Teslascan

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.

0 Tesla. 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.

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. System Organ Class Adverse Reactions Frequency Immune system disorders Hypersensitivity reactions (such as skin reactions, rhinitis, pharyngitis) Anaphylactic/anaphylactoid reactions Uncommon Not known Nervous system disorders Headache Dizziness, paraesthesia, transient perverted sensation of taste Common Uncommon Eye disorders Visual disturbance Very rare Cardiac disorders Palpitation Uncommon Vascular disorders Hypertension Rare Gastrointestinal disorders Nausea Abdominal pain, diarrhoea, vomiting Flatulence Common Uncommon Very rare General disorders and administration site conditions Flushing, feeling hot Fever, injection site pain Chest pain Common Uncommon Very rare 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). Medicinal product no longer authorised5

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.

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

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.