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

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 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.

No interaction studies have been performed.

Pregnancy

The safety of TESLASCAN in human pregnancy has not been established. TESLASCAN must not be used during pregnancy (see section 4.3).

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

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

Lactation

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.

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

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, 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.

Immune system disorders

Uncommon: Hypersensitivity reactions (such as skin reactions, rhinitis, pharyngitis)

Not known: Anaphylactic/anaphylactoid reactions

Nervous system disorders

Common: Headache

Uncommon: Dizziness, paraesthesia, transient perverted sensation of taste

Eye disorders

Very rare: Visual disturbance

Cardiac disorders

Uncommon: Palpitation

Vascular disorders

Rare: Hypertension

Gastrointestinal disorders

Common: Nausea

Uncommon: Abdominal pain, diarrhoea, vomiting

Very rare: Flatulence

General disorders and administration conditions

Common: Flushing, feeling hot

Uncommon: Fever, injection site pain

Very rare: Chest pain

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 is administered at the faster rate advised (4–6 ml/min).

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

A separate cannula should be used.