DOTAREM INJECTION 27.932 G/ 100 ML [SIN09008P]

Product Info

DOTAREM INJECTION 27.932 G/ 100 ML

[SIN09008P]

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/1.73m² ).

Dotarem should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m² ) 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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If it is necessary to use Dotarem, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Dotarem injections should not be repeated unless the interval between injections is at least 7 days.

Elderly (aged 65 years and above)
No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Impaired hepatic function
The adult dose applies to these patients. Caution is recommended, especially in the case of perioperative liver transplantation period.

Paediatric population (2–18 years)
MRI of brain and spine / whole-body MRI: the recommended and maximum dose of Gadoteric acid is 0.1 mmol/kg body weight. More than one dose should not be used during a scan.

Method of administration

The product is indicated for intravenous administration only.
Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time.

Paediatric population (2–18 years)
Depending on the amount of gadoteric acid to be given to the child, it is preferable to use gadoteric acid vials with a single use syringe of a volume adapted to this amount in order to have a better precision of the injected volume. In infants the required dose should be administered by hand.

4.3. Contraindications

Hypersensitivity to gadoteric acid, to meglumine or to any medicinal products containing gadolinium.