IOSCAN sodium amidotrizoate 3.705 g/10 mL oral liquid sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium amidotrizoate, Quantity: 3.705 g

Available from:

Iotech Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: sorbitol; acesulfame potassium; quinoline yellow; methyl hydroxybenzoate; citric acid; purified water; Flavour

Administration route:

Oral

Units in package:

50 sachets x 10mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Ioscan is a contrast medium for Computerised Axial Tomograpghy examination of the gastrointestinal tract. It should be made up with water prior to use, and administered orally. It is indicated primarily for use when barium sulphate is not appropriate.

Product summary:

Visual Identification: Clear yellow liquid.; Container Type: Sachet; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-09-21

Patient Information leaflet

IOTECH PTY LTD
_CMI-Aust sachet-rev2-241017.doc_
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IOSCAN
CONSUMER MEDICINE INFORMATION
WHAT IS IN IOSCAN?
IOSCAN is a product which has sodium amidotrizoate as the active
ingredient.
Plus
sorbitol
acesulfame potassium
methylhydroxybenzoate
citric acid-anhydrous
quinoline yellow colour
lemon flavouring
water
in 10 mL sachets which are diluted with water prior to use.
WHAT IS IT USED FOR AND HOW DOES IT WORK?
IOSCAN is an oral solution for CAT-SCAN examination of the
gastrointestinal
tract. It must be diluted with water according to the directions prior
to ingestion. It
may be used when barium sulphate is not suitable.
Your doctor will have explained why you are being treated with IOSCAN
and told
you what dose to take.
WHAT DO I DO BEFORE TAKING IOSCAN?
Let your doctor know if you have used IOSCAN before and if you had any
problems with it.
Tell your doctor if you are pregnant, if you are planning to become
pregnant or
are breastfeeding
Tell your doctor if you have ever sufferd from asthma or a history of
allergy
Let your doctor know if you have any known allegic reaction to
contrast media or
iodine, or you are being treated for thyroid disease.
Tell your doctor if you are dehydrated or if you have any problem with
the amount
of salt in your body.
IOTECH PTY LTD
_CMI-Aust sachet-rev2-241017.doc_
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HOW DO I TAKE IOSCAN PROPERLY?
IOSCAN must be diluted with water according to instructions prior to
drinking.
The doctor will tell you when and how much you need to drink.
_Instruction_
Open the IOSCAN sachet and pour into a cup, graduated to indicate a
volume of 200 ml, and fill with water to the 200 ml mark, stir briefly
with a
spoon and drink. Do not store the diluted solution.
_Usual dose_
1 Sachet, diluted as in the instruction, at one and a half hour, one
hour,
and half hour before examination, or as instructed by the radiologist.
WHAT IF I HAVE ANY PROBLEMS TAKING IOSCAN?
The most common adverse effect seen with IOSCAN is a mild diarrhoea
but this
ceases as soon as the intestinal has been emptied.
Like a

Summary of Product characteristics

Page 1 of 6
AUSTRALIAN PRODUCT INFORMATION
IOSCAN
Sodium amidotrizoate, oral liquid, solution
1.
NAME OF THE MEDICINE
Sodium amidotrizoate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IOSCAN is a clear, yellow, light syrupy liquid, containing sodium
amidotrizoate as
active
ingredient,
flavouring
agent,
preservative
and
sorbitol as the
osmolality
builder.
The
concentration
of
the
diluted
IOSCAN
solution
is
1.853
%w/v.
Osmolality of the diluted IOSCAN solution is 200 ±
20 mOsm/kg
INGREDIENTS:
Sodium
amidotrizoate
(37.05%w/v),
sorbitol,
D&C
Yellow
10,
methyl
hydroxybenzoate,
lemon
flavour
06-0404,
acesulphame
potassium,
citric
acid
anhydrous, water.
PRESENTATION
Sachet containing 10 mL concentrated sodium amidotrizoate solution.
Each mL of the
solution contains 370 mg of sodium amidotrizoate.
Plastic Bottle, 100 ml, containing 100mL concentrated sodium
amidotrizoate solution.
Each mL of the solution contains 370 mg of sodium amidotrizoate.
3.
PHARMACEUTICAL FORM
Dosage form:
Oral Liquid, solution
Visual description:
Clear, yellow, light syrupy liquid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IOSCAN
is
a
contrast
medium
for
Computerised
Axial
Tomography
examination of the gastrointestinal tract. It should be made up with
water prior to
use, and administered orally. It is indicated primarily for use when
barium sulphate
is not appropriate.
4.2 DOSE AND METHOD OF ADMINISTRATION
200 ml of diluted solution, diluted as per instructions, at one and a
half hour, one
hour, and half hour before examination, or as instructed by the
radiologist.
INSTRUCTION
10ML SACHET:
Open the IOSCAN sachet and pour into a 250 mL cup, fill with water to
the 200 mL
mark, mix with a spoon and drink. Do not store the diluted solution.
100 ML BOTTLE:
Measure each 10ml and dilute to 200 ml with drinking water and mix. Do
not
Page 2 of 6
store the diluted solution.
4.3 CONTRAINDICATIONS
History of anaphylaxis or other severe allergic reaction to iodine or
iodine- containing
contrast media.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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