A number of units of Baxter’s
peritoneal dialysis solution of the brands Extraneal® and Nutrineal® manufactured in Ireland are suspected of containing a too high content of endotoxin. A too high content of endotoxin may pose a risk of aseptic peritonitis (infection of abdominal fluid).
On Monday 13 December 2010, the situation will be discussed by the European Pharmacovigilance Working Party.
Until the situation is clarified, we urge everyone to exercise particular caution and to report all side effects.
For further information, please contact Chief Medical Officer Doris Stenver on +45 4488 9247 or +45 2246 0979.
Danish Medicines Agency, 10 December 2010