ADDAVEN Concentrate for solution for infusion

Parenterally administered iron or iodine may rarely cause hypersensitivity reactions, including severe and potentially life-threatening anaphylactic reactions.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ Patients must be clinically monitored for signs and symptoms of hypersensitivity reactions. In the event of hypersensitivity reactions, the infusion must be stopped immediately and appropriate measures must be taken. If oral iron is administered concurrently with Addaven infusion, total iron intake must be determined to ensure accumulation does not occur. Hepatic impairment Addaven should be administered with caution in patients with hepatic impairment. Hepatic impairment, including impaired biliary excretion, may reduce the rate of elimination of trace elements provided by Addaven, thereby leading to a risk of accumulation. Renal impairment Addaven should be administered with caution in patients with renal impairment, as urinary excretion of some trace elements may be considerably reduced. If treatment continues for more than 4 weeks, plasma levels of trace elements must be monitored, particularly manganese levels. If a patient has considerably increased requirements for certain trace elements, the treatment regimen may be adjusted by using additional trace element supplementation products.