MULTIHANCE gadobenate dimeglumine 2.645g/5mL solution for injection vial

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

gadobenate dimeglumine

Доступна с:

Bracco Pty Ltd

Статус Авторизация:

Registered

тонкая брошюра

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

Характеристики продукта

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
Imaging of the liver
2 of 19
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 infus