new colonic preparation based on macrogol and sodium ascorbate/ascorbic acid

LThe PLENVU powder for oral solution specialty is a colonic preparation indicated in adults for intestinal lavage prior to any examination requiring a clean intestine.

PLENVU is formulated with macrogol 3350, electrolytes and sodium ascorbate/ascorbic acid.

PLENVU and other colonic preparations: conclusion of the CT

PLENVU is an osmotic laxative whose composition is similar to that of MOVIPREP, but whose administration methods differ, particularly in terms of the volume of liquid to be administered:

• hydration with 2 L of water for PLENVU instead of 3 L for MOVIPREP

Studies have been carried out to compare PLENVU with three other colonic preparations: MOVIPREP, IZINOVA and CITRAFLEET.

Based on the results of these studies, the Transparency Commission (CT) attributed an insufficient medical service rendered (SMR) to PLENVU in light of the available alternatives for the following reasons: [1] :

• demonstration of non-inferiority compared to MOVIPREP, IZINOVA and CITRAFLEET but superiority not demonstrated compared to these other colonic preparations;
• Possible increased risk of fluid and electrolyte disturbances with PLENVU: In clinical studies, clinical dehydration and hypernatremia on the day of the examination occurred more frequently (up to 39% for hypernatremia) in patients receiving PLENVU than in those receiving MOVIPREP, IZINOVA or CITRAFLEET.

PLENVU in practice

Two doses, three sachets

PLENVU comes in the form of 3 separate sachets corresponding to the two doses to be administered according to the recommended dosage:

• dose 1 contained in a sachet: macrogol 3350 and electrolytes;
• dose 2 corresponding to the contents of sachet A plus those of sachet B:
  • sachet A: macrogol 3350 and electrolytes,
  • sachet B: sodium ascorbate/ascorbic acid.

The dose and an additional fluid intake

Each dose is reconstituted in a container by adding up to 500 mL of water:

• for dose 1, the contents of the single sachet must be dissolved in water to obtain 500 mL of solution;
• for dose 2, the contents of both sachets A and B must be dissolved in water to obtain 500 mL of solution.

Dissolving may take up to 8 minutes.

After reconstitution, the solutions can be stored in a closed container at a temperature not exceeding 25 °C or in the refrigerator; they should be drunk within 24 hours.

Taking pattern: split or single

To prevent fluid loss (dehydration), it is mandatory to drink at least 500 mL of additional clear fluid after each dose, including water, clear soup, fruit juice without pulp, soft drink, tea and/or coffee without milk. Any red or purple colored fluid (e.g. blackcurrant juice) should be avoided, as this may discolor the intestine.

For both doses, the reconstituted solution and an additional 500 mL of clear liquid should be drunk over a 60-minute period. It is possible to alternate between the reconstituted solution and the clear liquids.

Two intake patterns are possible, in 2 times or in a single intake:

• split dose with night break: the first dose is taken the evening before the examination and the second dose ingested in the morning on the day of the examination, approximately 12 hours after the start of the first dose;
• single take:
  • in the morning: both doses are taken in the morning of the day of the examination, the second dose should be taken at least 2 hours after the start of the first dose;
  • the day before: both doses are taken the evening before the examination, the second dose must be taken at least 2 hours after the start of the first dose.

Food instructions

Before starting the colonic preparation, the following dietary instructions apply, taking into account the intake schedule:

• in case of split dose with night break and single dose the day before: the day before the examination, patients can have a light breakfast followed by a light lunch which must be finished at least 3 hours before the start of taking the first dose;
• in case of single dose in the morning: the day before the examination, patients can have a light breakfast followed by a light lunch and a clear soup and/or plain yogurt for dinner which should be finished around 8 p.m.

No solid food should be ingested from the start of preparation until the end of the examination.

Any fluid intake must be stopped at least:

• 2 hours before the examination if it is carried out under general anesthesia;
• 1 hour before the examination if it takes place without general anesthesia.

Advice to patients

Patients are advised to stay close to the toilet from the start of colonic preparation.

To go further

• List I
• Box of 3 sachets, CIP 3400930124673
• Non-refundable and not approved for communities
• Norgine Laboratory