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CSL Biostate powder for injection: Safety of albumin content

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  • Human albumin
    Links to all TGA information about human albumin products (e.g. Albumex)

9 March 2012

CSL Biotherapies notified the TGA on 7 March 2012 that some batches of human albumin solutions manufactured prior to 25 January 2012 have been contaminated with ethylene glycol as a consequence of an equipment failure.

As a result the TGA took steps to quarantine all batches of albumin in hospitals around Australia until further tests were conducted to ensure the safety of the product.

Today CSL has informed the TGA that albumin is also used at low concentration in CSL Biostate (plasma derived Factor VIII concentrate) as a stabilising agent. CSL advises that the volume of albumin added to this product is very small and therefore the final concentration of any contaminating ethylene glycol is likely to be negligible based on the levels that have been found by CSL in albumin solutions.

Ethylene glycol is permitted at very low levels as a residual solvent in pharmaceutical products administered by both oral and intravenous routes according to European Medicines Agency (EMA)/International Committee for Harmonisation (ICH) guidelines that have been adopted by the TGA.

Calculations based on theoretical maximum doses of Biostate that might be administered to patients, even if repeated and assuming the highest levels of ethylene glycol that have been found in CSL's albumin product, indicate that the amount administered is likely to be at a level many times below the maximum exposure recommended in the EMA/ICH guideline.

Therefore, TGA advises that Biostate is not subject to the present recall actions. Continued use of the product for patient treatment should pose no safety concerns for clinicians or patients.

Content last updated: Friday, 9 March 2012

Web page last updated: Monday, 25 June 2012

URL: http://www.tga.gov.au/safety/alerts-medicine-biostate-powder-120309.htm