MULTIHANCE Solution for injection Ref.[9501] Active ingredients: Gadobenic acid

Posology

The recommended dose of gadobenic acid in adult patients and children is 0.05 mmol/kg body weight (0.1 mL/kg of the 0.5 M solution). 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.

If required, the injection can be repeated in subjects with normal kidney function.

Method of administration

MultiHance should be drawn up into the syringe immediately before use and should not be diluted. Any unused product should be discarded and not be used for other MRI examinations.

To minimise the potential risks of soft tissue extravasation of MultiHance, it is important to ensure that the i.v. needle or cannula is correctly inserted into a vein.

The product should be administered intravenously either as a bolus or slow injection (10 mL/min.), see table for post-contrast imaging acquisition.

The injection should be followed by a flush of sodium chloride 9 mg/ml (0.9%) solution for injection.

Post-contrast imaging acquisition:

Special Populations

Impaired renal function

Use of MultiHance should be avoided in patients with severe renal impairment (GFR <30 ml/min/1.73m²) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI (see information on renal impairment in section 4.4).

If use of MultiHance cannot be avoided, the dose should not exceed 0.05 mmol/kg body weight. Because of the lack of information on repeated administration, MultiHance injections should not be repeated unless the interval between injections is at least 7 days.

Hepatic impairment

No dose adjustment is considered necessary in patients with impaired liver function because hepatic impairment had little effect on the pharmacokinetics of MultiHance.

Elderly (aged 65 years and above)

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

Paediatric population

No dosage adjustment is considered necessary.

Use of MultiHance is not recommended in children less than 2 years of age.

There have been no cases of overdose reported. Therefore, the signs and symptoms of overdosage have not been characterised. Doses up to 0.4 mmol/kg were administered to healthy volunteers, without any serious adverse events. However, doses exceeding the specific approved dosage are not recommended. In the event of overdosage, the patient should be carefully monitored and treated symptomatically.

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

3 years.

From a microbiological point of view, the product should be used immediately after drawing into the syringe.

Do not freeze.

5 mL, 10 mL, 15 mL and 20 mL of a clear aqueous solution filled into single dose colourless type I glass vials with elastomeric closures, aluminium sealing crimps and polypropylene caps.

Kit with administration devices: 15 and 20 mL vial, syringe for magnetic resonance automatic injector ((65 mL syringe (polyethelene terephthalate/polycarbonate), 115 mL syringe (polyethelene terephthalate/polycarbonate), connector (PVC/polycarbonate/polypropylene/silicone), 2 spikes (ABS)), 20 G secured catheter.

Not all pack sizes may be marketed.

MultiHance should be drawn up into the syringe immediately before use and should not be diluted.

Before use, examine the product to assure that the container and closure have not been damaged, the solution is not discoloured and no particulate matter is present.

When MultiHance is used in conjunction with an injector system, the connecting tubes to the patient and the relevant disposable parts should be disposed after each patient examination. Any additional instructions from the respective equipment manufacturer must also be adhered to.

The peel-off tracking label on the vials should be stuck onto the patient records 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.

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