Pharmacovigilance

Dear Healthcare Professional letter on the new list of devices compatible for blood glucose level determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin)

09.04.2014

The company Agmar d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new list of devices compatible for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin). The letter contains the new list of devices for blood glucose determination permitted to be used in those patients. The letter follows up to the previous letters addressed to doctors, that HALMED reported on its webpages in June 2008, July 2010 and August 2011 (in Croatian).

Extraneal (icodextrin 7.5 %) is a solution for peritoneal dialysis containing icodextrin as active substance metabolising in maltose. The presence of maltose and other sugars may influence the results of device and/or test strips that are not specific for glucose. This interference leads to a false increased glucose level result in blood. False readings of glucose levels with tests that are not specific for glucose may mask the real hypoglycaemia or lead to a false diagnosis of hyperglycaemia. Due to the above mentioned, only devices and test strips specific for glucose may be used for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis.

Here you may view the Dear Healthcare Professional Letter.

HALMED has not received any report of false increased readings of blood glucose levels in patients treated with Extraneal solution for peritoneal dialysis.

We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.

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