MULTIHANCE gadobenate dimeglumine 5.29g/10mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gadobenate dimeglumine, Quantity: 529 mg/mL

Available from:

Bracco Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

10 x 10mL vials

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: For use in adults for the enhancement of magnetic resonance imaging (MRI) of the liver and Central Nervous System (CNS) for diagnostic use only. For use in adult patients with suspected or known vascular disease for contrast-enhanced magnetic resonance angiography of the abdominal or peripheral arteries where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease.

Product summary:

Visual Identification: Clear, colourless to slightly yellow solution, free from visible particulate matter.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-07-07

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
MULTIHANCE® INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about MultiHance®.
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 MultiHance® 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 WITH THE MEDICINE.
You might need to read it again.
WHAT MULTIHANCE® IS USED FOR
MultiHance® is a substance known as a paramagnetic contrast medium.
It is used in magnetic
resonance imaging (MRI) for adults; in particular:
• For the enhancement of Magnetic Resonance Imaging (MRI) in order
to improve the scans or
images (pictures) of certain parts of the body (in particular, the
brain, spine and surrounding
tissue) and liver.
• In adult patients with suspected or known vascular disease for
contrast-enhanced Magnetic
Resonance Angiography (MRA) of the abdominal or peripheral arteries
where it improves the
diagnostic accuracy for detecting vascular diseases
This medicine belongs to a group of medicines called contrast agents.
MultiHance® is given by injection into a vein. MRI and MRA are
medical technologies which use
magnetic fields and radio waves to produce images of parts of the
body, which a doctor can then
use to make a diagnosis. MRI and MRA examinations are carried out by
specialist doctors called
radiologists, using sophisticated medical equipment. MRI and MRA do
not use X-rays and
therefore the minor risks associated with X-rays are avoided.
ASK YOUR DOCTOR 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 AN INJECTION OF MULTIHANCE®
_ _
_WHEN YOU MUST NOT TAKE IT: _
DO NOT TAKE MULTIHANCE® IF YOU HAVE AN

Summary of Product characteristics

1 of 19
AUSTRALIAN PRODUCT INFORMATION - MULTIHANCE
® (DIMEGLUMINE GADOBENATE)
1 NAME OF THE MEDICINE
Dimeglumine gadobenate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MultiHance contains Gadolinate(2
-
),(4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)-1-phenyl-2-oxa-
5,8,11-triazatridecan-13-oato-(5
-
)-N
5
,N
8
,N
11
,O
4
,O
5
,O
8
,O
11
,O
13
]- dihydrogen compound with 1-
deoxy-1-(methylamino)-D-glucitol (1:2).
1 mL of solution for injection contains: gadobenic acid 334 mg (0.5M)
as the dimeglumine salt.
[dimeglumine gadobenate 529 mg = gadobenic acid 334 mg + meglumine 195
mg].
MultiHance
®
contains dimeglumine gadobenate 0.529g per mL (0.5M).
MultiHance
®
has a pH of 6.5 to 7.3. Pertinent physicochemical data follow:
PARAMETER
Osmolality (mOsmol/kg water) @ 37°C: 1970
Viscosity (cP) @ 37°C: 5.3
Density @ 20°C: 1.220g/mL
MultiHance
®
has an osmolality 6.9 times that of plasma (285 mOsm/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, non-pyrogenic, clear colourless to slightly yellow, aqueous
solution for intravenous
injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MultiHance
®
is a paramagnetic contrast agent for use in diagnostic magnetic
resonance imaging
(MRI) indicated for:

For use in adults for the enhancement of magnetic resonance imaging
(MRI) of the liver
and Central Nervous System (CNS) for diagnostic use only.

For use in adult patients with suspected or known vascular disease for
contrast-enhanced
magnetic resonance angiography of the abdominal or peripheral arteries
where it improves the
diagnostic accuracy for detecting clinically significant
steno-occlusive vascular disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
MRI
2 of 19
Imaging of the liver
The recommended dose of MultiHance
®
in adult patients is 0.05 mmol/kg body weight. This
corresponds to 0.1 mL/kg of the 0.5 M solution.
The product should be administered intravenously either as a bolus or
as an infusi