Teslascan

Overdose

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 Pharmacokinetic properties under CLINICAL PHARMACOLOGY).

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
Pregnancy and lactation.
Phaeochromocytoma.
Severely reduced liver function (Child - Pugh class C), especially severe obstructive hepatobiliary disease.
Severely reduced renal function.

Undesirable effects

Most of the adverse reactions reported were transient and of mild intensity. Those most commonly reported were: feeling of warmth/flushing, headache and nausea. In clinical trials with Teslascan (mangafodipir) , adverse reactions have been reported with the following frequencies given in the table below (very common ≥ 1/10; common ( ≥ 1/100 to < 1/10); uncommon ( ≥ 1/1,000 to < 1/100); rare ( ≥ 1/10,000 to < 1/1,000); very rare < 1/10,000, not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Mangafodipir can cause transient increases of bilirubin and liver transaminases and transient decreases in plasma zinc.

The frequency of mild and moderate, non-serious adverse reactions, mainly transient warmth and flushing, is likely to increase when TESLASCAN (mangafodipir) is administered at the faster rate advised (4–6 ml/min).

Therapeutic indications

This medicinal product is for diagnostic use only.

Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.

Name of the medicinal product

Qualitative and quantitative composition

Ascorbic acid
Sodium chloride
Sodium hydroxide and/or hydrochloric acid (pH adjustment)
Water for injections.

This medicinal product must not be mixed with other medicinal products.

A separate cannula should be used.

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 above).

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

TESLASCAN (mangafodipir) is supplied in packs of 1 x 50 ml and 10 x 50 ml vials.

Not all pack sizes may be marketed

TESLASCAN (mangafodipir) 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.

Marketing Authorisation Holder:
GE Healthcare AS
Nycoveien 1-2
P.O. Box 4220 Nydalen
NO-0401 OSLO, Norway

Marketing Authorisation Numbers:
EU/1/97/040/001
EU/1/97/040/002

Date Of First Authorisation/Renewal Of The Authorisation:
Date of first authorisation: 22.05.1997
Date of latest renewal: 22.05.2007

Date Of Revision Of The Text: 22.05.2007

Special warnings and precautions for use

Included as part of the PRECAUTIONS section

Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) or anaphylactoid reactions may occur. Familiarity with the practice and technique of resuscitation and treatment of anaphylaxis is essential. Appropriate medicinal products and instruments should be readily available.

Care should be exercised in patients with severe cardiac disease and in patients with injuries of the blood brain barrier and severe cerebral disease.

The fact that long term parenteral nutrition with manganese supplementation can cause manganese accumulation in the basal ganglia should be considered when administering TESLASCAN (mangafodipir) to patients on such treatment.

This medicinal product contains 5.5 mmol (126 mg) sodium per normal dose of 35 ml. To be taken into consideration by patients on a controlled sodium diet.

The safety of TESLASCAN (mangafodipir) in human pregnancy has not been established. TESLASCAN (mangafodipir) must not be used during pregnancy (see the CONTRAINDICATIONS section).

Prior to administration of TESLASCAN (mangafodipir) to women of child bearing potential, pregnancy should be excluded.

Pre-clinical studies in rats have established teratogenic effects when TESLASCAN (mangafodipir) was given repeatedly during major organogenesis. TESLASCAN (mangafodipir) causes foetotoxicity and embryotoxicity in rabbits. TESLASCAN (mangafodipir) is not teratogenic in rabbits. TESLASCAN (mangafodipir) has no effect on male or female fertility in rats.

The degree of excretion into human breast milk is not known. Breast-feeding should be discontinued from the time of administration and should not be recommenced until 14 days after administration of TESLASCAN (mangafodipir).

No studies on the effects on the ability to drive and use machines have been performed.

Dosage (Posology) and method of administration

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 T2-effect, and pre- and post- T2-weighted images are equivalent. The clinical use of TESLASCAN (mangafodipir) has been investigated at field strengths from 0.5 to 2.0 Tesla.

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 4

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

Safety and efficacy in patients below the age of 18 have not been documented i.e. children (2-11 years) and adolescents (12-18 years).

Interaction with other medicinal products and other forms of interaction

Most of the adverse reactions reported were transient and of mild intensity. Those most commonly reported were: feeling of warmth/flushing, headache and nausea. In clinical trials with Teslascan (mangafodipir) , adverse reactions have been reported with the following frequencies given in the table below (very common ≥ 1/10; common ( ≥ 1/100 to < 1/10); uncommon ( ≥ 1/1,000 to < 1/100); rare ( ≥ 1/10,000 to < 1/1,000); very rare < 1/10,000, not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Mangafodipir can cause transient increases of bilirubin and liver transaminases and transient decreases in plasma zinc.

The frequency of mild and moderate, non-serious adverse reactions, mainly transient warmth and flushing, is likely to increase when TESLASCAN (mangafodipir) is administered at the faster rate advised (4–6 ml/min).

No interaction studies have been performed.