DOTAREM PRE-FILLED SYRINGES

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

GADOTERIC ACID

から入手可能:

PROMEDICO LTD

ATCコード:

V08CA02

医薬品形態:

SOLUTION FOR INJECTION

構図:

GADOTERIC ACID 27.932 G / 100 ML

投与経路:

I.V

処方タイプ:

Required

製:

GUERBET, FRANCE

治療群:

GADOTERIC ACID

治療領域:

GADOTERIC ACID

適応症:

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.

承認日:

2013-06-12

製品の特徴

_ _
_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS

DOTAREM -
VIALS, SOLUTION FOR INJECTION

DOTAREM PRE-FILLED SYRINGES - SOLUTION FOR INJECTION IN PREFILLED SYRINGE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 100 mL of solution:
Gadoteric acid*
........................................................................................................
27.932 g
corresponding to DOTA
.................................................................................
20.246 g
corresponding to gadolinium oxide
..................................................................
9.062 g
*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 the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for I.V injection in prefilled syringe or vial .
Clear, colourless to pale yellow solution.
Osmolality: 1350 mOsm.kg
-1
Viscosity at 20°C: 3.2 mPa.s
Viscosity at 37°C: 2.0 mPa.s
pH: 6.5 to 8.0.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS

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.
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 injection of