Ultravist 300mg/ml Solution for Injection (50ml, 75ml, 100ml, 150ml, 200ml and 500ml)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iopromide

Available from:

Bayer Limited

ATC code:

V08AB; V08AB05

INN (International Name):

Iopromide

Dosage:

300 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

Watersoluble, nephrotropic, low osmolar X-ray contrast media; iopromide

Authorization status:

Not marketed

Authorization date:

1986-09-24

Patient Information leaflet

20084
PACKAGE LEAFLET: INFORMATION
FOR THE PATIENT
ULTRAVIST® 240 mg/ml Solution
for injection
ULTRAVIST® 300 mg/ml Solution
for injection
ULTRAVIST® 370 mg/ml Solution
for injection
iopromide
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You
may need to read it again

if you have any further
questions, ask the doctor
giving you Ultravist (the
radiologist) or the X-ray
department staff

If you get any side
effects, talk to your
doctor or the X-ray
department
staff/radiologist. This
includes any possible
side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT ULTRAVIST IS AND WHAT IT
IS USED FOR
2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN ULTRAVIST
3. HOW YOU WILL BE GIVEN
ULTRAVIST
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ULTRAVIST
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
7. INFORMATION FOR HEALTHCARE
PROFESSIONALS ONLY
1. WHAT ULTRAVIST IS AND WHAT IT
IS USED FOR
Ultravist is an injectable contrast
medium (a dye) which contains
iodine. It is used to clearly show
in X-rays the area of your body
that your doctor wants to
investigate.
X-rays, like radio waves, can
pass through objects and can be
focused to make a picture. When
you have an X-ray, the beam of
rays goes through your body
where it is absorbed to differing
degrees by different tissues such
as bones, muscles and organs.
When the rays come out on the
other side they make a pattern of
light and shade on a film.
Ultravist helps to make this
pattern clearer. The film is then
examined by a specialist who
will make a diagnosis.
This medicine is for diagnostic
use only.
2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN ULTRAVIST
DO NOT USE ULTRAVIST:

if you are allergic to
iodine or iodine
containing contrast
media or any of the other
ingredients of this
medicine (listed in
Section 6)

if you have a condition
caused by too much
thyroid hormone
(uncontrolled
thyrotoxicosis).
WARNINGS AND PRECAUTIONS
You must tell

Summary of Product characteristics

Health Products Regulatory Authority
14 October 2020
CRN009Z6T
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ultravist 300mg/ml Solution for Injection (50ml, 75ml, 100ml, 150ml,
200ml and 500ml)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultravist 300: 1ml contains 623mg iopromide, equivalent to 300mg
iodine.
This medicinal product contains 12.3 micrograms sodium per ml.
For a full list of excipients, _see Section 6.1._
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to pale yellow aqueous solution.
The physico-chemical properties of Ultravist at the concentrations
listed below are:
Iodine concentration (mg/ml)
240
300
370
Osmolality (osm/kg H
2
O)
at 37 °C
Viscosity (mPa.s)
at 20 °C
at 37 °C
0.48
4.9
2.8
0.59
8.9
4.7
0.77
22.0
10.0
Density (g/ml)
at 20 °C
at 37 °C
1.263
1.255
1.328
1.322
1.409
1.399
pH-value
6.5-8.0
6.5-8.0
6.5-8.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Ultravist 300: For intravascular use and use in body cavities.
Contrast enhancement in computerised tomography (CT), digital
subtraction angiography (DSA), intravenous urography,
phlebography of the extremities, venography, arteriography,
visualisation of body cavities (e.g. arthrography,
hysterosalpingography, fistulography) with the exception of
myelography, ventriculography, cisternography.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL INFORMATION
WARNING PRIOR TO USE
Contrast media which are warmed to body temperature before
administration are better tolerated and can be injected more
easily because of reduced viscosity.
Health Products Regulatory Authority
14 October 2020
CRN009Z6T
Page 2 of 12
For additional instructions see section 6.6.
Posology and method of administration
DOSAGE FOR INTRAVASCULAR USE
In patients suffering from marked renal or cardiovascular
insufficiency and in patients in a poor general condition, the
contrast
medium dose must be kept as low as possible. In these patients it is
advisable to monitor re