Not for injection. Special warnings Severe adverse reactions have been reported in combination with the administration of barium sulfate compositions, including aspiration, intravasation, perforation, anaphylaxis, with possible life-threatening or fatal outcome.
These reactions were usually related to the administration technique, the underlying pathological condition and/or patients hypersensitivity. The product should be taken under medical supervision. Rapid detection, assessment and diagnosis are essential for an effective implementation of treatment of potentially severe adverse reactions.
Imaging facilities should have trained and specialised personnel for the diagnosis and treatment of hypersensitivity reactions. Urgent specialised medical measures are required in the event of aspiration, intravasation or perforation (intensive care, surgery).
To prevent potentially severe adverse reactions, care must be taken to keep barium sulfate from entering parenteral regions such as tissues, intravascular space or body cavities as well as the airways. The indication must be very carefully considered in small children and elderly patients with multiple organ failure, especially in the cardiovascular system, as the examination and preparatory measures can be stressful.
Precautions for use Hypersensitivity Patients who have already experienced a reaction during previous administration of barium sulfate present an increased risk of experiencing another reaction on subsequent administration of this contrast agent, or possibly other barium sulfate contrast agents, and are therefore considered to be at high risk.
Hypersensitivity reactions can occur even after the first administration of the product, and are often unpredictable. Should this occur, treatment must be discontinued immediately. Such reactions call for immediate medical treatment.
The administration of barium sulfate may aggravate symptoms of an existing asthma. In patients with asthma unbalanced by the treatment, the decision to use barium sulfate must be made after careful evaluation of the benefit/risk ratio.
Perforation Because of the increased risk of perforation, the benefit-to-risk ratio must be carefully assessed in patients with oesophageal atresia or with severe stenosis, especially distal to the stomach, as well as in patients with disorders and diseases involving a high risk of perforation such as intestinal carcinoma, inflammatory bowel diseases, diverticulosis, diverticulitis, and parasitic disease.