País: Israel
Língua: inglês
Origem: Ministry of Health
HUMAN FIBRINOGEN; THROMBIN
CTS LTD
B02BB01
SEALANT MATRIX
THROMBIN 2 IU/CM2; HUMAN FIBRINOGEN 5.5 MG/CM2
TOPICAL IN SURGERY, EPILESIONAL, EPILESIONAL
Required
TAKEDA AUSTRIA GMBH
HUMAN FIBRINOGEN
HUMAN FIBRINOGEN
Tachosil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for sutute support in vascular surgery where standard techniques are insufficient.
2023-09-30
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור _____________ ךיראת 51.2.51 __________ םושירה רפסמו תילגנאב רישכת םש : TACHOSIL 139-51-31704-00 םושירה לעב םש ________ טצכ מ"עב __________________ ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ב קרפ ןולע יחכונ טסקט שדח טסקט SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 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. 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 neurosurgery, or in gastrointestinal anastomoses surgery. 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. To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before ad Leia o documento completo
1 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT TachoSil sealant matrix. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TachoSil sealant matrix contains per cm 2 : Human Fibrinogen 5.5 mg Human Thrombin 2.0 IU For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sealant matrix TachoSil is an off-white sealant matrix. The active side of the matrix, which is coated with fibrinogen and thrombin, is marked by a yellow colour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TachoSil is indicated 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 (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The use of TachoSil is restricted to experienced surgeons. The quantity of TachoSil to be applied should always be oriented towards the underlying clinical need for the patient. The quantity of TachoSil 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 units (9.5 cm x 4.8 cm); application of up to 10 units has been reported. For smaller wounds, e.g. in minimal invasive surgery the smaller size matrices (4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) are recommended. Method and route of administration For epilesional use only. Do not use intravascularly See section 6.6 for more detailed instructions. Paediatric patients Tachosil is not recommended for use in children below age 18 years due to insufficient data on safety and efficacy. 4.3 CONTRAINDICATIONS TachoSil must not be applied intravascularly Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For epilesional use only. Do not use intravascularly. Life threatening thromboembolic complications may occur if the preparation is applied intravascularly 2 Specific data have not Leia o documento completo