Mangafodipir

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 safety of mangafodipir in human pregnancy has not been established. Mangafodipir must not be used during pregnancy.

Prior to administration of mangafodipir 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 mangafodipir was given repeatedly during major organogenesis. Mangafodipir causes foetotoxicity and embryotoxicity in rabbits. Mangafodipir is not teratogenic in rabbits. 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 mangafodipir.

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 mangafodipir, adverse reactions have been reported with the following frequencies given 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 mangafodipir is administered at the faster rate advised (4–6 ml/min).