DOTAREM INJECTION 27.932 g 100 ml

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

GADOTERIC ACID

Tillgänglig från:

TRANSMEDIC PTE LTD

ATC-kod:

V08CA02

Dos:

27.932 g/ 100 ml

Läkemedelsform:

INJECTION

Sammansättning:

GADOTERIC ACID 27.932 g/ 100 ml

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

Prescription Only

Tillverkad av:

GUERBET

Bemyndigande status:

ACTIVE

Tillstånd datum:

1996-11-18

Bipacksedel

Produktens egenskaper

IS1200SG02 (clean version) – based on CCSI ver. 4 & HSA requested
wordings
1
DOTAREM
®
0.5 mmol/mL
solution for injection in vials
Gadoteric acid
1.
NAME OF THE MEDICINAL PRODUCT
Dotarem 0.5 mmol/mL, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 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 oxide with 1, 4, 7, 10
tetraazacyclododecane-N,N’,N’’,N’’’ tetraacetic acid
(DOTA).
Contrast agent concentration:
……………………………………………………………0.5
mmol/mL
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in vials.
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
This medicinal product is for diagnostic use only.
Nuclear magnetic resonance imaging:

Neuroradiology: tumour of the spine and the surrounding tissues,
intracranial tumours.

Abdominal radiology: primary and secondary tumours.

Primary tumour of the bone and soft tissues.
4.2.
Posology and method of administration
Posology
Adults
The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg, in adults.
Special populations
Impaired renal function
The adult dose applies to patients with mild to moderate renal
impairment (GFR ≥ 30 ml/min/1.73m
2
).
Dotarem should only be used in patients with severe renal impairment
(GFR < 30 ml/min/1.73m
2
) and in patients in the
perioperative liver transplantation period after careful risk/benefit
assessment and if the diagnostic information is
essential and not available with non-contrast enhanced MRI (see