EndoStar_usage information:Layout 1

Dr. Deppe
Denomination of the product:
EndoStar ® -Lavage
Powder for the preparation of a bowel
cleaning solution
Composition:
Macrogol (PEG) 3350 52,500 g
Sodium Chloride 1,402 g
Sodium Hydrogencarbonate 0,714 g
Potassium Chloride 0,186 g
Other ingredients:
Saccharine-Sodium, Aroma (lemon + lime)
Application areas:
Cleansing of the bowel as a preparation of
a colonoscopy, as well as before surgical
interventions on the bowel.
usage information – please read carefully!
Contraindications:
You must not take EndoStar ® -Lavage bowel
cleansing with:
– bowel stricture (narrowing) or intestinal
blockage or suspicion of it
– existing danger of breakouts in the gastrointestinal
tract
– evacuation disorders of the stomach
– toxic inflammations of the colon
(toxic colitis; toxic megacolon)
– hypersensitivity against one of the
ingredients or other macrogols
For patients with heart- and kidney-insufficiency
(myocardial insufficiency and limited
kidney function) and liver diseases as well as
for patients with heavy dehydration (body
fluid deficit) the irrigation of the bowel
EndoStar ® -Lavage should not be applied,
because the security is not satisfactorily evaluated.
For patients with disturbed swallowing- and
Dr. Deppe EndoStar-Lavage usage information – page 1
gulping-reflex as well as for patients with
confused consciousness and patients with
tendency to aspiration (inhaling of solid or
liquid substances, e.g. contents of the stomach)
EndoStar ® -Lavage should not be applied.
Children:
For the application with children no sufficient
experiences are available.
EndoStar ® -Lavage should therefore not be
applied with children.
Interactions with other remedies:
Until up to one hour before, during and
until up to one hour after the in-taking of
the bowel cleaning solution no medicaments
should be taken, because these are being
washed out of the gastro-intestinal-tract
and can be not absorbed by the body.
This is also valid for oral contraceptives
(“the pill”).
If you absolutely have to take medicines, then
please ask your doctor for an alternative.
Dosage:
For a complete evacuation of the bowel 4
litres of the ready-to-use solution are taken
according to the instruction of the doctor.
If the actually taken quantity falls clearly short
of the recommended one the evacuation of
the bowel will be insufficient.
Kind and duration of the application,
Instruction of dosage:
1 pouch contains 54,83 gram powder for the
preparation of half a litre bowel cleansing
solution.
Prepare the solution before usage always
freshly. The content of one pouch is dissolved
in ½ litre of lukewarm tap water.

Dr. Deppe
After the preparation the ready-to-use solution
can be put into the fridge for cooling,
because cooled it is tastier.
The prepared drinking solution can be stored
in the fridge maximum 48 hours and at room
temperature maximum 3 hours. The solution
should be drunk in portions of about 250 ml
every 10 minutes until the rectal effluence is
clear or until maximum 4 litres have been
drunk.
Do not take solid food 3 – 4 hours before the
taking of the prepared drinking solution and
until the examination is finished.
The beginning of the taking of the irrigation
solution is normally about 4 hours before the
beginning of the examination. But the solution
can also be taken on the evening before,
as a whole or in parts, and the rest quantity
on the day of the examination.
The exact procedure of the bowel preparation
has to be coordinated with the doctor.
Emergency measures, symptoms and
counteragents:
with over dosage with extensive loss of liquid
through diarrhea or vomiting:
to prescribe abundant liquid and control
of the serum-electrolytes and the ph-value
through the doctor.
Other indications:
No other solutions or additives must be added
to the ready drinking solution, especially not
sugar, because these can cause a change of
the osmolality or of the composition of the
electrolytes or because the degradation of
the additives through bowel bacteria can
lead to the development of explosive gas
mixtures in the bowel.
EndoStar ® -Lavage is gluten free.
Shelf life /stability:
The minimum shelf life is printed on the
pouches. Please do not use EndoStar ® -Lavage
after the expiry date.
Storage indications:
Do not store above 25 °C.
The ready-to-use drinking solution can be
kept maximum 3 hours at room temperature
and 48 hours in the fridge.
Do not use already open or damaged pouches.
Presentation and packaging sizes:
– packages with 8 pouches each
– packages with 128 pouches each
EndoStar ® -Lavage is a pharmacy only medical
device product.
Status of the information:
June 2007
Producer:
Laboratorium
Dr. rer. nat. H. D. Deppe
Hooghe Weg 35
D-47906 Kempen
Distribution:
CLOVERLINE
International Trading Company GmbH
Teinacher Str. 62
D-71634 Ludwigsburg
Tel: 0049 7141 385 777 0
Fax: 0049 7141 385 777 77
E-Mail: export@cloverline.com
CE 0481
Dr. Deppe EndoStar-Lavage usage information – page 2