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MULTIHANCE
®
INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MultiHance
®
.
It does not contain all the
available information.
It does not take the place of
talking with your radiologist, your
doctor or your pharmacist.
All products of this type have risks
and benefits. Your radiologist and
your doctor have weighed the risk
of you being given MultiHance
®
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS PREPARATION,
ASK YOUR RADIOLOGIST, DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You might need to read it again.
WHAT MULTIHANCE
®
IS USED
FOR
MultiHance
®
is a substance
known as a paramagnetic
contrast medium. It is used in
magnetic resonance imaging
(MRI) for adults; in particular:
•
For the enhancement of
Magnetic Resonance
Imaging (MRI) in order to
improve the scans or
images (pictures) of
certain parts of the body
(in particular, the brain,
spine and surrounding
tissue) and liver.
•
In adult patients with
suspected or known
vascular disease for
contrast-enhanced
Magnetic Resonance
Angiography (MRA) of
the abdominal or
peripheral arteries where
it improves the
diagnostic accuracy for
detecting vascular
diseases
This medicine belongs to a group
of medicines called contrast
agents.
MultiHance
®
is given by injection
into a vein. MRI and MRA are
relatively new medical
technologies which use magnetic
fields and radio waves to produce
images of parts of the body, which
a doctor can then use to make a
diagnosis. MRI and MRA
examinations are carried out by
specialist doctors called
radiologists, using sophisticated
medical equipment. MRI and
MRA do not use X-rays and
therefore the minor risks
associated with X-rays are
avoided.
ASK YOUR DOCTOR IF YOU
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MultiHance
®
PI
Page 1
PRODUCT INFORMATION
NAME OF THE MEDICINE: MultiHance
®
(dimeglumine gadobenate)
DESCRIPTION
MultiHance
®
is supplied as a sterile, non-pyrogenic, clear colourless to
slightly yellow, aqueous solution at
neutral pH (6.5-7.3) for intravenous injection. MultiHance
®
contains no preservatives.
1 mL of solution for injection contains: gadobenic acid 334 mg (0.5M)
as the dimeglumine salt.
[dimeglumine gadobenate 529 mg = gadobenic acid 334 mg +
meglumine 195 mg].
Chemical name
Gadolinate(2
-
),(4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)-1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato-(5
-
)-
N
5
,N
8
,N
11
,O
4
,O
5
,O
8
,O
11
,O
13
]- dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol
(1:2).
Laboratory name
B19036/7
Gd-BOPTA/dimeg
The structural formula of dimeglumine gadobenate is:
MOLECULAR
FORMULA
MOLECULAR
WEIGHT
C
36
H
62
N
5
O
21
Gd
1058.17
CAS Number: 127000-20-8
PARAMETER
Osmolality (mOsmol/kg water) @ 37°C: 1970
Viscosity (cP) @ 37°C: 5.3
Density @ 20°C: 1.220g/mL
MultiHance
®
has an osmolality 6.9 times that of plasma (285 mOsm/kg water) and
is hypertonic under
conditions of use.
PHARMACOLOGY
Pharmacodynamic properties
Dimeglumine gadobenate is an octadentatate chelate of
gadolinium salified with meglumine.
As a paramagnetic contrast agent, it shortens longitudinal (T1),
and, to a lesser extent, transversal (T2)
relaxation times of tissue water protons.
The relaxivities of dimeglumine gadobenate in aqueous solution (r
1
= 4.39 and r
2
= 5.56 mM
-1
s
-1
at 20 MHz), are
only slightly higher than those of other paramagnetic contrast agents
already in clinical use. However, unlike
MultiHance
®
PI
Page 2
other contrast agents, dimeglumine gadobenate
experiences strong increase in relaxivity on going from
aqueous solution to solutions containing serum protei
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