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PLENVU is a brand name for Sodium Chloride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Plenvu is indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults and elderly A course of treatment consists of two separate non-identical 500 ml doses of Plenvu. At least 500 ml of additional clear fluid, which may include water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk must be taken with each dose.
This course of treatment can be taken according to a two-day or one-day dosing schedules as specified below: Two-day dosing schedule: • The first dose taken in the evening before the clinical procedure and the second dose in the morning of the day of the clinical procedure, approximately 12 hours after the start of the first dose.
One-day dosing schedules: • Morning only dosing schedule with both doses taken in the morning of the day of the clinical procedure; the second dose should be taken a minimum of 2 hours after the start of the first dose, or • Day before dosing schedule with both doses taken in the evening before the clinical procedure; the second dose should be taken a minimum of 2 hours after the start of the first dose.
The appropriate dosing schedule should be selected according to the timing of the clinical procedure. Paediatric population The safety and efficacy in children below 18 years of age has not yet been established. Plenvu is therefore not recommended for use in this population.
Patients with renal impairment No special dosage adjustment is deemed necessary in patients with mild to moderate renal impairment. Patients with mild to moderate renal impairment were included in clinical studies. Patients with hepatic impairment No special dosage adjustment is deemed necessary in patients with mild to moderate hepatic impairment.
Patients with elevated liver function tests were included in clinical studies. Method of administration For oral use.
Dose 1:
The contents of the single sachet for dose 1 should be made up to 500 ml with water. The reconstituted solution, plus an additional 500 ml of clear fluid, should be taken over a period of 60 minutes. Alternating between the reconstituted solution and clear fluid is acceptable.
Dose 2:
The contents of the two sachets (sachets A and B together) for dose 2 should be made up to 500 ml with water. The reconstituted solution, plus an additional 500 ml of clear fluid, should be taken over a period of 60 minutes. Alternating between the reconstituted solution and clear fluid is acceptable.
Diarrhoea is an expected outcome of bowel preparation. Due to the nature of the intervention, undesirable effects occur in the majority of patients during the process of bowel preparation. Whilst these vary between preparations, nausea, vomiting, bloating, abdominal pain, anal irritation and sleep disturbance commonly occur in patients undergoing bowel preparation.
Dehydration may occur as a result of diarrhoea and/or vomiting. Data from clinical studies are available in a population of over a thousand subjects treated with Plenvu in which undesirable effect data were actively elicited. The table below is a list of treatment emergent adverse events reported in the clinical studies of Plenvu.
The frequency of adverse reactions to Plenvu is defined using the following convention: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Very common (≥1/10) # Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Frequency Not Known Gastrointestinal disorders Vomiting, Nausea Abdominal distension, Anorectal discomfort, Abdominal pain, Abdominal pain upper, Abdominal pain lower Oesophageal rupture (Boerhaave syndrome) Immune system disorder Drug hypersensitivity Metabolism and nutrition disorders Dehydration Nervous system disorders Headache, Migraine, Somnolence Seizure General disorders and administration site conditions Thirst*, Fatigue, Asthenia, Chills**, Pains, Aches Cardiac disorders Palpitation, Sinus tachycardia Vascular disorders Transient increase in blood pressure, Hot flush Investigations Transient increase in liver enzymes*** Hypernatraemia, Hypercalcaemia, Hypophosphataemia, Hypokalaemia, Decreased bicarbonate, Anion gap increased/ decreased, Hyperosmolar state *Thirst includes the Preferred Terms; Thirst, Dry mouth and Dry throat **Chills includes the Preferred Terms; Chills, Feeling hot and Feeling cold ***Transient increase in liver enzymes includes the Preferred Terms; ALT increased, AST increased, GGT increased, Hepatic enzymes increased, Transaminases increased # No adverse events with a frequency of “very common” were reported during the clinical trials.
The fluid content of Plenvu when reconstituted with water does not replace regular fluid intake and 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 the administration of Plenvu to frail or debilitated patients. Plenvu should also be used with caution in patients with: • impaired gag reflex, with the possibility of regurgitation or aspiration, or with diminished levels of consciousness.
73 m2) • cardiac failure (grade III or IV of NYHA) • those at risk of arrhythmia, for example those with or on treatment for cardiovascular disease, thyroid disease or electrolyte imbalance • dehydration • 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. 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.
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.
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.
g. ) • phenylketonuria (due to presence of aspartame) • glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate) • toxic megacolon
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). g. water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk) may be taken throughout the bowel preparation process. g. blackcurrant juice) as this can stain the bowel. Consumption of all fluids should be stopped at least; • two hours before the clinical procedure when under general anaesthesia, or • one hour before the clinical procedure without general anaesthesia.
Information regarding meals No solid food should be taken from the start of the course of treatment until after the clinical procedure. Patients should be advised to allow adequate time after bowel movements have subsided to travel to the clinical unit.
Two-day split dosing schedule and day before dosing schedule:
The day before the clinical procedure, patients can have a light breakfast followed by a light lunch which must be completed at least 3 hours prior to the start of the first dose. 00H. 6.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
g. oedema, shortness of breath, increasing fatigue, cardiac failure), 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.
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