ULTRAVIST 300 Iopromide 93.51g/150mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

iopromide, Quantity: 623.4 mg/mL

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Injection

Composition:

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

Administration route:

Intraarterial, Intracardial, Intravenous

Units in package:

150mL X 1

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

All angiographic and urographic examinations and for contrast enhancement in computerised tomography.

Product summary:

Visual Identification: Clear solution, colour no darker than B5, Y5 or BY5 (Ph Eur); Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1994-06-08

Patient Information leaflet

ULTRAVIST®
1
ULTRAVIST®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I GIVEN ULTRAVIST?
ULTRAVIST contains the active ingredient iopromide. ULTRAVIST is a
contrast agent used during an X-ray examination.
For more information, see Section 1. Why am I given ULTRAVIST? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN ULTRAVIST?
Do not use if you have ever had an allergic reaction to ULTRAVIST or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR, RADIOGRAPHER OR NURSE IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given ULTRAVIST? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ULTRAVIST and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN ULTRAVIST?
ULTRAVIST is injected by the doctor, radiographer or nurse into
different parts of your body depending on the area of your
body to be examined.
More instructions can be found in Section 4. How am I given ULTRAVIST?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING ULTRAVIST?
THINGS YOU
SHOULD DO
Tell your doctor, radiographer or nurse if you have:
•
experience any of the severe symptoms of loss of consciousness or
heart attack, increase in heart
rate, difficulty breathing, low blood pressure and swelling of the
face, lips or tongue leading to
severe breathing difficulties and shock
•
experience any asthma symptoms e.g. chest tightening.
DRIVING OR USING
MACHINES
Avoid driving a car or operating machinery for 24 hours after
receiving ULTRAVIST
LABORATORY TEST
ULTRAVIST can affect the results of some thyroid tests up to several
weeks after receiving it.
LOOKING AFTER
YOUR MEDICINE
The X-Ray unit will store ULTRAVIST

Summary of Product characteristics

211117 ULTRAVIST PI – CCDS v15 & v16
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
ULTRAVIST
® (IOPROMIDE)
1.
NAME OF THE MEDICINE
Iopromide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultravist 150 injection contains 312 mg of iopromide per mL,
equivalent to 150 mg iodine per mL.
Ultravist 240 injection contains 499 mg of iopromide per mL,
equivalent to 240 mg iodine per mL.
Ultravist 300 injection contains 623 mg of iopromide per mL,
equivalent to 300 mg iodine per mL.
Ultravist 370 injection contains 769 mg of iopromide per mL,
equivalent to 370 mg iodine per mL.
Iopromide is a triiodinated, non-ionic, water-soluble X-ray contrast
medium.
PHYSICOCHEMICAL PROPERTIES
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
at 37°C
2.3
1.5
4.9
2.8
8.9
4.7
22.0
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
Density (g/mL) 37°C
1.164
1.157
1.262
1.255
1.330
1.322
1.409
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).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ULTRAVIST is indicated for all angiographic and urographic
examinations and for contrast
enhancement in computerised tomography.
ULTRAVIST 240 is additionally indicated for lumbar myelography in
adults.
211117 ULTRAVIST PI – CCDS v15 & v16
Page 2 of 19
4.2
DOSE AND METHOD OF ADMINISTRATION
ADMINISTRATION TECHNIQUE
•
Contrast media should be visually inspected prior to use and must not
be used, if
discolour