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KLEAN-PREP®
Powder for oral solution
Each sachet of powder for preparation of extemporaneous solution contains:
Polietylenoglicol 3350................59.000 g
Anhydrous sodium sulphate......... 5.685 g
Sodium bicarbonate................... 1.685 g
Sodium chloride........................ 1.465 g
Potassium chloride................... 0.7425 g
and
Aspartame............................. 0.0494 g
Vanilla flavour......................... 0.3291 g
Concentrations
after reconstitution:
Sodium............................... 125 mmol/L
Potassium............................. 10 mmol/L
Sulphate............................... 40 mmol/L
Chloride................................ 35 mmol/L
Bicarbonate........................... 20 mmol/L
Polietylenoglicol................... 17.6 mmol/L
and
Aspartame........................... 0.0494 g/L
Vanilla.................................
0.3291 g/L
Packages
with 4 sachets.
PHARMACOTHERAPEUTIC
CLASS
XIX -1-c – Contrast medium and other products used in radiology
MARKET
AUTHORISATION HOLDER
Helsinn Birex Pharmaceuticals, Ltd. Ireland
REPRESENTED
IN PORTUGAL BY:
Angelini Farmacêutica, Lda
Rua João Chagas 53, Piso 3,
1495-072 Algés
WHAT IS KLEAN- PREP?
KLEAN-PREP is an electrolytical solution for gastrointestinal lavage,
which is presented under the form of a crystalline powder, with a white
to cream colour, vanilla flavour and, once prepared produces a perfectly
transparent solution.
IN
WHICH SITUATIONS IS KLEAN-PREP INDICATED?
KLEAN-PREP is indicated in gastrointestinal lavages and preparation of
complementary diagnostic exams or surgery, mainly in the large intestine.
WHEN
IT SHOULD NOT BE USED AND WHICH SIDE EFFECTS MAY OCCUR?
Klean-Prep is contraindicated in cases of known hypersensitivity to any
of its ingredients.
KLEAN-PREP should not be administered in patients with suspicion of perforation
or gastrointestinal obstruction, ileum, gastric retention, gastric or
intestinal ulceration, toxic colitis or toxic megacolon.
Do not administer in patients under 20 Kg of body weight.
Nauseas
or abdominal repletion may occur with possible sensation of fullness.
Abdominal colics, vomits and anal irritation occur less frequently. Generally,
these effects disappear rapidly. It has been rarely reported any other
adverse effects such as cutaneous manifestations
(particularly urticaria) and allergic reactions (anaphylactic kind). Very
rare cases of anaphylactic shock were reported.
DRUG
INTERACTIONS AND OTHER FORMS OF INTERACTIONS
One must bear in mind that all the medication administered orally in the
first hour of the use of KLEAN-PREP, may be evacuated by the gastrointestinal
system, therefore, not absorbed.
SPECIAL
PRECAUTIONS FOR USE
Do not eat solid food 2 hours before the ingestion of KLEAN-PREP.
The product may be administered with caution in patients with decreased
vomit reflex, reflux esophagitis or change in the alertness state.
During administration, unconscient and semiconscient patients or patients
inclined to aspiration or regurgitation
specially if administration is made through nasogastric route. In this
case, the normal administration rate should be 20 to 30 ml per minute.
In the case of distension or pain, the administration rate should be reduced
or temporarily interrupted until symptoms cease.
KLEAN-PREP
should be used with great caution in patients with ulcerous colitis or
proctitis.
It
should not be used in patients with phenylketonuria.
It
is recommended the monitoring of hydroelectrolytic balance with the use
of Klean-Prep, particularly in patients with changes of the referred balance.
USE
IN PREGNANT WOMEN, CHILDREN AND PATIENTS WITH SPECIAL PATHOLOGIES
There is no experience with the use of KLEAN-PREP during pregnancy and
lactation; therefore, the product should not be used during this period,
unless expressly indicated by the doctor.
There
is not enough experience in the administration of this product to children.
In
patients with renal or hepatic impairment it is not necessary to adjust
the recommended dose.
EFFECTS
ON THE ABILITY TO DRIVE OR TO USE MACHINES
No studies were performed on the ability to drive and concomitant use
of Klean-Prep. Except in rare cases of hypersensitivity, no effects are
expected on the ability to drive and use machines and the simultaneous
use of Klean-Prep.
EXCIPIENTS
KLEAN-PREP contains Sodium and Aspartame.
WHEN AND HOW SHOULD IT BE USED?
KLEAN-PREP should be administered in the eve of the exam and according
to the doctor’s indication.
Do
not eat solid food 2 hours before the ingestion of KLEAN-PREP and during
the whole period immediately prior to the exam. However, liquids such
as tea, coffee (without milk) or refrigerants may be ingested.
In order to use KLEAN-PREP solution, please proceed as follows:
1.
Dissolve the content of one sachet in one litre of warm water, agitating
until the complete dissolution of the powder.
2. Drink 250 ml of the obtained solution every 10 minutes.
3. Repeat this procedure with the remaining sachets. Try to drink the
solution of the 4 sachets over a period of 4 to 6 hours.
4. KLEAN-PREP is intended to clean the intestine, thus, it will cause
a liquid diarrheic evacuation. The first evacuation should occur 1 to
2 hours after the beginning of the ingestion of the solution.
WHAT
TO DO IN CASE OF OVERDOSAGE OR INTOXICATION?
In case of severe overdosage with intense diarrhoea the following conservative
measures are usually sufficient: great quantities of liquids, particularly
fruit juices, should be administered.
Any
side effect not included in this patient leaflet should be reported to
your doctor or pharmacist.
Do
not use after the expiry term stated on the package.
Keep
the reconstituted solution fresh and use it within 48 hours. Do not use
the sachet if damaged.
Keep
in a dry and cold place, under 25ºC.
MARCH
03
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