PLENVU powder for oral liquid sachet composite pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

sodium ascorbate, Quantity: 48.11 g; ascorbic acid, Quantity: 7.54 g

Beschikbaar vanaf:

Norgine Pty Ltd

farmaceutische vorm:

Solution, powder for

Samenstelling:

Excipient Ingredients:

Toedieningsweg:

Oral

Eenheden in pakket:

3 sachets

Prescription-type:

(S3) Pharmacist Only Medicine

therapeutische indicaties:

Bowel cleansing prior to any procedure requiring a clean bowel.

Product samenvatting:

Visual Identification: White to yellow powder; Container Type: Multiple containers; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2018-01-09

Bijsluiter

Plenvu
® powder for oral solution
1
PLENVU® POWDER FOR ORAL SOLUTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PLENVU?
Plenvu contains the active ingredients Macrogol 3350, Sodium sulphate,
Sodium chloride, Potassium chloride, Sodium ascorbate
and Ascorbic acid. Plenvu is a type of medicine called a bowel
preparation. It makes your bowels clean so that they are ready
for examination or surgery. Plenvu works by emptying the contents of
your bowels, so you should expect to have lots of watery
bowel movements.
For more information, see Section 1. This leaflet provides important
information about using Plenvu powder for oral solution
(Plenvu). You should also speak to your doctor or pharmacist if you
would like further information or if you have any
concerns or questions about using Plenvu.
2.
WHAT SHOULD I KNOW BEFORE I USE PLENVU?
Do not use if you have ever had an allergic reaction to Plenvu or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR
PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Plenvu?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Plenvu and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE PLENVU?
Plenvu is a dual flavoured laxative with two doses contained in three
sachets. There is one sachet for Dose 1 (‘Dose 1 Sachet’)
and two sachets for Dose 2 (‘Dose 2 Sachet A’ and ‘Dose 2 Sachet
B’).
You need to take all three sachets for one treatment. Dose 1 is mango
flavour, Dose 2 is fruit punch flavour.
More instructions can be found in Section 4. How do I use Plenvu?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PLENVU?
THI

Productkenmerken

PLENVU PI
10 July 2023
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – PLENVU
® POWDER FOR SOLUTION
1
NAME OF THE MEDICINE
Macrogol 3350, sodium sulfate, ascorbic acid, sodium ascorbate, sodium
chloride, and potassium
chloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The ingredients of PLENVU are contained in three separate sachets. The
first dose is supplied
in one sachet and the second dose is supplied in two sachets, A and B.
DOSE 1 SACHET
contains the following active substances:
Macrogol 3350
100.0 g
Sodium sulfate
9.0 g
Sodium chloride
2.0 g
Potassium chloride
1.0 g
The concentration of electrolyte ions when the first dose is made up
to 500 mL of solution is as
follows:
Sodium
160.9 mmol/500 mL
Sulfate
63.4 mmol/500 mL
Chloride
47.6 mmol/500 mL
Potassium
13.3 mmol/500 mL
DOSE 2 (SACHETS A AND B)
contains the following active substances:
SACHET A
:
Macrogol 3350
40.0 g
Sodium chloride
3.2 g
Potassium chloride
1.2 g
SACHET B
:
Sodium ascorbate
48.1 g
Ascorbic acid
7.5 g
The concentration of electrolyte ions when the second dose (Sachets A
and B) is made up to
500 mL of solution is as follows:
Sodium
297.6 mmol/500 mL
Ascorbate
285.7 mmol/500 mL
Chloride
70.9 mmol/500 mL
Potassium
16.1 mmol/500 mL
Dose 1 contains 790 mg of sucralose. Dose 2 (Sachet A) contains 875 mg
of aspartame.
The complete treatment contains 10.5 g of sodium and 1.1 g of
potassium.
For the full list of excipients, see ‘Section 6.1 List of
Excipients’
3
PHARMACEUTICAL FORM
Powder for oral solution.
PLENVU PI
10 July 2023
Page 2 of 14
One pack of PLENVU contains a single treatment of three sachets.
Dose 1 (mango flavour) Sachet contains 115.96 g of white to off-white
powder.
Dose 2 (fruit punch flavour) Sachet A contains 46.26 g of white to
off-white powder and Dose 2
Sachet B contains 55.65 g of white to yellow powder.
4 CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PLENVU is indicated for bowel cleansing prior to any procedure
requiring a clean bowel.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults (18 years of age and over), inc