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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case report, 3 elderly men aged 75−84 years were described, who developed anaphylaxis during treatment with protamine sulfate [Protamine] alone, insulin [Humulin] or insulin-suspension-isophane [isophane insulin, Insulatard InnoLet] containing protamine sulfate as an ingredient used for heparin reversal. Additionally, one man had lack of efficacy during anaphylaxis treatment with calcium chloride, epinephrine and metaraminol [not all routes, dosages and time to reactions onset stated].
Case.1: The 78-year-old man developed anaphylaxis during treatment with protamine sulfate alone, and insulin-containing protamine sulfate as an ingredient. The diabetic man underwent elective coronary artery bypass grafting (CABG). While receiving insulin containing protamine sulfate as an...
- Valchanov K, et al. Three Cases of Anaphylaxis to Protamine: Management of Anticoagulation Reversal. Journal of Cardiothoracic and Vascular Anesthesia 33: 482-486, No. 2, Feb 2019. Available from: URL: http://doi.org/10.1053/j.jvca.2018.03.014 - United Kingdom