WARNING

Potential for Incorrect Blood Glucose Reading

 

 

Patients using EXTRANEAL (icodextrin) peritoneal dialysis solution may have incorrect blood glucose results when using particular blood glucose monitors or test strips.

 

ONLY use glucose-specific monitors and test strips.  These methods are common in clinical laboratories. 

 

The term "glucose-specific" applies to monitors or test strips that are not affected by the presence of maltose or certain other sugars.  Because EXTRANEAL (icodextrin) peritoneal dialysis solution results in elevated blood levels of maltose, only glucose-specific monitors and test strips should be used.

 

DO NOT use monitors or test strips that utilise glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods.  In addition, some but not all monitors or test strips that utilise a glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) method should not be used.  Use of these methods may result in falsely elevated blood glucose readings in patients using EXTRANEAL (icodextrin) due to maltose interference.  Falsely elevated blood glucose readings may mask true hypoglycemia or lead to the erroneous diagnosis of hyperglycemia, leading to life-threatening events.

 

To determine what type of method is used for monitoring glucose levels, review the labelling for BOTH the glucose monitor and the test strips used.  If in doubt, contact the manufacturer of the glucose monitors and test strips to determine the method that is used.

 

For important information about EXTRANEAL (icodextrin) and glucose monitors and test strips, please see the links below.  Details about glucose monitor manufacturers and product compatibility with EXTRANEAL (icodextrin) are included in the Country-Specific Glucose Monitor List (under "Additional Links").

 

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard

Any adverse events relating to Baxter products can also be reported direct to Baxter Pharmacovigilance on +44 (0)1635 206360, or by email to vigilanceuk@baxter.com

Any drug product quality complaints (including suspected defective medicines) relating to Baxter products can be reported directly to the Baxter Country Quality Assurance Team on 01604 704603, or by e-mail to uk_shs_qa_complaints@baxter.com. Alternatively please report directly to your Baxter Representative, who will take the details and forward to the Baxter Country Quality Assurance Team.

Any suspected defective medicines, should be reported to the MHRA. Reporting forms and information can be found at:
www.mhra.gov.uk/safetyinformation/reportingsafetyproblems/index.htm

Product labelling Important Safety Information Additional Links

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