IV Thiamine (access to)

28 July 2010

The TGA is notifying clinicians that is no longer possible to extend the previous exemption for Baxter Healthcare to supply IV Thiamine in Australia. The TGA is working closely with Baxter Healthcare to identify an alternative supply mechanism.

At the present time, the only available options for supply of this product are under the Special Access Scheme (SAS) (Sections 18 and 19(1)(a) of the Therapeutic Goods Act 1989), or the Authorised Prescriber scheme (Section 19(5) of the Act).

Further information on these schemes can be found on the TGA website at the following link: Access to unapproved therapeutic goods in Australia.

Specific information on the SAS can be found at: Access to unapproved therapeutic goods via the Special Access Scheme.

Specific information on the Authorised Prescriber scheme can be found at: Access to unapproved therapeutic goods - Authorised prescribers.

Further information on the Baxter Healthcare product can be obtained from Baxter Healthcare Medical and Regulatory Affairs Department:

• Tel: 02 8845 1523; or
• Fax: 02 8845 1655.

An alternative registered product with similar indications but in an intramuscular injection form containing Thiamine 100mg/mL is BIOLOGICAL THERAPIES B-DOSE FORTE 2.5ml injection vial (Aust R 22408) which is available from the sponsor, Biological Therapies. Note that this product has additional ingredients to Thiamine which need to be reviewed before use.