TACHOSIL

What it is

TACHOSIL is a medicated sponge containing human fibrinogen 5.5 mg/square cm and human thrombin 2.0 IU/square cm.

Approved indications

— Adjunct to haemostasis during surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

Key safety warnings

Administration of fibrin sealants may result in allergic reactions in some patients. For patients with a known allergic diathesis, a history of hypersensitivity to medical products or a history of having previously received aprotinin-containing products, a careful risk-benefit assessment should be carried out prior to administration. The risk of immunisation against proteins is increased if repeated exposure occurs within six months. If it is decided to proceed with treatment in such patients, prior administration of antihistamines should be considered. Products made from human plasma may contain infectious agents which can cause disease, such as viruses and theoretically, the agent that causes Creutzfeldt-Jakob Disease (CJD) in humans. Standard measures to prevent infections include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, the possibility of transmitting infective agents cannot be totally excluded. The measures taken are considered effective for inactivation/removal of enveloped viruses such as HIV, HBV, and HCV, and for the non-enveloped virus HAV. The measures taken may be of limited value against small non-enveloped viruses such as parvovirus B19.

Contraindications

Known hypersensitivity to aprotinin or known hypersensitivity to any other component of the product is contraindicated.

Regulatory history

TACHOSIL received approval on 2 February 2012. The product was first listed on the ARTG on 22 March 2012 under registration number 176631.