VISIPAQUE iodixanol 32.6g/50mL (652mg/mL) injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

iodixanol, Quantity: 652 mg/mL

Available from:

GE Healthcare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: calcium chloride dihydrate; trometamol; sodium chloride; sodium hydroxide; sodium calcium edetate; hydrochloric acid; water for injections

Administration route:

Intravenous, Intraarterial

Units in package:

50mL x 10

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.

Product summary:

Visual Identification: A clear to practically clear, colourless to slightly yellow solution; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-11-30

Patient Information leaflet

Visipaque
™ CMI
Page 1 of 5
CONSUMER PRODUCT INFORMATION
VISIPAQUE™ INJECTION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about VISIPAQUE. It does
not contain all the available information. It
does not take the place of talking to your radiologist (the specialist
doctor who does X-rays), doctor or pharmacist.
All preparations of this type have risks and benefits. Your
radiologist and/or your doctor have weighed the risks of you
receiving VISIPAQUE against the benefits they expect it will have for
you.
If you have any concerns about being given this preparation, ask your
radiologist, doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT VISIPAQUE IS USED FOR
VISIPAQUE is one of a group of medicines known as “contrast media”
for diagnostic use. VISIPAQUE is used to
improve the clarity of X-ray images of the internal organs of the body
by increasing the degree of contrast of different
structures within the body.
VISIPAQUE is used to study the heart, veins and arteries in the
body’s circulatory system and the urinary tract.
VISIPAQUE is intended for use in hospitals and radiology clinics only
and will be given to you as an injection. Your
doctor may have prescribed VISIPAQUE for another reason. Ask your
doctor if you have any questions about why
VISIPAQUE has been prescribed for you.
HOW DOES VISIPAQUE WORK?
As VISIPAQUE flows through your blood vessels and organs, the Iodine
in VISIPAQUE makes them appear darker
during radiographic examinations. This makes them stand out on the
X-ray film. This aids the doctor in identifying any
problems with a particular organ.
BEFORE YOU ARE GIVEN VISIPAQUE
WHEN YOU MUST NOT BE GIVEN IT.
VISIPAQUE SHOULD NOT BE GIVEN TO YOU IF
:
1.
You have ever had an allergic reaction to VISIPAQUE or, to any of the
ingredients listed at the end of this leaflet
(see Product Description) or to any other contrast medium. Symptoms of
an allergic reaction may include
wheeziness, difficulty in breathing or tightness or pain in the chest,
skin ra

Summary of Product characteristics

Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
VISIPAQUE
®
(IODIXANOL) INJECTION
1. NAME OF THE MEDICINE
Iodixanol
2.&3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
VISIPAQUE 270 mg I/ml and 320 mg I/ml Solution for Injection.
ACTIVE INGREDIENT
STRENGTH
CONTENT PER. ML.
Iodixanol (INN)
Iodixanol (INN)
270 mg I/ml
320 mg I/ml
550 mg equiv. 270 mg I
652 mg equiv. 320 mg I
Solution for injection. VISIPAQUE is supplied ready to use as clear,
colourless to pale yellow
aqueous solutions.
All solutions are terminally sterilised by autoclaving and contain no
preservatives.
Iodixanol is a non-ionic, dimeric, hexaiodinated, water-soluble X-ray
contrast medium.
Pure aqueous solutions of iodixanol in all clinical relevant
concentrations have a lower osmolality than
whole blood and the corresponding strengths of the non-ionic monomeric
contrast media. VISIPAQUE is
made isotonic with normal body fluids by addition of electrolytes.
For a full list of excipients, see section 6.1 List of Excipients
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
VISIPAQUE is indicated, in adult patients, for angiocardiography,
peripheral arteriography, visceral
arteriography, cerebral arteriography, contrast-enhanced computed
tomography of the head and body,
excretory
urography
and
venography.
In
arteriography,
VISIPAQUE
may
be
used
for
both
conventional radiography and digital subtraction angiography (DSA).
In children, VISIPAQUE is indicated for cardioangiography, urography,
CT-enhancement and
studies of the upper gastrointestinal tract.
4.2
DOSE AND METHOD OF ADMINISTRATION
Diagnostic procedures that involve the use of radiopaque imaging
agents should be carried out under
the direction of personnel with the prerequisite training and with a
thorough knowledge of the
particular procedure to be performed.
Page 2 of 17
Preparation of the patient will vary with the particular agent used,
preference of the radiologist and
the type of radiologic procedure performed. Specific ra