Communication on the resumed distribution of Dianeal, Extraneal and Nutrineal solutions manufactured in Castlebar, Ireland

Over the past twelve months, Baxter has been working closely with the European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) and MHRA to ensure the production of endotoxin-free PD solutions. In October 2011 the EMA / CHMP finalized recommendations for quality improvement measures at the Castlebar manufacturing plant in Ireland. The conclusion of the EMA / CHMP was that healthcare professionals and patients can now be reassured that a variety of corrective and preventative measures have now taken place to ensure the quality of Baxter’s PD solutions (Dianeal, Extraneal and Nutrineal) manufactured in Castlebar, Ireland.

Dialysis patients should still be monitored for any adverse events (AEs) or symptoms that suggest the development of aseptic peritonitis (e.g. cloudy effluent seen in drain bag at the end of dialysis, abdominal pain, nausea, vomiting or fever).

If you observe any suspected AEs in association with Dianeal, Extraneal and Nutrineal over the next six months please complete the adverse event reporting form here, and return it to Baxter UK Pharmacovigilance at Baxter Healthcare Ltd, Wallingford Road, Compton, Newbury RG20 7QW, by email to
vigilanceuk@baxter.com or by fax to 01635 206281. You can also report by telephone on 01635 206360. 

It is very important that you provide the batch number of the product used by the patient at the time of onset of the AE when completing the form, or when contacting the Baxter Pharmacovigilance team.

UK Headquarters

Registered address

Caxton Way,
Thetford, IP24 3SE

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Wallingford Road
Compton
Newbury
Berkshire, RG20 7QW

Switchboard
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Email: compton_reception@baxter.com

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Phone: (Out of Hours Emergencies) 07717 542284
Email: vigilanceuk@baxter.com

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