|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.Antibodies against components of fibrin sealant/haemostatic products may occur rarely.Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.4).For viral safety see section 4.4Frequency of undesirable effects for TachoSil based on all adverse event data from six clinical trials, two post-authorisation safety studies and spontaneous reporting.|
Summary of the safety profileThe 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.
Tabulated summary of adverse reactionsData from the six controlled clinical trials conducted by the MAH has been pooled into an integrated dataset and the frequencies of occurrence in this SmPC originate from this integrated dataset. In the integrated analyses, 521 patients were treated with TachoSil and 511 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.The following categories are used to rank the undesirable effects by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).
*Pyrexia occurred in 6.3% of the patients treated with TachoSil and in 5.9% of the patients treated with comparator treatment.
|FrequencyOrgan class||Common(≥1/100 to <1/10)
||Uncommon(≥1/1,000 to <1/100)
||Very rare(<1/10,000), not known (cannot be estimated from the available data)
|Immune system disorders|| ||Hypersensitivity
|Vascular disorders|| || ||Thromboembolism
(if applied intravascularly)
|General disorders and administration site conditions||Pyrexia*
|| || |