Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
human fibrinogen, human thrombin
Corza Medical GmbH
B02BC30
human fibrinogen, human thrombin
Antihemorrhagics
Hemostasis, Surgical
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).
Revision: 25
Authorised
2004-06-08
B. PACKAGE LEAFLET Package leaflet: Information for the user TachoSil sealant matrix human fibrinogen/human thrombin Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What TachoSil is and what it is used for 2. What you need to know before TachoSil is used 3. How to use TachoSil 4. Possible side effects 5. How to store TachoSil 6. Contents of the pack and other information 1. What TachoSil is and what it is used for How does TachoSil work? The yellow side of TachoSil contains the active components: fibrinogen and thrombin. The yellow side of TachoSil is therefore the active side. When the active side comes into contact with fluids (such as blood, lymph or saline solution) the fibrinogen and the thrombin are activated and form a fibrin network. This means that the TachoSil sticks to the tissue surface, the blood coagulates (local haemostasis) and the tissue is sealed. In the body TachoSil will dissolve and disappear completely. What is TachoSil used for? TachoSil is used during surgery to stop local bleeding (haemostasis) and to seal tissue surfaces on internal organs in adults and in children from 1 month of age. TachoSil is also indicated in adults in neurosurgery to support sealing of dura mater and prevent postoperative cerebrospinal leakage. 2. What you need to know before TachoSil is used Do not use TachoSil - if you are allergic to human fibrinogen, human thrombin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions TachoSil is for local use only and should not be applied inside a blood vessel. Blood clots may occur if TachoSil is unintentionally applied inside a blood vessel. It is possible that you could suffer an allergic react Прочетете целия документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TachoSil sealant matrix 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TachoSil 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 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). 4.2 Posology and method of administration The use of TachoSil is restricted to experienced surgeons. Posology 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 studies, the individual doses 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 minimally invasive surgery the smaller size matrices (4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) or the pre-rolled matrix (based on a matrix of 4.8 cm x 4.8 cm) is recommended. Method of administration For epilesional use only. Do not use intravascularly. See section 6.6 for more detailed instructions. 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 Traceability In order to improve the traceability of biological medi Прочетете целия документ