DOTAREM PRE-FILLED SYRINGES

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

GADOTERIC ACID

Dostopno od:

PROMEDICO LTD

Koda artikla:

V08CA02

Farmacevtska oblika:

SOLUTION FOR INJECTION

Sestava:

GADOTERIC ACID 27.932 G / 100 ML

Pot uporabe:

I.V

Tip zastaranja:

Required

Izdeluje:

GUERBET, FRANCE

Terapevtska skupina:

GADOTERIC ACID

Terapevtsko območje:

GADOTERIC ACID

Terapevtske indikacije:

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 dovoljenje:

2013-02-28

Lastnosti izdelka

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_ _
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