Tachosil

/ CTS

The use of TachoSil is restricted to experienced surgeons. The number of TachoSil sponges to be applied should always be oriented towards the underlying clinical need for the patient. The number of TachoSil sponges to be applied is governed by the size of the wound area. Application of TachoSil must be individualised by the treating surgeon. In clinical trials, the individual dosages have typically ranged from 1-3 sponges (9.5 cm x 4.8 cm); application of up to 7 sponges has been reported. For smaller wounds, e.g. in minimal invasive surgery the smaller size sponges (4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) are recommended.

For supportive treatment in surgery for improvement of hemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient.

TachoSil must not be applied intravascularly. Hypersensitivity to the active substances or to any of the excipients.

For local use only. Do not use intravascularly. Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly Specific data have not been obtained on the use of this product in neurosurgery, or in gastrointestinal anastomoses surgery. As with any protein product, allergic type hypersensitivity reactions are possible. Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, the administration has to be discontinued immediately. In case of shock, the current medical standards for shock treatment should be observed. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma 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, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the nonenveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia). It is strongly recommended that every time that TachoSil is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/haemostatics. In isolated cases, these reactions may progress to severe anaphylaxis. Such reactions may especially be seen, if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product. Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly. Antibodies against components of fibrin sealant/haemostatic products may occur rarely.

No formal interaction studies have been performed. Similar to comparable products or thrombin solutions, the sealant may be denaturated after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions). Such substances should be removed to the greatest possible extent before applying the sealant.

The safety of TachoSil for use in human pregnancy or breastfeeding has not been established in controlled clinical trials. Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development. Therefore, TachoSil should be administered to pregnant and lactating women only if clearly needed.

No case of overdose has been reported.