European Union - The European Agency for the Evaluation of Medicinal Products (EMEA) has issued a warning on the risk of leakage during use of recombinant human insulin cartridges (Insuman Infusat®; 100 IU/ml solution for injection in cartridges of 3.15 ml). Insufficient supply of insulin has led to reports of hyperglycaemia with hospitalization in four cases.
The marketing authorization holder, Aventis Pharma, recently informed the EMEA of 15 reports concerning leakage of cartridges used for semi-synthetic insulin. Faulty cartridges should be returned via the pharmacy or medical pump centre.
Reference: EMEA Public Statement on Insuman Infusat® 100 IU/ml solution for injection in cartridges of 3.15 ml (insulin human), 14 February 2000.