Ultravist 370

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IODINE

Available from:

Bayer Limited

ATC code:

V08AB05

INN (International Name):

IODINE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

IODINE 769 milligram(s)/millilitre

Prescription type:

POM

Therapeutic area:

CONTRAST MEDIA

Authorization status:

Authorised

Authorization date:

2007-02-06

Patient Information leaflet

PACKAGING TECHNOLOGY BERLIN GFDXO
page 1
Bayer AG
client: 0021
material-no.: 85663437
PZ: 2698O-3
code-no.:
name: LF-INS-ULTRAVIST 240/300/370
country: IE/-/BAG
colors: BLACK
version: 16.01.2017/01
Restricted Document
dimension: 210 X 462 MM
85663437
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU ARE GIVEN THIS MEDICINE.
R keep this leaflet. You may need to read it
again
R if you have any further questions, ask the
doctor giving you Ultravist (the
radiologist) or the X-ray department staff
R if any of the side effects gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or the
X-ray department staff/radiologist.
IN THIS LEAFLET:
1. WHAT ULTRAVIST IS AND WHAT IT IS USED
FOR?
2. BEFORE YOU ARE GIVEN ULTRAVIST
3. HOW YOU WILL BE GIVEN ULTRAVIST?
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ULTRAVIST?
6. FURTHER 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. BEFORE YOU ARE GIVEN ULTRAVIST
DO NOT USE ULTRAVIST IF:
R you are, or suspect you are, allergic
(hypersensitive) to iodine or iodine
containing contrast media or any of the
other ingredients of Ultravist (see Section 6:
Further Information)
R you have a condition caused by too much
thyroid hormone (uncontrolled
thyrotoxicosis).
TAKE SPECIAL CARE WITH ULTRAVIST
You must tell the X-ray department staff if

Summary of Product characteristics

Bayer Limited

Ultravist 240/300/370 Combined SPC 
 December 2014 

1 
of 
16

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Ultravist
370 mg/ml Solution for injection  (50 ml, 100 ml, 150 ml and 200 ml) 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Ultravist 370: 1 ml contains 769
mg iopromide, equivalent to 370 mg 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
370: For intravascular use and use in body cavities. 
Contrast
enhancement in computerised tomography (CT), digital subtraction 
angiography (DSA), intravenous urography, arteriography and especially 
angiocardiography, visualisation of body cavities (e.g. arthrography, 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. 

Bayer Limited

Ultravist 240/300/370 Combined SPC 
 December 2014 

2 
of