PIL
UROGRAFIN
®
CMI
1
UROGRAFIN
®
(YOU·ROW·GRAF·IN)
_sodium diatrizoate and meglumine diatrizoate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Urografin. 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 using
Urografin against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS DIAGNOSTIC AGENT, ASK
YOUR DOCTOR OR RADIOLOGIST.
KEEP THIS LEAFLET
You may need to read it again.
Only the doctors conducting your
X-Ray examination are able to
weigh up all the relevant facts and
you should consult them about all
aspects of this medicine as it
relates to you.
Should you have any questions on
the use of Urografin in your X-ray
examination, these should be
discussed immediately with the
staff at the X-ray unit performing
the examination.
WHAT UROGRAFIN IS
USED FOR
Urografin is an ionic X-ray
contrast medium or X-ray dye that
is injected directly into the
bloodstream while X-rays are
being taken. All injectable X-ray
dyes, including Urografin, contain
iodine. Just as X-rays are unable
to pass through bones in your body
and thus produce a ‘picture’, X-
rays are unable to pass through the
iodine in contrast dyes. When
Urografin is injected into your
body it is used by X-ray specialist
doctors (radiologists) in one of the
following ways, depending on the
condition that is being investigated
in your particular case:
following injection into an arm
vein, Urografin travels with the
bloodstream to every organ of
the body. Using sensitive
computer assisted X-ray
machines known as CT or CAT
scanners,
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SPC
1
PRODUCT INFORMATION
UROGRAFIN
®
NAME OF THE MEDICINE
Urografin 30% contains 40 mg/mL sodium diatrizoate and 260 mg/mL
meglumine diatrizoate in
aqueous solution.
Urografin 76% contains 100 mg/mL sodium diatrizoate and 660 mg/mL
meglumine diatrizoate in
aqueous solution.
Urografin also contains sodium calcium edetate
and water for injections.
STRUCTURE
Sodium diatrizoate
I
I
I
N
N
O
O
H
H
ONa
O
Meglumine diatrizoate
CH
2
OH +
(CHOH)
4
CH
2
COO
NH
2
-CH
3
I
I
I
N
N
O
O
H
H
Molecular formula
Chemical name
Molecular
weight
Solubility
in water
Sodium
diatrizoate
(CAS No. 737-31-5)
C
11
H
8
I
3
N
2
NaO
4
Sodium 3,5-diacetamido-
2,4,6-triiodobenzoate
635.90
Freely
soluble
Meglumine diatrizoate
(CAS No. 131-49-7)
C
18
H
26
I
3
N
3
O
9
N-Methylglucamine 3,5-
diacetamido-2,4,6-
triiodobenzoate
809.13
Freely
soluble
2
DESCRIPTION
PHYSICO-CHEMICAL PROPERTIES
Urografin
30%
76%
Iodine concentration (mg/mL)
146
370
Iodine content (g) per
ampoule of 10mL
1.46
-
bottle of 50mL
-
18.5
bottle of 100mL
-
37.0
bottle of 250mL
36.5
-
Contrast medium concentration
(mg/mL)
300
760
Contrast medium content (g) per
ampoule of 10mL
3.0
-
bottle of 50mL
-
38.0
bottle of 100mL
-
76.0
bottle of 250mL
75.0
-
Viscosity (mPa . s or cP)
at 20
C
2.2
18.5
at 37
C
1.4
8.9
Osmotic pressure at 37
C
(MPa)
1.78
5.4
(atm)
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