ABLAVAR Solution for injection Ref.[9499] Active ingredients: Gadofosveset

This medicinal product should only be used by physicians experienced in the field of diagnostic imaging.

Posology

Adults: 0.12 ml/kg body weight (equivalent to 0.03 mmol/kg)

Imaging time points

Dynamic imaging begins immediately upon injection. Steady state imaging can begin after the dynamic scan has been completed. In clinical trials, imaging was completed up to approximately one hour following injection.

No clinical information is available about repeated use of this medicinal product.

Special populations

Elderly (aged 65 years and above)

No dose adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).

Renal impairment

Use of Ablavar should be avoided in patients with severe renal impairment (GFR <30 ml/min/1.73 m²) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI) (see section 4.4). If use of Ablavar cannot be avoided, the dose should not exceed 0.03 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Ablavar injections should not be repeated unless the interval between injections is at least 7 days.

Hepatic impairment

Dose adjustments in hepatic impairment are not necessary (see section 5.2).

Paediatric population

Use is not recommended in neonates, infants, children and adolescents. No clinical experience is yet available for patients younger than 18.

Method of administration

This medicinal product should be administered as a single intravenous bolus injection, manually, or by magnetic resonance injector (MR injector) over a period of time up to 30 seconds followed by a 25-30 ml normal saline flush.

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

3 years.

After first opening: the medicinal product should be used immediately.

Keep the injection vial in the outer carton in order to protect from light.

10 and 20 ml colourless type I glass vials with chloro- or bromobutyl elastomer stopper and aluminium bordered cap (plastic disk).

Pack sizes:

1, 5, or 10 vials x 10 ml (in 10-ml glass vial)
1, 5, or 10 vials x 15 ml (in 20-ml glass vial)
1, 5, or 10 vials x 20 ml (in 20-ml glass vial)

Not all pack sizes may be marketed.

This medicinal product is supplied ready to use as a clear, colourless to pale yellow aqueous solution. Contrast media should not be used in case of severe discolouration, the occurrence of particulate matter, or defective container.

Vials are not intended for the withdrawal of multiple doses. The rubber stopper should never be pierced more than once. After withdrawal of the solution from the vial, it should be used immediately.

The peel-off tracking label included with the vials should be stuck onto patient record to enable accurate recording of the gadolinium contrast agent used.

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