DOTAREM Solution for injection Ref.[8532] Active ingredients: Gadoteric acid

Dose

The lowest effective dose should be used.

Adult population

The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg, in adults.

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 when confirming isolated metastasis or detecting leptomeningeal tumours, a second injection of 0.2 mmol/kg can be administered.

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). 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).

Impaired hepatic function

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

Paediatric population (0-18 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.

Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Dotarem should only be used in these patients after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. 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.

Angiography: Gadoteric acid is not recommended for angiography in children under 18 years of age due to insufficient data on its efficacy and safety in this indication.

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 (0-18 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 neonates and infants the required dose should be administered by hand.

Gadoteric acid can be removed by haemodialysis. However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

Shelf life: 3 years.

Store below 30°C.

Do not freeze.

Bottles: Single bottles containing 5 mL, 10 mL, 15 mL, 20 mL, 60 mL and 100 mL, closed by an elastomeric stopper.

Pre-filled syringes: Single disposable syringes containing 10 mL, 15 mL and 20 mL with latex-free elastometric seals.

Not all pack sizes may be marketed.

Pre-filled syringes: Screw the piston rod onto the syringe and intravenously inject the quantity of the product required for the examination.

Bottles: Prepare a syringe with a needle. Remove the plastic disk. After cleaning the stopper with a pad soaked in alcohol, puncture the stopper with the needle. Withdraw the quantity of product required for the examination and inject it intravenously.

The peel-off tracking label on the bottles and syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.

Any unused product or waste material should be disposed of in accordance with local requirements.