资料单张
PRIMOVIST
®
CMI
1
PRIMOVIST
®
(PREE·MOE·VIST)
_disodium gadoxetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about Primovist.
It does not contain all 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 Primovist
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 PRIMOVIST IS
USED FOR
Primovist is used to help detect and
diagnose changes that may be found
in the liver. Abnormal signs within
the liver can be better evaluated.
Primovist can also help the doctor
determine the nature of any
abnormalities, thereby increasing
the confidence one can have in the
diagnosis. The diagnosis can be
made quicker, earlier, and with
greater accuracy than without using
Primovist.
Primovist is used together with an
imaging technique called magnetic
resonance imaging (MRI). MRI is a
form of medical diagnostic imaging
that distinguishes between normal
and abnormal tissues without using
x-rays.
Primovist is a magnetic liquid that
alters the way in which tissues
appear, showing abnormalities that
may not be visible using MRI alone.
Primovist is available only at MRI
units for use in conjunction with
MRI.
Primovist is for diagnostic use only.
ASK YOUR DOCTOR/RADIOLOGIST IF YOU
HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE
GIVEN PRIMOVIST
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN PRIM
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产品特点
1204 Primovist PI
1
PRODUCT INFORMATION
PRIMOVIST
®
NAME OF THE MEDICINE
Primovist 0.25 mmol/mL, solution for injection is an
injectable contrast media
agent for use in Magnetic Resonance Imaging (MRI) and
contains disodium
gadoxetate (Gd-EOB-DTPA). The chemical name
for disodium gadoxetate is
(4S)-4-(4-ethoxybenzyl)-3,6,9-triazaundecanedioic acid, gadolinium-complex,
disodium salt and has the following chemical structure:
O
N
N
N
O
O
O
O
O
O
Gd
3+
2 Na
+
O
O
O
O
Molecular Formula: C
23
H
28
N
3
O
11.
Gd.2Na
Molecular Weight: 725.7
CAS No.:
135326-22-6
PHYSICO-CHEMICAL PROPERTIES
The physico-chemical properties of Primovist are listed below:
Osmolality at 37°C (mOsm/kg H
2
O)
688
Density at 37
o
C (g/mL)
1.0881
Viscosity at 37°C (mPa·s)
1.19
pH
6.8-8.0
DESCRIPTION
Primovist is presented as a solution for injection. Each 1
mL of the MRI
contrast agent Primovist contains 0.25
mmol disodium gadoxetate (equivalent
to 181.43 mg disodium gadoxetate as the active
ingredient). The excipients
are: trisodium caloxetate
trometamol, hydrochloric acid (for pH adjustment),
sodium hydroxide (for pH adjustment) and water for injections. Each
mL
contains 0.511 mmol (equivalent to
11.755 mg) of sodium. (See Precautions)
.
Primovist contains no antimicrobial preservative.
1204 Primovist PI
2
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Primovist is a
paramagnetic contrast agent for magnetic resonance imaging.
The contrast-enhancing effect is mediated by gadoxetate, an
ionic complex
consisting of gadolinium (III) and the ethoxybenzyl-diethylenetriamine-
pentaacetic acid which contains the
lipophilic ethoxybenzyl moiety(Gd-EOB-
DTPA).
When T
1
-weighted scanning sequences are used in proton magnetic
resonance imaging, the gado
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