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 iron is administered orally concurrently with Addaven infusion, the total iron intake must be determined to ensure that 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 received via Addaven, thereby leading to a risk of accumulation in the body. 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 significantly increased requirements for certain trace elements, the treatment regimen may be adjusted by using additional trace element supplementation products.