PICO SALAX CRANBERRY

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

CITRIC ACID ANHYDROUS; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Tilgængelig fra:

FERRING PHARMACEUTICALS LTD

ATC-kode:

A06AB58

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

CITRIC ACID ANHYDROUS 12 G; MAGNESIUM OXIDE 3.5 G; SODIUM PICOSULFATE 10 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

FERRING GmbH ,GERMANY

Terapeutisk område:

SODIUM PICOSULFATE, COMBINATIONS

Terapeutiske indikationer:

To clean the bowel Prior to X-ray examination, endoscopy or surgery.

Autorisation dato:

2017-02-12

Indlægsseddel

[לוגו מדינת ישראל] [http://www.gov.il/]
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הבריאות] [*5400]
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Produktets egenskaber

Page
1
of
9
1.
NAME OF THE MEDICINAL PRODUCT
PICO - SALAX Orange
PICO - SALAX Cranberry
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following active ingredients:
Sodium picosulfate
10.0mg
Magnesium oxide, light
3.5g
Citric acid, anhydrous
12.0g
Each sachet also contains:
Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg)
potassium]
Lactose (as a component of the orange flavour)
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution in sachet.
White crystalline powder.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
To clean the bowel prior to X-ray examination or endoscopy or surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including elderly): _
The two PICO - SALAX
sachets are taken dependent on the planned time of the
procedure:
•
The first reconstituted sachet is taken 10 to 18 hours before the
procedure, followed by at least 5 x 250 ml drinks of clear liquids
(not only water),
spread over several hours
•
The second reconstituted sachet is taken 4 to 6 hours before the
procedure, followed by at least 3 x 250 ml drinks of clear liquids
(not only water),
spread over several hours
•
Clear liquids (not only water) may be consumed until 2 hours before
the time of the
procedure
_ _
_Special populations _
Limited data is available for treatment of patients with low body
weight (BMI
less than 18). The rehydration regimen above has not been tested in
such
individuals and therefore monitoring of their hydration status is
required and
the regimen may need to be altered appropriately (see section 4.4).
Page
2
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9
_Pediatric population: _
A measuring spoon is provided with the product. It is recommended that
a
narrow flat edge, for example the back of a knife blade, is drawn
across the top
of a heaped measuring spoon to obtain a flat surface of the measure.
This will give ¼ of a
sachet (4 g powder) per spoonful.
For the timing of dosing in children, refer to the instructions given
for adults
from 1 up to 2 years: first dose