Plenvu Pulver till oral lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

askorbinsyra; kaliumklorid; makrogol; natriumaskorbat; natriumklorid; natriumsulfat, vattenfritt

Tillgänglig från:

Norgine BV

ATC-kod:

A06AD65

INN (International namn):

ascorbic acid; potassium chloride; macrogol; sodium ascorbate; sodium chloride; sodium sulfate, anhydrous

Läkemedelsform:

Pulver till oral lösning

Sammansättning:

natriumsulfat, vattenfritt 9 g Aktiv substans; makrogol 100 g Aktiv substans; makrogol 40 g Aktiv substans; natriumklorid 3,2 g Aktiv substans; natriumklorid 2 g Aktiv substans; kaliumklorid 1 g Aktiv substans; kaliumklorid 1,2 g Aktiv substans; aspartam Hjälpämne; natriumaskorbat 48,11 g Aktiv substans; askorbinsyra 7,54 g Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Dospåsar, 160 x (1+ 2A + 2B) st; Dospåsar, 1 x (1+ 2A + 2B) st; Dospåsar, 40 x (1+ 2A + 2B) st; Dospåsar, 80 x (1+ 2A + 2B) st; Dospåsar, 320 x (1+ 2A + 2B) st

Bemyndigande status:

Godkänd

Tillstånd datum:

2018-03-16

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PLENVU POWDER FOR ORAL SOLUTION
Macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic
acid, sodium chloride and
potassium chloride.
[For medicines available
ONLY ON PRESCRIPTION
]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
[For medicines available
WITHOUT A PRESCRIPTION
]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse have
told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1. What Plenvu is and what it is used for
2. What you need to know before you take Plenvu
3. How to take Plenvu
4. Possible side effects
5. How to store Plenvu
6. Contents of the pack and other information
1. WHAT PLENVU IS AND WHAT IT IS USED FOR
Plenvu contains the combination of active substances macrogol 3350,
sodium ascorbate, sodium sulfate
anhydrous, ascorbic acid, sodium chloride and potassium chloride.
Plenvu is a laxative.
Plenvu is intended for adults 18 years of age and older prior to any
clinical procedure requiring a clean
bowel.
Plenvu cleans your bowel

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Plenvu powder for oral solution
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 g
Sodium sulfate anhydrous
9 g
Sodium chloride
2 g
Potassium chloride
1 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
Chloride
Potassium
63.4 mmol/500 ml
47.6 mmol/500 ml
13.3 mmol/500 ml
Dose 1 also contains 0.79 g of sucralose (E955).
DOSE 2 (SACHETS A AND B)
contains the following active substances:
SACHET A
:
Macrogol 3350
40 g
Sodium chloride
3.2 g
Potassium chloride
1.2 g
SACHET B
:
Sodium ascorbate
48.11 g
Ascorbic acid
7.54 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
Chloride
285.7 mmol/500 ml
70.9 mmol/500 ml
Potassium
16.1 mmol/500 ml
Excipients with known effect
Dose 2 (Sachet A) also contains 0.88 g of aspartame (E951).
2
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
White to yellow powders.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plenvu is indicated in adults for bowel cleansing prior to any
procedure requiring a clean
bowel.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 pro