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TACHOSIL is a brand name for Fibrinogen, supplied as a patch. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TachoSil® (Human fibrinogen, human thrombin and collagen sponge, absorbable fibrin sealant patch) is indicated for: supportive treatment in surgery for improvement of hemostasis suture support in vascular surgery where standard techniques are insufficient 1.1 Pediatrics (<18 years of age) No data are available to…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations TachoSil® is intended for topical use only. Do not use intravascularly. Apply the yellow, active side of the patch to the bleeding area. TachoSil® comes ready-to-use in sterile packages and must be handled accordingly.
Use only undamaged packages. Once the package is opened post-sterilisation is not possible. The outer aluminium foil sachet may be opened in a non-sterile operating area. The inner sterile blister must be opened in a sterile operating room area.
Due to the strong affinity of collagen to blood, TachoSil® may also stick to surgical instruments or gloves covered with blood. This can be avoided by pre-moistening surgical instruments and gloves with sterile physiological saline solution.
2 Recommended Dose and Dosage Adjustment The number of TachoSil® patches to be applied should always be oriented towards the underlying clinical need for the patient. The number of TachoSil® patches to be applied is governed by the size of the wound area.
The TachoSil® patch should be applied so that it extends 1-2 cm beyond the margins of the wound. If more than one patch is used the patch should overlap by at least 1 cm. The TachoSil®, Absorbable fibrin sealant patch Page 5 of 18 patch can be cut to the correct size and shaped if too large.
Open, unused TachoSil® should be discarded as it cannot be re-sterilized. Application of TachoSil® must be individualized by the treating surgeon. 8 cm); application of up to 7 patches has been reported. g. 5 cm) are recommended. 0 IU Human Thrombin Health Canada has not authorized an indication for pediatric use (see section 1 INDICATION).
4 Administration TachoSil® is used under sterile conditions. g. from blood, disinfectants and other fluids. The fibrinogen and thrombin proteins can be denatured by alcohol, iodine or heavy metal ions. If any of these substances have been used to clean the wound area, thoroughly irrigate the area before the application of TachoSil®.
It is important to note that failure to adequately clean adjacent tissues may cause adhesions. After removal of TachoSil® from the sterile package the patch should be pre-moistened in sterile saline solution. Once moistened TachoSil® should be applied immediately.
The yellow, active side of the patch is applied to the bleeding surface and held against it with a gentle pressure for 3-5 minutes. This procedure enables an easy adhesion of TachoSil® to the wound surface. g. in case of stronger bleeding or wet wound area, TachoSil® may be applied without pre-moistening, while also pressing gently to the wound for 3-5 minutes.
2% of patients treated with comparator treatments. 0% of comparator treated patients. Rarely, hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in patients treated with fibrin sealants/ hemostatics.
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/hemostatic products may occur rarely. 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 of TachoSil®. Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of TachoSil® has been evaluated in six controlled clinical trials, in which 521 patients were treated with TachoSil® and 511 patients were treated with comparator treatment.
When medicinal products manufactured from human plasma are administered, the possibility of transmission of infective agents cannot be totally excluded. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering to the patients General TachoSil® is intended for topical use only by experienced surgeons.
Do not use intravascularly. Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly. 4 Administration). 1 mg Collagen Sponge per cm2 Human albumin, Riboflavin (E 101), L-arginine- hydrochloride, Sodium chloride, Sodium citrate (E331) TachoSil®, Absorbable fibrin sealant patch Page 7 of 18 leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel.
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 and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
These standard measures are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV. However, these measures may be of limited value against non-enveloped viruses such as parvovirus B19.
g. haemolytic anaemia). Peri-Operative Considerations Do not use TachoSil® for the treatment of severe or brisk arterial bleeding because TachoSil® has not been evaluated in this treatment. Do not use TachoSil® as the primary mode to control hemostasis.
Patients who are hypersensitive to the active substances or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
TachoSil® must not be applied intravascularly.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fibrinogen in Canada.
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It is recommended that a moist surgical tissue or pad is used for applying pressure if TachoSil® is applied dry. Pressure should be applied with moistened gloves or a moist pad. After pressing TachoSil® to the wound, the glove or the pad must be removed carefully.
g. with a pair of forceps. Leave TachoSil® in place once it adheres to organ tissue. Remove unattached TachoSil® patches (or part of) and replace with new patches. It is strongly recommended that every time 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 batch of the product.
5 Missed Dose Not applicable TachoSil®, Absorbable fibrin sealant patch Page 1 of 33
Due to practical reasons (comparison to standard surgical and standard hemostatic treatment), blinding was not possible in the TachoSil® trials. Therefore, the studies were performed as open-label studies. 0% of comparator treated patients.
1 - 94 years of age) to collect information, following exposure to TachoSil®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. The TachoSil®, Absorbable fibrin sealant patch Page 9 of 18 trial was designed as an international, non- interventional, prospective, single cohort trial of the use of TachoSil® in supportive treatment in surgery for improvement of hemostasis where standard techniques are insufficient.
3% had risk factors for immunological events). 3% of patients had at least one thromboembolic, major bleeding, or immunological event, respectively. No cases were reported where an investigator suspected an interaction with concomitant medication as responsible for an adverse event.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings This information is not available for this drug product. Post-Market Findings This information is not available for this drug product.
5 Post-Market Adverse Reactions The following adverse drug reactions have been reported in post-marketing experience: Immune disorders: Anaphylactic shock, hypersensitivity Gastrointestinal disorders: Intestinal obstruction (in abdominal surgeries), ileus (in abdominal surgeries) General disorders and administration site conditions: Adhesions, Drug ineffective Vascular disorders: Thrombosis TachoSil®, Absorbable fibrin sealant patch Page 1 of 33 Because post-marketing reporting of adverse reaction is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.
TachoSil® is not intended as a substitute for meticulous surgical technique and the proper application of suture, ligature or other conventional procedures for hemostasis. Do not leave TachoSil® in an infected or contaminated space because it may theoretically potentia te an existing infection.
When placing TachoSil® into cavities or closed spaces, avoid over-packing because this may cause compression of underlying tissue. Use only the minimum amount of TachoSil® patches necessary to achieve hemostasis. Carefully remove or reposition unattached pieces of TachoSil®, if medically necessary.
Do not use TachoSil® in neurosurgical or gastrointestinal anastomosis procedures as safety and efficacy has not been evaluated. Sensitivity/Resistance As with any protein product, allergic type hypersensitivity reactions are possible.
Signs of hypersensitivity reactions include hives, generalized urticaria, and tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, the administration should be discontinued immediately. In case of shock, the current medical standards for shock treatment should be observed.
1 Pregnant Women The safety of fibrin sealants/haemostatics for use in pregnancy has not been established in controlled clinical trials. 2 Breast-feeding The safety of fibrin sealants/haemostatics for use in nursing women has not been established in controlled clinical trials.
TachoSil®, Absorbable fibrin sealant patch Page 1 of 33 It is unknown if TachoSil® is excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk. 3 Pediatrics (<18 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics (> 65 years of age) Efficacy and safety of TachoSil® has been evaluated in 204 patients of 65 years of age or older. Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.