ProHance

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Gadoteridol

Tilgjengelig fra:

Bracco Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

CONSUMER MEDICINE INFORMATION 
PROHANCE
® 
INJECTION

WHAT IS IN THIS LEAFLET? 
This leaflet answers some common questions about ProHance
®
. 
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 ProHance
® 
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. You might need to read it again. 

WHAT PROHANCE 

IS USED FOR AND HOW IT WORKS 
Prohance
® 
is a substance known as a paramagnetic contrast medium. It is used
in magnetic resonance imaging (MRI) to 
enhance or improve the scans or images (pictures) of certain parts of
the body (in particular, the brain, spine and 
surrounding tissue), obtained by MRI alone. 

ProHance
® 
can also be used for whole body MRI, including the head, neck,
liver, breast, musculoskeletal system (all of 
the muscles, bones, joints and related structures that are
involved in the movement of the parts and organs of the body) 
and diseases of the soft tissues. 

ProHance
® 
is given by injection into a vein. ProHance
® 
is not recommended for use in children under the age of 2 years
as 
there is not enough experience with the use of ProHance
® 
in this group. MRI is a relatively new medical technology which 
uses magnetic fields and radio waves to produce images of parts of
the body, which a doctor can then use to make a 
diagnosis. MRI examinations are carried out specialist doctors
called radiologists, using sophisticated medical 
equipment. MRI does not use X-rays and therefore the minor risks
associated with X-rays are avoided. 

BEFORE YOU HAVE AN INJECTION OF PROHANCE

YOU MUST NOT HAVE AN INJECTION OF 

Preparatomtale

                          PROHANCE® 

                         GADOTERIDOL 

PRODUCT INFORMATION 

NAME OF THE DRUG: Gadoteridol 

DESCRIPTION 

ProHance® (gadoteridol) is a nonionic paramagnetic contrast medium
for magnetic 
resonance imaging (MRI), available as a 0.5M sterile clear
colourless to slightly yellow 
solution for intravenous injection. 

Chemically, gadoteridol is
[10-(2-hydroxypropyl-O)-1,4,7,10-tetra-azacyclododecane-1,4,7-
triyltriacetato O
1
, O
4
, O
7
, N
1
, N
4
, N
7
, N
10
 (3-)]gadolinium(III). 

CAS Number: 120066-54-8 
The structural formula of gadoteridol is: 

MOLECULAR FORMULA                             
                                MOLECULAR
WEIGHT 
C
17
 H
29
 GdN
4
 O
7

     558.7  

Gadoteridol is freely soluble in water and methanol, soluble in
isopropanol, sparingly soluble 
in dimethylformamide, slightly soluble in acetonitrile and
methylene chloride and very slightly 
soluble in ethyl acetate, acetone, toluene and hexane. 

ProHance® contains the following excipients: 
calteridol calcium, trometamol, hydrochloric acid, sodium
hydroxide and water for injections. 

ProHance® contains no antimicrobial preservative. 

ProHance® has a pH of 6.5 to 8. Pertinent physicochemical data
follow: 

PARAMETER 

Osmolality (mOsmol/kg water) @ 37°C: 630 
Viscosity (cP) @ 20°C: 2.0 
Viscosity (cP) @ 37°C: 1.3 
Specific Gravity @ 25°C: 1.140 
Density (g/mL)  @ 25°C: 1.137 
Octanol:H
2
O coefficient: -3.68 ± 0.02 

ProHance® has an osmolality 2.2 times that of plasma (285 mOsmol/kg
water) and is 
hypertonic under conditions of use. 

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of 
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PHARMACOLOGY 

Pharmacodynamic properties 
Gadoteridol is�