CLARISCAN

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

GADOTERIC ACID

Dostupné s:

ELDAN ELECTRONIC INSTRUMENTS CO LTD, ISRAEL

ATC kód:

V08CA02

Léková forma:

SOLUTION FOR INJECTION

Složení:

GADOTERIC ACID 279.3 MG / 1 ML

Podání:

I.V

Druh předpisu:

Required

Výrobce:

GE HEALTHCARE AS, NORWAY

Terapeutické oblasti:

GADOTERIC ACID

Terapeutické indikace:

Enhancement of contrast in magnetic resonance imaging.Aencephalic and spinal pathologies: brain tumours, tumours of the spine and the surrounding tissue, intervertebral disk prolapse infectious diseases.Abdominal pathologies: primary and secondary liver tumours.Osteo-articular pathology: bone and soft tissue tumours synovial diseases.Magnetic resonance imaging for angiography.

Datum autorizace:

2020-02-04

Charakteristika produktu

_ _
_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
Clariscan
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of solution:
Gadoteric acid*
.......................................................................................................
279.3 mg
corresponding to gadoterate meglumine
...................................................... 376.9 mg
corresponding to gadolinium oxide
............................................................... 90.62
mg
corresponding to
tetraxetan…………………………………………………….202.46
mg
*Gadoteric acid: complex of gadolinium with
1,4,7,10-tetraazacyclododecane-N,N’,N’’,N’’’-tetraacetic
acid
Concentration in the contrast agent: 0.5 mmol/mL
For a full list the excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for I.V injection in pre-filled syringe, vial or bottles
(glass and polypropylene).
Clear, colourless to slightly yellow solution.
Osmolality: 1350 mOsm.kg
-1
Viscosity at 20°C: 3.0 mPa.s
Viscosity at 37°C: 2.1 mPa.s
pH: 6.5 to 8.0.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Enhancement of contrast in magnetic resonance imaging.
•
Encephalic and spinal pathologies: brain tumours, tumours of the spine
and the surrounding tissue,
intervertebral disk prolapse infectious diseases.
•
Abdominal pathologies: primary and secondary liver tumours.
•
Osteo-articular pathology: bone and soft tissue tumours synovial
diseases.
•
Magnetic resonance imaging for angiography.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest dose that provides sufficient enhancement for diagnostic
purposes should be used.
The recommended dose is 0.1 mmol/kg, i.e., 0.2 mL/kg, in adults,
children and infants.
In angiography, depending on the results of the examination being
performed, a second injection may be
administered during the same session if necessary.
In some exceptional cases, as in the confirmation of isolated
metastasis or the detection of leptomeningeal
tumours, a second injec