Dianeal letter

13 September 2024
 
Dear Patient, 
 
Shortage of DIANEAL Low Calcium with 1.5% w/v Glucose Peritoneal Dialysis Solution bag AHB9807R (AUST R 16750) and DIANEAL Low Calcium with 2.5% w/v Glucose Peritoneal Dialysis Solution bag AHB9776R (AUST R 16847) - alternate supply arrangement under section 19A of the Therapeutic Goods Act 1989
 
This letter is to advise of alternate supply arrangements for the Australian registered medicines, DIANEAL Low Calcium with 1.5% w/v Glucose Peritoneal Dialysis Solution bag AHB9807R (AUST R 16750) and DIANEAL Low Calcium with 2.5% w/v Glucose Peritoneal Dialysis Solution bag AHB9776R (AUST R 16847), sponsored by Vantive Pty Ltd (a legal entity of Baxter Healthcare).

In response to the short supply of the Australian registered medicine, Baxter has secured supply of an alternative products, DIANEAL Peritoneal Dialysis Solution Low Calcium with 1.5% Dextrose bag 2000mL (Philippines) and DIANEAL Peritoneal Dialysis Solution Low Calcium with 2.5% Dextrose bag 2000mL (Philippines), on a temporary basis. These products are NOT registered in Australia and supply is authorised by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 13 March 2025.

DIANEAL Peritoneal Dialysis Solution Low Calcium with 1.5% Dextrose bag 2000mL (Philippines) and DIANEAL Peritoneal Dialysis Solution Low Calcium with 2.5% Dextrose bag 2000mL (Philippines) are marketed and registered in the Philippines and the packaging has labelling in English language. The section 19A products contains the same active ingredients and strength to the Australian registered products. 
 
There are some minor differences in the way the section 19A products are packaged. These differences are as described below:

Please refer to the product leaflet provided each carton of DIANEAL Peritoneal Dialysis Solution Low Calcium with 1.5% Dextrose bag 2000mL (Philippines) and DIANEAL Peritoneal Dialysis Solution Low Calcium with 2.5% Dextrose bag 2000mL (Philippines) for more information. 

If you have any questions or concerns regarding the use of this alternative product, please contact your dialysis unit or healthcare professional.

Timing Of Alternate Supply
 
You will start to see DIANEAL Peritoneal Dialysis Solution Low Calcium with 1.5% Dextrose bag 2000mL (Philippines) and DIANEAL Peritoneal Dialysis Solution Low Calcium with 2.5% Dextrose bag 2000mL (Philippines) in your deliveries in the coming weeks.  
 
Adverse Event Reporting

Reporting any suspected adverse event is important for the continued monitoring of the safety of all medicines.  Any adverse events which are experienced with the section 19A product, DIANEAL Peritoneal Dialysis Solution Low Calcium with 1.5% Dextrose bag 2000mL (Philippines) and DIANEAL Peritoneal Dialysis Solution Low Calcium with 2.5% Dextrose bag 2000mL (Philippines) should be reported by healthcare professionals and patients to Baxter Healthcare on 1800 920 133 or email to [email protected]. Alternatively, this information can be reported to the TGA at: https://www.tga.gov.au/reporting-problems.
 
We have contacted your healthcare team to advise them of this temporary change and we appreciate this change may cause some inconvenience.  We are focused on securing the ongoing supply of Dianeal and appreciate your patience as we transition to this alternative supply.   
 
For further information, please contact your dialysis unit or Baxter Healthcare on 1800 920 133. 

Yours faithfully, 

Matthew Bain      
General Manager – Renal Care
Baxter Healthcare Australia