ULTRAVIST

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Iopromide

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Patient Information leaflet

120920 Ultravist CMI 
1
ULTRAVIST
®

(UHL·TRA·VIST)

_IOPROMIDE _
_ _
CONSUMER MEDICINE INFORMATION_ _

WHAT IS IN THIS 
LEAFLET 
This leaflet answers some 
common questions about 
Ultravist. It does not contain all 
the available information. It 
does not take the place of 
talking to your doctor.  
All diagnostic agents have risks 
and benefits. Your doctor has 
weighed the risks of you being 
given Ultravist against the 
benefits he/she expects it will 
have for you. 
IF YOU HAVE ANY CONCERNS 
ABOUT BEING GIVEN ULTRAVIST, 
ASK YOUR DOCTOR. 
KEEP THIS LEAFLET. 
You may need to read it again. 
WHAT ULTRAVIST IS 
USED FOR 
Ultravist is an injectable 
contrast medium (a dye) which 
contains iodine. It is used to 
clearly show on X-rays the area 
of your body that your doctor 
wants to investigate, for 
example, your kidney, bladder, 
heart, vessels or spinal cord. It 
can also be used with sensitive 
computer-assisted X-ray 
machines (CT scanners) to 
investigate other parts of your 
body. 
Ultravist is only available in 
X-ray departments and X-ray 
practices. 
ASK YOUR DOCTOR OR THE STAFF AT 
THE X-RAY DEPARTMENT IF YOU 
HAVE ANY QUESTIONS ABOUT WHY 
ULTRAVIST IS BEING GIVEN TO YOU. 
It may be given to you for 
another reason. 
BEFORE YOU ARE 
GIVEN ULTRAVIST 
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN ULTRAVIST 
IF YOU HAVE AN ALLERGY TO: 
• 
iopromide, the active 
ingredient in Ultravist 
• 
other iodine-containing 
contrast media (dyes) 
• 
any of the ingredients listed 
at the end of this leaflet 
Some of the symptoms of an 
allergic reaction may include: 
• 
shortness of breath 
• 
wheezing or difficulty 
breathing 
• 
swelling of the face, lips, 
tongue or other parts of the 
body 
• 
rash, itching or hives on the 
skin 
YOU MUST NOT BE GIVEN A SECOND 
INJECTION OF ULTRAVIST LESS THAN 
48 HOURS AFTER A FIRST INJECTION 
INTO THE SPINE BECAUSE THERE IS

Summary of Product characteristics

130829UltravistPI 

Page 1 of 1 
PRODUCT INFORMATION 

ULTRAVIST
®

NAME OF THE MEDICINE 

Proprietary name: 
ULTRAVIST 150, ULTRAVIST 240, ULTRAVIST 300, ULTRAVIST 370 

Non-proprietary name: 
iopromide 

ULTRAVIST is a non-ionic contrast medium containing iopromide as the
active 
ingredient. 

Chemically, iopromide
is _N_,_N_’-Bis(2,3-dihydroxypropyl)-2,4,6-tri-iodo-5-(2-
methoxyacetamido)-_N_-methylisophthalamide and has the following
structural formula. 

 Molecular 
Weight: 791.12 

CAS No.: 
73334-07-3 

Chemical Formula: 
C
18
H
24
I
3
N
3
O
8

DESCRIPTION 

Iopromide is a triiodinated, non-ionic, water-soluble X-ray contrast
medium. 

ULTRAVIST solution for injection/infusion is a clear, colourless to
pale yellow 
solution, free of particles and has a pH of 6.5-8.0.  It contains no
antimicrobial 
preservatives.  ULTRAVIST also contains small amounts of trometamol,
sodium 
calcium edetate, dilute hydrochloric acid (10%) (for pH adjustment)
in water for 
injections. 

130829UltravistPI 

Page 2 of 2 
The iodine concentrations (mg I/mL) available have the following
physicochemical 
properties: 

Property ULTRAVIST 
150 
150 mg I/mL 
ULTRAVIST 
240 
240 mg I/mL 
ULTRAVIST 
300 
300 mg I/mL 
ULTRAVIST 
370 
370 mg I/mL 
Viscosity  
(mPa.s or cP) 

at 20°C 
2.3 
4.9 
8.9 
22.0 
at 37°C 
1.5 
2.8 
4.7 
10.0 
Osmolality at 37°C 

(osm/kg H
2
O)  0.33 0.48 0.59 0.77 
Osmolarity at 37°C 

(osm/L 
solution) 0.28 0.36 0.43 0.49 
Osmotic 
pressure 

Density (g/mL) 20°C
1.164 
1.262 
1.330 
1.409 
Density (g/mL) 37°C
1.157 
1.255 
1.322 
1.399 

Solutions of ULTRAVIST injection 150 mg I/mL, 240 mg I/mL, 300 mg I/mL
and 
370 mg I/mL have osmolalities from approximately 1.1 to 2.7 times that
of plasma 
(285 mOsmol/kg water). 

PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 

The contrast-giving substance in the ULTRAVIST formulati