PRIMOVIST Solution for injection Ref.[9494] Active ingredients: Gadoxetic acid

Method of administration

Primovist is a ready-to-use aqueous solution to be administered undiluted as an intravenous bolus injection at a flow rate of about 2 ml/sec. After the injection of the contrast medium the intravenous cannula/line should be flushed using sterile 9 mg/ml (0.9%) saline solution.

For detailed imaging information refer to section 5.1.

For additional instructions see section 6.6.

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.

The recommended dose of Primovist is:

Adults

0.1 ml per kg body weight Primovist.

Repeated use

No clinical information is available about repeated use of Primovist.

Additional information on special populations

Impaired renal function

Use of Primovist 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 section 4.4). If use of Primovist cannot be avoided, the dose should not exceed 0.025 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Primovist injections should not be repeated unless the interval between injections is at least 7 days.

Patients with hepatic impairment

No dosage adjustment is necessary.

Paediatric population

The safety and efficacy of Primovist have not been established in patients under 18 years old. Currently available data are described in section 5.1.

Elderly population (aged 65 years and above)

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

No cases of overdose have been reported and no symptoms could be characterised.

Single doses of Primovist as high as 0.4 ml/kg (0.1mmol/kg) body weight were tolerated well.

In a limited number of patients, a dose of 2.0 ml/kg (0.5 mmol/kg) body weight was tested in clinical trials, more frequent occurrences of adverse events but no new undesirable effects were found in these patients.

In the event of excessive inadvertent overdose, the patient should be carefully observed including cardiac monitoring. In this case induction of QT prolongations is possible (see section 5.3).

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

Shelf life:

• 5 years (glass prefilled syringe).
• 3 years (plastic prefilled syringe).

The product should be used immediately after opening.

This medicinal product does not require any special storage precautions.

Glass syringes: 10 ml prefilled syringes consisting of a colourless siliconized PhEur type I glass barrel, a siliconized chlorobutyl elastomer plunger stopper, a chlorobutyl elastomer rubber tip cap, a polysulfone Luer Lock adapter and a polypropylene safety cap.

Plastic syringes: 10 ml prefilled syringes consisting of a colourless cycloolefin polymer plastic barrel with a thermoplastic elastomer tip seal, closed with a siliconized bromobutyl plunger.

Package sizes:

1, 5 and 10 × 5 ml (in 10 ml prefilled syringe)
1, 5 and 10 × 7.5 ml (in 10 ml prefilled syringe) (glass only)
1, 5 and 10 × 10 ml (in 10 ml prefilled syringe)

Not all pack sizes may be marketed.

Inspection

This medicinal product is a clear, colorless to pale yellow solution. It should be visually inspected before use.

Primovist should not be used in case of severe discoloration, the occurrence of particulate matter or a defective container.

Handling

The prefilled syringe must be taken from the pack and prepared for the injection immediately before the examination.

The tip cap should be removed from the prefilled syringe immediately before use.

Disposal

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

The peel-off tracking label on the pre-filled 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.