PROHANCE gadoteridol 2793mg/10mL injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

gadoteridol, Quantity: 279.3 mg/mL

Tilgjengelig fra:

Bracco Pty Ltd

INN (International Name):

Gadoteridol

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: hydrochloric acid; calteridol calcium; trometamol; sodium hydroxide; water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

10 x 10ml

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

Do not freeze (syringe only). ProHance is indicated for use in adults and children from 2 years of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity. ProHance can also be used for whole body MRI.

Produkt oppsummering:

Visual Identification: Clear, colourless to slightly yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2016-04-26

Informasjon til brukeren

1
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 by 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 PROHANCE_
®
:
If you are allergic to the active ingredient of ProHance
®
, gadoteridol, or the other ingredients in
ProHance
®
injection, or to simil

Preparatomtale

1 of 11
AUSTRALIAN PRODUCT INFORMATION - PROHANCE
® (GADOTERIDOL)
1 NAME OF THE MEDICINE
Gadoteridol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ProHance
®
(gadoteridol) is a nonionic paramagnetic contrast medium for magnetic
resonance
imaging (MRI). 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).
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 gadoteridol 279.3mg per mL (0.5M).
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.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Sterile clear colourless to slightly yellow solution for intravenous
injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ProHance
®
is indicated for use in adults and children from 2 years of age for
enhancement of
magnetic resonance images of intracranial and spinal lesions where
there is an abnormal
blood-brain barrier or abnormal vascularity. ProHance
®
can also be used for whole body MRI.
4.2 DOSE AND METHOD OF ADMINISTRATION
ProHance
®
is administered by intravenous injection. ProHance
®
vials and syringes contain no
antimicrobial agent and are for single use only. They are to be used
once only and any
residue discarded.
Extreme caution during injection of any contrast media is necessary to
avoid extravasation.
Adults
The recommended dose range of ProHance
®
for imaging most brain and spine patholog