GADOVIST

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Gadobutrol

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Patient Information leaflet

1304 GADOVIST
® 
CMI (Approved PI dated 9 April 2013)          

1 
GADOVIST
®

(GAD·OH·VIST) 
_gadobutrol _
______________________________________________________________________ 
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS 
LEAFLET 

This leaflet answers some 
common questions about 
Gadovist. It does not contain all 
the available information. It does 
not take the place of talking to 
your doctor or health care 
professional.  

All diagnostic agents have risks 
and benefits. Your doctor has 
weighed the risks of you using 
Gadovist against the benefits it is 
expected to 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 GADOVIST IS 
USED FOR 

Gadovist is used at the same time 
as magnetic resonance imaging 
(MRI) to aid in the detection of 
known or suspected 
abnormalities in the brain, spinal 
cord, blood vessels, liver and 
kidneys. 

Gadovist is for use in adults, 
adolescents and children aged 2 
years and older. 

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.  

Gadovist is itself a magnetic 
liquid that alters the way in 
which the MRI machine detects 
certain tissues within the body, 
often making the pictures clearer 
and often showing things that 
may not have been visible using 
MRI alone. 

Gadovist is only available at MRI 
units for use in conjunction with 
MRI. 

ASK YOUR DOCTOR IF YOU HAVE 
ANY QUESTIONS ABOUT WHY 
GADOVIST IS BEING USED IN YOU. 
Your doctor may be using it for 
another reason.  
BEFORE YOU ARE 
GIVEN GADOVIST

_WHEN YOU MUST NOT BE _
_GIVEN IT _
Your�

Summary of Product characteristics

130409 Gadovist PI 
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Supersedes: 120827 Gadovist PI 
PRODUCT INFORMATION 

GADOVIST
®

NAME OF THE MEDICINE 
Gadovist injection is a 1.0 mmol/mL solution of
10-(2,3-Dihydroxy-1-
hydroxymethylpropyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetic
acid, 
Gd-Complex, with a molecular weight of 604.7 and has the following
structural 
formula: 

CAS Registry No. 138071-82-6 

PHYSICO-CHEMICAL PROPERTIES 

Contrast Medium Concentration 
(mg/mL) 
(mmol/mL) 

GADOVIST 1.0 
604.72 
1.0 
Osmolarity at 37º C 
(mOsm/L solution) 

1117 
Osmolality at 37º C 
(mOsm/kg H
2
O) 

1603 
Viscosity at 37º C (mPa.s) 

4.96 
_ _
Gadovist 1.0 solution has a pH of 6.6 to 8.0 

DESCRIPTION 

Gadovist (gadobutrol) solution for injection is the complex consisting
of 
gadolinium (III) and the macrocyclic dihydroxy-hydroxymethylpropyl-
tetraazacyclododecane-triacetic acid (butrol), and is an injectable
neutral 
contrast medium for magnetic resonance imaging (MRI). Gadobutrol is to
be 
administered by intravenous injection. 

Gadovist is available as a 1.0 mmol/mL solution for injection and
each mL of 
Gadovist 1.0 contains 604.72 mg (1.0 mmol) gadobutrol, 0.513 mg
calcobutrol 
sodium, 1.211 mg trometamol, hydrochloric acid and water for
injections.  
Each mL contains 0.00056 mmol (equivalent to 0.013 mg) of sodium.
Based 

130409 Gadovist PI 
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Supersedes: 120827 Gadovist PI 
on the average amount given to a 70 kg person this medicinal
product 
contains less than 1 mmol sodium (23 mg) per dose. 
Gadovist solution for injection contains no antimicrobial
preservative and is a 
clear, colourless to pale yellow solution. 

PHARMACOLOGY 

CLINICAL PHARMACOLOGY 
Mechanism of action 
Gadovist is a paramagnetic contrast agent for magnetic resonance
imaging.  
The contrast-enhancing effect is mediated by gadobutrol, a neutral
(non-ionic) 
complex consisting of gadolinium (III) and the macro