Introduction of Flebogamma 5% DIF for patients who previously received Octagam
29 September 2010
On 24 September 2010, Octopharma Australia Pty Ltd instituted a voluntary recall of all batches of Octagam intravenous immunoglobulin (IVIg) solutions from the Australian market. The TGA website has more information about this voluntary recall.
To ensure adequate supplies of IVIg at this time, the National Blood Authority (NBA) has arranged for an alternative imported IVIg product, Flebogamma 5% DIF, to be supplied under the National Blood Arrangements.
► Revised supply arrangements for imported IVIg [on www.nba.gov.au]
Flebogamma 5% DIF is produced by Instituto Grifols SA, is registered on the Australian Register of Therapeutic Goods, and is supplied in Australia by Lateral Grifols Pty Ltd.
The supply of this product will ensure ongoing supply sufficiency and security for Australia.
The Australian Red Cross Blood Service Transfusion Medicine Service is distributing a letter to Australian Health Providers answering key clinical questions on the transition from Octagam® to Flebogamma 5% DIF.
Information for Health Professionals regarding patients who have previously received Octagam® and will now be supplied with Flebogamma 5% DIFFurther medical queries on the introduction of the product can be directed to Blood Service Transfusion Medicine Services teams. Information on Flebogamma 5% DIF can be found on the Lateral Grifols website.
► Flebogamma 5% DIF Information Pack
The supply of other IVIg products provided under the national blood arrangements (Intragam P supplied by CSL) is not affected.
