Posology
Adults and elderly
You are viewing: What Does The Second Dose Of Plenvu Do
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
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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.
In some instances, the intake of the reconstituted solution may be slowed or temporarily discontinued (see section 4.4).
In addition to the fluids taken as part of the course of treatment, any amount of supplementary clear fluid (e.g. water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk) may be taken throughout the bowel preparation process. Note: Avoid any fluid coloured red or purple (e.g. blackcurrant juice) as this can stain the bowel.
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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.
Morning only dosing schedule:
The day before the clinical procedure, patients can have a light breakfast followed by a light lunch, and clear soup and/or plain yogurt for dinner, which should be completed by approximately 20.00H.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
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