Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
human fibrinogen, human thrombin
Omrix Biopharmaceuticals N. V.
B02BC
human fibrinogen, human thrombin
Antihemorrhagics
Hemostasis, Surgical
Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.Evicel is also indicated as suture support for haemostasis in vascular surgery.
Revision: 18
Authorised
2008-10-05
23 B. PACKAGE LEAFLET 24 Package Leaflet: Information for the patient EVICEL solutions for sealant 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What EVICEL is and what it is used for 2. What you need to know before you use EVICEL 3. How to use EVICEL 4. Possible side effects 5 How to store EVICEL 6. Contents of the pack and other information 1. What EVICEL is and what it is used for EVICEL is a Human Fibrin Sealant which is supplied as a package containing two separate vials, each containing 1 ml, 2 ml or 5 ml of solution (Human Fibrinogen and Human Thrombin respectively). An application device and appropriate accessory tips are supplied separately. Fibrinogen is a concentrate of clottable protein and thrombin is an enzyme that causes clottable protein to coalesce. Thus, when the two components are mixed together they clot instantly. EVICEL is applied in adults during surgical operations to reduce bleeding and oozing during and after the operation. EVICEL can be used in blood vessel surgery and in surgery taking place on the posterior abdominal wall. EVICEL can also be used to support the watertight closure of the cerebral envelopes (dura mater) during neurosurgery when other surgical techniques are insufficient. It is dripped or sprayed onto cut tissue where it forms a thin layer that seals the tissue and/or stops bleeding. 2. What you need to know before you use EVICEL Do not use EVICEL If you are hypersensitive (allergic) to products made from human blood or to any of the other ingredients of EVICEL (listed in section 6). Signs of allergic reactions include hives, rash, tightness of the chest, wheezing, drop in b Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT EVICEL solutions for sealant 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredients are as follows: 1 ml vial 2 ml vial 5 ml vial Component 1 Human clottable protein containing mainly fibrinogen and fibronectin * 50 – 90 mg 100 – 180 mg 250 – 450 mg Component 2 Human thrombin 800 – 1,200 IU 1,600 – 2,400 IU 4,000 – 6,000 IU * Total quantity of protein is 80 - 120 mg/ml For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Solutions for sealant. Clear or slightly opalescent solutions. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications EVICEL is indicated in adults as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis (see section 5.1). EVICEL is also indicated in adults as suture support for haemostasis in vascular surgery and for suture line sealing in dura mater closure. 4.2 Posology and method of administration The use of EVICEL is restricted to experienced surgeons who have been trained in the use of EVICEL. Posology The volume of EVICEL to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient. The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application and the number of applications. Application of the product must be individualised by the treating physician. In controlled clinical trials in vascular surgery, the individual dosage used was up to 4 ml; for suture line sealing in dura mater closure, doses of up to 8 ml were used, whereas in retroperitoneal or intra-abdominal surgery the individual dosage used was up to 10 ml. However, for some procedures (e.g., liver traumata) larger volumes may be required. 3 The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the i Pročitajte cijeli dokument