) which may be harmful for people with phenylketonuria. If patients develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes, plasma electrolytes should be measured and any abnormality treated appropriately. If patients experience symptoms such as severe bloating, abdominal distension, abdominal pain or any other reaction which makes it difficult to continue the preparation, they may slow down or temporarily stop consuming MOVIPREP® and should consult their doctor. In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment 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. There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives, occurring predominantly in those with underlying cardiac risk factors and electrolyte disturbance. Contains 56.2mmol of absorbable sodium and 14.2mmol of potassium per litre, which should be taken into consideration by patients on a controlled sodium/potassium diet. Patients with rare glucosegalactose malabsorption should not take this medicine. Interactions: Oral medication should not be taken within 1 hour of the start of administration of MOVIPREP® as it may be flushed from the gastrointestinal tract and not absorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected. Fertility, pregnancy and lactation: There are no data on the use of MOVIPREP® during pregnancy or lactation. The preparation should only be used during pregnancy or lactation if considered essential by the physician. There are no data on the effect of MOVIPREP® on fertility. Undesirable effects: Diarrhoea is an expected outcome. The following undesirable reactions have been reported during the use of MOVIPREP®: Very common (≥10%): abdominal pain and distension, nausea, anal discomfort, malaise, pyrexia. Common (≥1%, <10%): vomiting, dyspepsia, rigors, thirst, hunger, headache, dizziness, sleep disorder. Uncommon (≥0.1%, <1%): dysphagia, abnormal liver function tests, discomfort. Not known: allergic reaction including anaphylactic reaction, dyspnoea, dehydration, convulsions associated with severe hyponatraemia, transient increase in blood pressure, arrhythmia, palpitations, flatulence, retching, angioedema, pruritus, urticaria, rash, erythema, electrolytes disturbances including blood bicarbonate decreased, hyper and hypocalcaemia, hypophosphataemia, hypokalaemia, hyponatraemia and changes in the blood chloride levels. Prescribers should consult country approved Summary of Product Characteristics for further information in relation to undesirable effects. 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. In the rare event of overdose provoking severe metabolic derangement, intravenous rehydration may be used. Price and pack sizes: Price and pack sizes vary according to country. Legal category: Prescription only medicine or Pharmacy medicine according to country. Market authorisation holder: Norgine BV, Hogehilweg 7, 1101 CA Amsterdam ZO, The Netherlands. Product licence number: PL 20142/0005, PL 20011/0006 (UK). ATC code: A06AD Date International Prescribing Information prepared: September 2017 Company reference: GL/MPR/0814/0019(3) MOVIPREP® and MOVIPREP® Orange have varying availabilities and licensing internationally. Before prescribing, consult your country approved prescribing information, available from your local distributor or Norgine Limited.

Adverse events should be reported to your regulatory agency. Adverse events should also be reported to your local distributor or Norgine Limited, Norgine House, Moorhall Road, Harefield, Uxbridge, Middlesex, UB9 6NS, United Kingdom.
Email: globalmedinfo@norgine.com

Adverse events should be reported to your regulatory agency. Adverse events should also be reported to either your local distributor, Norgine Limited, Norgine House, Moorhall Road, Harefield, Uxbridge, Middlesex, UB9 6NS, United Kingdom or using our reporting form.