Omniscan

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Gadodiamide

Tilgjengelig fra:

GE Healthcare Australia Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

AUSTRALIA CMI 

PAGE 1 OF 6 
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet tells you about OMNISCAN™.  The information in this
leaflet applies only 
to OMNISCAN.   

This leaflet answers some common questions about OMNISCAN.  It does
not contain 
all the available information about the product and is not intended to
replace discussions 
you may wish to have with your doctor, radiologist or other health
professional. 

All medicines have risks and benefits.  Your doctors have weighed the
risks of you 
being given this medicine against the benefits they expect it will
have for you. 

PLEASE READ THIS LEAFLET BEFORE YOU ARE GIVEN OMNISCAN. 

IF YOU HAVE ANY QUESTIONS, ARE NOT SURE ABOUT ANYTHING OR IF YOU HAVE
ANY CONCERNS 
ABOUT BEING GIVEN THIS MEDICINE - ASK YOUR DOCTOR, RADIOGRAPHER OR
NURSE.   

KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN. 

WHAT OMNISCAN IS USED FOR

OMNISCAN is one of a group of medicines known as ‹contrast media›
which are used 
in Magnetic Resonance Imaging (MRI) examinations. 

OMNISCAN is used in MRI examinations of the brain or spine, as well
as other parts of 
the body.  OMNISCAN makes it easier to detect and locate changes and
to improve the 
diagnostic information your radiologist needs. 

OMNISCAN is intended for use in hospitals and radiology clinics
only. 

OMNISCAN is for use in adults, children and babies. 

HOW OMNISCAN WORKS

MRI uses the magnetic properties of molecules in the body to
“see” organs and other 
structures in the body and how they may have changed as a result of
any condition you 
may have.  OMNISCAN can greatly improve the clarity of the images the
radiologist 
looks at to enable better, and more accurate, diagnosis of your
condition. 
OMNISCAN™ CONSUMER MEDICINE INFORMATION 

          AMENDED MARCH 2007 
AUSTRALIA CMI 

PAGE 2 OF 6 

WHAT IS IN OMNISCAN

The name of your medicine is OMNISCAN.  It

Preparatomtale

AUSTRALIA PI 

PAGE 1 OF 
11 

OMNISCAN
TM
 PRODUCT INFORMATION 

80307 
PRODUCT INFORMATION 

OMNISCAN
TM
 (GADODIAMIDE) INJECTION 

Sterile Aqueous Injection 287 mg/mL 

DESCRIPTION

OMNISCAN (gadodiamide) injection is the formulation
of the gadolinium complex of 
diethylenetriamine pentaacetic acid bismethylamide, and is an injectable,
non-ionic 
extracellular enhancing agent for magnetic resonance imaging. 
OMNISCAN is to be 
administered by intravenous injection.  OMNISCAN is provided
as a sterile, clear, and 
colourless to slightly yellow aqueous solution.  Each
mL contains 287 mg gadodiamide, 
12 mg caldiamide sodium and water for injection.
 The pH is adjusted between 6.0 and 
7.0 with hydrochloric acid or sodium hydroxide.
 OMNISCAN contains no 
antimicrobial preservative.  OMNISCAN is a 0.5 mol/L solution
of gadolinium, [5,8-
bis(carboxymethyl)-11-[2-methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-
13-oato(3)-, with a molecular weight of 573.66 (anhydrous), and
empirical formula of 
C
16
H
26
GdN
5
O
8
, and the following structural formula: 

Pertinent physicochemical data for OMNISCAN are noted below: 

PARAMETER 
Osmolality (mOsm/kg H
2
O) 
@ 37
o
C 
780 
Viscosity (mPa.s) 
@ 20
o
C 
@ 37
o
C 
2.8 
1.9 
Density (g/cm
3
) 
@ 20
o
C 
1.15 

OMNISCAN has an osmolality 2.8 times that
of plasma (285 mOsm/kg H
2
O @ 37
o
C) 
and is hypertonic under conditions of use. 
AUSTRALIA PI 

PAGE 2 OF 
11 

OMNISCAN
TM
 PRODUCT INFORMATION 

80307 
CLINICAL PHARMACOLOGY

The pharmacokinetics of intravenously administered OMNISCAN in
normal subjects 
conforms to an open, two compartment model with mean distribution
and elimination 
half-lives (reported as mean +  SD) of 3.7 +  2.7
minutes and 77.8 +  16 minutes, 
respectively.  Gadodiamide is eliminated primarily in
the