资料单张
1210 MAGNEVIST
®
CMI
1
MAGNEVIST
®
(MAG·NE
⋅VIST)
_DIMEGLUMINE GADOPENTETATE _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Magnevist. 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
Magnevist 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.
WHAT MAGNEVIST IS
USED FOR
Magnevist is used at the same
time as magnetic resonance
imaging (MRI) to aid in the
detection of abnormalities in the
brain, spinal cord, neck, chest,
abdomen, pelvis, bones and
muscles in adults; and in the
brain and spinal cord in children
and babies.
MRI is a form of medical
diagnostic imaging that forms
pictures after detecting water
molecules in normal and
abnormal tissues. This is done
using a complex system of
magnets and radiowaves.
Magnevist is a liquid that alters
the way in which the MRI
machine detects certain tissues
within the body. Magnevist often
makes the pictures clearer and
often shows things that may not
have been visible using MRI
alone.
Magnevist is only available at
MRI units for use in conjunction
with MRI.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
MAGNEVIST IS BEING USED IN YOU.
Your doctor may be using it for
another reason.
BEFORE YOU ARE
GIVEN MAGNEVIST
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
MAGNEVIST IF YOU HAVE AN
ALLERGY TO:
• dimeglumine gadopentetate,
the active ingredient in
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产品特点
- 1 -
MAGNEVIST
®
PRODUCT INFORMATION
NAME OF THE MEDICINE
Magnevist
®
(dimeglumine gadopentetate) 0.5 mmol/mL solution
for intravenous
injection is the N-methylglucamine salt of the
gadolinium complex of
diethylenetriamine pentaacetic acid, and is an injectable
contrast medium for
magnetic resonance imaging (MRI).
DESCRIPTION
Dimeglumine gadopentetate is to be administered
by intravenous injection or
infusion.
Each mL of Magnevist solution
for injection or infusion contains 469 mg
dimeglumine gadopentetate, 530 micrograms meglumine, 1.02 mg
meglumine
pentetate and water for injections. Magnevist Injection
contains no antimicrobial
preservative.
Magnevist Injection is provided as a
sterile, clear, colourless to slightly yellow
aqueous solution.
Magnevist Injection is a 0.5 mol/L solution
of 1-deoxy-1-(methylamino)-D-glucitol
dihydrogen
[_N,N_-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato-(5-)]gadolinate
(2-)
(2:1) with a molecular weight of 938 and has the following
structural formula:
Dimeglumine Gadopentetate (USAN)
Gadopentetate Dimeglumine (INN)
Molecular Formula: C
28
H
54
GdN
5
O
20
CAS Registry No.: 86050-77-3
N
N
O
N
O
O
O
O
O
O
O
O
O
Gd
3+
C
H
3
NH
2
+
O
H
O
H
H
O
H
H
OH
H
H
OH
2
- 2 -
Magnevist Injection has a pH of 7.0-7.9. Magnevist Injection
is hypertonic under
conditions of use.
PHARMACOLOGY
The pharmacokinetics of intravenously administered dimeglumine
gadopentetate in
normal subjects conforms to a two compartment open-model with
mean distribution
and elimination half-lives (reported as mean ± SD) of about 0.2
± 0.13 hours and 1.6
± 0.13 hours, respectively.
Dimeglumine gadopentetate does not cross the intact blood-brain
barrier and,
therefore, does not accumulate in normal brain or in
lesions that do not have an
abnormal blood-brain barrier, e.g.
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