Editor, – I wish to draw your attention to some inaccuracy in the new drug comment about Tisseel Duo 500 (Aust Prescr 2003;26:46).
The article commenced by correctly referring to Tisseel Duo 500 with regard to available sizes and approved indications. It then refers to the composition of the 'kit', referring to vials of thrombin, calcium chloride, fibrinolysis inhibitor etc. This description refers to the lyophilised kit form of Tisseel which required reconstitution. The kit was previously available in Australia under the Special Access Scheme of the Therapeutic Goods Administration, until the registered Tisseel Duo 500 became available. This kit was only viable for four hours following reconstitution. It is no longer available in Australia.
Tisseel Duo 500 is deep frozen fibrin sealant, in a preloaded double syringe delivered with the same Duploject device. It does not require reconstitution, only thawing and warming to 37oC. Once thawed, Tisseel Duo 500 is viable for 48 hours. The thawing process requires very little time once removed from the freezer, significantly less than an autologous cryoprecipitate preparation process.
With regards to viral safety, I can state that the previous formulation of the product has been used for 25 years in 50 countries around the world in over 8 million applications resulting in no reported transmissions of HIV, Hepatitis B or C and prion disease. This is due to the donor screening program, the double steam heat treated processing and PCR testing of the product during the manufacturing process.
There are numerous published articles about fibrin sealants available from our Medical Affairs department.
Peter van Gaalen
Bio Surgery Manager
Baxter Healthcare
Toongabbie, NSW
