TELESCAN Solution for infusion Ref.[9492] Active ingredients: Mangafodipir

The medicinal product is for single intravenous use only as repeated dosing has not been studied. It should be administered as an intravenous infusion at the rate of 2-3 ml/min for liver imaging and at a rate of 4-6 ml/min for imaging of the pancreas.

Near maximal enhancement of the normal liver and pancreas parenchyma is generally observed 15-20 minutes from the start of administration and lasts for approximately 4 hours.

At the clinical dose the contrast agent has no T₂effect, and pre and post- T₂-weighted images are equivalent. The clinical use of TESLASCAN has been investigated at field strengths from 0.5 to 2.0 Tesla.

Dosage for adults

The recommended dose is 0.5 ml/kg bodyweight (5 μmol/kg bodyweight). This corresponds to a dose of 35 ml for a 70 kg person. Above 100 kg body weight, 50 ml is usually sufficient to provide a diagnostically adequate contrast effect.

Dosage for elderly

Pharmacokinetics in the elderly has not been investigated. However, clinical studies to date do not suggest that a dose adjustment is required.

Use in children

There are limited data available on the use of Teslascan in children. The available data do not support safety and efficacy in the paediatric population and therefore such use is not recommended.

Serious adverse events have not been reported in healthy subjects with dosages up to 5 times the normal clinical dose (maximum dose investigated).

High doses of manganese can have negative inotropic and vasodilatory effects as well as effects on heart rhythm and conduction because of calcium antagonism.

Treatment of an overdose should be symptomatic and directed towards the support of vital functions. There is no antidote to this contrast medium.

Mangafodipir and its metabolites are dialysable whereas manganese is not dialysable because of protein binding (see also section 5.2).

Unopened: 2 years.

Once opened the product should be used immediately.

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

The product should be used immediately after first opening (see section 6.3).

50 ml clear, colourless vials (type 1 glass). The containers are closed with rubber stoppers and sealed with aluminium caps with polypropylene lids.

TESLASCAN is supplied in packs of 1 × 50 ml and 10 × 50 ml vials.

Not all pack sizes may be marketed.

TESLASCAN vials should be visually inspected for particulate matter and for the integrity of the container prior to use. Vials are intended for single use only; any unused portions must be discarded.

The required volume to be given to the patient should be determined and any excess volume should be withdrawn from the vial before infusion.

Connective tubing may be flushed with physiological saline (sodium chloride 9 mg/ml (0.9%)), to ensure complete administration of the contrast medium.