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Human albumin solutions have been reported to contain trace amounts of aluminium. In accordance with the limits set by Ph.Eur. (1995/255), HUMAN ALBUMIN 200 g/l contains less than 200 μg per litre. It is, therefore, suitable for use in premature infants and patients with renal disease. Nevertheless, accumulation of aluminium in patients with chronic renal insufficiency has led to toxic effects such as hypercalcaemia, vitamin D refractory osteodystrophy, anaemia, and severe progressive encephalopathy. When large volumes of human albumin solutions are considered for administration to such patients, the potential risks as compared to expected benefits should be carefully evaluated.
Allergic Reaction/Anaphylactic Shock: Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Transmission of Infectious Agents: Standard measures to prevent infections resulting fr om the use of medicinal products prepared from human blood or plasmas include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
There are no reports of viral transmissions with products manufactured to European Pharmacopeia specifications by established processes.
It is strongly recommended that every time that Albumin (Human) is administered to a patient, the name and batch n umber of the product are recorded in order to maintain a link between the patient and the batch of the product.
