human fibrinogen;human thrombin

HOS-216144 · has-adverse-reaction-information · PDF-Seite 4

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. Immunogenicity Antibodies against components of fibrin sealant/haemostatic products may occur rarely. However, in a clinical study with TachoSil in hepatic surgery, in which patients were investigated for the development of antibodies, 26% of the 96 patients tested and treated with TachoSil developed antibodies to equine collagen. The equine collagen antibodies that developed in some patients after TachoSil use were not reactive with human collagen. One patient developed antibodies to human fibrinogen. There were no adverse events attributable to the development of human fibrinogen or equine collagen antibodies. There is very limited clinical data available regarding re-exposure to TachoSil. Two subjects have been re-exposed in a clinical study and have not reported any immune-mediated adverse events; however, their antibody status to collagen or fibrinogen is unknown. Thromboembolic complications may occur if the preparation is applied intravascularly (see section 4.4). Some cases of product residue, that might have caused a foreign-body reaction in the form of granuloma, have been reported. For viral safety see section 4.4. 4 Summary of the safety profile The safety data of TachoSil generally reflect the type of post-operative complications related to the surgical settings in which the trials were conducted and the underlying disease of the patients. Data from the eight controlled clinical studies conducted by the MAH has been pooled into an integrated dataset. In the integrated analyses, 997 patients were treated with TachoSil, and 984 patients were treated with comparator treatment. Due to practical reasons (comparison to standard surgical and standard haemostatic treatment), blinding was not possible in the TachoSil trials. Therefore, the studies were performed as open-label studies

Auszug; vollständigen Abschnitt im Original lesen.

HOS-216140 · has-contraindication-information · PDF-Seite 3

TachoSil must not be applied intravascularly. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

HOS-216139 · has-indication-information · PDF-Seite 2

TachoSil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. TachoSil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).

HOS-216142 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. Similar to comparable products or thrombin solutions, the sealant may be denatured 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.

HOS-216143 · has-pregnancy-information · PDF-Seite 4

The safety of TachoSil for use in human pregnancy or breastfeeding has not been established in controlled clinical studies. 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 breastfeeding women only if clearly needed.

HOS-216141 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Precautions For epilesional use only. Do not use intravascularly. Life threatening thromboembolic complications may occur if the preparation is applied intravascularly. Specific data have not been obtained on the use of this product in gastrointestinal anastomoses surgery. It is not known whether recent radiation therapy affects the efficacy of TachoSil when used for dura mater sealing. Hypersensitivity Reactions As with any protein-containing 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. Adhesions To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of TachoSil (see section 6.6). Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel. In case of shock, the current medical standards for shock treatment should be observed. Transmissible Agents 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 non-enveloped 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 (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g., haemolytic anaemia). 3