AlbuRx Adverse Reactions

Summary of the safety profile: Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. In very rare cases, severe allergic reactions such as anaphylactic shock can occur. In these cases, the infusion must be stopped and an appropriate treatment must be initiated.
Adverse reactions after launch: The adverse reactions presented in the following have been observed with AlbuRx during the postmarketing phase and are summarised and categorised according to MedDRA system organ classification and frequencies.
As the postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reaction. Hence the frequency category "not known (cannot be estimated from the available data)" is used.
Immune system disorders: hypersensitivity reactions (including anaphylaxis and shock).
Gastrointestinal disorders: nausea.
Skin and subcutaneous tissue disorders: flush, urticaria.
General disorders and administration site conditions: fever.
For information concerning viral safety, see "Precautions".