Multihance

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Gadobenate dimeglumine 0.529 g/mL equivalent to to 0.5 M gadobenic acid

Dostupno od:

Regional Health Ltd

INN (International ime):

Gadobenate dimeglumine 0.529 g/mL (equiv. to 0.5 M gadobenic acid)

Doziranje:

0.529 g/mL

Farmaceutski oblik:

Solution for injection

Sastav:

Active: Gadobenate dimeglumine 0.529 g/mL equivalent to to 0.5 M gadobenic acid Excipient: Water for injection

Jedinice u paketu:

Vial, glass, single dose, 5 mL

Razred:

General sale

Tip recepta:

General sale

Proizveden od:

Bracco SpA.

Terapijske indikacije:

MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) of the liver and Central Nervous System (CNS). MultiHance is indicated, for the detection of focal liver lesions in patients with known or suspected primary liver cancer (eg. hepatocellular carcinoma) or metastatic disease. MultiHance is also indicated for the MRI of the brain and spine where it improves the detection of lesions and provides diagnostic information additional to that obtained with unenhanced MRI. MultiHance is indicated for contrast enhance Magnetic Resonance Angiography to improve the diagnostic accuracy of detecting clinical significant steno-occlusive vascular diseases in patients with known vascular diseases of the abdominal, supra-aortic or peripheral arteries.

Proizvod sažetak:

Package - Contents - Shelf Life: Vial, glass, single dose, - 5 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 10 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 15 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 20 mL - 36 months from date of manufacture stored at or below 25°C

Datum autorizacije:

2002-05-30

Svojstava lijeka

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NEW ZEALAND DATASHEET - 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
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.
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The product should be administered intravenously either as a bolus or
as an infusion (10
m