Diagnostic Category | Symptoms & Signs |
---|---|
Anaphylactic Reaction | Generalized immediate hypersensitivity response (urticaria, pruritis, angioedema, vascular collapse, life-threatening respiratory distress) after the administration of Mectizan® |
Mild Mazzotti Reaction† | Manifestation of 2 or more of the following symptoms within 7 days of the administration of Mectizan®: pruritis, fever, headache, edema, lymphadenopathy, myalgia, generalized body aches |
Severe Mazzotti Reaction† | Manifestation of 1 or both of the following symptoms within 7 days of the administration of Mectizan®: hypotension, asthma attacks in known patients; or manifestation of bullous skin lesions after 1–2 weeks of administration of Mectizan® |
Functional Impairment with Normal Mental Status‡ | Manifestation of symptoms typical of Mild Mazzotti Reaction at a severity such that patient required assistance with Activities of Daily Living (ADLs) (eating, bathing, walking) but maintained normal mental status within 7 days of the administration of Mecizan |
Neurologic | Encephalopathy, meningitis, or other neurologic sequelae within 7 days of the administration of Mectizan® |
Cardiovascular | Cardiovascular symptoms and signs, excluding hypotension, within 7 days of the administration of Mectizan® |
Pulmonary | Respiratory symptoms and signs, excluding Mazzotti-type bronchoconstriction, within 7 days of the administration of Mectizan® |
Gastrointestinal | Gastrointestinal symptoms including dehydration within 7 days of the administration of Mectizan® |
Other | Any other symptoms and signs within 7 days of the administration of Mectizan® |