ARTG Entry
TISSEEL
ARTG entry for TISSEEL (calcium chloride dihydrate, human thrombin, aprotinin, Factor XIII, Fibrinogen), ARTG 147141 — Product Information, dosage form,…
- Sponsor: Baxter Healthcare
- Active ingredient: calcium chloride dihydrate, human thrombin, aprotinin, Factor XIII, Fibrinogen
- Therapeutic area: Other
What it is
TISSEEL contains aprotinin (synthetic), factor XIII, fibrinogen, thrombin and calcium chloride dihydrate. The active ingredients are formulated as two sterile, deep-frozen solutions: the Sealer Protein Solution and Thrombin Solution. Each solution is presented in a separate pre-filled chamber of one double-chamber syringe. The active ingredients are fractionated from pooled human plasma.
Approved indications
— Mesh fixation in non-iatrogenic abdominal wall hernia repair, as an alternative to sutures, staples or tacks.
Key safety warnings
In intraperitoneal approaches or laparoscopic ventral hernia repair techniques, where mesh needs to be fixed to an intact peritoneum, TISSEEL alone may not be adequate and additional fixation using sutures and/or tacks may be necessary.
Regulatory history
TISSEEL VH S/D fibrin sealant syringe was first listed on the ARTG on 13 March 2009. On 25 January 2012, the TGA approved an extension of indications for TISSEEL VH/SD for mesh fixation in non-iatrogenic abdominal wall hernia repair, as an alternative to sutures, staples or tacks.