DOTAGRAF Solution for injection Ref.[28334] Active ingredients: Gadoteric acid

Posology

The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient’s body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section.

Encephalic and spinal MRI

In neurological examinations, the dose can vary from 0.1 to 0.3 mmol/kg BW, corresponding to 0.2 to 0.6 ml/kg BW. After administration of 0.1 mmol/kg BW to patients with brain tumours, the additional dose of 0.2 mmol/kg BW may improve tumour characterisation and facilitate therapeutic decision making.

Whole body MRI and Angiography

The recommended dose for intravenous injection is 0.1 mmol/kg BW (i.e. 0.2 ml/kg BW) to provide diagnostically adequate contrast.

Angiography: In exceptional circumstances (e.g. failure to gain satisfactory images of an extensive vascular territory) administration of a second consecutive injection of 0.1 mmol/kg BW, equivalent to 0.2 ml/kg BW may be justified. However, if the use of 2 consecutive doses of Dotagraf is anticipated prior to commencing angiography, use of 0.05 mmol/kg BW, equivalent to 0.1ml/kg BW for each dose may be of benefit, depending on the imaging equipment available.

Special populations

Impaired renal function

The adult dose applies to patients with mild to moderate renal impairment (GFR ≥ 30 ml/min/1.73m²).

Dotagraf 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 Dotagraf, 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, Dotagraf 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 (see above impaired renal function).

Paediatric population

MRI of brain and spine/whole-body MRI: the recommended and maximum dose of Dotagraf is 0.1 mmol/kg BW. 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, Dotagraf should only be used in these patients after careful consideration at a dose not exceeding 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, Dotagraf injections should not be repeated unless the interval between injections is at least 7 days.

Dotagraf is not recommended for angiography in children under 18 years of age due to insufficient data on efficacy and safety in this indication.

Method of administration

The product is indicated for intravenous administration only.

Infusion rate: 3-5 ml/min (higher infusion rates up to 120 ml/min, i.e. 2 ml/sec, may be used for angiographic procedures)

Optimal imaging: within 45 minutes after injection

Optimal image sequence: T1-weighted

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.

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.

For single use only, any unused solution should be discarded.

The solution for injection should be inspected visually prior to use. Only clear solutions free of visible particles should be used.

Paediatric population

Depending on the amount of Dotagraf to be given to the child, it is preferable to use Dotagraf 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).

3 years.

Chemical and physical in-use stability has been demonstrated for 72 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless opening has taken place in controlled and validated aseptic conditions.

This medicinal product does not require any special storage conditions.

1 and 10 Type II single-use colourless glass vials of 10 ml and 20 ml (filled to 15 or 20 ml), sealed with a stopper of bromobutyl rubber and packed in unit carton box.

Not all pack sizes may be marketed.

The peel-off tracking label on the vials 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 medicinal product or waste material should be disposed of in accordance with local requirements.